WO2018037594A1

WO2018037594A1 - Handle for medical device and medical device

Info

Publication number: WO2018037594A1
Application number: PCT/JP2017/007072
Authority: WO
Inventors: 拓也桝田; 小林　洋平
Original assignee: 日本ライフライン株式会社
Priority date: 2016-08-25
Filing date: 2017-02-24
Publication date: 2018-03-01
Also published as: JP2018029795A

Abstract

The purpose of the invention is to provide a handle for a medical device and a medical device such that convenience can be improved. The present invention provides a handle which is for a medical device (handle 3) and is mounted on a base end of a flexible tubular member (sheath tube 2), said handle comprising a handle body 31; a rotation manipulation unit 32 which is mounted on the handle body 31 so as to be rotatable about a rotation axis in the direction of extension (Z axis direction) of the handle body 31 and which is used for rotation manipulation to deform the shape of the tubular member near the distal end thereof; and a movement mechanism (wire securing members 312a, 312b) that move inside the handle body 31 in conjunction with the rotation manipulation of the rotation manipulation unit 32. The handle body 31 has a transparent region At at least in a region corresponding to a portion of the movement mechanism.

Description

Medical device handle and medical device

The present invention relates to a medical device such as an electrode catheter or a sheath introducer used for, for example, examination (diagnosis) or treatment of arrhythmia, and a medical device handle applied to such a medical device.

The electrode catheter is inserted into the body (for example, the inside of the heart) through a blood vessel, and is used for arrhythmia examination and treatment. In such electrode catheters, in general, the shape near the tip (distal end) of the catheter tube inserted into the body is attached to the proximal end (proximal end, rear end, hand side) placed outside the body. Depending on the operation of the part, it changes (deflects, curves, bends) in one direction or both directions.

In addition, when inserting a catheter such as an electrode catheter into the body, a sheath introducer (catheter sheath) provided with a sheath (sheath tube) that is introduced into the blood vessel and assists the insertion of the catheter in advance. Device) is known.

An example of a handle for a medical device such as an electrode catheter or a sheath introducer is disclosed in Patent Document 1, for example. In the handle of this Patent Document 1, a rotation operation portion (pick) that is rotatable about the extending direction (longitudinal direction) of the handle body as a rotation axis is mounted on the handle body. In such a rotation operation portion, a proximal end side of an operation wire for bending the vicinity of the distal end of a tubular member such as a catheter tube or a sheath tube is extended from the inside of the tubular member. By rotating such a rotation operation unit, the vicinity of the tip of the tubular member can be bent.

Special table 2009-512497

By the way, in the medical device as described above, for example, in a state where the distal end side of the tubular member is inserted into the body of the patient, the deformed state (flexed state, curved state, etc.) near the distal end of the tubular member is confirmed. The case you want can happen.

However, for example, in the handle described in Patent Document 1, the rotation operation unit may be rotated a plurality of times in order to obtain a desired shape near the tip, and thus the following problem may occur in the case described above. That is, it is difficult to confirm (grab) the deformed state in the vicinity of the tip of the tubular member on the operator's hand side, and as a result, convenience may be impaired.

The present invention has been made in view of such problems, and an object of the present invention is to provide a medical device handle and a medical device capable of improving convenience.

The handle for a medical device of the present invention is a handle attached to the proximal end side of a flexible tubular member, and is rotatable with the handle body and the extending direction of the handle body as a rotation axis. Is attached to the handle body, and is used for a rotation operation for deforming the shape of the vicinity of the tip of the tubular member, and a moving mechanism that moves within the handle body in conjunction with the rotation operation for the rotation operation section. It is equipped with. The handle body has a transparent region in a region corresponding to at least a part of the moving mechanism. The “transparent region” means a region through which light having at least a wavelength in the visible band can be transmitted, and so on.

The medical device of the present invention comprises a flexible tubular member and a handle as the medical device handle of the present invention mounted on the proximal end side of the tubular member.

The medical device handle and the medical device of the present invention are provided with a moving mechanism that moves in the handle body in conjunction with a rotation operation (an operation for deforming the shape of the vicinity of the tip of the tube-shaped member) on the rotation operation unit. Yes. Further, the handle main body is provided with a transparent region at least in a region corresponding to a part of the moving mechanism. Thereby, for example, even when the distal end side of the tubular member is inserted into the patient's body, the inside of the handle main body (the movement state of the moving mechanism) is visually recognized through the transparent region. The deformed state in the vicinity of the tip can be confirmed (obtained) on the operator's hand side (handle body).

In the medical device handle and the medical device of the present invention, a rotation mechanism configured to rotate with the extending direction as a rotation axis in conjunction with the rotation operation, and further including a rotation mechanism having a portion disposed in the handle body, One or a plurality of wire fixing members configured to engage with the rotation mechanism while fixing a base end of one or a plurality of operation wires for deforming a shape in the vicinity of a distal end of the tubular member. The moving mechanism may be provided. In this case, as the rotation mechanism rotates in conjunction with the rotation operation, the wire fixing member moves in the handle body along the extending direction. For this reason, it becomes easy to intuitively grasp the deformed state near the tip of the tubular member through the transparent region, and the convenience is further improved. Further, the deformation state near the tip of the tubular member can be confirmed with a simple structure, and the manufacturing cost can be reduced and the reliability can be improved.

In this case, for example, the operation wire and the wire fixing member may be provided as a pair and the following may be performed. That is, of the pair of operation wires and the pair of wire fixing members, the base end of one operation wire is fixed to one wire fixing member, and the base end of the other operation wire is fixed to the other wire The one wire fixing member and the other wire fixing member are moved in opposite directions along the extending direction in conjunction with the rotation operation in the rotation mechanism. It may be. In this case, the deformation state (for example, both the deformation direction and the deformation amount) near the distal end of the tubular member is more intuitive depending on the movement state of the one wire fixing member and the other wire fixing member. As a result, the convenience can be further improved.

Here, the rotation mechanism includes, for example, a first recess extending in a left spiral shape along the extending direction and a second recess extending in a right spiral shape along the extending direction. The one wire fixing member is selectively engaged with the first recess of the first and second recesses, and the other wire fixing member is You may make it selectively engage with the said 2nd recessed part of the 1st and 2nd recessed parts. In this case, the reverse operation of the one wire fixing member and the other wire fixing member in conjunction with the rotation operation in the rotation mechanism can be realized with a simple structure, and the assembly is facilitated. Thus, the manufacturing cost can be reduced and the reliability can be improved.

In the medical device handle and the medical device of the present invention, the entire region of the surface of the handle body may be the transparent region. In this case, the surface (exterior member) of the handle main body can be constituted by a single member, so that the manufacturing cost can be reduced and the reliability can be improved.

Note that examples of the tubular member include a sheath tube and a catheter tube. In other words, examples of the medical device to which the present invention is applied include a sheath introducer or various catheters (electrode catheter or the like). In addition, as the “rotating operation for deforming the shape near the tip of the tube-shaped member” described above, for example, the “rotating operation near the tip of the tube-shaped member” or “the loop-shaped portion near the tip of the tube-shaped member” For example, a rotation operation or the like that changes the diameter.

According to the medical device handle and the medical device of the present invention, a transparent region is provided in a region corresponding to at least a part of a moving mechanism (a mechanism that moves in the handle main body in conjunction with a rotation operation with respect to the rotation operation unit) in the handle main body. Since it provided, the deformation | transformation state near the front-end | tip of a tubular member can be confirmed on the operator's hand side. Therefore, it is possible to improve convenience when using the medical device.

It is a schematic diagram showing the example of schematic structure of the sheath introducer as a medical device which concerns on one embodiment of this invention. FIG. 2 is an exploded side view illustrating a detailed configuration example inside a handle illustrated in FIG. 1. It is a schematic diagram showing the structure of the medical device which concerns on a comparative example. It is a schematic diagram showing an example of the use condition of the medical device shown in FIG. 10 is a schematic diagram illustrating a schematic configuration example of a sheath introducer as a medical device according to Modification 1. FIG. 10 is a schematic diagram illustrating a schematic configuration example of an electrode catheter as a medical device according to Modification Example 2. FIG. 10 is a schematic diagram illustrating a schematic configuration example of an electrode catheter as a medical device according to Modification 3. FIG.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The description will be given in the following order.
1. Embodiment (example when medical device is sheath introducer)
2. Modified example Modified example 1 (example in which only a part of the surface of the handle body is a transparent region)
Modification 2 (Example 1 when the medical device is an electrode catheter: Example of bending)
Modification 3 (Example 2 when the medical device is an electrode catheter: Example in which the loop diameter changes)
3. Other variations

<Embodiment>
[Constitution]
FIG. 1 schematically shows a schematic configuration example of a sheath introducer 1 as a medical device according to an embodiment of the present invention. Specifically, FIG. 1 schematically shows a side configuration example (ZX side configuration example) of the sheath introducer 1. In FIG. 1, an enlarged view of a portion indicated by a broken line arrow (a portion surrounded by a broken line) (a rotating mechanism 311 and

wire fixing members

312a, 312b, etc., which will be described later) in the portion indicated by the reference sign P1 It is also illustrated.

When the sheath introducer 1 inserts the catheter tube 6 of an electrode catheter or the like into a patient's body, the sheath tube 2 is introduced into the body prior to the insertion, so that the catheter tube 6 is inserted into the blood vessel. It is a device for securing a passage. The sheath introducer 1 includes a sheath tube 2 (sheath shaft) as a sheath main body (long portion), and a handle 3 attached to the proximal end side of the sheath tube 2.

(A. Sheath tube 2)
The sheath tube 2 is formed of a flexible tubular structure (hollow tubular member) and has a shape that extends along its own axial direction (Z-axis direction). Specifically, the length of the sheath tube 2 in the axial direction is several times to several tens of times longer than the length of the handle 3 in the axial direction (Z-axis direction). The sheath tube 2 may be composed of a tube having the same characteristics in the axial direction, but the distal end portion having relatively high flexibility and the distal end portion are integrated in the axial direction. It is preferable to have a proximal end portion that is formed and is relatively stiffer than the distal end portion.

In the sheath tube 2, for example, as shown in FIG. 1, a catheter tube 6 can be inserted. In addition, on the distal end side of the sheath tube 2, the distal ends of a pair of operation wires (

operation wires

41a and 41b) to be described later are fixed. The proximal ends of the

operation wires

41a and 41b are extended from the sheath tube 2 into the handle 3 (on

wire fixing members

312a and 312b described later).

The sheath tube 2 is made of a synthetic resin such as polyolefin, polyamide, polyether polyamide, or polyurethane. The axial length of the sheath tube 2 is about 300 to 900 mm, and the length of the flexible portion near the tip of the sheath tube 2 is about 20 to 150 mm. The outer diameter of the sheath tube 2 (the outer diameter of the XY cross section) is about 2.0 to 5.0 mm (preferably about 2.6 to 4.3 mm). The (inner diameter of the XY cross section) is about 1.6 to 4.3 mm (preferably about 2.0 to 2.8 mm).

In the vicinity of the distal end of the catheter tube 6, for example, as shown in FIG. 1, a plurality of electrodes (here, three ring electrodes 61 and one distal electrode 62) are arranged at a predetermined interval. Yes. Specifically, the ring electrode 61 is fixedly disposed on the outer peripheral surface of the catheter tube 6, while the tip electrode 62 is fixedly disposed at the forefront of the catheter tube 6.

(B. Handle 3)
The handle 3 is a portion that is gripped (gripped) by an operator (doctor) when the sheath introducer 1 is used. As shown in FIG. 1, the handle 3 includes a handle main body 31 attached to the proximal end side of the sheath tube 2 and a rotation operation portion (pick, dial) 32. As will be described later, the rotation operation unit 32 is a portion used in a rotation operation that is an operation of deforming (bending or deflecting in this example) the vicinity of the distal end of the sheath tube 2.

Here, with reference to FIG. 2 in addition to FIG. 1, a detailed configuration example of such a handle 3 will be described. FIG. 2 schematically shows a detailed configuration example of the handle 3 in an exploded side view. Specifically, FIG. 2A schematically shows a side surface configuration example (ZX side surface configuration example) of a rotation mechanism 311 described later. 2B schematically shows a side surface configuration example (YZ side surface configuration example) of a wire fixing member 312a, which will be described later, and FIG. 2C shows a side surface configuration example of a wire fixing member 312b, which will be described later. (YZ side surface configuration example) is schematically shown.

(B-1. Rotation operation unit 32)
As shown in FIG. 1, the rotation operation unit 32 is configured to be rotatable about the extending direction (longitudinal direction; Z-axis direction) of the handle body 31 as a rotation axis. It is attached to the side. Specifically, as indicated by arrows d1 (d1a, d1b) in FIG. 1, the rotation operation unit 32 is rotatable around the rotation axis in the XY plane. In this example, the rotation operation unit 32 is configured to be able to rotate the XY plane bidirectionally (right rotation and left rotation) (see arrows d1a and d1b). Although details will be described later, the operator can perform such a rotation operation on the rotation operation unit 32 to bend (bidirectionally) the vicinity of the distal end of the sheath tube 2.

Note that such a rotation operation unit 32 has a cylindrical shape extending in the Z-axis direction. The rotation operation unit 32 is made of, for example, a synthetic resin such as polycarbonate, acrylonitrile-butadiene-styrene copolymer (ABS), acrylic, polyolefin, polyoxymethylene.

(B-2. Handle body 31)
As shown in FIG. 1, the handle main body 31 corresponds to a portion (grip part) that is actually gripped by the operator, and in this example, has a cylindrical shape extending along the Z-axis direction. The length of the handle body 31 in the extending direction is, for example, about 100 to 200 mm (preferably about 150 mm).

As shown in FIGS. 1 and 2, the handle body 31 includes a handle member 310, a part of the rotation mechanism 311, a pair (two) of

wire fixing members

312 a and 312 b, and a tube fixing member 315. is doing. In addition, each member (the handle member 310, the rotation mechanism 311, the

wire fixing members

312a and 312b, the tube fixing member 315, and the like) in the handle main body 31 is made of, for example, the same material (synthetic resin) as the rotation operation unit 32 described above. Etc.).

The handle member 310 functions as an exterior member of the handle main body 31. Specifically, as shown in FIG. 1, a part of the rotation mechanism 311,

wire fixing members

312 a and 312 b, a tube fixing member 315, and the like are accommodated inside the handle member 310. The handle member 310 is configured by using, for example, a pair of members that are substantially hook-shaped to fit with each other. Specifically, for example, one member is arranged in the positive direction of the Z axis, and the other member is arranged in the negative direction of the Z axis. A detailed configuration example (configuration example of the characteristic part) of such a handle member 310 will be described later.

The tube fixing member 315 is a member for fixing the proximal end of the sheath tube 2 to the handle body 31 as shown in FIG. In this example, the tube fixing member 315 is provided in a region near the proximal end of the handle member 310.

The rotation mechanism 311 extends the handle main body 31 in conjunction with the rotation operation (rotation operation in the XY plane) to the rotation operation unit 32 described above, for example, as indicated by reference numeral P1 in FIG. It is configured to rotate with the current direction (Z-axis direction) as a rotation axis. Specifically, in conjunction with a bidirectional rotation operation (see arrow d1) with respect to the rotation operation unit 32, the rotation mechanism 311 also uses the extending direction (Z-axis direction) of the handle body 31 as a rotation axis. Bi-directional rotation operation (right rotation and left rotation in the XY plane) is possible. The details of the bidirectional rotation operation in the rotation mechanism 311 will be described later (FIG. 4A, FIG. 4B, etc.).

In this example, the rotating mechanism 311 has a cylindrical structure extending along the Z-axis direction as shown in FIGS. 1 and 2A. Specifically, in this example, as shown in FIG. 2A, the rotation mechanism 311 has a cylindrical main body portion 311P extending along the Z-axis direction and a diameter larger than that of the main body portion 311P. And an engaging portion 311F which is a cylindrical portion. The main body portion 311P and the engaging portion 311F have a structure integrated with each other. In addition, as shown in FIG. 2A, the rotation mechanism 311 has two spirals independent of each other in a region on the base end side (tube fixing member 315 side) with respect to the engagement portion 311F on the main body portion 311P. Recesses (grooves) 311a and 311b, and projections (projections) 311c for forming these

recesses

311a and 311b. The length of the rotating mechanism 311 in the extending direction is, for example, about 30 to 100 mm (preferably about 50 mm). The outer diameter of the main body 311P in the rotation mechanism 311 is, for example, about 5 to 20 mm (preferably about 10 mm). In the rotating mechanism 311, the portions where the

recesses

311 a and 311 b and the protrusion 311 c are formed on the main body portion 311 P correspond to the portion disposed in the handle main body 31.

As described above, the engaging portion 311F is a cylindrical portion having a diameter larger than that of the main body portion 311P, and engages with the rotation operation portion 32. Specifically, the protruding portion (convex portion) in the engaging portion 311F and the groove portion (recessed portion) provided on the inner surface of the rotation operation portion 32 are engaged (fitted) with each other. Yes. As described above, the rotation mechanism 311 (engagement portion 311F) and the rotation operation portion 32 are engaged with each other inside the handle body 31 in this manner, and thus interlocked with the rotation operation to the rotation operation portion 32 as described above. The bidirectional rotation operation of the rotation mechanism 311 is realized.

The recess 311a extends in a left spiral shape along the extending direction (Z-axis direction) of the rotating mechanism 311 (main body portion 311P), as schematically shown by oblique lines in FIG. (Refer to the symbol “L” shown in parentheses in the code). On the other hand, the recess 311b extends in the extending direction of the rotation mechanism 311 (main body portion 311P) as schematically shown by a hatched line in FIG. 2A (a hatched line intersecting with the hatched line indicating the recess 311a). (Refer to the symbol “R” shown in parentheses in the reference numeral). As shown in FIG. 2A, the recess 311a and the recess 311b are spiral recesses extending in opposite directions and partially intersect in the region on the main body 311P. It is like that. Further, as shown in FIG. 2A, the convex portion 311c is formed in a region between the

concave portions

311a and 311b in the region on the main body portion 311P, and has a substantially rhombus shape. In other words, in the region on the main body portion 311P, the groove portions formed between the plurality of convex portions 311c correspond to the

concave portions

311a and 311b. The recess 311a corresponds to a specific example of “first recess” in the present invention, and the recess 311b corresponds to a specific example of “second recess” in the present invention.

The

wire fixing members

312a and 312b are members to which the base ends of the pair of

operation wires

41a and 41b described above are fixed. In this example, a pair of

fasteners

42a and 42b are provided on the

wire fixing members

312a and 312b as schematically shown in the symbol P1 in FIG. These

fasteners

42a and 42b are members (wire fasteners) for individually fixing the base ends of the

operation wires

41a and 41b by screwing or the like. In addition, in these

fasteners

42a and 42b, it is possible to arbitrarily adjust the pull-in lengths near the base ends when fixing the base ends of the

operation wires

41a and 41b, respectively.

Specifically, as schematically shown in P1 in FIG. 1, the proximal end of the operation wire 41a extended from the sheath tube 2 into the handle main body 31 is the wire fixing member 312a. It is fixed by the upper fastener 42a. On the other hand, the proximal end of the operation wire 41b extended from the sheath tube 2 into the handle main body 31 is fixed by a fastener 42b on the wire fixing member 312b.

Each of these

operation wires

41a and 41b is made of a superelastic metal material such as stainless steel (SUS) or nickel titanium (NiTi), and has a diameter of about 100 to 500 μm (for example, 200 μm). It is. However, it does not necessarily need to be comprised with a metal material, for example, may be comprised with the high intensity | strength nonelectroconductive wire.

Such

wire fixing members

312a and 312b are also configured to engage with the rotation mechanism 311 described above. Specifically, in this example, as schematically shown in FIGS. 2A and 2B, a substantially rectangular convex portion (protruding portion) formed on the inner surface of the wire fixing member 312a. ) Ca and the recess 311a in the rotation mechanism 311 are engaged (fitted) (see the broken arrow P2a). Further, a substantially rectangular convex portion (protruding portion) Cb formed on the inner surface of the wire fixing member 312b and a concave portion 311b in the rotating mechanism 311 are engaged (fitted) (broken arrow P2b). reference). That is, the wire fixing member 312a is selectively engaged with the concave portion 311a of the

concave portions

311a and 311b, and the wire fixing member 312b is selective with respect to the concave portion 311b of the

concave portions

311a and 311b. Is engaged.

Note that these

wire fixing members

312a and 312b have overhang portions Ea and Eb, respectively, that are portions overhanging in the opposing direction (X-axis direction). Specifically, as schematically shown in P1 in FIG. 1, the wire fixing member 312a has a protruding portion Ea that is a portion protruding in the X-axis direction toward the wire fixing member 312b. is doing. On the other hand, the wire fixing member 312b has a protruding portion Eb that is a portion protruding in the X-axis direction toward the wire fixing member 312a. In this example, the overhang portions Ea and Eb are disposed at positions that are in contact with or close to each other along the X-axis direction.

Here, as described above, the rotation mechanism 311 performs bidirectional rotation operation with the extending direction (Z-axis direction) in the handle main body 31 as the rotation axis in conjunction with the rotation operation to the rotation operation unit 32. Configured to do. Further, as described above, the

wire fixing members

312 a and 312 b are configured to engage with the rotation mechanism 311. Therefore, as schematically shown in the symbol P1 in FIG. 1, these

wire fixing members

312a and 312b also extend in the handle main body 31 in conjunction with the rotation operation to the rotation operation unit 32. It moves (slides) in both directions along the direction (see arrows d3a and d3b). Although details will be described later, at this time, the wire fixing member 312a and the wire fixing member 312b are opposite to each other along the extending direction of the handle body 31 in conjunction with the bidirectional rotation operation in the rotation mechanism 311. It is designed to move in the direction.

Note that each of the

wire fixing members

312a and 312b corresponds to a specific example of the “moving mechanism (sliding mechanism)” in the present invention.

Here, in the present embodiment, the handle main body 31 has a transparent area At that allows the inside of the handle main body 31 to be visually recognized from the outside in an area corresponding to at least a part of the

wire fixing members

312a and 312b (movement mechanism). Yes. Specifically, in this example, as shown in FIG. 1, the entire area of the surface of the handle main body 31 is such a transparent area At. In other words, in this example, the entire handle member 310 is configured by a single transparent member (a member made of a material capable of transmitting visible light). In addition, as a material which comprises such a transparent member, synthetic resins, such as a polycarbonate, ABS, an acryl, are mentioned, for example.

[Action / Effect]
(A. Basic operation)
In the sheath introducer 1, the sheath tube 2 is inserted into the patient's body through the blood vessel prior to the catheter tube 6 in the electrode catheter or the like when examining or treating arrhythmia or the like. Thereby, an insertion path is secured in the blood vessel at the insertion destination, and insertion of the catheter tube 6 is assisted.

Here, examples of a method for introducing the sheath tube 2 into the body (an operation method by the operator) include the following methods.

That is, first, a dilator (not shown) is inserted into the inner hole of the sheath tube 2, and the sheath tube 2 integrated with the dilator is inserted into the blood vessel of the patient. Then, the sheath tube 2 is moved toward the target site (affected site) along a guide wire (not shown) inserted in advance while the operator performs a rotation operation on the rotation operation unit 32. At this time, the shape of the vicinity of the distal end of the sheath tube 2 inserted into the body changes in both directions according to the rotation operation to the rotation operation unit 32.

Specifically, when the operator grasps the handle main body 31 and rotates the rotation operation unit 32 with a finger, for example, the rotation operation unit 32 is moved in the direction of the arrow d1a in FIG. When it is rotated clockwise (as viewed along), it will be as follows. That is, as shown in FIG. 1, the

wire fixing members

312a and 312b are respectively extended in the handle body 31 in the extending direction (in accordance with the rotation operation in conjunction with the rotation operation). It moves along the Z-axis direction (see arrows d3a and d3b). Particularly in this case, the wire fixing member 312b moves to the proximal end side in the handle main body 31 (see arrow d3b). Then, inside the sheath tube 2 and the handle main body 31, the operation wire 41b is pulled toward the base end side (the fastener 42b side) (see the arrow d4b). As a result, the vicinity of the distal end of the sheath tube 2 is illustrated in FIG. 1 bends (bends) along the direction indicated by the arrow d2a in FIG.

Further, when the operator rotates the rotation operation unit 32, for example, the rotation operation unit 32 is rotated in the direction of the arrow d1b in FIG. 1 (counterclockwise when viewed along the positive direction of the Z axis). When rotated, it becomes as follows. That is, as shown in FIG. 1, the

wire fixing members

312a and 312b are respectively extended in the handle body 31 in the extending direction (in accordance with the rotation operation in conjunction with the rotation operation). It moves along the Z-axis direction (see arrows d3a and d3b). Particularly in this case, the wire fixing member 312a moves to the proximal end side in the handle main body 31 (see arrow d3a). Then, inside the sheath tube 2 and the handle main body 31, the operation wire 41a is pulled toward the base end side (fastener 42a side) (see arrow d4a), and as a result, the vicinity of the distal end of the sheath tube 2 is shown in FIG. Curved along the direction indicated by the arrow d2b in FIG.

In this way, the operator can perform the swing deflection operation of the sheath tube 2 by rotating the rotation operation unit 32. In addition, by rotating the handle body 31 around the axis (in the XY plane), the direction of the bending direction in the vicinity of the distal end of the sheath tube 2 can be freely set while the sheath tube 2 is inserted into the patient's body. can do.

Subsequently, when the distal end opening of the sheath tube 2 reaches the vicinity of the target site (affected site), the above-described dilator and guide wire are removed. Thereby, the front-end | tip part of the sheath tube 2 is detained in a patient's body. The catheter tube 6 can be inserted into the body using the sheath tube 2 thus introduced into the body.

In addition, as a method for inserting the catheter tube 6 into the body, for example, the following method may be mentioned.

That is, first, the distal end of the catheter tube 6 is inserted into the inner hole of the sheath tube 2 from the proximal end of the handle 3. Then, the operator performs a rotation operation on the catheter rotation operation section (arranged in the handle provided on the proximal end side of the catheter tube 6: not shown in FIG. 1), while the operator rotates the inner hole of the sheath tube 2. The catheter tube 6 is moved along. Thereby, for example, as shown in FIG. 1, the vicinity of the distal end of the catheter tube 6 extends from the distal end opening of the sheath tube 2.

Subsequently, the operator swings and deflects the catheter tube 6 by rotating the above-described catheter rotation operation unit. Further, as necessary, the swing operation of the sheath tube 2 is performed by rotating the rotation operation unit 32 of the sheath introducer 1. As a result, the position of the distal end portion of the catheter tube 6 (for example, the ring-shaped electrode 61 and the one distal end electrode 62 in the electrode catheter) is adjusted and can reach the target site (affected site).

After the distal end portion of the catheter tube 6 is positioned in this way, a catheter procedure (examination or treatment) is performed. After the procedure using the catheter is completed, the catheter tube 6 is removed from the body, and then the sheath tube 2 is removed from the body. As described above, examination and treatment of arrhythmia and the like are performed using the sheath introducer 1 and a catheter such as an electrode catheter.

(B. Action on handle 3)
Next, the action of the sheath introducer 1 on the handle 3 will be described in detail in comparison with a comparative example.

(B-1. Comparative Example)
FIG. 3 schematically shows a configuration of the sheath introducer 101 according to the comparative example in a side view (ZX side view).

The sheath introducer 101 of this comparative example is a device that assists the insertion of the catheter tube 6 by introducing the sheath tube 2 into the body prior to the catheter tube 6 in the same manner as the sheath introducer 1. As shown in FIG. 3, the sheath introducer 101 includes a sheath tube 2 and a handle 103 attached to the proximal end side of the sheath tube 2. That is, the sheath introducer 101 corresponds to the sheath introducer 1 in which the handle 103 is provided instead of the handle 3.

The handle 103 has a handle main body 102 and a rotation operation unit 32 as shown in FIG. That is, the handle 103 corresponds to the handle 3 in which the handle body 102 is provided instead of the handle body 31, and the other configurations are basically the same.

This handle main body 102 corresponds to the handle main body 31 in which the transparent region At is not provided (omitted), and other configurations are basically the same. That is, unlike the handle member 310 in the handle main body 31, the handle member 100 in the handle main body 102 is entirely composed of a non-transparent member (a member made of a material that cannot transmit visible light).

By the way, in a sheath introducer, for example, there may be a case where it is desired to check a bent state (curved state) near the distal end of the sheath tube while the distal end side of the sheath tube is inserted into the patient's body.

However, in the handle 103 according to this comparative example, the following problem may occur in such a case. That is, for example, in order to realize fine adjustment of the curved shape, it is desirable that the amount of bending near the tip that changes according to the amount of rotation of the rotation operation unit 32 is small. The part 32 may be rotated a plurality of times. Particularly in such a case, it is difficult to confirm (grab) the bent state near the distal end of the sheath tube 2 on the operator's hand side, and as a result, the convenience when using the sheath introducer 101 is increased. May be damaged.

(B-2. This embodiment)
On the other hand, the handle 3 in the sheath introducer 1 of the present embodiment has the following configuration as shown in FIGS. That is, the handle 3 has a moving mechanism (in this example, a wire fixing member 312a) that moves in the handle main body 31 in conjunction with a rotation operation on the rotation operation unit 32 (an operation for bending the vicinity of the distal end of the sheath tube 2). 312b) is provided. The handle main body 31 is provided with a transparent area At in an area corresponding to at least a part of the moving mechanism.

Thus, unlike the handle 103 of the comparative example, the handle 3 is as follows even when the distal end side of the sheath tube 2 is inserted into the patient's body, for example. That is, by visually recognizing the inside of the handle main body 31 (the movement state of the moving mechanism described above) through the transparent region At, the bending state near the distal end of the sheath tube 2 is changed on the operator's hand side (handle main body 31). You can check (understand). As a result, convenience when using the sheath introducer 1 is improved.

Specifically, first, for example, as shown in FIG. 4A, the rotation operation unit 32 is rotated by the operator in the direction of the arrow d1a (clockwise when viewed along the positive direction of the Z axis). When operated, it is as follows. That is, in this case, as described above, the rotation mechanism 311 performs a rotation operation with the extending direction (Z-axis direction) in the handle body 31 as the rotation axis. With this rotation operation, the wire fixing member 312a that engages with the rotation mechanism 311 (recess 311a) moves to the distal end side of the handle body 31 (see the arrow d3a in FIG. 4A). ). On the other hand, the wire fixing member 312b that engages with the rotation mechanism 311 (recess 311b) is in a direction opposite to the moving direction of the wire fixing member 312a, that is, the proximal end of the handle main body 31 as the rotation mechanism 311 rotates. (See arrow d3b in FIG. 4A). The movement operation (slide operation) of the

wire fixing members

312a and 312b in conjunction with such a rotation operation can be visually recognized by the operator through the transparent region At in the handle main body 31 (handle member 310). Therefore, the bending state (see arrow d2a in FIG. 4A) in the vicinity of the distal end of the sheath tube 2 can be confirmed on the handle body 31.

On the other hand, for example, as shown in FIG. 4B, when the rotation operation unit 32 is rotated by the operator in the direction of the arrow d1b (counterclockwise when viewed along the positive direction of the Z axis), It becomes as follows. That is, also in this case, as described above, the rotation mechanism 311 performs a rotation operation with the extending direction in the handle main body 31 as the rotation axis. Then, along with this rotation operation, the wire fixing member 312b that engages with the rotation mechanism 311 (recess 311b) moves to the distal end side of the handle body 31 (see the arrow d3b in FIG. 4B). ). On the other hand, the wire fixing member 312a that engages with the rotation mechanism 311 (recess 311a) is in the direction opposite to the moving direction of the wire fixing member 312b, that is, the proximal end of the handle body 31 with the rotation operation in the rotation mechanism 311. (See arrow d3a in FIG. 4B). The movement operation of the

wire fixing members

312a and 312b interlocked with such a rotation operation can also be visually recognized by the operator through the transparent region At in the handle body 31. Therefore, the bending state (see arrow d2b in FIG. 4B) near the distal end of the sheath tube 2 can be confirmed on the handle body 31.

Thus, in the handle 3 of the present embodiment, the rotation mechanism 311 and the

wire fixing members

312a and 312b (moving mechanisms) having the above-described configuration are provided as follows. That is, as the rotation mechanism 311 performs a rotation operation in conjunction with the rotation operation to the rotation operation unit 32, the

wire fixing members

312a and 312b move in the handle body 31 in the extending direction (Z-axis direction). Will move along. For this reason, the bending state (deformed state) near the distal end of the sheath tube 2 can be easily grasped intuitively through the transparent region At, and the convenience can be further improved.

Further, in the handle 3, the bending state near the distal end of the sheath tube 2 can be confirmed with a simple structure by the rotation mechanism 311 and the

wire fixing members

312a and 312b having such a configuration (confirmation of the bending state). Function can be realized easily). Therefore, it is possible to reduce the manufacturing cost and improve the reliability of the handle 3 (sheath introducer 1).

Furthermore, in the present embodiment, the base end of the operation wire 41a is fixed by the wire fixing member 312a, while the base end of the operation wire 41b is fixed by the wire fixing member 312b. Then, these two

wire fixing members

312a and 312b move in opposite directions along the extending direction (Z-axis direction) of the handle body 31 in conjunction with the rotation operation in the rotation mechanism 311. Yes. Thereby, according to the movement state of

wire fixing member

312a, 312b, the bending state (for example, both a bending direction and a bending amount) near the front-end | tip of the sheath tube 2 can be grasped | ascertained more intuitively now. As a result, convenience is further improved. In order to make it possible to more intuitively understand the movement state of the

wire fixing members

312a and 312b in the reverse direction from the outside through the transparent region At, for example, these two

wire fixing members

312a and 312b. Different appearances may be provided (for example, provided with different colors).

In addition, since the base ends of the pair of

operation wires

41a and 41b are fixed to the

wire fixing members

312a and 312b by the simple path (linear path) as described above, the following is performed. Become. That is, a mechanism for bi-directionally bending the vicinity of the distal end of the sheath tube 2 can be realized with a simple structure, and the manufacturing cost of the handle 3 (sheath introducer 1) can be reduced and the reliability can be improved.

In particular, in the present embodiment, the entire area of the surface of the handle body 31 is a transparent area At. Accordingly, the surface of the handle body 31 (handle member 310) can be formed of a single member, so that the manufacturing cost can be reduced and the reliability can be improved. Specifically, for example, when the handle member 310 is formed of a combination of a plurality of members, for example, during clinical practice, liquids such as blood and physiological saline enter the inside of the handle main body 31 from a joint portion between the members. May adversely affect its internal structure. In such a case, the reliability of the product is reduced.

As described above, in the present embodiment, since the transparent region At is provided in a region corresponding to at least a part of the moving mechanism (

wire fixing members

312a and 312b) in the handle main body 31, the vicinity of the distal end of the sheath tube 2 is provided. The bending state can be confirmed on the operator's hand side (handle body 31). Therefore, it is possible to improve convenience when using the sheath introducer 1.

Further, as described above, the sheath tube 31 is also rotated when the handle body 31 is rotated around the axis (within the XY plane) to freely set the direction of the bending direction (rotation direction) near the distal end of the sheath tube 2. The rotation direction can be confirmed on the operator's hand side while 2 is inserted into the patient's body. Specifically, such a rotation direction can be confirmed by the orientation of the moving mechanism (

wire fixing members

312a and 312b) in the handle main body 31. Therefore, the convenience at the time of using the sheath introducer 1 also in this respect can be improved. Assuming that the handle main body 31 is not provided with any transparent region At (the entire handle main body 31 is non-transparent), the handle main body 31 is cylindrical in the present embodiment. The following disadvantages occur. That is, in this case, even if the handle body 31 is visually recognized from the outside, the operator cannot grasp how much the handle body 31 is rotated (by how much angle). In addition, the direction (rotation direction) of the above-described bending direction cannot be understood. For this reason, it can be said that it is useful to provide the transparent region At in the handle body 31 as in the present embodiment.

<Modification>
Subsequently, modified examples (modified examples 1 to 3) of the present invention will be described. In addition, the same code | symbol is attached | subjected to the same component as the said embodiment, and description is abbreviate | omitted suitably.

[Modification 1]
FIG. 5 schematically illustrates a schematic configuration example of a sheath introducer 1A as a medical device according to the first modification. Specifically, FIG. 5 schematically shows a side surface configuration example (ZX side surface configuration example) of the sheath introducer 1A. Also in FIG. 5, in the same manner as in FIG. 1 described above, in the portion indicated by reference numeral P1 (the portion surrounded by the broken line), the vicinity of the portion indicated by the broken arrow (rotating mechanism 311 and

wire fixing members

312a, 312b, etc.) The enlarged view of FIG.

Similar to the sheath introducer 1 of the embodiment, the sheath introducer 1A of the modification 1 is a device that assists the insertion of the catheter tube 6 by introducing the sheath tube 2 into the body prior to the catheter tube 6. It is. As shown in FIG. 5, the sheath introducer 1 A includes a sheath tube 2 and a handle 3 A attached to the proximal end side of the sheath tube 2. That is, the sheath introducer 1A corresponds to the sheath introducer 1 in which the handle 3A is provided instead of the handle 3, and other configurations are basically the same.

The handle 3A has a handle main body 31A and a rotation operation section 32 as shown in FIG. That is, the handle 3A corresponds to the handle 3 in which the handle body 31A (handle member 310A) is provided instead of the handle body 31 (handle member 310), and other configurations are basically the same. Yes.

In the handle main body 31A, as shown in FIG. 5, unlike the handle main body 31 (the entire area of the surface thereof is a transparent area At), only a part of the surface of the handle main body 31A has a transparent area At. It has become. Specifically, in this example, in the handle main body 31A, the transparent region At is provided only in a region corresponding to a part of the

wire fixing members

312a and 312b (movement mechanism). More specifically, as shown in FIG. 5, in this example, the handle main body 31 A (in order that the regions facing the protruding portions Ea and Eb in the

wire fixing members

312 a and 312 b can be selectively visually recognized from the outside. The transparent region At is formed in a rectangular shape having a long axis along the axial direction (Z-axis direction) of the handle member 310A). This is because it is possible to grasp the movement state of the

wire fixing members

312a and 312b if only these overhang portions Ea and Eb are visible from the outside through the transparent region At.

Also in this modified example having such a configuration, basically the same effect can be obtained by the same operation as in the above embodiment.

In particular, in the present modification, as described above, only a part of the surface of the handle main body 31A (an area corresponding to a part of the

wire fixing members

312a and 312b) is the transparent area At. The following effects can also be obtained. That is, a non-transparent area (an area other than the transparent area At) that cannot be visually recognized from the outside is provided in the handle body 31A. It is also possible to realize a structure that is appropriately hidden so that it cannot be visually recognized.

Note that the position, size, shape, number, etc., of the partial transparent region At in the handle main body 31A are not limited to the example shown in FIG. It is possible to set.

[Modification 2]
(Constitution)
FIG. 6 schematically illustrates a schematic configuration example of the electrode catheter 5 as a medical device according to the second modification. Specifically, FIG. 6 schematically shows a side configuration example (ZX side configuration example) of the electrode catheter 5. 6, as in FIGS. 1 and 5 described above, in the portion indicated by reference numeral P 1 (the portion surrounded by the broken line), the vicinity of the portion indicated by the broken arrow (the rotating mechanism 311 and the wire fixing member 312 a, The enlarged view of 312b etc. is also shown.

The electrode catheter 5 is inserted into the body (for example, the inside of the heart) through a blood vessel, and is used for arrhythmia examination or treatment. The electrode catheter 5 includes a catheter tube 6 (catheter shaft) as a catheter main body (long portion) and a handle 3 attached to the proximal end side of the catheter tube 6. The configuration of the handle 3 is basically the same as that of the handle 3 described in the embodiment.

Like the sheath tube 2, the catheter tube 6 has a flexible tubular structure (hollow tube-like member) and has a shape extending along its own axial direction (Z-axis direction). Further, as in the case of the sheath tube 2, the distal ends of the pair of

operation wires

41a and 41b described above are fixed to the distal end side of the catheter tube 6. And each base end side of these

operation wires

41a and 41b is also extended from the inside of the catheter tube 6 into the handle 3 (the

fasteners

42a and 42b in the

wire fixing members

312a and 312b) as in the case of the sheath tube 2. It has become so. Such a catheter tube 6 is made of, for example, the same material (synthetic resin or the like) as the sheath tube 2.

The catheter tube 6 is also formed with a so-called single lumen structure in which one lumen (pore, through-hole) is formed so as to extend along the axial direction of the catheter tube 6 or a plurality of (for example, four) lumens. So-called multi-lumen structure. In addition, in the inside of the catheter tube 6, both the area | region which consists of a single lumen structure, and the area | region which consists of a multi-lumen structure may be provided. Various lumens (the pair of

operation wires

41a and 41b described above, conductive wires (not shown) and the like) are inserted into the lumen of the catheter tube 6 in a state where they are electrically insulated from each other.

In the vicinity of the distal end of the catheter tube 6, a plurality of electrodes (here, three ring electrodes 61 and one distal electrode 62) are arranged at a predetermined interval. Specifically, the ring electrode 61 is fixedly disposed on the outer peripheral surface of the catheter tube 6, while the tip electrode 62 is fixedly disposed at the forefront of the catheter tube 6. These electrodes are electrically connected to the inside of the handle 3 through a plurality of conductive wires (not shown) inserted into the lumen of the catheter tube 6 described above. Such a conductive wire is made of a metal material such as copper and covered with an insulating resin, and has a diameter of about 50 to 200 μm (for example, 100 μm).

Each of the ring electrode 61 and the tip electrode 62 is made of a metal material having good electrical conductivity, such as aluminum (Al), copper (Cu), SUS, gold (Au), platinum (Pt). ing. In addition, in order to make the contrast property with respect to X-rays favorable at the time of use of the electrode catheter 5, it is preferable to be comprised with platinum or its alloy. Further, the outer diameters of the ring-shaped electrode 61 and the tip electrode 62 are not particularly limited, but it is desirable to be approximately the same as the outer diameter of the catheter tube 6 described above.

(Action / Effect)
In this electrode catheter 5, the catheter tube 6 is inserted into the patient's body through the blood vessel when examining or treating arrhythmia or the like. At this time, the shape of the vicinity of the distal end of the catheter tube 6 inserted into the body changes in both directions according to the rotation operation on the rotation operation unit 32 by the operator.

Specifically, when the operator grasps the handle body 31 and rotates the rotation operation unit 32 with a finger, for example, the rotation operation unit 32 is moved in the direction of the arrow d1a in FIG. 6 (in the positive direction of the Z axis). When it is rotated clockwise (as viewed along), it will be as follows. That is, as shown in FIG. 6, the

wire fixing members

312a and 312b move in the handle body 31 in the extending direction (Z) as the rotation mechanism 311 rotates in conjunction with the rotation operation. Axial direction) (see arrows d3a and d3b). Particularly in this case, the wire fixing member 312b moves to the proximal end side in the handle main body 31 (see arrow d3b). Then, inside the catheter tube 6 and the handle main body 31, the operation wire 41b is pulled to the proximal end side (the fastener 42b side) (see the arrow d4b), and as a result, the vicinity of the distal end of the catheter tube 6 is illustrated in FIG. 6 bends (bends) along the direction indicated by the arrow d2a in FIG.

Further, when the operator rotates the rotation operation unit 32, for example, the rotation operation unit 32 is rotated in the direction of the arrow d1b in FIG. 6 (counterclockwise when viewed along the positive direction of the Z axis). When rotated, it becomes as follows. That is, as shown in FIG. 6, the

wire fixing members

312a and 312b move in the handle body 31 in the extending direction (Z) as the rotation mechanism 311 rotates in conjunction with the rotation operation. Axial direction) (see arrows d3a and d3b). Particularly in this case, the wire fixing member 312a moves to the proximal end side in the handle main body 31 (see arrow d3a). Then, inside the catheter tube 6 and the handle main body 31, the operation wire 41a is pulled to the proximal end side (the fastener 42a side) (see arrow d4a), and as a result, the vicinity of the distal end of the catheter tube 6 is shown in FIG. Curved along the direction indicated by the arrow d2b in FIG.

Thus, the operator can perform the swing deflection operation of the catheter tube 6 by rotating the rotation operation unit 32. By rotating the handle body 31 around the axis (in the XY plane), the direction of the bending direction near the distal end of the catheter tube 6 can be freely set while the catheter tube 6 is inserted into the patient's body. can do.

Here, for example, when used for examination of arrhythmia or the like, the cardiac potential is measured using the electrode (tip electrode 62 or ring electrode 61) of the catheter tube 6 inserted into the patient's body. Then, based on the information on the electrocardiogram, an examination regarding the presence and degree of arrhythmia or the like at the examination site is performed.

On the other hand, when used for the treatment of arrhythmia, for example, a high frequency (RF) between a counter electrode (not shown) mounted on the patient's body surface and the electrode of the electrode catheter 5 inserted in the patient's body. Radio (Frequency) is energized. By such high-frequency energization, a site to be treated (blood vessel or the like) is selectively cauterized (ablated), and percutaneous treatment such as arrhythmia is performed.

Also in this modification, it is basically possible to obtain the same effect by the same operation as in the above embodiment. Specifically, since the handle 3 having the same configuration as that of the above-described embodiment is also provided in the electrode catheter 5 of this modification, the bending state near the distal end of the catheter tube 6 is changed to the operator's hand side ( This can be confirmed with the handle body 31). Therefore, the convenience when using the electrode catheter 5 can be improved.

Note that the handle 3A described in Modification 1 may be applied to the electrode catheter 5 of this modification instead of the handle 3 of the embodiment.

[Modification 3]
(Constitution)
FIG. 7 schematically illustrates a schematic configuration example of an electrode catheter 5A as a medical device according to the third modification. Specifically, FIG. 7 schematically illustrates a perspective configuration example of the electrode catheter 5A.

The electrode catheter 5A is inserted into the body (for example, the inside of the heart) through a blood vessel, and is used for arrhythmia examination or treatment. The electrode catheter 5A includes a catheter tube 6A and a handle 3 attached to the proximal end side of the catheter tube 6A. The configuration of the handle 3 is basically the same as that of the handle 3 described in the embodiment.

As shown in FIG. 7, the catheter tube 6A has a long catheter body 60a and a catheter tip 60b connected to the tip of the catheter body 60a.

The catheter body 60a basically has the same configuration as the catheter tube 6 described in the second modification. That is, the catheter main body 60a is formed of a flexible tubular structure (hollow tubular member) and has a shape that extends along its own axial direction (Z-axis direction). However, both the ring-shaped electrode 61 and the tip electrode 62 are provided on the catheter tip portion 60b described below.

The catheter distal end portion 60b is connected to the distal end side of the catheter main body 60a as described above, and has a loop-shaped portion formed so as to form a substantially circular shape as shown in FIG. Further, the catheter distal end portion 60b has a flexible tubular structure having a lumen communicating with one or a plurality of lumens in the catheter body 60a.

As shown in FIG. 7, the catheter tip 60b has a loop-shaped portion that forms a loop surface (virtual surface) that is not parallel to the extending direction (axial direction: Z-axis direction in this example) of the catheter body 60a. Have. Specifically, in this example, the loop surface is substantially orthogonal (for example, orthogonal) to the extending direction of the catheter body 60a.

In this example, the loop portion has a substantially circular shape (substantially circular shape) having a predetermined loop diameter. Specifically, in this example, as shown in FIG. 7, in this example, the loop-shaped portion is counterclockwise (counterclockwise) when viewed along the positive direction of the Z axis. It is wound so as to be clockwise (clockwise) when viewed along the negative direction of the Z-axis.

However, strictly speaking, this loop-shaped portion is not a flat circular closed loop, but, for example, as shown in FIG. It has become. That is, in the present specification, the term “circular shape” or “elliptical shape” includes strictly a spiral shape.

Such a catheter tip portion 60b is constituted by the insulating tube as the flexible tubular structure described above. Such an insulating tube is made of a bio-acceptable resin material such as polyurethane or PEBAX (polyether block amide). The outer diameter of the catheter tip 60b is about 0.6 to 2.0 mm (eg, 1.3 mm), and the loop diameter is about 10 to 35 mm (eg, 20 mm).

Further, as shown in FIG. 7, a plurality of electrodes (in this example, six ring-shaped electrodes 61 and one tip electrode 62) are arranged on the catheter tip portion 60b at a predetermined interval. Yes. Specifically, the ring-shaped electrode 61 is fixedly disposed on the outer peripheral surface of the catheter distal end portion 60b, while the distal electrode 62 is fixedly disposed at the most distal end of the catheter distal end portion 60b. Note that the number of the ring-shaped electrodes 61 in the present modification is not limited to the number (six) given in this example.

A core wire (not shown) having a shape memory characteristic is inserted into the catheter distal end portion 60b. Specifically, a core wire (loop core) storing the shape of the loop portion (loop shape) is inserted from the vicinity of the distal end in the catheter main body 60a to the catheter distal end portion 60b. The core wire having such a shape memory characteristic is easily deformed (for example, linearly deformed) when an external force is applied. However, when the force is removed, the core wire returns to the original shape (loop shape). ing. The core wire is made of a shape memory alloy such as a Ni—Ti alloy.

In addition, an operation wire (a diameter-changing wire) (not shown) is further inserted into the catheter distal end portion 60b. This operation wire is used for an operation (rotation operation to the rotation operation unit 32) for changing (for example, reducing) the loop diameter of the loop-shaped portion in the catheter distal end portion 60b, and from inside the catheter distal end portion 60b. It is inserted into the handle 3 through the catheter body 60a. In addition, the distal end of the operation wire is fixed near the distal end of the catheter distal end portion 60b, while the proximal end of the operation wire is extended from the catheter body 60a into the handle 3 and into the handle 3 (described above). It is fixed on the

wire fixing members

312a and 312b). Such an operation wire is made of a material such as stainless steel, nickel alloy, iron alloy, or carbon fiber. The outer diameter of the operation wire is about 0.1 to 0.3 mm (for example, 0.2 mm).

(Action / Effect)
In the electrode catheter 5A of this modification, the catheter tube 6A (the catheter body 60a and the catheter tip portion 60b) is inserted into the patient's body through the blood vessel when examining or treating arrhythmia or the like. At this time, the shape of the vicinity of the distal end of the catheter tube 6A inserted into the body changes according to the rotation operation on the rotation operation unit 32 by the operator.

Specifically, in this electrode catheter 5A, for example, by performing a rotation operation on the rotation operation unit 32 (see arrow d1 in FIG. 7), the above-described operation wire (diameter changing wire) is used, An operation (a diameter changing operation) for changing the loop diameter of the loop-shaped portion in the catheter distal end portion 60b can be performed (see an arrow d5 in FIG. 7). Specifically, for example, when the rotation operation unit 32 is rotated, the operation wire is pulled toward the base end side, so that the loop diameter is changed in a decreasing direction. Further, by subsequently returning the rotation operation unit 32 to the original position (initial position) (rotating in the reverse direction), the pulling operation with respect to the operation wire is also released, and the loop diameter is changed in an increasing direction to be initialized. Will return to the value.

As described above, when the operator rotates the rotation operation unit 32, an operation of changing the loop diameter of the loop-shaped portion in the catheter distal end portion 60b can be performed. Also in this modification, by rotating the handle body 31 around the axis (within the XY plane), the loop portion of the catheter distal end portion 60b remains in a state where the catheter tube 6A is inserted into the patient's body. The direction can be set freely.

Here, when used for the treatment of arrhythmia, for example, high-frequency energization is performed between a counter electrode (not shown) mounted on the patient's body surface and the electrode of the electrode catheter 5A inserted in the patient's body. Made. By such high-frequency energization, a site to be treated (blood vessel or the like) is selectively cauterized, and percutaneous treatment such as arrhythmia is performed.

On the other hand, when used for examination of arrhythmia, for example, the cardiac potential is measured using the electrodes (tip electrode 62 and ring electrode 61) of the catheter tube 6A inserted into the patient's body. Then, based on the information on the electrocardiogram, an examination regarding the presence and degree of arrhythmia or the like at the examination site is performed. At this time, in the electrode catheter 5A of the present modified example, the catheter distal end portion 60b having a plurality of ring-shaped electrodes 61 and distal end electrodes 62 is formed in a loop shape, for example, an inner peripheral portion of a blood vessel (pulmonary vein etc.) In this case, the potentials at a plurality of locations along the circumferential direction can be measured collectively (simultaneously). In particular, in the catheter tip 60b, as described above, the loop diameter of the loop-shaped portion can be changed. For example, variations in the inner diameter of blood vessels (pulmonary veins, etc.) between patients (individual differences) ) And changes in the inner diameter of the blood vessel according to the measurement site, etc., can be appropriately handled.

Also in this modification, it is basically possible to obtain the same effect by the same operation as in the above embodiment. Specifically, in the electrode catheter 5A of the present modification, the handle 3 having the same configuration as that of the above embodiment is provided, so that the deformed state in the vicinity of the distal end of the catheter tube 6A (the loop-shaped portion in the catheter distal end portion 60b) Can be confirmed on the operator's hand side (handle body 31). Therefore, it is possible to improve the convenience when using the electrode catheter 5A.

Note that the handle 3A described in Modification 1 may be applied to the electrode catheter 5A of this modification instead of the handle 3 of the embodiment.

<Other variations>
While the present invention has been described with reference to the embodiments and modifications, the present invention is not limited to these embodiments and the like, and various modifications can be made.

For example, the configuration (shape, arrangement position, number, material, etc.) of each member described in the above embodiments is not limited, and other shapes, arrangement positions, number, material, etc. may be used. Specifically, for example, the configuration (shape, arrangement position, number, material, etc.) of the handle main body, the rotation operation unit, the wire fixing member (movement mechanism) and the like are not limited to those described in the above embodiments. Other configurations may be used.

In the above embodiment, the configuration of the tubular members (the sheath tube 2 and the

catheter tubes

6 and 6A) has been specifically described. However, it is not always necessary to include all the members, and other members may be used. Furthermore, you may provide. Specifically, for example, a leaf spring that can be deformed in the bending direction may be provided as a swing member inside the

catheter tubes

6 and 6A. In addition, the configuration of the electrodes in the

catheter tubes

6 and 6A (the arrangement, shape, number, and the like of the ring-shaped electrode 61 and the tip electrode 62) is not limited to those described in the above embodiments. Furthermore, for example, the loop surface formed by the loop-shaped portion of the catheter distal end portion 60b of the catheter tube 6A may be non-parallel other than perpendicular to the extending direction of the catheter body 60a. Further, for example, the shape of the loop portion (loop shape) may be a substantially elliptical shape instead of the substantially circular shape described in the third modification. In addition, unlike the example described in the third modification, for example, by rotating the rotation operation unit 32 in the reverse direction, the loop diameter of the loop-shaped portion is changed in a direction to be expanded from the initial value. May be.

Furthermore, in the above-described embodiment and the like, the configuration of the handle (the handle body and the rotation operation unit) has been specifically described, but it is not always necessary to include all the members, and further includes other members. May be.

In addition, the shape of the shape near the tip of the tubular member (sheath tube 2 or catheter tube 6) is not limited to that described in the above embodiment. Specifically, in the above-described embodiment and the like, a medical device of a type (bi-direction type) in which the shape near the tip of the tubular member changes in both directions according to the rotation operation to the rotation operation unit will be described as an example. However, it is not limited to this. That is, the present invention can be applied to, for example, a medical device of a type (single direction type) in which the shape near the tip of the tubular member changes in one direction according to the rotation operation to the rotation operation unit. is there. In this case, only one (one) operation wire, fastener, wire fixing member and the like are provided.

The electrode catheter as a specific example of the medical device according to the present invention is any of an electrode catheter for testing arrhythmia (so-called EP catheter) and an electrode catheter for treating arrhythmia (so-called ablation catheter). It is possible to apply.

Furthermore, in the above-described embodiments and the like, the sheath introducer and the electrode catheter have been described as specific examples of the medical device according to the present invention, but the present invention is not limited thereto. That is, the medical device handle according to the present invention can be applied to other medical devices such as a guide catheter (guiding catheter), an angiographic catheter, and a microcatheter.

Claims

A handle attached to the proximal end of a flexible tubular member,
The handle body,
A rotation operation unit that is attached to the handle body so as to be rotatable about the extending direction of the handle body as a rotation axis, and is used in a rotation operation for deforming a shape near the tip of the tubular member;
A movement mechanism that moves in the handle body in conjunction with the rotation operation on the rotation operation unit,
The handle body has a transparent region in a region corresponding to at least a part of the moving mechanism.
A rotation mechanism configured to rotate about the extending direction as a rotation axis in conjunction with the rotation operation, further comprising a rotation mechanism having a portion disposed in the handle body;
One or a plurality of wire fixing members configured to be fixed to the base ends of one or a plurality of operation wires for deforming the shape in the vicinity of the tip of the tubular member and to engage with the rotation mechanism The medical device handle according to claim 1, wherein the handle is provided as the moving mechanism.
The operation wire and the wire fixing member are provided in pairs,
Of the pair of operation wires and the pair of wire fixing members,
The proximal end of one operation wire is fixed to one wire fixing member,
The proximal end of the other operation wire is fixed to the other wire fixing member,
The medical device handle according to claim 2, wherein the one wire fixing member and the other wire fixing member move in opposite directions along the extending direction in conjunction with a rotation operation in the rotation mechanism. .
The rotation mechanism is
A first recess extending in a left spiral shape along the extending direction;
A second recess extending in a right spiral shape along the extending direction,
The one wire fixing member is selectively engaged with the first recess of the first and second recesses,
The medical device handle according to claim 3, wherein the other wire fixing member is selectively engaged with the second recess of the first and second recesses.
The medical device handle according to any one of claims 1 to 4, wherein an entire area of the surface of the handle body is the transparent area.
A tubular member having flexibility;
A handle mounted on the proximal end side of the tubular member,
The handle is
The handle body,
A rotation operation unit that is attached to the handle body so as to be rotatable about the extending direction of the handle body as a rotation axis, and is used in a rotation operation for deforming a shape near the tip of the tubular member;
A movement mechanism that moves in the handle body in conjunction with the rotation operation on the rotation operation unit,
The handle main body has a transparent region in a region corresponding to at least a part of the moving mechanism.