JP6772095B2 - Medical device handles and medical devices - Google Patents

Description

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

The electrode catheter is inserted into the body (for example, inside the heart) through a blood vessel and is used for examination and treatment of arrhythmia. In such an electrode catheter, generally, 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) arranged outside the body. It changes (deflects, bends, bends) in one direction or both directions depending on the operation of the part.

Further, 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 a blood vessel in advance and plays a role of assisting the insertion of the catheter. 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. The handle of Patent Document 1 is equipped with a rotation operation unit that can rotate around the extending direction (longitudinal direction) of the handle body as a rotation axis. In such a rotation operation portion, the proximal end side of the operation wire for bending the vicinity of the tip of the 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, it is possible to bend the vicinity of the tip of the tubular member.

Japanese Unexamined Patent Publication No. 2014-54513

By the way, in a medical device as described above, for example, it is required to easily realize a rotation operation unit using the operation wire described above to improve convenience. Therefore, it is desirable to provide a handle for a medical device and a medical device that can improve convenience.

The handle for a medical device according to an embodiment of the present invention is a handle attached to the base end side of a flexible tubular member, and is rotatably attached to the handle body and the handle body. It is configured to include a rotating plate, and is provided with a rotation operation unit used in a rotation operation for bending the vicinity of the tip of a tubular member. The rotary plate is configured to be detachable from the main body portion operated during the rotation operation and the main body portion, and is used to bend the vicinity of the tip of the tubular member in response to the rotation operation. Alternatively, it is provided with a mounting member having a guide mechanism for defining a route in a plurality of operating wires. Further, the base end of the operation wire is fixed not to the mounting member side but to the main body portion.

The medical device according to the embodiment of the present invention includes a flexible tubular member and a handle for the medical device according to the embodiment of the present invention, which is attached to the proximal end side of the tubular member. It is equipped with a handle as.

In the medical device handle and the medical device according to the embodiment of the present invention, the rotating plate in the rotating operation unit is operated in the rotation operation of bending the vicinity of the tip of the tubular member, and the main body portion. It is composed of a detachable mounting member. The mounting member is provided with a guide mechanism that defines a path in the operation wire for bending the vicinity of the tip of the tubular member in response to the rotation operation. That is, a guide mechanism for defining the path of the operation wire is provided on the mounting member, which is a separate member that can be attached to and detached from the main body of the rotating plate. As a result, the guide mechanism can be easily formed on the rotating plate, and for example, a plurality of types of mounting members having different shapes of the guide mechanism can be shared with respect to a single main body.

In the medical device handle and the medical device according to the embodiment of the present invention, the mounting member is configured to be detachable along the inward direction of the rotating surface of the rotating plate, and is mounted on the peripheral side surface of the guiding mechanism. Grooves may be formed to define the path. In this case, the attachment / detachment operation of the mounting member becomes easy, and the groove for defining the path can be easily formed on the peripheral side surface of the guide mechanism. Therefore, the convenience can be further improved.

Further, the amount of pulling of the operation wire to the proximal end side during the rotation operation may be defined according to the magnitude of the curvature (radius of curvature) that defines the path in the guide mechanism. Specifically, for example, as the curvature becomes relatively large (the radius of curvature becomes relatively small), the amount of pull-in becomes relatively small and the curvature becomes relatively small. (The radius of curvature may be relatively large), and the amount of pull-in may be relatively large. In this case, the degree of bending (curvature) near the tip of the tubular member with respect to the rotation operation to the rotation operation part (main body part of the rotating plate) is the curvature (radius of curvature) that defines the above path in the guide member. Can be set arbitrarily according to the size of. As a result, the convenience is further improved.

In the medical device handle and the medical device according to the embodiment of the present invention, the operation wire is composed of the first and second operation wires for bidirectionally bending the vicinity of the tip of the tubular member. At the same time, in the guide mechanism, a first curvature (first radius of curvature) that defines the path for the first operating wire and a second curvature that defines the path for the second operating wire. (Second radius of curvature) may be different from each other. In this case, the degree of bending in one direction and the degree of bending in the other direction can be made different from each other in the vicinity of the tip of the tubular member. Further, the ratio of the degree of bending in each direction can be arbitrarily adjusted according to the ratio of the magnitudes of the first curvature (first radius of curvature) and the second curvature (second radius of curvature). Will be. Therefore, the convenience can be further improved.

Further, a plurality of types of mounting members having different path shapes in the guide mechanism may be attached to and detached from the main body. In this case, as described above, as a result of being able to share a plurality of types of mounting members with respect to a single main body, for example, simply replacing them with different types of mounting members will result in the rotation operation unit. The degree of bending near the tip of the tubular member with respect to the rotation operation can be arbitrarily adjusted. Therefore, the convenience can be 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 catheters and the like).

According to the medical device handle and the medical device according to the embodiment of the present invention, a guide mechanism for defining the path of the operation wire is provided on the attachment member that can be attached to and detached from the main body of the rotating plate. Therefore, the guide mechanism can be easily formed on the rotating plate, and for example, a plurality of types of mounting members having different shapes of the guide mechanism can be shared for a single main body. Therefore, it is possible to improve the convenience of the medical device.

It is a schematic diagram which shows the schematic configuration example of the electrode catheter as a medical device which concerns on one Embodiment of this invention. It is a schematic plan view which shows the internal structure example near the rotation operation part shown in FIG. It is a schematic perspective view which shows the internal structure example of the rotation operation part shown in FIG. It is a schematic disassembled perspective view which shows the example of the internal structure in the vicinity of the rotation operation part shown in FIG. It is a schematic diagram which shows an example of the use state of the medical device shown in FIG. It is a schematic diagram which shows another example of the use state of the medical device shown in FIG. It is a schematic plan view which shows the internal structure in the vicinity of the rotation operation part which concerns on a comparative example. It is a schematic plan view which shows the internal structure example near the rotation operation part which concerns on modification 1. FIG. It is a schematic plan view which shows the internal structure example near the rotation operation part which concerns on modification 2. FIG. It is a schematic diagram which shows the schematic configuration example of the sheath introducer as a medical device which concerns on modification 3. FIG.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The explanation will be given in the following order.
1. 1. Embodiment (Example when the medical device is an electrode catheter)
2. Deformation example Deformation example 1 (Example of rotation operation unit when the curvature of the guide mechanism is relatively small)
Deformation example 2 (Example of rotation operation unit when the curvature of the guide mechanism is asymmetrical on the left and right)
Modification 3 (Example when the medical device is a sheath introducer)
3. 3. Other variants

<Embodiment>
[Constitution]
FIG. 1 schematically shows a schematic configuration example of an electrode catheter 1 as a medical device according to an embodiment of the present invention. Specifically, FIG. 1 schematically shows a top surface configuration example (ZX top surface configuration example) of the electrode catheter 1.

The electrode catheter 1 is inserted into the body (for example, inside the heart) through a blood vessel and is used for examination and treatment of arrhythmia. The electrode catheter 1 includes a catheter tube 2 (catheter shaft) as a catheter body (long portion) and a handle 3 attached to the proximal end side of the catheter tube 2.

(A. Catheter tube 2)
The catheter tube 2 has a flexible tubular structure (hollow tubular member) and has a shape extending along its own axial direction (Z-axis direction). Specifically, the axial length of the catheter tube 2 is several to several tens of times longer than the axial length (Z-axis direction) of the handle 3. The catheter tube 2 may be composed of tubes having the same characteristics in the axial direction, but the tip portion having relatively excellent flexibility and the tip portion are integrally formed in the axial direction. It is preferable to have a proximal portion that is formed and is relatively more rigid than the distal portion.

Each tip of a pair of operating wires (operating wires 41a and 41b) is fixed to the tip side of the catheter tube 2. Each of these operating wires 41a and 41b will be described in detail later, but is a wire for bidirectionally bending the vicinity of the tip of the catheter tube 2. Each base end side of these operating wires 41a and 41b is extended from the inside of the catheter tube 2 to the inside of the handle 3 (fasteners 323a and 323b in the rotating plate 320 described later). The operating wires 41a and 41b correspond to specific examples of the "second operating wire" and the "first operating wire" in the present invention, respectively.

The catheter tube 2 also has a so-called single lumen structure in which one lumen (pore, through hole) is formed so as to extend along its own axial direction, or a plurality of (for example, four) lumens. It has a formed, so-called multi-lumen structure. In the catheter tube 2, both a region having a single lumen structure and a region having a multi-lumen structure may be provided. Various thin wires (the pair of operating wires 41a and 41b described above, a lead wire (not shown), and the like) are inserted into the lumen of such a catheter tube 2 in a state of being electrically insulated from each other.

The catheter tube 2 is made of, for example, a synthetic resin such as polyolefin, polyamide, polyether polyamide, or polyurethane. The axial length of the catheter tube 2 is about 300 to 1200 mm, and the length of the flexible portion near the tip thereof is about 20 to 150 mm. The outer diameter of the catheter tube 2 (outer diameter of the XY cross section) is about 0.6 to 3 mm (for example, 2.0 mm).

Further, a plurality of electrodes (here, three ring-shaped electrodes 21 and one tip electrode 22) are arranged near the tip of the catheter tube 2 at predetermined intervals. Specifically, the ring-shaped electrode 21 is fixedly arranged on the outer peripheral surface of the catheter tube 2, while the tip electrode 22 is fixedly arranged at the tip of the catheter tube 2. These electrodes are electrically connected to the inside of the handle 3 via a plurality of conducting wires (not shown) inserted into the lumen of the catheter tube 2 described above. It should be noted that such a conducting wire is made of a metal material such as copper and is coated with an insulating resin, and its diameter is about 50 to 200 μm (for example, 100 μm).

Each of the ring-shaped electrode 21 and the tip electrode 22 is made of a metal material having good electrical conductivity, such as aluminum (Al), copper (Cu), SUS, gold (Au), and platinum (Pt). ing. In order to improve the contrast with respect to X-rays when the electrode catheter 1 is used, it is preferably composed of platinum or an alloy thereof. The outer diameters of the ring-shaped electrode 21 and the tip electrode 22 are not particularly limited, but are preferably about the same as the outer diameter of the catheter tube 2 described above.

(B. Handle 3)
The handle 3 is a portion to be grasped (grasped) by an operator (doctor) when using the electrode catheter 1. As shown in FIG. 1, the handle 3 has a handle main body 31 mounted on the proximal end side of the catheter tube 2 and a rotation operation unit 32 including a rotation plate 320. The rotary plate 320 is a member rotatably mounted on the handle body 31 about a rotary axis Ar (Y-axis direction) perpendicular to the longitudinal direction (Z-axis direction). As will be described later, the rotation operation unit 32 is a portion used during a rotation operation, which is an operation of bending (deflecting) the vicinity of the tip of the catheter tube 2.

(B-1. Handle body 31)
The handle body 31 has a divided structure composed of two divided pieces (not shown) extending along the Z-axis direction, and the rotating plate 320 is sandwiched between the two divided pieces. The length of the entire handle body 31 in the axial direction is preferably such that the operator can grip it with one hand, but is not particularly limited. Such a handle body 31 is made of, for example, a synthetic resin such as polycarbonate, acrylonitrile-butadiene-styrene copolymer (ABS), acrylic, polyolefin, or polyoxymethylene.

(B-2. Rotation operation unit 32)
Here, a detailed configuration example of the rotation operation unit 32 in such a handle 3 will be described with reference to FIGS. 2 to 4 in addition to FIG. FIG. 2 is a schematic plan view (ZX plan view) showing an example of the internal configuration of the handle 3 shown in FIG. 1 in the vicinity of the rotation operation unit 32. FIG. 3 is a schematic perspective view showing an example of the internal configuration of the rotation operation unit 32 shown in FIG. FIG. 4 is a schematic exploded perspective view of an example of the internal configuration in the vicinity of the rotation operation unit 32 shown in FIG.

As shown in FIGS. 1 to 4, the rotation operation unit 32 includes the above-mentioned rotating plate 320. It should be noted that such a line operation unit 32 (line plate 320) is also composed of two dividing members that can be divided along the Y axis, similarly to the handle body 31 described above, and has a divided structure. .. In the following FIGS. 2 to 4, one of these two dividing members (internal structure of the rotation operation unit 32) is mainly illustrated.

The rotating plate 320 corresponds to a portion actually operated by the operator during the above-mentioned rotation operation, and has a substantially disk-shaped shape. Specifically, in this example, as shown by the arrows d1a and d1b in FIGS. 1 and 2, the operation of rotating the rotating plate 320 in both directions in the ZX plane with respect to the handle body 31 (rotation axis). Rotation operation centered on Ar) is possible. A hole (through hole) for enabling such a rotation operation is formed on the rotating plate 320 near the rotation axis Ar (rotation center).

A pair of knobs 321a and 321b are provided integrally with the rotating plate 320 on the side surface of the rotating plate 320. In this example, as shown in FIGS. 1 to 4, the knobs 321a and 321b are arranged at positions that are line-symmetrical with each other with the Z-axis as the axis of symmetry, with the rotation axis Ar as the center. Each of these knobs 321a and 321b corresponds to a portion operated (pushed) by, for example, a finger of one hand when the operator rotates the rotating plate 320. The rotating plate 320 is made of, for example, the same material (synthetic resin or the like) as the handle body 31 described above.

Further, a pair of fasteners 323a and 323b shown in FIGS. 1 to 4 are provided on the surface of such a rotating plate 320 (on the surface of the main body portion D1 described later). Further, a recess for arranging such fasteners 323a and 323b is formed on the surface of the rotating plate 320 (main body portion D1). Each of these fasteners 323a and 323b is a member (wire fastener) for individually fixing the base ends of the pair of operating wires 41a and 41b described above by screwing or the like. In addition, in these fasteners 323a and 323b, it is possible to arbitrarily adjust the pull-in length (pull-in amount) in the vicinity of the base ends when fixing the base ends of the operation wires 41a and 41b, respectively. There is.

Such operating wires 41a and 41b are each made of superelastic metal materials such as stainless steel (SUS) and nickel titanium (NiTi), and their diameters are about 100 to 500 μm (for example, 200 μm). is there. However, it does not necessarily have to be made of a metal material, and may be made of, for example, a high-strength non-conductive wire.

Here, for example, as shown in FIGS. 2 to 4, the rotating plate 320 in the rotating operation unit 32 of the present embodiment is composed of two members that can be separated from each other, a main body portion D1 and a mounting member D2. ing.

The main body portion D1 corresponds to a portion actually operated by the operator during the above-mentioned rotation operation. As shown in FIGS. 2 and 4 in this example, the main body D1 is a substantially semi-disc-shaped member located on the base end side of the rotating plate 320. The pair of knobs 321a and 321b described above are integrally provided on the side surface of the main body D1. Further, the pair of fasteners 323a and 323b described above are provided in the region on the base end side on the main body D1, respectively. That is, the base ends of the operating wires 41a and 41b are fixed on the main body D1.

The mounting member D2 is, for example, a member that is detachably (attachable) to the main body D1 as shown by the broken line arrow P1 in FIG. Specifically, as shown in FIG. 4 in this example, the mounting member D2 is configured to be detachable along the in-plane direction (ZX in-plane direction) of the rotating plate 320.

As shown in FIGS. 2 to 4, such a mounting member D2 is provided with a guide rail 322 as a guide mechanism for defining each path in the operating wires 41a and 41b. In this example, the guide rail 322 has a shape protruding along the Y-axis direction as a whole, as shown in FIGS. 3 and 4. Further, on the peripheral side surface of the guide rail 322 (a part of the outer peripheral surface of the rotating plate 320), a groove G1 for defining each path in the operation wires 41a and 41b is provided along the Z-axis direction. It is formed. That is, since such a groove G1 is formed on the peripheral side surface of the guide rail 322, each path of the operation wires 41a and 41b is defined in the groove G1. In other words, the groove G1 along the Z-axis direction is formed on the peripheral side surface of the guide rail 322, for example, as shown in FIG. 3, in the thickness direction (Y-axis direction) of the guide rail 322. ), The upper part has a shape protruding along the Z-axis direction.

Here, for example, as shown in FIG. 2, the shape of each path (groove G1) of the operation wires 41a and 41b in the guide rail 322 is substantially arcuate. Further, assuming that the curvature defining each of these paths is the curvature k1 and the radius of curvature is the radius of curvature R1 (= 1 / k1), the results are as follows. That is, although details will be described later according to the magnitude of such curvature k1 (radius of curvature R1), the base ends of the operating wires 41a and 41b during the rotation operation with respect to the rotating plate 320 (main body portion D1). The amount of pulling to the side is regulated.

[Action / Effect]
(A. Basic operation)
In the electrode catheter 1, the catheter tube 2 is inserted into the patient's body through a blood vessel at the time of examination or treatment of arrhythmia or the like. At this time, the shape near the tip of the catheter tube 2 inserted into the body changes in both directions in response to the rotation operation of the rotation operation unit 32 (rotation plate 320) by the operator.

Specifically, for example, when the operator grasps the handle body 31 with one hand and operates the pinching 321a with the fingers of the one hand, the rotating plate 320 is moved in the direction of the arrow d1a (clockwise) in FIGS. 1 and 2. When rotated, it becomes as follows.

That is, for example, as shown in FIG. 5A, inside the catheter tube 2 and the handle body 31, one of the pair of operating wires 41a and 41b described above (in this example, the operating wire 41a) is on the proximal end side. Pulled to. Then, the vicinity of the tip of the catheter tube 2 is curved (bent) along the direction indicated by the arrow d2a in FIG.

On the other hand, for example, when the rotating plate 320 is rotated in the direction of the arrow d1b (counterclockwise) in FIGS. 1 and 2 by operating the knob 321b, the result is as follows.

That is, for example, as shown in FIG. 5B, inside the catheter tube 2 and the handle body 31, the other of the pair of operating wires 41a and 41b (in this example, the operating wire 41b) is pulled toward the proximal end side. Be done. Then, the vicinity of the tip of the catheter tube 2 is curved along the direction indicated by the arrow d2b in FIG.

In this way, the operator can rotate the rotation operation unit 32 (rotation plate 320) to swing and deflect the catheter tube 2. By rotating the handle body 31 around the axis (in the XY plane), the direction of the bending direction near the tip of the catheter tube 2 can be freely adjusted while the catheter tube 2 is inserted into the patient's body. Can be set.

Here, when the electrode catheter 1 is used for an examination of, for example, arrhythmia, the electrocardiographic potential is measured using the electrodes (tip electrode 22 and ring-shaped electrode 21) of the catheter tube 2 inserted into the patient's body. .. Then, based on this electrocardiographic potential information, an examination regarding the presence or absence and degree of arrhythmia or the like at the examination site is performed.

On the other hand, when the electrode catheter 1 is used for the treatment of arrhythmia, for example, between the counter electrode plate (not shown) attached to the patient's body surface and the electrode of the electrode catheter 1 inserted into the patient's body. , Radio Frequency (RF) is energized. By such high-frequency energization, the site to be treated (blood vessel or the like) is selectively ablated, and percutaneous treatment such as arrhythmia is performed.

(B. Action on handle 3)
Subsequently, the action of the electrode catheter 1 on the handle 3 will be described in detail in comparison with a comparative example.

(B-1. Comparative example)
FIG. 6 is a schematic plan view (ZX plan view) showing the internal configuration of the handle according to the comparative example in the vicinity of the rotation operation unit 103. The line operation unit 103 (line plate 101 described later) of this comparative example is also a two division member that can be divided along the Y axis, like the rotation operation unit 32 (rotation plate 320) of the present embodiment. It is composed of and has a divided structure. In FIG. 6, one of these two dividing members (internal structure of the rotation operation unit 103) is shown.

The rotation operation unit 103 of this comparative example corresponds to the rotation operation unit 32 of the present embodiment in which the rotation plate 101 is provided instead of the rotation plate 320. Unlike the rotary plate 320 of the present embodiment, the rotary plate 101 of this comparative example is composed of a single substantially disk-shaped member. That is, unlike the rotary plate 320, the rotary plate 101 serves as a guide mechanism for defining the paths of the pair of knobs 321a and 321b, the pair of fasteners 323a and 323b, and the pair of operation wires 41a and 41b. All of the guide rails 102 of the above are provided.

The guide rail 102 has an arcuate shape that defines the paths of the operation wires 41a and 41b, and has a wall-like structure that is erected along the Y-axis direction on the rotating plate 101. .. The base end of the operation wire 41a is fixed to the fastener 323a on the rotating plate 101 via the guide rail 102, and the base end of the operation wire 41b passes through the guide rail 102. It is fixed to the fastener 323b on the rotating plate 101.

However, the rotation operation unit 103 of the comparative example having such a configuration may cause the following problems.

That is, first, since the guide rail 102 described above has a wall-like structure erected on the rotating plate 101, the following can be said. That is, it is difficult to fix the base ends of the operation wires 41a and 41b to the fasteners 323a and 323b, respectively, with the operation wires 41a and 41b along the wall surface of the guide rail 102. Become.

Further, when forming such a guide rail 102, a mold is generally used. Here, for example, when the rotary plate provided with the guide rail 102 having the wall-like structure described above is molded by a mold, the mold sandwiches the rotary plate 101 along the Y-axis direction. This is for arranging holes and dents along the Y-axis direction (for example, through holes near the rotation axis Ar and fasteners 323a and 323b described above) in a mold that is sandwiched along the Z-axis direction. This is because dents, etc.) cannot be formed. On the other hand, when such a mold sandwiched along the Y-axis direction is used, a groove along the Z-axis direction is formed on the side surface of the guide rail 102 having a wall-like structure erected along the Y-axis direction. Cannot be formed. This is because when the mold is removed along the Y-axis direction after molding, the mold is caught in the groove along the Z-axis direction and the mold cannot be removed. When the guide rail 102 is integrally molded on the rotating plate 101 using a mold in this way, a groove (Z-axis) for aligning the operation wires 41a and 41b on the wall surface (side surface) of the guide rail 102. It can be said that a groove along the direction cannot be formed.

For these reasons, it becomes difficult for the rotary operation unit 103 of this comparative example to form a guide rail 102 that facilitates the work of aligning the operation wires 41a and 41b, which may impair convenience. is there.

(B-2. Embodiment of this present)
On the other hand, the handle 3 in the electrode catheter 1 of the present embodiment has the following configuration as shown in FIGS. 2 to 4.

That is, in the handle 3, the rotating plate 320 in the rotating operation unit 32 is operated during the rotation operation of bending the vicinity of the tip of the catheter tube 2, and the main body portion D1 and the attachment member D2 that can be attached to and detached from the main body portion D1. It is composed of and. The mounting member D2 is provided with a guide rail 322 that defines each path in the operating wires 41a and 41b for bending the vicinity of the tip of the catheter tube 2 in response to the above-mentioned rotation operation. That is, in the handle 3, the mounting member D2, which is a separate member that can be attached to and detached from the main body D1 of the rotating plate 320, is provided with a guide rail 322 that defines each path of the operating wires 41a and 41b.

With such a configuration, in the handle 3, the guide rail 322 can be easily formed on the rotating plate 320 as compared with the handle of the comparative example described above. Specifically, as described above, the guide rail 322 is provided on the mounting member D2, which is a separate member from the main body D1, and therefore, when the mounting member D2 is molded, each operation wire is formed. It becomes easy to form the guide rail 322 that facilitates the work along which the 41a and 41b are aligned. Specifically, when forming such a guide rail 322 using a mold, it becomes easy to form the groove G1 described above. Therefore, the grooves G1 are used to form the operating wires 41a and 41b. The work of fixing becomes easy.

This is due to the following reasons. That is, first, unlike the rotating plate 101 of the comparative example described above, the mounting member D2 is provided with holes, dents, etc. (for example, through holes near the rotating shaft Ar, fasteners 323a, 323b) along the Y-axis direction. There are no dents, etc. for placement). Therefore, the mounting member D2 can be molded by using a mold sandwiched along the Z-axis direction. Further, in the case of the mold sandwiched along the Z-axis direction, unlike the above comparative example, the Z-axis direction is on the peripheral side surface of the guide rail 322 having a shape (wall-like structure) protruding along the Y-axis direction. It becomes possible to form a groove G1 along the line. This is because, unlike the above comparative example, when the mold is removed along the Z-axis direction after molding, there is no possibility that the mold will be caught in the groove G1 along the Z-axis direction and the mold will not come off. In this way, in the rotation operation unit 32 (rotation plate 320) of the present embodiment, the main body portion D1 is molded by using a mold sandwiched along the Y-axis direction in the same manner as in the above comparative example. The mounting member D2 is molded using a mold sandwiched along the Z axis. In this way, in the present embodiment, since the main body portion D1 and the mounting member D2 are each molded by using individual molds, both members are easily molded by using a mold having a simple structure. It becomes possible to do. As a result, as described above, it can be said that the groove G1 can be easily formed when the guide rail 322 is formed by using the mold.

Further, in such a handle 3, for example, a plurality of types of mounting members D2 having different shapes of guide rails 322 can be shared with a single main body D1. As a result, as will be described in detail in Modifications 1 and 2 described later, for example, by replacing the catheter tube 2 with a mounting member D2 having a guide rail 322 having a different shape and length, the degree of bending (curvature) near the tip of the catheter tube 2 Condition) can be easily adjusted.

From these facts, the handle 3 of the present embodiment is improved in convenience as compared with the handle of the comparative example.

Further, in the handle 3 of the present embodiment, as shown in FIG. 4, for example, the mounting member D2 is configured to be detachable along the inward direction of the rotating surface of the rotating plate 320, and the guide rail 322. A groove G1 for defining each of the above-mentioned paths is formed on the peripheral side surface. As a result, the attachment / detachment operation of the mounting member D2 becomes easy, and such a groove G1 can be easily formed on the peripheral side surface of the guide rail 322. Therefore, the convenience can be further improved.

Further, in this handle 3, as described above, depending on the magnitude of the curvature k1 (radius of curvature R1) in the guide rail 322, the base end side of each of the operation wires 41a and 41b during the rotation operation with respect to the rotating plate 320. The amount of pull-in to is specified. Specifically, as the curvature k1 becomes relatively large (the radius of curvature R1 becomes relatively small), the reactions of the operating wires 41a and 41b to the rotation operation become relatively insensitive, and the pull-in amount increases. It becomes relatively small. On the other hand, as the curvature k1 becomes relatively small (the radius of curvature R1 becomes relatively large), the reactions of the operating wires 41a and 41b to the rotation operation become relatively sensitive, and the pull-in amount is relatively large. growing. In this way, the degree of bending (curvature) near the tip of the catheter tube 2 with respect to the rotation operation to the rotating plate 320 can be arbitrarily set according to the magnitude of the curvature k1 (radius of curvature R1) on the guide rail 322. Will be. As a result, the convenience is further improved.

As described above, in the present embodiment, the guide rail 322 that defines the path of the operation wires 41a and 41b is provided on the attachment member D2 that can be attached to and detached from the main body D1 of the rotating plate 320. become that way. That is, the guide rail 322 can be easily formed on the rotating plate 320, and for example, a plurality of types of mounting members D2 having different shapes of the guide rail 322 can be shared with respect to the single main body D1. Can be done. Therefore, it is possible to improve the convenience of the electrode catheter 1 as a medical device.

<Modification example>
Subsequently, modification examples (modification examples 1 to 3) of the present invention will be described. The same components as those in the above embodiment are designated by the same reference numerals, and the description thereof will be omitted as appropriate.

[Modification 1]
FIG. 7 is a schematic plan view (ZX plan view) showing an example of the internal configuration of the handle according to the first modification in the vicinity of the rotation operation unit 32A.

The rotation operation unit 32A of the modification 1 is configured to include a rotation plate 320A having a main body portion D1 and a mounting member D2, similarly to the rotation operation unit 32 in the embodiment. Further, the rotary plate 320A of the present modification corresponds to the rotary plate 320 of the embodiment in which the shape of the mounting member D2 is partially changed, and other configurations (configuration of the main body D1 and the like) are basic. It is the same.

Specifically, the mounting member D2 of the present modification corresponds to the mounting member D2 of the embodiment in which the guide rail 322A is provided instead of the guide rail 322. A groove G2 is formed on the peripheral side surface of the guide rail 322A (a part of the outer peripheral surface of the rotating plate 320A) to define each path in the operation wires 41a and 41b, as in the case of the guide rail 322. Has been done. That is, since such a groove G2 is formed on the peripheral side surface of the guide rail 322A, each path of the operation wires 41a and 41b is defined in the groove G2.

Here, for example, as shown in FIG. 7, assuming that the curvature defining each path of the operation wires 41a and 41b is the curvature k2 and the radius of curvature is the radius of curvature R2 (= 1 / k2) in the guide rail 322A, the following It looks like this. That is, the following equations (1) and (2) are established with respect to the magnitude relationship between the curvature k2 and the radius of curvature R2 and the curvature k1 and the radius of curvature R2 in the guide rail 322 described in the embodiment. ing. Specifically, the curvature k2 of this modification is set to be larger than the curvature k1 of the embodiment, and the radius of curvature R2 of this modification is smaller than the radius of curvature R1 of the embodiment. It is set to be.
k2> k1 …… (1)
R2 <R1 …… (2)

The curvatures k1 and k2 correspond to specific examples of the "first curvature" and the "second curvature" in the present invention, respectively. Further, the radii of curvature R1 and R2 correspond to specific examples of the "first radius of curvature" and the "second radius of curvature" in the present invention, respectively.

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

Further, in particular, in this modification, a plurality of types of mounting members D2 having different shapes defining the paths of the operating wires 41a and 41b can be actually attached to and detached from the main body D1. Specifically, for example, the mounting member D2 having the guide rail 322 described in the embodiment, the mounting member D2 having the guide rail 322A described in this modification, and the like are respectively for a single main body D1. It is removable. Therefore, as described in the embodiment, as a result of being able to share a plurality of types of mounting members D2 with respect to a single main body D1, for example, simply replacing them with different types of mounting members D2 causes rotation. The degree of bending (curvature) near the tip of the catheter tube 2 with respect to the operation can be arbitrarily adjusted. Therefore, in this modified example, it is possible to further improve the convenience.

Contrary to this modification, a guide rail having a curvature smaller than the curvature k1 of the embodiment (a radius of curvature larger than the radius of curvature R1 of the embodiment) is provided on the mounting member of the rotating plate. May be good.

[Modification 2]
FIG. 8 is a schematic plan view (ZX plan view) showing an example of the internal configuration of the handle according to the second modification in the vicinity of the rotation operation unit 32B.

The rotation operation unit 32B of the modification 2 is also configured to include the rotation plate 320B having the main body portion D1 and the mounting member D2, similarly to the rotation operation unit 32 in the embodiment. Further, the rotary plate 320B of this modified example also corresponds to the rotary plate 320 of the embodiment in which the shape of the mounting member D2 is partially changed, and other configurations (configuration of the main body D1 and the like) are basic. It is the same.

Specifically, the mounting member D2 of the present modification corresponds to the mounting member D2 of the embodiment in which the guide rail 322B is provided instead of the guide rail 322. On the peripheral side surface of the guide rail 322B (a part of the outer peripheral surface of the rotating plate 320B), as in the case of the guide rails 322 and 322A, a groove for defining each path in the operation wires 41a and 41b is provided. It is formed.

However, in the guide rail 322B of this modified example, unlike the case of the guide rails 322 and 322A, the magnitude of the curvature (radius of curvature) that defines such a path is the area on the operation wire 41a side and the operation. It is asymmetric with the region on the wire 41b side. That is, in this guide rail 322B, as shown in FIG. 8, the curvature k2 (radius of curvature R2) defining the path for the operating wire 41a and the curvature k1 (radius of curvature k1) defining the path for the operating wire 41b. R1) is different from each other (k1 ≠ k2, R1 ≠ R2). Specifically, referring to FIG. 7 described above, the curvature k2 on the operation wire 41a side is set to be larger than the curvature k1 on the operation wire 41b side, and the curvature on the operation wire 41a side. The radius R2 is set to be smaller than the radius of curvature R1 on the operation wire 41b side (k2> k1, R2 <R1). As described above, on the peripheral side surface of the guide rail 322B, a groove G1 having a curvature k1 and a radius of curvature R1 (region on the operation wire 41b side) and a groove G2 having a curvature k2 and a radius of curvature R2 (the operation wire 41a side) Area) and are formed respectively.

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

Further, particularly in the guide rail 322B of the present modification, as described above, the curvature k2 (curvature radius R2) that defines the path for the operation wire 41a and the curvature k1 (curvature k1) that defines the path for the operation wire 41b. The radius R1) is different from each other. As a result, in the vicinity of the tip of the catheter tube 2, the degree of bending in one direction (for example, see arrow 2a in FIG. 1) and the degree of bending in the other direction (for example, see arrow d2b in FIG. 1) are different from each other. You will be able to do it. Further, the ratio of the degree of bending in each direction can be arbitrarily adjusted according to the ratio of the magnitudes of the curvature k1 (radius of curvature R1) and the curvature k2 (radius of curvature R2). Therefore, in this modified example, it is possible to further improve the convenience.

[Modification 3]
(Constitution)
FIG. 9 schematically shows a schematic configuration example of the sheath introducer 5 as a medical device according to the modified example 3. Specifically, FIG. 9 schematically shows a top surface configuration example (ZX top surface configuration example) of the sheath introducer 5.

In the sheath introducer 5, when the catheter tube 2 in the electrode catheter or the like is inserted into the patient's body, the sheath tube 6 is introduced into the body prior to this, so that the catheter tube 2 is inserted into the blood vessel. It is a device for securing a passage. The sheath introducer 5 includes a sheath tube 6 (sheath shaft) as a sheath body (long portion) and a handle 3 attached to the base end side of the sheath tube 6.

Here, the configuration of the handle 3 is basically the same as that of the handle 3 described in the embodiment and the like. Specifically, the handle 3 includes a handle main body 31 and any of the rotation operation units 32, 32A, and 32B. Further, as shown in FIG. 9, for example, the tip end side of the extension tube 70 is inserted into the handle body 31 of the sheath introducer 5, and two branch paths 721 are inserted into the base end side of the extension tube 70. , 722 is provided with a three-way stopcock 71.

Like the catheter tube 2, the sheath tube 6 has a flexible tubular structure (hollow tubular member) and has a shape extending along its own axial direction (Z-axis direction). A catheter tube 2 can be inserted into the sheath tube 6 as shown in FIG. 9, for example. Further, the tips of the pair of operating wires 41a and 41b described above are fixed to the tips of the sheath tube 6 as in the case of the catheter tube 2. Then, as in the case of the catheter tube 2, the respective base end sides of the operating wires 41a and 41b are also from the inside of the sheath tube 6 to the inside of the handle 3 (fasteners 323a and 323b in any of the rotating plates 320, 320A and 320B). ) Is extended.

Such a sheath tube 6 is made of, for example, a material (synthetic resin or the like) similar to that of the catheter tube 2. The axial length of the sheath tube 6 is about 300 to 900 mm, and the length of the flexible portion near the tip thereof is about 20 to 150 mm. The outer diameter of the sheath tube 6 (outer diameter of the XY cross section) is about 2.0 to 5.0 mm (preferably about 2.6 to 4.3 mm), and the inner diameter of the sheath tube 6 is about 2.6 to 4.3 mm. (Inner diameter of XY cross section) is about 1.6 to 4.3 mm (preferably about 2.0 to 2.8 mm).

The extension tube 70 is a tubular member that serves as a flow path for the chemical solutions L1, L2 and the like when the chemical solutions L1, L2 and the like described below are injected into the sheath tube 6 via the handle body 31. The extension tube 70 is also made of, for example, the same synthetic resin as the catheter tube 2.

The three-way stopcock 71 is a member (branch connector) capable of selectively switching the connection state and the cutoff state of the flow path between the branch paths 721 and 722 and the extension tube 70. As a result, in this example, the chemical solution L1 injected from the branch path 721 side is selectively injected into the extension tube 70 side, and the chemical solution L2 injected from the branch path 722 side is selectively injected into the extension tube 70 side. It is possible to make the branch roads 721 and 722 sides shut off. Examples of such chemical solutions L1 and L2 include contrast media.

(Action / effect)
In the sheath introducer 5, the sheath tube 6 is inserted into the patient's body through a blood vessel prior to the catheter tube 2 in the electrode catheter or the like when examining or treating an arrhythmia or the like. As a result, an insertion passage is secured in the blood vessel of the insertion destination, and the insertion of the catheter tube 2 is assisted.

Here, as a method of introducing the sheath tube 6 into the body (operation method by an operator), for example, the following method can be mentioned.

That is, first, a dilator (not shown) is inserted into the inner hole of the sheath tube 6, and the sheath tube 6 integrated with the dilator is inserted into the blood vessel of the patient. Then, the sheath tube 6 is moved toward the target portion (affected portion) along the guide wire (not shown) inserted in advance while the operator performs the rotation operation on the rotation operation portion 32. At this time, the shape near the tip of the sheath tube 6 inserted into the body changes in both directions in response to the rotation operation to the rotation operation unit 32.

Specifically, for example, the operator grabbed the handle body 31 with one hand and operated the 321a with the fingers of the one hand to rotate the rotary plate 320 in the direction of the arrow d1a (clockwise) in FIG. In the case, it becomes as follows. That is, inside the sheath tube 6 and the handle body 31, one of the pair of operating wires 41a and 41b (in this example, the operating wire 41a) is pulled toward the proximal end side. Then, the vicinity of the tip of the sheath tube 6 is curved (bent) along the direction indicated by the arrow d2a in FIG.

On the other hand, for example, when the rotating plate 320 is rotated in the direction of the arrow d1b (counterclockwise) in FIG. 9 by operating the knob 321b, the result is as follows. That is, inside the sheath tube 6 and the handle body 31, the other of the pair of operating wires 41a and 41b (in this example, the operating wire 41b) is pulled toward the proximal end side. Then, the vicinity of the tip of the sheath tube 6 is curved along the direction indicated by the arrow d2b in FIG.

In this way, the operator can rotate the rotation operation unit 32 to perform the swing deflection operation of the sheath tube 6. By rotating the handle body 31 around the axis (in the XY plane), the direction of the bending direction near the tip of the sheath tube 6 can be freely set while the sheath tube 6 is inserted in the patient's body. can do.

Subsequently, when the tip opening of the sheath tube 6 reaches the vicinity of the target site (affected portion), the dilator and the guide wire described above are removed. As a result, the tip portion of the sheath tube 6 is placed inside the patient's body. Then, the catheter tube 2 can be inserted into the body by using the sheath tube 6 introduced into the body in this way.

Examples of the method for inserting the catheter tube 2 into the body include the following methods.

That is, first, the tip of the catheter tube 2 is inserted into the inner hole of the sheath tube 6 from the base end of the handle 3. Then, while the operator performs a rotation operation on the rotation operation portion of the catheter (located in the handle provided on the proximal end side of the catheter tube 2: not shown in FIG. 9), the inner hole of the sheath tube 6 is filled. The catheter tube 2 is moved along. As a result, for example, as shown in FIG. 9, the vicinity of the tip of the catheter tube 2 extends from the tip opening of the sheath tube 6.

Subsequently, the operator rotates the rotation operation unit of the catheter described above to perform a swing deflection operation of the catheter tube 2. Further, if necessary, the rotation operation unit 32 of the sheath introducer 5 is rotated to perform a swing deflection operation of the sheath tube 6. As a result, the position of the tip portion of the catheter tube 2 (for example, the ring-shaped electrode 21 in the electrode catheter and one tip electrode 22) can be adjusted to reach the target site (affected portion).

After the tip of the catheter tube 2 is positioned in this way, a procedure (examination, treatment, etc.) using the catheter is performed. Then, after the catheter procedure is completed, the catheter tube 2 is removed from the body, and then the sheath tube 6 is removed from the body. As described above, examination and treatment of arrhythmia and the like are performed using a catheter such as a sheath introducer 5 and an electrode catheter.

Also in this modified example, it is possible to obtain the same effect basically by the same action as that of the above embodiment. Specifically, since the sheath introducer 5 of the present modification is also provided with the handle 3 having the same configuration as that of the above embodiment, the sheath introducer 5 as a medical device can be improved in convenience. Is possible.

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

For example, the configuration (shape, arrangement position, number, material, etc.) of each member described in the above-described embodiment is not limited, and other shapes, arrangement positions, numbers, materials, etc. may be used. Specifically, for example, the configuration (shape, arrangement position, number, material, etc.) of the handle body, the rotation operation part, the rotating plate (main body part and the mounting member), the guide mechanism (guide rail), etc. is the above-described embodiment. The configuration is not limited to that described in the above, and other configurations may be used. Specifically, for example, in the above-described embodiment, a groove is formed on the peripheral side surface of the guide mechanism, so that the path of the operation wire is defined inside the groove. A guide mechanism that defines such a path may be configured by a protrusion (wall-like structure) erected on the rotating plate. Further, for example, in the above embodiment, the case where the shape of the path (groove) of the operation wire is substantially arcuate has been described, but the present invention is not limited to this example, and for example, for this operation. The wire path (groove) may have another shape such as a straight line. Further, the size and magnitude relation of various parameters (curvature, radius of curvature, etc.) described in the above-described embodiment are not limited to those described in the above-described embodiment, and other sizes, magnitude-relationships, etc. There may be.

Further, in the above-described embodiment, the configurations of the tubular members (catheter tube 2 and sheath tube 6) have been specifically described, but it is not always necessary to include all the members, and other members are further provided. You may be. Specifically, for example, a leaf spring that can be deformed in the bending direction may be provided as a swinging member inside the catheter tube 2. Further, the electrode configuration (arrangement, shape, number, etc. of the ring-shaped electrode 21 and the tip electrode 22) in the catheter tube 2 is not limited to those mentioned in the above-described embodiment.

Further, in the above-described embodiment and the like, the configuration of the handle (handle body and rotation operation unit) has been specifically described and described, but it is not always necessary to include all the members, and other members are further provided. You may. Specifically, for example, in the above-described embodiment, the case where the base end of the operation wire is fixed on the rotating plate (main body portion) has been described, but the present invention is not limited to this example. .. That is, for example, the base end of the operation wire may not be fixed on the rotating plate (main body portion). Specifically, for example, the base end of the operation wire may be fixed to a member that moves (displaces) in conjunction with the rotation operation of the rotating plate.

In addition, the shape of the tubular member (catheter tube 2 or sheath tube 6) near the tip 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 (bidirection 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 a tubular member changes in one direction in response to a rotation operation to a rotation operation unit. is there. In this case, only one (one) operation wire and one fastener will be provided.

Further, the electrode catheter as a specific example of the medical device according to the present invention can be either an electrode catheter for examining arrhythmia or the like (so-called EP catheter) or an electrode catheter for treating arrhythmia or the like (so-called ablation catheter). It is possible to apply.

Further, in the above-described embodiment and the like, an electrode catheter and a sheath introducer 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), angiography catheter and microcatheter.

1 ... electrode catheter, 2 ... catheter tube, 21 ... ring-shaped electrode, 22 ... tip electrode, 3 ... handle, 31 ... handle body, 32, 32A, 32B ... rotation operation unit, 320, 320A, 320B ... rotating plate, 321a , 321b ... Picking, 322, 322A, 322B ... Guide rail (guide mechanism), 323a, 323b ... Fasteners, 41a, 41b ... Operating wire, 5 ... Sheath introducer, 6 ... Sheath tube, 70 ... Extension tube, 71 ... Three-way tap, 721,722 ... Branch path, Ar ... Rotating shaft, D1 ... Main body, D2 ... Mounting member, R1, R2 ... Radius of curvature, k1, k2 ... Curvature, G1, G2 ... Groove, L1, L2 ... Chemical solution ..

Claims (7)

A handle attached to the base end side of a flexible tubular member.
With the handle body
It is configured to include a rotating plate rotatably attached to the handle body, and is provided with a rotating operation unit used for a rotating operation to bend the vicinity of the tip of the tubular member.
The rotating plate is
The main body operated during the rotation operation and
A mounting member that is detachable from the main body and has a guide mechanism that defines a path in one or a plurality of operating wires for bending the vicinity of the tip of the tubular member in response to the rotation operation. equipped with a door,
A medical device handle in which the base end of the operation wire is fixed to the main body portion instead of the mounting member side . The mounting member is configured to be removable along the direction in the rotating surface of the rotating plate.
The medical device handle according to claim 1, wherein a groove for defining the path is formed on the peripheral side surface of the guide mechanism. The medical device according to claim 1 or 2, wherein the amount of pulling of the operation wire toward the proximal end side during the rotation operation is defined according to the magnitude of the curvature defining the path in the guide mechanism. Equipment handle. As the curvature becomes relatively large, the pull-in amount becomes relatively small, and
The handle for a medical device according to claim 3, wherein the pull-in amount becomes relatively large as the curvature becomes relatively small. The operating wire is composed of first and second operating wires for bidirectionally bending the vicinity of the tip of the tubular member.
In the guide mechanism, the first curvature that defines the path for the first operating wire and the second curvature that defines the path for the second operating wire are different from each other. The handle for a medical device according to any one of claims 1 to 4. The handle for a medical device according to any one of claims 1 to 5, wherein a plurality of types of mounting members having different path shapes in the guide mechanism are detachably attached to the main body. .. Flexible tubular members and
It is provided with a handle mounted on the base end side of the tubular member.
The handle
With the handle body
It is configured to include a rotating plate rotatably attached to the handle body, and is provided with a rotating operation unit used for a rotating operation to bend the vicinity of the tip of the tubular member.
The rotating plate is
The main body operated during the rotation operation and
A mounting member that is detachable from the main body and has a guide mechanism that defines a path in one or a plurality of operating wires for bending the vicinity of the tip of the tubular member in response to the rotation operation. equipped with a door,
A medical device in which the base end of the operation wire is fixed to the main body portion instead of the mounting member side .

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