TW202224625A - Electrode catheter - Google Patents

Abstract

Provided is an electrode catheter capable of improving reliability while being reduced in size. An electrode catheter according to an embodiment of the present invention is provided with: a catheter shaft that has a plurality of lumens and a distal flexible portion having a plurality of metal electrodes; and a handle having an operation unit that is operated in a deflection operation for bidirectionally deflecting the distal flexible portion. The plurality of metal electrodes includes a distal end electrode having a through hole, and one or more ring-shaped electrodes. The plurality of lumens includes a main lumen through which an elongated instrument is inserted, and first and second sub-lumens through which a single operation wire is inserted. The single operation wire includes: a first extension portion extending from a first end into the distal end electrode through the first sub-lumen; a second extension portion extending from the inside of the distal end electrode to a second end through the second sub-lumen; and a folded portion that is located between the first and second extension portions and is at least partially fixed within the distal end electrode.

Description

lead

The present invention relates to an electrode catheter including a catheter shaft having electrodes near its distal end.

As an example of a medical device having electrodes in the vicinity of the distal end, there is an electrode catheter in which electrodes are provided on a catheter shaft in this way (for example, Patent Document 1). [Prior Art Literature] [Patent Literature]

Patent Document 1: Japanese Patent No. 3830521

However, in general, the electrode catheter as described above is required to be reduced in size and improved in reliability. It is desired to provide an electrode catheter that can achieve miniaturization and improved reliability.

An electrode catheter according to an embodiment of the present invention includes a catheter shaft and a handle. The catheter shaft has a distal flexible portion and a plurality of lumens, a plurality of metal electrodes are arranged along the axial direction on the distal flexible portion, and the multiple lumens extend along the axial direction. The handle is attached to the proximal end side of the catheter shaft, and has an operating portion that is operated when a deflection operation for deflecting the distal end flexible portion in two directions is performed. The above-mentioned plural metal electrodes include a front end electrode and one or plural annular electrodes. The distal end electrode is disposed near the most distal end of the distal end flexible portion, and has a through hole through which the elongated tool penetrates in the axial direction. One or a plurality of annular electrodes are arranged on the proximal end side of the distal electrode. The plurality of inner cavities include a main cavity, a first auxiliary cavity and a second auxiliary cavity. The above-mentioned single operation wire includes a first extension portion, a second extension portion and a bent portion. The first extension part extends from the first end of the single operation wire fixed on the operation part to the front end electrode through the first sub cavity, and the second extension part is fixed to the operation part from the front end electrode through the second auxiliary cavity The second end of the single operating wire extends. The bent portion is located between the first extension portion and the second extension portion, and at least a part of the area is fixed in the front end electrode.

In the electrode catheter according to an embodiment of the present invention, both ends of the single operation wire (the first end and the second end: the base ends of the first extension portion and the second extension portion) are passed through a catheter tube. The inside of the shaft (in the above-mentioned first sub-cavity and in the second sub-cavity) is fixed in the handle (on the above-mentioned operating part). In addition, the bent portion of the operation wire is arranged in the distal end electrode of the catheter shaft. In this way, a single operation wire (a pair of operation wires is not used) can realize the bidirectional deflection operation of the distal end flexible portion. In addition, at least a partial region of the above-mentioned bent portion is fixed in the tip electrode. Thereby, even in the structure in which the tip electrode having the above-mentioned through-hole is provided, the fixing strength (size of the fixing area) of the operation wire can be easily ensured. As a result, it is easy to prevent the operation wire from falling off in the vicinity of the distal electrode without increasing the outer diameter of the distal electrode and the length in the axial direction.

In the electrode catheter according to one embodiment of the present invention, the distal end electrode may have a reduced diameter portion, and the reduced diameter portion may be formed on a proximal end side portion of the distal end electrode and can be inserted into the distal end portion of the catheter shaft. The at least a partial region of the bent portion is fixed to the diameter-reduced portion. In such a case, the distal end electrode and the distal end of the catheter shaft are easily connected by the above-mentioned diameter-reduced portion. As a result, the reliability of the electrode catheter can be further improved.

In this case, a groove may be formed on the outer peripheral surface of the diameter-reduced portion, and the at least a partial region of the bent portion may be fixed in the groove. In such a case, by fixing the bent portion in the groove, since the fixing strength of the operation wire increases, it becomes easier to prevent the operation wire from falling off in the vicinity of the distal end electrode. As a result, the reliability of the electrode catheter can be further improved.

Furthermore, in the electrode catheter according to an embodiment of the present invention, the bent portion may extend in an arc shape in a plane orthogonal to the axial direction in the distal electrode. In such a case, the bending portion extending in the shape of an arc in the above-mentioned orthogonal planes is fixed in the distal electrode, whereby the fixing strength of the operation wire increases, so that it is easier to prevent the operation wire from being in the vicinity of the distal electrode. fall off. As a result, the reliability of the electrode catheter can be further improved.

Furthermore, in the electrode catheter according to one embodiment of the present invention, in the distal electrode, the entire area of the bent portion may be fixed. In such a case, it is easier to prevent the operation wire from falling off in the vicinity of the distal electrode than when, for example, only a part of the bent portion is fixed in the distal electrode. As a result, the reliability of the electrode catheter can be further improved.

According to the electrode catheter of one embodiment of the present invention, since at least a part of the bent portion of the single operation wire is fixed in the distal electrode, the outer diameter of the distal electrode and the length in the axial direction are not increased. , it is also easy to prevent the operation wire from falling off near the front end electrode. Therefore, it is possible to reduce the size of the electrode catheter and improve the reliability.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. In addition, the description is performed in the following order. 1. Embodiment (Example in which the entire area of the bent portion of the operation wire is fixed in the distal electrode) 2. Modification (an example in which a part of the bent portion of the operation wire is fixed in the tip electrode) 3. Other modifications

<1. Embodiment> [A. Schematic structure] FIG. 1 is a schematic diagram showing a schematic structural example of an electrode catheter (electrode catheter 1 ) according to an embodiment of the present invention. In addition, in this FIG. 1, the vicinity of the front-end|tip part of the catheter shaft 11 mentioned later is enlarged and shown. Moreover, FIG. 2 is a schematic diagram for demonstrating the detailed structure example of the handle|steering-wheel 12 shown in FIG. 1 and mentioned later. FIG. 3 is a cross-sectional view (X-Y cross-sectional view) taken along the arrow direction of line III-III shown in FIG. 1 .

The electrode catheter 1 is inserted into a patient's body (eg, inside the heart) through a blood vessel, and is used for examination, treatment, and the like of arrhythmia and the like. Specifically, a plurality of metal electrodes, which will be described later, of the electrode catheter 1 is used to measure the potential in the vicinity of the affected part in the body, and to perform cauterization (ablation) and the like on the affected part.

As shown in FIG. 1 , the electrode catheter 1 includes a catheter shaft 11 (catheter tube portion) as a catheter main body (long portion), and a handle 12 attached to the proximal end side of the catheter shaft 11 . The electrode catheter 1 further includes an insertion port 14 for inserting the guide wire 9 into the catheter shaft 11 through the handle 12 , a protective tube 15 covering the circumference of the lead wire 50 to be described later, and electrical connection with the lead wire 50 via the protective tube 15 . connected connector 16.

In addition, the said guide wire 9 corresponds to a specific example of the "long implement" of this invention.

(catheter tube shaft 11) The catheter shaft 11 is composed of a flexible tubular structure (hollow tubular member), and has a shape extending in its own axial direction (Z-axis direction) (see FIGS. 1 and 2 ). Specifically, the length in the axial direction of the catheter shaft 11 is about several times to several tens of times longer than the length in the axial direction (Z-axis direction) of the handle 12 .

As shown in FIG. 1 , the catheter shaft 11 has a distal end portion (a distal end flexible portion 11A), and the distal end flexible portion 11A is configured to have relatively excellent flexibility. The catheter shaft 11 also has a so-called multi-lumen structure in which a plurality of lumens (inner holes, pores, and through holes) are formed so as to extend in its own axial direction (Z-axis direction). In the lumen of the catheter shaft 11 as described above, various thin wires (the guide wire 50, the operation wire 40, etc., which will be described later) are respectively inserted in a state of being electrically insulated from each other, and the above-mentioned guide wire 9 is inserted.

Specifically, as shown in FIG. 3 , the catheter shaft 11 is provided with one main lumen 61 and a plurality of (six in this example) sub-lumens 62A to 62F, and one main lumen 61 is arranged in In the center portion, a plurality of sub cavities 62A to 62F are isotropically arranged on the outer peripheral side of the main cavity 61 .

In addition, each of these main cavity 61 and sub-cavities 62A to 62F corresponds to one specific example of the "plurality of cavities" of the present invention. In addition, among the sub-chambers 62A to 62F, the sub-chamber 62A corresponds to a specific example of the "first sub-chamber" of the present invention, and the sub-chamber 62B corresponds to a specific example of the "second sub-chamber" of the present invention.

In the main cavity 61 , the above-mentioned guide wire 9 , which is a long tool extending in the axial direction (Z-axis direction), is inserted into the inside.

The operation wires 40 are inserted through the sub-cavities 62A and 62B, respectively. In addition, the lead wire 50 (lead wire) is inserted into the sub-lumen 62D, and the lead wire 51 (lead wire) is inserted into the sub-lumens 62C, 62E, and 62F, respectively. Moreover, each of these thin wires (the operation wire 40 and the guide wires 50 and 51 ) extends along the axial direction (Z-axis direction) of the catheter shaft 11 .

Here, the above-mentioned operation wire 40 is composed of a single (one) wire instead of a pair (two wires) of a general structure. In addition, as shown in FIGS. 1 to 3 , such a single operation wire 40 includes two extending parts 40 a and 40 b extending inside the catheter shaft 11 and a bending part 40 c which will be described later.

In the extension part 40a, as shown in FIG. 2, the base end (the first end of the operation wire 40) side extends into the handle 12 (the fixing part 42a on the rotary plate 41 to be described later), and, as shown in FIG. 3 As shown, from the proximal end side of the extending portion 40a, it extends into the metal electrode (the distal end electrode 110 described later) disposed on the distal flexible portion 11A through the sub-lumen 62A of the catheter shaft 11.

In the extension part 40b, as shown in FIG. 2, the base end (the second end of the operation wire 40) side extends into the handle 12 (the fixing part 42b on the rotary plate 41 to be described later), and, as shown in FIG. 3 As shown, from the proximal end side of the extension portion 40b, it extends into the distal electrode 110 described later via the inside of the sub-lumen 62B of the catheter shaft 11 described above.

The bent portion 40c is a portion located between the extension portions 40a and 40b (in the example of this embodiment, the extension portions 40a and 40b are connected), and is arranged in the distal electrode 110 described later, which will be described in detail later.

In addition, the extension part 40a mentioned above corresponds to a specific example of the "first extension part" of the present invention, and the extension part 40b corresponds to a specific example of the "second extension part" of the present invention.

The distal ends of the lead wires 50 and 51 are individually electrically connected to a plurality of metal electrodes (the distal electrode 110 and the annular electrode 111 described later) to be described later. Specifically, one lead wire 50 is electrically connected to one distal electrode 110 , and a plurality of lead wires 51 are individually electrically connected to a plurality of annular electrodes 111 . In addition, the base end sides of these guide wires 50 and 51 can be connected to the electrode catheter 1 from the inside of the catheter shaft 11 (in the auxiliary lumens 62C, 62D, 62E, 62F), through the inside of the handle 12, the inside of the protection tube 15, and the inside of the connector 16. external connection.

Here, as shown in FIG. 3 , the catheter shaft 11 is basically composed of a tubular tube 60A located on the inner peripheral side and a tubular tube 60B located on the outer peripheral side. In addition, the main cavity 61 is formed in the tubular tube 60C positioned on the inner peripheral side of the tube 60A, and the sub-cavities 62A to 62F are each formed in the tubular tube 60E arranged inside the tube 60A.

In addition, as shown in FIG. 3 , the main lumen 61 and the sub-lumens 62A to 62F are respectively arranged in the catheter shaft 11 so as not to contact each other. In short, the main chamber 61 and the sub chambers 62A to 62F are arranged to be separated from each other via the pipe 60A.

Here, the outer diameter of the catheter shaft 11 is, for example, about 1.0 to 4.0 mm, and the axial length of the catheter shaft 11 is, for example, about 300 to 1500 mm. Moreover, as a constituent material of the catheter shaft 11 (the above-mentioned tubes 60A, 60B, 60C, 60E), for example, polyamide, polyether polyamide, polyurethane, and polyether block amide (PEBAX) (registered trademark) can be exemplified. ) and thermoplastic resins such as nylon. In addition, as the tubes 60C and 60E, among such thermoplastic resins, fluororesins such as perfluoroalkoxyalkane (PFA) and polytetrafluoroethylene (PTFE) can be used. In addition, the tube 60B may be composed of, for example, an outer peripheral side layer (layer made of polyamide or the like) and an inner peripheral side layer (layer made of SUS (stainless steel) blades).

Furthermore, as shown in FIG. 1 , in the vicinity of the distal end of the catheter shaft 11 (the distal end flexible portion 11A), the aforementioned plurality of metal electrodes (one distal electrode 110 and a plurality of annular electrodes 111 ) are arranged along the axial direction (Z axis direction) are arranged side by side at predetermined intervals. Specifically, the distal electrode 110 is arranged in the vicinity of the most distal end of the distal flexible portion 11A, and the plurality of annular electrodes 111 are respectively arranged in the region on the proximal side of the distal electrode 110 of the distal flexible portion 11A.

As described above, each of the front end electrode 110 and the ring electrode 111 is, for example, an electrode for potential measurement or cauterization, and is made of, for example, aluminum (Al), copper (Cu), SUS, gold (Au), and platinum (Pt). It is composed of metal materials with good electrical conductivity. In addition, although the outer diameters of the distal end electrode 110 and the annular electrode 111 are not particularly limited, they are preferably substantially the same as the outer diameter of the catheter shaft 11 described above.

In addition, each of these front-end|tip electrodes 110 and the ring-shaped electrode 111 corresponds to one specific example of "a plurality of metal electrodes" of this invention. In addition, the detailed structure example of the front-end|tip electrode 110 is mentioned later (FIG. 4-FIG. 6).

(handle 12) The handle 12 is the portion that is grasped (held) by the operator (doctor) when using the lead 1 . As shown in FIG. 1 , the handle 12 includes a handle body 121 attached to the proximal end side of the catheter shaft 11 , and a rotation operation portion 122 .

In addition, this rotation operation part 122 corresponds to a specific example of the "operation part" of this invention.

The handle body 121 corresponds to a portion (grip portion) actually held by the operator, and has a shape extending along the axial direction (Z-axis direction). Moreover, this handle main body 121 is comprised using a pair of handle member 121a, 121b which can be divided|segmented along the Y-axis direction, as shown in FIG.1, FIG.2. In other words, these handle members 121a, 121b are connected to each other to constitute the handle main body 121 . Moreover, as shown in FIG. 2, the fixing member 123 for fixing the catheter shaft 11 in the handle main body 121 is arrange|positioned in the handle member 121b. The handle main body 121 (handle members 121a, 121b) in this way is made of synthetic resin such as polycarbonate, acrylonitrile-butadiene-styrene copolymer (ABS), for example.

The rotation operation part 122 is a part that is operated when a deflection operation of deflecting the vicinity of the distal end of the catheter shaft 11 (the distal end flexible part 11A) in two directions is performed, which will be described in detail later. In other words, the rotation operation part 122 is a part used when performing such a deflection operation together with the aforementioned operation wire 40 (extended parts 40a, 40b). Specifically, when performing such a deflection operation, the rotation operation portion 122 is operated (rotation operation) by the operator of the electrode catheter 1 . In this way, as shown in FIG. 1 , the rotation operation portion 122 is configured to include the rotation plate 41 .

As shown in FIG. 1 , the rotary plate 41 is attached to the handle body 121 so as to be rotatable around a rotation axis (Y-axis direction) perpendicular to the longitudinal direction (Z-axis direction). The rotary plate 41 corresponds to the portion actually operated by the operator at the time of the above-described rotary operation, and has a substantially disc shape. Specifically, in this example, as indicated by the arrows d1a, d1b in FIG. 1 , the rotary plate can be rotated in two directions in the Z-X plane relative to the handle body 121 (rotation operation with the above-mentioned rotation axis as the rotation center) 41. In addition, as shown in FIGS. 1 and 2 , the rotating plate 41 is configured using a pair of rotating plate members 411 and 412 that can be divided in the Y-axis direction. In other words, these rotating plate members 411 , 412 are connected to each other to constitute the rotating plate 41 .

As shown in FIGS. 1 and 2 , on the side surface of the rotating plate 41 in this way, a pair of knobs 41 a and 41 b are provided integrally with the rotating plate 41 . In this example, as shown in FIG. 1 , the knob 41a and the knob 41b are arranged at mutually point-symmetrical positions about the rotation axis of the rotary plate 41 . When the operator rotates the rotary plate 41, each of these knobs 41a, 41b corresponds to a portion operated (pressed) with, for example, a finger of one hand. In addition, the rotating plate 41 in this way is made of, for example, the same material (synthetic resin or the like) as the aforementioned handle body 121 .

Moreover, as shown in FIG. 2, on the rotating plate 41 (rotating plate member 412), a pair of fixing|fixed parts 42a and 42b are provided. These fixing parts 42a and 42b are members (lead fixing parts) for individually fixing the base ends of the above-mentioned operation wires 40 (extended parts 40a and 40b ) by screwing or the like. Specifically, in the example of FIG. 2 , the base end of the extension portion 40a of the manipulation wire 40 (the first end of the manipulation wire 40 described above) is fixed to the rotating plate member 412 by the fixing part 42a. In addition, the base end of the extension part 40b of the operation wire 40 (the aforementioned second end of the operation wire 40) is fixed to the rotating plate member 412 by the fixing part 42b. In addition, in these fixing parts 42a, 42b, the retraction length of each base end vicinity when fixing each base end of these extension parts 40a, 40b can be adjusted arbitrarily, respectively.

[B. Detailed Configuration of Front-End Electrode 110 ] Next, with reference to FIGS. 4 to 6 , a detailed configuration example of the aforementioned distal electrode 110 will be described.

FIGS. 4(A) and 4(B) are side views showing detailed structural examples of the distal end electrode 110 shown in FIGS. 1 and 2 , respectively. Specifically, FIG. 4(A) shows a detailed configuration example of the distal electrode 110 on the Y-Z side surface, and FIG. 4(B) shows a detailed structural example of the distal electrode 110 on the Z-X side surface. 5 is a perspective view showing a configuration example of the distal electrode 110 shown in FIG. 4 , and FIG. 6 is an X-Y side view showing a configuration example of the distal electrode 110 shown in FIG. 4 .

As shown in FIGS. 4 to 6 , a through hole (lumen) 70 is formed in the distal electrode 110 , and the guide wire 9 penetrates through the through hole 70 in the axial direction (Z-axis direction). Further, the distal electrode 110 is provided with a base portion 71 and a reduced diameter portion (neck portion) 72 , the base portion 71 is located on the distal end side, and the reduced diameter portion 72 is located at the proximal end side of the base portion 71 and has a larger outer diameter than the outer diameter of the base portion 71 . Small diameter. In addition, the outer diameter of the base portion 71 is, for example, about 0.3 mm to 5 mm, and the outer diameter of the reduced diameter portion 72 is, for example, about 0.1 mm to 4.8 mm. In addition, the diameter of the through hole 70 is about 0.3 mm to 3 mm, for example.

The reduced diameter portion 72 is formed on the proximal end side portion of the distal end electrode 110 as described above, as indicated by the broken lines in FIGS. way to constitute. As shown in FIG. 4(A) , FIG. 5 , and FIG. 6 , grooves 720 are formed on the outer peripheral surface of the diameter-reduced portion 72 as described above, and the grooves 720 extend in the X-Y plane (the plane orthogonal to the axial direction) as Arc shape. In addition, the width (length in the Z-axis direction) of the groove 720 in this way is, for example, about 0.5 mm to 5 mm.

Here, as shown in FIGS. 4 to 6 , in the groove 720 of the diameter-reduced portion 72 as described above, the aforementioned bent portion 40 c of the operation wire 40 is arranged. Specifically, as shown in FIGS. 5 and 6 , the front ends of the extension portions 40a and 40b are inserted into the respective openings 74a and 74b of the communication groove 720 to connect the base ends of the extension portions 40a and 40b. The bent portion 40c is arranged in the groove 720 . Also, as shown in FIGS. 5 and 6 , the bent portion 40c is bent and folded back in the X-Y plane from the respective base ends of the extension portions 40a and 40b extending in the Z-axis direction, and in the X-Y plane (along the direction of the X-Y plane) The shape of the groove 720) extends in an arc shape. In addition, in the example shown in FIG. 6, the said openings 74a and 74b are formed at mutually point-symmetrical positions with respect to the center of the through-hole 70 (positions deviated from each other by 180° along the outer periphery of the through-hole 70). Therefore, the bent portion 40c extends in a semi-circular arc shape (semi-circular shape) in the X-Y plane.

Here, in the bent portion 40c of the operation wire 40 in this way, at least a part of the region is fixed in the tip electrode 110 . Specifically, as shown in FIG. 4(A) , FIG. 5 , and FIG. 6 , in the groove 720 of the reduced diameter portion 72 of the distal end electrode 110 , at least a partial region of the bent portion 40 c is fixed. In particular, in this embodiment, as shown in FIG. 6 , in the tip electrode 110 (in the groove 720 ), the entire area of the bent portion 40 c is fixed as the fixing area Af. Moreover, in this groove|channel 720 (fixation area|region Af), the bending part 40c is fixed (adhered) using the solder 732, for example.

In addition, as shown in FIGS. 4(A) and 6 , in the front end electrode 110 (reduced diameter portion 72 ), the vicinity of the front end of the above-mentioned lead wire 50 is also fixed (adhered) with solder 731 . However, a fixing member (adhesive member) other than these solders 731 and 732 may be used to fix the vicinity of the tip of the lead wire 50 and the bent portion 40c.

[C. Actions and Actions · Effects] Next, the operation, action, and effect of the electrode catheter 1 of the present embodiment will be described in detail while comparing with the comparative example.

(C-1. Action example) First, in this electrode catheter 1, the shape of the vicinity of the distal end of the catheter shaft 11 (the distal end flexible portion 11A) changes in two directions in response to the rotation operation of the rotary plate 41 by the operator. That is, in response to such a rotational operation, an operation of deflecting the distal end flexible portion 11A in two directions (the aforementioned bidirectional deflection operation) is performed.

Specifically, for example, when the operator grasps the handle 12 (handle main body 121 ) with one hand and manipulates the knob 41 a with the fingers of the hand, the rotary plate 41 is rotated in the direction of the arrow d1 a in FIG. 1 (right rotation) The situation is as follows. That is, in the catheter shaft 11 , the first end (the proximal end of the extension portion 40 a ) of the aforementioned operation wire 40 is pulled toward the proximal end side (see FIG. 2 ). Then, the distal end flexible portion 11A of the catheter shaft 11 is bent (bent) in the direction indicated by the arrow d2a in FIG. 1 .

In addition, for example, when the operator operates the knob 41b to rotate the rotary plate 41 in the direction of the arrow d1b in FIG. 1 (leftward rotation) as follows. That is, within the catheter shaft 11 , the second end (the proximal end of the extension portion 40 b ) of the aforementioned operation wire 40 is pulled toward the proximal end side (see FIG. 2 ). Then, the vicinity of the distal end of the catheter shaft 11 is bent in the direction indicated by the arrow d2b in FIG. 1 .

In this way, when the operator rotates the rotary plate 41 , the bidirectional (swing) yaw motion of the catheter shaft 11 can be performed. Further, by rotating the handle body 121 around the axis (in the XY plane), for example, the bending direction (yaw direction) of the catheter shaft 11 in the vicinity of the distal end of the catheter shaft 11 can be freely set in a state where the catheter shaft 11 is inserted into the patient. In this way, since the deflection mechanism for deflecting the distal end flexible portion 11A in two directions is provided in the electrode catheter 1, it is possible to change the shape of the vicinity of the distal end (the distal end flexible portion 11A) of the catheter shaft 11 while changing the shape. The catheter shaft 11 is inserted into the patient's body.

In addition, in this electrode catheter 1, the distal electrode 110 disposed near the most distal end of the catheter shaft 11 (the distal flexible portion 11A) is also made of a metal material (not a resin material) like the plurality of annular electrodes 111 . constitute. Thereby, even in the vicinity of the most distal end of the distal end flexible portion 11A, the aforementioned potential measurement and cauterization can be performed.

Furthermore, in the electrode catheter 1 of the present embodiment, both ends (the first end and the second end: the base ends of the extension parts 40 a and 40 b ) of the operation wire 40 pass through the inside of the catheter shaft 11 (the sub-lumen 62A). , 62B), fixed in the handle 12 (on the rotating plate 41). In addition, the bent portion 40 c of the operation wire 40 is arranged in the distal electrode 110 of the catheter shaft 11 . Thereby, the above-mentioned bidirectional deflection operation of the distal end flexible portion 11A can be realized by using a single operation wire 40 (a pair of operation wires is not used).

(C-2. Comparative Example) Here, FIG. 7 is a schematic side view (Z-X side view) showing the structure in the vicinity of the distal end electrode 102 of the electrode catheter (electrode catheter 101 ) of the comparative example.

The electrode catheter 101 of this comparative example includes a catheter shaft 103, and the catheter shaft 103 has a distal electrode 102, and is different from the electrode catheter 1 of the present embodiment and has the following structure. That is, first, in the present embodiment, a single operation wire 40 is used to realize the above-mentioned bidirectional deflection operation; in contrast, in this comparative example, a pair of operation wires 104a and 104b are used in the same way as a general electrode catheter. , to achieve bidirectional deflection action. In addition, as shown in FIG. 7 , in the catheter shaft 103 and the distal electrode 102 of the comparative example, like the catheter shaft 11 and the distal electrode 110 of the present embodiment, the main guide wires 9 are respectively provided. Cavity 61 and through hole 70 .

In such a comparative example, as shown in FIG. 7 , the vicinity of the distal ends of the pair of operation wires 104 a and 104 b is each fixed (adhered) to an area (fixed area Af102 ) on the outer peripheral side of the through hole 70 in the distal electrode 102 . However, in this front end electrode 102 , since the through hole 70 is provided as described above, the thickness of the outer peripheral side of the through hole 70 (refer to the thickness d103 shown in FIG. 7 ) becomes small. For this reason, in the distal electrode 102, in order to prevent the respective manipulation wires 104a, 104b from falling off and ensure reliability, if an attempt is made to secure a certain fixation strength near the tip ends of the respective manipulation wires 104a, 104b (size of the fixation area Af102) , for example, the following problems will occur.

That is, first, as indicated by the arrow P101 in FIG. 7 , when the diameter of the through hole 70 is reduced in order to secure the thickness (size in the X-axis direction) of the above-mentioned fixed region Af102 , there is a possibility that the guide wire 9 cannot be inserted through inside the through hole 70 . Furthermore, as indicated by arrow P102 in FIG. 7 , in order to secure the thickness (size in the X-axis direction) of the fixed region Af102 and increase the outer diameter in the tip electrode 102 , the following will be described. That is, in this case, the size of the distal electrode 102 is increased, and the entire distal electrode 102 and the electrode catheter 101 may not be inserted into the sheath when the entire distal electrode 102 and the electrode catheter 101 are inserted into the patient. On the other hand, in order to secure the length of the fixed region Af102 (the size in the Z-axis direction), the length of the distal electrode 102 in the axial direction (Z-axis direction) increases accordingly, and the distal electrode 102 increases in size. In addition, if the axial length of the distal end electrode 102 is increased in this manner, the aforementioned bidirectional deflection operation may be difficult to perform.

In this way, in the electrode catheter 101 of this comparative example, it can be said that it is difficult to achieve both miniaturization and reliability improvement.

(C-3. This Embodiment) In contrast, in the electrode catheter 1 of the present embodiment, the following functions and effects can be obtained by the above-mentioned structure.

First, in the electrode catheter 1 of the present embodiment, at least a partial region of the bent portion 40 c of the single operation wire 40 is fixed in the distal electrode 110 . Thereby, even in the structure of the distal electrode 110 provided with the through hole 70 for the guide wire 9 , the fixing strength (size of the fixing area) of the operation wire 40 can be easily ensured compared with the case of the above-mentioned comparative example. As a result, it is easy to prevent the operation wire 40 from falling off in the vicinity of the distal electrode 110 without increasing the outer diameter of the distal electrode 110 and the length in the axial direction (Z-axis direction). Therefore, in the present embodiment, the size of the electrode catheter 1 can be reduced, and the reliability can be improved.

In addition, in the present embodiment, since the reduced diameter portion 72 is provided at the proximal end side portion of the distal end electrode 110, the reduced diameter portion 72 can be inserted into the distal end portion of the catheter shaft 11, and at least a part of the bent portion 40c is fixed to the This diameter-reduced part 72 is as follows. That is, the distal end electrode 110 and the distal end of the catheter shaft 11 are easily connected by the reduced diameter portion 72 as described above. As a result, the reliability of the electrode catheter 1 can be further improved.

Furthermore, in the present embodiment, since at least a partial region of the bent portion 40c is fixed in the groove 720 formed on the outer peripheral surface of the diameter-reduced portion 72, it is as follows. That is, by fixing the bent portion 40c in the groove 720, the fixing strength of the operation wire 40 is increased, so that it is easier to prevent the operation wire 40 from falling off near the distal electrode 110. As a result, the reliability of the electrode catheter 1 can be further improved.

In addition, in the present embodiment, since the bent portion 40c extends in an arc shape in the plane (X-Y plane) orthogonal to the axial direction (Z-axis direction) in the distal electrode 110, it is as follows. That is, by fixing the bent portion 40c extending in an arc shape in such an orthogonal plane to the distal electrode 110, since the fixing strength of the operation wire 40 is increased, it is easier to prevent the operation wire 40 from being stuck. The vicinity of the front end electrode 110 falls off. As a result, the reliability of the electrode catheter 1 can be further improved.

Moreover, in this embodiment, since the whole area|region of the bent part 40c is fixed in the front-end|tip electrode 110, it is as follows. That is, it is easier to prevent the operation wire 40 from falling off in the vicinity of the distal electrode 110 than when, for example, only a part of the bent portion 40 c is fixed in the distal electrode 110 (corresponding to the following modification). As a result, the reliability of the electrode catheter 1 can be further improved.

<2. Modifications> Next, a modification of the above-described embodiment will be described. In addition, the same code|symbol is attached|subjected to the same component as the component of the said embodiment, and the description is abbreviate|omitted suitably.

8 is an X-Y side view showing a configuration example of a distal electrode 110A of an electrode catheter (electrode catheter 1A) according to a modification.

In the distal electrode 110A of the electrode catheter 1A of the present modification, the fixing area Af of the bent portion 40c is changed as compared with the distal electrode 110 of the electrode catheter 1 described in the embodiment. Specifically, in the tip electrode 110 (refer to FIG. 6 ) of the embodiment, the entire area of the bent portion 40 c is fixed in the tip electrode 110 (in the groove 720 ) as the fixing region Af, and the tip electrode of this modification 110A, as described below. That is, as shown in FIG. 8 , only a part of the area of the bent portion 40c is fixed in the front end electrode 110A (in the groove 720 ) as the fixing area Af.

Specifically, along the arcuate extending direction of the groove 720 , the plurality of fixed regions Af ( Af1 , Af2 , and Af3 ) are intermittently arranged in a row. In short, as shown in FIG. 8, between the fixed areas Af1, Af2, a certain interval (the non-fixed area of the bent portion 40c) is provided, and between the fixed areas Af2, Af3, a certain interval (the folded area) is provided. the non-fixed area of the curved portion 40c). In addition, in these fixing regions Af1 to Af3, as described above, the bent portion 40c is fixed (adhered) using the solder 732, respectively; on the other hand, the solder 732 is not arranged in the above-mentioned non-fixing region.

Even in such a modification example, the same effect can be obtained because of basically the same operation as that of the embodiment.

<3. Other modifications> As mentioned above, although the present invention has been described with reference to the embodiments and modified examples, the present invention is not limited to these embodiments and the like, and various modifications can be made.

For example, it is not limited to the shape, arrangement position, size, number, material, etc. of each member described in the above-described embodiments and the like, and other shapes, arrangement positions, dimensions, number, material, etc. may be employed.

Specifically, for example, in the above-described embodiments and the like, although the structure of the catheter shaft 11 has been specifically described as an example, it is not necessary to provide all the members, and other members may be further provided. Specifically, for example, inside the catheter shaft 11 , a deformable leaf spring may be provided in the bending direction as the rocking member. In addition, the arrangement, shape, number (one or plural) of the annular electrode 111 and the auxiliary lumen of the catheter shaft 11 are not limited to those described in the above-described embodiment and the like. Specifically, in the above-described embodiments and the like, the case where a plurality of annular electrodes 111 are provided is described as an example, but, for example, only one annular electrode 111 may be provided.

In addition, in the above-mentioned embodiments and the like, although the structure of the front-end electrode 110 is specifically described as an example, the shape, size, material, etc. of the front-end electrode 110 are not limited to those described in the above-mentioned embodiments and the like. Specifically, for example, in the above-described embodiment and the like, the case where the bent portion 40c of the operation wire 40 is fixed to the diameter-reduced portion 72 (in the groove 720 ) of the distal electrode 110 has been described as an example, but it is not limited to this example. . That is, the bent portion 40c of the operation wire 40 may be fixed to, for example, other places in the distal electrode 110 . In addition, in the above-described embodiment and the like, the case where the bent portion 40c extends in the shape of an arc in the plane perpendicular to the front end electrode 110 has been described as an example, but the present invention is not limited to this example. That is, for example, the bent portion 40 c may extend in a non-arc shape (straight line, angular shape, etc.) within the distal electrode 110 . In addition, the fixing region Af of the bent portion 40c in the front end electrode 110 is not limited to the region described in the above-described embodiment and the like, and the bent portion 40c may be fixed in other regions.

Furthermore, in the above-described embodiments and the like, although the structure of the handle 12 (the handle main body 121 and the rotary operation portion 122 ) has been specifically described as an example, it is not necessary to provide all the components, and other components may be further provided. member.

In addition, in the above-described embodiments and the like, the guide wire 9 is exemplified as an example of a long tool to be inserted into the catheter shaft 11 (and into the distal electrode 110 ), but it is not limited to this example. That is, for example, a predetermined injection needle (an injection needle for injecting a drug into a patient, etc.) and the like may also be such a long device.

1. 1A: Electrode catheter 9: Guide line 11: Catheter tube shaft 11A: Front flexible part 12: handle 14: Insertion port 15: Protection tube 16: Connector 40: Operation line 40a, 40b: Extensions 40c: Bending part 41: Rotary plate 41a, 41b: Knob 42a, 42b: Fixed parts 50, 51: wire 60A, 60B, 60C, 60E: Tube 61: Main cavity 62A, 62B, 62C, 62D, 62E, 62F: auxiliary cavity 70: Through hole 71: Base 72: Reduced diameter part 74a, 74b: Opening 101: Leads 102: Front electrode 104a, 104b: Operation wires 110, 110A: front electrode 111: Ring electrode 121: handle body 121a, 121b: handle member 122: Rotary operation part 123: Fixed components 411, 412: Rotary plate member 720: Ditch 731, 732: Solder Af, Af1, Af2, Af3, Af102: fixed regions d1a, d1b, d2a, d2b: arrows d103: Thickness P101, P102: Arrow

Fig. 1 is a schematic diagram showing a schematic structural example of an electrode catheter according to an embodiment of the present invention. 2 is a schematic diagram for explaining a detailed structural example of the handle shown in FIG. 1 . [ Fig. 3] It is a cross-sectional view taken along the arrow direction of the III-III line shown in Fig. 1 . [ Fig. 4] Fig. 4 is a side view showing a detailed structural example of the distal end electrode shown in Figs. 1 and 2 . [ Fig. 5] Fig. 5 is a perspective view showing a configuration example of the distal electrode shown in Fig. 4 . [ Fig. 6] Fig. 6 is another side view showing a configuration example of the distal end electrode shown in Fig. 4 . [ Fig. 7] Fig. 7 is a schematic side view of a structure in the vicinity of a distal end electrode of an electrode catheter of a comparative example. [ Fig. 8] Fig. 8 is a side view showing a configuration example of a distal electrode of an electrode catheter according to a modification.

1: Electrode catheter

9: Guide line

11: Catheter tube shaft

11A: Front flexible part

12: handle

14: Insertion port

15: Protection tube

16: Connector

41: Rotary plate

41a, 41b: Knob

50, 51: wire

110: Front electrode

111: Ring electrode

121: handle body

121a: Handle member

122: Rotary operation part

411: Rotary plate member

d1a, d1b, d2a, d2b: arrows

Claims (6)

An electrode catheter having: a catheter shaft, having a front-end flexible portion and a plurality of lumens, a plurality of metal electrodes are arranged along the axial direction on the front-end flexible portion, and the plurality of lumens extend along the axial direction; and a handle mounted on the proximal end side of the catheter shaft, and having an operating portion for operating when the front-end flexible portion is deflected in two directions; The aforementioned plurality of metal electrodes include a front-end electrode and one or a plurality of annular electrodes; The front end electrode is disposed near the foremost end of the front end flexible portion, and has a through hole in which the long tool penetrates along the axial direction; The one or a plurality of annular electrodes are arranged on the base end side of the front end electrode; The plurality of inner cavities include a main cavity, a first auxiliary cavity and a second auxiliary cavity, in the main cavity the long tool is inserted into the interior, and a single operation wire is inserted into the first auxiliary cavity and the second auxiliary cavity. internal; The aforementioned single operation wire includes a first extension portion, a second extension portion and a bending portion; The first extension part extends from the first end of the single operation wire fixed on the operation part to the front end electrode through the first sub-cavity; The second extension portion extends from the front end electrode to the second end of the single operation wire fixed on the operation part through the second sub-cavity; The bent portion is located between the first extension portion and the second extension portion, and at least a part of the area is fixed in the front end electrode. The lead of claim 1, wherein, The distal end electrode has a diameter-reduced portion, and the diameter-reduced portion is formed on a proximal end side portion of the distal end electrode and is configured to be insertable into the distal end portion of the catheter shaft; The at least a partial region of the bent portion is fixed to the diameter-reduced portion. The lead of claim 2, wherein, A groove is formed on the outer peripheral surface of the reduced diameter portion; The at least a partial region of the bent portion is fixed in the groove. The lead of any one of claims 1 to 3, wherein, The bent portion extends in the shape of an arc in a plane orthogonal to the axial direction in the front end electrode. The lead of any one of claims 1 to 3, wherein, In the front end electrode, the entire area of the bent portion is fixed. The lead of claim 4, wherein, In the front end electrode, the entire area of the bent portion is fixed.

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