TW201630632A - Catheter - Google Patents

Abstract

Provided is a catheter having higher functionality. An electrode catheter 1 includes a manipulation section, a shaft 2, and manipulating wires PW1 and PW2. The shaft 2 extends to include a base end region A1, an intermediate region Am, and a distal end region A2 that are arranged in order from the manipulation section side, and is provided with a first passage and a second passage that penetrate those regions. The manipulating wires PW1 and PW2 are respectively inserted into the first passage and the second passage. A distance between a lumen 4H1 and a central axis CL is less than a distance between a lumen 5H1 and the central axis CL, and a distance between a lumen 4H2 and the central axis CL is less than a distance between a lumen 5H2 and the central axis CL. Lumens 6H1 and 6H2 are so inclined relative to the central axis CL as to be away from each other as they head to the distal end region A2 from the base end region A1. The shaft 2 includes, in the base end region A1, a multi-lumen tube 40 formed with the lumens 4H1 and 4H2.

Description

catheter

The present invention relates to a catheter that can be used, for example, for examination (diagnosis), treatment of arrhythmia, and the like.

The catheter is inserted into the body (for example, inside the heart) through a blood vessel, and is used for examination and treatment of arrhythmia and the like (for example, refer to Patent Document 1). Such a catheter generally has a shape that is inserted into the vicinity of the front end (distal end) of the body, and is adapted to be changed in one direction or two directions (biasing, bending) according to the operation of the operating portion, wherein the operating portion is mounted in the configuration The proximal end of the body (near end, back end, hand).

[Previous Technical Literature]

[Patent Literature]

[Patent Document 1] Japanese Patent Laid-Open Publication No. 2002-360704

Further, in the catheter of Patent Document 1, a single metal tube (or a metal coil such as a rectangular coil) having a metal inner tube is attached to the proximal end of the distal end side tubular member having a porous structure in which a plurality of tubes are housed. The proximal end side tubular member of the lumen configuration. Such a metal pipe or a metal coil functions as a compression-resistant member that prevents bending, bending, and twisting of the proximal end side tubular member during the operation of the operation portion.

However, from the viewpoints of weight reduction of the lead pipe, improvement of operability, and the like, the thinning of such a metal pipe or a metal coil tends to be unavoidable. As a result, there is a concern that the function as a compression-resistant member of the metal pipe or the metal coil cannot be sufficiently exhibited, and the flaw of the tubular member at the proximal end side cannot be sufficiently prevented.

The present invention has been made in view of the problem, and an object thereof is to provide a catheter having a higher function.

The catheter of the present invention includes: an operation portion; and a flexible shaft connected to the operation portion, and includes a base end region, an intermediate portion, and a front end region which are sequentially arranged from the operation portion side along the central axis, and is provided with All of the base end region, the intermediate region and the front end region are respectively arranged in the first passage and the second passage which are paralleled along the central axis; the first lead is inserted into the first passage; and the second lead is inserted into the second passage. Here, the distance between the first base end region portion of the through-base region in the first passage and the central axis is closer than the distance between the first front end region portion of the first passage in the first passage and the central axis; the second passage The distance between the second base end region portion of the through base end region and the central axis is closer than the distance between the second front end region portion of the through end region in the second passage and the central axis. Further, the first intermediate portion portion of the first passage that penetrates the intermediate portion and the second intermediate portion portion of the second passage that penetrates the intermediate portion are centered away from each other as they move away from the base end region toward the front end region The shaft is inclined, and the flexible shaft has a multi-lumen tube having a first base end portion and a second base end portion in the base end region.

In the catheter of the present invention, the first passage and the second passage, which are independent of each other, are located closer to the central axis in the proximal end region and at a position farther from the central axis in the distal end region. Therefore, the first lead and the second lead respectively inserted through the first and second paths are not in contact with each other and are pulled, so that the displacement of the flexible shaft in the distal end region can be smoothly performed. Work. On the other hand, in the proximal end region, since the first lead and the second lead are located closer to the central axis, it is possible to suppress bending and squeezing of the flexible shaft in the proximal end region.

Further, the multi-lumen tube may further have a first lumen and a second lumen symmetrically arranged on the central axis, and a third lumen and a fourth lumen symmetrically arranged to the central axis. Here, the first lumen and the third lumen may be symmetrically arranged with the first surface including the central axis as a plane of symmetry, and the second lumen and the fourth lumen are symmetrically arranged with the first surface as a plane of symmetry, first The lumen and the fourth lumen are symmetrically arranged as a plane of symmetry including a second plane orthogonal to the first plane of the central axis, and the second lumen and the third lumen are symmetrically arranged with the second plane as a plane of symmetry.

According to the catheter of the present invention, since the first passage through which the first lead is inserted and the second passage through which the second lead is inserted are present in the proximal end region at a position closer to the central axis and in the distal end region are present at the center The shaft has a far position, so it has excellent torque response and bending response.

1‧‧‧ lead

2‧‧‧Axis

A1‧‧‧ base area

A2‧‧‧ front end area

Am‧‧‧Intermediate area

21A~21C‧‧‧Ring electrode

22‧‧‧ front electrode

3‧‧‧Operation Department

31‧‧‧handle

32‧‧‧Rotating plate

4,5‧‧‧Tubular components

4A‧‧‧ wall section

4B‧‧‧Grouping section

40‧‧‧Multi-lumen tube

4H1, 4H2, 5H1~5H6, 6H1, 6H2‧‧‧ lumen

51~56‧‧‧ pipes

57‧‧‧Spring element

6‧‧‧ Guide members

71A~71C, 72‧‧‧ wire

PW1, PW2‧‧‧ operation lead

Fig. 1A is a schematic view showing a schematic configuration example of a catheter according to an embodiment of the present invention.

Figure 1B is an enlarged schematic view of the vicinity of the front end of the catheter shown in Figure 1A.

Fig. 2 is a cross-sectional view showing a detailed configuration example of the vicinity of the intermediate portion of the catheter shown in Fig. 1A along the central axis.

Fig. 3A is a perspective view showing a detailed configuration example of the vicinity of the intermediate portion of the catheter shown in Fig. 1A.

Fig. 3B is another perspective view showing a detailed configuration example of the vicinity of the intermediate portion of the catheter shown in Fig. 1A.

4A is a view showing a detailed configuration example of the base end region of the catheter shown in FIG. 1A, which is straight to the central axis. Cross section view.

Fig. 4B is a cross-sectional view showing a detailed configuration example of the front end region of the catheter shown in Fig. 1A and orthogonal to the central axis.

Fig. 5A is a plan view showing an end surface of the guide member for a shaft shown in Fig. 2 opposite to the base end region.

Fig. 5B is a plan view showing the end surface of the guide member for the shaft shown in Fig. 2 facing the front end region.

Embodiments of the present invention will be described in detail below with reference to the drawings.

<Embodiment>

[Summary structure]

Fig. 1A schematically shows a schematic configuration of an electrode catheter 1 according to an embodiment of the present invention. 1B is an enlarged view of a region IB surrounded by a broken line in FIG. 1A. The lead 1 is inserted into the body (for example, inside the heart) through a blood vessel for examination, treatment of arrhythmia and the like. The lead conduit 1 includes a shaft 2 (a catheter shaft) as a catheter body and an operation portion 3 attached to a proximal end (a proximal end, a rear end, and a hand) of the shaft 2.

(axis 2)

The shaft 2 has a tubular structure (a tubular member 4, 5 to be described later) that exhibits flexibility, and has a base end area A1 and an intermediate area (boundary area) Am from the side of the operation portion 3 in the direction of its own (Z-axis direction). And the front end area A2. The shaft 2 corresponds to a specific example of the "flexible shaft" of the present invention.

The axial length of the shaft 2 is about 500 to 1200 mm (for example, 1100 mm), and the outer diameter of the shaft 2 (the outer diameter of the X-Y section) is about 0.6 to 3 mm (for example, 2.0 mm). In addition, the shaft The lengths of the base end region A1, the tip end region A2, and the intermediate portion Am of 2 are about 400 to 1200 mm (for example, 800 mm), about 100 to 400 mm (for example, 150 mm), and about 1 to 100 mm (for example, 50 mm).

In the front end region A2 of the shaft 2, as shown in Fig. 1B, a plurality of electrodes (here, three annular electrodes 21A, 21B, 21C and one front end electrode 22) are provided. Specifically, in the vicinity of the front end of the shaft 2, the ring-shaped electrodes 21A, 21B, 21C and the front end electrode 22 are arranged in this order and at a predetermined interval toward the front end side. Further, the ring-shaped electrodes 21A, 21B, and 21C are fixedly disposed on the outer peripheral surface of the shaft 2 (tubular structure), respectively. On the other hand, the front end electrode 22 is fixedly disposed at the foremost end of the shaft 2. These electrodes are electrically connected to a connector provided in the operation unit 3 through a plurality of wires 71A to 71C and 72 (not shown in FIGS. 1A and 1B) which are inserted into the tubular structure of the shaft 2, which will be described later.

Each of the ring-shaped electrodes 21A, 21B, and 21C and the distal end electrode 22 is made of a metal material having good conductivity such as aluminum (A1), copper (Cu), stainless steel (SUS), gold (Au), or platinum (Pt). Further, in order to improve the imaging of X-rays when the electrode catheter 1 is used, the above electrode is preferably made of platinum or an alloy thereof. Further, the outer diameters of the annular electrodes 21A, 21B, 21C and the distal end electrode 22 are not particularly limited, but are preferably equal to the outer diameter of the shaft 2.

(Operation section 3)

The operation unit 3 corresponds to a specific example of the "operation unit" of the present invention. The operation portion 3 is attached to the base end of the shaft 2 (the end portion of the base end region A1), and has, for example, a handle 31 (handle portion) and a rotary plate 32 in addition to the above-described connector.

The handle 31 is a portion that is grasped (held) by the operator (physician) when the electrode catheter 1 is used. Inside the handle 31, various thin wires (the wires 71A to 71C and 72 and the operation wires PW1 and PW2) which will be described later are drawn from the inside of the shaft 2, respectively.

The rotating plate 32 is a member that performs a biasing movement operation (swinging operation) that biases (bends) the vicinity of the front end of the shaft 2. Specifically, the rotating plate 32 has protrusions 32A, 32B. For example, as indicated by the arrows in FIG. 1A, by rotating the protrusions 32A, 32B in the rotational direction d1a or the rotational direction d1b, the rotating plate 32 can be rotated in the rotational direction d1a or The operation of rotating in the direction of the rotation direction d1b.

[Detailed structure of the shaft 2]

(the whole structure of the shaft 2)

Next, a detailed structure of the shaft 2 will be described with reference to Figs. 2 to 5B. Fig. 2 is a schematic view showing a configuration example of a detailed cross section (Y-Z cross section) in the vicinity of the intermediate portion Am of the shaft 2 shown in Fig. 1A. 3A and 3B are schematic views showing a detailed three-dimensional configuration example in the vicinity of the intermediate portion Am. 4A is a schematic view showing a configuration example of a cross section (XY cross section) along the arrow direction of the IVA-IVA line shown in FIG. 1A, and FIG. 4B is an arrow direction along the IVB-IVB line shown in FIG. 1A. A schematic diagram of a configuration example of a cross section (XY cross section). That is, FIG. 4A is a cross-sectional view showing a detailed configuration example of the proximal end region A1 and a central axis CL, and FIG. 4B is a cross-sectional view showing a detailed configuration example of the distal end region A2 and a central axis CL. 5A shows an end surface of the guide member 6 (described later) provided in the intermediate portion Am facing the base end region A1, and FIG. 5B shows the guide member 6 provided in the intermediate portion Am disposed opposite to the front end region A2. End face.

As shown in FIG. 2, the inside of the shaft 2 is penetrated by the operation lead PW1 and the operation lead PW2. Specifically, in the shaft 2, two passages (a first passage and a second passage) through which all of the base end region A1, the intermediate portion Am, and the tip end region A2 are continuously arranged in parallel along the central axis CL are formed. The operation lead PW1 is slidably inserted into the "first passage", and the operation lead PW2 is slidably inserted into the "second passage". Here, the "first path" is passed through the base end region. A lumen (hole, through hole) 4H1 of the domain A1, a lumen 6H1 penetrating the intermediate region Am, and a lumen 5H1 penetrating the distal end region A2 are formed to communicate with each other. The "second passage" is formed by a lumen 4H2 penetrating the proximal end region A1, a lumen 6H2 penetrating the intermediate region Am, and a lumen 5H2 penetrating the distal end region A2. The lumens 4H1, 4H2, 5H1, 5H2 all extend substantially parallel to the central axis CL. On the other hand, the lumens 6H1 and 6H2 are all inclined and extended toward the central axis CL so as to be apart from each other from the proximal end region A1 toward the distal end region A2. Further, the lumens 4H1, 4H2, 5H1, 5H2, 6H1, and 6H2 are respectively associated with the "first base end region portion", the "second base end region portion", the "first front end region portion", and the "second front end" of the present invention. A specific example of the area portion, the "first intermediate portion", and the "second intermediate portion" corresponds to each other.

As shown in FIG. 2, the distance between the lumen 4H1 in the first passage and the central axis CL is closer than the distance between the lumen 5H1 and the central axis CL in the first passage. Similarly, the distance between the lumen 4H2 in the second passage and the central axis CL is closer than the distance between the lumen 5H2 in the second passage and the central axis CL. Here, the distance between the lumen 4H1 and the central axis CL is preferably substantially equal to the distance between the lumen 4H2 and the central axis CL. Further, the distance between the lumen 5H1 and the central axis CL is preferably substantially equal to the distance between the lumen 5H2 and the central axis CL.

(base area A1)

In the proximal end region A1, the shaft 2 has the following configuration as shown in Fig. 4A: inside the tubular (hollow) tubular member 4, a multi-lumen tube 40 extending in the Z-axis direction is accommodated. The multi-lumen tube 40 is made of, for example, a resin such as polyetheretherketone (PEEK) or polytetrafluoroethylene (PTFE). In the multi-lumen tube 40, a plurality of lumens extending along the central axis CL including the lumens 4H1, 4H2 disposed opposite to each other across the central axis CL are formed. Specifically, in addition to the lumens 4H1, 4H2, for example, the opposing lumens are provided with the lumens 4H1, 4H2 interposed therebetween. The pair of lumens 41A and 41B are disposed; the pair of lumens 42A and 42B disposed to face each other across the central axis CL; and the pair of lumens 43A and 43B disposed to face the central axis CL. Further, although the lumens 4H1, 4H2, 41A, 41B, 42A, 42B, 43A, and 43B all have a circular cross section, for example, the shape and size (inner diameter) are not particularly limited. For example, the inner diameters of the lumens 4H1 and 4H2 are about 0.15 to 0.4 mm, the inner diameters of the lumens 41A and 41B are about 0.1 to 0.7 mm, and the inner diameters of the lumens 42A, 42B, 43A, and 43B are about 0.2 to 0.7 mm. . Further, the pair of lumens 41A and 41B, the pair of lumens 42A and 42B, and the pair of lumens 43A and 43B correspond to a specific example of the "pore pair" of the present invention.

Here, the lumen 41A of the multi-lumen tube 40 and the lumen 41B may be symmetrically arranged with respect to the central axis CL, and the lumen 42A and the lumen 42B may be symmetrically arranged with respect to the central axis CL, and the lumen 43A and the lumen 43B may be opposite to the central axis CL. Symmetrical configuration. Further, the lumens 41A, 42A, and 43A and the lumens 41B, 42B, and 43B may be symmetrically arranged in the Y-axis direction with the XZ plane including the central axis CL as a plane of symmetry. Further, the lumens 42A, 43B and the lumens 43A, 42B may be symmetrically arranged in the X-axis direction with the YZ plane including the central axis CL as a plane of symmetry.

The lumens 4H1, 4H2 are slidably inserted by the operation leads PW1, PW2, respectively. Further, the lumens 42A, 42B, 43A, and 43B are inserted through the wires 71A, 72, 71B, and 71C, respectively. Therefore, in the lead electrode 1, the number of the wires which are respectively inserted into the lumen 42A and the lumen 43B which are symmetrically arranged with the XZ plane including the central axis CL as the plane of symmetry is the same (one in the example of FIG. 4A), Similarly, the number of the wires which are respectively inserted into the lumen 43A and the lumen 42B which are symmetrically arranged with the XZ plane including the central axis CL as the plane of symmetry is the same (one in the example of FIG. 4A). Further, in the lead electrode 1, the number of the wires which are respectively inserted into the lumen 42A and the lumen 43A which are symmetrically arranged with the YZ plane including the central axis CL as the plane of symmetry is also the same (in the example of Fig. 4A, one) ), also the lumen 43B symmetrically arranged with the YZ plane including the central axis CL as a plane of symmetry The number of wires that are respectively inserted into the lumen 42B is also the same (one in the example of Fig. 4A). Here, for example, the wire 71A is electrically connected to the ring-shaped electrode 21A, the wire 71B is electrically connected to the ring-shaped electrode 21B, and the wire 71C is electrically connected to the ring-shaped electrode 21C. Further, the wire 72 is electrically connected to the front end electrode 22. The front ends of the wires 71A to 71C (distal sides of the shaft 2) are respectively fixed to the respective electrodes by welding or welding (not shown), and the base ends (near sides of the shaft 2) are respectively pulled into the operation portion 3 (handles) 31) inside.

On the other hand, the front ends of the operation lead wires PW1 and PW2 are fixed to the front end side of the shaft 2 (the inner circumferential surface of the front end electrode 22) by anchoring, welding, or the like, and the base end is attached to the rotary plate 32 of the operation portion 3. Thereby, the tension of the operation lead wires PW1, PW2 changes according to the rotation operation of the rotary plate 32 (operation of the rotary plate 32), and the operation lead PW1 can be operated along the central axis CL inside the shaft 2 (inside the tubular structure). Traction action (sliding action) of PW2. Therefore, when the rotary plate 32 is rotated, the front end portion of the lead electrode 1 is deflected.

By the fact that the operation leads PW1, PW2 are individually inserted into the lumens 4H1, 4H2, the radial movement (movement in the XY plane) of the operation leads PW1, PW2 to the multi-lumen tube 40 can be restricted. Since the movement of the operation lead PW1 in the XY plane stays inside the lumen 4H1, the movement of the operation lead PW2 in the XY plane stays inside the lumen 4H2. As a result, it is possible to suppress a decrease in the maximum amount of bending of the tip end region A2 of the electrode catheter 1 caused by the movement of the operation leads PW1, PW2 in the radial direction of the multi-lumen tube 40 in the lumens 4H1, 4H2. Therefore, the front end curve responsiveness at the time of the bending operation can be improved.

Further, the wires 71A to 71C and 72 are each made of a metal material such as copper, and have a diameter of about 50 to 200 μm (for example, 100 μm). Further, the operation leads PW1 and PW2 are made of a superelastic metal material such as stainless steel (SUS) or NiTi, and have a diameter of 0.10 mm to 0.35 mm. about. Here, the difference between the inner diameters of the lumens 4H1, 4H2 and the diameters of the operation leads PW1, PW2 is, for example, preferably 0.05 to 0.25 mm. By reducing the difference between the inner diameters of the lumens 4H1, 4H2 and the diameters of the operation leads PW1, PW2 in this manner, the amount of radial movement of the operation leads PW1, PW2 into the multi-lumen tube 40 can be further reduced. As a result, the curve of the front end curve of the lead electrode 1 can be further improved.

The tubular member 4 corresponds to a specific example of the "first outer tube" of the present invention. The tubular member 4 has a cylindrical wall portion 4A extending in the direction (Z-axis direction) of the central axis CL of the shaft 2, and a braid 4B embedded therein.

The wall portion 4A is composed of a synthetic resin such as polyolefin, polyamide, polyether polyamine or polyurethane. The wall portion 4A has a thickness of about 0.4 to 1.5 mm (for example, 0.8 mm), preferably 0.6 to 1.2 mm.

The grouping portion 4B has a grouping structure in which a plurality of plate-like wire members (flat-plate-shaped wires) are arranged to intersect each other and woven. The thickness of the grouping portion 4B is, for example, about 10 to 200 μm (for example, 50 μm).

(front end area A2)

In the front end region A2, the shaft 2 has the following configuration as shown in Fig. 4B: inside the tubular (hollow) tubular member 5, a plurality of tubes (here, 6 pieces) respectively extending along the central axis CL are accommodated. Tubes 51~56). Here, the tube 51 and the tube 52 are disposed to face each other across the central axis CL, and the tube 53 and the tube 54 are disposed to face each other across the central axis CL, and the tube 55 and the tube 56 are disposed to face each other across the central axis CL. The shaft 2 further has a leaf spring member 57 at the front end region A2.

The tubular member 5 has a multilayer structure in which the inner layer 5A, the intermediate layer 5B, and the outer layer 5C are sequentially laminated from the inner peripheral side toward the outer peripheral side. The inner layer 5A, the intermediate layer 5B, and the outer layer 5C are each made of, for example, the same material as the above-described wall portion 4A. Further, the tubular member 5 is preferably constructed as follows: The front end side has a relatively high flexibility and the base end side has a relatively low flexibility. Thereby, the shaft 2 is easily bent selectively in the vicinity of the front end. Further, the inner layer 5A is provided in close contact with the tubes 51 to 56 and the leaf spring member 57 and covers the same. The thickness of the outer layer 5C of the tubular member 5 is, for example, about 50 to 500 μm (for example, 200 μm). Further, the tubular member 5 corresponds to a specific example of the "second outer tube" of the present invention. Near the base end of the tubular member 5, toward the base end, a portion of the tubular member 5 is cut, and the thickness of the meat is thinned. The thinned portion near the base end of the tubular member 5 is fused with one end of the tubular member 4 extending from the base end region A1 via the intermediate portion Am to a portion of the front end region A2.

The leaf spring member 57 is interposed, for example, between the tube 51 that houses the operation lead PW1 and the tube 52 that houses the operation lead PW2, and extends along the central axis CL. The leaf spring member 57 is, for example, a plate-like member that expands along the X-Z plane, and the both end sides in the X-axis direction are locked by the inner layer 5A of the tubular member 5 in the entire length in the Z-axis direction. Therefore, the leaf spring member 57 can suppress the distortion of the tubular member 5 which is generated, for example, when the operation leads PW1, PW2 are pulled. As a result, the torsional rigidity of the shaft 2 is enhanced, and the torque responsiveness and bending responsiveness of the shaft 2 can be improved.

The tubes 51 to 56 extend along the central axis CL of the shaft 2, respectively, and each has a hollow structure having one lumen. As shown in FIG. 4B, an operation lead PW1 is slidably inserted into the lumen 5H1 which is inside the tube 51, and an operation lead PW2 is slidably inserted into the lumen 5H2 which is inside the tube 52. Further, a wire 71A is inserted into the lumen 5H3 which is inside the tube 53, a wire 72 is inserted into the lumen 5H4 which is inside the tube 54, and a wire 71B is inserted into the lumen 5H5 which is inside the tube 55, A wire 71C is inserted into the lumen 5H6 which is inside the tube 56.

The tubes 51-56 are each composed of, for example, polyolefin, polyamine, polyether polyamine, It is composed of a synthetic resin such as polyurethane, and the thicknesses thereof are each about 10 to 200 μm (for example, 30 μm). Further, the inner diameter of each of the tubes 51 to 56 (the diameter of each of the lumens 5H1 to 5H6) is about 100 to 800 μm (for example, 500 μm).

(middle area Am)

A guide member 6 is provided between the multi-lumen tube 40 provided in the proximal end region A1 and the tubes 51 to 56 provided in the distal end region A2. The guide member 6 is made of, for example, ceramic, liquid crystal polymer or the like. As shown in FIG. 5A and FIG. 5B, the guide member 6 has a plurality of grooves extending along the central axis CL (in this case, four grooves 61~) in addition to the lumens 6H1 and 6H2 penetrating the inside thereof. 64). Further, although the grooves 61 to 64 each have a substantially elliptical cross-sectional shape, the shape and size (inner diameter) are not particularly limited.

The end surface of the groove 61 on the proximal end side communicates with the lumen 42A and the end surface on the distal end side The lumen 5H3 is in communication, and a wire 71A is inserted therein. The groove 62 communicates with the lumen 42B at the end surface on the proximal end side, and communicates with the lumen 5H4 at the end surface on the distal end side, and a lead wire 72 is inserted therein. The groove 63 communicates with the lumen 43A on the end surface on the proximal end side, and communicates with the lumen 5H5 on the distal end side end surface, and a lead wire 71B is inserted therein. The groove 64 communicates with the lumen 43B on the end surface on the proximal end side, and communicates with the lumen 5H6 on the distal end side end surface, and a lead wire 71C is inserted therein.

〔Effect〕

(A. Basic action)

When the patient is examined for arrhythmia, treatment, or the like, the shaft 2 in the lead catheter 1 is inserted into the body (for example, inside the heart) through the blood vessel. At this time, according to the operation of the operation unit 3 (disposed outside the body) by the operator, the shape near the front end of the shaft 2 inserted into the body changes, for example, in one direction or in two directions (biasing, bending). Specifically, if the operator presses the protrusion 32A by the finger, For example, when the rotary plate 32 is rotated in the rotational direction d1a indicated by the arrow in FIG. 1A, the inner operation lead PW1 is pulled toward the proximal end side of the shaft 2. As a result, the vicinity of the front end of the shaft 2 is bent in the direction d2a indicated by the arrow in Fig. 1A.

Here, for example, in the case of the above-described examination for arrhythmia, the cardiac potential can be measured using the electrodes (the distal end electrode 22 and the annular electrodes 21A, 21B, and 21C) of the electrode catheter 1 inserted into the body. Then, based on the information of the cardiac potential, an examination of the presence or absence of the abnormal potential at the examination site and the degree thereof is performed.

On the other hand, for example, in the case of the above-described treatment for arrhythmia, between the counter electrode plate (not shown) attached to the body surface of the patient and the electrode (front end electrode 22) of the electrode catheter 1 inserted into the body. High frequency (RF: Radio Frequency) is energized. By such high-frequency energization, the site (blood vessel, etc.) of the treatment subject is selectively ablated, and the percutaneous treatment of arrhythmia is completed.

(B. Effect according to the action of the axis 2)

Here, in the electrode catheter 1 of the present embodiment, the shaft 2 has a porous structure in which a plurality of lumens (cavities 5H1 to 5H6) extending in the direction (Z-axis direction) along the central axis CL are formed in the distal end region A2. . Further, a plurality of thin wires (wires 71A to 71C, 72 and operation leads PW1, PW2) are respectively inserted into the six lumens 5H1 to 5H6. Therefore, compared with the case where the shaft 2 has a single-hole structure in the front end region A2, the operability (lifting torque transmission characteristics, etc.) of the lead wire 1 can be improved.

Further, in the electrode catheter 1, the shaft 2 also has a porous structure in which a plurality of lumens (cavities 4H1, 4H2, 41A, 41B, 42A, 42B, 43A, 43B) are formed in the proximal end region A1. Among them, since the operation lead PW1 is inserted in the lumen 4H1 and the operation lead PW2 is inserted in the lumen 4H2, the operation lead PW1 and the operation lead PW2 can be avoided during the operation of the operation portion 3. Mutual interference, rectification, etc. interfere with each other. Furthermore, the movement of the operation lead PW1 and the operation lead PW2 in the radial direction of the shaft 2 can be restricted. As a result, the operability of the lead 1 (elevation of the front end curve responsiveness) can be improved. Specifically, according to the electrode catheter 1, by the operation of the operation portion 3, the shaft 2 of the front end region A2 can be quickly bent in a desired curved shape. In other words, according to the electrode lead 1, it is possible to avoid problems such as that the shaft 2 of the operation distal end region A2 of the operation portion 3 is not sufficiently curved and the desired curved shape is not obtained.

Further, by inserting the wires 71A to 71C and the wires 72 into the lumens 42A, 42B, 43A, 43B of the multi-lumen tube 40, for example, all the wires 71A to 71C, 72 are inserted into one lumen. Compared with the case of 42A, the torque transmission characteristics (torque responsiveness) can be improved. If a plurality of wires are inserted into one lumen, a plurality of operation leads are offset (localized) in the lumen. As a result, when a rotational force is applied to the proximal end side of the shaft 2, the rotational force may not be sufficiently transmitted to the distal end side to be in a stagnant state (a state in which so-called torque accumulation occurs), and the continuous response may be hindered. In this regard, according to the electrode catheter 1 of the present embodiment, since the plurality of wires are dispersed and inserted into the plurality of lumens, the occurrence of the above-described torque accumulation can be avoided.

Further, in the lead pipe 1, even if the shaft 2 does not have a compression-resistant member such as a metal pipe in the proximal end region A1, it is possible to sufficiently prevent the bending and deflection from being unintended. This is because the lumen 4H1 through which the operation lead PW1 is inserted and the lumen 4H2 through which the operation lead PW2 is inserted are disposed closer to the central axis CL, and on the other hand, in the distal end region A2, the insertion is performed. The lumen 5H1 of the operation lead PW1 and the lumen 5H2 through which the operation lead PW2 is inserted are disposed at positions near the outer peripheral surface farther from the central axis CL. Therefore, high operability (torque transmission characteristics and front end curve responsiveness at the time of bending operation) of the lead wire 1 can be ensured.

Therefore, in the lead electrode 1, since there is no compression resistance such as a conventional metal tube Since the member is a member, the thickness of the tubular member 4 which is a portion of the space occupied by the anti-compressibility member in the past can be increased. As a result, not only the torque transmission characteristics but also the pushability can be improved. The so-called pushability refers to the ease of the operator when inserting the shaft 2 into the patient. In the lead pipe 1, by increasing the thickness of the tubular member 4, the rigidity of the tubular member 4 becomes high. Therefore, when the front end region A2 of the shaft 2 is inserted into the blood vessel of the patient, for example, when the distal end electrode 22 reaches the inside of the heart and the proximal end region A1 of the shaft 2 is grasped while pressing toward the distal end side, the tubular member 4 is less likely to occur. Bend, squat. This can improve the pushability. In particular, since the multi-lumen tube 40 is made of a resin having a relatively high hardness such as PEEK, it is preferable because it can obtain higher pushability.

Further, in the electrode catheter 1, the cross-sectional shape of each of the lumens or grooves provided inside the tubular members 4, 5 and the inside of the guide member 6 is substantially circular or elliptical. Thereby, on the one hand, the weight of the shaft 2 can be reduced, and on the other hand, the strength of the shaft 2 can be increased in a balanced manner. Therefore, the shaft 2 can firmly maintain a stable shape with respect to external forces from multiple directions.

Further, in the electrode catheter 1, a plurality of lumens of the multi-lumen tube 40 provided in the proximal end region A1 are symmetrically arranged with respect to the central axis CL. Specifically, for example, the lumen 41A and the lumen 41B are symmetrically arranged with respect to the central axis CL, the lumen 42A and the lumen 42B are symmetrically arranged with respect to the central axis CL, and the lumen 43A and the lumen 43B are symmetrically arranged with respect to the central axis CL. Further, the XZ plane including the central axis CL is used as a plane of symmetry, and the lumens 41A, 42A, and 43A and the lumens 41B, 43B, and 42B are symmetrically arranged in the Y-axis direction. Further, the lumens 42A and 43B and the lumens 43A and 42B are symmetrically arranged in the X-axis direction with the YZ plane including the central axis CL as a plane of symmetry. According to this configuration, the rotational force applied to the proximal end side of the shaft 2 can be more easily transmitted to the distal end side, and the torque transmission characteristics can be further improved. In particular, if the lumens 41A, 41B disposed at mutually symmetrical positions have the same diameter, The lumens 42A, 43A, 42B, 43B disposed at mutually symmetrical positions all have the same diameter, which is more advantageous in terms of lifting torque transmission characteristics.

In the lead electrode 1, the number of the wires which are respectively inserted into the lumen 42A and the lumen 43B which are symmetrically arranged with the XZ plane including the central axis CL as the plane of symmetry is the same, and the XZ plane including the central axis CL is also used as the plane of symmetry. The number of wires in which the symmetrically configured lumen 43A is inserted into the lumen 42B is the same. Further, the number of the wires which are respectively inserted into the lumen 42A and the lumen 43A which are symmetrically arranged with the YZ plane including the central axis CL as the plane of symmetry is the same, and is also symmetrically arranged with the YZ plane including the central axis CL as a plane of symmetry. The number of wires through which the lumen 43B is inserted is the same as that of the lumen 42B. Thus, in the lead electrode 1, the lumens through which the wires are inserted are disposed at symmetrical positions, and the wires inserted through the respective lumens are disposed in an equal number of ways. Therefore, in the lead wire 1, it is possible to avoid occurrence of torque accumulation, and the rotational force applied to the proximal end side of the shaft 2 can be more easily transmitted to the distal end side, and the torque transmission characteristics can be further improved.

As described above, in the present embodiment, as in the distal end side, a porous structure is also adopted on the proximal end side, and a plurality of operation leads are inserted into the respective lumens. Therefore, in the electrode catheter 1, it is possible to prevent interference between the plurality of operation leads, and it is possible to smoothly perform the displacement operation of the shaft 2. Further, since the operation lead wires PW1 and PW2 are inserted into the position close to the central axis CL in the proximal end region A1, it is possible to suppress the bending or the like in the proximal end region A1 of the shaft 2.

<Modification>

Although the invention has been described above by way of examples, the invention is not limited to the embodiment, and various modifications can be made.

For example, the shape, arrangement position, material, and the like of each member described in the above embodiment are not limited, and other shapes, arrangement positions, materials, and the like may be employed. Again, the lumen The number, the number of operation leads, and the like are not limited to those described in the above embodiments. Further, the materials of the respective layers and members described in the above embodiments are not limited, and other materials may be employed. In the above-described embodiment, the configuration of the electrode catheter (shaft) is specifically described. However, it is not always necessary to have all the layers, and other layers may be further provided. Specifically, for example, the leaf spring member 57 of the shaft 2 may not be provided.

Further, in the above-described embodiment, various types of wires are inserted into the respective lumens of the shaft 2, but for example, a thermocouple or the like as a temperature sensor may be inserted. In this way, the combination of the plurality of tubes (cavities) and the insertion of the plurality of thin wires can be arbitrarily set according to the use or the like.

Further, in the above-described embodiment, the configuration of the electrode of the distal end region A2 of the shaft 2 is specifically described. However, the arrangement, shape, number, and the like of the annular electrode and the distal end electrode are not limited thereto.

Further, the present invention can be applied to any of an electrode catheter (so-called EP catheter) for examination (diagnosis) such as arrhythmia and a therapeutic electrode catheter (so-called ablation catheter) such as arrhythmia. Further, the present invention is not limited to the electrode catheter, and may be applied, for example, to an esophageal catheter that is inserted into the esophagus close to the heart for temperature measurement when ablated by the ablation catheter.

2‧‧‧Axis

A1‧‧‧ base area

A2‧‧‧ front end area

Am‧‧‧Intermediate area

4,5‧‧‧Tubular components

40‧‧‧Multi-lumen tube

4H1, 4H2, 41A, 41B, 5H1, 5H2, 6H1, 6H2‧‧‧ lumen

51,52‧‧‧ pipes

57‧‧‧Spring element

6‧‧‧ Guide members

PW1, PW2‧‧‧ operation lead

CL‧‧‧ center axis

Claims (2)

A catheter includes: an operation portion; and a flexible shaft connected to the operation portion, and includes a base end region, an intermediate portion, and a front end region that are sequentially arranged from the operation portion side along a central axis, and is disposed a first path and a second path through which all of the base end region, the intermediate portion, and the front end region are juxtaposed along the central axis; a first lead wire inserted through the first path; and a second lead wire Inserting into the second passage; a distance of a portion of the first base end region of the first passage that penetrates the base end region from the central axis is greater than a first front end region of the first passage that penetrates the front end region a portion is closer to the central axis; a distance of the second base end region of the second passage through the base end region to the central axis is greater than a second front end region of the second passage extending through the front end region a portion being closer to the central axis; a first intermediate portion portion of the first passage that extends through the intermediate portion, and a second intermediate portion portion of the second passage that extends through the intermediate portion to follow from the base End zone The manner toward each other away from the distal region of the center axis inclination, the flexible shaft having a proximal end formed with the first region of the base portion and the second portion of the end region of the multi-lumen tube at the base end area. The catheter of claim 1, wherein the multi-lumen tube further has a first lumen and a second tube symmetrically disposed about the central axis a cavity, a third lumen symmetrically disposed with respect to the central axis, and a fourth lumen, the first lumen and the third lumen being symmetrically disposed with the first surface including the central axis as a plane of symmetry, the second tube The cavity and the fourth lumen are symmetrically arranged with the first surface as a plane of symmetry, and the first lumen and the fourth lumen are symmetrically arranged symmetrically with a second surface including the central axis orthogonal to the first surface The second lumen and the third lumen are symmetrically disposed with the second surface as a plane of symmetry.