JP6113682B2 - 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.

  As an example of such a handle for a medical device such as an electrode catheter or a sheath introducer, as disclosed in Patent Document 1, for example, an operation unit including a rotating plate rotatably mounted on the handle body (Rotary operation unit) is used. On the rotating plate, 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 these tubular members. With such a configuration, it is possible to bend the vicinity of the tip of the tubular member by rotating the rotating plate.

JP 2010-94353 A

  By the way, in the medical device as described above, there is a case where it is desired to keep the curved state in the vicinity of the tip of the tubular member depending on the use situation. In such a case, for example, in the medical device handle disclosed in Patent Document 1, the rotary plate is fixed to the handle body by twisting a knob provided on the handle body, so that the rotation position of the rotary plate (the curved state near the tip) ) Is fixed (held).

  However, when the operator performs such work, it is necessary to twist the knob on the handle body with the other hand while fixing the rotating plate at a desired rotational position with one hand. That is, an operation using both hands is required. Therefore, there is a possibility that the work efficiency is deteriorated and the operability is lowered, and therefore, a proposal of a method for improving the operability is desired.

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

The handle for a medical device according to the present invention is a handle attached to the proximal end side of a flexible tubular member, and is used in a rotating operation for bending the handle body and the vicinity of the distal end of the tubular member. And a rotation operation unit. The rotation operation unit is rotatably attached to the handle body, and at least a part of the rotation operation unit is configured to be elastically displaceable along the orthogonal direction of the rotation axis, and the rotation axis of the rotation plate is orthogonal. According to the position state along the direction, the rotation operation is possible and the rotation position of the rotation plate is arbitrarily set, and the rotation operation is disabled and the rotation position of the rotation plate is fixed. And a switching mechanism for switching between them. The handle body is configured by first and second handle members facing each other along the rotation axis, and the rotating plate is disposed to face each other between the first and second handle members. The first rotating member located on the handle member side and the second rotating member located on the second handle member side and capable of the elastic displacement, and the switching mechanism is arranged on the second handle member. The first switching member is provided, and the second switching member is provided on the second rotating member.

  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 rotating plate is configured such that at least a part thereof can be elastically displaced along the orthogonal direction of the rotation axis, and the position state of the rotating plate along the orthogonal direction of the rotation axis Accordingly, a switching mechanism is provided for switching between the free state and the locked state. As a result, while the rotary plate is being rotated, the rotary plate is elastically displaced in the direction orthogonal to the rotation axis, thereby switching between the free state and the locked state according to the position state. Therefore, unlike the case where switching between the free state and the locked state is performed according to, for example, an operation along the rotation axis direction of the rotating plate (twisting operation, etc.), the vicinity of the distal end of the tubular member is in a desired curved state. The work to be held in can be done with one hand. Further, since only one of the first and second rotating members (second rotating member) undergoes the elastic displacement, the free state and the lock are compared with the case where both of them undergo the elastic displacement. It becomes easy to determine which of the states is currently set. Specifically, according to the relative positional relationship (relative position state) between the first rotating member and the second rotating member, whether or not the second rotating member is elastically displaced, That is, it is easy to determine whether the state is the free state or the locked state even when the operator holds the state.

  Here, for example, the second rotating member is configured by a pair of divided members that are arranged side by side along the orthogonal direction of the rotation axis and at least one of which is provided with the second switching member. In the divided member provided with at least the second switching member among the divided members, it is desirable that the elastic displacement can be performed along a direction orthogonal to the rotation axis. In this case, the direction in which the operator grips the rotating plate (second rotating member) during the rotation operation (direction in which a force is applied with the finger) and the direction of the elastic displacement (with the finger during the switching operation). Therefore, it is not necessary to apply a force in an extra direction, and the operability is further improved.

  In this case, it is desirable to provide the second switching member in each of the pair of split members. In this case, since the strength in the locked state (lock strength) is increased as compared with the case where the second switching member is provided only in one of the pair of split members, the reliability of the product during the switching operation is increased. Will improve. In this case, further, for example, in a non-pressed state in which the divided members are spaced apart from each other, the first switching member in the second handle member and the second switching member in each divided member are engaged with each other. On the other hand, in the pressed state in which each divided member is pressed along the gap direction between each other and the elastic displacement is made, the first switching member in the second handle member and the second in each divided member are brought into the locked state. The switching members may be disengaged from each other to enter the free state. That is, the locked state may be set in the non-pressed state, and the free state may be set in the pressed state. In this case, since the switching between the free state and the locked state is realized by a simple operation, the operability is further improved. Conversely, compared with the case where the non-pressed state is the free state and the pressed state is the locked state, the operation in the operation of holding the vicinity of the distal end of the tubular member in a desired curved state. More improved.

  In the medical device handle and the medical device according to the present invention, it is preferable that the rotation operation unit includes a spring member that realizes the elastic displacement of the split member. In this case, the elastic displacement in the divided member can be realized with a simple configuration. In this case, the spring member includes a rod-like spring member that extends along the rotation axis and connects the first rotation member and the divided member to each other, and the rod-like spring member extends along a direction orthogonal to the rotation axis. It is further desirable that the elastic displacement of the divided member is realized by partially elastically deforming. In this case, the elastic displacement in the divided member can be realized with a simpler and space-saving configuration while securing the role as the connecting member between the first rotating member and the divided member. In addition, since the rod-shaped spring member is inserted and arranged in the rotating plate and the elastic displacement mechanism is completed only by the rotating plate, such an elastic displacement mechanism does not hinder the rotation operation, and the operability is improved. Further improvement is realized.

  In the medical device handle and the medical device of the present invention, it is desirable that the pair of divided members have a non-slip shape that fits together. In such a case, when the divided members are engaged with each other, sliding (mutual displacement) along the boundary direction between them is prevented, and malfunction during rotation operation is avoided.

  Further, in the pair of divided members, it is desirable that one second switching member is disposed one by one at positions that are substantially point-symmetric with each other along the direction of the elastic displacement. In this case, first, the second switching member is disposed along the direction of the elastic displacement (the direction orthogonal to the rotation axis), so that the second switching member is located at a position excluding such a direction. Compared with the case where is arranged, the engagement state between the first and second switching members becomes better. In addition, since the second switching members are arranged one by one at positions that are substantially point-symmetric to each other, the first and the second switching members are compared with the case where a plurality of second switching members are arranged on each divided member. The engagement failure between the two switching members (such as a phenomenon that the locked state cannot be set) is less likely to occur (desirably not occur).

  Further, it is desirable that the first handle member is also provided with a first switching member, and the first and second handle members have the same shape. In this case, although the first switching member in the first handle member is not actually used, the first and second handle members have the same shape, for example, manufacture using the same mold. Therefore, the manufacturing becomes easy and the manufacturing cost is reduced.

  In the medical device handle and the medical device of the present invention, the first and second switching members may be shaped to fit each other, for example (first configuration example). One of the first and second switching members may be a ring-shaped member and the other may be a convex member (second configuration example). Alternatively, each of the first and second switching members may be a ring-shaped member (third configuration example). In the case of these second and third configuration examples, since the ring-shaped member is used, the rotational position of the rotating plate can be set to an arbitrary continuous (non-discrete) position. In contrast, in the case of the first configuration example, the pitch is limited according to the shape to be fitted, and the rotational position of the rotating plate is set to a discrete position.

  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).

  According to the medical device handle and the medical device of the present invention, since the rotating plate and the switching mechanism having the above-described configuration are provided, the operation of holding the vicinity of the distal end of the tubular member in a desired curved state is performed with one hand. Can be realized by the operation. Therefore, it is possible to improve work efficiency and improve operability.

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. It is a disassembled perspective view showing the detailed structural example of the handle | steering-wheel shown in FIG. It is sectional drawing showing the detailed structural example of the handle shown in FIG. FIG. 3 is a plan view illustrating a configuration example of a handle member illustrated in FIG. 2. FIG. 3 is a plan view illustrating a configuration example of a rotating member illustrated in FIG. 2. It is a schematic diagram showing schematic structure of the sheath introducer which concerns on a comparative example. It is sectional drawing showing the detailed structural example of the handle shown in FIG. It is a top view which represents typically about an operation of a handle member and a rotation member in a locked state. It is a top view which represents typically about an operation of a handle member and a rotation member in a free state. It is sectional drawing for demonstrating the shape of the rod-shaped spring member in a locked state. It is sectional drawing for demonstrating the shape of the rod-shaped spring member in a free state. It is a schematic diagram for demonstrating the effect | action of the sheath introducer in a free state. It is a schematic diagram for demonstrating the effect | action of the sheath introducer in a locked state. It is a top view showing the other structural example of a rotating member. It is a top view showing the further another structural example of a rotating member. 10 is a plan view illustrating a configuration example of a handle member according to Modification Example 1. FIG. 10 is a plan view illustrating a configuration example of a rotating member according to Modification Example 1. FIG. 10 is a plan view illustrating a configuration example of a handle member according to Modification 2. FIG. 12 is a plan view illustrating a configuration example of a rotating member 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 Example 5. 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 shapes of the first and second switching members are opposite combinations)
Modification 2 (example in which each of the first and second switching members is a ring-shaped member)
Modifications 3 and 4 (examples in which the first and second switching members are a combination of a ring-shaped member and a convex member)
Modification 5 (example when the medical device is an electrode catheter)
3. Other variations

<Embodiment>
[Constitution]
FIG. 1 schematically shows a schematic configuration example of a sheath introducer 1 as a medical device according to an embodiment of the present invention. The sheath introducer 1 introduces the sheath tube 2 into the body prior to the insertion of the catheter tube 6 such as an electrode catheter into the patient's body, 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.

(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. 1, for example. Further, distal ends of operation wires 41a and 41b (not shown in FIG. 1) to be described later are fixed to the distal end side of the sheath tube 2. The proximal ends of the operation wires 41a and 41b are extended from the sheath tube 2 into the handle 3 (on a rotating plate 32 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 500 to 800 mm, and the length of the flexible portion near the tip of the sheath tube 2 is about 20 to 150 mm. The outer diameter of the sheath tube 2 (the outer diameter of the XY cross section) is about 2.0 to 5.0 mm (preferably about 2.6 to 4.3 mm). The (inner diameter of the XY cross section) is about 1.6 to 4.3 mm (preferably about 2.0 to 2.8 mm).

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

(Handle 3)
The handle 3 is a portion that is gripped (gripped) by an operator (doctor) when the sheath introducer 1 is used. As shown in FIG. 1, the handle 3 has a handle main body 31 (gripping part) mounted on the proximal end side of the sheath tube 2 and a rotation operation part including a rotating plate 32. The rotating plate 32 is a member that is attached to the handle main body 31 so as to be rotatable about a rotation axis (Y-axis direction) perpendicular to the longitudinal direction (Z-axis direction). As will be described later, this rotation operation portion is a portion used in the operation (rotation operation) of bending (deflecting) the vicinity of the distal end of the sheath tube 2.

  FIG. 2 is an exploded perspective view showing a detailed configuration example of the handle 3, and R shown in FIG. 2 represents the rotation axis of the rotating plate 32. FIG. 3 shows an example of a cross-sectional configuration taken along the line II-II in the handle 3 shown in FIG. In addition, in this FIG. 3, the expanded sectional view of the part in the broken line shown with the code | symbol P1 is shown collectively.

  2 and 3, the handle main body 31 includes a handle member 311 (first handle member) and a handle member 312 (first handle members) facing each other along the rotation axis R (Y-axis direction) of the rotating plate 32. 2 handle members). Each of these handle members 311 and 312 extends along the axial direction (Z-axis direction) of the handle main body 31, and the rotating plate 32 is sandwiched therebetween. The axial length of the handle body 31 is preferably such that the operator can hold it with one hand, but is not particularly limited.

  Here, FIG. 4 illustrates a planar configuration example of the handle members 311 and 312. As shown in FIG. 4, the handle members 311 and 312 have the same shape. As shown in FIGS. 2 to 4, these handle members 311 and 312 respectively project toward the rotating plate 32 in the vicinity of the center region thereof (near the rotation axis R and the region near the rotating plate 32). The connecting pins 311p and 312p are shaped. The connecting pin 311p is a member for connecting the handle member 311 and the rotary plate 32 or the like (specifically, a rotary member 321 and an intermediate member 33 described later in the rotary plate 32) to each other. The connecting pin 312p is a member for connecting the handle member 312 and the rotating plate 32 and the like (specifically, a rotating member 322 and an intermediate member 33 described later in the rotating plate 32) to each other. Each of the connecting pins 311p and 312p is formed with a guide groove g1 for inserting (extending) the sheath tube 2 and the like along the axial direction of the handle body 31.

  The handle members 311 and 312 are each provided with a switching member Ex1 along a predetermined circumference centered on the connecting pins 311p and 312p. The switching member Ex1 has a shape that fits with a switching member Ex2 to be described later, and in this example, has a female screw shape. The details of the switching member Ex1 will be described later.

  Such a handle body 31 (handle members 311 and 312) is made of, for example, a synthetic resin such as polycarbonate, acrylonitrile-butadiene-styrene copolymer (ABS), acrylic, polyolefin, or polyoxymethylene.

  As shown in FIGS. 2 and 3, the rotation operation unit described above includes an intermediate member 33, connecting members 341 and 342, rod-like spring members 35 a and 35 b and the like in addition to the rotating plate 32.

  The rotating plate 32 corresponds to a portion where the operator actually operates during the above-described rotating operation, and has a substantially disk shape. Specifically, in this example, as indicated by arrows d1a and d1b in FIG. 1, an operation of rotating the rotating plate 32 bidirectionally in the ZX plane (rotating the rotation axis R) with respect to the handle main body 31. Centered rotation operation) is possible. Although details will be described later, a part of the rotating plate 32 is configured to be elastically displaceable along a direction orthogonal to the rotation axis R (a predetermined direction in the ZX plane).

  A pair of knobs 32 a and 32 b are provided integrally with the rotating plate 32 on the side surface of the rotating plate 32. In this example, the knob 32a and the knob 32b are arranged at positions that are point-symmetric with respect to the rotation axis R. Each of these knobs 32a and 32b corresponds to a portion operated (pressed) by a finger of one hand, for example, when the operator rotates the rotary plate 32.

  In this example, as shown in FIGS. 1 and 2, the knobs 32 a and 32 b are not spherical, but are U-shaped having a thickness along the rotation axis R. By using the knobs 32a and 32b having such a shape, the curvature of the U-shaped curved surface is reduced (curvature) while suppressing (holding) the entire width (length in the X-axis direction) of the sheath introducer 1. The radius can be increased), and the pressure applied to the finger during operation (degree of pain) can be reduced.

  As shown in FIGS. 2 and 3, the rotating plate 32 includes a rotating member 321 (first rotating member) and a handle member 311, 312 which are arranged to face each other along the rotation axis R between the handle members 311 and 312. The rotating member 322 (second rotating member) is used. These rotating members 321 and 322 also have a substantially disk shape. The rotating member 321 is disposed on the handle member 311 side, and the rotating member 322 is disposed on the handle member 312 side. In this example, only the rotating member 322 among these rotating members 321 and 322 is configured to be elastically displaceable as described above. Further, as will be described later, these rotating members 321 and 322 are connected to each other and rotate integrally with each other. Such a rotating plate 32 (rotating members 311 and 312) is made of, for example, the same material (synthetic resin or the like) as the above-described handle main body 31 (handle members 311 and 312).

  Here, as shown in FIGS. 2 and 3, a pair of knobs 321 a and 321 b, which are parts of the pair of knobs 32 a and 32 b, are provided on the side surface of the rotating member 321. Further, as shown in FIG. 2, a hole 321 h (through hole) through which the connecting pin 311 p described above is formed is formed near the center of the rotating member 321. The rotating member 321 is fixed to the handle main body 31 (handle member 311) by the connecting pin 311p, and can rotate around the connecting pin 311p. Further, as shown in FIG. 2, a pair of adjustment fasteners 321pa and 321pb are provided on the surface of the rotating member 321 on the rotating member 322 side.

  These adjustment fasteners 321pa and 321pb are members (wire fasteners) for individually fixing the base ends of the aforementioned operation wires 41a and 41b by screwing or the like. Specifically, as shown in FIG. 2, the operation wire 41 a passes through a guide path g <b> 32 on the knob 321 a side of the intermediate member 33 described later, and the base end thereof is fixed to the adjustment fastener 321 pa. ing. On the other hand, the operation wire 41b passes through the guide path g32 on the knob 321b side of the intermediate member 33, and the base end thereof is fixed to the adjustment fastener 321pb. In addition, in these adjustment fasteners 321pa and 321pb, it is possible to arbitrarily adjust the pull-in lengths near the base ends when the base ends of the operation wires 41a and 41b are fixed.

  Each of these operation wires 41a and 41b is made of a super elastic 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.

  On the other hand, as shown in FIGS. 2 and 3, a pair of knobs 322a and 322b, which are parts of the pair of knobs 32a and 32b, are also provided on the side surface of the rotating member 322. That is, as shown in FIG. 3, the knob 32 a on the rotating plate 32 is configured by the knob 321 a on the rotating member 321 and the knob 322 a on the rotating member 322. Similarly, a knob 32 b in the rotating plate 32 is configured by the knob 321 b in the rotating member 321 and the knob 322 b in the rotating member 322. Further, as shown in FIG. 2, a hole 322 h (through hole) through which the connecting pin 312 p described above passes is also formed near the center of the rotating member 322.

  FIG. 5 shows a planar configuration example of such a rotating member 322. In addition, in this FIG. 5, the enlarged plan view of the part in the broken line shown with the code | symbol P2 is shown collectively. As shown in FIGS. 2 and 5, the rotating member 322 is a pair of divided members arranged side by side along a direction orthogonal to the rotation axis R (a predetermined direction in the ZX plane: for example, the X-axis direction). It is comprised by 322d1 and 322d2. The dividing member 322d1 is disposed on the knob 322b side, and the dividing member 322d2 is disposed on the knob 322a side. Each of these dividing members 322d1 and 322d2 has a substantially semi-disc shape.

  Here, in each of the divided members 322d1 and 322d2, the above-described elastic displacement is possible along the orthogonal direction of the rotation axis R (a predetermined direction in the ZX plane) (shown in FIGS. 2 and 5). (See symbols m1 and m2). Such elastic displacement is made in accordance with the presence / absence and magnitude of the pressing in the gap direction with respect to each of the divided members 322d1 and 322d2, as indicated by reference numerals Fa and Fb in FIGS. It has become. Moreover, these division members 322d1 and 322d2 have anti-slip shapes S1 and S2 that fit each other. Specifically, in this example, the non-slip shapes S1 and S2 are configured by a combination of a semicircular convex portion and a concave portion fitted to the semicircular convex portion, respectively.

  In such a rotating member 322, a switching member Ex2 is provided along a predetermined circumference centered around the hole 322h. Specifically, in the pair of divided members 322d1 and 322d2, one switching member Ex2 is arranged at a position that is substantially point-symmetric with respect to the vicinity of the hole 322h (in this example, along the X-axis direction). Yes. Such a switching member Ex2 has a shape that fits with the switching member Ex1 described above, and in this example, has a male screw shape.

  Here, in the handle 3 according to the present embodiment, the switching member Ex1 (first switching member) provided on the handle member 312 and the rotating member 322 (a pair of divided members 322d1 and 322d2) described above are provided. The following switching mechanism is configured by the switching member Ex2 (second switching member). This switching mechanism is a mechanism used when switching between the “locked state” and the “free state (unlocked state)”. Here, the “free state” refers to the rotating plate 32 according to the position state along the direction orthogonal to the rotation axis R (predetermined direction in the Z-X plane) of the rotating plate 32 (rotating member 322 in this example). This means that the rotational position of the rotary plate 32 can be arbitrarily set. On the other hand, the “locked state” means a state in which such a rotation operation becomes impossible and the rotational position of the rotating plate 32 is fixed. The details of the switching action between the locked state and the free state by such a switching mechanism (switching members Ex1, Ex2) will be described later.

  As shown in FIGS. 2 and 3, the intermediate member 33 is disposed between the rotating members 321 and 322, and functions as a spacer between the rotating members 321 and 322. The intermediate member 33 is formed in a linear shape extending along the axial direction (Z-axis direction) of the handle 3, and the guide path g31 through which the sheath tube 2 and the like are inserted, and the operation wires 41a and 41b described above. And a pair of arcuate guide paths g32 that define the respective paths. These guide paths g31 and g32 are basically separated by a partition as shown in FIGS. The intermediate member 33 is fixed to the handle body 31 so as not to rotate, unlike the rotating plate 32 (the rotating members 321 and 322). The intermediate member 33 is made of a synthetic resin such as a fluororesin, a polyolefin, or polyoxymethylene.

  By providing the intermediate member 33 having such a configuration, a space for inserting a long component (such as the sheath tube 2) (a space formed by the guide path g31) is secured between the rotating members 321 and 322. It is possible. Further, the extending direction of such a long component is defined by the guide path g31 formed in the intermediate member 33 and the guide grooves g1 formed in the connection pins 311p and 312p in the handle main bodies 311 and 312. Thereby, this long component can be extended (linearly) along the central axis of the handle body 31 in the longitudinal direction (Z-axis direction). Since the intermediate member 33 and the connecting pins 311p and 312p are fixed to the handle body 31 so as not to rotate, even if the rotating plate 32 is rotated, the intermediate member 33 and the connecting pins 311p and 312p The extending direction of the specified long component does not change.

  As shown in FIG. 2, the connecting members 341 and 342 are attached to the distal end side and the proximal end side of the handle members 311 and 312, thereby connecting the handle members 311 and 312 (sealing members). Member). Thus, the handle main body 31 is fixed in a state where the rotating plate 32 (the rotating members 311 and 312) and the intermediate member 33 are sandwiched between the handle members 311 and 312, and the entire handle 3 shown in FIGS. Will be composed. The connecting members 341 and 342 are formed with holes 341h and 342h through which the sheath tube 2 and the operation wires 41a and 41b are inserted. Such connecting members 341 and 342 are also made of, for example, the same material (synthetic resin or the like) as the handle body 31 (handle members 311 and 312) described above.

  The rod-like spring members 35a and 35b are spring members (elastic members) that realize the above-described elastic displacement (see the reference numerals m1 and m2 in FIGS. 2 and 5) in the divided members 322d1 and 322d2 of the rotating member 322, respectively. As shown in FIG. 3, each of the rod-shaped spring members 35a and 35b is a rod-shaped member (for example, an elongated columnar member) extending along the rotation axis R (Y-axis direction), and rotates with the rotation member 321. The member 322 also has a function of connecting the divided members 322d1 and 322d2 to each other. That is, each of the rod-like spring members 35a and 35b is a spring member and functions as a connecting member. Specifically, the rod-shaped spring member 35a connects the knob 321a of the rotating member 321 and the knob 322a of the dividing member 322d2. On the other hand, the rod-shaped spring member 35b connects the knob 321b of the rotating member 321 and the knob 322b of the dividing member 322d1 to each other.

  Thus, the rotating member 321 and the rotating member 322 are connected to each other at the portions of the knobs 321a and 321b. As a result, the rotating members 321 and 322 can freely rotate integrally with each other around the rotation axis R. That is, the rotating member 321 and the rotating member 322 do not rotate separately (individually). For this reason, in the locked state described above, the rotating member 321 as well as the rotating member 322 provided with the switching member Ex2 become non-rotatable, while in the free state described above, the rotating member 321 can also rotate together with the rotating member 322.

  Here, as shown in the enlarged cross-sectional view in FIG. 3, gap spaces Gs21 and Gs22 are formed around (around) the rod-shaped spring member 35a in the knob 322a. Further, a gap space Gs11 is formed around the rod-shaped spring member 35a in the knob 321a. Although not shown, similar gap spaces are also formed around the rod-shaped spring member 35b in the knobs 321b and 322b. The gap spaces Gs11, Gs21, Gs22, and the like are formed, and the details will be described later. However, along the orthogonal direction (predetermined direction in the ZX plane) of the rotation axis R of each of the divided members 322d1, 322d2. During the elastic displacement, the rod-like spring members 35a and 35b are partially elastically deformed. That is, the spring properties of the bar-shaped spring members 35a and 35b are secured by utilizing the play portions (gap spaces Gs11, Gs21, Gs22, etc.) in the knobs 321a, 321b, 322a, 322b. In other words, the rod-shaped spring members 35a and 35b are partially elastically deformed along the direction orthogonal to the rotation axis R (predetermined direction in the ZX plane), so that the elastic displacement in each of the divided members 322d1 and 322d2 is caused. It has come to be realized. Such rod-shaped spring members 35a and 35b are each made of, for example, a shape memory alloy such as a nickel-titanium (Ni-Ti) alloy.

[Action / Effect]
(basic action)
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 rotates the rotating plate 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 of the rotating plate 32.

  Specifically, for example, when the operator grasps the handle 3 with one hand and operates the knob 32a with the finger of the one hand to rotate the rotating plate 32 in the direction of the arrow d1a (clockwise) in FIG. It becomes as follows. That is, in the sheath tube 2, the operation wire 41a is pulled to the proximal end side (adjustment fastener 321pa side). Then, the vicinity of the distal end of the sheath tube 2 is bent (bent) along the direction indicated by the arrow d2a in FIG.

  Further, for example, when the rotary plate 32 is rotated in the direction of the arrow d1b in FIG. 1 (counterclockwise) by operating the knob 32b, the following is performed. That is, in the sheath tube 2, the operation wire 41b is pulled to the proximal end side (adjustment fastener 321pb side). 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 rotating plate 32. In addition, by rotating the handle body 31 around the axis (within the XY plane in FIG. 1), the direction of the bending direction in the vicinity of the distal end of the sheath tube 2 while the sheath tube 2 is inserted into the patient's body is maintained. Can be set freely.

  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 operates the rotating plate of the catheter (arranged in the handle provided on the proximal end side of the catheter tube 6; not shown in FIG. 1) while performing the operation along the inner hole of the sheath tube 2. The catheter tube 6 is moved. Thereby, for example, as shown in FIG. 1, the vicinity of the distal end of the catheter tube 6 extends from the distal end opening of the sheath tube 2.

  Subsequently, the operator swings and deflects the catheter tube 6 by rotating the catheter rotation plate described above. Further, as necessary, the sheath tube 2 is swung and deflected by rotating the rotating plate 32 in 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.

(Operation in the handle 3)
By the way, in such a sheath introducer 1, when the rotating plate 32 is rotated to perform the swing deflection operation of the sheath tube 2, the curved state near the distal end of the sheath tube 2 is changed depending on the use situation. There are cases that you want to keep. The operation of the handle 3 in such a case will be described in detail in comparison with a comparative example.

  FIG. 6 is a schematic diagram illustrating a schematic configuration of the sheath introducer 101 according to the comparative example. FIG. 7 illustrates a cross-sectional configuration example taken along the line III-III in the handle 103 of the sheath introducer 101 illustrated in FIG. 6.

  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 102 into the body prior to the catheter tube 6. As shown in FIG. 6, the sheath introducer 101 includes a sheath tube 102 and a handle 103 attached to the proximal end side of the sheath tube 102.

  As shown in FIGS. 6 and 7, the handle 103 includes a handle body 91 including a pair of handle members 911 and 912 that are arranged to face each other, and a rotating plate 92 that is arranged between the handle members 911 and 912. It has. The handle 103 also includes an O-ring 93 disposed between the handle member 911 and the rotating plate 92, and a washer 94 disposed between the handle member 912 and the rotating plate 92. The handle 103 is further arranged so that its base 913a is fixed to the handle member 911 by an adhesive 914 and penetrates the rotary plate 92 along the rotation axis R of the rotary plate 92, and its tip is a male screw portion. An adjustment pin 913 serving as 913b is provided. A through hole 913h through which the sheath tube 102 and the like are inserted is formed on the axis (Y-axis direction) of the adjustment pin 913. The handle 103 also has an adjustment knob 910 that has a female screw portion 910 b that is screwed with the male screw portion 913 b of the adjustment pin 913 and is rotatably attached to the handle member 912. On the adjustment knob 910, a knob 910a corresponding to a portion actually picked by the operator is provided.

  In the sheath introducer 101, when the adjustment knob 910 in the handle 103 is rotated with respect to the handle member 912 (see the arrow d103 in FIGS. 6 and 7), the following occurs. That is, when the adjustment knob 910 is rotated, the screwing depth (screwing depth) between the male screw portion 913b of the adjustment pin 913 and the female screw portion 910b of the adjustment knob 910 changes (see reference numeral m101 in FIG. 7). ). Then, when the screwing depth is changed, the tightening force of the O-ring 93 to the rotating plate 92 is changed. Specifically, when the tightening force by the O-ring 93 is increased, the operation of the rotating plate 92 becomes heavier, and when the tightening force is decreased, the operation of the rotating plate 92 is lightened.

  As described above, in the handle 103 of the sheath introducer 101, the rotating plate 92 is fixed to the handle main body 91 by twisting the adjustment knob 910 provided on the handle main body 91 (handle member 912). (Curved state near the tip) is fixed (held). However, such a handle 103 has the following problems.

  That is, when the operator performs such work, the adjustment knob 910 on the handle main body 91 (handle member 912) is fixed with the other hand while the rotating plate 92 is fixed at a desired rotation position with one hand. Need to twist. That is, in the case of the handle 103, an operation using both hands is required. Therefore, in this comparative example, work efficiency may be deteriorated, and operability may be reduced.

  In general, when performing a procedure using a sheath introducer, the shape near the distal end of the sheath tube and the shape near the distal end of the catheter tube are adjusted at the same time, so that the vicinity of the distal end of the electrode catheter is brought to an optimum position. There is a case to try to place. In such a case, when the sheath introducer 101 of the comparative example is used, as described above, both hands are used for the operation (rotation operation and rotation position fixing operation) on the sheath tube 102 side. Therefore, the operation on the catheter tube 6 side cannot be performed. In other words, in this comparative example, the shape near the distal end of the sheath tube 102 and the shape near the distal end of the catheter tube 6 cannot be adjusted at the same time. There is a risk that.

  On the other hand, in the handle 3 of the sheath introducer 1 of the present embodiment, as shown in FIGS. 1, 2, and 5, the rotating plate 32 is in the direction orthogonal to the rotation axis R (in the ZX plane). (A predetermined direction) is partially elastically displaceable. Further, a switching mechanism (in this example, a switching member) that switches between the above-described free state and the locked state with respect to the rotational position of the rotating plate 32 in accordance with the position state of the rotating plate 32 along the orthogonal direction of the rotation axis R. Ex1, Ex2) are provided.

  In this manner, in the handle 3, the rotary plate 32 is rotationally operated, and the rotary plate 32 is elastically displaced in the direction orthogonal to the rotation axis R, so that the free state and the locked state are changed according to the position state. Switching is realized. Hereinafter, the switching action between the locked state and the free state by such a switching mechanism (switching members Ex1, Ex2) will be described in detail.

  First, as shown in FIGS. 8A and 9A, for example, in a non-pressed state in which the operator's fingers do not press the knobs 322a and 322b (press the center of the rotating member 322), the following is performed. Will be locked. That is, in this non-pressed state, for example, as shown in FIG. 8A, the divided members 322d1 and 322d1 in the rotating member 322 are spaced apart from each other. For this reason, the switching member Ex1 in the handle member 321 and the switching member Ex2 in each of the divided members 322d1 and 322d2 are engaged (fitted in this example). As a result, the rotating operation of the rotating plate 32 becomes impossible, and the rotating position of the rotating plate 32 is fixed (locked state).

  In such a locked state (non-pressed state), the divided members 322d1 and 322d2 are not elastically displaced. Therefore, as shown in FIG. 9A, for example, a rod-shaped spring member 35a for realizing this elastic displacement. , 35b are also not elastically deformed.

  On the other hand, for example, as shown in FIG. 8B and FIG. 9B, the operator's fingers press the knobs 322a and 322b (the pressing of the divided members 322d1 and 322d2 in the gap direction: see the signs Fa and Fb in FIG. 8B). In the pressed state, the free state (unlocked state) is obtained as follows. That is, in this pressed state, for example, as shown in FIG. 8B, the divided members 322d1 and 322d2 of the rotating member 322 are elastically displaced along the direction orthogonal to the rotation axis R (in this example, the X-axis direction) (see FIG. 8B). (Refer to symbols m1 and m2 in 8B). For this reason, the switching member Ex1 in the handle member 321 and the switching member Ex2 in each of the divided members 322d1 and 322d2 are not engaged with each other (in this example, not fitted). In other words, the engagement (fitting) state between the switching members Ex1, Ex2 in the locked state described above is released. As a result, the rotating plate 32 can be rotated, and the rotating position of the rotating plate 32 is arbitrarily set (free state).

  In such a free state (pressed state), as described above, each of the divided members 322d1 and 322d2 is elastically displaced. Therefore, for example, as shown in FIG. 9B, the rod-like spring members 35a and 35b for realizing this elastic displacement are also partially (in this example, on the rotating member 322 side) toward the center of the rotating plate 32. The portion will be elastically deformed (see symbol ma in FIG. 9B).

  As described above, in the handle 3 according to the present embodiment, the switching state between the free state and the locked state of the rotating plate 92 is performed according to the operation (twisting operation) along the rotation axis R direction of the rotating plate 92. Unlike the handle 103 of FIG. That is, by using only the rotating plate 32 (the knobs 322a and 322b in the rotating member 322), the rotation operation of the rotating plate 32 and the switching between the locked state and the free state relating to the rotational position of the rotating plate 32 are performed by the mechanism described above. Both operations can be performed. Therefore, unlike the handle 103, the handle 3 can be operated with one hand (simple operation) to set the vicinity of the distal end of the sheath tube 2 in a desired curved state and hold the curved state. It becomes like this. As a result, in the present embodiment, unlike the comparative example described above, for example, the shape near the distal end of the sheath tube 2 and the shape near the distal end of the catheter tube 6 can be adjusted simultaneously.

  Specifically, in the sheath introducer 1 of the present embodiment, for example, the rotation operation and the switching operation described above are performed as follows.

  That is, first, as shown in FIG. 10A, for example, the operator holds the handle body 31 and holds the knobs 322a and 322b of the rotary plate 32 (the divided members 322d1 and 322d2 in the rotary member 322) with, for example, the fingers of the hand. Press (see symbols Fa and Fb in FIG. 10A). As a result, the divided members 322d1 and 322d2 are elastically displaced toward the center of the rotating plate 32 (see symbols m1 and m2 in FIG. 10A), and the rotating plate 32 is set to a free state by the mechanism described above.

  Next, the operator rotates the rotary plate 32 using the knobs 322a and 322b while pressing the knobs 322a and 322b (while maintaining the free state) (see the arrow d1a in FIG. 10A). The vicinity of the distal end of the sheath tube 2 is set to a desired curved state (see arrow d2a in FIG. 10A).

  Thereafter, for example, as shown in FIG. 10B, when the operator puts the knobs 322a and 322b into a non-pressed state, the divided members 322d1 and 322d2 are elastically displaced toward the original positions (positions separated from each other) (see FIG. 10B). 10A), the rotating plate 32 is set to the locked state by the mechanism described above. In this way, as shown in FIG. 10B, the vicinity of the distal end of the sheath tube 2 is held in a desired curved state.

  Further, in the handle 3 according to the present embodiment, as shown in FIGS. 2 and 5, the divided members 322d1 and 322d2 of the rotating member 322 have anti-slip shapes S1 and S2 that fit into each other. Specifically, in this example, the non-slip shapes S1 and S2 are configured by a combination of a semicircular convex portion and a concave portion fitted to the semicircular convex portion, respectively. Thereby, in the rotating member 322, for example, as shown in FIG. 11, the following advantages are obtained as compared with the rotating member 322A in which such anti-slip shapes S1 and S2 are not provided. That is, when the divided members 322d1 and 322d2 are engaged (fitted) with each other, sliding (mutual misalignment) along the boundary direction between them is prevented, and malfunction or the like during the rotation operation of the rotating plate 32 is avoided. Is done. In contrast, in the case of the rotating member 322A shown in FIG. 11, since such anti-slip shapes S1, S2 are not provided, when the divided members 322d1, 322d2 are engaged (contacted), There is a possibility that sliding along the boundary direction (see reference numeral SL in FIG. 11) may occur.

  Further, in this handle 3, in the pair of divided members 322d1 and 322d2 constituting the rotating member 322, the vicinity of the hole 322h is centered along the direction of elastic displacement of each of the divided members 322d1 and 322d2 (the direction orthogonal to the rotation axis R). As described above, one switching member Ex2 is disposed at positions that are substantially point-symmetric with respect to each other.

  Thereby, since the switching member Ex2 is first disposed along the direction of the elastic displacement described above, the switching member is compared with the case where the second switching member is disposed at a position excluding such a direction. The engagement (fitting) state between Ex1 and Ex2 becomes better. Specifically, since the switching member Ex2 is disposed along the direction of elastic displacement (the direction orthogonal to the rotation axis R), the position of the concavo-convex shape (male shape and female shape) between the switching members Ex1 and Ex2 is determined. Match and make it easier to fit together. Further, in this case, it can be said that the amount of displacement at the time of elastic displacement is the largest, so that it can be easily fitted. On the other hand, when the switching member Ex2 is arranged along a direction other than the elastic displacement direction, the positions of the concavo-convex shape between the switching members Ex1 and Ex2 do not match each other, so that it becomes difficult to fit each other. In this case, depending on the length of the switching member Ex2 in the protruding direction, the outer edge portion (side surface) in the elastic displacement direction of the divided members 322d1 and 322d2 comes into contact with the switching member Ex1 before the switching member Ex2, and the switching is performed. There is also a possibility that the fitting between the members Ex1 and Ex2 becomes insufficient.

  In addition, since one switching member Ex2 is disposed at positions that are substantially point-symmetric with respect to each other, for example, as shown in FIG. 12, a plurality of switching members Ex2 are provided in each of the divided members 322d1 and 322d2 (in this example, 2). The following advantages can be obtained as compared with the case where each piece is arranged. That is, an engagement (fitting) failure between the switching members Ex1 and Ex2 (a phenomenon that the rotating plate 32 cannot be set in a locked state or the like; a state where the rotating plate 32 is not engaged (fitted) is balanced) occurs. It becomes difficult (desirably it does not occur). Specifically, since the switching members Ex2 are arranged one by one, even if the positions of the concave and convex shapes between the switching members Ex1 and Ex2 are shifted in the pressed state, the positions where they are fitted to each other by the elastic force (The misalignment is repaired), and poor fitting is avoided. On the other hand, when a plurality of switching members Ex2 are arranged, if the position of the concavo-convex shape between the switching members Ex1 and Ex2 is shifted in the pressed state, the displacement due to such elastic force There is a case where the repair is not performed and the mating state is engaged with the fitting state being insufficient. In such a case, there is a possibility that the rotating plate 32 rotates with some time signature (fitting failure occurs).

  As described above, in the present embodiment, a rotating plate 32 that is partly elastically displaceable along the direction orthogonal to the rotation axis R is provided, and the position along the direction orthogonal to the rotation axis R on the rotation plate 32 is provided. Switching mechanisms (switching members Ex1, Ex2) for switching between the free state and the locked state of the rotating plate 32 according to the state are provided. Thereby, the operation | work which hold | maintains the front-end | tip vicinity of the sheath tube 2 in a desired curved state is realizable by operation by one hand. Therefore, it is possible to improve work efficiency and improve operability.

  Further, since it can be realized by an operation with one hand, unlike the comparative example described above, for example, the following erroneous operation can be prevented during the work of holding the vicinity of the distal end of the sheath tube 2 in a desired curved state. It becomes possible to do. That is, in the case of the comparative example, when the adjustment knob 910 is twisted with one hand, the rotational position of the rotating plate 92 held by the other hand may slightly vary due to camera shake or the like. (Incorrect operation may occur.) On the other hand, in the present embodiment, as described above, since the work at this time is completed by an operation with one hand, the occurrence of such an erroneous operation is avoided.

  Further, the rotating plate 32 is constituted by a pair of rotating members 321 and 322, and only one of the rotating members 321 and 322 (the rotating member 322) is elastically displaced along the direction orthogonal to the rotation axis R. Therefore, the following effects can also be obtained. That is, as compared with the case where both of the rotating members 321 and 322 undergo such elastic displacement, it becomes easier to determine which state is currently set between the above-described free state and locked state, and operability ( Convenience) can be improved. Specifically, whether or not the rotating member 322 is elastically displaced according to the relative positional relationship (relative position state) between the rotating member 321 and the rotating member 322, that is, a free state and a locked state. It is easy to determine which state is in the state held by the operator. This is because the rotation member 322 elastically displaces in the locked state, so that the positions of the side surfaces of the rotation members 321 and 322 do not coincide with each other (side surface positions deviate from each other), while the rotation member 322 elastically displaces in the free state. This is because the positions of the side surfaces of the rotating members 321 and 322 coincide with each other.

  In addition, the rotating member 322 is configured by a pair of divided members 322d1 and 322d2 that are arranged side by side along the direction orthogonal to the rotation axis R and each provided with a switching member Ex2, and in each divided member 322d1 and 322d2 Since the elastic displacement is enabled along the orthogonal direction of the rotation axis R, the following effects can be obtained. That is, the direction in which the operator holds the rotating plate 32 (rotating member 322) during the rotation operation (direction in which a force is applied by the finger) and the direction of the elastic displacement (direction in which the finger is pressed during the switching operation). Are coincident (in the direction orthogonal to the rotation axis R), it is not necessary to apply a force in an extra direction, and the operability can be further improved. Specifically, when the operator performs a rotation operation, the rotary plate 32 is picked and gripped by, for example, the thumb and the index finger at the portions 32a and 32b, and the force is always applied along the direction orthogonal to the rotation axis R. The rotating plate 32 is rotated while being added. Therefore, it is possible to perform the switching operation between the free state and the locked state by simply increasing the force applied in that state and pressing the knobs 322a and 322b, and a smooth switching operation can be realized. .

  In addition, the rotating plate 32 is set in the locked state in the non-pressed state described above, and the rotating plate 32 is set in the free state in the pressed state described above. Switching is realized by a simple operation, and the operability can be further improved. Conversely, compared with the case where the non-pressed state is set to the free state and the pressed state is set to the locked state, the operation in the operation of holding the vicinity of the distal end of the sheath tube 2 in a desired curved state. It is possible to further improve the performance. Specifically, for example, when the handle 3 is not held with both hands (when held with one hand), when the curved shape near the distal end of the sheath tube 2 is determined, the hand is released from the handle 3 of the sheath introducer 1. After removing the finger from the knobs 32a and 32b, the operation of the catheter is started. Therefore, as in the present embodiment, the rotating plate 32 is set to the locked state in the non-pressed state (the state where the hand is released from the handle 3), and the desired curved state is maintained. It can be said that operability becomes easy.

  Furthermore, since the switching member Ex1 is provided on the handle member 311 in addition to the handle member 312, and the handle members 311 and 312 have the same shape, the following effects can be obtained. That is, although the switching member Ex1 in the handle member 311 is not actually used, the two handle members 311 and 312 have the same shape, which makes it possible to manufacture using the same mold, for example, and facilitate the manufacturing. And manufacturing cost can be reduced.

  In the present embodiment, since the connection pins 311p and 312p and the switching member Ex1 are formed in the handle members 311 and 312, as in the above-described comparative example, a dedicated separate for ensuring their functions. There is no need to separately provide members (adjustment pins 913 and adjustment knobs 910). Therefore, in the handle 3 of the present embodiment, the number of parts can be reduced as compared with the handle 103 of the comparative example, the manufacturing cost can be reduced, and the work during the manufacturing (assembly) is simplified. Can be realized.

  In addition, since the rotation operation part in the handle 3 has a spring member that realizes the elastic displacement in each of the divided members 322d1 and 322d2, the elastic displacement in each of the divided members 322d1 and 322d2 can be realized with a simple configuration. It becomes possible.

  Particularly in the present embodiment, such a spring member is constituted by rod-like spring members 35a and 35b extending along the rotation axis R and connecting the rotary member 321 and the divided members 322d1 and 322d2 to each other. ing. And since each said rod-shaped spring member 35a, 35b was elastically deformed partially along the orthogonal direction of the rotating shaft R, since the said elastic displacement in each division member 322d1, 322d2 was implement | achieved, the following effects Can also be obtained. That is, it is possible to realize the elastic displacement in each of the divided members 322d1 and 322d2 with a simpler and space-saving configuration while ensuring the role as a connecting member between the rotating member 321 and each of the divided members 322d1 and 322d2. Become. Further, since the rod-like spring members 35a and 35b are inserted and arranged in the rotating plate 32, and a mechanism (elastic displacement mechanism) for applying an elastic displacement only by the rotating plate 32 is completed, such an elastic displacement mechanism is rotated. In this case, the operability can be further improved. When the elastic displacement mechanism is provided in a portion other than the rotating plate 32 (for example, the handle main body 31), the relative positional relationship between the handle main body 31 and the rotating plate 32 is changed by the rotation operation. It will be caught by a member, and it will become an obstacle at the time of rotation operation. In addition, when such rod-shaped spring members 35a and 35b are used, the spring property can be arbitrarily adjusted (set) by adjusting the material and thickness of the rod-shaped portion, for example.

  In addition, you may make it use other spring members (for example, the coil spring etc. which connect each division member 322d1,322d2) other than rod-shaped spring member 35a, 35b as such a spring member.

<Modification>
Subsequently, modified examples (modified examples 1 to 5) 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. 13A illustrates a planar configuration example of the handle members (handle members 311B and 312B) according to the first modification. FIG. 13B illustrates a planar configuration example of a rotating member (rotating member 322B) according to Modification 1.

  The handle members 311B and 312B shown in FIG. 13A correspond to the handle members 311 and 312 described in the above embodiment, in which a switching member Ex1B is provided instead of the switching member Ex1, and other configurations are as follows. It is the same. Specifically, the switching member Ex1B has a shape that fits with a switching member Ex2B described below. In this example, the switching member Ex1B has a male screw shape.

  On the other hand, the rotating member 322B shown in FIG. 13B corresponds to the rotating member 322 described in the above embodiment, in which the switching member Ex2B is provided instead of the switching member Ex2, and the other configurations are the same. ing. Specifically, the switching member Ex2B has a shape that fits with the switching member Ex1B described above, and in this example, has a female screw shape.

  Thus, in this modification, the shape of the switching members Ex1B, Ex2B (switching member Ex1B: male screw shape, switching member Ex2B: female screw shape) is the shape of the switching members Ex1, Ex2 in the above embodiment (switching member Ex1: female screw). The shape and switching member Ex2: male screw shape) are the opposite combination.

  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.

[Modification 2]
FIG. 14A illustrates a planar configuration example of a handle member (handle members 311C and 312C) according to Modification 2. FIG. 14B illustrates a planar configuration example of a rotating member (rotating member 322C) according to Modification 2.

  The handle members 311C and 312C shown in FIG. 14A correspond to the handle members 311 and 312 described in the above embodiment, in which a switching member Ex1C is provided instead of the switching member Ex1, and other configurations are as follows. It is the same. Specifically, the switching member Ex1C is a ring-shaped member that circulates around the connection pins 311p and 312p (rotation axis R).

  On the other hand, the rotating member 322C shown in FIG. 14B corresponds to the rotating member 322 described in the above embodiment, in which the switching member Ex2C is provided instead of the switching member Ex2, and the other configurations are the same. ing. Specifically, the switching member Ex2C is a ring-shaped member that circulates around the hole 322h (rotating axis R) in the rotating member 322C.

  As described above, in the present modification, the switching members Ex1C and Ex2C are ring-shaped members that are engaged (contacted) with each other. In the pressed state described in the above embodiment, the switching members Ex1C and Ex2C are in contact with each other, and the friction state (coefficient of friction) between these contact surfaces is used, whereby the locked state of the rotating plate 32 is achieved. Will be realized. Such switching members Ex1C and Ex2C (ring-shaped members) can be made of a material such as a fluorine-based resin such as silicon or polytetrafluoroethylene, for example.

  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, since the ring-shaped members are used as the switching members Ex1C and Ex2C, the rotational position of the rotating plate 32 can be set to an arbitrary continuous (non-discrete) position. . In contrast, in the case of the switching members Ex1 and Ex2 and the switching members Ex1B and Ex2B described so far, the rotational position of the rotating plate 32 is a shape that fits between these members (in these examples, the screw The rotation position of the rotating plate 32 is set to a discrete position.

[Modifications 3 and 4]
The “first switching member” and the “second switching member” in the present invention are, for example, combinations of the ring-shaped member and the convex member (such as a male screw-shaped member) described so far. May be.

  That is, for example, the switching member Ex1B that is a convex member is used as the “first switching member” on the handle body 31 side, and the switching that is a ring-shaped member is used as the “second switching member” on the rotating plate 32 side. The member Ex2C may be used (Modification 3).

  Further, for example, a switching member Ex1C that is a ring-shaped member is used as the “first switching member” on the handle main body 31 side, and a switching that is a convex member is used as the “second switching member” on the rotating plate 32 side. The member Ex2 may be used (Modification 4).

  Also in the modified examples 3 and 4 having such a configuration, basically the same effect can be obtained by the same operation as in the above-described embodiment. Further, in these modified examples 3 and 4, since a ring-shaped member is used for one of the “first switching member” and the “second switching member”, the same as in the case of the modified example 2 above. The rotational position of the rotating plate 32 can be set to an arbitrary continuous position.

  In addition, when these modified examples 3 and 4 are compared with each other, in terms of manufacturing, a ring-shaped member is not used for the “second switching member” on the rotating plate 32 side (the ring-shaped member is divided member 322d1, (It is not necessarily divided into two semicircular shapes corresponding to the shape of 322d2). In the modified example 4 having such a configuration, a ring-shaped member is used as the “second switching member” on the rotating plate 32 side (the ring-shaped member has two half members corresponding to the shapes of the divided members 322d1 and 322d2). This is because the “second switching member” is easier to manufacture than the third modification example (divided into a circle). However, it can be said that the modification 3 and 4 have the same functional effect of the first and second switching members.

[Modification 5]
(Constitution)
FIG. 15 schematically illustrates a schematic configuration example of the electrode catheter 5 as a medical device according to the fifth modification. 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 operation wires 41a and 41b are fixed to the distal end side of the catheter tube 6. Each proximal end side of the operation wires 41 a and 41 b is also extended from the catheter tube 6 onto the rotary plate 32 as in the case of the sheath tube 2. 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 thin wires (such as operation wires 41a and 41b and conductive wires (not shown)) are inserted through 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 of the rotating plate 32 by the operator.

  Specifically, for example, when the operator grips the handle 3 with one hand and operates the knob 32a with the finger of one hand to rotate the rotating plate 32 in the direction of the arrow d1a (clockwise) in FIG. It becomes as follows. That is, in the catheter tube 6, the operation wire 41a is pulled to the proximal end side (adjustment fastener 321pa side). 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, for example, when the rotary plate 32 is rotated in the direction of the arrow d1b in FIG. 15 (counterclockwise) by operating the knob 32b, the following is performed. That is, in the catheter tube 6, the operation wire 41b is pulled to the proximal end side (adjustment fastener 321pb side). 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 rotating plate 32. In addition, by rotating the handle body 31 around the axis (within the XY plane in FIG. 15), the direction of the bending direction in the vicinity of the distal end of the catheter tube 6 while the catheter tube 6 is inserted into the patient's body is maintained. Can be set freely.

  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 provided also in the electrode catheter 5 of the present modification, the operation of holding the vicinity of the distal end of the catheter tube 6 in a desired curved state is performed. It can be realized by operation with one hand. Therefore, it is possible to improve work efficiency and improve operability.

  In addition, also in the handle 3 of the electrode catheter 5 of this modified example, the various members (handle members 311B, 311C, 312B, 312C, rotating members 322A, 322B, 322C, switching members Ex1B, Ex1C described in the modified examples 1 to 4 and the like). , Ex2B, Ex2C, etc.) may be applied.

<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 shape, arrangement position, material, and the like of each member described in the above embodiments are not limited, and other shapes, arrangement positions, materials, and the like may be used.

  In the above embodiment, the configuration of the tubular member (the sheath tube 2 or the catheter tube 6) is specifically described. However, it is not always necessary to include all the members, and other members are further included. It may be. Specifically, for example, a leaf spring that can be deformed in the bending direction may be provided inside the catheter tube 6 as a swinging member. Further, the configuration of the electrodes in the catheter tube 6 (arrangement, shape, number, etc. of the ring-shaped electrode 61 and the tip electrode 62) is not limited to those described in the above-described embodiment and the like.

  Furthermore, in the above-described embodiment and the like, the configuration of the handle 3 (the handle body 31 and the rotation operation unit) has been specifically described. However, it is not always necessary to include all the members, and other members may be further provided. You may have. Specifically, for example, the intermediate member 33 may not be provided depending on circumstances. In addition, the configuration of the switching mechanism is not limited to that described in the above embodiment and the like (switching members Ex1, Ex2, etc.), and other configurations may be employed. Furthermore, the rotating plate 32 is not limited to the case where only a part of the rotating plate 32 is configured to be elastically displaceable along the direction orthogonal to the rotation axis R as described in the above-described embodiment, and at least a part of the rotating plate 32 is elastically displaced. What is necessary is just to be comprised. In the above-described embodiment and the like, the case where the second switching member (switching member Ex2 or the like) is provided in each of the pair of split members 322d1 and 322d2 is not limited thereto. The second switching member may be provided only on one of the divided members 322d1 and 322d2. However, when each of the second switching members is provided as in the above-described embodiment and the like, the strength in the locked state (lock strength) is increased as compared with the case where the second switching member is provided only on one side. The reliability of the product at the time can be improved.

  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, the medical device of the type (bi-direction type) in which the shape near the tip of the tubular member changes in both directions according to the operation of the rotating plate 32 has been described as an example. This is not a limitation. That is, the present invention can be applied to, for example, a medical device of a type (single direction type) in which the shape near the tip of the tubular member changes in one direction according to the operation of the rotating plate 32. In this case, only one (one) operation wire and one adjustment fastener are provided.

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

  Furthermore, in the 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 ... Sheath introducer, 2 ... Sheath tube, 3 ... Handle, 31 ... Handle body, 311, 311B, 311C, 312, 312B312C ... Handle member, 311p, 312p ... Connecting pin, 32 ... Rotating plate, 321, 322, 322A , 322B, 322C... Rotating member, 32a, 32b, 321a, 321b, 322a, 322b... , 342 ... connecting member, 341h, 342h ... hole, 35a, 35b ... rod spring member, 41a, 41b ... operating wire, 5 ... electrode catheter, 6 ... catheter tube, 61 ... ring electrode, 62 ... tip electrode, R: rotating shaft, g1: guide groove, g31, g32: guide path, x1, Ex1B, Ex1C, Ex2, Ex2B, Ex2C ... switching member, Gs11, Gs21, Gs22 ... gap space, S1, S2 ... antislipping shape.

Claims (13)

A handle attached to the proximal end of a flexible tubular member,
The handle body,
A rotation operation unit used in a rotation operation for bending the vicinity of the tip of the tubular member,
The rotation operation unit is
A rotating plate that is rotatably attached to the handle body, and at least a part of which is configured to be elastically displaceable along a direction orthogonal to the rotation axis thereof;
According to the position state along the orthogonal direction of the rotation axis in the rotating plate, the rotating operation is enabled and the rotating position of the rotating plate is arbitrarily set, and the rotating operation is disabled. rotational position of the rotary plate Te has been closed and locked state to be immobilized, and a switching mechanism for switching,
The handle body is constituted by first and second handle members facing each other along the rotation axis;
The rotating plate is disposed opposite to each other between the first and second handle members, and is located on the first handle member side and the second handle member side. A second rotating member capable of elastic displacement;
The medical device handle , wherein the switching mechanism includes a first switching member provided on the second handle member and a second switching member provided on the second rotating member . The second rotating member is configured by a pair of divided members that are arranged side by side along an orthogonal direction of the rotating shaft and at least one of which is provided with the second switching member,
The medical device according to claim 1 , wherein the elastic member is capable of being displaced along a direction orthogonal to the rotation axis in a split member provided with at least the second switching member of the pair of split members. Handle. Each of the pair of split members is provided with the second switching member;
In the non-pressed state in which the divided members are spaced apart from each other, the first switching member in the second handle member and the second switching member in each divided member are engaged with each other to be in the locked state,
In a pressed state in which each divided member is pressed along the gap direction and the elastic displacement is made, the first switching member in the second handle member and the second switching member in each divided member; The medical device handle according to claim 2 , wherein the two are disengaged from each other to enter the free state. The rotation operating part, medical instrument handle of claim 2 or claim 3 having the spring member to realize the elastic displacement in the dividing member. The spring member is a rod-shaped spring member that extends along the rotation axis and connects the first rotation member and the split member to each other;
The handle for a medical device according to claim 4 , wherein the elastic displacement of the split member is realized by the elastic deformation of the rod-shaped spring member partially along a direction orthogonal to the rotation axis. The handle for a medical device according to any one of claims 2 to 5 , wherein the pair of split members have a non-slip shape that fits together. Wherein the pair of divided members, the a position to be substantially point symmetrical to each other along the direction of the elastic displacement, any one of the second switching member is claims 2 to 6 are arranged one by one A handle for medical equipment as described in 1. The first of said first switching member is provided in the handle member, said any one of the first and second handle members are the same shape as going on claims 1 to 7 with each other The medical device handle described. It said first and second switching member is a medical device handle according to any one of claims 1 to 8 which is shaped to mate with each other. Wherein one of the first and second switching member, one handle for a medical device according to any one of claims 1 to 8 and the other is convex member with a ring-shaped member. It said first and second switching member, respectively, medical equipment handle according to one of claims 1 to 8 is ring-shaped member. The tubular member, medical device handle according to any one of claims 1 to 1 1 is a sheath tube or catheter tube. A tubular member having flexibility;
A handle having a handle main body and a rotation operation unit used in a rotation operation for bending the vicinity of the distal end of the tube-shaped member, the handle being mounted on the proximal end side of the tube-shaped member;
The rotation operation unit is
A rotating plate that is rotatably attached to the handle body, and at least a part of which is configured to be elastically displaceable along a direction orthogonal to the rotation axis thereof;
According to the position state along the orthogonal direction of the rotation axis in the rotating plate, the rotating operation is enabled and the rotating position of the rotating plate is arbitrarily set, and the rotating operation is disabled. rotational position of the rotary plate Te has been closed and locked state to be immobilized, and a switching mechanism for switching,
The handle body is constituted by first and second handle members facing each other along the rotation axis;
The rotating plate is disposed opposite to each other between the first and second handle members, and is located on the first handle member side and the second handle member side. A second rotating member capable of elastic displacement;
The medical device in which the switching mechanism includes a first switching member provided on the second handle member and a second switching member provided on the second rotating member .

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