JP6482337B2 - Medical device handle and medical device - Google Patents

Description

  The present invention relates to medical devices such as electrode catheters and sheath introducers used for, for example, arrhythmia examination (diagnosis) and treatment, and a medical device handle applied to such medical devices.

  An electrode catheter is inserted into a body (for example, the inside of a heart) through a blood vessel, and is used for arrhythmia examination or 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.

JP-T 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 problems may occur in the case described above. That is, the deformed state near the tip of the tubular member cannot be confirmed (understood) on the operator's hand side, and convenience may be impaired.

  The present invention has been made in view of such problems, and an object thereof is to provide a medical device handle and a medical device that can improve convenience.

A handle for a medical device according to the present invention is a handle attached to a proximal end side of a flexible tubular member, and the handle main body and an extension direction of the handle main body with respect to the handle main body as a rotation axis . A rotation operation unit that is attached to the handle main body so as to be rotatable and that is used in a rotation operation for deforming the shape near the tip of the tubular member is provided. The handle body is held on the surface of the slide mechanism that slides along the extending direction in the handle body in conjunction with the rotation operation on the rotation operation unit, and is interlocked with the rotation operation. Thus, it has a marker that moves along the extending direction, and one or a plurality of openings for exposing the marker to the outside. Further, the proximal end of at least one operation wire for deforming the shape near the distal end of the tubular member in accordance with the rotation operation is fixed to the slide mechanism.

  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.

In the medical device handle and the medical device of the present invention, the handle body is provided with a marker that operates in conjunction with a rotation operation on the rotation operation unit (an operation for deforming the shape near the tip of the tubular member). Thereby, for example, even when the distal end side of the tubular member is inserted into the patient's body, the deformation state near the distal end of the tubular member is confirmed on the operator's hand side (handle body) ( Grasp). In addition, the slide mechanism and the one or more openings are respectively provided in the handle body, and a proximal end of the at least one operation wire is fixed to the slide mechanism. It becomes as follows. That is, since the marker moves along the extending direction in conjunction with the rotation operation, it becomes easy to intuitively grasp the deformation state near the tip of the tubular member, and further improvement of convenience is achieved. Is planned. 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 the medical device handle and the medical device of the present invention, of the pair of operation wires as the at least one operation wire, the proximal end of one operation wire is connected to the inside of the handle body from the inside of the tubular member. Via a detour that passes through the base end side, the base is fixed to the slide mechanism, and the base end of the other operation wire goes straight from the inside of the tubular member to the slide mechanism in the handle body. It may be fixed to the slide mechanism. In such a configuration, when the rotation operation in the first direction is performed on the rotation operation unit, the one operation wire is pulled toward the proximal end side, thereby the tubular member. The vicinity of the distal end of the handle deforms in the first deformation direction, and the marker moves toward the distal end side of the handle body. In addition, when the rotation operation is performed on the rotation operation unit in the second direction which is the reverse direction of the first direction, the other operation wire is pulled to the proximal end side. As a result, the vicinity of the distal end of the tubular member is deformed in a second deformation direction different from the first deformation direction, and the marker is moved to the proximal end side of the handle body.

  In this case, the opening may have a shape showing at least one of the deformation direction and the deformation amount in the vicinity of the tip of the tubular member. In this case, using the shape of the opening, at least one of the deformation direction and the deformation amount can be intuitively grasped, and the convenience is further improved.

  In the medical device handle and the medical device of the present invention, the marker may be disposed in a region near the rotation operation portion in the handle body. In this case, the marker is arranged avoiding the part (grip part) gripped by the operator, and the possibility that the marker is hidden by the hand when the operator is holding the handle body is avoided. . Therefore, it becomes possible to confirm the deformation state while grasping the grip portion, and the convenience is further improved.

  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, since the handle body is provided with the marker that is linked to the rotation operation with respect to the rotation operation unit, the deformed state near the tip of the tubular member is changed to the operator's hand side. Can be confirmed. 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 perspective view schematically illustrating a detailed configuration example of the handle illustrated in FIG. 1. FIG. 3 is a schematic perspective view illustrating an arrangement example of operation wires and the like in the handle illustrated in FIG. 2. 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 FIGS. 10 is a schematic diagram illustrating a schematic configuration example of a sheath introducer as a medical device according to Modification 1. FIG. 12 is a schematic diagram illustrating a schematic configuration example of a sheath introducer as a medical device according to Modification 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. 10 is a schematic diagram illustrating a schematic configuration example of an electrode catheter as a medical device according to Modification Example 4. 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 the marker is arranged near the rotation operation portion of the handle body)
Modification 2 (example in which the opening for exposing the marker has a shape indicating the bending direction and the bending amount)
Modification 3 (Example 1 when the medical device is an electrode catheter: Example of bending)
Modification 4 (Example 2 when the medical device is an electrode catheter: Example in which the loop diameter changes)
3. Other variations

<Embodiment>
[Constitution]
FIG. 1A and FIG. 1B each schematically show a schematic configuration example of a sheath introducer 1 as a medical device according to an embodiment of the present invention. Specifically, FIG. 1A schematically illustrates an upper surface configuration example (ZX upper surface configuration example) of the sheath introducer 1, and FIG. 1B illustrates the sheath introducer 1. A cross-sectional configuration example (YZ cross-sectional configuration example) is schematically shown. In FIG. 1A, an enlarged view of a portion indicated by reference numeral P1 (a portion surrounded by a circular broken line) is also shown.

  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.

  A catheter tube 6 can be inserted into the sheath tube 2 as shown in FIG. 1A, for example. 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 a slide mechanism 314 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).

  Note that a plurality of electrodes (here, three ring-shaped electrodes 61 and one tip electrode 62) are provided at predetermined intervals near the tip of the catheter tube 6, for example, as shown in FIG. Has been placed. 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 FIGS. 1 (A) and 1 (B), the handle 3 has a handle body 31 attached to the proximal end side of the sheath tube 2 and a rotation operation portion (pick, dial) 32. doing. 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 and FIG. 3 in addition to FIG. 1, a detailed configuration example of such a handle 3 will be described. FIG. 2 is a schematic exploded perspective view of a detailed configuration example of the handle 3. FIG. 3 is a perspective view schematically showing an arrangement example of the operation wires 41a and 41b and the like in the handle 3 shown in FIG. In FIG. 2, an enlarged view of a portion indicated by reference numeral P <b> 2 (portion surrounded by a circular broken line) is also shown.

(B-1. Rotation operation unit 32)
As shown in FIGS. 1 (A), 1 (B), 2 and 3, the rotation operation unit 32 is rotatable about the extending direction (longitudinal direction; Z-axis direction) of the handle body 31 as a rotation axis. The handle body 31 is attached to the distal end side. Specifically, as indicated by the arrow d1 in FIG. 1A and FIG. 2 and the arrows d1a and d1b in FIG. 3, the rotation operation unit 32 is around the rotation axis in the XY plane. It is free to rotate. In this example, the rotation operation unit 32 is configured to be able to rotate the XY plane in both directions (right rotation and left rotation). 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 ring shape extending in the Z-axis direction. Moreover, the rotation operation part 32 is comprised by synthetic resins, such as a polycarbonate, an acrylonitrile butadiene styrene copolymer (ABS), an acryl, polyolefin, polyoxymethylene, for example.

(B-2. Handle body 31)
As shown in FIGS. 1A and 1B, the handle main body 31 corresponds to a portion (gripping portion) that is actually gripped by the operator, and in this example, a cylinder extending along the Z-axis direction. It has become a shape. 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. 1A, 1B, 2 and 3, the handle body 31 includes a pair of handle members 310a and 310b, one opening 311 and a plurality (7 in this example). ) Scale 312, marker (index part) 313, slide mechanism 314, and fixing member 315. Each member (handle members 310a and 310b, slide mechanism 314, fixing member 315, etc.) in the handle main body 31 is made of, for example, the same material (synthetic resin, etc.) as that of the rotation operation unit 32 described above. Yes.

  The handle members 310a and 310b function as exterior members of the handle main body 31, respectively. Specifically, as shown in FIGS. 1B, 2 and 3, a marker 313, a slide mechanism 314, a fixing member 315 and the like are accommodated inside the handle members 310a and 310b. Yes. Each of these handle members 310a and 310b has a substantially bowl-like shape that fits each other. In this example, the handle member 310a is arranged in the positive direction of the Z axis, and the handle member 310b is arranged in the negative direction of the Z axis. ing.

  The fixing member 315 is a member for fixing the proximal end of the sheath tube 2 to the handle main body 31 as shown in FIG. 1B, for example. In this example, the fixing member 315 is provided in a region near the base end of the handle member 310b.

  As shown in FIG. 1B, FIG. 2 and FIG. 3, the slide mechanism 314 is operated in conjunction with the rotation operation (rotation operation in the XY plane) to the rotation operation unit 32 described above. It is configured to slide (move) along the extending direction (Z-axis direction) in the interior 31. Specifically, as shown by an arrow d3 in FIGS. 2 and 3, this slide mechanism 314 is also linked to the handle main body 31 in conjunction with a bidirectional rotation operation (see arrow d1) with respect to the rotation operation unit 32. It is configured to be slidable in both directions along the extending direction. More specifically, in this example, as shown in FIG. 3, when the rotation operation unit 32 is rotated clockwise (clockwise) when viewed along the positive direction of the Z axis (arrow d1a). The slide mechanism 314 slides in the handle main body 31 to the tip side (see arrow d3a). Conversely, when the rotation operation unit 32 is rotated counterclockwise (counterclockwise) when viewed along the positive direction of the Z-axis (see arrow d1b), the slide mechanism 314 is moved inside the handle body 31. Is slid to the base end side (see arrow d3b).

  In this example, the slide mechanism 314 has a spiral structure extending along the Z-axis direction as shown in FIG. And the groove part (concave part) in the spiral structure in this slide mechanism 314, and the protrusion part (convex part) in the part extended toward the handle body 31 from the inner peripheral part in the rotation operation part 32, They are engaged with each other (see FIG. 1B). As shown in FIG. 1B, a predetermined space (empty space) is secured between the tip of the slide mechanism 314 and the inside of the rotation operation unit 32. Since the slide mechanism 314 and the rotation operation unit 32 are engaged inside the handle main body 31 in this way, the slide mechanism 314 is interlocked with the rotation operation to the rotation operation unit 32 as described above. The slide operation is realized. The length of the slide mechanism 314 in the extending direction is, for example, about 30 to 100 mm (preferably about 50 mm). The outer diameter of the slide mechanism 314 is, for example, about 5 to 20 mm (preferably about 10 mm).

  As shown in FIG. 1A and FIG. 2, the marker 313 is provided on the surface of the slide mechanism 314 (the surface on the handle member 310a side). Specifically, in this example, the marker 313 is held on the surface of the protruding portion (marker holding portion 314a) toward the handle member 310a provided on the proximal end side of the slide mechanism 314. In this example, the marker 313 is configured using a triangular figure. However, the configuration (shape and the like) of the marker 313 is not limited to that shown in FIG. 1A and FIG. In addition, the magnitude | size (length of one side) of such a marker 313 is about 3-10 mm (preferably about 5 mm), for example.

  Here, as described above, since the slide mechanism 314 is configured to be interlocked with the rotation operation to the rotation operation unit 32, the marker 313 held on the surface of the slide mechanism 314 also has such a structure. It is linked to the rotation operation. Specifically, as shown by an arrow P3 in FIG. 1A and FIG. 2, the marker 313 is linked to the inside of the handle body 31 along the extending direction in conjunction with such a rotation operation. It slides (moves) in the direction. More specifically, as in the case of the slide mechanism 314 described above, in this example, as shown in FIG. 3, the rotation operation unit 32 rotates clockwise as viewed along the positive direction of the Z axis. When operated (see arrow d1a), the marker 313 is also slid to the front end side in the handle body 31 (see arrow d3a). Conversely, when the rotation operation unit 32 is rotated counterclockwise when viewed along the positive direction of the Z-axis (see arrow d1b), the marker 313 is also moved to the proximal end side in the handle body 31. It slides (see arrow d3b).

  Further, on this slide mechanism 314, a pair of fasteners 42a and 42b are provided in this example as schematically shown in FIG. These fasteners 42a and 42b are members (wire fasteners) for individually fixing the base ends of the pair of operation wires 41a and 41b described above 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.

  Here, specifically, as schematically shown in FIG. 3, the fastener 42 a fixes the base end of the operation wire 41 a extended from the sheath tube 2 into the handle main body 31. Specifically, in this example, the proximal end of the operation wire 41a passes through the detour La passing from the inside of the sheath tube 2 to the proximal end side in the handle main body 31 (in this example, the proximal end side of the fixing member 315). And fixed to the fastener 42a. On the other hand, the fastener 42b fixes the proximal end of the operation wire 41b extended from the sheath tube 2 into the handle main body 31, as schematically shown in FIG. Specifically, in this example, the proximal end of the operation wire 41b is fixed to the fastener 42b by a path (direct path Lb) that goes straight from the sheath tube 2 to the slide mechanism 314 in the handle body 31.

  Each of the 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). ). 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.

  As shown in FIG. 1A, the opening 311 is formed in the handle member 310a and functions as a through hole for exposing the marker 313 on the slide mechanism 314 to the outside. In this example, the opening 311 is formed in a slit shape extending along the extending direction (Z-axis direction) of the handle main body 31. The length of the opening 311 in the extending direction is, for example, about 15 to 50 mm (preferably about 20 mm), and the width of the opening 311 (the length in the X-axis direction) is, for example, About 3 to 10 mm (preferably about 5 mm).

  As shown in FIG. 1A, a plurality of scales 312 (seven in this example) are provided along the extending direction of the opening 311 on the surface of the handle member 310a (the peripheral area of the opening 311). . Specifically, the plurality of scales 312 are arranged side by side along the extending direction of the opening 311 with a predetermined interval (for example, about 2 to 10 mm). As will be described in detail later by arranging a plurality of such scales 312 side by side, the bending state (the bending direction) in the vicinity of the distal end of the sheath tube 2 depending on the relative positional relationship between the marker 313 and the scale 312. And the amount of deflection) are defined. The “deflection state”, “deflection direction”, and “deflection amount” in this specification correspond to specific examples of “deformation state”, “deformation direction”, and “deformation amount” in the present invention, respectively, and so on. It is.

[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 an 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 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. 3 (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. 3, when the slide mechanism 314 slides to the distal end side in the handle body 31 (see arrow d3a), the operation wire 41a is moved inside the sheath tube 2 and the handle body 31. Pulled to the base end side (fastener 42a side) (see arrow d4a). Then, the vicinity of the distal end of the sheath tube 2 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 moved in the direction of the arrow d1b in FIG. 3 (counterclockwise when viewed along the positive direction of the Z axis). When rotated, it becomes as follows. That is, as shown in FIG. 3, when the slide mechanism 314 slides to the proximal end side in the handle main body 31 (see arrow d3b), the operation wire 41b is moved inside the sheath tube 2 and the handle main body 31. It is pulled to the base end side (fastener 42b side) (see arrow d4b). Then, the vicinity of the distal end of the sheath tube 2 is curved along the direction indicated by the arrow d2b in FIG.

  As described above, 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 rotates the sheath tube 2 while performing the rotation operation on the catheter rotation operation portion (arranged in the handle provided on the proximal end side of the catheter tube 6; not shown in FIG. 1A). The catheter tube 6 is moved along the inner hole. As a result, for example, as shown in FIG. 1A, 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 procedure (examination, treatment, etc.) using the catheter 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. 4 schematically shows a configuration of the sheath introducer 101 according to the comparative example in a side view (ZX side view).

  Similar to the sheath introducer 1, 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. As shown in FIG. 4, 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.

  As shown in FIG. 4, the handle 103 has a handle body 102 and a rotation operation unit 32. 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.

  The handle body 102 corresponds to the handle body 31 in which the opening 311, the scale 312, and the marker 313 are not provided (omitted), and other configurations are basically the same. .

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

  However, in the handle 103 according to this comparative example, in such a case, the bending state in the vicinity of the distal end of the sheath tube 2 cannot be confirmed (understood) on the operator's hand side. Convenience in use may be impaired.

(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. 1 (A), 1 (B), 2 and 3. That is, in the handle 3, a marker 313 is provided on the handle 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).

  Thereby, in the handle 3, unlike the handle 103 of the comparative example, for example, even when the distal end side of the sheath tube 2 is inserted into the patient's body, the bent state in the vicinity of the distal end of the sheath tube 2 is It can be confirmed (grown) on the operator's hand side (handle body 31). As a result, the convenience when using the sheath introducer 1 is improved.

  Specifically, first, for example, as shown in FIG. 5A, 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 shown in FIG. 3 described above, the slide mechanism 314 slides to the tip end side in the handle main body 31 (see arrow d3a in FIG. 3). Along with this, the marker 313 held on the slide mechanism 314 also moves to the distal end side of the handle main body 31 (see arrow P3a in FIG. 5A). Since the operation (sliding operation) of the marker 313 in conjunction with such a rotation operation can be visually recognized by the operator through the opening 311, the bent state in the vicinity of the distal end of the sheath tube 2 (see the arrow d <b> 2 a in FIG. 5A). ) Can be confirmed on the handle body 31.

  On the other hand, as shown in FIG. 5B, for example, 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, in this case, as shown in FIG. 3 described above, the slide mechanism 314 slides to the proximal end side within the handle main body 31 (see arrow d3b in FIG. 3). Accordingly, the marker 313 held on the slide mechanism 314 also moves to the proximal end side of the handle main body 31 (see arrow P3b in FIG. 5A). Therefore, in this case as well, as in the case of FIG. 5A described above, the bending state (see the arrow d2b in FIG. 5B) near the distal end of the sheath tube 2 can be confirmed on the handle body 31. .

  In this way, since the marker 313 moves along the extending direction of the handle body 31 in conjunction with the rotation operation to the rotation operation unit 32, it is easy to intuitively grasp the bending state near the distal end of the sheath tube 2. Thus, the convenience can be further improved.

  Further, in the handle 3, since the slide mechanism 314 and the opening 311 having the above-described configuration are provided in the handle body 31, the bent state near the distal end of the sheath tube 2 can be confirmed with a simple structure. (The confirmation function of the bending state can be easily realized). Therefore, it is possible to reduce the manufacturing cost and improve the reliability of the handle 3 (sheath introducer 1).

  Furthermore, since a scale 312 that defines a bending state (a bending direction and a bending amount) in the vicinity of the distal end of the sheath tube 2 is provided around the opening 311, such a bending direction can be obtained using the scale 312. And the amount of deflection can be easily confirmed. Therefore, the convenience can be further improved.

  In addition, of the pair of operation wires 41a and 41b, the proximal end of the operation wire 41b is connected to the slide mechanism 314 (fastener 42b) by a route (direct route Lb) that goes straight from the sheath tube 2 to the slide mechanism 314. ). The proximal end of the operation wire 41a is fixed to the slide mechanism 314 (fastener 42a) via a detour La passing from the sheath tube 2 to the proximal end side in the handle main body 31. Since the base ends of the pair of operation wires 41a and 41b are fixed to the slide mechanism 314 by such paths, a mechanism for bi-directionally bending the vicinity of the distal end of the sheath tube 2 can be realized with a simple structure. The manufacturing cost of the handle 3 (sheath introducer 1) can be reduced and the reliability can be improved.

  As described above, in the present embodiment, since the handle body 31 is provided with the marker 313 that is linked to the rotation operation with respect to the rotation operation unit 32, the bending state in the vicinity of the distal end of the sheath tube 2 is changed to the operator's hand side ( This can be confirmed with the handle body 31). Therefore, it is possible to improve convenience when using the sheath introducer 1.

  In the present embodiment, the case where both the deflection direction and the deflection amount in the vicinity of the distal end of the sheath tube 2 are defined by the scale 312 is described as an example. However, the present invention is not limited to this. Further, only one of the deflection amounts may be defined by the scale 312.

<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 thing as the component in the said embodiment, and description is abbreviate | omitted suitably.

[Modification 1]
FIG. 6 schematically illustrates a schematic configuration example of a sheath introducer 1A as a medical device according to the first modification. Specifically, FIG. 6 schematically shows an upper surface configuration example (ZX upper surface configuration example) of the sheath introducer 1A.

  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. 6, the sheath introducer 1 </ b> A includes a sheath tube 2 and a handle 3 </ b> 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.

  As shown in FIG. 6, the handle 3 </ b> A includes a handle main body 31 </ b> A and a rotation operation unit 32. That is, the handle 3A corresponds to the handle 3 in which the handle body 31A is provided instead of the handle body 31, and the other configurations are basically the same.

  In the handle main body 31A, as shown in FIG. 6, the marker 313, the opening 311 and the plurality of scales 312 are all arranged in a region (near region) near the rotation operation unit 32 in the handle main body 31A. In other words, the marker 313, the opening 311 and the plurality of scales 312 are all arranged in the handle main body 31A while avoiding the operator's gripping region (on the tip side of the gripping region).

  Although not shown in FIG. 6, the arrangement (shape) of the slide mechanism 314 that holds the marker 313 is also changed from the above-described embodiment in accordance with such an arrangement change of the marker 313 and the like. Yes. Specifically, for example, the extension length (length along the Z-axis direction) of the slide mechanism 314 is changed to be shorter than the extension length in the embodiment.

  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, the marker 313 is arranged in the region near the rotation operation unit 32 in the handle main body 31A. Avoiding this, the marker 313 is arranged. This avoids the possibility of the marker 313 being hidden by the hand when the operator is grasping the handle body 31A (a margin area for the grip portion is secured). Therefore, it becomes possible to confirm the bending state of the sheath tube 2 while grasping the grip portion, and it is possible to further improve convenience.

  Note that the arrangement regions such as the marker 313, the opening 311 and the plurality of scales 312 are not limited to those described in the embodiment and the present modification, and may be set to be other arrangement regions. Good.

[Modification 2]
FIG. 7 schematically illustrates a schematic configuration example of a sheath introducer 1B as a medical device according to the second modification. Specifically, FIG. 7 schematically illustrates an upper surface configuration example (ZX upper surface configuration example) of the sheath introducer 1B.

  Similar to the sheath introducer 1 of the embodiment, the sheath introducer 1B of the modification 2 is an apparatus 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. 7, the sheath introducer 1 </ b> B includes a sheath tube 2 and a handle 3 </ b> B attached to the proximal end side of the sheath tube 2. That is, the sheath introducer 1B corresponds to the sheath introducer 1 in which the handle 3B is provided instead of the handle 3, and other configurations are basically the same.

  As shown in FIG. 7, the handle 3 </ b> B includes a handle body 31 </ b> B and a rotation operation unit 32. That is, the handle 3B corresponds to the handle 3 in which the handle body 31B is provided instead of the handle body 31, and the other configurations are basically the same.

  In the handle body 31B, an opening 311B described below is provided on the surface of the handle member 310a in place of the opening 311 and the plurality of scales 312 described in the embodiment. The openings 311B are a plurality (five in this example) of openings 311s, 311a1, 311a2, 311b1, which are arranged side by side along the extending direction (Z-axis direction) of the handle main body 31B at a predetermined interval. 311b2. Specifically, the openings 311a2, 311a1, 311s, 311b1, and 311b2 are arranged in this order from the distal end side to the proximal end side of the handle main body 31B.

  Here, these openings 311 s, 311 a 1, 311 a 2, 311 b 1, 311 b 2 have shapes that indicate the bending state (the bending direction and the bending amount) in the vicinity of the distal end of the sheath tube 2. Specifically, the opening 311 s has a shape (linear shape) indicating (bending amount = 0, bending direction: none). The opening 311a1 has a shape indicating (amount of deflection: small, direction of deflection: right direction (direction of arrow d2a)), and the opening 311a2 indicates (amount of deflection: large, direction of deflection: right direction). It has a shape. Similarly, the opening 311b1 has a shape indicating (deflection amount: small, deflection direction: left direction (direction of arrow d2b)), and the opening 311b2 has (deflection amount: large, deflection direction: left direction). It has the shape shown.

  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 this modification, the opening 311B (openings 311s, 311a1, 311a2, 311b1, 311b2) has a shape indicating the bending state (the bending direction and the bending amount) in the vicinity of the distal end of the sheath tube 2. Therefore, the following effects can also be obtained. That is, using the shapes of the openings 311s, 311a1, 311a2, 311b1, and 311b2 (depending on the relative positional relationship with the marker 313), the bending state (the bending direction and the bending amount) near the distal end of the sheath tube 2 can be changed. , You will be able to grasp intuitively. Therefore, in this modification, it is possible to further improve convenience.

  In the present modification, the case where the opening 311B has a shape indicating both the bending direction and the bending amount near the distal end of the sheath tube 2 has been described as an example, but the present invention is not limited thereto. That is, for example, the opening 311B may have a shape that shows only one of the bending direction and the bending amount. Also, the shape and number of the openings 311s, 311a1, 311a2, 311b1, 311b2, etc. are not limited to the example given in this modification, and may be other shapes and numbers.

  Further, in the present modified example, as in the first modified example, the marker 313, the opening 311B, the slide mechanism 314, and the like may be arranged in an area near the rotation operation unit 32 in the handle main body 31B.

[Modification 3]
(Constitution)
FIG. 8 schematically illustrates a schematic configuration example of the electrode catheter 5 as a medical device according to the third modification. Specifically, FIG. 8 schematically illustrates an upper surface configuration example (ZX upper surface configuration example) of the electrode catheter 5.

  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.

  Similar to the sheath tube 2, the catheter tube 6 has a flexible tubular structure (hollow tubular member) and has a shape that extends 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 slide mechanism 314) as in the case of the sheath tube 2. It has become. 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 addition, a plurality of electrodes (here, three ring-shaped electrodes 61 and one tip electrode 62) are arranged at a predetermined interval near the tip of the catheter tube 6. 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, for example, a metal material such as copper and is 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. 3 (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. 3, when the slide mechanism 314 slides to the distal end side in the handle body 31 (see arrow d3a), the operation wire 41a is moved inside the catheter tube 6 and the handle body 31. Pulled to the base end side (fastener 42a side) (see arrow d4a). Then, the vicinity of the distal end of the catheter tube 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 moved in the direction of the arrow d1b in FIG. 3 (counterclockwise when viewed along the positive direction of the Z axis). When rotated, it becomes as follows. That is, as shown in FIG. 3, when the slide mechanism 314 slides to the proximal end side in the handle body 31 (see arrow d3b), the operation wire 41b is moved inside the catheter tube 6 and the handle body 31. It is pulled to the base end side (fastener 42b side) (see arrow d4b). Then, the vicinity of the distal end of the catheter tube 6 is 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 electrodes (tip electrode 62 and 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 modified example, basically the same effect can be obtained 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.

  In the electrode catheter 5 of this modification, the handles 3A and 3B described in the modifications 1 and 2 may be applied instead of the handle 3 of the embodiment.

[Modification 4]
(Constitution)
FIG. 9 schematically illustrates a schematic configuration example of an electrode catheter 5A as a medical device according to the fourth modification. Specifically, FIG. 9 schematically shows a perspective configuration example of the electrode catheter 5A.

  The electrode catheter 5A is inserted into a 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. 9, the catheter tube 6A has a long catheter body 60a and a catheter distal end portion 60b connected to the distal end side of the catheter body 60a.

  The catheter main body 60a basically has the same configuration as the catheter tube 6 described in the third 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. 9, the catheter tip 60b has a loop-shaped portion that forms a loop surface (virtual surface) that is non-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-shaped portion has a substantially circular shape (substantially circular shape) having a predetermined loop diameter. Specifically, in this example, as shown in FIG. 9, 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 distal end 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. 9, a plurality of electrodes (in this example, six ring electrodes 61 and one tip electrode 62) are arranged at predetermined intervals on the catheter tip portion 60b. Yes. Specifically, the ring-shaped electrode 62 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 forefront 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 shape memory characteristics 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. In addition, this core wire is comprised by shape memory alloys, such as a Ni-Ti alloy, for example.

  In addition, an operation wire (shrink 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 slide mechanism 314). Such an operation wire is made of a material such as stainless steel, nickel alloy, iron alloy, or carbon fiber. Moreover, the outer diameter of this operation wire is about 0.1-0.3 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. 9), the above-described operation wire (contraction wire) is used to make a catheter. An operation (shrinking operation) for changing the loop diameter of the loop-shaped portion at the distal end portion 60b is possible (see arrow d5 in FIG. 9). 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, for example, when used for examination of arrhythmia and the like, the cardiac potential is measured using the electrodes (tip electrode 62 and ring electrode 61) of the catheter tube 6A inserted into the body of the patient. 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. It is possible to measure the potentials at a plurality of locations along the same (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 modified example, basically the same effect can be obtained 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.

  In the electrode catheter 5A of this modification, the handles 3A and 3B described in the modifications 1 and 2 may be applied 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, material, etc.) of each member described in the above embodiments is not limited, and other shapes, arrangement positions, materials, etc. may be used. Specifically, for example, the configuration (shape, arrangement position, material, etc.) of the handle main body, the rotation operation unit, the marker, the opening, the scale, and the slide mechanism are not limited to those described in the above embodiment, etc. 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 fourth modification.

  Further, in the above-described embodiment and the like, the configuration of the handle 3 (the handle body 31 and the rotation operation unit 32) has been specifically described, but it is not always necessary to include all the members, and other members may be used. Furthermore, you may provide. Specifically, for example, the scale 312 may not be provided in some cases.

  In addition, the shape of the shape in the vicinity of the distal end of the tubular member (the sheath tube 2 or the catheter tube 6) is not limited to that described in the above embodiment and the like. 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 32 is taken as an example. Although explained, it is not limited to this. That is, the present invention can also 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 32. is there. In this case, only one (one) operation wire and one fastener are provided.

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

  Furthermore, in the said embodiment etc., although the sheath introducer and the electrode catheter were mentioned and demonstrated as a specific example of the medical device which concerns on this invention, it is not restricted to these. 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.

  DESCRIPTION OF SYMBOLS 1,1A, 1B ... Sheath introducer, 2 ... Sheath tube, 3, 3A, 3B ... Handle, 31, 31A, 31B ... Handle body, 310a, 310b ... Handle member, 311, 311B (311s, 311a1, 311a2, 311b1 311b2) ... Opening, 312 ... Scale, 313 ... Marker, 314 ... Sliding mechanism, 314a ... Marker holding part, 315 ... Fixing member, 32 ... Rotating operation part, 41a, 41b ... Operation wire, 42a, 42b ... Clamp DESCRIPTION OF SYMBOLS 5 ... Electrode catheter, 6 ... Catheter tube, 61 ... Ring electrode, 62 ... Tip electrode, La ... Detour, Lb ... Direct path | route.

Claims (5)

A handle attached to the proximal end of a flexible tubular member,
The handle body,
Rotation that is attached to the handle main body so as to be rotatable with respect to the handle main body with the extending direction of the handle main body as a rotation axis, and is used in a rotation operation for deforming the shape near the tip of the tubular member With an operation unit and
The handle body is
A slide mechanism that slides along the extending direction in the handle body in conjunction with the rotation operation on the rotation operation unit;
A marker that is held on the surface of the slide mechanism and moves along the extending direction in conjunction with the rotation operation;
One or more openings for exposing the marker to the outside;
Have
A handle for a medical device , wherein a proximal end of at least one operation wire for deforming a shape near a distal end of the tubular member in accordance with the rotation operation is fixed to the slide mechanism . Of the pair of operation wires as the at least one operation wire,
The proximal end of one operation wire is fixed to the slide mechanism via a detour passing from the inside of the tubular member to the proximal end side in the handle body, and
The proximal end of the other operation wire is fixed to the slide mechanism by a straight path that goes straight from the inside of the tubular member to the slide mechanism in the handle body.
When the rotation operation in the first direction is performed on the rotation operation portion, the one operation wire is pulled toward the base end side so that the vicinity of the distal end of the tubular member is the first. And the marker moves to the distal end side of the handle body,
When the rotation operation is performed on the rotation operation unit in the second direction which is the reverse direction of the first direction, the other operation wire is pulled to the proximal end side. As a result, the vicinity of the distal end of the tubular member is deformed in a second deformation direction different from the first deformation direction, and the marker is moved to the proximal end side of the handle body.
The medical device handle according to claim 1. The handle for a medical device according to claim 1 or 2 , wherein the opening has a shape indicating at least one of a deformation direction and a deformation amount in the vicinity of a distal end of the tubular member. The medical instrument handle according to any one of claims 1 to 3, wherein the marker is disposed in a region of the handle body close to the rotation operation unit. A tubular member having flexibility;
A handle mounted on the proximal end side of the tubular member,
The handle is
The handle body,
Rotation that is attached to the handle main body so as to be rotatable with respect to the handle main body with the extending direction of the handle main body as a rotation axis, and is used in a rotation operation for deforming the shape near the tip of the tubular member With an operation unit and
The handle body is
A slide mechanism that slides along the extending direction in the handle body in conjunction with the rotation operation on the rotation operation unit;
A marker that is held on the surface of the slide mechanism and moves along the extending direction in conjunction with the rotation operation;
One or more openings for exposing the marker to the outside;
Have
A medical device in which a proximal end of at least one operation wire for deforming a shape near the distal end of the tubular member in accordance with the rotation operation is fixed to the slide mechanism .

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