≪ First Embodiment >
The electrode catheter 100 according to one embodiment of the tip deflectable catheter of the present invention is used, for example, for diagnosing or treating arrhythmias in the heart.
The electrode catheter 100 of the present embodiment shown in Figs. 1 to 3 includes a catheter shaft 10 having a distal flexible portion 10A and a cap member 20 connected to the distal end of the catheter shaft 10, Shaped electrode 32 mounted on the distal end flexible portion 10A of the catheter shaft 10 and a twisted wire S In order to bend the distal end flexible portion 10A of the catheter shaft 10 in the first direction (the direction indicated by the arrow A in Figs. 1 and 2), the catheter shaft 10 is inserted into the catheter shaft 10 And a distal end of the catheter shaft 10 is connected to a distal end of the catheter shaft 10 by a connecting member 20 and a first operation wire 41 capable of performing a tension operation on a rear end thereof and a twisted wire In order to bend the portion 10A in the second direction (the direction indicated by the arrow B in Figs. 1 and 2), the catheter shaft 10 A second operation wire 42 which is inserted into the inside of the catheter shaft 10 and whose distal end is connected and fixed to the diaphragm member 20 and whose rear end is to be tensioned, A leaf spring 60 for swing disposed in the inside of the catheter shaft 10A, a control handle 70 mounted at the rear end of the catheter shaft 10,
The distal end flexible portion 10A of the catheter shaft 10 is a multi lumen structure in which six lumen tubes 11 to 16 for forming the lumens 11L to 16L are arranged in a state of being fixed by binder resin ,
Tip flexible part (10A), the catheter shaft 10, the central axis [M 10], the first manipulation wire 41 is the central axis [M 11], and Article 2 of the insertion through the lumen (11L), action of the wire Including a central axis M 10 of the catheter shaft 10 as a plane orthogonal to the first virtual plane P 1 including the central axis M 12 of the lumen 12 L into which the catheter shaft 42 is inserted, a plane P2, the catheter shaft 10, the third imaginary center axis by twisting of the line twisting at an angle (θ) in the same direction as the direction of the [M 10] (in the embodiment being θ = 45 °) formed by the rotation of the An inner tube 51 (high rigidity member) for forming a flow path having a central axis M 51 on the plane P 3 and an inner tube 52 (a high rigidity member) for forming a flow path having a central axis M 52 on the third imaginary plane P 3 the high-stiffness member), across the central axis [10] M of the catheter shaft 10, is arranged opposite.
The electrode catheter 100 of the present embodiment includes a catheter shaft 10, a cap member 20 fixed to the distal end of the catheter shaft 10, a tip electrode 30 fixed to the tip of the cap member 20, Shaped electrode 32 mounted on the distal end flexible portion 10A of the catheter shaft 10 and the first and second operation wires 41 and 41 inserted into the catheter shaft 10, A leaf spring 60 disposed at the distal end flexible portion 10A of the catheter shaft 10, a control handle 70 mounted at the rear end of the catheter shaft 10, (80).
The tip end region of the catheter shaft 10 constituting the electrode catheter 100 is a tip end flexible portion 10A.
Here, the "tip end flexible portion" refers to a portion of the catheter shaft which can be bent (bent) by pulling the rear end of the operation wire (the first operation wire 41 or the second operation wire 42) it means.
The outer diameter of the catheter shaft 10 is typically 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 leading end flexible portion 10A is, for example, 30 to 300 mm, 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 lead wires (also not shown) connected to each of the tip electrodes 30 and the three ring- The lead wire 30L and the lead wire 32L shown in Fig. 2) are connected.
The control handle 70 is also provided with a handle 75 for performing a pulling operation when the distal end flexible portion 10A of the catheter shaft 10 is bent.
The injection tube 80 shown in Figure 1 is connected to the catheter shaft 10 through the interior of the control handle 70 and is connected to the inside of the catheter shaft 10 The interior of the inner tubes 51 and 52).
As the " liquid ", physiological saline can be mentioned.
The distal end flexible portion 10A of the catheter shaft 10 is made of a multi-lumen structure.
2, the tip end flexible portion 10A includes an inner (core) portion 18 in which the lumen tubes 11 to 16 are fixed by a binder resin, a resin (resin) covering the inner portion 18, And lumens 11L to 16L are formed inside each of the lumen tubes 11 to 16 constituting the inner portion 18. The lumens 11L to 16L are formed in the lumen tube 11 to 16,
The D hardness (hardness measured by the durometer (D type)) of the binder resin constituting the inner portion 18 is, for example, 40 or less, preferably 25 to 35. [
The bending elastic modulus of the binder resin constituting the inner portion 18 (bending elastic modulus measured in accordance with JIS K 7171) is, for example, 80 MPa or less, preferably 10 to 30 MPa.
Examples of the resin material constituting the inner portion 18 include nylon resin, polyether block polyamide resin, polyurethane resin, and polyolefin resin.
The center of the lumen formed in the distal end flexible portion (10A), (11L and 12L), the catheter shaft, and 10 is the center is placed oppositely disposed between the axis [M 10], the lumen (11L) (lumen tube 11) The central axis M 12 of the axis M 11 and the lumen 12L (lumen tube 12) is located above the first virtual plane P 1.
The inner diameters of the lumens 11L and 12L are preferably 0.15 to 0.50 mm, and more preferably 0.20 to 0.40 mm.
2, a first operation wire 41 for bending the distal end flexible portion 10A of the catheter shaft 10 in a first direction indicated by an arrow A is inserted into the lumen 11L, . The first operation wire 41 is inserted through the catheter shaft 10 (the lumen 11L in the distal end flexible portion 10A) so as to be movable in the axial direction.
The distal end of the first working wire 41 is connected and fixed to the connecting member 20. Further, the rear end of the first operation wire 41 is connected to the handle 75 of the control handle 70, so that the tension operation can be performed.
The lumen 12L is inserted with a second operation wire 42 for bending the distal end flexible portion 10A of the catheter shaft 10 in a second direction indicated by an arrow B. The second operation wire 42 is inserted into the catheter shaft 10 (the lumen 12L in the distal end flexible portion 10A) so as to be movable in the axial direction.
The distal end of the second working wire 42 is fixedly connected to the cap member 20. Further, the rear end of the second operation wire 42 is connected to the handle 75 of the control handle 70 so that the operation can be performed.
The first working wire 41 and the second working wire 42 are each constituted by a twisted wire of S-twist.
By using a twisted wire as the first operation wire 41 and the second operation wire 42, flexibility can be imparted to the tip end flexible portion 10A of the catheter shaft 10, It is possible to improve workability in connecting each of the rear ends of the wire 41 and the second operation wire 42 to the handle 75 of the control handle 70. [
As the twisted wire constituting the first operation wire 41 and the second operation wire 42, a plurality of metal wires made of, for example, stainless steel or a Ni-Ti based superelastic alloy can be formed have.
The outer diameter of the twisted wire constituting the first operation wire 41 and the second operation wire 42 is, for example, 0.10 to 0.30 mm, preferably 0.15 to 0.25 mm, and preferably 0.20 Mm.
The outer diameter of the metal strand for forming the first working wire 41 and the second working wire 42 is, for example, 0.03 to 0.1 mm, preferably 0.04 to 0.07 mm.
The number of strands constituting the twisted wire is, for example, 7 to 19, and a preferable example is seven.
2 and 3, a leaf spring 60 extending in the axial direction of the catheter shaft 10 on the second virtual plane P2 is disposed in the distal end flexible portion 10A.
In this embodiment, the second virtual plane P2 is a virtual plane including the central axis 10 [M] of the first a plane perpendicular to the imaginary plane P1, the catheter shaft 10.
The tip end flexible portion 10A is easily bent in the direction perpendicular to the plane of the leaf spring 60 (second virtual plane P2) by disposing the leaf spring 60 inside the tip end flexible portion 10A.
The center of the lumen formed in the distal end flexible portion (10A), (13L and 14L), the catheter shaft, and 10 is the center is placed oppositely disposed between the axis [M 10], the lumen (13L) (lumen tube 13) axis M [13], and the lumen (14L) (lumen tube 14), the central axis [14] of the M, the second is located on the third imaginary plane P3.
In this embodiment, the third imaginary plane P3, the second virtual the plane P2, around the central axis [M 10] of the catheter shaft 10, the first manipulation wire 41 and the second manipulation wire (Counterclockwise in Fig. 2) that is the same as the direction of twist of the twisted wire constituting the wedge member 42 in Fig.
The "direction of twist of the twisted wire" is a direction in which the twisted wires (the first operation wire 41 and the second operation wire 42) formed by the twisted wires are twisted in the twist direction Direction), and when the rear end of the operation wire is subjected to a tensile operation, a direction opposite to the direction in which the distal end side of the operation wire rotates (the direction in which the twist is released).
The inner diameters of the lumens 13L and 14L are preferably 0.25 to 1.00 mm, and more preferably 0.40 to 0.90 mm.
As shown in Fig. 2, a passage forming inner tube 51 (hereinafter referred to as " passage forming tube 51 ") is inserted through the lumen 13L as a high rigidity member, [M 51 ] coincides with the center axis [M 13 ] of the lumen 13L.
Further, the lumen (14L), the high and a rigid member inner tube 52, the passage-forming (hereinafter referred to as "passage-forming tube 52") are inserted through, the central axis [M 52], the Coincides with the central axis [M 14 ] of the lumen 14L.
In the inside of the flow path forming tubes 51 and 52, a circulating liquid (physiological saline solution) flows.
By sealing the liquid inside the flow path forming tubes 51 and 52, it is possible to improve the sealability (the effect of preventing leakage of the liquid from the lumen) of the circulating liquid.
Examples of the constituent material of the flow path forming tubes 51 and 52 which are high rigidity members include resin materials such as polyimide, polyetheretherketone (PEEK) and nylon 11, and metal materials such as stainless steel and Ni-Ti superelastic alloy Can be used.
The D hardness of the resin constituting the flow path forming tubes 51 and 52 is, for example, 72 or more, and preferably 77 to 95. [
The bending elastic modulus of the resin constituting the flow path forming tubes 51 and 52 is, for example, 1,500 to 19,000 MPa, preferably 2,000 to 7,000 MPa.
The inner diameter of the flow path forming tubes 51 and 52 is preferably 0.20 to 0.95 mm, and more preferably 0.30 to 0.80 mm.
The thickness of the flow path forming tubes 51 and 52 is usually 10 to 100 占 퐉, preferably 20 to 80 占 퐉.
The flow path forming tubes 51 and 52 in which the respective central axes M 51 and M 52 are positioned on the third virtual plane P 3 are opposed to each other with the central axis M 10 of the catheter shaft 10 therebetween, The distal end flexible portion 10A of the catheter shaft 10 is in a form approximate to the leaf spring existing on the third virtual plane P3.
That is, the drag force when the tip flexible portion 10A is bent along the third virtual plane P3 is significantly larger than the drag force when the tip flexible portion 10A is bent in the direction perpendicular to the third virtual plane P3 Thus, the tip end flexible portion 10A is hard to bend along the third virtual plane P3, and is easily bent in a direction perpendicular to the third virtual plane P3.
The center of the distal end flexible portion lumen (15L and 16L) formed in (10A), the catheter shaft, and 10 is the center is placed oppositely disposed between the axis [M 10], the lumen (15L) (lumen tube 15) axis M [15], and the lumen (16L) (lumen tube 16), the central axis [16] M is a and the fourth is located on the virtual plane P4.
In this embodiment, the fourth imaginary plane P4, the second virtual the plane P2, around the central axis [M 10] of the catheter shaft 10, the first manipulation wire 41 and the second manipulation wire (A clockwise direction in Fig. 2) opposite to the twist direction (twist direction at the tip side) of the twisted wire constituting the second electrode 42. [
The inner diameters of the lumens 15L and 16L are the same as the inner diameters of the lumens 13L and 14L.
2, the lead wire 32L of the ring-shaped electrode 32 shown in Fig. 1 is inserted into the lumen 15L, and the lead wire 32L of the lead electrode 30 30L are inserted.
The lumen tubes 11 to 16 forming the lumens 11L to 16L are made of resin.
It is preferable that the resin constituting the lumen tubes 11 to 16 has rigidity (D hardness and flexural modulus) equal to or higher than that of the binder resin constituting the inner portion 18.
The D hardness of the resin constituting the lumen tubes 11 to 16 is, for example, 80 or less, preferably 50 to 75. [
The bending elastic modulus of the resin constituting the lumen tubes 11 to 16 is, for example, 15 to 1,000 MPa, preferably 100 to 800 MPa.
The thickness of the lumen tubes 11 to 16 is usually 10 to 50 占 퐉, preferably 20 to 40 占 퐉.
The resin material constituting the lumen tubes 11 to 16 is not particularly limited as long as it is capable of being formed into a tube shape as long as it has the hardness condition described above. For example, a fluororesin, a nylon resin such as nylon 11 / nylon 12 , A polyurethane resin, a polyolefin resin, or the like can be used, but it is preferable that it is made of a fluorine resin from the viewpoint of excellent lubrication (ease of movement of the member through which the operation wire penetrates) in the tube (lumen).
Specifically, it is possible to use polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), tetrafluoroethylene- Ethylene copolymer (ETFE), and the like.
The outer portion 19 of the leading end flexible portion 10A is made of a resin material that covers the inner portion 18. 3, the outer portion 19 constitutes the distal end flexible portion 10A, and the catheter shaft 10 (tube member) is provided on the rear end side of the distal end flexible portion 10A Respectively.
Here, the D hardness of the resin constituting the outer portion 19 of the tip end flexible portion 10A is, for example, 35 to 63. [
The outer portion 19 (the portion of the distal end flexible portion 10A and the portion of the rear end side than the distal end flexible portion 10A) may be formed of a tube having the same physical properties along the axial direction, It is preferable that the stiffness (hardness) is increased stepwise.
The thickness of the outer portion 19 is preferably about 3 to 15% of the outer diameter of the catheter shaft 10.
As the resin material constituting the outer section 19, a thermoplastic polyamide-based elastomer can be mentioned, and it is preferable that the resin material is a polyester block amide copolymer.
As shown in Fig. 3, the portion of the catheter shaft 10 beyond the distal flexible portion 10A is composed of a hollow tube member (a single lumen structure formed of a tube member corresponding to the outer portion 19) have.
A coil tube 54 is mounted inside the rear end portion of the tip end flexible portion 10A.
The coil tube 54 forms a tube by winding a wire having a square cross section or a circular shape in the form of a coil so that a reaction force of a tensile force acting on the first operation wire 41 or the second operation wire 42 To receive.
Thereby, when a tensile force is exerted on the first operation wire 41 or the second operation wire 42, the portion of the catheter shaft 10 to which the coil tube 54 is attached (the distal end flexible portion 10A (I.e., a portion closer to the rear end side than the rear end side).
A connecting member 20 is connected and fixed to the distal end of the catheter shaft 10.
The cap member 20 is provided with a plurality of (for example, eight (for example, eight) nozzles for spraying the liquid supplied from the catheter shaft 10 (the inside of the flow path forming tubes 51 and 52) (Not shown) are arranged at the same angular intervals along the outer periphery of the cap member 20.
A tip electrode 30 is connected and fixed to the tip end of the cap member 20.
The distal end flexible portion 10A of the catheter shaft 10 is also fitted with a ring-shaped electrode 32. [
The method of fixing the tip electrode 30 and the ring electrode 32 is not particularly limited, and for example, a method such as adhesion may be used.
The tip electrode 30 and the ring electrode 32 are made of a metal having good electrical conductivity, such as aluminum, copper, stainless steel, gold, and platinum. In addition, in order to favorably enhance the X-ray contrast, platinum or the like is preferable.
Although the outer diameter of the tip electrode 30 and the ring electrode 32 is not particularly limited, it is preferably about the same as the outer diameter of the catheter shaft 10.
The pulling operation of the first operation wire 41 is performed by rotating the handle 75 of the control handle 70 constituting the electrode catheter 100 of the present embodiment in the direction A1 shown in Fig.
The distal end side of the first working wire 41 made of the twisted wire of the S-twist in the pulling operation of the first working wire 41 (during the tip deflecting operation) is in the direction of twisting of the twisted wire (Clockwise direction) indicated by an arrow r1).
The rotation torque from the first operation wire 41 is transmitted to the connecting member 20 because the tip end of the first operation wire 41 is connected and fixed to the connecting member 20.
Therefore, when the high-rigidity member such as the tube for forming the flow path is not inserted into each of the lumens 13L and 14L of the tip end flexible portion 10A, the cross member 20 and the cross member 20, The distal end side of the catheter shaft 10 (the distal end flexible portion 10A) to which the catheter shaft 10 is fixed is positioned at the same center as the rotational direction of the first operation wire 41 about the central axis M 10 of the catheter shaft 10 (Clockwise direction indicated by arrow R in Fig. 2).
On the other hand, the rear end side of the tip end flexible portion 10A can not freely rotate like the tip end side, whereby the tip end flexible portion 10A is twisted in the direction indicated by the arrow R, A '.
However, in the electrode catheter 100 of the present embodiment, the flow path forming tubes 51 and 52, which are highly rigid members, are inserted through the lumens 13L and 14L, respectively (the center axis [M 10 ] And the leaf spring is present on the third virtual plane P3 (in this case, the first virtual plane P3 is arranged in a manner of being opposed to the third virtual plane P3) The tip end flexible portion 10A is twisted in the counterclockwise direction and bent in the direction indicated by the arrow A " in Fig. 2, for example), and the tension of the first operation wire 41 It is possible to suppress or prevent the tip end flexible portion 10A from being twisted in the direction indicated by the arrow R (clockwise direction) during operation, and as a result, the tip end flexible portion 10A without twist is divided into the first virtual plane P1 Arrows along It is possible to bend the tip in the first direction shown in Table A (to deflect the tip).
By rotating the handle 75 of the control handle 70 constituting the electrode catheter 100 of the present embodiment in the B1 direction shown in Fig. 1, the pulling operation of the second operation wire 42 is performed All.
In the tensioning operation of the second working wire 42, the tip end side of the second working wire 42, which is formed of the twisted wire of the S-twist, is in the direction of twisting of the twisted wire (Clockwise direction)].
Since the distal end of the second working wire 42 is connected and fixed to the cap member 20, the rotational torque from the second working wire 42 is transmitted to the cap member 20.
Therefore, when the high-rigidity member such as the tube for forming the flow path is not inserted into each of the lumens 13L and 14L of the tip end flexible portion 10A, the cross member 20 and the cross member 20, The distal end side of the catheter shaft 10 (the distal end flexible portion 10A) to which the catheter shaft 10 is fixed is positioned at the same center as the rotational direction of the second operation wire 42 about the central axis M 10 of the catheter shaft 10 (Clockwise direction indicated by arrow R in Fig. 2).
On the other hand, the rear end side of the tip end flexible portion 10A can not freely rotate like the tip end side, whereby the tip end flexible portion 10A is twisted in the direction indicated by the arrow R, B '.
However, in the electrode catheter 100 of the present embodiment, the flow path forming tubes 51 and 52, which are highly rigid members, are inserted through the lumens 13L and 14L, respectively (the center axis [M 10 ] And the plate spring is present on the third imaginary plane P3 (in this form, the second virtual plane P3 is arranged in a direction opposite to the third virtual plane P3) The tip end flexible portion 10A is twisted in the counterclockwise direction and bent in the direction indicated by the arrow B " in Fig. 2, for example) It is possible to suppress or prevent the tip end flexible portion 10A from being twisted in the direction indicated by the arrow R (clockwise direction) during operation, and as a result, the tip end flexible portion 10A without twist is divided into the first virtual plane P1 Arrows along It is possible to bend (deflect the tip) in the second direction shown in Table B. [
Further, by rotating the control handle 70 around the axis, it is possible to freely set the directions of the first and second directions with respect to the electrode catheter 100 in a state of being inserted into the body cavity.
According to the electrode catheter 100 of the present embodiment, the first operation wire 41 and the second operation wire 42 are constituted by twisted wires, and the first operation wire 41 or the second The shape of the tip end flexible portion 10A is changed over substantially the same plane (the first virtual plane P1) by tensioning the rear end of the manipulating wire 42 so that the direction in which the operator intends One direction or the second direction).
≪ Second Embodiment &
The electrode catheter 200 of this embodiment shown in Figs. 4 and 5 includes a catheter shaft 210 having a distal flexible portion 210A and a distal electrode 230 fixed to the distal end of the catheter shaft 210, Shaped electrode 232 mounted on the distal end flexible portion 210A of the catheter shaft 210 and a twisted wire (S twisted), and the tip end flexible portion 210A of the catheter shaft 210 In order to bend the catheter shaft 210 in the first direction (the direction indicated by the arrow A in Figs. 4 and 5), the distal end of the catheter shaft 210 is inserted and fixed to the distal end electrode 230, 4 and 5, the distal end flexible portion 210A of the catheter shaft 210 is made of a first operation wire 241 and a twisted wire (S-twist) And the tip of the catheter shaft 210 is inserted into the catheter shaft 210 so as to be bent at the tip A second operation wire 242 connected and fixed to the pole 230 and capable of tensioning the rear end of the catheter shaft 210 and a leaf spring (not shown) disposed inside the flexible portion 210A along the axial direction of the catheter shaft 210 260 and a control handle 270 mounted at the rear end of the catheter shaft 210,
The distal end flexible portion 210A of the catheter shaft 210 is a multi lumen structure in which six lumen tubes 211 to 216 for forming the lumens 211L to 216L are arranged in a state of being fixed by a binder resin,
The distal end flexible portion 210A is provided with a central axis M 210 of the catheter shaft 210 and a central axis M 211 of the lumen 211L through which the first operation wire 241 is inserted, second virtual to 242 containing a central axis [M 210] of the insertion through the lumen (212L), the center axis as the first orthogonal plane with respect to the imaginary plane P1 catheter shaft 210, including the [M 212] of The plane P2 is rotated by a predetermined angle? (In this embodiment,? = 45 degrees) in the same direction as the twist direction of the twist line about the central axis M 210 of the catheter shaft 210, A high rigidity lumen tube 213 (high rigidity member) having a central axis M 213 on the plane P 3 and a high rigidity lumen tube 214 having a central axis M 214 on the third virtual plane P 3 Are disposed opposite to each other with the central axis M 210 of the catheter shaft 210 interposed therebetween.
The electrode catheter 200 of the present embodiment includes a catheter shaft 210, a distal electrode 230 fixed to the distal end of the catheter shaft 210, and a distal end electrode 230 fixed to the distal end flexible portion 210A of the catheter shaft 210 Shaped electrode 232 and a first operation wire 241 and a second operation wire 242 inserted into the catheter shaft 210 and a distal end flexible portion 210A of the catheter shaft 210, And a control handle 270 mounted on the rear end of the catheter shaft 210. The plate spring 260 is provided on the catheter shaft 210,
The tip end region of the catheter shaft 210 constituting the electrode catheter 200 is a tip end flexible portion 210A.
A control handle 270 is attached to the rear end of the catheter shaft 210.
The control handle 270 has the same structure as that of the control handle 70 constituting the electrode catheter 100 of the first embodiment. The control handle 270 includes a distal end flexible portion 210A of the catheter shaft 210, A handle 275 for performing a tensioning operation for bending the workpiece W is mounted.
The distal flexible portion 210A of the catheter shaft 210 is comprised of a multi-lumen structure.
5, the tip end flexible portion 210A includes an inner (core) portion 218 in which the lumen tubes 211 to 216 are fixed by a binder resin, and an inner (core) And lumens 211L to 216L are formed inside each of the lumen tubes 211 to 216 constituting the inner portion 218. The lumen tubes 211 to 216L are formed by lumens 211L to 216L.
The physical properties and types of the resin constituting the inner portion 218 and the outer portion 219 are the same as the physical properties and kinds of the resin constituting the inner portion 18 and the outer portion 19 constituting the tip end flexible portion 10A in the first embodiment It is similar to resin.
The lumens 211L and 212L formed in the tip flexible portion 210A are arranged opposite to each other with the central axis M 210 of the catheter shaft 210 therebetween and the center of the lumen 211L The central axis M 212 of the axis M 211 and lumen 212L (lumen tube 212) is located above the first virtual plane P 1.
5, the first operation wire 241 for bending the distal end flexible portion 210A of the catheter shaft 210 in the first direction indicated by the arrow A is inserted through the lumen 211L have. A second operation wire 242 for bending the distal end flexible portion 210A of the catheter shaft 210 in a second direction indicated by an arrow B is inserted in the lumen 212L.
A leaf spring 260 extending in the axial direction of the catheter shaft 210 on the second virtual plane P2 is disposed inside the tip end flexible portion 210A.
In the present embodiment, the second virtual plane P2 is a plane orthogonal to the first virtual plane P1, and is a virtual plane including the central axis M 210 of the catheter shaft 210.
The first operation wire 241 and the second operation wire 242 are connected to each other by a twist line (S twist) like the first operation wire 41 and the second operation wire 42 in the first embodiment, . The tips of the first working wire 241 and the second working wire 242 are connected and fixed to the tip electrodes 230 respectively and these rear ends are respectively connected to the handle 275 of the control handle 270 So that the pulling operation can be performed.
The lumens 213L and 214L formed in the tip end flexible portion 210A are opposed to each other with the central axis M 210 of the catheter shaft 210 therebetween and the lumens 213L and 213L a central axis [213], and M lumen (214L), a central axis [214] of the M (highly rigid lumen tubes 214) are located on the third imaginary plane P3.
In the present embodiment, the third virtual plane P3 is formed by connecting the second virtual plane P2 with the first operation wire 241 and the second operation wire 242 around the central axis M 210 of the catheter shaft 210, (Counterclockwise in Fig. 5) in the twist direction of the twisted wire constituting the twisted wire 242 (twist direction at the tip end side).
The lumens 215L and 216L formed in the tip flexible portion 210A are opposed to each other with the central axis M 210 of the catheter shaft 210 therebetween and the center of the lumen 215L The central axis M 216 of the axis M 215 and lumen 216L (lumen tube 216) is located above the fourth virtual plane P4.
In the present embodiment, the fourth virtual plane P4 is a plane in which the second virtual plane P2 is parallel to the center axis M 210 of the catheter shaft 210, between the first and second operation wires 241 and 241, (The clockwise direction in Fig. 5) opposite to the twist direction (twist direction on the tip side) of the twisted wire constituting the twisted wire 242, as shown in Fig.
The lead wire 232L of the ring electrode 232 shown in Fig. 1 is inserted into the lumen 215L as shown in Fig. 5 and the lead wire 232L of the lead electrode 230 230L are inserted.
The lumen tubes 211 to 216 forming the lumens 211L to 216L are made of resin.
It is preferable that the resin constituting the lumen tubes 211, 212, 215, and 216 has rigidity equal to or higher than that of the binder resin constituting the inner portion 218.
The D hardness of the resin constituting the lumen tubes 211, 212, 215, and 216 is, for example, 80 or less, preferably 50 to 75. [
The bending elastic modulus of the resin constituting the lumen tubes 211, 212, 215, and 216 is, for example, 15 to 1,000 MPa, preferably 100 to 800 MPa.
As the resin material constituting the lumen tubes 211, 212, 215 and 216, resins similar to those constituting the lumen tubes 11 to 16 in the first embodiment can be mentioned.
The high rigidity lumen tube 213 forming the lumen 213L and the high rigidity lumen tube 214 forming the lumen 214L are made of a binder resin and other lumen tubes (lumen tubes 211, 212, 215 and 216) Is a high rigidity member made of a resin having a stiffness higher than that of the resin.
Examples of the resin material constituting the high rigidity lumen tubes 213 and 214 include polyimide, polyether ether ketone (PEEK), nylon 11, and the like.
The D hardness of the resin constituting the high rigidity lumen tubes 213 and 214 is higher than the D hardness of the resin constituting the lumen tubes 211, 212, 215 and 216 and is, for example, 72 or higher, 77 to 95.
The bending elastic modulus of the resin constituting the high rigidity lumen tubes 213 and 214 is, for example, 1,500 to 19,000 MPa, preferably 2,000 to 7,000 MPa.
The thickness of the lumen tubes 211 to 216 is usually 20 to 60 占 퐉, preferably 30 to 50 占 퐉.
The high rigidity lumen tubes 213 and 214 with their respective central axes M 213 and M 214 located above the third virtual plane P 3 are positioned in opposition to each other with the central axis M 210 of the catheter shaft 210 therebetween The distal end flexible portion 210A of the catheter shaft 210 is in a shape approximate to the leaf spring existing on the third virtual plane P3.
That is, the drag force when the tip flexible portion 210A is bent along the third virtual plane P3 is significantly larger than the drag force when the tip flexible portion 210A is bent in the direction perpendicular to the third virtual plane P3 Thus, the tip end flexible portion 210A is hard to bend along the third virtual plane P3, and is easily bent in a direction perpendicular to the third virtual plane P3.
In the electrode catheter 200 of the present embodiment, the portion of the catheter shaft 210 on the rear end side than the flexible portion 210A of the catheter shaft 210 has a hollow tube member And a single lumen structure made of a tube member corresponding to the portion 219). Further, a coil tube is mounted inside the portion on the rear end side of the tip end flexible portion 210A.
The pulling operation of the first operation wire 241 is performed by rotating the handle 275 of the control handle 270 constituting the electrode catheter 200 of the present embodiment in the direction of A1 shown in Fig. In the tensioning operation of the first working wire 241, the tip end side of the first working wire 241 made of the twisted wire of the S twist turns in the direction in which the twist of the twisted wire is unwound (clockwise in FIG. 5) do.
Since the tip of the first operation wire 241 is connected and fixed to the tip electrode 230, the rotational torque from the first operation wire 241 is transmitted to the tip electrode 230.
This allows the distal and proximal electrodes 230 and 230 to be spaced apart from each other when the lumen tube forming the lumens 213L and 214L is not of a high rigidity member but of the same rigidity as the lumen tubes 215 and 216 The distal end side of the fixed catheter shaft 210 (distal end flexible portion 210A) is positioned in the same direction as the rotational direction of the first operation wire 241 with the center axis M 210 of the catheter shaft 210 as the center (Clockwise direction indicated by the arrow R in Fig. 5).
On the other hand, the rear end side of the tip end flexible portion 210A can not freely rotate as in the tip end side. Thus, the tip end flexible portion 210A is twisted in the direction indicated by the arrow R, '.
However, in the electrode catheter 200 of the present embodiment, the lumens 213L and 214L are formed by the high-rigidity lumen tubes 213 and 214 (high rigidity members), respectively, (In this embodiment, in the case of using the first working wire composed of a single wire, the tip end flexible portion 210A is twisted in the counterclockwise direction, for example, (In the direction indicated by the arrow A in Fig. 5), the tip end flexible portion 210A is twisted in the direction indicated by the arrow R (clockwise direction) during the pulling operation of the first operation wire 241 As a result, it is possible to bend the distal end flexible portion 210A without twisting in the first direction indicated by the arrow A along the first virtual plane P1.
By rotating the handle 275 of the control handle 270 constituting the electrode catheter 200 of the present embodiment in the direction of B1 shown in Fig. 4, the pulling operation of the second operation wire 242 is performed All. In the tensioning operation of the second working wire 242, the tip end side of the second working wire 242 made of the twisted wire of the S twist turns in the direction of twisting of the twisted wire (clockwise in FIG. 5) do.
Since the tip end of the second working wire 242 is connected and fixed to the front end electrode 230, the rotational torque from the second working wire 242 is transmitted to the front end electrode 230.
This allows the distal electrode 230 and the distal electrode 230 to be fixedly attached to the lumen tubes 215 and 216 when the lumen tube forming the lumens 213L and 214L is not a high rigid member, The distal end side of the catheter shaft 210 (the distal end flexible portion 210A) which is provided in the catheter shaft 210 is positioned in the same direction as the rotational direction of the second operation wire 242 about the central axis M 210 of the catheter shaft 210 (Clockwise direction) indicated by an arrow R in Fig. 5).
On the other hand, the rear end side of the tip end flexible portion 210A can not freely rotate as in the tip end side. Thus, the tip end flexible portion 210A is twisted in the direction indicated by the arrow R, '.
However, in the electrode catheter 200 of the present embodiment, the lumens 213L and 214L are formed by the high-rigidity lumen tubes 213 and 214 (high rigidity members), respectively, (In this form, in the case of using the second working wire composed of a single wire, the tip end flexible portion 210A is twisted counterclockwise, for example, (In the direction indicated by the arrow B in Fig. 5), the tip end flexible portion 210A is twisted in the direction indicated by the arrow R (clockwise direction) during the tensioning operation of the second operation wire 242 As a result, it is possible to bend the distal end flexible portion 210A without twisting in the second direction indicated by the arrow B along the first virtual plane P1.
According to the electrode catheter 200 of the present embodiment, the first operation wire 241 and the second operation wire 242 are constituted by twisted wires, and the first operation wire 241 or the second The shape of the tip end flexible portion 210A is changed over substantially the same plane (the first virtual plane P1) by tensioning the rear end of the operation wire 242 so that the direction in which the operator intends (the first direction or the second direction As shown in Fig.
≪ Third Embodiment >
The electrode catheter 300 of this embodiment shown in Fig. 6 having a cross-sectional shape of the tip end flexible portion has a catheter shaft 310 having a tip end flexible portion 310A and a distal end fixed to the distal end of the catheter shaft 310 Shaped electrode and a twisted wire (S-twisted) mounted on the distal flexible portion 310A of the catheter shaft 310. The tip end flexible portion 310A of the catheter shaft 310 is connected to the first (The direction indicated by the arrow A in Fig. 6), the distal end of the catheter shaft 310 is connected and fixed to the distal electrode, and the distal end of the catheter shaft 310 is connected to the distal end of the catheter shaft 310, A catheter shaft 310 (see FIG. 6) is provided for bending the distal flexible portion 310A of the catheter shaft 310 in the second direction And a tip end thereof is inserted into the front end A second operation wire 342 that is fixedly connected to the distal end of the catheter shaft 310 and capable of tensioning the distal end of the catheter shaft 310 and a leaf spring 360 disposed inside the flexible portion 310A along the axial direction of the catheter shaft 310, , A control handle mounted at the rear end of the catheter shaft 310,
The distal flexible portion 310A of the catheter shaft 310 is configured such that six lumen tubes 311 to 316 for forming the lumens 311L to 316L are arranged in a fixed state by the binder resin 318, Structure,
Tip flexible portion (310A), the central axis [M 311] and the second manipulation of the catheter shaft 310, the central axis [M 310], the first manipulation wire 341 is inserted through the lumen (311L) of the wire Including the central axis M 310 of the catheter shaft 310 as a plane orthogonal to the first virtual plane P 1 including the central axis M 312 of the lumen 312 L inserted through the catheter shaft 342, The plane P2 is rotated by a predetermined angle? (In the present embodiment,? = 45 degrees) in the same direction as the twist direction of the twisted line about the central axis M 310 of the catheter shaft 310 Shaped rigid body 355 (high rigidity member) having a central axis M 355 on the plane P3 and a rod-like rigid body 356 having a central axis M 356 on the third virtual plane P3 The high rigidity member) is embedded in the constituent resin (binder resin 318) of the catheter shaft 310, And are disposed so as to face each other with a central axis [ M310 ] interposed therebetween.
The electrode catheter 300 of the present embodiment includes a catheter shaft 310, a tip electrode fixed to the distal end of the catheter shaft 310, and a distal end electrode fixed to the distal end flexible portion 310A of the catheter shaft 310, A first operation wire 341 and a second operation wire 342 inserted into the catheter shaft 310 and a leaf spring 342 disposed at the distal end flexible portion 310A of the catheter shaft 310 360 and a control handle mounted at a rear end of the catheter shaft 310. [
The outer shape of the electrode catheter 300 of the present embodiment is similar to that of the electrode catheter 200 of the second embodiment shown in Fig.
The tip electrode, the ring electrode and the control handle constituting the electrode catheter 300 have the same configuration as the tip electrode 230, the ring electrode 232 and the control handle 270 in the second embodiment .
The tip end region of the catheter shaft 310 constituting the electrode catheter 300 is a tip end flexible portion 310A.
The distal end flexible portion 310A of the catheter shaft 310 is a multi-lumen structure in which the lumen tubes 311 to 316 are arranged while being fixed by the binder resin 318. The distal end flexible portion 310A of the lumen tubes 311 to 316 And lumens 311L to 316L are formed inside each of them.
The lumens 311L and 312L formed on the tip end flexible portion 310A are opposed to each other with the central axis M 310 of the catheter shaft 310 interposed therebetween and the center of the lumen 311L The center axis M 312 of the axis M 311 and the lumen 312L (lumen tube 312) is located above the first virtual plane P 1.
The lumen 311L is inserted with a first operation wire 341 for bending the distal end flexible portion 310A of the catheter shaft 310 in a first direction indicated by an arrow A. A second operation wire 342 for bending the distal end flexible portion 310A of the catheter shaft 310 in the second direction indicated by an arrow B is inserted in the lumen 312L.
A leaf spring 360 extending in the axial direction of the catheter shaft 310 on the second virtual plane P2 is disposed inside the tip end flexible portion 310A.
In this embodiment, the second virtual plane P 2 is a plane orthogonal to the first virtual plane P 1, and is a virtual plane including the central axis M 310 of the catheter shaft 310.
The first working wire 341 and the second working wire 342 are arranged so as to be twisted in the same manner as the first working wire 41 and the second working wire 42 in the first embodiment, . The distal ends of the first working wire 341 and the second working wire 342 are connected and fixed to the front end electrodes respectively, and these rear ends are respectively connected to the handle of the control handle so that the pulling operation can be performed.
The lumens 313L and 314L formed in the distal end flexible portion 310A are opposed to each other with the central axis M 310 of the catheter shaft 310 interposed therebetween and the center of the lumen 313L The center axis M 314 of the axis M 313 and the lumen 314L (the lumen tube 314) is located above the third virtual plane P3.
In the present embodiment, the third virtual plane P3 is formed by connecting the second virtual plane P2 with the first operation wire 341 and the second operation wire 342 about the central axis M 310 of the catheter shaft 310, (A counterclockwise direction in Fig. 6) that is the same as the twist direction (twist direction on the tip side) of the twist line constituting the twisted wire 342.
The lumens 315L and 316L formed in the distal end flexible portion 310A are opposed to each other with the central axis M 310 of the catheter shaft 310 interposed therebetween and the center of the lumen 315L (lumen tube 315) The central axis M 316 of the axis M 315 and the lumen 316L (lumen tube 316) is located above the fourth virtual plane P4.
In the present embodiment, the fourth virtual plane P4 is a plane in which the second virtual plane P2 is parallel to the center axis M 310 of the catheter shaft 310, and the first and second operation wires 241, (The clockwise direction in Fig. 6) opposite to the twist direction (twist direction at the tip side) of the twist line constituting the twisted wire 242, as shown in Fig.
6, the lead wire 332L of the ring-shaped electrode shown in Fig. 1 is inserted into the lumen 315L, and the lead wire 330L of the lead electrode is inserted into the lumen 316L have.
The lumen tubes 311 to 316 forming the lumens 311L to 316L are made of resin.
It is preferable that the resin constituting the lumen tubes 311 to 316 has rigidity equal to or higher than that of the binder resin 318.
The D hardness of the resin constituting the lumen tubes 311 to 316 is, for example, 80 or less, preferably 50 to 75. [
The bending elastic modulus of the resin constituting the lumen tubes 311 to 316 is, for example, 15 to 1,000 MPa, preferably 100 to 800 MPa.
As the resin material constituting the lumen tubes 311 to 316, resins similar to those constituting the lumen tubes 11 to 16 in the first embodiment can be mentioned.
In the front end flexible portion (310A) of the catheter shaft 310, a third imaginary plane P3 the outer central axis [M 355] rigid body 355, a rod shape having a lumen (313L) as above (high-stiffness member) Shaped rigid body 356 (high rigid member) having a central axis M 356 on the outer circumferential side of the lumen 314L on the third virtual plane P3 is connected to the constituent resin of the catheter shaft 310 (M 310 ) of the catheter shaft 310 in a state where the catheter shaft 310 is embedded in the catheter shaft 318.
Here, the rigid members 355 and 356 are made of a rod spring made of a resin material such as polyimide, polyether ether ketone, nylon 11, or the like, and a metal material such as stainless steel and Ni-Ti superelastic alloy.
The rigid bodies 355 and 356 in which the respective central axes M 355 and M 356 are positioned on the third virtual plane P3 are opposed to each other with the central axis M 310 of the catheter shaft 310 interposed therebetween The distal end flexible portion 310A of the catheter shaft 310 is in a form approximate to the leaf spring existing on the third virtual plane P3.
That is, the drag force when the tip flexible portion 310A is bent along the third virtual plane P3 becomes significantly larger than the drag force when the tip flexible portion 310A is bent in the direction perpendicular to the third virtual plane P3 So that the tip end flexible portion 310A is hard to bend along the third virtual plane P3 and is bent along the fourth virtual plane P4 in the direction perpendicular to the third virtual plane P3.
The distal end side of the first working wire 341 made of the twisted wire of the S-twist in the tensile operation of the first working wire 341 constituting the electrode catheter 300 is set so that the direction of twist of the twisted wire 6 in the clockwise direction).
Here, since the tip of the first operation wire 341 is connected and fixed to the tip electrode, the rotational torque from the first operation wire 341 is transmitted to the tip electrode.
The distal end side of the catheter shaft 310 (distal end flexible portion 310A) to which the distal end electrode and the distal end electrode are fixed is connected to the center of the catheter shaft 310 And rotates in the same direction as the rotation direction of the first operation wire 341 (the direction indicated by the arrow R in FIG. 6 (clockwise direction)) about the axis [M 310 ].
On the other hand, the rear end side of the tip end flexible portion 310A can not freely rotate like the tip end side, whereby the tip end flexible portion 310A is twisted in the direction indicated by the arrow R, '.
However, in the electrode catheter 300 of the present embodiment, the rigid bodies 355 and 356 (high rigidity members), in which the central axes M 355 and M 356 are positioned above the third virtual plane P 3, Is arranged so as to be opposed to the catheter shaft 310 with the central axis [M 310 ] therebetween, so that the plate spring is present on the third virtual plane P3 (in this form, When the first working wire is used, since the tip flexible portion 310A is twisted in the counterclockwise direction and bent in the direction indicated by the arrow A " in Fig. 6, for example), the first working wire 341 It is possible to suppress or prevent the tip end flexible portion 310A from being twisted in the direction indicated by the arrow R (clockwise direction) during the tensioning operation of the end flank 310A, 1 along virtual plane P1 It can be bent in the first direction indicated by the arrow A.
In the tensioning operation of the second operation wire 342 constituting the electrode catheter 300, the distal end side of the second operation wire 342 made of the twisted wire of the S twist is in the direction of twisting of the twisted wire (Clockwise in Fig. 6).
Here, since the tip of the second operation wire 342 is connected and fixed to the tip electrode, the rotational torque from the second operation wire 342 is transmitted to the tip electrode.
The distal end side of the catheter shaft 310 (distal end flexible portion 310A) to which the distal end electrode and the distal end electrode are fixed is connected to the center of the catheter shaft 310 And rotates in the same direction as the rotation direction of the second operation wire 342 (the direction indicated by the arrow R in FIG. 6 (clockwise direction)) about the axis [M 310 ].
On the other hand, the rear end side of the tip end flexible portion 310A can not freely rotate as in the tip end side. Thus, the tip end flexible portion 310A is twisted in the direction indicated by the arrow R, '.
However, in the electrode catheter 300 of the present embodiment, the rigid bodies 355 and 356 (high rigidity members), in which the central axes M 355 and M 356 are positioned above the third virtual plane P 3, Is arranged so as to be opposed to the catheter shaft 310 with the center axis [M 310 ] therebetween, and in a form approximate to the presence of the leaf spring on the third virtual plane P3 (in this form, When the twin operation wire is used, the distal end flexible portion 310A is twisted in the counterclockwise direction, for example, because it is bent in the direction indicated by the arrow B " in Fig. 6) It is possible to suppress or prevent the tip end flexible portion 310A from being twisted in the direction indicated by the arrow R (clockwise direction) during the tensioning operation of the end flank 310A, 1 along virtual plane P1 It can be bent in the second direction indicated by the arrow B.
According to the electrode catheter 300 of the present embodiment, the first operation wire 341 and the second operation wire 342 are constituted by twisted wires, and the first operation wire 341 or the second The shape of the tip end flexible portion 310A is changed over substantially the same plane (first virtual plane P1) by tensioning the rear end of the operation wire 342 so that the direction of the operator's intended direction (the first direction or the second direction As shown in Fig.
≪ Fourth Embodiment &
The electrode catheter 400 of the present embodiment shown in Fig. 7 having a cross section of the tip end curved portion has a catheter shaft 410 having a tip end flexible portion 410A and a distal end fixed to the distal end of the catheter shaft 410 An electrode and a twisted wire (S-twist), and in order to bend the tip flexible portion 410A of the catheter shaft 410 in the first direction (the direction indicated by arrow A in Fig. 7) And a tip end of the catheter shaft 410 is inserted into the distal end of the catheter shaft 410 and is connected to the tip electrode and is capable of performing a tension operation on the distal end thereof and a twisted wire (S twist) In order to bend the flexible portion 410A in the second direction (the direction indicated by the arrow B in Fig. 7), it is inserted into the catheter shaft 410 so that its tip is connected and fixed to the tip electrode, The second working wire 442 And a control handle mounted at the rear end of the catheter shaft 410. The distal flexible portion 410A of the catheter shaft 410 includes a lumen tube 419 for forming a central lumen 419L, And lumen tubes 411 to 418 for forming eight sub lumens 411L to 418L arranged at intervals of 45 degrees around the periphery of the lumen tubes 411 to 418L are fixed by the binder resin,
Tip flexible portion (410A), the catheter shaft 410, the central axis [M 410], Article 1 the center axis of the operation wire sub-lumen (411L), the 441 is inserted through [M 411] and second operations of Article comprising a central shaft [M 410] of claim 1 as the perpendicular plane with respect to the imaginary plane P1 catheter shaft 410 comprising a central shaft [M 415] of the inserted sub-wire 442, the lumen (415L) A high rigidity lumen tube 413 (high rigidity member) having a central axis M 413 on the second virtual plane P 2 and a high rigidity lumen tube 417 having a central axis M 417 on the second virtual plane P 2 with that the rigid member) is interposed between the central axis [M 410] of the catheter shaft (410) is disposed opposite the second around the central axis [M 410] of the imaginary plane P2, the catheter shaft (410) (In this embodiment,? = 45 degrees) in the same direction as the twist direction of the twisted wire, Phase and having a central axis [M 412] on the plane P3 rigid lumen tube 412 (high-rigidity member) with the third and having a central axis [M 416] on the imaginary plane P3 rigid lumen tube 416 (high rigidity Are disposed opposite to each other with a central axis [M 410 ] of the catheter shaft 410 interposed therebetween.
The electrode catheter 400 of the present embodiment includes a catheter shaft 410, a tip electrode fixed to the distal end of the catheter shaft 410, and a first operation wire 441 inserted into the catheter shaft 410 And a second operation wire 442, and a control handle mounted at the rear end of the catheter shaft 410.
The outer shape of the electrode catheter 400 of the present embodiment is similar to that of the electrode catheter 200 of the second embodiment shown in Fig.
The tip electrode and the control handle constituting the electrode catheter 400 have the same configuration as the tip electrode 230 and the control handle 270 in the second embodiment.
The tip end region of the catheter shaft 410 constituting the electrode catheter 400 is a tip end flexible portion 410A.
The distal flexible portion 410A of the catheter shaft 410 is comprised of a multi-lumen structure.
7, the tip end flexible portion 410A includes an inner (core) portion 428 in which the lumen tubes 411 to 419 are fixed by a binder resin, a resin A central lumen 419L is formed inside the lumen tube 419 constituting the inner portion 428 and the inner lumen 419L is formed inside each lumen tube 411 to 418 The sub lumens 411L to 418L are formed.
A lead wire (not shown) such as a tip electrode is inserted into the center lumen 419L formed in the tip end flexible portion 410A.
The sub-lumen 411L and the sub-lumen 415L formed in the tip flexible portion 410A are opposed to each other with the central axis M 410 of the catheter shaft 410 interposed therebetween.
The central axis M 411 of the sub lumen 411L (lumen tube 411) and the central axis M 415 of the sub lumen 415L (lumen tube 415) are located above the first virtual plane P1.
A first operation wire 441 for bending the distal end flexible portion 410A of the catheter shaft 410 in a first direction indicated by an arrow A is inserted into the sub lumen 411L. A second operation wire 442 for bending the distal end flexible portion 410A of the catheter shaft 410 in a second direction indicated by an arrow B is inserted into the sub lumen 415L.
The first operation wire 441 and the second operation wire 442 are arranged in a manner similar to the first operation wire 41 and the second operation wire 42 in the first embodiment, . The distal ends of the first operation wire 441 and the second operation wire 442 are respectively connected and fixed to the tip electrodes, and these rear ends are respectively connected to the handle of the control handle so that the operation can be performed.
The sub lumen 413L and the sub lumen 417L formed in the tip end flexible portion 410A are arranged opposite to each other with the central axis M 410 of the catheter shaft 410 interposed therebetween.
The central axis M 413 of the sub lumen 413L (the high rigidity lumen tube 413 ) and the central axis M 417 of the sub lumen 417L (the high rigid lumen tube 417) .
In this embodiment, the second virtual plane P 2 is a plane orthogonal to the first virtual plane P 1, and is a virtual plane including the central axis M 410 of the catheter shaft 410.
The sub-lumen 412L and the sub-lumen 416L formed in the tip flexible portion 410A are opposed to each other with the central axis M 410 of the catheter shaft 410 interposed therebetween.
Sub-lumen (412L) (High-rigid lumen tube 412), the central axis [M 412] and the sub-lumen (416L), the central axis [M 416] of the (high-rigidity lumen tube 416) of the third virtual plane P3 .
In the present embodiment, the third virtual plane P3 is formed by connecting the second virtual plane P2 with the first operation wire 441 and the second operation wire 442 about the central axis M 410 of the catheter shaft 410, (A counterclockwise direction in Fig. 7) that is the same as the twist direction (twist direction at the tip end side) of the twisted wire constituting the twisted wire 442.
The sub lumen 414L and the sub lumen 418L formed on the tip end flexible portion 410A are disposed opposite to each other with the central axis M 410 of the catheter shaft 410 interposed therebetween.
The central axis M 414 of the sub lumen 414L (lumen tube 414) and the central axis M 418 of the sub lumen 418L (lumen tube 418) are located above the fourth virtual plane P4.
In the present embodiment, the fourth virtual plane P4 is formed by connecting the second virtual plane P2 with the first operation wire 441 and the second operation wire 442 around the central axis M 410 of the catheter shaft 410, (The clockwise direction in Fig. 7) opposite to the twist direction (twist direction at the tip end side) of the twisted wire constituting the twisted wire 442, as shown in Fig.
The lumen tubes 411 to 419 forming each of the sub lumens 411L to 418L and the central lumen 419L are made of resin.
The resin constituting the lumen tubes 411, 414, 415, 418 and 419 for forming each of the sub lumens 411L, 414L, 415L and 418L and the central lumen 419L is preferably made of a resin having a rigidity .
The D hardness of the resin constituting the lumen tubes 411, 414, 415, 418 and 419 is, for example, 80 or less, preferably 50 to 75. [
The bending elastic modulus of the resin constituting the lumen tubes 411, 414, 415, 418 and 419 is, for example, 15 to 1,000 MPa, preferably 100 to 800 MPa.
As the resin material constituting the lumen tubes 411, 414, 415 and 419, resins similar to those constituting the lumen tubes 11 to 16 in the first embodiment can be mentioned.
The rigid lumen tubes 412, 413, 416, and 417 forming the sub lumens 412L, 413L, 416L, and 417L are made of a resin material having a higher hardness than the resin constituting the binder resin and the lumen tubes 411, 414, 415, 418, and 419 And is a highly rigid member made of a resin having high rigidity.
Examples of the resin material constituting the high rigidity lumen tubes 412, 413, 416, and 417 include polyimide, polyether ether ketone (PEEK), nylon 11, and the like.
The D hardness of the resin constituting the high rigidity lumen tubes 412, 413, 416 and 417 is higher than the D hardness of the resin constituting the lumen tubes 411, 414, 415, 418 and 419, , And preferably from 77 to 95. [
The bending elastic modulus of the resin constituting the high rigidity lumen tubes 412, 413, 416 and 417 is, for example, 1,500 to 19,000 MPa, preferably 2,000 to 7,000 MPa.
The high rigidity lumen tubes 413 and 417 with their respective central axes M 413 and M 417 located above the second virtual plane P 2 are positioned opposite each other across the central axis M 410 of the catheter shaft 410 The distal end flexible portion 410A of the catheter shaft 410 is shaped so as to approximate that the leaf spring is present on the second virtual plane P2 and the leaf spring is arranged inside the distal flexible portion 410A It is difficult to bend along the second virtual plane P2 and to be bent in the direction perpendicular to the second virtual plane P2 along the first virtual plane P1.
Rigid lumen tubes 412 and 416 in which the respective central axes M 412 and M 416 are located above the third virtual plane P 3 are positioned between the center axis M 410 of the catheter shaft 410 The tip end flexible portion 410A of the catheter shaft 410 is formed in a shape approximate to the leaf spring existing on the third virtual plane P3 and is hard to bend along the third virtual plane P3, It is easy to pivot in a direction perpendicular to the virtual plane P3.
The distal end side of the first operation wire 441 composed of the twisted wire of the S twist in the tensile operation of the first operation wire 441 constituting the electrode catheter 400 is set so that the direction of the twist of the twisted wire 7). ≪ / RTI >
Here, since the tip of the first operation wire 441 is connected and fixed to the tip electrode, the rotational torque from the first operation wire 441 is transmitted to the tip electrode.
For this reason, for example, if the lumen tube forming the sub lumens 412L and 416L is not a high rigidity member but has a stiffness equivalent to that of the lumen tubes 414 and 418, the catheter shaft 410 side front end of the (leading flexible portion (410A)), around the central axis [M 410] of the catheter shaft 410, the same direction as the rotation direction of the first manipulating wire (441) [in Fig. 7 (Clockwise direction) indicated by an arrow R).
On the other hand, the rear end side of the tip end flexible portion 410A can not freely rotate as in the tip end side. Thus, the tip end flexible portion 410A is twisted in the direction indicated by the arrow R, '.
However, in the electrode catheter 400 of the present embodiment, the sub lumens 412L and 416L are formed by the high-rigidity lumen tubes 412 and 416 (high rigidity members) (In this form, in the case of using the first working wire constituted by a single wire, the tip end flexible portion 410A is twisted in the counterclockwise direction, The tip end flexible portion 410A is twisted in the direction indicated by the arrow R (clockwise direction) at the time of pulling operation of the first operation wire 441 As a result, the tip end curled portion 410A having no twist can be bent in the first direction indicated by the arrow A along the first virtual plane P1.
In the tensioning operation of the second operation wire 442 constituting the electrode catheter 400, the distal end side of the second operation wire 442, which is formed of the twisted wire of the S twist, is in the direction of twisting of the twisted wire (Clockwise in Fig. 7).
Here, since the tip of the second working wire 442 is connected and fixed to the tip electrode, the rotational torque from the second working wire 442 is transmitted to the tip electrode.
For this reason, for example, if the lumen tube forming the sub lumens 412L and 416L is not a high rigidity member but has a stiffness equivalent to that of the lumen tubes 414 and 418, the catheter shaft 410 side front end of the (leading flexible portion (410A)), around the central axis [M 410] of the catheter shaft 410, parts 2 the same direction as the rotational direction of the operation wire (442) [in Fig. 7 (Clockwise direction) indicated by an arrow R).
On the other hand, the rear end side of the tip end flexible portion 410A can not freely rotate as in the tip end side. Thus, the tip end flexible portion 410A is twisted in the direction indicated by the arrow R, '.
However, in the electrode catheter 400 of the present embodiment, the sub lumens 412L and 416L are formed by the high-rigidity lumen tubes 412 and 416 (high rigidity members) (In this embodiment, in the case of using the second working wire composed of a single wire, the tip end flexible portion 410A is twisted in the counterclockwise direction, The tip end flexible portion 410A is twisted in the direction indicated by the arrow R (clockwise direction) during the pulling operation of the second operation wire 442 As a result, the tip end curled portion 410A having no twist can be bent in the second direction indicated by the arrow B along the first virtual plane P1.
According to the electrode catheter 400 of the present embodiment, the first operation wire 441 and the second operation wire 442 are constituted by twisted wires, and the first operation wire 441 or the second The shape of the tip end flexible portion 410A is changed over substantially the same plane (first virtual plane P1) by tensioning the rear end of the operation wire 442 so that the direction of the operator's intended direction (the first direction or the second direction As shown in Fig.
≪ Embodiment 5 >
The electrode catheter 500 of this embodiment shown in Fig. 8 having a cross-sectional shape of the tip end flexible portion has a catheter shaft 510 having a tip flexible portion 510A and a distal end fixed to the distal end of the catheter shaft 510 An electrode and a twisted wire (S-twist), and in order to bend the tip flexible portion 510A of the catheter shaft 510 in the first direction (the direction indicated by the arrow A in Fig. 8) And a tip end of the catheter shaft 510 is inserted into the distal end of the catheter shaft 510 and connected and fixed to the distal end electrode, In order to bend the flexible portion 510A in the second direction (the direction indicated by the arrow B in Fig. 8), it is inserted into the catheter shaft 510 so that its tip is connected and fixed to the tip electrode, The second working wire 542 And a control handle mounted at the rear end of the catheter shaft 510,
The distal end flexible portion 510A of the catheter shaft 510 is a multi lumen structure in which four lumen tubes 511 to 514 for forming the lumens 511L to 514L are arranged in a state of being fixed by a binder resin,
The distal end flexible portion 510A is provided with a central axis M 510 of the catheter shaft 510 and a central axis M 511 of the lumen 511 L through which the first operation wire 541 is inserted, Including a central axis M 510 of the catheter shaft 510 as a plane orthogonal to the first virtual plane P 1 including the central axis M 512 of the lumen 512 L inserted through the catheter shaft 510 The plane P2 is rotated by a predetermined angle? (In the present embodiment,? = 45 degrees) in the same direction as the twist direction of the twist line about the central axis M 510 of the catheter shaft 510 Shaped rigid body 551 having a central axis M 551 on the plane P3 and a rigid rod body 552 having a central axis M 552 on the third virtual plane P3 high-stiffness member) is embedded in a resin, the configuration of the catheter shaft (510) state, the catheter shaft 510, the central axis [510] of the M Sandwiching and is disposed opposed to each other.
The electrode catheter 500 of the present embodiment includes a catheter shaft 510, a tip electrode fixed to the distal end of the catheter shaft 510 and a first operation wire 541 inserted into the catheter shaft 510 A second operative wire 542, and a control handle mounted at the rear end of the catheter shaft 510. [
The outer shape of the electrode catheter 500 of the present embodiment is similar to that of the electrode catheter 200 of the second embodiment shown in Fig.
The tip electrode and the control handle constituting the electrode catheter 500 have the same structure as the tip electrode 230 and the control handle 270 in the second embodiment.
The tip end region of the catheter shaft 510 constituting the electrode catheter 500 is a tip end flexible portion 510A.
The distal flexible portion 510A of the catheter shaft 510 is comprised of a multi-lumen structure.
8, the leading end flexible portion 510A includes an inner (core) portion 518 formed by fixing the lumen tubes 511 to 514 by a binder resin, a resin And an outer (shell) portion 519 made up of lumens 511L to 514L formed inside lumen tubes 511 to 514, respectively.
The lumens 511L and 512L formed in the tip flexible portion 510A are opposed to each other with the central axis M 510 of the catheter shaft 510 therebetween and the center of the lumen 511L (lumen tube 511) The central axis [M 512 ] of axis M 511 and lumen 512L (lumen tube 512) is located above the first virtual plane P 1.
The lumen 511L is inserted with a first operation wire 541 for bending the distal end flexible portion 510A of the catheter shaft 510 in a first direction indicated by an arrow A. [ A second operation wire 542 for bending the distal end flexible portion 510A of the catheter shaft 510 in a second direction indicated by an arrow B is inserted into the lumen 512L.
The first operation wire 541 and the second operation wire 542 are connected to each other by a twisted wire (S twist) like the first operation wire 41 and the second operation wire 42 in the first embodiment, . The distal ends of the first working wire 541 and the second working wire 542 are respectively connected and fixed to the tip electrodes and these rear ends are respectively connected to the handle of the control handle so that the pulling operation is possible .
The lumens 513L and 514L formed in the tip flexible portion 510A are arranged opposite to each other with the central axis M 510 of the catheter shaft 510 therebetween and the center of the lumen 513L The central axis M 514 of the axis M 513 and lumen 514 L (lumen tube 514) is located above the second virtual plane P 2.
In this embodiment, the second virtual plane P 2 is a plane orthogonal to the first virtual plane P 1, and is a virtual plane including the central axis M 510 of the catheter shaft 510.
The lumen tubes 511 to 514 forming the lumens 511L to 514L are made of resin.
It is preferable that the resin constituting the lumen tubes 511 to 514 has rigidity equal to or higher than that of the binder resin.
The D hardness of the resin constituting the lumen tubes 511 to 514 is, for example, 80 or less, preferably 50 to 75. [
The bending elastic modulus of the resin constituting the lumen tubes 511 to 514 is, for example, 15 to 1,000 MPa, and preferably 100 to 800 MPa.
As the resin material constituting the lumen tubes 511 to 514, resins similar to those constituting the lumen tubes 11 to 16 in the first embodiment can be mentioned.
Shaped rigid body 551 (high rigidity member) having a central axis [M 551 ] on the third virtual plane P3 and a rigid body 551 The central axis M 510 of the catheter shaft 510 is inserted between the stiffening members 552 (high rigidity member) having the axis M 552 embedded in the constituent resin of the catheter shaft 510 Respectively.
In the present embodiment, the third virtual plane P3 is formed by connecting the second virtual plane P2 to the first operating wire 541 and the second operating wire 541 around the central axis M 510 of the catheter shaft 510, (A counterclockwise direction in Fig. 8) that is the same as the twist direction (twist direction at the tip end side) of the twist line constituting the twisted wire 542.
The rigid bodies 551 and 552 in which the central axes M 551 and M 552 are positioned on the third virtual plane P3 are disposed opposite to each other with the central axis M 510 of the catheter shaft 510 therebetween The distal end flexible portion 510A of the catheter shaft 510 is in a shape approximate to the leaf spring existing on the third virtual plane P3.
That is, the drag force when the tip flexible portion 510A is bent along the third virtual plane P3 becomes significantly larger than the drag force when the tip flexible portion 510A is bent in the direction perpendicular to the third virtual plane P3 So that the tip end flexible portion 510A is hard to bend along the third virtual plane P3 and is easily bent in the direction perpendicular to the third virtual plane P3.
The distal end side of the first operation wire 541 made of the twisted wire of the S twist in the tensile operation of the first operation wire 541 constituting the electrode catheter 500 is set so that the direction of twisting of the twisted wire 8 in the clockwise direction).
Here, since the tip of the first operation wire 541 is connected and fixed to the tip electrode, the rotational torque from the first operation wire 541 is transmitted to the tip electrode.
The distal end side of the catheter shaft 510 (distal end flexible portion 510A) having the distal end electrode and the distal end electrode fixed thereto is positioned at the center of the catheter shaft 510 Is rotated in the same direction as the rotation direction of the first operation wire 541 (clockwise direction indicated by an arrow R in Fig. 8) about the axis [M 510 ].
On the other hand, the rear end side of the tip end flexible portion 510A can not freely rotate as in the tip end side. Thus, the tip end flexible portion 510A is twisted in the direction indicated by the arrow R, '.
However, in the electrode catheter 500 of the present embodiment, the rigid bodies 551 and 552 (high rigidity members) in which the central axes M 551 and M 552 are positioned above the third virtual plane P 3, And a plate spring is disposed on the third virtual plane P3 so as to be opposed to each other with the central axis [ M510 ] of the catheter shaft 510 interposed therebetween (in this embodiment, When the first working wire is used, the leading flexible portion 510A is twisted in the counterclockwise direction, for example, because it is bent in the direction indicated by the arrow A " in Fig. 8) It is possible to suppress or prevent the leading end flexible portion 510A from being twisted in the direction indicated by the arrow R (clockwise direction) during the tensioning operation of the end folded portion 510A, 1 along virtual plane P1 It can be bent in the first direction indicated by the arrow A.
The distal end side of the second operation wire 542, which is formed by the twisted S-twisted wire in the tensile operation of the second operation wire 542 constituting the electrode catheter 500, (Clockwise in Fig. 8).
Here, since the tip of the second working wire 542 is connected and fixed to the tip electrode, the rotational torque from the second working wire 542 is transmitted to the tip electrode.
The distal end side of the catheter shaft 510 (distal end flexible portion 510A) having the distal end electrode and the distal end electrode fixed thereto is positioned at the center of the catheter shaft 510 And rotates in the same direction as the rotation direction of the second operation wire 542 (the direction indicated by the arrow R in FIG. 8 (clockwise direction)) about the axis [M 510 ].
On the other hand, the rear end side of the tip end flexible portion 510A can not freely rotate as in the tip end side. Thus, the tip end flexible portion 510A is twisted in the direction indicated by the arrow R, '.
However, in the electrode catheter 500 of the present embodiment, the rigid bodies 551 and 552 (high rigidity members) in which the central axes M 551 and M 552 are positioned above the third virtual plane P 3, Is arranged so as to be opposed to the catheter shaft 510 with the center axis [M 510 ] interposed therebetween and in a form approximate to the presence of the leaf spring on the third virtual plane P3 (in this form, When the twin operation wire is used, the tip flexible portion 510A is twisted in the counterclockwise direction, for example, because it is bent in the direction indicated by the arrow B 'in Fig. 8) It is possible to suppress or prevent the leading end flexible portion 510A from being twisted in the direction indicated by the arrow R (clockwise direction) during the tensioning operation of the end folded portion 510A, 1 along virtual plane P1 It can be bent in the second direction indicated by the arrow B.
According to the electrode catheter 500 of the present embodiment, since the first operation wire 541 and the second operation wire 542 are formed by twisted wires and the first operation wire 541 or the second The shape of the tip end flexible portion 510A is changed over substantially the same plane (first virtual plane P1) by tensioning the rear end of the operation wire 542 so that the direction of the operator's intended direction (the first direction or the second direction As shown in Fig.
Although the embodiment of the present invention has been described above, the catheter of the tip deflectable operation of the present invention is not limited to these, but various modifications are possible.
For example, the angle? Formed by the second virtual plane P2 and the third virtual plane P3 need not be 45 占 and can be appropriately adjusted within a range where 0 占 <? <90 占.
However, from the viewpoint of sufficiently securing the shape flatness of the tip end curled portion, the angle? Is preferably 20 to 70, more preferably 30 to 60, and particularly preferably 40 to 50.
The twisted wire of the Z twist may be used as the twisted wire constituting the operating wire.
Further, a single bidirectional tip deflectable operation catheter having one operation wire may be used.
Although the present invention has been described by taking an electrode catheter as an example of an embodiment of the tip deflectable catheter of the present invention, the present invention can be applied to a catheter having a guide catheter (guiding catheter), a catheter for angiography, a sheath catheter Penetrating catheters, and the like.
