JP2013123508A - Catheter having deflectable leading end - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a catheter having a deflectable leading end, that allows a leading end flexible portion to be an intended warped shape with the pulling operation of operation wires, regardless of the shape of a shaft portion at a rear end where a coil tube being an anti-compression member is arranged.SOLUTION: The catheter includes: a catheter shaft 100 having a leading end flexible portion 10A; a leading end electrode 50; and operation wires 61, 62. The catheter shaft 100 includes: a first multi-lumen tube 10 constituting the leading end flexible portion 10A; a single lumen tube 40 connected to the rear end; a coil tube 30 arranged at the lumen; and a second multi-lumen tube 20 arranged at the lumen. The operation wires 61/62 are put through the lumens 11/12 of the first multi-lumen tube 10 and the lumens 21/22 of the second multi-lumen tube 20.

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 direction of the distal end (distal end) of the catheter inserted into the heart is set to the rear end (proximal end or hand) of the catheter placed outside the body. It is necessary to change (deflection) by operating the operation unit mounted on the side.

  As a mechanism for operating and deflecting the distal end of the catheter on the hand side, a mechanism shown in Patent Document 1 below is known. In the mechanism shown in Patent Document 1, a plate-like lead spring is arranged inside the distal end flexible portion of the catheter, and the tip of the operation wire is connected and fixed to one side or both sides of the lead spring. Then, by pulling the rear end of the operation wire, the lead spring (the rear end side from the connection fixing position of the operation wire) is bent, and the direction of the distal end of the catheter is changed.

  Also, as a catheter that deflects the tip by pulling on the proximal side, a multi-lumen tube that forms the flexible portion of the tip, a single-lumen tube connected to the rear end side of the multi-lumen tube, and a single lumen tube A coil tube (anti-compressible member) disposed in a lumen, and a multi-lumen tube lumen and an operation wire inserted into the coil tube lumen are known (for example, Patent Document 2 below) reference).

  5 and 6 show a portion of the internal structure of such a catheter. In the figure, 110 is a multi-lumen tube constituting the tip flexible portion, 140 is a single lumen tube, 130 is a coil tube, 150 is a tip electrode, and 161 and 162 are operation wires (first operation wire and first wire). 2 operation wires).

The first operation wire 161 extends into the catheter shaft by being inserted through the lumen 111 of the multi-lumen tube 110 and the lumen of the coil tube 130. The tip of the first operation wire 161 is connected and fixed to the tip electrode 150 by being embedded in the solder 163 filled in the inner recess of the tip electrode 150.
The rear end of the first operation wire 161 can be pulled. By pulling the rear end of the first operation wire 161, the catheter shaft can be pulled according to the amount of tension (tensile length). The tip flexible portion can be bent in the first direction (the direction indicated by arrow A).

  The second operation wire 162 extends through the catheter shaft by being inserted through the lumen 112 of the multi-lumen tube 110 and the lumen of the coil tube 130. The tip of the second operation wire 162 is connected and fixed to the tip electrode 150 by being embedded in the solder 163 filled in the inner recess of the tip electrode 150. The rear end of the second operation wire 162 can be pulled. By pulling the rear end of the second operation wire 162, the catheter shaft can be pulled according to the amount of tension (tensile length). The tip flexible portion can be bent in the second direction (the direction indicated by arrow B).

In the catheter shown in FIGS. 5 and 6, a plurality of conducting wires (not shown) are usually inserted into a space defined by the inner peripheral surface of the single lumen tube 140 and the outer peripheral surface of the coil tube 130. From the standpoint of securing the space for inserting the conducting wire, the outer diameter (D ₁₃₀ ) of the coil tube 130 is somewhat smaller than the inner diameter (d ₁₄₀ ) of the single lumen tube 140. For example, the inner diameter (d ₁₄₀ ) The outer diameter (D ₁₃₀ ) of the coil tube 130 disposed in the lumen of the single lumen tube 140 of 1.5 mm is about 1.1 mm.
Further, the outer diameters of the operation wires 161 and 162 are considerably smaller than the inner diameter of the coil tube 130 through which they are inserted.

Japanese Patent No. 3232308 Japanese Patent No. 4679668

However, in a conventional catheter having a catheter shaft having a single lumen tube connected to the rear end side of the multi-lumen tube and a coil tube disposed in the lumen of the single lumen tube, the coil tube is disposed. There is a problem that the degree of bending (maximum amount of bending) of the distal end flexible portion varies depending on the shape (state) of the rear end side shaft portion.
Specifically, the maximum deflection amount of the tip flexible portion when the rear end shaft portion is curved or meandering is the maximum of the tip flexible portion when the rear end shaft portion is linear. It becomes smaller than the amount of deflection.
For this reason, depending on the shape of the shaft portion on the rear end side, there is a problem that the tip flexible portion cannot be formed into the intended bent shape by the pulling operation of the operation wire.

As described above, the outer diameter (D ₁₃₀ ) of the coil tube 130 is somewhat smaller than the inner diameter (d ₁₄₀ ) of the single lumen tube 140 in the catheter shown in FIGS. The coil tube 130 disposed in the lumen is movable in the radial direction of the single lumen tube 140. Furthermore, since the outer diameters of the operation wires 161 and 162 are considerably smaller than the inner diameter of the coil tube 130, the operation wires 161 and 162 inserted through the lumen of the coil tube 130 are arranged in the radial direction of the coil tube 130. It is movable.

  For this reason, when the first operation wire 161 or the second operation wire 162 is pulled in a state where the shaft portion (the single lumen tube 140 and the coil tube 130) on the rear end side where the coil tube is disposed is curved. The first operation wire 161 and the second operation wire 162 inserted through the lumen of the coil tube 130 move in the radial direction of the coil tube 130 and inward of the curve, and are disposed in the single lumen tube 140. The coil tube 130 moves in the radial direction of the single lumen tube 140 and inward of the curve, and the first operation wire 161 and the second operation wire 162 extend at the shortest distance in the shaft portion on the rear end side. The flexible portion at the distal end of the catheter shaft is bent It will be.

  Further, when the first operation wire 161 or the second operation wire 162 is pulled while the rear end side shaft portion is meandering, as schematically shown in FIG. After the 161 and the second operation wire 162 extend in the shortest distance inside the shaft portion on the rear end side, the distal end flexible portion of the catheter shaft is bent.

  That is, if the operation wire is pulled while the rear end side shaft portion is curved or meandering, a part of the pull amount (tensile length) on the hand side will cause the operation wire to move in the shaft radial direction. Used to move in the direction of the inside of the curve, the amount of tension (tensile length) for bending the distal flexible portion is insufficient, and as a result, the distal flexible portion of the catheter shaft is deformed to the intended bending shape. It cannot be formed.

The present invention has been made based on the above situation.
It is an object of the present invention to provide a distal deflection controllable catheter having a coil tube that is an anti-compressible member on the rear end side of a catheter shaft, and the distal end of the catheter shaft according to the shape of the shaft portion on the rear end side where the coil tube is disposed. The degree of bending (maximum amount of bending) of the flexible portion does not change, and the tip flexible portion can be formed into the intended bending shape by pulling the operation wire regardless of the shape of the shaft portion on the rear end side. It is an object of the present invention to provide a tip deflection operable catheter.

  As a result of repeated studies by the inventor in order to achieve the above object, the movement of the operation wire in the lumen of the coil tube (movement in the radial direction of the coil tube) is restricted, and the coil in the lumen of the single lumen tube By restricting tube movement (moving in the radial direction of a single lumen tube), the degree of bending (maximum amount of bending) of the tip flexible part during pulling operation does not change depending on the shape of the shaft part on the rear end side. The present invention was completed based on this finding.

(1) The distal deflection operable catheter of the present invention includes a catheter shaft having a distal flexible portion, a distal electrode fixed to the distal end of the catheter shaft, and the catheter shaft to bend the distal flexible portion. A catheter having an operation wire extending inside and having a rear end capable of being pulled,
The catheter shaft includes a first multi-lumen tube constituting the distal end flexible portion, a single lumen tube connected to a rear end side of the first multi-lumen tube, and a coil disposed in the lumen of the single lumen tube A tube, and a second multi-lumen tube disposed in the lumen of the coil tube;
The operation wire is inserted into each lumen of the first multi-lumen tube and the second multi-lumen tube.

(2) In the distal deflection operable catheter of the present invention, in order to bend the distal flexible portion in the first direction, it extends inside the catheter shaft, and its rear end is capable of being pulled. A second operating wire extending inside the catheter shaft and having a rear end capable of being pulled to bend the wire and the distal flexible portion in a second direction opposite to the first direction; With
It is preferable that the first operation wire and the second operation wire are inserted into different lumens in each of the first multi-lumen tube and the second multi-lumen tube.

  According to the distal deflection operable catheter configured as described above, the second multi-lumen tube is disposed in the lumen of the coil tube that is an anti-compressible member, and an operation wire (first wire) is disposed in the lumen of the second multi-lumen tube. Since the operation wire and the second operation wire) are inserted, movement of the operation wire in the lumen of the coil tube (movement in the radial direction of the coil tube) is limited. It is possible to suppress a change in the maximum deflection amount of the distal end flexible portion due to the shape of the shaft portion on the rear end side, which has occurred due to the movement.

  Further, by inserting a conducting wire through the lumen of the second multi-lumen tube through which the operation wires (the first operation wire and the second operation wire) are not inserted, the inner peripheral surface of the single lumen tube and the outer periphery of the coil tube Since there is no need to form a space for inserting the conductive wire between the coil and the surface, the outer diameter of the coil tube can be made substantially equal to the inner diameter of the single lumen tube. As a result, the movement of the coil tube in the lumen of the single lumen tube (the movement of the single lumen tube in the radial direction) is limited. Therefore, in the conventional catheter, the shaft on the rear end side caused by this movement A change in the maximum amount of deflection of the tip flexible portion due to the shape of the portion can be suppressed.

(3) In the distal deflection operable catheter of the present invention, the coil tube is disposed without being fixed to the inner periphery of the single lumen tube, and the second multi-lumen is not fixed to the inner periphery of the coil tube. It is preferable that the tube is arranged.

  According to the distal deflection operable catheter having such a configuration, a good anti-compression property is provided by the coil tube in the shaft portion on the rear end side where the coil tube is disposed, and the single lumen tube and the second multi-tube are provided. The coil tube that is not fixed to any of the lumen tubes maintains its characteristics as a “coil” without being damaged, so when a force other than the axial direction is applied to the shaft portion on the rear end side. This shaft portion can be bent easily.

(4) Further, the difference (d ₄₀ −D ₃₀ ) between the inner diameter (d ₄₀ ) of the single lumen tube and the outer diameter (D ₃₀ ) of the coil tube is 0.2 mm or less,
The difference (d ₃₀ −D ₂₀ ) between the inner diameter (d ₃₀ ) of the coil tube and the outer diameter (D ₂₀ ) of the second multi-lumen tube is preferably 0.2 mm or less.

According to the distal deflection operable catheter having such a configuration, when (d ₄₀ -D ₃₀ ) is 0.2 mm or less, movement of the coil tube in the lumen of the single lumen tube (in the radial direction of the single lumen tube) The movement of the second multi-lumen tube in the lumen of the coil tube (movement in the radial direction of the coil tube) can be sufficiently restricted, and (d ₃₀ -D ₂₀ ) is 0.2 mm or less. ) Can be sufficiently limited. Therefore, it is possible to sufficiently suppress the change in the maximum deflection amount of the distal end flexible portion due to the shape of the shaft portion on the rear end side.

(5) Moreover, it is preferable that the said coil tube is what formed the tube shape by winding the wire of a cross-sectional flat angle in a coil shape.

  When a compressive force is applied to the coil tube having such a structure, the wire rods having a flat cross section come into surface contact with each other, so that the positional deviation between the wire rods (bending of the coil tube) hardly occurs. Therefore, the anti-compression property in the shaft portion on the rear end side where such a coil tube is arranged is particularly excellent.

(6) Moreover, it is preferable that the front-end | tip of the said operation wire is connected and fixed to the said front-end | tip electrode by being embedded in the solder with which the inner side recessed part of the said front-end | tip electrode was filled.

  According to the distal deflection operable catheter of the present invention, the degree of deflection (maximum deflection amount) of the distal end flexible portion does not substantially change depending on the shape of the shaft portion on the rear end side where the coil tube is disposed. Regardless of the shape (state) of the shaft portion on the rear end side, the distal end flexible portion can be formed into an intended bending shape by pulling the operation wire.

1 is a schematic side view of an electrode catheter according to an embodiment of the present invention. It is a longitudinal cross-sectional view which shows the principal part of the electrode catheter shown in FIG. FIG. 3 is a transverse cross-sectional view (III-III cross-sectional view of FIG. 2) showing the main part of the electrode catheter shown in FIG. 1. FIG. 4 is a transverse cross-sectional view (IV-IV cross-sectional view of FIG. 2) showing the main part of the electrode catheter shown in FIG. It is a longitudinal cross-sectional view which shows the principal part of the conventional electrode catheter. FIG. 6 is a transverse cross-sectional view (cross-sectional view taken along the line VI-VI in FIG. 5) showing a main part of the electrode catheter shown in FIG. FIG. 6 is a schematic diagram showing a state when the operation wire is pulled when the shaft portion on the rear end side of the electrode catheter shown in FIG. 5 is meandering.

  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. 1-4 is used for the diagnosis or treatment of the arrhythmia in the heart, for example.

  The electrode catheter 1 of the present embodiment includes a 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 the distal flexible portion 10A in the first direction. In order to bend in the direction indicated by arrow A in FIGS. 1 and 2, the distal end 611 extends into the catheter shaft 100 and is embedded in the solder 63 filled in the inner recess 51 of the distal electrode 50. As a result, the first operation wire 61 that is connected and fixed to the tip electrode 50 and whose rear end can be pulled and the tip flexible portion 10A in the second direction (the direction indicated by the arrow B in FIGS. 1 and 2). The solder 63 extends inside the catheter shaft 100 and has a tip 621 filled in the inner recess 51 of the tip electrode 50. The catheter is provided with a second operation wire 62 that is connected and fixed to the distal electrode 50 by being embedded, and whose rear end can be pulled, 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 the first lumen 11 and the second lumen 12 that face each other at intervals of 180 ° (with the central axis in between), and at intervals of 180 °. The first multi-lumen tube 10 in which the third lumen 13 and the fourth lumen 14 facing each other are formed, a single lumen tube 40 connected to the rear end side of the first multi-lumen tube 10, and the single lumen tube A coil tube 30 arranged in 40 lumens and the coil tube 3 A first lumen 21 and a second lumen 22 facing each other at intervals of 180 ° (with the central axis sandwiched), and a third lumen 23 facing each other at intervals of 180 ° A second multi-lumen tube 20 having a fourth lumen 24 formed therein; the first operating wire 61 includes a first lumen 11 of the first multi-lumen tube 10 and a second multi-lumen tube 20 The second operation wire 62 is inserted into the second lumen 12 of the first multi-lumen tube 10 and the second lumen 22 of the second multi-lumen tube 20.

  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.

  2 to 4, the catheter shaft 100 includes a first multi-lumen tube 10, a single lumen tube 40 connected to the rear end side of the first multi-lumen tube 10, and a lumen of the single lumen tube 40. The coil tube 30 is disposed, and the second multi-lumen tube 20 is disposed in the lumen of the coil tube 30.

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, four lumens (a first lumen 11, a second lumen 12, a third lumen 13, and a fourth lumen 14) are formed in the first multi-lumen tube 10 constituting the distal end flexible portion 10A. The first operation wire 61 is inserted through the first lumen 11, and the second operation wire 62 is inserted through the second lumen 12.

  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 (flexible tip portion 10A) is usually 20 to 300 mm, preferably 30 to 150 mm, and 100 mm if a suitable example is shown.
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.
The single lumen tube 40 is made of a material having higher rigidity than the first multi-lumen tube 10. Specifically, it is preferably made 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 about the same as the outer diameter of the first multi-lumen tube 10.
The inner diameter (d ₄₀ ) of the single lumen tube 40 is usually 0.8 to 3.5 mm, preferably 1.0 to 3.0 mm, and 1.78 mm if a suitable example is shown.
The length of the single lumen tube 40 is usually 300 to 1500 mm, preferably 500 to 1200 mm, and 1000 mm if a suitable example is shown.

The lumen of the single lumen tube 40 is provided with a coil tube 30 formed by winding a wire with a flat cross section into a coil shape as an anti-compressible member.
Even if a compressive force (axial force) is applied to the coil tube 30 that is an anti-compressible member, the wire members constituting the surface are in surface contact with each other, so that the positional displacement between the wire members hardly occurs, and the shape of the coil tube 30 (Linearity) is maintained.
Therefore, by arranging the coil tube 30 in the lumen of the single lumen tube 40, the single lumen tube 40 bends together with the distal end flexible portion when the first operation wire 61 or the second operation wire 62 is pulled. This can be prevented.

  The coil tube 30 can maintain linearity with respect to the compressive force associated with the pulling operation of the operation wire and can be easily bent by a force other than the axial direction. The single lumen tube 40 (the shaft portion other than the distal end flexible portion 10A) can be easily deformed (bent or meandered).

  As a constituent material of the coil tube 30, metals, such as stainless steel, titanium, Ni-Ti, can be mentioned, for example.

The outer diameter (D ₃₀ ) of the coil tube 30 is usually 0.8 to 3.5 mm, preferably 1.0 to 3.0 mm, and 1.75 mm if a suitable example is shown.
The inner diameter (d ₃₀ ) of the coil tube 30 is usually 0.7 to 3.4 mm, preferably 0.9 to 2.9 mm, and 1.40 mm if a suitable example is shown.
The length of the coil tube 30 is preferably about the same as the length of the single lumen tube 40.

The outer peripheral surface of the coil tube 30 is not fixed to the inner peripheral surface of the single lumen tube 40, and a minute gap (not shown in FIGS. 2 and 4) exists between the two.
Here, the difference (d ₄₀ -D ₃₀ ) between the inner diameter (d ₄₀ ) of the single lumen tube 40 and the outer diameter (D ₃₀ ) of the coil tube 30 is preferably 0.2 mm or less, and more preferably 0.8. If it shows 01-0.1mm and a suitable example, it will be 0.03mm (1.78mm-1.75mm). When (d ₄₀ −D ₃₀ ) is 0.2 mm or less, the movement of the coil tube 30 in the lumen of the single lumen tube 40 (movement of the single lumen tube 40 in the radial direction) can be sufficiently limited.

  A second multi-lumen tube 20 is disposed in the lumen of the coil tube 30.

As shown in FIG. 4, the second multi-lumen tube 20 disposed in the lumen of the coil tube 30 has four lumens (first lumen 21, second lumen 22, third lumen 23, and fourth lumen 24). Is formed.
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 first 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.

  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 outer diameter (D ₂₀ ) of the second multi-lumen tube 20 is usually 0.7 to 3.4 mm, preferably 0.6 to 3.0 mm, and 1.35 mm if a suitable example is shown.

The outer peripheral surface of the second multi-lumen tube 20 is not fixed to the inner peripheral surface of the coil tube 30, and a minute gap (not shown in FIGS. 2 and 4) exists between the two.
The difference (d ₃₀ -D ₂₀ ) between the inner diameter (d ₃₀ ) of the coil tube 30 and the outer diameter (D ₂₀ ) of the second multi-lumen tube 20 is preferably 0.2 mm or less, more preferably 0.01. If it shows -0.1mm and a suitable example, it will be 0.05mm (1.40mm-1.35mm). When (d ₃₀ -D ₂₀ ) is 0.2 mm or less, the movement of the second multi-lumen tube 20 in the lumen of the coil tube 30 (movement of the coil tube 30 in the radial direction) can be sufficiently limited. .

The length of the second multi-lumen tube 20 is preferably approximately the same as the length of the single lumen tube 40 and the coil tube 30.
Further, 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. .

  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, the distal end flexible portion 10 </ b> A is indicated in the first direction (indicated by an arrow A) on 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 the axial direction is inserted so as to be movable in the axial direction.
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 inserted so as to be movable in the axial direction.

  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 4, 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. However, the lead wire of the tip electrode 50 is inserted into these lumens, and when a ring-shaped electrode is attached, the lead wire, and when a thermocouple is provided as a temperature sensor, the wiring or the like is appropriately set. Can be inserted.

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 coil tube 30 that is an anti-compressible member is disposed in the lumen of the single lumen tube 40 connected to the rear end side of the first multi-lumen tube 10. The second multi-lumen tube 20 is disposed in the lumen of the second multi-lumen tube, the first operation wire 61 is inserted into the first lumen 21 of the second multi-lumen tube 20, and the second operation wire 62 is inserted into the second lumen 22. Since the movement of the first operation wire 61 and the second operation wire 62 (movement in the radial direction of the coil tube 30) is restricted in the lumen of the coil tube 30, the conventional catheter is inserted. In this case, the shaft portion on the rear end side that is caused by this movement is curved or meandering. Maximum deflection amount of change of the tip flexible portion 10A due to or the (lack of) can be suppressed.

Further, in the second multi-lumen tube 20, a lead wire (lead wire of the tip electrode 50) is passed through the third lumen 23 and the fourth lumen 24 through which the operation wires (the first operation wire 61 and the second operation wire 62) are not inserted. It is necessary to secure a space for inserting the conductive wire between the inner peripheral surface of the single lumen tube 40 and the outer peripheral surface of the coil tube 30 by inserting a ring electrode conductive wire and a thermocouple wiring as a temperature sensor. Therefore, the outer diameter (D ₃₀ ) of the coil tube 30 can be made substantially equal to the inner diameter (d ₄₀ ) of the single lumen tube 40 (for example, (d ₄₀ -D ₃₀ ) is 0.2 mm or less). As a result, the movement of the coil tube 30 in the lumen of the single lumen tube 40 (movement of the single lumen tube in the radial direction) is restricted. Therefore, in the conventional catheter, the change in the maximum deflection amount of the distal end flexible portion 10A caused by the bending or meandering of the shaft portion on the rear end side caused by this movement is caused. (Insufficient) can be suppressed.

That is, according to the electrode catheter 1 of the present embodiment, the first operation wire 61 or the second operation wire 62 in a state where the shaft portion on the rear end side where the coil tube 30 is disposed is curved or meandering. The first operation wire 61 and the second operation wire 62 in the shaft portion on the rear end side cannot move in the radial direction of the shaft even when the pulling operation is performed. ) Are all used to deflect the tip flexible part.
Therefore, when a pulling operation is performed with a constant pulling amount on the proximal side, the maximum bending amount of the distal end flexible portion is always constant regardless of the shape (state) of the shaft portion on the rear end side. Can be formed into a bent shape.

  In the electrode catheter 1 of the present embodiment, the coil tube 30 is disposed without being fixed to the inner peripheral surface of the single lumen tube 40, and the second multi-lumen is not fixed to the inner peripheral surface of the coil tube 30. Since the tube 20 is disposed, a good anti-compressibility is provided by the coil tube 30 in the shaft portion on the rear end side where the coil tube 30 is disposed in the lumen of the single lumen tube 40, and the single lumen tube is provided. The coil tube 30 that is not fixed to any of the 40 and the second multi-lumen tube 20 maintains the characteristic as a “coil” without being impaired, and therefore is axially oriented with respect to the shaft portion on the rear end side. This shaft part can be easily bent or snaked by applying a force other than It can be or is.

Further, the difference (d ₄₀ -D ₃₀ ) between the inner diameter (d ₄₀ ) of the single lumen tube 40 and the outer diameter (D ₃₀ ) of the coil tube 30 is 0.2 mm or less, and the inner diameter (d ₃₀ ) of the coil tube 30. And the outer diameter (D ₂₀ ) of the second multi-lumen tube 20 (d ₃₀ -D ₂₀ ) is 0.2 mm or less, so that the movement of the coil tube 30 in the lumen of the single lumen tube 40 (single lumen tube) The movement of the second multi-lumen tube 20 (the first operation wire 61 and the second operation wire 62) in the lumen of the coil tube 30 can be sufficiently limited. Thus, the change in the maximum deflection amount of the distal end flexible portion 10A due to the shape of the shaft portion on the rear end side can be sufficiently suppressed. Door can be.

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.
An intermediate member having a communication path between each lumen of the first multi-lumen tube and each lumen of the second multi-lumen tube may be provided.
The first multi-lumen tube and the second multi-lumen tube may be integrally formed.
Moreover, as a coil tube, you may arrange | position what was comprised by winding the wire of circular cross section in a coil shape.
Further, the characteristics as a “coil” can be maintained, and the rear end side shaft portion (single lumen tube, coil tube and second multi-lumen tube) can be easily deformed by a force other than the axial direction. If present, the inner periphery of the single lumen tube and the outer periphery of the coil tube, and / or the inner periphery of the coil tube and the outer periphery of the second multi-lumen tube may be fixed.
Further, a leaf spring (swing member) may be accommodated in the catheter 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 (tip flexible part)
10A Flexible tip (first multi-lumen tube)
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 4th lumen 30 coil tube 40 single lumen tube 50 tip electrode 51 inside Recess 61 First operation wire 611 tip 62 Second operation wire 621 tip 63 Solder 70 Connector 75 Knob

Claims (6)

A catheter shaft having a tip flexible portion;
A tip electrode fixed to the tip of the catheter shaft;
A catheter comprising an operation wire extending inside the catheter shaft and having a rear end capable of being pulled in order to bend the distal flexible portion,
The catheter shaft includes a first multi-lumen tube constituting the distal end flexible portion;
A single lumen tube connected to a rear end side of the first multi-lumen tube; a coil tube disposed in the lumen of the single lumen tube;
A second multi-lumen tube disposed in the lumen of the coil tube;
The catheter for manipulating a tip can be operated, wherein the operation wire is inserted into the lumen of each of the first multi-lumen tube and the second multi-lumen tube. A first operating wire extending inside the catheter shaft and having 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, the distal end flexible portion includes a second operation wire extending inside the catheter shaft and having a rear end capable of being pulled. Become
The first operation wire and the second operation wire are inserted into different lumens in each of the first multi-lumen tube and the second multi-lumen tube. The catheter for manipulating the tip deflection as described.   The coil tube is disposed without being fixed to the inner periphery of the single lumen tube, and the second multi-lumen tube is disposed without being fixed to the inner periphery of the coil tube. The catheter which can be operated by tip deflection according to claim 1 or 2. The difference (d ₄₀ -D ₃₀ ) between the inner diameter (d ₄₀ ) of the single lumen tube and the outer diameter (D ₃₀ ) of the coil tube is 0.2 mm or less,
The difference (d ₃₀ -D ₂₀ ) between the inner diameter (d ₃₀ ) of the coil tube and the outer diameter (D ₂₀ ) of the second multi-lumen tube is 0.2 mm or less. Item 4. The distal deflection operable catheter according to Item 3.   The catheter according to any one of claims 1 to 4, wherein the coil tube is formed in a tube shape by winding a wire having a rectangular cross section into a coil shape.   6. The tip of the operation wire is connected and fixed to the tip electrode by being embedded in solder filled in an inner recess of the tip electrode. The tip deflection of the catheter can be operated.

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