JP2015188569A - Tip-deflectable steerable catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a tip-deflectable steerable catheter preventing a shaft part at a rear end side from being bent even by pulling operations of operation wires in the catheter having no anti-compression member disposed at the shaft part at the rear end side of a tip flexible portion.SOLUTION: The catheter includes: a catheter shaft 100 of a multilumen structure having a tip flexible portion 10A; and operation wires 61 and 62 that are inserted into lumens of the catheter shaft 100 for bending the tip flexible portion 10A and, the rear end of which is pullingly operable. At the shaft part in the rear end side of the tip flexible portion 10A, lumens 21 and 22 of the catheter shaft 100 in which the operation wires 61 and 62 are inserted are spirally formed so as to rotate about a central axis of the catheter shaft 100.

Description

  The present invention relates to a catheter capable of operating a tip deflection, and more specifically, by operating an operation portion arranged outside the body, the tip flexible portion of the catheter inserted into the body cavity is bent and the direction of the tip is changed. The present invention relates to a tip deflection operable catheter.

  For example, in the case of an electrode catheter inserted into the heart through an arterial blood vessel, the orientation of the distal end (distal end) of the catheter inserted into the heart is set to the rear end (proximal end or It is necessary to change (deflection) by operating the operation unit attached to the hand side.

  A multi-lumen tube that forms the tip flexible portion, a single-lumen tube connected to the rear end side of the multi-lumen tube, and a single-lumen tube as a catheter capable of deflecting the tip by pulling on the proximal side to deflect the tip. A coil tube (inner cylinder) that is an anti-compressible member placed in the lumen of the tube (outer cylinder) and a single lumen tube between the multi-lumen tube and the coil tube, and the outer circumference side of the multi-lumen tube A coil stopper (intermediate member) in which a communication path between the lumen located in the tube and the lumen of the coil tube is formed, and a lumen and coil stopper located on the outer peripheral side of the multi-lumen tube in order to bend the tip flexible part. Inserted through the lumen of the connected communication path and coil tube. Comprising an operation wire rear is possible tensile operated catheters have been proposed by the applicant (see Patent Document 1 below).

According to such a catheter, the distal end flexible portion can be deflected by a pulling operation of the operation wire.
Further, the shaft portion on the rear end side from the distal end flexible portion is given good anti-compressibility by the coil tube, and the operation wire in the shaft portion on the rear end side is inserted into the lumen of the coil tube so that the catheter By extending in the vicinity of the central axis, linearity is maintained without being bent even by a pulling operation of the operation wire.

  The applicant also has a catheter shaft having a distal flexible portion, a distal electrode fixed to the distal end of the catheter shaft, and an extension of the distal end of the catheter shaft to bend the distal flexible portion. Is a catheter having an operation wire that can be pulled, and the catheter shaft is connected to the first multi-lumen tube constituting the distal end flexible portion and the rear end side of the first multi-lumen tube A single lumen tube, a coil tube which is an anti-compressible member disposed in the lumen of the single lumen tube, and a second multi-lumen tube disposed in the lumen of the coil tube, and the operation wire is a first multi-lumen tube. Tip deflection operation inserted through the lumen of each of the lumen tube and the second multi-lumen tube Proposes capacity catheter (see Patent Document 2 below).

According to such a tip deflection operable catheter, the tip flexible portion can be deflected by pulling the manipulation wire.
Further, the shaft portion on the rear end side with respect to the distal end flexible portion is imparted with a good anti-compression property by the coil tube, so that the linearity is maintained without being bent.
Furthermore, because the multi-lumen tube (second multi-lumen tube) is arranged in the lumen of the coil tube, the tip flexible part is intended by pulling the operation wire regardless of the shape of the shaft part on the rear end side. The bent shape can be obtained.

Japanese Patent No. 4679668 JP2013-123508A

  However, in the catheter capable of tip deflection operation, as described in Patent Document 1 and Patent Document 2 described above, in which the coil tube is arranged in the lumen of the shaft portion on the rear end side, the coil shaft can be used for the catheter shaft. A sufficient internal space (space) cannot be secured, and therefore, a required number of conducting wires cannot be inserted into the shaft, or the diameter of the catheter cannot be reduced.

  In addition, the wire rods constituting the coil tube may be displaced in the radial direction of the shaft. In such a case, the single lumen tube containing the coil tube is spread outward and the rear end The shaft part on the side will be deformed.

Further, it is conceivable that a lead wire or an operation wire inserted through the lumen of the catheter shaft is damaged by coming into contact with the edge of the coil tube.
In addition, the number of parts such as a coil stopper (see Patent Document 2) increases, and the coil tube processing (such as chamfering after material cutting) and mounting work become complicated, which is not preferable from the viewpoint of manufacturing efficiency.

  For this reason, the development of a catheter capable of distal deflection operation that does not bend the shaft portion on the rear end side due to the pulling operation of the operation wire without arranging the coil tube as an anti-compressible member on the shaft portion on the rear end side. That is, development of an alternative structure for the coil tube has been strongly desired.

The present invention has been made based on the above situation.
An object of the present invention is a catheter in which a coil tube which is an anti-compressible member is not disposed on a shaft portion on the rear end side of a distal end flexible portion, and the distal end flexible portion is bent by a pulling operation of an operation wire. It is another object of the present invention to provide a catheter capable of tip deflection operation which can prevent the shaft portion on the rear end side from bending with respect to the tip flexible portion.

  As a result of extensive studies by the inventor in order to achieve the above object, the bending of the shaft portion on the rear end side causes the operation wire to be biased in the same direction (diameter direction of the shaft) over the entire shaft portion. This is because the shaft portion on the rear end side continuously changes the eccentric direction (eccentric position) of the operation wire along the tube axis direction, so that the shaft portion on the rear end side is not bent. The present invention has been completed based on this finding.

(1) That is, the distal deflection operable catheter of the present invention is inserted into the lumen of the catheter shaft in order to deflect the distal flexible portion, and the multi-lumen structure catheter shaft having the flexible distal portion. A catheter comprising an operation wire having an end capable of being pulled;
The lumen of the catheter shaft through which the operation wire is inserted is formed in a spiral shape that rotates at least once around the central axis of the catheter shaft in a shaft portion on the rear end side of the distal end flexible portion. It is characterized by being.

  According to the distal deflection operable catheter having such a configuration, the operation wire on the rear end side from the distal flexible portion extends to the lumen of the catheter shaft while changing the eccentric direction along the tube axis direction. Therefore, it is possible to prevent the shaft portion on the rear end side from bending with respect to the tip flexible portion from being bent.

(2) In the catheter capable of tip deflection operation according to the present invention, the catheter shaft includes a first multi-lumen tube constituting the tip flexible portion, and a single lumen tube connected to a rear end of the first multi-lumen tube. A second multi-lumen tube disposed in the lumen of the single lumen tube,
The single lumen tube has higher rigidity than any of the first multi-lumen tube and the second multi-lumen tube,
It is preferable that the lumen of the second multi-lumen tube into which the operation wire is inserted is formed in a spiral shape that rotates at least once around the central axis of the catheter shaft.

According to the distal deflection operable catheter having such a configuration, the manipulation wire on the rear end side of the distal flexible portion changes the eccentric direction along the tube axis direction while changing the lumen direction of the second multi-lumen tube (that is, , The rear end side shaft portion can be prevented from being bent more than the front end flexible portion.
In addition, since the second multi-lumen tube is disposed in the lumen of the single lumen tube having high rigidity, even if the second multi-lumen tube is distorted during molding processing, it is covered with the single lumen tube. This can be corrected.

(3) In the catheter capable of distal deflection operation according to (2), the lumen of the second multi-lumen tube in which the length of the second multi-lumen tube is 500 mm or more and the operation wire is inserted is The central axis of the catheter shaft is preferably formed in a spiral shape that makes one rotation or more per 500 mm in the length in the tube axis direction.

(4) In the catheter (2) or (3), the second multi-lumen tube is formed by rotating the tube material in which a plurality of lumens extending in parallel with each other along the tube axis direction is formed one or more times. It is preferable that each of the plurality of lumens including the lumen through which the operation wire is inserted is formed by forming a spiral shape by twisting.

(5) In the distal deflection operable catheter of the present invention, a first manipulation wire that is inserted through the lumen of the catheter shaft and can be pulled at the rear end thereof to bend the distal flexible portion in the first direction. And a second operation wire that is inserted through the lumen of the catheter shaft and can be pulled at the rear end thereof in order to bend the flexible end portion in the second direction opposite to the first direction. It is preferable that the catheter is a bidirectional catheter.

  According to the distal deflection operable catheter of the present invention, despite the fact that the coil tube which is an anti-compressible member is not disposed on the shaft portion on the rear end side from the distal flexible portion, The distal end flexible portion can be bent, and the shaft portion on the rear end side from the distal end flexible portion can be reliably prevented from being bent.

1 is a schematic side view of an electrode catheter according to an embodiment of the present invention. FIG. 2 is a partially cutaway side view showing a longitudinal cross-sectional shape of a distal end flexible portion of a catheter shaft constituting the electrode catheter shown in FIG. 1. FIG. 3 is a cross-sectional view (III-III cross-sectional view of FIG. 2) showing a cross-sectional shape of a distal end flexible portion of a catheter shaft constituting the electrode catheter shown in FIG. 1. It is a partially broken side view which shows the catheter shaft which comprises the electrode catheter shown in FIG. It is sectional drawing (VA-VA sectional drawing) which shows the cross-sectional shape of the rear-end part of the catheter shaft shown in FIG. It is sectional drawing (VB-VB sectional drawing) which shows the cross-sectional shape of the rear-end part of the catheter shaft shown in FIG. It is sectional drawing (VC-VC sectional drawing) which shows the cross-sectional shape of the rear-end part of the catheter shaft shown in FIG. It is sectional drawing (VD-VD sectional drawing) which shows the cross-sectional shape of the rear-end part of the catheter shaft shown in FIG. It is a perspective view which shows typically a part of lumen shape of the 2nd multi-lumen tube which comprises the catheter shaft shown in FIG. It is a partially broken side view which shows the catheter shaft which comprises the electrode catheter which concerns on other embodiment of this invention. It is sectional drawing (VIIIA-VIIIA sectional drawing) which shows the cross-sectional shape of the rear-end part of the catheter shaft shown in FIG. It is sectional drawing (VIIIB-VIIIB sectional drawing) which shows the cross-sectional shape of the rear-end part of the catheter shaft shown in FIG. It is sectional drawing (VIIIC-VIIIC sectional drawing) which shows the cross-sectional shape of the rear-end part of the catheter shaft shown in FIG. It is sectional drawing (VIIID-VIIID sectional drawing) which shows the cross-sectional shape of the rear-end part of the catheter shaft shown in FIG.

  Hereinafter, an electrode catheter which is an embodiment of the catheter capable of tip deflection operation according to the present invention will be described. The electrode catheter 1 of this embodiment shown in FIGS. 1 to 4 and FIGS. 5A to 5D is used for diagnosis or treatment of arrhythmia in the heart, for example.

The electrode catheter 1 of this embodiment includes a multi-lumen structure catheter shaft 100 having a distal flexible portion 10A (bendable portion), a distal electrode 50 fixed to the distal end of the catheter shaft 100, and a distal flexible portion 10A. Is inserted into the lumen of the catheter shaft 100 (the lumens 11 and 21 described later) in order to bend in the first direction (the direction indicated by the arrow A in FIGS. 1 and 2), and the tip 611 thereof is inserted into the inner recess 51 of the tip electrode 50. The first operation wire 61 that is connected and fixed to the tip electrode 50 by being embedded in the filled solder 63 and whose rear end can be pulled and the tip flexible portion 10A in the second direction (FIGS. 1 and 2 to bend in the direction indicated by the arrow B in FIG. 22), and the tip 621 of the tip electrode 50 is embedded in the solder 63 filled in the inner recess 51 to be connected and fixed to the tip electrode 50, and the rear end of the second operation can be pulled. A catheter comprising a connecting wire 62 and a connector 70 attached to the rear end of the catheter shaft 100;
The catheter shaft 100 is a tube member that constitutes the distal end flexible portion 10A, and in the cross-sectional view thereof, the first lumen 11 and the second lumen 12 that are opposed to each other at intervals of 180 ° (that is, across the central axis), In addition, a first multi-lumen tube 10 in which a third lumen 13 and a fourth lumen 14 facing each other at an interval of 180 ° are formed, and a single lumen tube 40 connected to the rear end of the first multi-lumen tube 10 The tube member disposed in the lumen of the single lumen tube 40, and in the cross-sectional view thereof, the first lumen 21 and the second lumen 22 facing each other at an interval of 180 °, and facing each other at an interval of 180 °. A second multi-lumen formed with a third lumen 23 and a fourth lumen 24 And a down tube 20;
The single lumen tube 40 has a higher stiffness than either the first multi-lumen tube 10 or the second multi-lumen tube 20;
In the shaft portion on the rear end side with respect to the distal end flexible portion 10A, the lumens 21, 22, 23 and 24 of the second multi-lumen tube 20 constituting the shaft portion maintain the relative positional relationship (cross-sectional shape) of each other. However, it is formed in a spiral shape that rotates around the central axis of the catheter shaft 100.

  As shown in FIG. 1, the electrode catheter 1 of this embodiment is attached to a catheter shaft 100 having a flexible distal end portion 10 </ b> A, a distal electrode 50 fixed to the distal end of the catheter shaft 100, and a rear end of the catheter shaft 100. Connector 70 is provided.

  As shown in FIGS. 2 to 4 and FIGS. 5A to 5D, the catheter shaft 100 includes a first multi-lumen tube 10, a single-lumen tube 40 connected to the rear end of the first multi-lumen tube 10, And a second multi-lumen tube 20 disposed in the lumen of the single lumen tube 40.

The distal end region of the catheter shaft 100 is a distal flexible portion 10 </ b> A, and the distal flexible portion 10 </ b> A is configured by the first multi-lumen tube 10.
Here, the “tip flexible portion” refers to the tip portion of the catheter shaft that can be bent by pulling the operation wire.

  As shown in FIG. 3, the first multi-lumen tube 10 constituting the distal end flexible portion 10A has four lumens (a first lumen 11, a second lumen 12, a third lumen) extending in parallel with each other along the tube axis direction. The lumen 13 and the fourth lumen 14) are formed at 90 ° intervals in a cross-sectional view. The first operation wire 61 is inserted into the first lumen 11, and the second operation wire 62 is inserted into the second lumen 12. Is inserted.

  Examples of the constituent material of the first multi-lumen tube 10 include synthetic resins such as polyolefin, polyamide, polyether polyamide, polyurethane, nylon, and PEBAX (polyether block amide).

The outer diameter of the first multi-lumen tube 10 is usually 1.0 to 4.0 mm, preferably 1.2 to 3.0 mm, and 2.3 mm if a suitable example is shown.
The length of the first multi-lumen tube 10 (the length of the distal flexible portion 10A indicated by [L1] in FIG. 4) is usually 20 to 300 mm, preferably 30 to 150 mm, and 100 mm if a suitable example is shown. Is done.
The diameter of the first lumen 11 and the second lumen 12 of the first multi-lumen tube 10 is usually 0.1 to 1.5 mm, preferably 0.2 to 1.0 mm, 0.3 mm if a suitable example is shown. It is said.

A single lumen tube 40 is connected to the rear end side of the first multi-lumen tube 10. Therefore, the single lumen tube 40 constitutes a shaft portion on the rear end side with respect to the distal end flexible portion 10A.
The single lumen tube 40 is made of a material having higher rigidity than the first multi-lumen tube 10 and the second multi-lumen tube 20. Specifically, it is composed of a blade tube obtained by braiding a tube made of the above synthetic resin with a stainless steel wire.

The outer diameter of the single lumen tube 40 is preferably approximately the same as the outer diameter of the first multi-lumen tube 10, and is 2.3 mm if a suitable example is shown.
The inner diameter of the single lumen tube 40 is usually 0.8 to 3.8 mm, preferably 1.0 to 2.5 mm, and 2.0 mm if a suitable example is shown.
The length of the single lumen tube 40 (the length of the rear end side shaft portion indicated by [L2] in FIG. 4) is usually 300 to 1500 mm, preferably 500 to 1200 mm, and 1000 mm if a suitable example is shown. The

  The second multi-lumen tube 20 is disposed in the lumen of the single lumen tube 40. The second multi-lumen tube 20 and the single lumen tube 40 constitute a shaft portion on the rear end side with respect to the distal end flexible portion 10A.

  As shown in FIGS. 4 and 5A to 5D, the second multi-lumen tube 20 disposed in the lumen of the single lumen tube 40 includes four lumens (first lumen 21, second lumen 22, The third lumen 23 and the fourth lumen 24) are formed at intervals of 90 ° in the cross sectional view.

The first lumen 21 and the second lumen 22 formed in the second multi-lumen tube 20 communicate with the first lumen 11 and the second lumen 12 formed in the first multi-lumen tube 10, respectively. A first operation wire 61 is inserted through the first lumen 21 of the multi-lumen tube 20, and a second operation wire 62 is inserted through the second lumen 22.
The third lumen 23 and the fourth lumen 24 formed in the second multi-lumen tube 20 communicate with the third lumen 13 and the fourth lumen 14 formed in the first multi-lumen tube 10, respectively.

Each of the lumens 21, 22, 23, and 24 formed from the front end to the rear end of the second multi-lumen tube 20 maintains the relative positional relationship (cross-sectional shape) with respect to the central axis of the catheter shaft 100. It is formed in a spiral shape that rotates continuously (smoothly).
That is, the central axis of the spiral that is the shape of each of the lumens 21, 22, 23, and 24 coincides with the central axis of the catheter shaft 100.

In the present invention, the lumen of the second multi-lumen tube through which the operation wire is inserted needs to rotate at least once around the central axis of the catheter shaft.
If it is less than one rotation, it is not possible to reliably prevent the shaft portion on the rear end side from being bent due to the pulling operation of the operation wire.

In the present embodiment, each of the lumens 21, 22, 23, and 24 rotates about the central axis of the catheter shaft 100 from the front end to the rear end of the second multi-lumen tube 20. As a result, the rear end portion of the first operation wire 61 inserted through the lumen 21 and the rear end portion of the second operation wire 62 inserted through the lumen 22 are arranged in an eccentric direction (eccentric position) along the tube axis direction. ) Continuously extending inside the shaft portion on the rear end side, so that the shaft portion on the rear end side accompanying the pulling operation of the first operation wire 61 or the second operation wire 62 is extended. Bending can be reliably prevented.
In FIG. 4, a part of the catheter shaft 100 in the length direction is omitted, but the lumens 21, 22, 23 and 23 are not included in the shaft portion on the rear end side of the distal end flexible portion 10 </ b> A. 24 rotates three times around the central axis of the catheter shaft 100.

  FIG. 6 shows that each of the lumens 21, 22, 23 and 24 of the second multi-lumen tube disposed in the lumen of the single lumen tube 40 is rotated once around the central axis of the catheter shaft 100 (extends spirally). Status).

  Examples of the constituent material of the second multi-lumen tube 20 include the same synthetic resin and fluorine-based resin as the constituent material of the first multi-lumen tube 10.

  The method for forming the second multi-lumen tube 20 is not particularly limited. However, if an example of a suitable method is shown, a tube material in which a plurality of lumens extending in parallel with each other along the tube axis direction is formed. A method of forming by extrusion or the like and then twisting the tube material while ensuring the shape of the lumen (so as not to be crushed) can be mentioned.

  The length of the second multi-lumen tube 20 is approximately the same as the length of the single lumen tube 40 that encloses it (usually 300 to 1500 mm), but is preferably 500 mm or more, and 1000 mm if a suitable example is shown. Is done.

  In the present invention, the lumen of the second multi-lumen tube through which the operation wire is inserted is at least one rotation around the central axis of the catheter shaft per 500 mm in length in the tube axis direction (the tube axis direction corresponding to one rotation). (The length indicated by [L3] in FIG. 4) is preferably 500 mm or less, and more preferably two or more turns per 500 mm in the tube axis direction.

  In the present embodiment, when the length of the second multi-lumen tube 20 is 1000 mm, each of the lumens 21, 22, 23, and 24 rotates 2.5 times per 500 mm in the tube axis direction.

  The diameters of the first lumen 21 and the second lumen 22 of the second multi-lumen tube 20 are preferably approximately the same as the diameters of the corresponding first lumen 11 and second lumen 12 in the first multi-lumen tube 10.

  The outer diameter of the second multi-lumen tube 20 is preferably approximately the same as the inner diameter of the single lumen tube 40.

  A tip electrode 50 is fixed to the tip (distal end) of the catheter shaft 100 (first multi-lumen tube 10). The method for fixing the tip electrode 50 is not particularly limited, and examples thereof include a method such as adhesion. A ring-shaped electrode may be attached to the outer periphery of the distal flexible portion 10A of the catheter shaft 100.

  Examples of the constituent material of the tip electrode 50 include metals having good thermal conductivity such as aluminum, copper, stainless steel, gold, and platinum. In addition, in order to give the favorable contrast property with respect to an X-ray, it is preferable to comprise with platinum etc. The outer diameter of the tip electrode 50 is not particularly limited, but is preferably about the same as the outer diameter of the catheter shaft 100 (the first multi-lumen tube 10 and the single lumen tube 40).

As shown in FIG. 2, the inner recess 51 of the tip electrode 50 is filled with solder 63 for connecting and fixing the first operation wire 61 and the second operation wire 62 to the tip electrode 50.
The material of the solder 63 is not particularly limited. For example, Sn—Pb is generally used, but Sn—Pb—Ag or Sn—Pb—Cu may be used, and Pb-free Sn—Ag— Cu, Sn—Cu, Sn—Ag, Sn—Ag—Cu—Bi, or the like can be used.

As shown in FIG. 1, a connector 70 is attached to the rear end (proximal end) of the catheter shaft 100. From the connector 70, a rear end portion of a conducting wire electrically connected to the tip electrode 50 is drawn out.
The connector 70 is provided with a knob 75 for performing a tip deflection operation (a pulling operation of the first operation wire 61 and the second operation wire 62).

As shown in FIGS. 2 to 4 and FIGS. 5A to 5D, the first flexible portion 10 </ b> A is provided in the first lumen 11 of the first multi-lumen tube 10 and the first lumen 21 of the second multi-lumen tube 20. A first operation wire 61 for bending in a direction (direction indicated by an arrow A) is movably inserted.
Further, the second lumen 12 of the first multi-lumen tube 10 and the second lumen 22 of the second multi-lumen tube 20 are configured to bend and deform the distal end flexible portion 10A in the second direction (the direction indicated by the arrow B). The second operation wire 62 is movably inserted.

  The first operation wire 61 and the second operation wire 62 are made of, for example, stainless steel or a Ni—Ti superelastic alloy, but are not necessarily made of metal, such as a high-strength non-conductive wire. You may comprise.

  The outer diameters of the first operation wire 61 and the second operation wire 62 are not particularly limited, but are preferably 0.05 to 1.0 mm, more preferably 0.1 to 0.5 mm, A suitable example is 0.25 mm.

As shown in FIG. 2, a large-diameter portion (a retaining portion) for retaining is formed at the distal end 611 of the first operating wire 61 and the distal end 621 of the second operating wire 62.
The tip 611 and the tip 621 are embedded in the solder 63 filled in the inner concave portion 51 of the tip electrode 50 at positions facing each other, and are prevented from coming off from the solder 63 by the retaining large-diameter portions formed respectively. Has been.

  As described above, the distal electrode 50 constituting the electrode catheter 1 is not only connected and fixed to the distal end of the catheter shaft 100 but also to the distal end 611 of the first operating wire 61 and the distal end 621 of the second operating wire 62. Since the connection is fixed to the distal end of the catheter shaft 100 and the distal electrode 50, the distal electrode 50 is connected to the distal ends 611 and 621 of the pair of operation wires. Therefore, the tip electrode 50 can be prevented from falling off.

  3 and 5A to 5D, nothing is shown in the third lumen 13 and the fourth lumen 14 of the first multi-lumen tube 10 and the third lumen 23 and the fourth lumen 24 of the second multi-lumen tube 20. Although not provided, a lead wire of the tip electrode 50 is inserted into these lumens, and when a ring-like electrode is mounted, the lead wire, and when a thermocouple is provided as a temperature sensor, the wiring is provided. Etc. can be inserted as appropriate.

The rear end of the first operation wire 61 and the rear end of the second operation wire 62 are each connected to a knob 75 of the connector 70.
By operating the knob 75, the first operation wire 61 or the second operation wire 62 is pulled, and the distal end flexible portion 10A bends in the first direction or the second direction, whereby the distal end of the electrode catheter 1 is moved. To deflect.

Specifically, by rotating the knob 75 in the A1 direction shown in FIG. 1, the first operation wire 61 is pulled, and the tip flexible portion 10A is bent in the first direction (the direction indicated by the arrow A). Its shape changes continuously.
Further, by rotating the knob 75 in the B1 direction shown in FIG. 1, the second operation wire 62 is pulled, and the distal end flexible portion 10A is bent in the second direction (the direction indicated by the arrow B), and the shape thereof is changed. It changes continuously.
Then, if the connector 70 is rotated around the axis, the orientations of the first direction and the second direction with respect to the catheter 100 can be freely set while being inserted into the body cavity.

  According to the electrode catheter 1 of the present embodiment, the first operation wire 61 and the second operation wire 62 on the rear end side with respect to the distal end flexible portion 10A (positioned on the rear end side with respect to the distal end flexible portion 10A). The wire portion) is inserted into the spiral lumens 21 and 22 each rotating around the central axis of the catheter shaft 100, thereby continuously changing the eccentric direction (eccentric position) along the tube axis direction. Since it extends inside the shaft portion on the rear end side, it is possible to reliably prevent the shaft portion from bending.

  As a means for preventing the deflection of the shaft portion on the rear end side from the distal flexible portion 10A, there is no need to arrange a coil tube as an anti-compressible member in the lumen of the single lumen tube 40, so that the conventional one Compared with, the internal space (space) of the catheter shaft can be greatly expanded. As a result, the number of conductors that could not be inserted by the same size catheter can be inserted into the shaft. Further, the diameter of the catheter can be reduced.

  Further, by not arranging the coil tube in the lumen of the single lumen tube 40, it is possible to avoid the above-mentioned problems due to the arrangement of the coil tube and to improve the manufacturing efficiency.

  In addition, since the second multi-lumen tube 20 is disposed in the lumen of the single-lumen tube 40 having a relatively high rigidity composed of a blade tube, the second multi-lumen tube 20 is subjected to distortion during molding (for example, Even if the distortion caused by the twisting of the tube member), the distortion can be corrected by the single lumen tube 40 covering the second multi-lumen tube 20.

  Further, in the second multi-lumen tube 20, a lead wire (lead wire of the tip electrode 50, ring-like electrode) is passed through the third lumen 23 and the fourth lumen 24 through which the first operation wire 61 or the second operation wire 62 is not inserted. A lead wire and a thermocouple wiring that is a temperature sensor) can be inserted, and the internal space (space) in the shaft portion on the rear end side can be used effectively.

The embodiment of the present invention has been described above, but the distal deflection operable catheter of the present invention is not limited to this, and various modifications can be made.
For example, the number of lumens formed in the first multi-lumen tube and the second multi-lumen tube may not be four, and may have, for example, 2 to 20 lumens.

Further, the first multi-lumen tube and the second multi-lumen tube may have different lumen structures.
For example, as shown in FIGS. 7 and 8, as the second multi-lumen tube 25 constituting the catheter shaft 150, the first lumen 26, the second lumen 27, and the central lumen that are opposed to each other at an interval of 180 ° in a cross-sectional view thereof. The tube member formed with 28 can be preferably used.

The first multi-lumen tube and the second multi-lumen tube may be integrally formed.
A leaf spring (swing member) may be accommodated inside the first multi-lumen tube.
The distal ends of the operation wires (first operation wire and second operation wire) may be connected and fixed to the distal end portion of the catheter shaft (first multi-lumen tube).
Moreover, the catheter of the single direction type which bends a front-end | tip flexible part only to one direction may be sufficient.

DESCRIPTION OF SYMBOLS 1 Electrode catheter 100 Catheter shaft 10 1st multi-lumen tube 10A Tip flexible part 11 1st lumen 12 2nd lumen 13 3rd lumen 14 4th lumen 20 2nd multi-lumen tube 21 1st lumen 22 2nd lumen 23 3rd Lumen 24 Fourth lumen 150 Catheter shaft 25 Second multi-lumen tube 26 First lumen 27 Second lumen 28 Central lumen 40 Single lumen tube 50 Tip electrode 51 Inner recess 61 First operation wire 611 Tip 62 Second operation wire 621 Tip 63 Solder 70 Connector 75 Knob

Claims (5)

A catheter shaft having a multi-lumen structure having a distal end flexible portion, and an operation wire inserted through the lumen of the catheter shaft to bend the distal end flexible portion and having a rear end capable of being pulled. A catheter,
The lumen of the catheter shaft through which the operation wire is inserted is formed in a spiral shape that rotates at least once around the central axis of the catheter shaft in a shaft portion on the rear end side of the distal end flexible portion. A catheter capable of tip deflection operation. The catheter shaft includes a first multi-lumen tube constituting the tip flexible portion, a single lumen tube connected to a rear end of the first multi-lumen tube, and a second lumen disposed in the lumen of the single lumen tube. A multi-lumen tube,
The single lumen tube has higher rigidity than any of the first multi-lumen tube and the second multi-lumen tube,
The lumen of the second multi-lumen tube into which the operation wire is inserted is formed in a spiral shape that rotates at least once around the central axis of the catheter shaft. A tip deflectable catheter.   The length of the second multi-lumen tube is 500 mm or more, and the lumen of the second multi-lumen tube through which the operation wire is inserted has a length in the tube axis direction around the central axis of the catheter shaft. The catheter according to claim 2, wherein the catheter is formed in a spiral shape that makes one rotation or more per 500 mm.   The second multi-lumen tube includes a lumen through which the operation wire is inserted by twisting a tube material in which a plurality of lumens extending in parallel with each other along the tube axis direction is twisted one or more times. 4. The tip deflectable manipulatable catheter according to claim 2, wherein each of the plurality of lumens is formed by forming a spiral shape. A first operation wire that is inserted through a lumen of the catheter shaft and has a rear end capable of being pulled to bend the distal flexible portion in a first direction;
In order to bend the distal end flexible portion in the second direction opposite to the first direction, a second operation wire is inserted through the lumen of the catheter shaft and the rear end thereof can be pulled. 5. A catheter capable of tip deflection operation according to any one of claims 1 to 4, wherein

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