WO2022137505A1

WO2022137505A1 - Electrode catheter

Info

Publication number: WO2022137505A1
Application number: PCT/JP2020/048737
Authority: WO
Inventors: 智春小磯; 綾季星田
Original assignee: 日本ライフライン株式会社
Priority date: 2020-12-25
Filing date: 2020-12-25
Publication date: 2022-06-30
Also published as: TW202224625A; JPWO2022137505A1

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

Electrode catheter

The present invention relates to an electrode catheter provided with a catheter shaft having an electrode near the tip.

An example of a medical device having an electrode near the tip is an electrode catheter in which such an electrode is provided on a catheter shaft (for example, Patent Document 1).

Japanese Patent No. 3830521

By the way, in the electrode catheter as described above, it is generally required to reduce the size and improve the reliability. It is desirable to provide an electrode catheter that can be miniaturized and improved in reliability.

The electrode catheter according to the embodiment of the present invention is a catheter shaft having a tip flexible portion in which a plurality of metal electrodes are arranged along the axial direction and a plurality of lumens extending along the axial direction. And a handle that is attached to the proximal end side of the catheter shaft and has an operating portion that is operated during a deflection operation that deflects the tip flexible portion in both directions. The plurality of metal electrodes are arranged near the tip end of the tip flexible portion, and have a tip electrode having a through hole through which a long instrument penetrates along the axial direction, and a base end of the tip electrode. Includes one or more ring-shaped electrodes arranged on the side. The plurality of lumens include a main lumen through which the elongated instrument is inserted and a first and second sublumens through which a single operating wire is inserted. The single operating wire extends from the first end of the single operating wire fixed on the operating portion into the tip electrode via the inside of the first sublumen. A second extending portion extending from the tip electrode to the second end of the single operating wire fixed on the operating portion via the second sublumen. Includes a folded portion located between the first and second stretched portions and at least a portion of which is fixed within the tip electrode.

In the electrode catheter according to the embodiment of the present invention, both ends of the single operating wire (the first end and the second end: the base ends of the first and second extension portions) are the catheter. It is fixed in the handle (on the operation unit) via the shaft (inside the first and second subsystems). The folded portion of the operating wire is arranged in the tip electrode of the catheter shaft. Thereby, a bidirectional deflection operation at the tip flexible portion is realized by utilizing a single operation wire (without using a pair of operation wires). Further, at least a part of the folded portion is fixed in the tip electrode. As a result, the fixing strength (the size of the fixing region) of the operation wire can be easily secured even in the structure of the tip electrode provided with the through hole. As a result, it becomes easy to prevent the operation wire from falling off in the vicinity of the tip electrode without increasing the outer diameter of the tip electrode or the length along the axial direction.

In the electrode catheter according to the embodiment of the present invention, the tip electrode is formed on the proximal end side portion thereof, and has a reduced diameter portion configured to be inserted into the distal end portion of the catheter shaft. Therefore, at least a part of the region in the folded portion may be fixed in the reduced diameter portion. In this case, the tip electrode and the tip of the catheter shaft can be easily connected (connected) by using the reduced diameter portion. As a result, the reliability of the electrode catheter is further improved.

In this case, a groove may be formed on the outer peripheral surface of the reduced diameter portion, and at least a part of the region of the folded portion may be fixed in the groove. In this case, by fixing the folded portion in the groove, the fixing strength of the operation wire is increased, so that the operation wire is more easily prevented from falling off in the vicinity of the tip electrode. As a result, the reliability of the electrode catheter is further improved.

Further, in the electrode catheter according to the embodiment of the present invention, the folded portion may extend in an arc shape in the tip electrode in the plane orthogonal to the axial direction. In this case, the folded portion extending in an arc shape in the orthogonal plane is fixed in the tip electrode, and the fixing strength of the operation wire is increased. Therefore, for operation in the vicinity of the tip electrode. It becomes easier to prevent the wire from falling off. As a result, the reliability of the electrode catheter is further improved.

Further, in the electrode catheter according to the embodiment of the present invention, all the regions in the folded portion may be fixed in the tip electrode. In this case, for example, it becomes easier to prevent the operation wire from falling off in the vicinity of the tip electrode as compared with the case where only a part of the folded portion is fixed in the tip electrode. As a result, the reliability of the electrode catheter is further improved.

According to the electrode catheter according to the embodiment of the present invention, at least a part of the folded portion of the single operation wire is fixed in the tip electrode, so that the outer diameter of the tip electrode is fixed. It becomes easy to prevent the operation wire from falling off in the vicinity of the tip electrode without increasing the length along the axial direction. Therefore, it is possible to improve the reliability while reducing the size of the electrode catheter.

It is a schematic diagram which shows the schematic structural example of the electrode catheter which concerns on one Embodiment of this invention. It is a schematic diagram for demonstrating the detailed configuration example of the handle shown in FIG. It is a cross-sectional view taken along the line III-III shown in FIG. It is a side view which shows the detailed structure example of the tip electrode shown in FIG. 1 and FIG. It is a perspective view which shows the structural example of the tip electrode shown in FIG. It is another side view which shows the structural example of the tip electrode shown in FIG. It is a side view schematically showing the structure of the vicinity of the tip electrode in the electrode catheter which concerns on a comparative example. It is a side view which shows the structural example of the tip electrode in the electrode catheter which concerns on the modification.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The explanation will be given in the following order.
1. 1. Embodiment (an example in which the entire region of the folded portion of the operating wire is fixed in the tip electrode)
2. 2. Modification example (an example in which a part of the folded part of the operating wire is fixed in the tip electrode)
3. 3. Other variants

<1. Embodiment>
[A. Outline configuration]
FIG. 1 schematically shows a schematic configuration example of an electrode catheter (electrode catheter 1) according to an embodiment of the present invention. In addition, in FIG. 1, the vicinity of the tip portion of the catheter shaft 11 described later is shown in an enlarged manner. Further, FIG. 2 is a schematic diagram for explaining a detailed configuration example of the handle 12 shown in FIG. 1, which will be described later. FIG. 3 is a cross-sectional view taken along the line III-III shown in FIG. 1 (XY cross-sectional view).

This electrode catheter 1 is a catheter that is inserted into the patient's body (for example, inside the heart) through a blood vessel and used for examination and treatment of arrhythmia and the like. Specifically, using a plurality of metal electrodes described later in the electrode catheter 1, measurement of electric potential in the vicinity of the affected area in the body, cauterization (ablation) of the affected area, and the like are performed.

As shown in FIG. 1, the electrode catheter 1 includes a catheter shaft 11 (catheter tube) as a catheter body (long portion) and a handle 12 attached to the proximal end side of the catheter shaft 11. There is. The electrode catheter 1 also has an insertion port 14 for inserting the guide wire 9 into the catheter shaft 11 via the handle 12, a protective tube 15 that covers the periphery of the conducting wire 50 described later, and the protective tube 15. It is provided with a connector 16 to which the conducting wire 50 is electrically connected.

The above-mentioned guide wire 9 corresponds to a specific example of the "long device" in the present invention.

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

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

Specifically, as shown in FIG. 3, the catheter shaft 11 has one main lumen 61 arranged at the center and a plurality (isotropically arranged on the outer peripheral side of the main lumen 61). In this example, six sublumens 62A to 62F are provided.

Note that these main lumens 61 and sub-lumens 62A to 62F each correspond to a specific example of the "plurality of lumens" in the present invention. Further, among the sub-lumens 62A to 62F, the sub-lumen 62A corresponds to a specific example of the "first sub-lumen" in the present invention, and the sub-lumen 62B is the "second sub-lumen" in the present invention. Corresponds to one specific example.

The guide wire 9 described above as a long instrument extending along the axial direction (Z-axis direction) is inserted into the main lumen 61.

The operation wire 40 is inserted in each of the sub-lumens 62A and 62B. Further, a conductor wire 50 (lead wire) is inserted through the sub-lumen 62D, and a conductor wire 51 (lead wire) is inserted into each of the sub-lumen 62C, 62E, 62F. Each of these thin wires (operation wire 40 and conductor 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 having a general structure. Then, as shown in FIGS. 1 to 3, such a single operating wire 40 includes two extending

portions

40a and 40b extending in the catheter shaft 11 and a folded portion 40c described later. I'm out.

As shown in FIG. 2, in the stretched portion 40a, the base end (first end of the operating wire 40) side is stretched into the handle 12 (fastener 42a on the rotating plate 41 described later). Then, as shown in FIG. 3, a metal electrode (tip electrode described later) arranged on the tip flexible portion 11A from the proximal end side of the stretched portion 40a via the sublumen 62A of the catheter shaft 11 described above. It extends into 110).

As shown in FIG. 2, in the stretched portion 40b, the base end (second end of the operating wire 40) side is stretched into the handle 12 (fastener 42b on the rotating plate 41 described later). Then, as shown in FIG. 3, the stretched portion 40b is stretched from the proximal end side to the tip electrode 110 described later via the sublumen 62B of the catheter shaft 11 described above.

The folded-back portion 40c is a portion located between these

stretched portions

40a and 40b (in the example of the present embodiment, the stretched

portions

40a and 40b are connected to each other), which will be described in detail later. It is arranged in the tip electrode 110.

The stretched portion 40a described above corresponds to a specific example of the "first stretched portion" in the present invention, and the stretched portion 40b described above corresponds to a specific example of the "second stretched portion" in the present invention. It corresponds to.

The tip side of each of the above-mentioned

conductors

50 and 51 is individually electrically connected to a plurality of metal electrodes (tip electrode 110 and ring-shaped electrode 111 described later) described later. Specifically, one conductor 50 is electrically connected to one tip electrode 110, and each of the plurality of conductors 51 is individually electrically connected to a plurality of ring-shaped electrodes 111. .. Further, each base end side of these

conductors

50 and 51 is an electrode from the inside of the catheter shaft 11 (inside the

sublumen

62C, 62D, 62E, 62F) through the inside of the handle 12, the protection tube 15, and the connector 16. It can be connected to the outside of the catheter 1.

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. Further, the main lumen 61 is formed in the tubular tube 60C located on the inner peripheral side of the tube 60A, and the sublumens 62A to 62F are in the tubular tube 60E arranged inside the tube 60A, respectively. Is formed in.

As shown in FIG. 3, the main lumen 61 and the sub-lumens 62A to 62F are arranged so as not to be in contact with each other in the catheter shaft 11. That is, these main lumens 61 and the sub-lumens 62A to 62F are arranged apart from each other via the tube 60A.

Here, the outer diameter of such a 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. The constituent materials of the catheter shaft 11 (

tubes

60A, 60B, 60C, 60E described above) include, for example, polyamide, polyether polyamide, polyurethane, polyether blockamide (PEBAX) (registered trademark), nylon and the like, and heat. Examples include plastic resin. As the

tubes

60C and 60E, among such thermoplastic resins, for example, fluororesins such as perfluoroalkoxy alkane (PFA) and polytetrafluoroethylene (PTFE) are used. Further, the tube 60B may be composed of, for example, a layer on the outer peripheral side (a layer made of polyamide or the like) and a layer on the inner peripheral side (a layer made of a SUS (stainless steel) blade).

Further, as shown in FIG. 1, a plurality of metal electrodes (one tip electrode 110 and a plurality of ring-shaped electrodes 111) described above are axially located near the tip of the catheter shaft 11 (tip flexible portion 11A). They are arranged side by side at predetermined intervals along (Z-axis direction). Specifically, the tip electrode 110 is arranged near the tip end of the tip flexible portion 11A, and the plurality of ring-shaped electrodes 111 are located in the region on the proximal end side of the tip electrode 110 in the tip flexible portion 11A, respectively. , Have been placed.

As described above, the tip electrode 110 and the ring-shaped electrode 111 are electrodes for, for example, potential measurement or cauterization, respectively, and are, for example, aluminum (Al), copper (Cu), SUS, and gold (Au). , Platinum (Pt) and other metal materials with good electrical conductivity. The outer diameters of the tip electrode 110 and the ring-shaped electrode 111 are not particularly limited, but are preferably the same as the outer diameter of the catheter shaft 11 described above.

Note that these tip electrodes 110 and ring-shaped electrodes 111 each correspond to a specific example of the "plurality of metal electrodes" in the present invention. A detailed configuration example of the tip electrode 110 will be described later (FIGS. 4 to 6).

(Handle 12)
The handle 12 is a portion that the operator (doctor) grasps (grasps) when using the electrode catheter 1. As shown in FIG. 1, the handle 12 has a handle body 121 mounted on the proximal end side of the catheter shaft 11 and a rotation operation unit 122.

The rotation operation unit 122 corresponds to a specific example of the "operation unit" in the present invention.

The handle body 121 corresponds to a portion (grip portion) actually gripped by the operator, and has a shape extending along the axial direction (Z-axis direction) thereof. Further, as shown in FIGS. 1 and 2, the handle body 121 is configured by using a pair of

handle members

121a and 121b that can be divided along the Y-axis direction. In other words, the handle main body 121 is configured by connecting these

handle members

121a and 121b to each other. As shown in FIG. 2, a fixing member 123 for fixing the catheter shaft 11 in the handle main body 121 is arranged in the handle member 121b. Such a handle body 121 (handle

members

121a, 121b) is made of, for example, a synthetic resin such as polycarbonate or acrylonitrile-butadiene-styrene copolymer (ABS).

Although the details will be described later, the rotation operation unit 122 is a portion operated during a deflection operation that bidirectionally deflects (deflects) the vicinity of the tip of the catheter shaft 11 (tip flexible portion 11A). In other words, the rotation operation unit 122 is a portion used in such a deflection operation together with the operation wire 40 (stretched

portions

40a and 40b) described above. Specifically, the rotation operation unit 122 is operated (rotation operation) by the operator of the electrode catheter 1 during such a deflection operation. As shown in FIG. 1, such a rotation operation unit 122 includes a rotation plate 41.

As shown in FIG. 1, the rotary plate 41 is a member rotatably mounted on the handle body 121 about a rotation axis (Y-axis direction) perpendicular to the longitudinal direction (Z-axis direction). be. The rotating plate 41 corresponds to a portion actually operated by the operator during the above-mentioned rotation operation, and has a substantially disk-shaped shape. Specifically, in this example, as shown by the arrows d1a and d1b in FIG. 1, the operation of rotating the rotating plate 41 bidirectionally in the ZX plane with respect to the handle body 121 (the above-mentioned rotating shaft). Rotation operation centered on the center of rotation) is possible. Further, as shown in FIGS. 1 and 2, the rotary plate 41 is configured by using a pair of

rotary plate members

411 and 412 that can be divided along the Y-axis direction. In other words, the rotating plate 41 is configured by connecting these

rotating plate members

411 and 412 to each other.

As shown in FIGS. 1 and 2, a pair of

knobs

41a and 41b are provided integrally with the rotating plate 41 on the side surface of such a rotating plate 41. In this example, as shown in FIG. 1, the

knobs

41a and 41b are arranged at positions that are point-symmetrical to each other with the rotation axis of the rotating plate 41 as the center. Each of these

knobs

41a and 41b corresponds to a portion operated (pushed) by, for example, a finger of one hand when the operator rotates the rotating plate 41. The rotating plate 41 is made of, for example, the same material (synthetic resin or the like) as the handle body 121 described above.

Further, as shown in FIG. 2, a pair of

fasteners

42a and 42b are provided on the rotating plate 41 (rotating plate member 412). These

fasteners

42a and 42b are members (wire fasteners) for individually fixing the base ends of the above-mentioned operation wires 40 (stretched

portions

40a and 40b) by screwing or the like. Specifically, in the example of FIG. 2, the base end of the drawn portion 40a of the operating wire 40 (the first end of the operating wire 40 described above) is fixed on the rotating plate member 412 by the fastener 42a. .. Further, the base end of the drawn portion 40b of the operating wire 40 (the second end of the operating wire 40 described above) is fixed on the rotating plate member 412 by the fastener 42b. In these

fasteners

42a and 42b, it is possible to arbitrarily adjust the pull-in length in the vicinity of each base end when fixing each base end of these stretched

portions

40a and 40b, respectively.

[B. Detailed configuration of the tip electrode 110]
Next, a detailed configuration example of the above-mentioned tip electrode 110 will be described with reference to FIGS. 4 to 6.

4 (A) and 4 (B) are side views showing detailed configuration examples of the tip electrode 110 shown in FIGS. 1 and 2, respectively. Specifically, FIG. 4 (A) shows a detailed configuration example of the tip electrode 110 on the YY side surface, and FIG. 4 (B) shows a detailed configuration example of the tip electrode 110. It is represented by the X side surface. Further, FIG. 5 is a perspective view showing a configuration example of the tip electrode 110 shown in FIG. 4, and FIG. 6 is an XY side view showing a configuration example of the tip electrode 110 shown in FIG. It is represented by.

As shown in FIGS. 4 to 6, the tip electrode 110 is formed with a through hole (lumen) 70 through which the guide wire 9 penetrates along the axial direction (Z-axis direction). Further, the tip electrode 110 is provided with a base portion 71 located on the tip end side and a reduced diameter portion (neck portion) 72 located on the base end side of the base portion 71 and having an outer diameter smaller than that of the base portion 71. ing. The outer diameter of the base 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. The diameter of the through hole 70 is, for example, about 0.3 mm to 3 mm.

As described above, the reduced diameter portion 72 is formed on the proximal end side portion of the tip electrode 110, and as shown by the broken line in FIGS. 4 (A) and 4 (B), the tip of the catheter shaft 11 is formed. It is configured to be insertable in the part. As shown in FIGS. 4 (A), 5 and 6, on the outer peripheral surface of the reduced diameter portion 72, the diameter-reduced portion 72 extends in an arc shape in the XY plane (orthogonal plane with respect to the axial direction). , Groove 720 is formed. The width (length in the Z-axis direction) of such a groove 720 is, for example, about 0.5 mm to 5 mm.

Here, as shown in FIGS. 4 to 6, the above-mentioned folded-back portion 40c of the operation wire 40 is arranged in the groove 720 in such a reduced diameter portion 72. Specifically, as shown in FIGS. 5 and 6, each tip side of the above-mentioned stretched

portions

40a and 40b is inserted through the

openings

74a and 74b communicating with the groove 720, and these stretches are formed. A folded portion 40c connecting the base ends of the

portions

40a and 40b to each other is arranged in the groove 720. Further, as shown in FIGS. 5 and 6, in the folded-back portion 40c, the folded-back portion 40c is folded back so as to be curved in the XY plane from each base end of the stretched

portions

40a and 40b extending along the Z-axis direction. It extends in an arc shape (along the shape of the groove 720) in this XY plane. In the example shown in FIG. 6, the above-mentioned

openings

74a and 74b are located at points symmetrical with respect to each other (positions 180 ° apart from each other along the outer periphery of the through hole 70) with respect to the center of the through hole 70. It is formed. Therefore, the folded portion 40c extends in a half arc shape (semicircular shape) in the XY plane.

Here, at least a part of the folded portion 40c of the operation wire 40 is fixed in the tip electrode 110. Specifically, as shown in FIGS. 4A, 5 and 6, at least a part of the folded-back portion 40c is fixed in the groove 720 in the reduced diameter portion 72 of the tip electrode 110. There is. In particular, in the present embodiment, as shown in FIG. 6, in the tip electrode 110 (inside the groove 720), all the regions in the folded-back portion 40c are fixed as the fixed region Af. Further, in the groove 720 (fixed region Af), the folded-back portion 40c is fixed (fixed) by using, for example, a solder 732.

Incidentally, as shown in FIGS. 4A and 6A, in such a tip electrode 110 (diameter-reduced portion 72), the vicinity of the tip of the above-mentioned conductor 50 is also fixed (fixed) by using solder 731. ing. However, a fixing member (fixing member) other than these

solders

731 and 732 may be used to fix the vicinity of the tip of the conducting wire 50 and the folded portion 40c.

[C. Operation and action / effect]
Subsequently, the operation, action, and effect of the electrode catheter 1 of the present embodiment will be described in detail while comparing with a comparative example.

(C-1. Operation example)
First, in this electrode catheter 1, the shape of the vicinity of the tip end (tip flexible portion 11A) of the catheter shaft 11 changes in both directions in response to the rotation operation of the rotating plate 41 by the operator. That is, in response to such a rotation operation, an operation of deflecting the tip flexible portion 11A in both directions (the above-mentioned bidirectional deflection operation) is performed.

Specifically, for example, the operator grasps the handle 12 (handle body 121) with one hand and operates the pinching 41a with the fingers of the one hand to rotate the rotating plate 41 in the direction of arrow d1a (clockwise) in FIG. When rotated to, it becomes as follows. That is, in the catheter shaft 11, the first end (base end of the stretched portion 40a) of the operation wire 40 described above is pulled toward the base end side (see FIG. 2). Then, the tip flexible portion 11A of the catheter shaft 11 bends (deflects) along the direction indicated by the arrow d2a in FIG.

Further, for example, when the operator rotates the rotating plate 41 in the direction of the arrow d1b (counterclockwise) in FIG. 1 by operating the knob 41b, the result is as follows. That is, in the catheter shaft 11, the second end (base end of the stretched portion 40b) of the operation wire 40 described above is pulled toward the base end side (see FIG. 2). Then, the vicinity of the tip of the catheter shaft 11 curves along the direction indicated by the arrow d2b in FIG.

In this way, the operator can rotate the rotating plate 41 to perform a bidirectional (swinging) deflection operation on the catheter shaft 11. By rotating the handle body 121 about an axis (in the XY plane), for example, the bending direction (deflection direction) near the tip of the catheter shaft 11 while the catheter shaft 11 is inserted in the patient's body. The orientation of can be set freely. In this way, since the electrode catheter 1 is provided with a deflection mechanism for deflecting the tip flexible portion 11A in both directions, the shape of the catheter shaft 11 near the tip thereof (tip flexible portion 11A) is changed. However, it can be inserted into the patient's body.

Further, in the electrode catheter 1, the tip electrode 110 arranged near the tip of the catheter shaft 11 (tip flexible portion 11A) is also made of metal (not a resin material) like the plurality of ring-shaped electrodes 111. It is composed of materials. As a result, the above-mentioned potential measurement and cauterization can be performed even at a location near the cutting edge of the tip flexible portion 11A.

Further, in the electrode catheter 1 of the present embodiment, both ends of the operation wire 40 (first end and second end: each base end of the

extension portions

40a and 40b) are inside the catheter shaft 11 (inside the sublumens 62A and 62B). ), It is fixed in the handle 12 (on the rotating plate 41). The folded portion 40c of the operating wire 40 is arranged in the tip electrode 110 of the catheter shaft 11. As a result, the bidirectional deflection operation in the tip flexible portion 11A as described above can be realized by using the single operation wire 40 (without using a pair of operation wires). ..

(C-2. Comparative example)
Here, FIG. 7 schematically shows the configuration of the vicinity of the tip electrode 102 in the electrode catheter (electrode catheter 101) according to the comparative example in a side view (ZX side view).

The electrode catheter 101 of this comparative example includes a catheter shaft 103 having a tip electrode 102, and is different from the electrode catheter 1 of the present embodiment in that it has the following configuration. That is, first, in the present embodiment, the above-mentioned bidirectional deflection operation is realized by using a single operation wire 40, whereas in this comparative example, it is the same as that of a general electrode catheter. Therefore, bidirectional deflection operation is realized by using a pair of

operation wires

104a and 104b. As shown in FIG. 7, in the catheter shaft 103 and the tip electrode 102 of such a comparative example, the guide wire 9 is inserted through the same as the catheter shaft 11 and the tip electrode 110 of the present embodiment. A lumen 61 and a through hole 70 are provided, respectively.

In such a comparative example, as shown in FIG. 7, the vicinity of the tips of the pair of

operation wires

104a and 104b are fixed in the outer peripheral side region (fixed region Af102) of the through hole 70 in the tip electrode 102, respectively. It will be (fixed). However, in the tip electrode 102, the thickness on the outer peripheral side of the through hole 70 (see the thickness d103 shown in FIG. 7) is small due to the provision of the through hole 70 as described above. It has become. Therefore, in order to prevent the

operation wires

104a and 104b from falling off in the tip electrode 102 and to secure reliability, the fixing strength near the tip of each

operation wire

104a and 104b (the size of the fixed region Af102). For example, the following problems may occur when trying to secure a certain amount.

That is, first, as shown by an 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 fixed region Af102 described above, the through hole is first formed. There is a possibility that the guide wire 9 cannot be inserted into the 70. Further, for example, as shown by the arrow P102 in FIG. 7, when the outer diameter inside the tip electrode 102 is increased in order to secure the thickness (size in the X-axis direction) of the fixed region Af102, the following It will be like. That is, in this case, the tip electrode 102 becomes large, and when the tip electrode 102 or the entire electrode catheter 101 is inserted into the patient's body, it may not be possible to insert the tip electrode 102 into the inside of the sheath. On the other hand, when an attempt is made to secure the length of the fixed region Af102 (the size in the Z-axis direction), the length of the tip electrode 102 in the axial direction (Z-axis direction) increases accordingly, and the tip electrode 102 becomes larger. It will be large. If the axial length of the tip electrode 102 is increased in this way, there is a possibility that the bidirectional deflection operation described above becomes difficult.

In this way, it can be said that it is difficult to improve the reliability of the electrode catheter 101 of this comparative example while reducing the size.

(C-3. Embodiment of this present)
On the other hand, the electrode catheter 1 of the present embodiment has the above-mentioned configuration, so that the following actions and effects can be obtained.

First, in the electrode catheter 1 of the present embodiment, at least a part of the folded portion 40c of the single operation wire 40 is fixed in the tip electrode 110. As a result, even in the structure of the tip electrode 110 provided with the through hole 70 for the guide wire 9, the fixing strength (size of the fixing region) of the operating wire 40 is secured as compared with the case of the above-mentioned comparative example. It becomes easy to be done. As a result, the operation wire 40 can be easily prevented from falling off in the vicinity of the tip electrode 110 without increasing the outer diameter or the length along the axial direction (Z-axis direction) of the tip electrode 110. Therefore, in the present embodiment, it is possible to improve the reliability while reducing the size of the electrode catheter 1.

Further, in the present embodiment, a reduced diameter portion 72 that can be inserted into the distal end portion of the catheter shaft 11 is provided on the proximal end side portion of the tip electrode 110, and at least a part of the folded-back portion 40c has this reduced diameter. Since it is fixed by the part 72, it becomes as follows. That is, the tip electrode 110 and the tip of the catheter shaft 11 can be easily connected (connected) by using 72 such a reduced diameter portion. As a result, the reliability of the electrode catheter 1 can be further improved.

Further, in the present embodiment, at least a part of the folded-back portion 40c is fixed in the groove 720 formed on the outer peripheral surface of the reduced diameter portion 72, so that the result is as follows. That is, by fixing the folded-back portion 40c in such a groove 720, the fixing strength of the operation wire 40 is increased, so that the operation wire 40 is more likely to be prevented from falling off in the vicinity of the tip electrode 110. .. As a result, the reliability of the electrode catheter 1 can be further improved.

In addition, in the present embodiment, the folded-back portion 40c extends in an arc shape in the plane orthogonal to the axial direction (Z-axis direction) (XY plane) in the tip electrode 110. , It becomes as follows. That is, since the folded-back portion 40c extending in an arc shape in such an orthogonal plane is fixed in the tip electrode 110, the fixing strength of the operation wire 40 is increased, and therefore, in the vicinity of the tip electrode 110. It becomes easier to prevent the operation wire 40 from falling off. As a result, the reliability of the electrode catheter 1 can be further improved.

Further, in the present embodiment, since all the regions in the folded-back portion 40c are fixed in the tip electrode 110, the result is as follows. That is, for example, as compared with the case where only a part of the region in the folded portion 40c is fixed in the tip electrode 110 (corresponding to the case of the modification described below), the operation wire 40 in the vicinity of the tip electrode 110 Dropping is more likely to be prevented. As a result, the reliability of the electrode catheter 1 can be further improved.

<2. Modification example>
Subsequently, a modified example of the above embodiment will be described. The same components as those in the above embodiment are designated by the same reference numerals, and the description thereof will be omitted as appropriate.

FIG. 8 is an XY side view showing a configuration example of the tip electrode 110A in the electrode catheter (electrode catheter 1A) according to the modified example.

The tip electrode 110A in the electrode catheter 1A of this modification is the tip electrode 110 of the electrode catheter 1 described in the embodiment, in which the fixed region Af of the folded-back portion 40c is changed. Specifically, in the tip electrode 110 (see FIG. 6) of the embodiment, in the tip electrode 110 (inside the groove 720), all the regions in the folded-back portion 40c are fixed as the fixed region Af. The tip electrode 110A of this modification is as follows. That is, as shown in FIG. 8, in the tip electrode 110A (inside the groove 720), only a part of the folded-back portion 40c is fixed as the fixed region Af.

Specifically, a plurality of fixed regions Af (Af1, Af2, Af3) are provided intermittently side by side along the arc-shaped extending direction of the groove 720. That is, as shown in FIG. 8, a predetermined interval (non-fixed region of the folded portion 40c) is provided between the fixed regions Af1 and Af2, and a predetermined interval is also provided between the fixed regions Af2 and Af3. (Non-fixed area of folded portion 40c) is provided. In each of these fixed regions Af1 to Af3, for example, as described above, the folded-back portion 40c is fixed (fixed) using the solder 732, while the solder 732 is not arranged in the non-fixed region described above. It has become.

Even in such a modified example, it is basically possible to obtain the same effect by the same action as that of the embodiment.

<3. Other variants>
Although the present invention has been described above with reference to embodiments and modifications, the present invention is not limited to these embodiments and the like, and various modifications are possible.

For example, the shape, arrangement position, size, number, material, etc. of each member described in the above-described embodiment are not limited, and other shapes, arrangement positions, sizes, numbers, materials, etc. may be used.

Specifically, for example, in the above-described embodiment, the configuration of the catheter shaft 11 has been specifically described, but it is not always necessary to include all the members, and other members may be further provided. .. Specifically, for example, a leaf spring that can be deformed in the bending direction may be provided as a swing member inside the catheter shaft 11. Further, the arrangement, shape, number (one or a plurality) of the ring-shaped electrodes 111 and the sublumens in the catheter shaft 11 are not limited to those mentioned in the above-described embodiment. Specifically, in the above-described embodiment and the like, the case where a plurality of ring-shaped electrodes 111 are provided has been described as an example, but for example, only one ring-shaped electrode 111 is provided. May be good.

Further, in the above-described embodiment and the like, the configuration of the tip electrode 110 has been specifically described, but the shape, size, material and the like of the tip electrode 110 are limited to those described in the above-described embodiment and the like. do not have. Specifically, for example, in the above embodiment, the case where the folded portion 40c of the operation wire 40 is fixed by the diameter-reduced portion 72 (inside the groove 720) of the tip electrode 110 will be described as an example. However, it is not limited to this example. That is, for example, the folded-back portion 40c of the operation wire 40 may be fixed at another position in the tip electrode 110. Further, in the above-described embodiment and the like, the case where the folded-back portion 40c extends in an arc shape in the above-mentioned orthogonal plane in the tip electrode 110 has been described as an example, but this example is limited. I can't. That is, for example, the folded-back portion 40c may extend in a non-arc shape (straight line shape, square shape, etc.) in the tip electrode 110. Further, the fixed region Af of the folded-back portion 40c in the tip electrode 110 is not limited to the region described in the above-described embodiment or the like, and the folded-back portion 40c may be fixed in another region. ..

Further, in the above-described embodiment and the like, the configuration of the handle 12 (handle main body 121 and rotation operation unit 122) has been specifically described, but it is not always necessary to include all the members, and other members may be provided. Further may be provided.

In addition, in the above-described embodiment and the like, the guide wire 9 has been described as an example of a long instrument inserted in the catheter shaft 11 (and in the tip electrode 110), but this example is limited to this example. I can't. That is, for example, a predetermined injection needle (such as an injection needle for injecting a drug into a patient) or the like may be such a long instrument.

Claims

A catheter shaft having a tip flexible portion in which a plurality of metal electrodes are arranged along the axial direction and a plurality of lumens extending along the axial direction.
It is provided with a handle that is mounted on the proximal end side of the catheter shaft and has an operating portion that is operated during a deflection operation that deflects the tip flexible portion in both directions.
The plurality of metal electrodes
A tip electrode that is arranged near the tip of the tip flexible portion and has a through hole through which a long instrument penetrates along the axial direction.
It includes one or more ring-shaped electrodes arranged on the proximal end side of the tip electrode.
The multiple lumens
The main lumen through which the long instrument penetrates,
It contains a first and second sublumen through which a single operating wire penetrates.
The single operating wire
A first stretched portion extending from the first end of the single operating wire fixed on the operating portion through the first sublumen into the tip electrode.
A second stretched portion extending from the tip electrode through the second sublumen to the second end of the single operating wire fixed on the operating portion.
An electrode catheter located between the first and second stretched portions and comprising a folded portion in which at least a portion of the region is secured within the tip electrode.
The tip electrode has a reduced diameter portion formed on the proximal end side portion thereof and configured to be insertable into the distal end portion of the catheter shaft.
The electrode catheter according to claim 1, wherein at least a part of the folded portion is fixed in the reduced diameter portion.
A groove is formed on the outer peripheral surface of the reduced diameter portion.
The electrode catheter according to claim 2, wherein at least a part of the folded portion is fixed in the groove.
The electrode catheter according to any one of claims 1 to 3, wherein the folded portion extends in an arc shape in an orthogonal plane with respect to the axial direction in the tip electrode.
The electrode catheter according to any one of claims 1 to 4, wherein all the regions in the folded portion are fixed in the tip electrode.