JP2014023721A - Electrode catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an electrode catheter in which lead wires extending from a shaft proximal end portion to the inside of an operating handle are not damaged or broken when making contact with an edge of an opening rim of the shaft proximal end portion.SOLUTION: An electrode catheter includes a catheter shaft 10, an operating handle 20 having a connector 70, a tip electrode 31, ring-shaped electrodes 32-34, lead wires 41-44 connected to the tip electrode 31 and the ring-shaped electrodes 32-34 respectively, and a tension wire 50 fixed on the tip electrode 31. The catheter shaft 10 includes a shaft proximal end portion 11 made of a metallic tube, a shaft distal end portion 12 made of a resin tube, and a resin coating layer 13 covering outer peripheries of the shaft proximal end portion and the shaft distal end portion. A lead wire protective tube 61 made of a soft tube and a wire protective tube 62 made of a soft tube are inserted into the shaft proximal end portion 11.

Description

  The present invention relates to an electrode catheter.

An electrode catheter is known as a medical device used for diagnosing or treating cardiac arrhythmia.
As an electrode catheter for measuring a potential at a site such as a pulmonary vein of the heart, the present applicant has connected a catheter shaft, an operation handle connected to the proximal end side of the catheter shaft, and a distal end side of the catheter shaft. Proposing an electrode catheter comprising a catheter tip formed in a circular loop shape, a plurality of ring electrodes attached to the outer periphery of the catheter tip, and a tip electrode attached to the tip of the catheter tip (See Patent Document 1).

The catheter shaft (catheter body) constituting the electrode catheter described in Patent Document 1 includes a resin tube (first tube) having a relatively high rigidity and a flexible resin tube (second tube) having a relatively low rigidity. And a single lumen structure (an elongated tubular structure having one inner hole).
Here, a suitable outer diameter of the catheter shaft is set to 2.3 to 2.4 mm (see [0021]-[0025] of Patent Document 1).

  Thus, for example, when a plurality of (for example, two to three) electrode catheters are inserted into the heart through one sheath and the intracardiac potentials at a plurality of sites are simultaneously measured, these electrode catheters are used. It is desirable that the outer diameter of the catheter shaft that constitutes is smaller than the outer diameter that is suitable in Patent Document 1 (for example, 1.4 mm or less).

  On the other hand, the electrode catheter needs to be bent greatly at the distal end portion of the catheter shaft when changing the direction to select a blood vessel to reach the target site or pressing the electrode against the target site. The catheter shaft is required to have good kink resistance and torque transmission. The catheter shaft is also required to have good pushing characteristics.

  However, since the catheter shaft having a small outer diameter as described above has low rigidity, it does not have good kink resistance and torque transmission. A catheter shaft with a small outer diameter is also inferior in pushing characteristics.

On the other hand, Patent Document 2 below introduces an electrode catheter in which a shaft base end portion (proximal portion of the shaft) is configured by a stainless steel hypotube coated with Teflon (registered trademark).
By configuring the shaft base end portion with the hypotube, it is possible to provide a catheter shaft with good kink resistance, torque transmission, and push-in characteristics.

JP 2008-245767 A JP 2009-142640 A

(1) However, when the shaft proximal end portion of the electrode catheter is constituted by a metal tube such as a hypotube, a lead wire or a wire extending from the proximal end side opening of the catheter shaft (opening of the shaft proximal end portion) Contact (interference) with the edge at the opening edge of the shaft base end may cause damage or disconnection.
Such damage to the lead wire or the wire due to contact with the opening edge (edge) does not occur when the constituent material of the shaft base end portion is a resin, and this is the constituent material of the shaft base end portion. This is a new problem caused by the use of metals.

(2) At the time of manufacturing the electrode catheter (the step of attaching the operation handle to the catheter shaft), the shaft base end portion of the catheter shaft with a plurality of lead wires extending therein was inserted into the operation handle. Thereafter, the shaft base end and the operation handle are fixed with an adhesive.
However, in this step, an adhesive for adhering the shaft base end portion and the operation handle may adhere to a lead wire extending from the opening of the shaft base end portion.
In such a case, these lead wires are fixed to the shaft base end portion and cannot be moved in the axial direction, so that, for example, when the distal end of the catheter shaft is deflected, it acts on the lead wires. The lead wire may break due to the tensile force.
Furthermore, when the adhesive for bonding the shaft proximal end and the operation handle adheres to a pulling wire (a wire for deflecting the distal end of the catheter shaft) extending from the opening of the shaft proximal end The tension wire is fixed to the shaft base end portion and cannot move in the axial direction, and as a result, the catheter shaft distal end deflection operation cannot be performed.

The present invention has been made based on the above situation. The object of the present invention is that even when the outer diameter is small, the kink resistance, torque transmission and pushing characteristics of the catheter shaft are excellent, and the operability as a catheter is excellent. It is an object of the present invention to provide an electrode catheter in which a lead wire extending inside does not come into contact with an edge of an opening edge of a shaft proximal end portion and is not damaged or disconnected.
Another object of the present invention is that the adhesive for bonding the shaft base end portion and the operation handle does not adhere to the lead wire extending from the shaft base end portion in the manufacturing process. An object of the present invention is to provide an electrode catheter that can ensure axial movement of a lead wire with respect to an end portion.

Still another object of the present invention is that the wire for deflecting the distal end of the catheter shaft can be operated to deflect the distal end without being damaged or broken by contact with the edge of the opening edge of the proximal end of the shaft. It is to provide an electrode catheter.
Still another object of the present invention is to prevent the adhesive for adhering the shaft proximal end portion and the operation handle from adhering to the wire for deflecting the distal end of the catheter shaft in the manufacturing process. It is an object of the present invention to provide an electrode catheter capable of tip deflection operation that can ensure the movement (pulling operation) of the wire in the axial direction relative to the end.

(1) The electrode catheter of the present invention is a catheter shaft formed by connecting a shaft base end portion made of a metal tube and a shaft tip end portion made of a resin tube;
An operating handle connected to the proximal side of the catheter shaft;
A connector provided on the operation handle;
A tip electrode attached to the tip of the catheter shaft;
A lead wire connected to the tip electrode, extending in the axial direction inside the catheter shaft to reach the inside of the operation handle, and a lead wire connected to the connector at the rear end;
The distal end is fixed to the distal end portion of the distal end electrode or the catheter shaft, extends in the axial direction inside the catheter shaft, and the rear end is fixed to the proximal end portion of the operation handle or the catheter shaft. Wire
The shaft is attached by being inserted into the shaft base end portion, and the base end portion is formed of a soft tube extending from the opening of the shaft base end portion to the inside of the operation handle, and the lead is provided therein. And a lead wire protection tube through which the wire is inserted.

  According to the electrode catheter having such a configuration, since the shaft base end portion is made of a metal tube, the catheter shaft has better kink resistance, torque transmission performance, and push-in characteristics than a catheter shaft made only of a resin tube. Therefore, the operability as a catheter can be improved.

  In addition, the lead wire protection tube made of a soft tube is inserted into the shaft base end, and the base end portion of the lead wire protection tube extends from the opening of the shaft base end to the inside of the operation handle. The lead wire inserted in the lead wire protection tube (lead electrode lead wire) is extended from the lead wire protection tube opening to the inside of the operation handle without contacting the opening edge of the shaft base end. Therefore, the lead wire is not damaged or disconnected.

(2) In the electrode catheter of the present invention, at least one ring-shaped electrode attached to the distal end portion of the catheter shaft;
Each tip is connected to each of the tip electrode and the ring electrode, extends in the catheter shaft along the axial direction to the inside of the operation handle, and each rear end to the connector. A plurality of connected leads,
The shaft is attached by being inserted into the shaft base end portion, and the base end portion is formed of a soft tube extending from the opening of the shaft base end portion to the inside of the operation handle, and the plurality of the tubes are disposed therein. And a lead wire protective tube through which the lead wire is inserted.

  According to the electrode catheter having such a configuration, a plurality of lead wires inserted through the lead wire protection tube (lead electrodes of the tip electrode and the ring electrode) can be brought into contact with the opening edge of the shaft base end portion, Since it can be extended from the opening of the lead wire protection tube to the inside of the operation handle, these lead wires are not damaged or disconnected.

(3) In the electrode catheter of the present invention, the distal end of the catheter shaft can be deflected by pulling the rear end of the wire.
The shaft is attached by being inserted into the shaft base end portion, and the base end portion is composed of a soft tube extending from the opening of the shaft base end portion to the inside of the operation handle, and the wire is inserted therein. It is preferable to provide a wire protection tube into which the (tensile wire) is inserted.

  According to the electrode catheter having such a configuration, the wire protection tube made of a soft tube is inserted into the shaft base end portion, and the base end portion of the wire protection tube is inserted into the operation handle from the opening of the shaft base end portion. By extending, the wire inserted into the wire protection tube can be extended from the opening of the wire protection tube to the inside of the operation handle without contacting the opening edge of the shaft base end. The wire will not be damaged or disconnected.

(4) In the electrode catheter according to (3), each of the lead wire protection tube and the wire protection tube is connected to the shaft proximal end via a connection member for connecting the shaft proximal end portion and the operation handle. It is preferable to be fixed (position fixed) to the part.

  According to the electrode catheter having such a configuration, when the shaft base end portion and the connection member are fixed in the manufacturing process, a protection tube (lead wire protection tube) is connected to the shaft base end portion via the connection member. And wire protection tube) can be fixed.

(5) In the electrode catheter of the present invention, the rear end of the wire extending from the opening of the shaft base end is fixed to the outer peripheral side of the shaft base end,
It is preferable that the lead wire protection tube is fixed to the shaft base end portion by bonding the base end portion of the lead wire protection tube to the operation handle for fixing the shaft base end portion. .

According to such an electrode catheter, the rear end of the wire extending from the opening of the shaft proximal end is fixed to the outer peripheral side of the shaft proximal end, so that the opening edge of the shaft proximal end is Since the edge and the wire in contact with the edge do not rub against each other, the wire is not damaged or disconnected even if the wire is not protected by the soft tube.
In addition, the base end of the lead wire protection tube is bonded and fixed to the operation handle that fixes the shaft base end, so that the shaft base end and the lead wire protection tube are fixed via the operation handle. can do.

(6) In the electrode catheter of the above (1) or (2), it is preferable that the lead wire protection tube is made of a polyimide tube.

(7) In the electrode catheter capable of performing a tip deflection operation according to (3) or (4), it is preferable that the lead wire protection tube and the wire protection tube are made of a polyimide tube.

(8) In the electrode catheter of the present invention, it is preferable that a spiral slit is formed at least at the distal end portion of the metal tube constituting the shaft proximal end portion.

(9) In the electrode catheter of the present invention, it is preferable that the resin tube has a multi-lumen structure.

(10) In the electrode catheter of the present invention, the outer diameter of the catheter shaft is preferably 1.4 mm or less.
In such an electrode catheter having a catheter shaft with a small outer diameter, the configuration of the catheter shaft according to the present invention (connection structure of a shaft base end portion made of a metal tube and a shaft tip end portion made of a resin tube) is adopted. This is particularly effective.

The electrode catheter of the present invention has excellent kink resistance, torque transmission and push-in characteristics of the catheter shaft even when the outer diameter of the catheter shaft constituting the electrode catheter is small, and has excellent operability as a catheter. Yes.
Further, according to the electrode catheter of the present invention, the lead wire extending from the inside of the catheter shaft to the inside of the operation handle does not come into contact with the edge of the opening edge of the shaft base end portion and is not damaged or disconnected. .
Furthermore, in the manufacturing process, the adhesive for adhering the shaft base end portion and the operation handle does not adhere to the lead wire extending from the lead wire protective tube, and the lead wire to the shaft base end portion is not attached. Axial movement can be ensured.

In addition, according to the electrode catheter of (3) above, in order to deflect the distal end of the catheter shaft, the wire extending from the inside of the catheter shaft to the inside of the operation handle contacts the edge of the opening edge of the shaft base end portion. And will not be damaged or disconnected.
Further, in the manufacturing process, the adhesive for bonding the shaft base end portion and the operation handle does not adhere to the wire extending from the wire protection tube, and the wire in the axial direction with respect to the shaft base end portion Movement (tensile operation) can be secured.

It is a longitudinal cross-sectional view (partial top view) which shows the electrode catheter which concerns on one Embodiment of this invention. It is a longitudinal cross-sectional view (detailed cross-sectional view of the A section of FIG. 1) which shows the shaft base end part of the catheter shaft which comprises the electrode catheter shown in FIG. It is a longitudinal cross-sectional view (detailed cross-sectional view of the B section of FIG. 1) which shows the connection part of the shaft base end part of a catheter shaft which comprises the electrode catheter shown in FIG. 1, and a shaft front-end | tip part. It is a longitudinal cross-sectional view (detailed cross-sectional view of the C part of FIG. 1) which shows the shaft tip part of the catheter shaft which comprises the electrode catheter shown in FIG. FIG. 3 is a transverse sectional view (DD sectional view) of a shaft base end portion shown in FIG. 2. It is a cross-sectional view (EE sectional drawing) of the connection part shown in FIG. FIG. 5 is a transverse cross-sectional view (FF cross-sectional view) of the shaft tip portion shown in FIG. 4. FIG. 2 is a longitudinal sectional view showing a main part of the electrode catheter shown in FIG. 1 (connection portion between a catheter shaft and an operation handle). It is a perspective view which shows the state which the protection tube has extended from the shaft base end part of the electrode catheter shown in FIG. It is a longitudinal cross-sectional view for demonstrating the manufacturing method of the electrode catheter shown in FIG. It is a longitudinal cross-sectional view for demonstrating the manufacturing method of the electrode catheter shown in FIG. It is a longitudinal cross-sectional view (partial top view) which shows the electrode catheter which concerns on other embodiment of this invention. It is a longitudinal cross-sectional view (detailed cross-sectional view of the G section of FIG. 12) which shows the shaft base end part of the catheter shaft which comprises the electrode catheter shown in FIG. FIG. 13 is a longitudinal cross-sectional view (detailed cross-sectional view of a portion H in FIG. 12) showing a connecting portion between a shaft base end portion and a shaft distal end portion of a catheter shaft constituting the electrode catheter shown in FIG. 12. It is a cross-sectional view (II sectional drawing) of the connection part shown in FIG. FIG. 13 is a longitudinal cross-sectional view showing the main part of the electrode catheter shown in FIG. 12 (connection portion between the catheter shaft and the operation handle). FIG. 13 is a perspective view showing a state in which a protective tube and a wire are extended from a shaft base end portion of the electrode catheter shown in FIG. 12.

<First Embodiment>
The electrode catheter 100 of this embodiment shown in FIGS. 1-9 is used in order to measure the electric potential in parts, such as a pulmonary vein of a heart, for example.

  The electrode catheter 100 is attached to the catheter shaft 10, the operation handle 20 connected to the proximal end side of the catheter shaft 10, the connector 70 attached to the inside of the operation handle 20, and the distal end of the catheter shaft 10. The distal end of each of the distal electrode 31, the three ring electrodes 32, 33, 34 mounted on the outer periphery of the distal end portion of the catheter shaft 10, and the distal electrode 31 and the ring electrodes 32, 33, 34 are respectively provided. The four lead wires 41, 42, 43, 44 connected to the inside of the catheter shaft 10 along the axial direction reach the inside of the operation handle 20, and each rear end is connected to the connector 70. The distal end of the operating electrode 20 is fixed to the distal end electrode 31 and extends in the axial direction inside the catheter shaft 10. The catheter shaft 10 constituting the electrode catheter 100 is formed with a spiral slit 115 at the distal end portion, which is provided with a tension wire 50 that reaches the inside and has a rear end fixed to the rotary plate 23 of the operation handle 20. The shaft base end portion 11 made of a metal tube and the rear end region of the rear end portion inserted into the tip end region of the tip end portion of the shaft base end portion 11 are connected to the shaft base end portion 11. The outer periphery of the shaft distal end portion 12 made of a resin tube having a multi-lumen structure (the first multi-lumen tube 121 and the second multi-lumen tube 122) and the rear end portions of the shaft base end portion 11 and the shaft distal end portion 12 are covered. In this electrode catheter 100, a lead wire 41, a lead wire 42, And 3,44, and the puller wire 50 is extended in a different lumen of the resin tube constituting the shaft tip portion 12.

  Furthermore, the electrode catheter 100 is mounted by being inserted into the shaft base end portion 11, and the base end portion 611 extends from the opening of the shaft base end portion 11 into the operation handle 20. The lead wire protection tube 61, which is made of a tube and into which the lead wires 41, 42, 43, and 44 are inserted, is mounted by being inserted into the shaft base end portion 11, and the base end portion 621 thereof. Is composed of a soft tube extending from the opening of the shaft base end portion 11 to the inside of the operation handle 20, and a wire protection tube 62 into which the tension wire 50 is inserted.

The catheter shaft 10 constituting the electrode catheter 100 includes a shaft proximal end portion 11, a shaft distal end portion 12, and a resin coating layer 13.
The length (L ₁₀ ) of the catheter shaft 10 is usually 400 to 1500 mm, preferably 600 to 1200 mm, and 1000 mm if a suitable example is shown.

The outer diameter of the catheter shaft 10 is preferably 1.4 mm or less, and 0.65 mm as a suitable example. Even if such a catheter shaft having a small outer diameter is formed only by a resin tube, it does not have sufficient rigidity, so that it is particularly effective to employ the configuration of the shaft of this embodiment.
The inner diameter of the catheter shaft 10 is preferably 1 mm or less, and 0.55 mm as a suitable example.

As shown in FIGS. 1, 2, 3, 5, and 6, the shaft proximal end portion 11 of the catheter shaft 10 is made of a metal tube (hypotube) in which a spiral slit 115 is formed at the distal end portion. Become.
The metal tube constituting the shaft base end portion 11 has a single lumen structure, and examples of the metal constituting the shaft base end portion 11 include stainless steel, NiTi, β-titanium and the like.

  The shaft base end portion 11 made of a metal tube has a remarkably high rigidity as compared with the case where the shaft is composed of a resin tube. Therefore, even if the outer diameter of the shaft is small, excellent kink resistance, torque transmission property and indentation are achieved. The characteristic can be exhibited.

  A spiral slit 115 is formed at the distal end portion of the metal tube constituting the shaft base end portion 11. Since the slit 115 is a through slit extending from the outer peripheral surface to the inner peripheral surface of the metal tube, when the electrode catheter 100 is manufactured as described later, the width of the slit 115 can be expanded in the axial direction of the shaft. It is also possible to enlarge the outer diameter of the portion where the slit 115 is formed.

  By forming the spiral slit 115, the rigidity of the metal tube in the formation portion is reduced to some extent and flexibility is imparted, and as a result, the inherent high rigidity (excellent kink resistance and indentation characteristics) of the metal tube. And the shaft base end part 11 which has the softness | flexibility in a front-end | tip part can be comprised.

In the distal end portion of the metal tube constituting the shaft base end portion 11, the pitch of the spiral slits 115 is formed so as to continuously narrow toward the distal end direction.
Thereby, the rigidity of the front-end | tip part of the shaft base end part 11 can be reduced continuously (smooth) toward the front-end | tip direction, and the catheter shaft 10 excellent in kink resistance can be comprised.

The length (L ₁₁ ) of the shaft base end portion 11 is usually 300 to 1000 mm, preferably 400 to 950 mm, and 880 mm if a suitable example is shown.
The length (L ₁₁₅ ) of the tip portion of the metal tube in which the spiral slit 115 is formed is usually 40 to 200 mm, preferably 50 to 160 mm, and 130 mm if a suitable example is shown.
The width of the slit 115 (indicated by (W ₀ ) in FIG. 2 and FIG. 3) in the shaft base end portion 11 (portion that is not a connecting portion with the shaft front end portion 12) is usually 0.005 to 0.100 mm. A suitable example is 0.01 mm.
The method for forming the slit 115 in the metal tube is not particularly limited, and laser machining, electric discharge machining, chemical etching, cutting, or the like can be employed.

As shown in FIGS. 1, 3, 4, 6, and 7, the distal end portion 12 of the catheter shaft 10 is made of an insulating resin tube having a multi-lumen structure.
The resin tube constituting the shaft tip 12 is formed by fusing two multi-lumen tubes (first multi-lumen tube 121 and second multi-lumen tube 122) having different hardnesses.
In the present invention, the shaft tip may be composed of three or more multi-lumen tubes having different hardnesses.

  As shown in FIG. 6, the first multi-lumen tube 121 constituting the rear end portion of the shaft front end portion 12 has four lumens (first lumen 1231, second lumen 1232, third lumen 1233, fourth lumen 1234). ) Is formed. In the same figure, 125 is resin which comprises the 1st multi-lumen tube 121 by dividing the lumens 1231-1234.

  As shown in FIG. 7, the second multi-lumen tube 122 constituting the tip portion of the shaft tip portion 12 has four lumens (first lumen 1241, second lumen 1242, third lumen 1243, fourth lumen 1244). Is formed. In the same figure, 126 is resin which comprises the 2nd multi-lumen tube 122 by dividing the lumens 1241-1244.

  Examples of the resin (resin 125, resin 126) constituting the resin tube (first multi-lumen tube 121, second multi-lumen tube 122) include polyether block amide copolymer resin (PEBAX (registered trademark)). Can do.

  As shown in FIGS. 6 and 7, the first multi-lumen tube 121 and the second multi-lumen tube 122 have the same multi-lumen structure (cross-sectional shape). That is, each of the first lumen 1231, the second lumen 1232, the third lumen 1233, and the fourth lumen 1234 formed in the first multi-lumen tube 121 is a first lumen formed in the second multi-lumen tube 122. 1241, the second lumen 1242, the third lumen 1243, and the fourth lumen 1244 communicate with each other.

The constituent resin 125 of the first multi-lumen tube 121 has a higher hardness than the constituent resin 126 of the second multi-lumen tube 122.
Here, the hardness of the resin 125 (according to a D-type hardness meter) is 55D to 72D, and 68D is a preferable example. On the other hand, the hardness of the resin 126 is 25D to 50D, and is 40D if a suitable example is shown.

The length (L ₁₂ ) of the shaft tip 12 is usually 30 to 300 mm, preferably 50 to 200 mm, and 120 mm if a suitable example is shown.
Further, the length (L ₁₂₁ ) of the first multi-lumen tube 121 is usually 15 to 150 mm, preferably 25 to 100 mm, and 60 mm if a suitable example is shown.
Further, the length (L ₁₂₂ ) of the second multi-lumen tube 122 is usually 15 to 150 mm, preferably 25 to 100 mm, and 60 mm if a suitable example is shown.

Like the resin tube constituting the shaft tip portion 12, the resin tube having a multi-lumen structure has a higher proportion of resin constituting the tube than the resin tube having a single lumen structure.
Here, in the cross-sectional view of the shaft front end portion 12 as shown in FIGS. 6 and 7, resins (resin 125 and resin 126) constituting the resin tubes (first multi-lumen tube 121 and second multi-lumen tube 122). ) Is preferably 60% or more, and 66% is a preferable example.
Thus, according to the resin tube having a multi-lumen structure in which the resin occupies a high ratio, the shaft tip portion 12 having sufficiently high rigidity can be configured.

Further, the rigidity of the shaft distal end portion 12 (resin tube) is increased by adopting the multi-lumen structure, and the rigidity of the shaft base end portion 11 (metal tube) is somewhat lowered by forming the slit 115. Therefore, although the shaft base end portion 11 and the shaft distal end portion 12 are made of different materials, the rigidity of the catheter shaft 10 does not change extremely between them. The rigidity can be smoothly changed (decreased) toward the tip.
Thereby, when the distal end portion of the catheter shaft 100 is bent, it is possible to effectively prevent kinks from occurring due to stress concentration between the shaft proximal end portion 11 and the shaft distal end portion 12.

  As shown in FIG. 3, the shaft distal end portion 12 and the shaft proximal end portion 11 are such that the rear end region of the former (first multi-lumen tube 121) is inserted into the distal end region of the latter distal end portion. It is connected by being (fitted).

The rear end region of the rear end portion of the shaft front end portion 12 is inserted into the front end region of the front end portion of the shaft base end portion 11 and connected to each other, thereby forming the front end portion of the shaft base end portion 11. The width of the slit 115 is easily widened at the connecting portion (the tip region of the tip portion).
As shown in FIG. 3, the width (W ₁ ) of the slit 115 of the shaft base end portion 11 at the connecting portion with the shaft tip portion 12 (first multi-lumen tube 121) is the shaft base end portion at the portion that is not the connecting portion. 11 is actually wider than the width (W ₀ ) of the slit 115.
Here, the width (W ₁ ) of the slit 115 in the connecting portion is preferably 1.3 times or more the width (W ₀ ) of the slit 115 in the portion that is not the connecting portion. Doubled.

Thus, the width (W ₁ ) of the slit 115 of the shaft base end portion 11 at the connecting portion with the shaft tip portion 12 is sufficiently wider than the width (W ₀ ) of the slit 115 at the portion not connecting portion. The rigidity of the connecting portion is lower than the rigidity of the distal end portion of the shaft base end portion 11 (the portion where the width of the slit 115 is formed with the normal width (W ₀ )) and higher than the rigidity of the shaft distal end portion 12. In other words, the connecting portion can be an intermediate rigid portion, and as a result, the catheter shaft 10 can be configured such that the rigidity of the entire shaft decreases in an inclined manner toward the distal end.

In addition, the width (W ₁ ) of the slit 115 of the shaft base end portion 11 at the connecting portion with the shaft distal end portion 12 is sufficiently wider than the width (W ₀ ) of the slit 115 at the portion that is not the connecting portion. As a result of sufficiently reducing the rigidity of the connecting portion, it is possible to reliably prevent the occurrence of kinks between the connecting portion and the shaft tip portion 12.

  Furthermore, in this catheter shaft 10, a part of the resin (the constituent resin 125 of the first multi-lumen tube 121) that constitutes the shaft distal end portion 12 flows into the slit 115 at the connection portion with the shaft distal end portion 12. The resin 125 flowing into the slit 115 comes into contact with the resin coating layer 13 and is fused to the resin coating layer 13.

  As a result, the anchor effect (meshing effect) between the slit 115 of the shaft base end portion 11 and the constituent resin 125 of the shaft distal end portion 12 flowing into the slit 115, the resin 125 flowing into the slit 115, and the resin coating layer 13, the shaft base end portion 11 made of a metal tube and the shaft tip end portion 12 made of a resin tube can be firmly joined.

  By the way, as a dilatation catheter used for percutaneous coronary angioplasty (PTCA), a shaft proximal end portion made of a metal tube having a spiral slit and a shaft distal end portion made of a resin tube are connected to the shaft proximal end portion. There is an expansion catheter provided with a catheter shaft that is connected by inserting (fitting) the distal end portion into the inside of the distal end portion of the shaft.

Therefore, in an electrode catheter having a catheter shaft with a small outer diameter, a shaft base end portion made of a metal tube in which a helical slit is formed and a shaft tip end portion made of a resin tube, like the above-described expansion catheter, It is conceivable that a catheter shaft is formed by connecting (fitting).
According to such an electrode catheter, sufficiently high rigidity can be ensured at the shaft base end portion made of a metal tube.
However, even with such an electrode catheter, the rigidity of the distal end portion of the shaft made of the resin tube still remains low, and the kink resistance and the pushing property of the distal end portion of the shaft cannot be improved.
In addition, in order to obtain a catheter shaft with good kink resistance, it is important to change (decrease) the rigidity in an inclined manner toward the distal direction. However, a shaft base end made of a metal tube and a resin are important. Since the rigidity changes extremely between the tip portion of the shaft made of a tube, the stress at the time of bending is concentrated there and it becomes easy to kink.

Further, in the catheter shaft formed by inserting the distal end portion of the shaft proximal end portion into the inside of the shaft distal end portion and connecting them together, such as the above-described dilatation catheter, the connecting portion between the shaft proximal end portion and the shaft distal end portion ( The fitting part) is the most rigid part.
In addition to the fact that this connection portion makes it impossible to decrease the rigidity of the shaft in the direction of the tip, the kink is likely to occur between this connection portion and the shaft tip portion (the portion that is not the connection portion). Become.

  In addition, when a catheter shaft is configured from a shaft base end portion made of a metal tube and a shaft tip end portion made of a resin tube, such as the above-described dilatation catheter, the metal tube and the resin tube are joined with high strength. It is difficult.

As shown in FIGS. 2 and 3, the resin coating layer 13 constituting the catheter shaft 10 covers the outer periphery of the rear end portion of the shaft base end portion 11 and the shaft distal end portion 12.
The resin coating layer 13 is formed on the outer periphery over the entire length of the shaft base end portion 11 and the outer periphery of the rear end portion of the shaft distal end portion 12 (first multi-lumen tube 121). The film thickness of the resin coating layer 13 is, for example, 5 to 50 μm, preferably 10 to 30 μm.

The resin coating layer 13 is formed by shrinking the heat-shrinkable resin tube in a state where the rear end portions of the shaft base end portion 11 and the shaft front end portion 12 are inserted therein.
Examples of the heat-shrinkable resin tube for forming the resin coating layer 13 include polyether block amide copolymer resin (PEBAX (registered trademark)).

  Since the resin coating layer 13 that covers the outer periphery of the rear end portion of the shaft proximal end portion 11 and the shaft distal end portion 12 is formed to constitute the catheter shaft 10, the shaft proximal end portion is used when the electrode catheter 100 is used. 11 can be prevented from coming into contact with blood, and the liquid-tightness of the shaft base end portion 11 in which the slit 115 is formed can be ensured.

The heat-shrinkable resin that forms the heat-shrinkable resin tube that forms the resin coating layer 13 has a higher melting point than the resin that forms the shaft tip 12 (the resin 125 that forms the first multi-lumen tube 121). .
Thereby, in the electrode catheter manufacturing method (resin coating layer forming step) described later, the heat-shrinkable resin tube (shaft forming material) in a state where the rear end portions of the shaft base end portion 11 and the shaft front end portion 12 are inserted. ) Is heated at a temperature condition that is equal to or higher than the melting point of the resin resin (resin 125) of the resin tube that becomes the shaft tip 12 and lower than the melting point of the heat-shrinkable resin. This melted resin can be caused to flow into a slit 115 formed in the shaft base end portion 11 at a connection portion with the shaft tip end portion 12.

As shown in FIG. 1, an operation handle 20 is connected to the proximal end side of the catheter shaft 10.
The operation handle 20 constituting the electrode catheter 100 includes a handle main body 21 and a rotary plate 23 having a knob 22, and a connector 70 is mounted inside the operation handle 20.

A distal electrode 31 is fixed to the distal end of the catheter shaft 10.
Examples of the constituent material of the tip electrode 31 include metals having good thermal conductivity such as aluminum, copper, stainless steel, gold, platinum, etc. In order to have good contrast with respect to X-rays, platinum etc. It is preferable that it is comprised.
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 shaft 10.

Three ring-shaped electrodes 32, 33, and 34 are attached to the outer periphery of the distal end portion of the catheter shaft 10.
As a constituent material of the ring-shaped electrodes 32, 33, 34, the metal exemplified as the constituent of the tip electrode 31 can be cited.
The outer diameters of the ring-shaped electrodes 32, 33, and 34 are not particularly limited, but are preferably approximately the same as the outer diameter of the catheter shaft 10.

  Inside the catheter shaft 10, four lead wires 41, 42, 43, and 44 are connected along the axial direction, with the tips connected to the tip electrode 31 and the ring-shaped electrodes 32, 33, and 34, respectively. doing. In addition, inside the catheter shaft 10, a pulling wire 50 whose tip is connected to the inside of the tip electrode 31 extends along the axial direction.

As shown in FIGS. 6 and 7, the three lead wires 42, 43, 44 connected to each of the ring-shaped electrodes 32, 33, 34 are made of resin tubes (first multi-layers) constituting the shaft tip portion 12. The lumen tube 121 and the second multi-lumen tube 122) extend to the first lumen (lumen 1231 and lumen 1241).
The rear ends of each of the lead wires 42, 43, 44 are connected to a connector 70 mounted inside the operation handle 20, as shown in FIG.

  The lead wire 41 connected to the tip electrode 31 extends to the third lumen (lumen 1233 and lumen 1243) of the resin tube constituting the shaft tip portion 12, and the rear end of the lead wire 41 is Similarly to the lead wires 42, 43, 44, the lead wires 42, 43, 44 are connected to a connector 70 mounted inside the operation handle 20.

Further, the tension wire 50 fixed to the tip electrode 31 extends to the fourth lumen (lumen 1234 and lumen 1244) of the resin tube constituting the shaft tip portion 12.
The tip of the tension wire 50 is firmly fixed by solder filled in the tip electrode 31.
On the other hand, the rear end of the pulling wire 50 is fixed to the rotary plate 23 of the operation handle 20 as shown in FIG.
Accordingly, it is possible to reliably prevent the tip electrode 31 from falling off, and the rotating wire 23 is rotated, whereby the pulling wire 50 is pulled, whereby the tip portion of the catheter shaft 10 (the shaft tip portion 12). ) Can be bent and the tip can be deflected (swinged).
Here, examples of the constituent material of the pull wire 50 include metal materials such as stainless steel and Ni-Ti superelastic alloys, and high strength non-conductive materials.

  In this embodiment, the lead wire and the tension wire do not extend to the second lumen (lumen 1232 and lumen 1242) of the shaft tip portion 12.

  As described above, the three lead wires 42, 43, and 44 extend to the first lumen (1231, 1241), the lead wire 41 extends to the third lumen (1233, 1243), and the tension wire 50 is Since it extends to the fourth lumen (1234, 1244), interference (contact) between the lead wires 41, 42, 43, 44 and the tension wire 50 can be avoided at the shaft tip portion 12.

Furthermore, the tension wire 50 and the lead wires 41, 42, 43, 44 that extend to different lumens at the shaft distal end portion 12 and the lead base portions 11, as shown in FIG. It becomes difficult to contact (interference).
As a result, during the tip deflection operation of the electrode catheter 100 of this embodiment, the lead wires 41, 42, 43, 44 are damaged (for example, scratched) or broken due to interference with the pulling wire 50 that moves in the axial direction. Can be prevented.

As shown in FIG. 8, a hollow connection member 80 including a truncated cone-shaped base portion 81 and a cylindrical distal end portion 82 is fixed to the distal end portion of the operation handle 20.
The shaft base end portion 11 of the catheter shaft 10 is inserted into the distal end portion 82 of the connecting member 80, and the shaft base end portion 11 (insertion portion) is connected by an adhesive 90 filled inside the distal end portion 82. It is fixed to the member 80.
Thereby, the operation handle 20 can be connected to the proximal end side of the catheter shaft 10 (shaft proximal end portion 11).

  As shown in FIGS. 8 and 9, a lead wire protection tube 61 and a wire protection tube 62 are inserted into the shaft base end portion 11.

The lead wire protection tube 61 is made of a soft tube, and the base end portion 611 of the lead wire protection tube 61 extends from the opening of the shaft base end portion 11 to the inside of the operation handle 20 (outside of the shaft base end portion 11). .
Lead wires 41, 42, 43, 44 are inserted into the lead wire protection tube 61, and the lead wires 41, 42, 43, 44 pass through the inside of the operation handle 20 from the opening of the lead wire protection tube 61. It extends to the outside of the lead wire protection tube 61.

  The wire protection tube 62 is a soft tube, and the proximal end portion 621 of the wire protection tube 62 extends from the opening of the shaft proximal end portion 11 to the inside of the operation handle 20 (outside of the shaft proximal end portion 11). A tension wire 50 is inserted into the wire protection tube 62, and the tension wire 50 extends from the opening of the wire protection tube 62 to the inside of the operation handle 20 (outside of the wire protection tube 62).

Each of the lead wire protection tube 61 and the wire protection tube 62 is adhesively fixed (position fixed) to the shaft base end portion 11 via the connection member 80.
Accordingly, when the shaft base end portion 11 and the connection member 80 are bonded and fixed in the manufacturing process of the electrode catheter 100, the shaft base end portion 11, the lead wire protection tube 61, and the wire are connected via the connection member 80. The protective tube 62 can be fixed.

  Examples of the constituent material of the lead wire protection tube 61 and the wire protection tube 62 include polyimide resin, polyamide resin, and polyamideimide resin. Among these, the lead wire group can be easily inserted and thin molding is possible. A polyimide resin is particularly preferred.

The lengths of the lead wire protection tube 61 and the wire protection tube 62 are usually 5 to 500 mm, preferably 10 to 200 mm, and 30 mm if a suitable example is shown.
The length of the portion inserted into the shaft base end portion 11 is usually 10 to 400 mm, preferably 20 to 200 mm, and 25 mm if a suitable example is shown.

The outer diameter of the lead wire protection tube 61 is preferably 0.24 to 0.50 mm, and is 0.32 mm if a suitable example is shown. Moreover, it is preferable that it is 0.20-0.46 mm as the internal diameter, and will be 0.28 mm if a suitable example is shown.
Moreover, it is preferable that it is 0.16-0.28 mm as an outer diameter of the wire protection tube 62, and will be 0.22 mm if a suitable example is shown. Moreover, it is preferable that it is 0.14-0.24 mm as the internal diameter, and will be 0.18 mm if a suitable example is shown.

  The electrode catheter 100 of this embodiment can be suitably manufactured by a method including the following steps (1) to (5).

(1) As shown in FIG. 10 (FIG. 10A), a metal tube 110 having a spiral slit 115 formed at the tip portion is prepared.
An example of the metal tube 110 is a stainless steel having an outer diameter (D ₀ ) of 0.65 mm, an inner diameter (d ₀ ) of 0.55 mm, and a slit 115 having a width (W ₀ ) of 0.01 mm. Tubes can be used.

(2) As shown in FIG. 10 (FIG. 10B), the diameter of the tip region (region near the opening) of the tip portion of the metal tube 110 is increased, and the width of the slit 115 in the tip region is expanded. Here, the length of the tip region to be expanded is about 4 mm.
For example, the distal end region of the expanded metal tube 110 has an outer diameter (D ₁ ) of 0.76 mm and an inner diameter (d ₁ ) of 0.66 mm, and the width (W ₁ ) of the slit 115 is 0.05 mm [ (W ₁ / W ₀ ) = 5).

(3) As shown in FIG. 11 (FIG. 11A), the rear end portion of the resin tube 120 having a multi-lumen structure is inserted into the distal end region of the expanded metal tube 110 so that the metal tube 110 and the resin are The tube 120 is fitted.
Here, the outer diameter of the rear end portion of the resin tube 120 is such that it can be inserted into the tip region of the metal tube 110 and does not easily fall off after insertion (for example, about 0.65 mm). The rear end portion of the resin tube 120 may be cut as necessary so as to have such an outer diameter.

(4) As shown in FIG. 11 (FIG. 11B), the fitted metal tube 110 and the rear end portion of the resin tube 120 are inserted into the heat-shrinkable resin tube 130.
Here, the metal tube 110 is inserted into the heat-shrinkable resin tube 130 over its entire length.

(5) The shaft forming material in the state shown in FIG. 11B is heated at a temperature equal to or higher than the melting point of the resin constituting the resin tube 120 and lower than the melting point of the heat-shrinkable resin constituting the heat-shrinkable resin tube 130. Thus, the heat-shrinkable resin tube 130 is contracted.

When the heat-shrinkable resin tube 130 contracts, the tip region of the metal tube 110 (the fitting portion between the metal tube 110 and the resin tube 120) is crimped, and the tip region of the metal tube 110 has an outer diameter before diameter expansion. (D ₀ ) The diameter is reduced to the same level as that of (D ₀ ), the metal tube 110 and the resin tube 120 are connected, and the heat-shrinkable resin tube 130 is contracted to form the outer periphery of the metal tube 110 and the resin. It is formed on the outer periphery of the rear end portion of the tube 120.

At this time, in the fitting portion between the metal tube 110 and the resin tube 120, a part of the constituent resin of the resin tube 120 is melted and flows into the expanded slit 115 in the metal tube 110, and the melt that flows into the slit 115 The resin in the state comes into contact with the inner peripheral surface of the contracted heat-shrinkable resin tube 130 and is fused thereto. Thereby, the anchor effect (meshing effect) and the fusion effect described above can be exhibited.
The slit 115 in the tip region of the metal tube 110 (the connection portion with the resin tube 120) has a width (W ₁ ) expanded by the above step (2) due to the flow of the constituent resin of the resin tube 120. Is maintained.

  Through the above process, the catheter shaft 10 having the connecting portion as shown in FIG. 3, that is, the shaft base end portion 11 made of the metal tube (110) and the shaft tip end portion 12 made of the resin tube (120) Are connected by inserting the rear end region of the rear end portion of the shaft front end portion 12 into the front end region of the front end portion of the shaft base end portion 11, and the rear end of the shaft base end portion 11 and the shaft front end portion 12. The catheter shaft 10 in which the outer periphery of the end portion is covered with the resin coating 13 formed by shrinking the heat-shrinkable resin tube (130) can be manufactured.

According to the electrode catheter 100 of this embodiment, even when the outer diameter of the catheter shaft 10 constituting the electrode catheter 100 is small, the entire shaft including the shaft distal end portion 12 has sufficiently high rigidity and is good as a whole. Excellent kink resistance and indentation characteristics.
Further, the catheter shaft 10 has a shaft base end portion 11 made of a metal tube and a shaft tip end portion 12 made of a resin tube, but between the shaft base end portion 11 and the shaft tip end portion 12. The rigidity does not change drastically, thereby preventing the occurrence of kinks between the shaft base end portion 11 and the shaft tip end portion 12.
Further, since a part of the constituent resin 125 of the shaft distal end portion 12 flows into the slit 115 of the shaft proximal end portion 11 at the connecting portion with the shaft distal end portion 12, the shaft distal end portion 12 and the shaft made of different materials are mixed. The proximal end portion 11 can be firmly joined.
In addition, when (W ₁ / W ₀ ) is 1.3 or more, the connecting portion between the shaft base end portion 11 and the shaft tip end portion 12 can be an intermediate rigid portion, and thereby, the portion toward the tip end can be directed. Thus, it is possible to configure the catheter shaft 10 whose rigidity gradually decreases, and to reliably prevent the occurrence of kinks between the connecting portion and the shaft distal end portion 12.
Further, it is possible to avoid interference between the lead wires 41, 42, 43, and 44 extending inside the catheter shaft 10 and the pulling wire 50, and the lead wire is caused by the interference with the pulling wire 50. It can be prevented from being damaged or disconnected.

Lead wires 41, 42, 43, 44 extending inside the catheter shaft 10 pass through the inside of the lead wire protection tube 61 made of a soft tube, and pass through the inside of the operation handle 20 from the opening of the lead wire protection tube 61. By extending to the upper end, the lead wire 41, 42, 43, 44 is not damaged or disconnected because it does not come into contact with the opening edge of the shaft base end portion 11 made of a metal tube.
Furthermore, the tension wire 50 extending inside the catheter shaft 10 also passes through the inside of the wire protection tube 62 made of a soft tube and extends from the opening of the wire protection tube 62 to the inside of the operation handle 20. Since there is no contact with the opening edge of the shaft base end portion 11 made of a metal tube, the pulling wire 50 is not damaged or disconnected.

Second Embodiment
An electrode catheter 150 shown in FIGS. 12 to 15 is used for measuring a potential at a site such as a pulmonary vein of a heart, and is connected to a catheter shaft 15 and a proximal end side of the catheter shaft 15. An operation handle 25, a connector (not shown) mounted inside the operation handle 25, a tip electrode 31 mounted on the distal end of the catheter shaft 15, and seven mounted on the outer periphery of the distal end portion of the catheter shaft 15. Ring-shaped electrodes 32, 33, 34, 35, 36, 37, and 38, the tip electrode 31, and the ring-shaped electrodes 32 to 38 are respectively connected to the distal ends, and are axially provided inside the catheter shaft 15. Eight lead wires 41, 42, 43, 44, 45, 46, 47, 48 that extend and have respective rear ends connected to the connector The distal end of the distal end electrode 31 is fixed to the distal end of the catheter shaft 15. The distal end of the distal end 31 extends along the axial direction of the catheter shaft 15, and the rear end of the core wire 55 is secured to the proximal end portion of the catheter shaft 15. The catheter shaft 15 constituting the electrode catheter 150 includes a shaft proximal end portion 16 made of a metal tube having a spiral slit 165 formed at the distal end portion, and a distal end region of the distal end portion of the shaft proximal end portion 16 and thereafter By inserting the rear end region of the end portion, the shaft distal end portion made of a resin tube having a multi-lumen structure (the first multi-lumen tube 171 and the second multi-lumen tube 172) connected to the shaft base end portion 16 17 and a resin coating covering the outer periphery of the rear end portion of the shaft base end portion 16 and the shaft distal end portion 17 In this electrode catheter 150, the lead wire 41, the lead wires 42, 43, 44, the lead wires 45, 46, 47, 48, and the core wire 55 constitute the shaft tip portion 17. Has been extended to different lumens.

The electrode catheter 150 is mounted by being inserted into the shaft base end portion 16, and the base end portion 651 extends from the opening of the shaft base end portion 16 into the operation handle 25. The lead wire protection tube 65 which consists of a soft tube and in which the lead wires 41-48 are penetrated is provided.
Further, in this electrode catheter 150, the core wire 55 extending from the opening of the shaft proximal end portion 16 is folded back in the distal direction, and the rear end of the core wire 55 is disposed on the outer peripheral side of the shaft proximal end portion 16 (the resin coating layer 18). The outer peripheral surface is fixed.

The catheter shaft 15 constituting the electrode catheter 150 includes a shaft base end portion 16, a shaft distal end portion 17, and a resin coating layer 18.
The length (L ₁₅ ) of the catheter shaft 15 is usually 600 to 1700 mm, preferably 700 to 1500 mm, and 1300 mm if a suitable example is shown.
The outer diameter of the catheter shaft 15 is preferably 1.4 mm or less, and 0.65 mm as a suitable example.
The inner diameter of the catheter shaft 15 is preferably 1 mm or less, and 0.55 mm as a suitable example.

  The shaft base end portion 16 of the catheter shaft 15 is made of a metal tube having a spiral slit 165 formed at the tip portion, and has substantially the same configuration as the shaft base end portion 11 according to the first embodiment. The same effects as the base end portion 11 are achieved.

The length (L ₁₆ ) of the shaft base end portion 16 is usually 500 to 1500 mm, preferably 600 to 1200 mm, and 1030 mm if a suitable example is shown.
The length (L ₁₆₅ ) of the tip of the metal tube in which the spiral slit 165 is formed is usually 50 to 200 mm, preferably 100 to 150 mm, and 130 mm if a suitable example is shown.

  As shown in FIGS. 12, 14, and 15, the shaft tip portion 17 of the catheter shaft 15 is made of an insulating resin tube having a multi-lumen structure, and has the same configuration as the shaft tip portion 12 according to the first embodiment. Thus, the same effects as the shaft tip 12 can be obtained.

  The resin tube constituting the shaft tip portion 17 is formed by fusing two multi-lumen tubes (first multi-lumen tube 171 and second multi-lumen tube 172) having different hardnesses.

  As shown in FIG. 15, the first multi-lumen tube 171 constituting the rear end portion of the shaft front end portion 17 has four lumens (a first lumen 1731, a second lumen 1732, a third lumen 1733, and a fourth lumen 1734). ) Is formed. In the figure, reference numeral 175 denotes a resin constituting the first multi-lumen tube 171 by partitioning lumens 1731 to 1734.

  The second multi-lumen tube 172 constituting the tip portion of the shaft tip portion 17 has the same multi-lumen structure (cross-sectional shape) as the first multi-lumen tube 171.

The length (L ₁₇ ) of the shaft tip portion 17 is usually 100 to 400 mm, preferably 150 to 300 mm, and 270 mm if a suitable example is shown.
In addition, the length (L ₁₇₁ ) of the first multi-lumen tube 171 is usually 80 to 300 mm, preferably 100 to 250 mm, and 220 mm if a suitable example is shown. The length (L ₁₇₂ ) of the second multi-lumen tube 172 is normally 15 to 80 mm, preferably 20 to 60 mm, and 50 mm if a suitable example is shown.

  As shown in FIG. 14, the shaft distal end portion 17 and the shaft proximal end portion 16 are configured such that the rear end region of the former (first multi-lumen tube 171) is inserted inside the distal end region of the latter distal end portion. It is connected by being (fitted).

  Further, in this catheter shaft 15, a part of the resin constituting the shaft distal end portion 17 (the constituent resin 175 of the first multi-lumen tube 171) flows into the slit 165 at the connection portion with the shaft distal end portion 17. The resin 175 flowing into the slit 165 is in contact with the resin coating layer 18 and is fused to the resin coating layer 18.

As shown in FIGS. 14 and 15, the resin coating layer 18 constituting the catheter shaft 15 covers the outer periphery of the rear end portion of the shaft proximal end portion 16 and the shaft distal end portion 17.
The resin coating layer 18 is formed on the outer periphery over the entire length of the shaft base end portion 16 and on the outer periphery of the rear end portion of the shaft distal end portion 17 (first multi-lumen tube 171). The resin coating layer 18 has the same configuration as that of the resin coating layer 13 according to the first embodiment, and has the same effects as the resin coating layer 13.

  As shown in FIG. 12, the catheter shaft 15 constituting the electrode catheter 150 is linear, but the shaft distal end portion 17 in a state where no external force is applied may have a specific curved shape. A catheter shaft having (remembering) such a curve shape is easily deformed by applying an external force (for example, passing the catheter shaft through the sheath), but when the external force is removed, the memorized curve shape Can be restored.

An operation handle 25 is connected to the proximal end side of the catheter shaft 15.
The operation handle 25 is a handle for rotating the catheter shaft 15 about its axis. A connector (not shown in FIG. 12) is mounted inside the operation handle 25.

A distal electrode 31 is fixed to the distal end of the catheter shaft 15.
Seven ring-shaped electrodes 32, 33, 34, 35, 36, 37, and 38 are attached to the outer periphery of the distal end portion of the catheter shaft 15.

  Within the catheter shaft 15, eight lead wires each having a tip connected to each of the tip electrode 31 and the ring-shaped electrodes 32 to 38 extend along the axial direction. A core wire 55 whose tip is connected to the tip electrode 31 extends in the axial direction inside the catheter shaft 15.

As shown in FIG. 15, the three lead wires 42, 43, 44 connected to each of the ring-shaped electrodes 32, 33, 34 are the first lumen (the first lumen) of the resin tube constituting the shaft tip 17. The first lumen 1731 of the multi-lumen tube 171 and the first lumen of the second multi-lumen tube 172 communicating with the first lumen 1731 are extended.
The rear ends of each of the lead wires 42, 43, 44 are connected to a connector mounted inside the operation handle 25.

Further, the lead wires 45, 46, 47, 48 connected to the ring-shaped electrodes 35, 36, 37, 38 are the second lumen of the resin tube (the first multi-lumen tube 171 of the first multi-lumen tube 171) constituting the shaft tip portion 17. 2 lumen 1732 and the second lumen of the second multi-lumen tube 172 communicating therewith).
The rear ends of each of the lead wires 45, 46, 47, 48 are connected to a connector mounted inside the operation handle 25, similarly to the lead wires 42, 43, 44.

  The lead wire 41 connected to the tip electrode 31 is a third lumen of the resin tube constituting the shaft tip portion 17 (a third lumen 1733 of the first multi-lumen tube 171 and a second multi-lumen communicating with the third lumen. The third lumen of the tube 172. Similar to the lead wires 42 to 48, the rear end of the lead wire 41 is connected to a connector mounted inside the operation handle 25.

The core wire 55 fixed to the tip electrode 31 is a fourth lumen of a resin tube constituting the shaft tip portion 17 (a fourth lumen 1734 of the first multi-lumen tube 171 and a second multi-lumen tube communicating with the fourth lumen. 172, the fourth lumen), further extends into the metal tube constituting the shaft base end portion 16, and extends from the opening of the shaft base end portion 16 into the operation handle 25.
The tip of the core wire 55 is firmly fixed by solder filled in the tip electrode 31. On the other hand, the rear end of the core wire 55 is fixed to the outer peripheral side of the proximal end portion of the shaft proximal end portion 16 of the catheter shaft 15 as described later.
Thereby, it is possible to reliably prevent the tip electrode 31 from falling off.

  The electrode catheter 150 of this embodiment is not one that pulls the core wire 55 and deflects the tip of the catheter shaft 15 (catheter that can be operated for tip deflection), but even if it is an electrode catheter that does not perform tip deflection operation, Since the shaft shape changes according to the shape of the blood vessel (sheath), a means for preventing the interference between the core wire 55 and the lead wires 41 to 48 is required.

In this embodiment, the lead wires 42, 43, 44 extend to the first lumen, the lead wires 45, 46, 47, 48 extend to the second lumen, and the lead wire 41 extends to the third lumen. Since the core wire 55 extends to the fourth lumen, interference between the lead wires 41 to 48 and the core wire 55 at the shaft tip portion 17 can be avoided.
Further, the core wire 55 extended to different lumens at the shaft distal end portion 17 and the lead wires 41 to 48 are separated from each other even within the shaft proximal end portion 16 and hardly contact (interfere). As a result, it is possible to prevent the lead wires 41 to 48 from being damaged or disconnected due to interference with the core wire 55.

As shown in FIG. 16, the shaft base end portion 16 of the catheter shaft 15 is inserted into the distal end side of the operation handle 25, and this shaft base end portion 16 (insertion portion) is tightened by the tightening member 251. The operation handle 25 is fixed.
Thereby, the operation handle 25 can be connected to the proximal end side of the catheter shaft 15 (shaft proximal end portion 16).

As shown in FIGS. 16 and 17, a lead wire protection tube 65 is inserted into the shaft base end portion 16.
The lead wire protection tube 65 is composed of a soft tube, and the base end portion 651 of the lead wire protection tube 65 extends from the opening of the shaft base end portion 16 to the inside of the operation handle 25 (outside of the shaft base end portion 16). Yes.

The lead wires 41 to 48 are inserted into the lead wire protection tube 65, and the lead wires 41 to 48 pass from the opening of the lead wire protection tube 65 to the inside of the operation handle 25 (outside of the lead wire protection tube 65). It is extended.
The rear ends of the lead wires 41 to 48 extending to the inside of the operation handle 25 are connected to the connector 75, and around the connection portion between the rear ends of the lead wires 41 to 48 and the connector 75 (connector pin). An adhesive layer 95 is formed.
Further, the base end portion 651 of the lead wire protection tube 65 extending into the operation handle 25 is embedded in the adhesive layer 95, and the connector 75 (the operation handle 25 is connected to the rear ends of the lead wires 41 to 48). ).
As described above, the base end portion 651 of the lead wire protection tube 65 is bonded and fixed to the operation handle 25 for fastening and fixing the shaft base end portion 16, so that the lead wire protection tube 65 is connected via the operation handle 25. Can be fixed (position fixed) to the shaft base end portion 16.

  As a constituent material of the lead wire protection tube 65, the same resin as the lead wire protection tube 61 of the first embodiment can be exemplified, and a polyimide resin is particularly preferable.

The length of the lead wire protection tube 65 is normally 5 to 500 mm, preferably 10 to 200 mm, and 30 mm if a suitable example is shown.
The length of the portion inserted into the shaft base end portion 16 is usually 10 to 400 mm, preferably 20 to 200 mm, and 25 mm if a suitable example is shown.
Moreover, it is preferable that it is 0.36-0.80 mm as an outer diameter of the lead wire protection tube 65, and if it shows a suitable example, it is 0.40 mm. Moreover, it is preferable that it is 0.32-0.76 mm as the internal diameter, and it will be 0.36 mm if a suitable example is shown.

  On the other hand, the core wire 55 extending into the operation handle 25 from the opening of the catheter shaft 15 (shaft base end portion 16) is folded back toward the distal end at the opening of the shaft base end portion 16, and is formed on the outer periphery of the shaft base end portion 16. The rear end of the core wire 55 is fixed to the outer peripheral side of the shaft base end portion 16 (the outer peripheral surface of the resin coating layer 18 that covers the outer periphery of the shaft base end portion 16). As a result, the edge of the opening edge of the shaft base end portion 16 and the core wire 55 do not rub against each other even if they are in contact with each other. Therefore, the core wire 55 may be damaged or disconnected even if it is not protected by the soft tube. Can be prevented.

  The resin coating layer 19 is formed on a part of the outer circumferential surface of the resin coating layer 18 that covers the shaft base end portion 16 (at least the outer circumferential surface on which the core wire 55 that is folded back and extends in the distal direction is located). The resin coating layer 19 can be formed by shrinking a heat-shrinkable resin tube.

According to the electrode catheter 150 of this embodiment, even when the outer diameter of the catheter shaft 15 constituting the electrode catheter 150 is small, the entire shaft including the shaft distal end portion 17 has sufficiently high rigidity and is good as a whole. Excellent kink resistance and indentation characteristics.
Further, the rigidity does not change extremely between the shaft base end portion 16 and the shaft front end portion 17, thereby preventing the occurrence of kinks between the shaft base end portion 16 and the shaft front end portion 17. be able to.
Further, since a part of the constituent resin 175 of the shaft distal end portion 17 flows into the slit 165 of the shaft proximal end portion 16 at the connecting portion with the shaft distal end portion 17, the shaft distal end portion 17 and the shaft made of different materials are flown. The base end portion 16 can be firmly joined.
Furthermore, the lead wires 41 to 48 extending to the inside of the catheter shaft 15 pass through the inside of the lead wire protecting tube 65 made of a soft tube, and extend from the opening of the lead wire protecting tube 65 to the inside of the operation handle 25. Therefore, the lead wires 41 to 48 are not damaged or disconnected because they do not contact the opening edge of the shaft base end portion 11 made of a metal tube.

DESCRIPTION OF SYMBOLS 100 Electrode catheter 10 Catheter shaft 11 Shaft base end part 110 Metal tube 115 Slit 12 Shaft tip part 120 Resin tube 121 1st multi-lumen tube 122 2nd multi-lumen tube 1231, 1241 1st lumen 1232, 1242 2nd lumen 1233, 1243 3rd lumen 1234, 1244 4th lumen 125, 126 Constitution resin of multi-lumen tube 13 Resin coating layer 130 Heat-shrinkable resin tube 20 Operation handle 21 Handle body 22 Knob 23 Rotating plate 31 Tip electrode 32-34 Ring-shaped electrode 41- 44 Lead wire 23 Rotating plate 50 Tension wire 61 Lead wire protection tube 62 Wire protection tube 70 Connector 80 Connection member 90 Adhesive 150 Electrode catheter 5 catheter shaft 16 shaft proximal end 165 the slits 17 the shaft distal portion 171 first multi-lumen tube 171
172 Second multi-lumen tube 172
1731 1st lumen 1732 2nd lumen 1732
1733 3rd lumen 1733
1734 4th lumen 1734
175 Composition resin of multi-lumen tube 18 Resin coating layer 19 Resin coating layer 25 Operation handle 35-38 Ring electrode 45-48 Lead wire 55 Core wire 65 Lead wire protection tube 75 Connector 95 Adhesive layer

Claims (10)

A catheter shaft formed by connecting a shaft base end portion made of a metal tube and a shaft tip end portion made of a resin tube;
An operating handle connected to the proximal side of the catheter shaft;
A connector provided on the operation handle;
A tip electrode attached to the tip of the catheter shaft;
A lead wire connected to the tip electrode, extending in the axial direction inside the catheter shaft to reach the inside of the operation handle, and a lead wire connected to the connector at the rear end;
The distal end is fixed to the distal end portion of the distal end electrode or the catheter shaft, extends in the axial direction inside the catheter shaft, and the rear end is fixed to the proximal end portion of the operation handle or the catheter shaft. The wire being
The shaft is attached by being inserted into the shaft base end portion, and the base end portion is formed of a soft tube extending from the opening of the shaft base end portion to the inside of the operation handle, and the lead is provided therein. An electrode catheter comprising: a lead wire protection tube through which a wire is inserted. At least one ring electrode attached to the distal end portion of the catheter shaft;
Each tip is connected to each of the tip electrode and the ring electrode, extends in the catheter shaft along the axial direction to the inside of the operation handle, and each rear end to the connector. A plurality of connected leads,
The shaft is attached by being inserted into the shaft base end portion, and the base end portion is formed of a soft tube extending from the opening of the shaft base end portion to the inside of the operation handle, and the plurality of the tubes are disposed therein. The electrode catheter according to claim 1, further comprising: a lead wire protection tube through which the lead wire is inserted. The tip of the catheter shaft can be deflected by pulling the rear end of the wire,
The shaft is attached by being inserted into the shaft base end portion, and the base end portion is composed of a soft tube extending from the opening of the shaft base end portion to the inside of the operation handle, and the wire is inserted therein. The electrode catheter according to claim 1, further comprising a wire protection tube through which is inserted.   The lead wire protection tube and the wire protection tube are each fixed to the shaft base end portion via a connecting member for connecting the shaft base end portion and the operation handle. Item 4. The electrode catheter according to Item 3. The rear end of the wire extending from the opening of the shaft base end is fixed to the outer peripheral side of the shaft base end,
The lead wire protection tube is fixed to the shaft base end portion by bonding the base end portion of the lead wire protection tube to the operation handle for fixing the shaft base end portion. The electrode catheter according to claim 1 or 2.   The electrode catheter according to claim 1, wherein the lead wire protection tube is made of a polyimide tube. The electrode catheter according to claim 3 or 4, wherein the lead wire protection tube and the wire protection tube are made of a polyimide tube.   The electrode catheter according to any one of claims 1 to 7, wherein a spiral slit is formed at least at a distal end portion of the metal tube constituting the shaft base end portion.   The electrode catheter according to claim 1, wherein the resin tube has a multi-lumen structure.   The electrode catheter according to any one of claims 1 to 9, wherein an outer diameter of the catheter shaft is 1.4 mm or less.

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