JP2013048711A - Deflectable tip catheter - Google Patents

Abstract

Disclosed is a catheter capable of tip deflection operation which can change the shape of the tip portion of the catheter on the same plane while having a mechanism without a leaf spring.
A distal end flexible portion (10A) is a multi-lumen structure having a central lumen (11C) and sub-lumens (111 to 118) arranged around the shaft (10). The operation wires 31 and 32 are inserted into the sub-lumens 111 and 115 arranged opposite to each other across the central axis 10, and the sub-lumens 111 and 115 through which the central axis O of the catheter shaft 10 and the operation wires 31 and 32 are inserted. Each of the sublumens 113 and 117 having a central axis on the second virtual plane P2 orthogonal to the first virtual plane P1 including the central axis of the catheter shaft and opposed to each other across the central axis O of the catheter shaft 10 , And is partitioned by a high elastic modulus resin tube 13.
[Selection] Figure 3

Description

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

  For example, in the case of an electrode catheter inserted into the heart through an arterial blood vessel, the direction of the distal end (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 leaf spring having a spring force is disposed inside the distal end portion of the catheter, and the distal end of the operation wire is connected and fixed to one side or both sides of the leaf spring. Then, the leaf spring is bent by pulling the rear end of the operation wire, and the distal end portion of the catheter is bent in a direction perpendicular to the flat surface of the leaf spring to change the direction of the distal end of the catheter.
As described above, by arranging the leaf spring inside the distal end portion of the catheter, when the manipulation wire is pulled, its shape can be changed on the same plane (bent in a direction perpendicular to the plane of the leaf spring). .

  However, in the mechanism shown in Patent Document 1, the lumen of the catheter is occupied by a deflection operation mechanism such as a leaf spring, so that the cross-sectional area of the lumen is narrowed, and there is sufficient space for inserting the lead wire of the electrode inside the lumen. There is a problem that cannot be secured.

  In order to solve such a problem, the present applicant has disclosed a catheter shaft having a lumen extending in the axial direction, a leaf spring accommodated in the lumen, and formed with ridges extending in the longitudinal direction. Has been proposed (see Patent Document 2). According to such a tip deflection operable catheter, the width of the leaf spring can be reduced, and the cross-sectional space of the lumen can be effectively used to some extent.

Japanese Patent No. 3232308 JP 2008-245766 A

However, even if the ridges are formed, there is a limit to narrowing the width of the leaf spring, so even the mechanism shown in Patent Document 2 has not sufficiently utilized the cross-sectional space of the lumen.
By the way, in an electrode catheter such as an ablation catheter, when a lead wire of a thermocouple arranged on the central axis of the tip electrode is inserted through the lumen of the catheter, the lead wire is prevented from being bent and kinked. From the viewpoint, it is desirable to insert the lead wire along the central axis of the catheter shaft.

Also, in a catheter shaft having a multi-lumen structure, it is desirable to form a lumen in the center where a lead wire or the like can be inserted.
By forming the lumen at the center of the shaft, the lead wire of the thermocouple can be inserted into the center lumen without bending, and therefore, the kink of the lead wire can be prevented. Also, by forming a lumen in the center of the shaft, the shaft cross section can be used more effectively (a large lumen space can be secured) than when a plurality of lumens are provided near the outer periphery inside the shaft. As a result, it is possible to increase the capacity for accommodating lead wires and the like.

  However, since the leaf spring is disposed along the central axis of the catheter shaft in the mechanism shown in Patent Document 1, a lead wire of a thermocouple or the like cannot be inserted along the central axis of the shaft. In order to avoid interference with the leaf spring, the wire must be bent in the outer peripheral direction and then inserted into the shaft (near the outer periphery).

Further, even when a multi-lumen structure catheter shaft is employed, in the mechanism shown in Patent Document 1, a leaf spring is disposed along the central axis of the catheter shaft, so that a lumen can be formed at the center of the shaft. Can not.
In the mechanism shown in Patent Document 2, it is possible to form a lumen in the center of the shaft by narrowing the width of the leaf spring, but the formed central lumen serves as a housing space for the leaf spring. There is no room for inserting lead wires or the like (see FIGS. 6 and 7 of Patent Document 2).

  On the other hand, if a leaf spring is not arranged to form a lumen in the center of the shaft in a conventional catheter capable of tip deflection operation, the shape of the tip portion of the catheter is changed on the same plane during the deflection operation (shape change). To ensure flatness).

The present invention has been made based on the above situation.
A first object of the present invention is to provide a distal deflection operable catheter that can change the shape of the distal end portion of the catheter on the same plane by a pulling operation of an operation wire, even though the mechanism does not have a leaf spring. There is to do.
A second object of the present invention is a tip-deflable manipulator capable of changing the shape of the tip portion of the catheter on the same plane by pulling the manipulation wire while having a lumen in the center of the shaft. Is to provide.
The third object of the present invention is to provide a catheter capable of operating a tip deflection capable of effectively utilizing the cross section of the shaft and enlarging the capacity of accommodating a lead wire or the like.

(1) The distal deflection operable catheter of the present invention includes a catheter shaft having a flexible portion (hereinafter referred to as “tip flexible portion”) at the distal end, a distal electrode fixed to the distal end of the catheter shaft, An operation wire that extends inside the catheter shaft to bend the distal flexible portion of the catheter shaft, the distal end of which is connected and fixed to the distal electrode or the distal end of the catheter shaft, and the rear end of which can be pulled. And
At least the distal flexible portion of the catheter shaft is a multi-lumen structure having a central lumen and a plurality of sub-lumens arranged at equiangular intervals around the central lumen;
The operation wire is inserted through one of the plurality of sublumens or two sublumens arranged opposite to each other across the central axis of the catheter shaft,
A second imaginary plane (one or more) that intersects the first imaginary plane including the central axis of the catheter shaft and the central axis of the sublumen through which the operation wire is inserted at an angle of 90 ° ± 20 °. Each of at least two sub-lumens having a central axis on the second virtual plane) and opposed to each other across the central axis of the catheter shaft has a bending elastic modulus of 1,500 to 19,000 MPa. It is characterized by being partitioned by a tube made of an elastic modulus resin (hereinafter also referred to as “high elastic modulus resin tube”).

According to the catheter capable of operating a tip deflection having such a configuration, each of at least two sublumens having a central axis on the second imaginary plane and opposed to each other across the central axis of the catheter shaft has a high elastic modulus. By being partitioned by the resin tube, the state becomes similar to the presence of the leaf spring on the second virtual plane, and the distal end flexible portion of the catheter shaft is easily bent in the direction perpendicular to the second virtual plane. . As a result, even if a leaf spring is not disposed inside the distal flexible portion of the catheter shaft, the distal end can be moved along the first virtual plane that intersects the second virtual plane at a certain angle (90 ° ± 20 °). The bending portion can be bent (change its shape on the same plane).
Further, since the central lumen is formed at least at the distal end flexible portion of the catheter shaft, the cross section (inside) of the shaft can be used effectively.

(2) In the distal deflection operable catheter of the present invention, among the plurality of sublumens, the operation wire is inserted into each of the two sublumens arranged opposite to each other across the central axis of the catheter shaft,
A second imaginary plane (one or more) that intersects the first imaginary plane including the central axis of the catheter shaft and the central axis of the sublumen through which the operation wire is inserted at an angle of 90 ° ± 20 °. It is preferable that each of at least two sublumens having a central axis on the second virtual plane) and opposed to each other across the central axis of the catheter shaft is partitioned by a high elastic modulus resin tube.

  According to the catheter having a distal end deflectable operation having such a configuration, even if a leaf spring is not disposed inside the distal end flexible portion of the catheter shaft, the catheter is arranged at a constant angle (90 ° ± 20 °) with respect to the second virtual plane. The tip flexible portion can be bent in both directions (changing its shape on the same plane) along the intersecting first virtual plane.

(3) In the catheter capable of distal deflection operation according to (2), the central axis of the catheter shaft has a central axis on a second virtual plane orthogonal to the first virtual plane among the plurality of sublumens. It is preferable that each of the two sub-lumens arranged opposite to each other with a gap be partitioned by a high elastic modulus resin tube.

  According to the catheter capable of tip deflection operation having such a configuration, each of the two sub-lumens having a central axis on the second virtual plane and arranged opposite to each other across the central axis of the catheter shaft has a high elastic modulus. By being partitioned by the resin tube, the state becomes similar to the presence of the leaf spring on the second virtual plane, and the distal end flexible portion of the catheter shaft is easily bent in the direction perpendicular to the second virtual plane. . As a result, the distal flexible portion can be bent along the first virtual plane perpendicular to the second virtual plane without arranging a leaf spring inside the distal flexible portion of the catheter shaft (on the same plane). The shape can be changed).

(4) In the catheter capable of distal deflection operation according to (2), a center on a second virtual plane intersecting the first virtual plane at an angle (θ ₁ ) of 70 to 80 ° among the plurality of sublumens. A second virtual plane having an axis and intersecting each of the two sub-lumens arranged opposite to each other across the central axis of the catheter shaft at an angle (θ ₂ ) of 100 to 110 ° with respect to the first virtual plane It is preferable that each of the two sub-lumens having a central axis on the top and opposingly arranged across the central axis of the catheter shaft is partitioned by the high elastic modulus resin tube.

  According to the distal deflection operable catheter having such a configuration, two high elastic modulus resin tubes on one operation wire side, and two high elastic modulus resin tubes on the other operation wire side, It is in a state that approximates the presence of a leaf spring on a plane sandwiched by (a virtual plane that bisects the intersection angle of two second virtual planes). As a result, the distal flexible portion is bent along the first virtual plane orthogonal to the plane without changing the leaf spring inside the distal flexible portion of the catheter shaft (the shape changes on the same plane). Can be made).

(5) In the distal deflection operable catheter of the present invention, it is preferable that the high elastic modulus resin constituting the high elastic modulus resin tube is made of an engineering plastic.

(6) In the catheter capable of tip deflection operation of (5), the high elastic modulus resin is preferably made of polyetheretherketone (PEEK).

(7) In the catheter capable of distal deflection operation according to the present invention, the sub-lumen other than the sub-lumen and the central lumen divided by the high-modulus resin tube have a low elastic modulus having a bending elastic modulus of 15 to 1,000 MPa. It is preferably partitioned by a tube made of resin (hereinafter also referred to as “low elastic modulus resin tube”).

(8) In the catheter capable of distal deflection operation of (7), the low elastic modulus resin is preferably made of a fluororesin.

According to the distal deflection operable catheter of the present invention, although the leaf spring is not disposed inside the distal flexible portion of the catheter shaft, the operation wire is pulled along the first virtual plane by the pulling operation. The distal flexible portion can be bent, and the shape of the distal flexible portion of the catheter shaft can be changed on the same plane (to ensure the flatness of the shape change).
Further, the distal deflection operable catheter of the present invention effectively utilizes the cross section of the shaft by not providing a leaf spring as a deflection mechanism and by forming a central lumen in the distal flexible portion of the catheter shaft. It is possible to increase the capacity of the lead wires and the like, and increase the flow rate in the irrigation.

It is a schematic front view of the electrode catheter which concerns on one Embodiment of this invention. It is a longitudinal cross-sectional view (II-II sectional drawing) which shows the front-end | tip part of the electrode catheter shown in FIG. It is III-III sectional drawing of FIG. It is a longitudinal cross-sectional view which shows the front-end | tip part of the electrode catheter which concerns on other embodiment of this invention. It is VV sectional drawing of FIG.

<First Embodiment>
The electrode catheter 100 as a catheter capable of tip deflection operation according to an embodiment of the present invention is used, for example, for diagnosis or treatment of arrhythmia in the heart.
The electrode catheter 100 of this embodiment shown in FIGS. 1 to 3 includes a catheter shaft 10 having a distal end flexible portion 10A, a distal end electrode 20 fixed to the distal end of the catheter shaft 10, and a distal end flexibility of the catheter shaft 10. In order to bend the ring-shaped electrode 22 attached to the portion and the distal flexible portion 10A of the catheter shaft 10 in the first direction (the direction indicated by the arrow A in FIGS. 1 and 3), the inside of the catheter shaft 10 The first operation wire 31 that extends, the distal end of which is connected and fixed to the distal electrode 20, and the rear end of which can be pulled, and the distal flexible portion 10A of the catheter shaft 10 are moved in the second direction (in FIGS. 1 and 3). In order to bend in the direction indicated by arrow B), it extends inside the catheter shaft 10 and its tip is connected and fixed to the tip electrode 20, and then A control handle 70 attached to the rear end of the catheter shaft 10; the distal flexible portion 10A of the catheter shaft 10 has a central lumen 11C and 45 around it. A multi-lumen structure having eight sub-lumens 111 to 118 arranged at intervals of °; sub-lumens 111 and sub-lumens 115 arranged opposite to each other across the central axis (O) of the catheter shaft 10 are respectively The first operation wire 31 and the second operation wire 32 are inserted; the central axis of the sub-lumen 111 through which the first operation wire 31 is inserted, the central axis (O) of the catheter shaft 10, and the second operation wire In the second virtual plane P2 perpendicular to the first virtual plane P1 including the central axis of the sub-lumen 115 through which 32 is inserted. A sub-lumen 113 and a sub-lumen 117 each having a central axis and opposed to each other across the central axis (O) of the catheter shaft 10 are partitioned by the high elastic modulus resin tube 13, and the other six sub-lumens ( Each of the sub-lumens 111, 112, 114, 115, 116, 118) is defined by the low elastic modulus resin tube 12, and the central lumen 11C is defined by the low elastic modulus resin tube 12C.

  As shown in FIG. 1, the electrode catheter 100 includes a catheter shaft 10, a distal electrode 20 fixed to the distal end thereof, a ring-shaped electrode 22 attached to the distal flexible portion of the catheter shaft 10, and the catheter shaft 10. And a control handle 70 attached to the rear end.

  The distal end region of the catheter shaft 10 is a distal flexible portion 10A. Here, the “tip flexible portion” refers to the tip portion of the catheter shaft that can be bent (bent) by pulling the operation wire (the first operation wire 31 or the second operation wire 32). Say.

The outer diameter of the catheter shaft 10 is usually 0.6 to 3 mm, preferably 1.3 to 2.4 mm.
The length of the catheter shaft 10 is usually 400 to 1500 mm, preferably 700 to 1200 mm.
The length of the tip flexible portion 10A is, for example, 30 to 300 mm, and preferably 50 to 250 mm.

A control handle 70 is attached to the rear end of the catheter shaft 10. A connector (not shown) having a plurality of terminals is provided in the control handle 70, and conductors (not shown) connected to the tip electrode 20 and the ring electrode 22 are connected to the terminals of the connector. Is done.
The control handle 70 is equipped with a knob 75 for performing an operation of bending the distal end flexible portion 10A of the catheter shaft 10.

The distal flexible portion 10A of the catheter shaft 10 is formed of a multi-lumen structure.
As shown in FIGS. 2 and 3, the distal flexible portion 10A (multi-lumen structure) includes an inner (core) portion in which a central lumen 11C and sub-lumens 111 to 118 are formed, and an outer (core) covering the inner portion. Shell) portion 19.

The diameter of the central lumen 11C is usually 0.2 to 2.0 mm, preferably 0.4 to 1.0 mm.
Further, the diameter of the sublumens 111 to 118 is usually 0.15 to 0.75 mm, and preferably 0.25 to 0.40 mm.

The first operation wire 31 is inserted through the sub-lumen 111 formed in the distal flexible portion 10A, and the second operation wire 32 is inserted through the sub-lumen 115.
In FIG. 3, P <b> 1 is a first virtual plane that includes the central axis of the sublumen 111, the central axis (O) of the catheter shaft 10, and the central axis of the sublumen 115.

The inner portion of the distal flexible portion 10A is formed by binding and fixing a tube that partitions each of the central lumen 11C and the sub-lumens 111 to 118 with a binder resin 14.
The binder resin 14 constituting the inner portion has a low hardness (for example, a durometer (D type) hardness (hereinafter abbreviated as “D hardness”) 25) and a low flexural modulus (for example, about 15 MPa). The nylon elastomer can be illustrated.

  The central lumen 11C of the distal flexible portion 10A is partitioned by a low elastic modulus resin tube 12C, and each of the sub-lumens 111, 112, 114, 115, 116 and 118 is partitioned by the low elastic modulus resin tube 12.

The bending elastic modulus of the low elastic modulus resin tube 12C and the “low elastic modulus resin” constituting the low elastic modulus resin tube 12 is usually 15 to 1,000 MPa, preferably 100 to 800 MPa, more preferably 350 to 600 MPa. It is said. The low elasticity resin preferably has a D hardness of 64 or less.
In the present invention, “flexural modulus” is measured in accordance with JIS K 7171.
The low elastic modulus resin is not particularly limited as long as it has the above-described conditions and can be formed into a tube shape. From the viewpoint of excellent ease of movement of the member to be inserted, a material made of a fluororesin is preferable. Examples of the fluororesin constituting the low elastic modulus resin tube include polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), and tetrafluoroethylene-hexafluoropropylene copolymer (FEP). Can be illustrated.
The wall thickness of the low elastic modulus resin tube 12C is usually 30 to 100 μm, preferably 50 to 70 μm.
The thickness of the low elastic modulus resin tube 12 is usually 10 to 50 μm, preferably 20 to 30 μm.

The sub-lumen 113 and the sub-lumen 117 of the distal flexible portion 10 </ b> A are each partitioned by a high elastic modulus resin tube 13.
In FIG. 3, P <b> 2 is a second imaginary plane including the central axis of the sublumen 113, the central axis (O) of the catheter shaft 10, and the central axis of the sublumen 117, and is partitioned by the high elastic modulus resin tube 13. It is a virtual plane including the central axis of two sub-lumens. As shown in the figure, the second virtual plane P2 and the virtual plane P1 are orthogonal to each other.

The flexural modulus of the “high modulus resin” constituting the high modulus resin tube 13 is usually 1,500 to 19,000 MPa, preferably 2,000 to 7,000 MPa, more preferably 3,500 to. The pressure is set to 4,200 MPa. The D hardness of the high modulus resin is preferably 72 or more.
By disposing the high elastic modulus resin tube 13 made of a resin having a bending elastic modulus in such a range as a tube that divides each of the sublumen 113 and the sublumen 117, the second virtual plane including these central axes is arranged. As a result, the distal end flexible portion 10A of the catheter shaft 10 is easily bent in the direction perpendicular to the second virtual plane P2. As a result, the distal end flexibility can be provided along the first virtual plane P1 perpendicular to the second virtual plane (in the direction perpendicular to the second virtual plane) without arranging a leaf spring inside the distal flexible portion of the catheter shaft. The part 10A can be bent, that is, its shape can be changed on the same plane.

  When this bending elastic modulus is less than 1,500 MPa, it is difficult to bend the distal flexible portion of the catheter shaft along the first virtual plane P1, and it is difficult to ensure flatness of shape change. .

  The high elastic modulus resin constituting the high elastic modulus resin tube 13 is not particularly limited as long as it has the above conditions and can be molded into a tube shape. A well-known engineering plastic etc. can be used conveniently. Specifically, polyether ether ketone (PEEK), polyimide and the like can be exemplified, and among these, PEEK is preferable from the viewpoint of forming a tube having good adhesion to the binder resin 14 (nylon elastomer). .

In the present embodiment (the present invention), a tube (high elasticity) for the binder resin 14 is obtained by using a high-strength resin instead of a metal material or a metal knitted material as a tube material that partitions the sub-lumen 113 and the sub-lumen 117. The adhesiveness of the resin tube 13) can be made much better than a tube made of a metal (braided) material.
As a result, the close contact state between the high elastic modulus resin tube 13 and the binder resin 14 can be reliably maintained by a shearing force that repeatedly acts between the two (adhesion surface) during the tip deflection operation. On the other hand, when a tube made of a metal (braided) material is used, the tube peels off from the binder resin during the tip deflection operation, and protrudes from the tip of the catheter or impairs the tip deflection operability. Sometimes.

  The wall thickness of the high modulus resin tube 13 is usually 10 to 50 μm, preferably 20 to 30 μm.

  In order to arrange the sub-lumens 111 to 118 at equiangular intervals (45 ° intervals) around the central lumen 11C, tubes that define the sub-lumens 111 to 118 (the low elastic modulus resin tube 12 and the high elastic modulus resin tube). The outer diameters of 13) are all equal.

  The outer diameters of the low elastic modulus resin tube 12 and the high elastic modulus resin tube 13 (sublumen diameter + tube thickness × 2) are usually 0.17 to 0.85 mm, preferably 0.29 to 0. .46 mm.

  The outer portion 19 of the distal flexible portion 10A is made of a resin material that covers the inner portion (the low elastic modulus resin tube 12C, the low elastic modulus resin tube 12 and the high elastic modulus resin tube 13 bound by the binder resin 14). .

  As shown in FIG. 2, the outer portion 19 constitutes the distal end flexible portion 10A and the catheter shaft 10 (tube member) on the rear end side of the distal end flexible portion 10A.

The outer portion 19 may be composed of tubes having the same physical properties along the axial direction, but it is preferable that the rigidity (hardness) increases stepwise toward the rear end side.
If a specific example of the change in hardness in the outer portion 19 (the tube material constituting the catheter shaft 10 on the rear end side of the distal end flexible portion 10A) is shown, the total length is 1100 mm, and the length of the distal end flexible portion 10A is 70 mm. In a certain catheter shaft 10, the D hardness of 0 to 50 mm from the tip is 40 (the bending elastic modulus of the resin constituting the portion is 84 MPa), and the D hardness of 50 to 60 mm from the tip is 55 (the bending of the resin constituting the portion). The elastic modulus is 160 MPa, the D hardness of 60 to 65 mm from the tip is 63 (the bending elastic modulus of the resin constituting the portion is 290 MPa), and the D hardness of 65 to 1100 mm from the tip is 72 (the bending of the resin constituting the portion). The elastic modulus is 730 MPa).

  The thickness of the outer portion 19 is preferably about 3 to 15% of the outer diameter of the catheter shaft 10.

A rear end side portion of the distal end flexible portion 10A of the catheter shaft 10 is configured by a hollow tube member (a single lumen structure by a tube member corresponding to the outer portion 19).
As shown in FIG. 2, a coil tube 54 is mounted inside the portion on the rear end side from the tip flexible portion 10A.
The coil tube 54 is configured by winding a wire having a rectangular cross section or a circular shape in a coil shape so as to receive a reaction force of a tensile force acting on the first operation wire 31 or the second operation wire 32. It has become.
Accordingly, when a tensile force is applied to the first operation wire 31 or the second operation wire 32, the portion of the catheter shaft 10 to which the coil tube 54 is attached (the rear end side of the distal end flexible portion 10A). Can be prevented from bending.

  A tip electrode 20 is fixed to the tip (distal end) of the catheter shaft 10. A ring-shaped electrode 22 is attached to the distal flexible portion 10A of the catheter shaft 10. A method for fixing the tip electrode 20 and the ring electrode 22 is not particularly limited, and examples thereof include a method such as adhesion.

The tip electrode 20 and the ring electrode 22 are made of a metal having good electrical conductivity, such as aluminum, copper, stainless steel, gold, or platinum. In addition, in order to give the contrast property with respect to a X-ray favorable, it is preferable to comprise with platinum etc.
The outer diameters of the tip electrode 20 and the ring electrode 22 are not particularly limited, but are preferably approximately the same as the outer diameter of the catheter shaft 10.

  The electrode catheter 100 of the present embodiment includes a first operation wire 31 for bending the distal flexible portion 10A of the catheter shaft 10 in the first direction (the direction indicated by the arrow A), and the distal flexible portion of the catheter shaft 10. A second operation wire 32 for bending 10A in the second direction (the direction indicated by arrow B) is provided.

The first operation wire 31 constituting the electrode catheter 100 is inserted inside the catheter shaft 10 (sublumen 111 in the distal end flexible portion 10A) so as to be movable in the tube axis direction.
The tip of the first operation wire 31 is connected and fixed to the tip electrode 20 by solder 60 filled in the internal space of the tip electrode 20.
Further, the rear end of the first operation wire 31 can be pulled by being connected to a knob 75 of the control handle 70.

On the other hand, the second operation wire 32 constituting the electrode catheter 100 is inserted inside the catheter shaft 10 (sublumen 115 in the distal end flexible portion 10A) so as to be movable in the tube axis direction.
The tip of the second operation wire 32 is connected and fixed to the tip electrode 20 by solder 60 in the same manner as the first operation wire 31.
Further, the rear end of the second operation wire 32 can be pulled by being connected to a knob 75 of the control handle 70.

Examples of the constituent material of the first operation wire 31 and the second operation wire 32 include metals such as stainless steel and Ni—Ti superelastic alloy.
The outer diameters of the first operation wire 31 and the second operation wire 32 are not particularly limited, but are preferably 0.10 to 0.30 mm, and more preferably 0.21 to 0.28 mm. A preferable example is 0.26 mm.

  The material of the solder 60 for connecting and fixing each of the first operation wire 31 and the second operation wire 32 to the tip electrode 20 is not particularly limited. For example, Sn-Pb is generally used. Although Sn-Pb-Ag or Sn-Pb-Cu may be used, Pb-free Sn-Ag-Cu, Sn-Cu, Sn-Ag, Sn-Ag-Cu-Bi, etc. should be used. Can do.

According to the electrode catheter 100 of this embodiment, the sublumen has a central axis on the second virtual plane P2 orthogonal to the first virtual plane P1, and is disposed opposite to the central axis (O) of the catheter shaft 10. 113 and sub-lumen 117 are each partitioned by the high elastic modulus resin tube 13 so that the resistance force (when bending the distal flexible portion 10A of the catheter shaft 10 along the second virtual plane P2) ( Bending stress) is greater than the resistance force when the distal flexible portion 10A is bent along the vertical direction of the second virtual plane P2, and a leaf spring exists on the second virtual plane P2. It becomes a state approximated to.
As a result, even if the leaf spring is not disposed inside the distal end flexible portion 10A of the catheter shaft 10, the first virtual plane P1 orthogonal to the second virtual plane P2 (the vertical direction of the second virtual plane P2). B) The tip flexible portion 10A can be bent (the shape thereof can be changed on the first virtual plane P1).

Accordingly, when the knob 75 of the control handle 70 is rotated in the A1 direction shown in FIG. 1, the first operation wire 31 is pulled and moved to the rear end side of the sub-lumen 111, and the distal end flexible portion 10A is moved to the first end. The shape can be continuously changed by bending in the first direction (the direction indicated by the arrow A perpendicular to the second virtual plane P2) along one virtual plane P1.
On the other hand, when the knob 75 of the control handle 70 is rotated in the direction B1 shown in FIG. 1, the second operation wire 32 is pulled and moved to the rear end side of the sub-lumen 115, and the distal end flexible portion 10A is moved to the first end. The shape can be continuously changed along the virtual plane P1 by bending in the second direction (direction indicated by the arrow B perpendicular to the second virtual plane P2).
Then, if the control handle 70 is rotated around the axis, the directions in the first direction and the second direction with respect to the catheter 100 can be freely set while being inserted into the body cavity.

In addition, according to the electrode catheter 100 of the present embodiment, the flatness of the shape change of the distal end flexible portion 10A can be ensured without arranging the leaf spring, so that the leaf spring is arranged in the conventional catheter. Since the central lumen 11C can be formed at the position where it has been placed, the cross section of the catheter shaft 10 can be used effectively (a large space can be secured inside the catheter shaft 10). Capacity can be expanded.
Further, when the irrigation mechanism is mounted on the electrode catheter 100, the flow rate of the liquid in the catheter shaft 10 (and thus the amount of liquid to be ejected) can be increased.
Further, when a thermocouple or the like is disposed on the central axis of the tip electrode 20, by inserting the lead wire through the central lumen 11C of the catheter shaft 10, it is possible to reliably prevent the lead wire from being bent and kinked. can do.

Second Embodiment
Similar to the electrode catheter 100 of the first embodiment, the electrode catheter 150 as a catheter capable of tip deflection operation according to another embodiment of the present invention is used for diagnosis or treatment of arrhythmia in the heart.
The electrode catheter 150 of the present embodiment shown in FIGS. 4 to 5 is attached to the catheter shaft 15 having the distal end flexible portion 15A, the distal end electrode 20 fixed to the distal end, and the distal end flexible portion of the catheter shaft 15. In order to bend the ring-shaped electrode 22 and the distal flexible portion 15A of the catheter shaft 15 in the first direction (the direction indicated by the arrow A in FIG. 5), it extends inside the catheter shaft 15 and its distal end For bending the first operation wire 31 connected and fixed to the distal electrode 20 and pulling the rear end thereof, and the distal flexible portion 15A of the catheter shaft 15 in the second direction (the direction indicated by the arrow B in FIG. 5). And a second operation wire 32 extending inside the catheter shaft 15, having a distal end connected and fixed to the distal electrode 20 and capable of pulling the rear end. That.
The overall appearance of the electrode catheter 150 is the same as that of the electrode catheter 100 according to the first embodiment shown in FIG.
4 and 5, the same reference numerals are used for the same or corresponding components as those in the first embodiment.

As shown in FIG. 5, the distal flexible portion 15A of the catheter shaft 15 is a multi-lumen structure having a central lumen 16C and ten sub-lumens 160 to 169 arranged around the central lumen 16C at intervals of 36 °. Yes; the first operation wire 31 and the second operation wire 32 are inserted through the sub-lumen 161 and the sub-lumen 166, respectively, which are opposed to each other across the central axis (O) of the catheter shaft 15; With respect to the first virtual plane P1 including the central axis of the sub-lumen 161 through which the working wire 31 is inserted, the central axis (O) of the catheter shaft 15 and the central axis of the sub-lumen 166 through which the second operation wire 32 is inserted. angle (θ ₁ = 72 °) has a central axis on a second imaginary plane P21 that intersect at, opposite sides the central axis of the catheter shaft 15 (O) Has a respective sub-lumen 163 and the sub lumen 168 location, the central axis relative to the first virtual plane P1 to the second virtual plane P22 that intersect at an angle (θ ₂ = 108 °), the catheter shaft 15 Each of the sub-lumens 164 and sub-lumens 169 arranged opposite to each other across the central axis (O) is partitioned by the high elastic modulus resin tube 13, and the other six sub-lumens (sublumens 160, 161, 162, 165). 166, 167) are defined by the low elastic modulus resin tube 17, and the central lumen 16C is defined by the low elastic modulus resin tube 17C.

  The distal flexible portion 15A (multi-lumen structure) of the catheter shaft 15 includes an inner (core) portion in which the central lumen 16C and the sub-lumens 160 to 169 are formed, and an outer (shell) portion 19 that covers the inner portion. Become.

  The diameter of the central lumen 16C is usually 0.2 to 2.0 mm, preferably 0.4 to 1.0 mm. Further, the diameter of the sublumens 160 to 169 is usually 0.1 to 0.5 mm, preferably 0.20 to 0.40 mm.

The first operation wire 31 is inserted through the sub-lumen 161 formed in the distal end flexible portion 15A, and the second operation wire 32 is inserted through the sub-lumen 166.
In FIG. 5, P <b> 1 is a first virtual plane that includes the central axis of the sub-lumen 161, the central axis (O) of the catheter shaft 15, and the central axis of the sub-lumen 166.

The inner portion of the distal end flexible portion 15 </ b> A is formed by binding and fixing a tube that divides each of the central lumen 16 </ b> C and the sub-lumens 160 to 169 with a binder resin 14.
Here, the central lumen 16C of the distal end flexible portion 15A is partitioned by the low elastic modulus resin tube 17C, and each of the sub-lumens 160, 161, 162, 165, 166 and 167 is partitioned by the low elastic modulus resin tube 17. Yes.

The “low elastic modulus resin” constituting the low elastic modulus resin tube 17C and the low elastic modulus resin tube 17 is the same as that constituting the low elastic modulus resin tube 12C and the low elastic modulus resin tube 12 in the first embodiment. .
The wall thickness of the low elastic modulus resin tube 17C is usually 30 to 100 μm, preferably 50 to 70 μm.
Further, the thickness of the low elastic modulus resin tube 17 is usually 10 to 50 μm, preferably 20 to 30 μm.

Sub-lumen 163, sub-lumen 164, sub-lumen 168 and sub-lumen 169 of the distal end flexible portion 15A are partitioned by a high elastic modulus resin tube 18.
In FIG. 5, P <b> 21 is a second virtual plane that includes the central axis of the sublumen 163, the central axis (O) of the catheter shaft 15, and the central axis of the sublumen 168, and is partitioned by the high elastic modulus resin tube 18. It is a virtual plane including the central axis of two sub-lumens. As shown in the figure, the intersection angle (θ ₁ ) between the second virtual plane P21 and the first virtual plane P1 is 72 °.
P22 is a second imaginary plane including the central axis of the sublumen 164, the central axis (O) of the catheter shaft 15, and the central axis of the sublumen 169. This is a virtual plane that includes the central axis of the sublumen. The intersection angle (θ ₂ ) between the second virtual plane P22 and the first virtual plane P1 is 108 °.

The “high modulus resin” constituting the high modulus resin tube 18 is the same as that constituting the high modulus resin tube 13 in the first embodiment.
By disposing the high elastic modulus resin tube 18 as a tube that partitions each of the sublumen 163, the sublumen 164, the sublumen 168, and the sublumen 169, two high elastic moduli that partition the sublumen 163 and the sublumen 169. A plane sandwiched between the resin tube 18 and the two high elastic modulus resin tubes 18 that define the sub-lumen 164 and the sub-lumen 168 (the angle at which the second virtual plane P21 and the second virtual plane P22 intersect is bisected) It becomes a state approximate to the presence of the leaf spring on the virtual plane). As a result, the distal flexible portion 15A is bent along the first virtual plane P1 perpendicular to the plane without changing the leaf spring inside the flexible distal portion 15A (the shape changes on the same plane). Can be made).

  The thickness of the high modulus resin tube 18 is usually 10 to 50 μm, preferably 20 to 30 μm.

  In order to arrange the sub-lumens 160 to 169 around the central lumen 16C at equiangular intervals (36 ° intervals), tubes that define the sub-lumens 160 to 169 (the low elastic modulus resin tube 17 and the high elastic modulus resin tube). The outer diameters of 18) are all equal.

  The outer diameters of the tubes (the low elastic modulus resin tube 17 and the high elastic modulus resin tube 18) that define the sublumen are usually 0.12 to 0.60 mm, preferably 0.24 to 0.46 mm. .

  The outer portion 19 of the distal end flexible portion 15A is made of a resin material that covers the inner portion (the low elastic modulus resin tube 17C, the low elastic modulus resin tube 17 and the high elastic modulus resin tube 18 bound by the binder resin 14). .

  The electrode catheter 150 of the present embodiment includes a first operation wire 31 for bending the distal flexible portion 15A of the catheter shaft 15 in the first direction (the direction indicated by the arrow A) and the distal flexible portion of the catheter shaft 15. A second operation wire 32 for bending 15A in the second direction (the direction indicated by arrow B) is provided.

The first operation wire 31 is inserted in the catheter shaft 15 (movable in the distal end flexible portion 15A) movably in the tube axis direction.
The tip of the first operation wire 31 is connected and fixed to the tip electrode 20 by solder 60 filled in the internal space of the tip electrode 20.
Further, the rear end of the first operation wire 31 can be pulled by being connected to a knob 75 of the control handle 70.

On the other hand, the second operation wire 32 is inserted inside the catheter shaft 10 (sublumen 166 in the distal end flexible portion 15A) so as to be movable in the tube axis direction.
The tip of the second operation wire 32 is connected and fixed to the tip electrode 20 by solder 60 in the same manner as the first operation wire 31.
Further, the rear end of the second operation wire 32 can be pulled by being connected to a knob 75 of the control handle 70.

According to the electrode catheter 150 of the present embodiment, among the 10 sub-lumens arranged at equal angular intervals around the central lumen 16C in the distal end flexible portion 15A of the catheter shaft 10, the first virtual plane P1 is defined. Two sub-lumens (sub-lumens 163 and 163) having a central axis on the second virtual plane P21 intersecting at an angle (θ ₁ ) of 72 ° and opposed to each other across the central axis (O) of the catheter shaft 15 Each sub-lumen 168) has a central axis on a second virtual plane P22 that intersects the first virtual plane P1 at an angle (θ ₂ ) of 108 °, and the central axis (O) of the catheter shaft 15 is Each of the two sub-lumens (sub-brumen 164 and sub-lumen 169) arranged opposite to each other is partitioned by the high elastic modulus resin tube 18. Each of the remaining six sub-lumens (sub-lumens 160, 161, 162, 165, 166 and 167) is partitioned by the low elastic modulus resin tube 17 so that the operation wire 31 is disposed on the side ( Two high elastic modulus resin tubes (the high elastic modulus resin tube 18 that defines the sub-lumen 163 and the sub-lumen 169) on the upper side of FIG. 5 and the side on which the operation wire 32 is disposed (the lower side of FIG. 5). ) Between the two high elastic modulus resin tubes (the high elastic modulus resin tubes 18 that define the sub-lumen 164 and the sub-lumen 168) (intersection angle between the second virtual plane P21 and the second virtual plane P22) It is a state that approximates the presence of a leaf spring on a virtual plane that bisects. As a result, the distal end flexible portion 15A is bent along the first virtual plane P1 orthogonal to the plane sandwiched between the high elastic modulus resin tubes 18 without arranging a leaf spring inside the distal end flexible portion 15A. (Change its shape on the same plane).

Accordingly, the first operation wire 31 moves to the rear end side of the sub-lumen 161 along with the pulling operation of the first operation wire 31, and the distal end flexible portion 15A moves along the first virtual plane P1. It can bend in the direction (direction shown by arrow A in FIGS. 1 and 5), and its shape can be continuously changed.
On the other hand, with the pulling operation of the second operation wire 32, the second operation wire 32 moves to the rear end side of the sub-lumen 166, and the distal end flexible portion 15A moves in the second direction along the first virtual plane P1. It can bend in the direction indicated by arrow B in FIGS. 1 and 5 and its shape can be continuously changed.
Then, if the control handle 70 is rotated around the axis, the directions of the first direction and the second direction with respect to the catheter 150 can be freely set while being inserted into the body cavity.

As mentioned above, although embodiment of this invention was described, this invention is not limited to these, A various change is possible.
For example, the number of sublumens is not 8 (first embodiment) or 10 (second embodiment), but 4 to 16 sublumens may be formed.
Also, the number of second virtual planes is not limited to one (first embodiment) or two (second embodiment), but may be three or more. That is, the number of high elastic modulus resin tubes is not two (first embodiment) or four (second embodiment), but may be six or more.
The number of operation wires may be one (single direction type).

DESCRIPTION OF SYMBOLS 100 Electrode catheter 10 Catheter shaft 10A Tip flexible part 11C Central lumen 111-118 Sublumen 12 Low elastic modulus resin tube 12C Low elastic modulus resin tube 13 High elastic modulus resin tube 14 Binder resin 19 Outer (shell) part 15 Catheter shaft 15A Tip flexible portion 16C Central lumen 160-169 Sublumen 17 Low modulus resin tube 17C Low modulus resin tube 18 High modulus resin tube 20 Tip electrode 22 Ring electrode 31 First operation wire 32 Second operation wire 60 Solder 70 Control handle 75 Pick

Claims (8)

A catheter shaft having a flexible portion at the distal end, a distal electrode fixed to the distal end of the catheter shaft, and the flexible portion of the catheter shaft are bent to extend inside the catheter shaft. An operation wire that is connected and fixed to the distal end portion of the distal electrode or the catheter shaft and capable of pulling the rear end thereof,
At least the flexible portion of the catheter shaft is a multi-lumen structure having a central lumen and a plurality of sub-lumens arranged at equiangular intervals around the central lumen;
The operation wire is inserted through one of the plurality of sublumens or two sublumens arranged opposite to each other across the central axis of the catheter shaft,
Having a central axis on a second virtual plane that intersects at a 90 ° ± 20 ° angle with respect to the first virtual plane including the central axis of the catheter shaft and the central axis of the sublumen through which the operation wire is inserted. Each of the at least two sublumens arranged opposite to each other across the central axis of the catheter shaft is partitioned by a tube made of a high elastic modulus resin having a bending elastic modulus of 1,500 to 19,000 MPa. A catheter capable of tip deflection operation. Among the plurality of sublumens, the operation wire is inserted into each of the two sublumens arranged opposite to each other across the central axis of the catheter shaft,
Having a central axis on a second virtual plane that intersects at a 90 ° ± 20 ° angle with respect to the first virtual plane including the central axis of the catheter shaft and the central axis of the sublumen through which the operation wire is inserted. 2. The tip deflection operation according to claim 1, wherein each of at least two sublumens arranged opposite to each other across the central axis of the catheter shaft is partitioned by the tube made of the high elastic modulus resin. catheter.   Of the plurality of sublumens, each of two sublumens having a central axis on a second virtual plane orthogonal to the first virtual plane and arranged to face each other across the central axis of the catheter shaft is The distal-deflectable catheter according to claim 2, wherein the catheter is partitioned by a tube made of a high elastic modulus resin.   Among the plurality of sublumens, 2 has a central axis on a second virtual plane that intersects the first virtual plane at an angle of 70 to 80 °, and is disposed so as to face the central axis of the catheter shaft. Two sub-lumens having a central axis on a second virtual plane that intersects the first virtual plane at an angle of 100 to 110 °, and two opposingly arranged across the central axis of the catheter shaft The catheter according to claim 2, wherein each of the sublumens is partitioned by a tube made of the high elastic modulus resin.   The distal-deflectable catheter according to any one of claims 1 to 4, wherein the high elastic modulus resin is made of an engineering plastic.   6. The distal deflection operable catheter according to claim 5, wherein the high elastic modulus resin is made of polyetheretherketone (PEEK).   The sub-lumen other than the sub-lumen that is partitioned by the tube made of the high elastic modulus resin and the central lumen are defined by the tube made of the low elastic modulus resin having a bending elastic modulus of 15 to 1,000 MPa. A catheter capable of tip deflection operation according to any one of claims 1 to 6, characterized in that:   The distal-deflectable catheter according to claim 7, wherein the low elastic modulus resin is made of a fluororesin.

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