JP2020062181A - Medical equipment - Google Patents

Abstract

To provide medical equipment whose operability when controlling direction of an end of a tube member can be improved.SOLUTION: Medical equipment 1 includes: a tube member 13 having flexibility; a handle part 14 controlling the direction of an end of the tube member 13; a first feed shaft 3 where a first moving member 2 moves; a second feed shaft 5 where a second moving member 4 moves; a first operation wire 6 one end of which is fixed to the end of the tube member 13 and the other end of which is fixed to the first moving member 2; a second operation wire 7 one end of which is fixed to the end of the tube member 13 and the other end of which is fixed to the second moving member 4; a first gear 8 fixed to the first feed shaft 3; a second gear 9 fixed to the second feed shaft 5; and a first main gear 10 which is provided between the first gear 8 and the second gear 9 and transmits a rotation driving force to the first gear 8 and the second gear 9.SELECTED DRAWING: Figure 4

Description

  The present invention relates to medical devices. More specifically, the present invention relates to a medical device that includes a flexible medical tube member such as a sheath, a catheter, or an endoscope tube, and that can control the orientation of the distal end of the tube member. .

Conventionally, as this type of medical device, the one disclosed in Patent Document 1 is known.
A medical device (bidirectionally propellable catheter control handle) disclosed in Patent Document 1 is a handle for controlling the deflection of a distal end of a catheter body including first and second deflection wires, A slide base including a first end, a second end and a slide chamber extending longitudinally within at least a portion of the slide base; and the first of the slide bases. An adjustment knob rotatably coupled to an end of the adjustment knob, the adjustment knob having a hole extending therethrough and at least a portion of an inner diameter of the hole including an inner right-hand thread and an inner left-hand thread. A first slide disposed in the slide chamber and adapted to be coupled to the first flexure wire and including an outer right hand thread; A second slide disposed and adapted to be coupled to the second flexure wire and including an outer left hand thread, wherein an inner thread of the adjustment knob includes: The slide is engaged with an outer screw, and the slides are displaced in opposite directions in the slide chamber by rotation of the adjustment knob (see claims of Patent Document 1).

Japanese Patent No. 4468296

  However, the configuration of the medical device disclosed in Patent Document 1 has a structure in which two semi-cylindrical slides move in opposite directions while sliding (see paragraph [0029] of Patent Document 1). The friction between the two slides causes a loss of force transmission. As a result, a strong turning force is required for the adjustment knob (dial), and there is a problem in that the operability when controlling the deflection of the distal end (direction of the tip) of the catheter body (tube member) is poor.

  Therefore, the present invention provides a medical device capable of improving the operability when controlling the direction of the distal end of the tube member by making it possible to suppress the rotational force applied to the rotary operation part (dial) to be small. The purpose is to do.

In order to achieve the above object, the configuration of the medical device according to the present invention is
(1) Flexible tube member,
A handle portion for controlling the direction of the tip of the tube member,
A first feed shaft on which the first moving member moves,
A second feed shaft on which the second moving member moves,
A first operating wire having one end fixed to the tip of the tube member and the other end fixed to the first moving member or a first other member interlocking with the first moving member;
A second operation wire having one end fixed to the tip of the tube member and the other end fixed to the second moving member or a second other member that works in conjunction with the second moving member;
A first gear fixed to the first feed shaft;
A second gear fixed to the second feed shaft;
A first main gear that is provided between the first gear and the second gear and that transmits a rotational driving force to the first gear and the second gear,
The handle portion has a first rotation operation portion that rotates the first main gear,
When the first rotation operation portion is rotated in the forward rotation direction, the first moving member moves to the proximal end side, so that the first operation wire causes the distal end of the tube member to move in the first direction. Biased to
When the first rotation operation portion is rotated in the reverse rotation direction opposite to the normal rotation direction, the second moving member moves to the proximal end side, so that the second operation wire moves to the tube member. Is deflected in a second direction opposite to the first direction.

The configuration (1) of the medical device of the present invention has the following operational effects. That is, since the first moving member (first slide) and the second moving member (second slide) are provided separately from each other, the friction between the two moving members (slides) causes the transmission of force. There is no loss.
Therefore, according to the above configuration (1) of the medical device of the present invention, a strong rotational force to the first rotary operation unit (dial) is not required, and therefore an operation for controlling the direction of the distal end of the tube member is performed. It is possible to improve the sex.

  In the above-mentioned configuration (1) of the medical device of the present invention, it is preferable to have the following configurations (2) to (4).

  (2) The curved shape of the distal end of the tube member is different between when the first rotation operation portion is rotated in the normal rotation direction and when the first rotation operation portion is rotated in the reverse rotation direction. Take a shape. According to the preferable configuration of the above (2), one tube member can selectively use two curves, and it is possible to reach a large number of sites.

  (3) The first fixing portion to which the one end of the first operation wire is fixed and the second fixing portion to which the one end of the second operation wire is fixed are provided at positions facing each other. ing.

(4) A third feed shaft on which the third moving member moves,
A fourth feed shaft on which the fourth moving member moves,
A third operation wire having one end fixed to the tip of the tube member and the other end fixed to the third moving member or a third other member interlocking with the third moving member;
A fourth operation wire having one end fixed to the tip of the tube member and the other end fixed to the fourth moving member or a fourth other member interlocking with the fourth moving member;
A third gear fixed to the third feed shaft,
A fourth gear fixed to the fourth feed shaft,
A second main gear that is provided between the third gear and the fourth gear and that transmits a rotational driving force to the third gear and the fourth gear,
The handle portion further includes a second rotation operation portion that rotates the second main gear,
When the second rotation operation portion is rotated in the forward rotation direction, the third moving member moves to the proximal end side, so that the third operation wire moves the distal end of the tube member in the third direction. Biased to
When the second rotation operation unit is rotated in the reverse rotation direction opposite to the normal rotation direction, the fourth moving member moves to the proximal end side, so that the fourth operation wire moves toward the tube member. Deflecting the tip of the to a fourth direction opposite to the third direction,
The third direction and the fourth direction are directions substantially orthogonal to the first direction and the second direction. According to the preferable configuration of (4) above, the tip of the tube member can be deflected in four directions. Furthermore, by combining deflections in four directions, it is possible to deflect in any direction of 360 degrees. For example, a cardiac catheter or the like to be inserted into the medical device of the present configuration can be correctly placed at the target site more easily without rotating the medical device of the present configuration itself.

  According to the present invention, since a strong rotational force is not required for the rotary operation part (dial), it is possible to improve operability when controlling the direction of the tip of the tube member.

FIG. 1 is a perspective view showing an external configuration of a medical device according to Embodiment 1 of the present invention. FIG. 2 is a perspective view showing an internal mechanism of the medical device according to the first embodiment of the present invention (a state in which the second case member is removed, and the first operation wire and the second operation wire are omitted). FIG. 3 is a plan view (a state in which the second case member is removed, the first operation wire and the second operation wire are omitted) showing an internal mechanism of the medical device according to the first embodiment of the present invention. FIG. 4 is a plan view (the second case member is omitted) showing the internal mechanism of the medical device according to the first embodiment of the present invention. FIG. 5 is a cross-sectional plan view showing the configuration of the distal end portion of the tube member that is a constituent member of the medical device according to the first embodiment of the present invention. FIG. 6 is an exploded perspective view (first operation wire and second operation wire are omitted) showing each component of the medical device according to the first embodiment of the present invention. FIG. 7 is an exploded plan view showing the components of the medical device according to the first embodiment of the present invention (the first operation wire and the second operation wire are omitted). FIG. 8: is a top view for demonstrating the 1st example of the usage type of the medical device in Embodiment 1 of this invention. FIG. 9: is a top view for demonstrating the 2nd example of the usage type of the medical device in Embodiment 1 of this invention. FIG. 10 is a perspective view showing an external configuration of a medical device according to the second embodiment of the present invention. FIG. 11 is a perspective view showing the internal mechanism of the medical device according to the second embodiment of the present invention (the second case member is removed, and the first to fourth operation wires are omitted). FIG. 12 is a plan view showing the internal mechanism of the medical device according to the second embodiment of the present invention (the state in which the second case member is removed, and the first to fourth operation wires are omitted). FIG. 13 is a plan view (the second case member is omitted) showing the internal mechanism of the medical device according to the second embodiment of the present invention. 14A and 14B are diagrams ((a) is a plan sectional view and (b) is a side sectional view) showing a configuration of a distal end portion of a tube member which is a constituent member of a medical device according to Embodiment 2 of the present invention. FIG. 15 is an exploded perspective view (first to fourth operation wires are omitted) showing each component of the medical device according to the second embodiment of the present invention. FIG. 16 is an exploded plan view (first to fourth operation wires are omitted) showing each component of the medical device according to the second embodiment of the present invention. FIG. 17 is a plan view for explaining the first example of the usage pattern of the medical device according to the second embodiment of the present invention. FIG. 18 is a plan view for explaining a second example of the usage pattern of the medical device according to Embodiment 2 of the present invention. 19A and 19B are views for explaining a third example of the usage pattern of the medical device according to the second embodiment of the present invention ((a) is a plan view and (b) is a view from a direction of an arrow W in (a)). It is a side view). 20A and 20B are views for explaining a fourth example of the usage pattern of the medical device according to the second embodiment of the present invention ((a) is a plan view and (b) is a view from a direction of an arrow W in (a)). It is a side view).

  Hereinafter, the present invention will be described more specifically by using preferred embodiments. However, the following embodiments are merely examples embodying the present invention, and the present invention is not limited thereto.

[Embodiment 1]
(Medical device configuration)
First, the configuration of the medical device according to the first embodiment of the present invention will be described with reference to FIGS. 1 to 7, taking as an example the case where the tube member is a sheath for an introducer.

  The medical device 1 shown in FIG. 1 is a distal end movable type sheath including an introducer sheath 13 and a handle portion 14. The sheath 13 is formed of a flexible tube member. The handle portion 14 controls the orientation of the distal end of the sheath 13. The sheath 13 includes a sheath tube 13a, a sheath hub 13b, a side port 13c, and a hemostatic valve (not shown) built in the sheath hub 13b. The sheath hub 13b is provided at the base end of the sheath tube 13a. The side port 13c is formed integrally with the sheath hub 13b and communicates with the inside of the sheath tube 13a. The hemostasis valve has a double structure, and a hemostasis effect can be expected as compared with the case of a single valve. The sheath 13 is used by being integrated with a dilator (not shown), and is used, for example, when inserting a heart catheter into the atrium / ventricle from a blood vessel. A dilator insertion port 13d for inserting a dilator is provided at the rear end of the sheath hub 13b.

  A three-way stopcock (not shown) is attached to the side port 13c via a side tube (not shown). For the purpose of preventing air from being mixed into the blood vessel, heparinized physiological saline (saline) is injected into the sheath tube 13a from the three-way stopcock before inserting the sheath tube 13a into the blood vessel (air portion is used as raw food). Replacement). The three-way stopcock is also used to suck in air that is mixed when the dilator is pulled out after inserting the sheath tube 13a into the blood vessel or when another combined device is put in and out of the sheath tube 13a. Furthermore, when injecting the drug solution, the injection is performed from the three-way stopcock.

  The material of the sheath tube 13a is preferably, for example, a biocompatible synthetic resin selected from polyether block amide, polyamide (nylon 11), polytetrafluoroethylene and the like. The material of the sheath hub 13b is preferably a hard material such as hard resin. Examples of the hard resin include polyethylene, polypropylene, polyamide, polycarbonate, polystyrene and the like. Examples of the material of the hemostatic valve include ABS resin and silicone rubber.

As shown in FIG. 1 to FIG. 3, FIG. 6, and FIG. 7, the handle portion 14 is provided with a first rotary operation portion (dial) 11 at the tip portion and a substantially cylindrical handle at the rear end portion. A case 12 is provided. The first rotation operation portion (dial) 11 is formed in a substantially columnar shape having substantially the same diameter as the handle case 12, and rotates a first main gear 10 described later.
The handle case 12 is formed by assembling the first case member 12a and the second case member 12b with each other. In the handle case 12, the first moving member 2, the first feed shaft 3, the second moving member 4, the second feed shaft 5, the first gear 8, the second gear 9, the first gear 9, The main gear 10 is housed.
The first moving member 2 is formed in a substantially rectangular parallelepiped shape and moves on the first feed shaft 3 in the longitudinal direction. The second moving member 4 is formed in a substantially rectangular parallelepiped shape and moves on the second feed shaft 5 in the longitudinal direction. The first feed shaft 3 and the second feed shaft 5 are arranged in the circumferential direction at intervals of approximately 180 degrees, and are accommodated in a separated state.
The first gear 8 is fixed to the tip of the first feed shaft 3. The second gear 9 is fixed to the tip of the second feed shaft 5. The first main gear 10 is provided between the first gear 8 and the second gear 9 and transmits the rotational driving force in the same direction to the first gear 8 and the second gear 9.

As shown in FIGS. 4 and 5, one end of the first operation wire 6 is fixed to the distal end of the sheath tube 13a, and the other end of the first operation wire 6 is fixed to the first moving member 2. . Further, one end of the second operation wire 7 is fixed to the tip of the sheath tube 13 a, and the other end of the second operation wire 7 is fixed to the second moving member 4. The first fixing portion to which one end of the first operating wire 6 is fixed and the second fixing portion to which one end of the second operating wire 7 is fixed are provided at opposite positions. The present invention is not limited to the configuration in which the other ends of the first and second operation wires 6 and 7 are fixed to the first and second moving members 2 and 4. For example, the other ends of the first and second operation wires 6 and 7 are fixed to another member (first and second other members (not shown)), and the first and second members are connected via the other member. The two operation wires 6 and 7 and the first and second moving members 2 and 4 may be interlocked. According to this configuration, it becomes easy to adjust the length when the operation wires 6 and 7 are assembled.
Further, in the configuration using the other member, when the moving members 2 and 4 move to the tip side, the other member does not interlock with the first and second moving members 2 and 4 and When the second moving members 2 and 4 move to the base end side, other members may be configured to interlock with the first and second moving members 2 and 4. According to this configuration, the tips of the first and second operation wires 6 and 7 do not move to the tip side more than necessary, and the play of the tips of the first and second operation wires 6 and 7 can be suppressed. .

When the first rotation operation unit 11 is rotated in the forward rotation direction, the first moving member 2 moves to the proximal end side, so that the first operation wire 6 causes the distal end of the sheath tube 13a to move in the first direction. (See FIG. 8). Further, when the first rotation operation unit 11 is rotated in the reverse rotation direction opposite to the normal rotation direction, the second moving member 4 moves to the proximal end side, so that the second operation wire 7 is sheathed. The tip of the tube 13a is deflected in a second direction opposite to the first direction (see FIG. 9). The number of teeth of the first gear 8 and the number of teeth of the second gear 9 are the same, and the pitch of the male screw of the first feed shaft 3 and the pitch of the male screw of the second feed shaft 5 which will be described later are also the same. is there. As a result, the curved shape of the distal end of the sheath tube 13a is substantially the same when the first rotation operation part 11 is rotated in the forward rotation direction and when the first rotation operation part 11 is rotated in the reverse rotation direction. Take
By stopping the rotation of the first rotation operation unit 11 at an arbitrary rotation angle, the degree of curve of the distal end of the sheath tube 13a can be maintained at an arbitrary degree. That is, the curved shape of the distal end of the sheath tube 13a can be selected according to the case.
The sheath tube 13a may have substantially uniform flexibility over the whole, but a flexible portion may be provided in the resin of the tip end portion so that only the tip end portion can be easily bent.

The configuration of the medical device 1 of this embodiment has the following operational effects. That is, since the first moving member (first slide) 2 and the second moving member (second slide) 4 are provided apart from each other, the friction between the two moving members (slides) 2 and 4 is reduced. There is no loss of force transmission.
Therefore, according to the configuration of the medical device 1 of the present embodiment, a strong rotational force to the first rotation operation unit (dial) 11 is not required, and thus operability when controlling the orientation of the distal end of the sheath tube 13a. Can be improved.

The configuration of the medical device disclosed in Patent Document 1 has a structure in which two semi-cylindrical slides (molded products) are arranged inside one slide base, and therefore, the size of the two molded products is equal. The variations will be added together. As a result, there is a problem that the variation in the rotational force of the adjustment knob (dial) required (variation in quality) becomes large.
On the other hand, in the configuration of the medical device 1 of the present embodiment, the feed shaft (first feed shaft 3, second feed shaft 5) and the moving member (first moving member 2, second moving member 4). The structure has a one-to-one correspondence with each other, so that the dimensional accuracy is good. As a result, it is possible to reduce the required fluctuation of the rotational force of the first rotary operation unit (dial) 11 and stabilize the quality.

In addition, the configuration of the medical device disclosed in Patent Document 1 has a problem that the product cost is increased because the structure uses a special member such as a semi-cylindrical slide.
On the other hand, in the configuration of the medical device 1 of the present embodiment, it is not necessary to use a special member, so that the product cost can be suppressed.

The details will be described below. As shown in FIGS. 6 and 7, the first case member 12a and the second case member 12b forming the handle case 12 are formed in a similar shape of a substantially semi-cylindrical shape, and a plurality of similar cases are provided inside. And a bearing portion are formed. Here, the first case member 12a will be described, and the second case member 12b has the same configuration, so description thereof will be omitted.
The first case member 12a is formed with a first feed shaft housing recess 31 and a second feed shaft housing recess 32 in which the first feed shaft 3 and the second feed shaft 5 are housed, respectively. There is. Here, the first feed shaft accommodating recess 31 and the second feed shaft accommodating recess 32 are formed parallel to each other along the longitudinal direction of the first case member 12a with a predetermined gap. Further, the first feed shaft housing recess 31 and the second feed shaft housing recess 32 are orthogonal to the longitudinal direction so that the first moving member 2 and the second moving member 4 can move. The cross section is formed in a substantially rectangular shape. Bearing portions 31a and 31b that rotatably support the first feed shaft 3 are formed at the front end position and the base end side position of the first feed shaft accommodation recess 31. Further, bearing portions 32a and 32b that rotatably support the second feed shaft 5 are formed at the front end position and the base end side position of the second feed shaft accommodation recess 32. A gear accommodating recess for accommodating the first gear 8, the second gear 9, and the first main gear 10 (see FIGS. 2 and 3) in mesh with each other is provided on the tip side of the first case member 12a. A place 33 is formed. In the first case member 12a, a base end portion accommodation recess 34, which is located further distal than the gear accommodation recess 33 and accommodates the base end portion 11a of the first rotation operation portion 11, A bearing portion 35 that rotatably supports the gear shaft portion 10a of the first main gear 10 is formed. Further, the first case member 12a is located between the first feed shaft accommodating recess 31 and the second feed shaft accommodating recess 32, and accommodates the proximal end portion of the sheath tube 13a. A sheath tube accommodating recess 36 is formed. Further, a distal end accommodating recess 37 in which the distal end of the sheath hub 13b is non-rotatably accommodated is formed at the proximal end of the first case member 12a.

  As shown in FIG. 1 to FIG. 3, FIG. 6, and FIG. 7, the first rotation operation unit 11 and the gear shaft portion 10a of the first main gear 10 have through-holes passing through their common central axes (FIG. (Not shown) is formed. The sheath tube 13a can be passed through this through hole.

  As shown in FIGS. 4 and 5, the sheath tube 13a includes a first sub-lumen 13f and a second sub-lumen 13f separately from the main lumen 13e through which a dilator or the like is passed from the position immediately before the first main gear 10 to the tip portion. The sub-lumen 13g is formed. Then, one ends (tips) of the first operating wire 6 and the second operating wire 7 which are respectively passed through the first sub-lumen 13f and the second sub-lumen 13g are used for wire joining at the distal end of the sheath tube 13a. It is fixed to the ring 15.

  As shown in FIG. 2, FIG. 3, FIG. 6, and FIG. 7, the first feed shaft 3 and the second feed shaft 5 are provided with externally threaded male screws. Further, the first moving member 2 and the second moving member 4 are provided with female screws threadedly engaged with the first feed shaft 3 and the second feed shaft 5, respectively. As a result, the first feed shaft 3 and the second feed shaft 5 are rotated in the same direction, and the first moving member 2 and the second moving member 4 are moved to the first feed shaft 3 and the second feed member, respectively. The axes 5 can be moved in opposite directions.

The medical device 1 is assembled as follows.
That is, as shown in FIG. 2, FIG. 3, FIG. 6, and FIG. 7, first, in the first feed shaft housing recess 31 and the second feed shaft housing recess 32 of the first case member 12a, respectively, The first feed shaft 3 and the second feed shaft 5 are housed in a rotatable state. At this time, the first moving member 2 and the second moving member 4 are slidably fitted into the first feed shaft accommodation recess 31 and the second feed shaft accommodation recess 32, respectively. Become. Next, the state in which the base end portion 11a of the first rotation operation portion 11 is accommodated in the base end portion accommodation recess 34 of the first rotation operation portion 11 and the first main gear 10 in a state of passing through the sheath tube 13a. Install with. At this time, the distal end of the sheath hub 13b is non-rotatably housed in the distal end housing recess 37, and the first main gear 10 is in a state of meshing with the first gear 8 and the second gear 9. Further, the proximal end side portion of the sheath tube 13a is accommodated in the sheath tube accommodation recess 36. Next, as shown in FIG. 4, the other ends of the first operating wire 6 and the second operating wire 7 are fixed to the first moving member 2 and the second moving member 4, respectively. Finally, the second case member 12b is attached to the first case member 12a.
From the above, the medical device 1 shown in FIG. 1 is obtained.

In the configuration of the medical device disclosed in Patent Document 1, since the catheter body (tube member) is arranged inside the central slide base, the catheter body (tube member) is passed through the handle (operating portion). However, there is a problem that it is difficult to fix the bending wire.
On the other hand, in the configuration of the medical device 1 of the present embodiment, since the sheath tube 13a is arranged separately from the first feed shaft 3 and the second feed shaft 5, the sheath tube 13a is placed inside the handle portion 14. The first operating wire 6 and the second operating wire 7 are also easily fixed.

(How to use medical equipment)
Next, a method of using the medical device according to the first embodiment of the present invention will be described with reference to FIGS. 8 and 9.

Medical device 1 of the present embodiment, for example, be used in integrated with dilator, used in such inserting a cardiac catheter from the blood vessel (aorta) to the atrium.

  First, before inserting the sheath tube 13a into the blood vessel, heparinized physiological saline (saline) is injected into the sheath tube 13a from the three-way stopcock. After securing access to the femoral vein, the guide wire is inserted into the superior vena cava, and the dilator and the sheath tube 13a are inserted along the guide wire. When the tip of the dilator reaches the superior vena cava, the guide wire is removed, and the septum puncture needle is inserted into the sheath tube 13a. Then, the atrial septum is punctured with the septal puncture needle, the dilator and the sheath tube 13a are advanced to the inside of the left atrium, and then the dilator is pulled out, and the cardiac catheter is inserted and placed at the target site.

In this case, the 1st rotation operation part (dial) 11 is rotated as needed, the tip of the sheath tube 13a is deflected, and the placement position of the cardiac catheter is adjusted.
For example, as shown in FIG. 8, when the handle case 12 is grasped by one hand and the first rotation operation portion 11 is rotated in the forward rotation direction by the other hand (see arrow A in FIG. 8), The first feed shaft 3 and the second feed shaft 5 rotate in the same direction (reverse rotation direction) via the main gear 10, the first gear 8, and the second gear 9. Then, the first moving member 2 moves to the base end side (see arrow B in FIG. 8), and the second moving member 4 moves to the tip end side (see arrow C in FIG. 8). As a result, the first operation wire 6 is pulled to the proximal end side, the second operation wire 7 is loosened (see FIG. 5), and the distal end of the sheath tube 13a is the side tube exit side (side port 13c side). In the first direction (see arrow D in FIG. 8).

  For example, as shown in FIG. 9, when the handle case 12 is grasped with one hand and the first rotation operation portion 11 is rotated in the reverse rotation direction with the other hand (see arrow E in FIG. 9), Through the main gear 10, the first gear 8 and the second gear 9, the first feed shaft 3 and the second feed shaft 5 rotate in the opposite directions. Then, the second moving member 4 moves to the base end side (see arrow F in FIG. 9), and the first moving member 2 moves to the tip end side (see arrow G in FIG. 9). As a result, the second operating wire 7 is pulled toward the proximal end side, the first operating wire 6 is loosened (see FIG. 5), and the distal end of the sheath tube 13a is the side tube side (side port 13c side). To the second direction on the opposite side (see arrow H in FIG. 9).

  As described above, since the placement position of the cardiac catheter can be adjusted, the cardiac catheter can be properly placed at the target site. Although the side tube exit side (side port 13c side) is used for description of the deflection direction, the deflection direction of the present invention is based on the side tube exit side (side port 13c side). However, the structure is not limited to the above, and any configuration that deflects in the opposite direction may be used.

  In the present embodiment, the case where the tube member is, for example, the introducer sheath 13 used when inserting the heart catheter from the blood vessel into the atrium or ventricle has been described as an example. However, the present invention is not necessarily limited to such a configuration. The tube member may be another tube member such as a catheter or an endoscopic tube as long as it has flexibility.

  In addition, in the present embodiment, the bending of the distal end of the sheath tube 13a is performed depending on whether the first rotation operation part 11 is rotated in the forward rotation direction or the first rotation operation part 11 is rotated in the reverse rotation direction. The case where the shapes are substantially the same has been described as an example. However, the present invention is not necessarily limited to such a configuration. The distal end of the sheath tube 13a may have different curved shapes depending on whether the first rotation operating unit 11 is rotated in the forward rotation direction or the first rotation operation unit 11 is rotated in the reverse rotation direction. May be. A desired shape can be obtained by partially changing the hardness of the tip of the sheath tube 13a. The lower hardness portion is more likely to bend and the curve becomes stronger, while the higher hardness portion is less likely to bend and the curve becomes loose. Therefore, the desired curved shape can be obtained by changing the hardness at a plurality of positions at the tip of the sheath tube 13a. According to such a configuration, one sheath tube 13a can selectively use two curves having different shapes, and it is possible to reach a large number of sites. In this case, it is considered that the first operation wire 6 and the second operation wire 7 have different tensile resistances. However, the number of teeth of the first gear 8 and the second gear 9 and the first feed shaft 3 and the first feed shaft 3 are different from each other. By changing the pitch of the male screw of the second feed shaft 5, it is possible to control the easiness of rotation of the first rotation operation portion (dial) 11 in the forward rotation direction and the reverse rotation direction.

[Embodiment 2]
(Medical device configuration)
First, the configuration of the medical device according to the second embodiment of the present invention will be described with reference to FIGS. 10 to 16, taking as an example the case where the tube member is a sheath for an introducer. Descriptions that are the same as those in the first embodiment are omitted. The members designated by the same reference numerals as those in the first embodiment are the same members.

  The medical device 17 shown in FIG. 10 includes a sheath 28 for an introducer, which is a flexible tube member, and a handle portion 29 that controls the direction of the distal end of the sheath 28. Similar to the sheath 13 of the first embodiment, the sheath 28 includes a sheath tube 28a, a sheath hub 28b, a hemostatic valve (not shown), and a side port 28c.

  As shown in FIGS. 10 to 12, 15, and 16, the handle portion 29 includes a handle case 30, a first rotation operation portion (dial) 11, and a second rotation operation portion (dial) in order from the base end side. ) 27. The handle case 30 has a substantially columnar shape and includes a first case member 30a and a second case member 30b that are assembled with each other. In the handle case 30, like the handle case 12 of the first embodiment, the first moving member 2, the first feed shaft 3, the second moving member 4, the second feed shaft 5, and the first moving member 4. The gear 8, the second gear 9, and the first main gear 10 are housed.

In the handle case 30, there are further provided a third feed shaft 19 on which the substantially rectangular parallelepiped third moving member 18 moves, and a fourth feed shaft 21 on which the substantially rectangular parallelepiped fourth moving member 20 moves. , Are housed in a separated state. The first feed shaft 3, the third feed shaft 19, the second feed shaft 5, and the fourth feed shaft 21 are arranged in the circumferential direction at intervals of approximately 90 degrees. A third gear 24 is fixed to the tip of the third feed shaft 19, and a fourth gear 25 is fixed to the tip of the fourth feed shaft 21. In addition, a second gear that is provided in the handle case 30 between the third gear 24 and the fourth gear 25 and transmits the rotational driving force in the same direction to the third gear 24 and the fourth gear 25. The main gear 26 is housed. The second rotation operation part (dial) 27 is formed in a substantially cylindrical shape having the same diameter as the first rotation operation part 11, is provided adjacent to the first rotation operation part 11, and The main gear 26 of is rotated.

  As shown in FIGS. 13 and 14, one end of the first operating wire 6 is fixed to the distal end of the sheath tube 28 a, and the other end of the first operating wire 6 is fixed to the first moving member 2. . Further, one end of the second operation wire 7 is fixed to the tip of the sheath tube 28 a, and the other end of the second operation wire 7 is fixed to the second moving member 4.

  Further, one end of the third operation wire 22 is fixed to the distal end of the sheath tube 28 a, and the other end of the third operation wire 22 is fixed to the third moving member 18. Further, one end of the fourth operation wire 23 is fixed to the distal end of the sheath tube 28 a, and the other end of the fourth operation wire 23 is fixed to the fourth moving member 20. The third fixing portion to which one end of the third operating wire 22 is fixed and the fourth fixing portion to which one end of the fourth operating wire 23 is fixed are provided at positions facing each other. The present invention is not limited to the configuration in which the other ends of the first to fourth operation wires 6, 7, 22, 23 are fixed to the first to fourth moving members 2, 4, 18, 20. Not something. For example, the other ends of the first to fourth operation wires 6, 7, 22, and 23 are fixed to another member (first to fourth other members (not shown)), and the other members are interposed. The configuration may be such that the first to fourth operation wires 6, 7, 22, 23 and the first to fourth moving members 2, 4, 18, 20 are interlocked. With this configuration, it becomes easy to adjust the length when the operation wires 6, 7, 22, 23 are assembled.

The 1st fixed part, the 3rd fixed part, the 2nd fixed part, and the 4th fixed part are located in a line in the direction of the circumference at intervals of about 90 degrees.
The number of teeth of the third gear 24 and the number of teeth of the fourth gear 25 are the same, and the pitch of the male screw of the third feed shaft 19 and the pitch of the male screw of the fourth feed shaft 21 described later are also the same. It is the same. As a result, the curved shape of the distal end of the sheath tube 28a is almost the same when the second rotation operation part 27 is rotated in the forward rotation direction and when the second rotation operation part 27 is rotated in the reverse rotation direction. Take the same shape.
In this case, by stopping the rotation of the first rotation operation unit 11 or the second rotation operation unit 27 at an arbitrary rotation angle, the curved shape of the distal end of the sheath tube 28a can be maintained in an arbitrary shape. That is, the curved shape of the distal end of the sheath tube 28a can be selected according to the case.
The sheath tube 28a may have substantially uniform flexibility over the whole, but a flexible portion may be provided in the resin of the tip end portion so that only the tip end portion can be easily bent.

The configuration of the medical device 17 of the present embodiment has the following effects in addition to the effects of the first embodiment. That is, since the third moving member (third slide) 18 and the fourth moving member (fourth slide) 20 are provided apart from each other, friction between the two moving members (slides) 18, 20 There is no loss of force transmission.
Therefore, according to the configuration of the medical device 17 of the present embodiment, a strong rotational force to the first rotary operation unit (dial) 11 and the second rotary operation unit (dial) 27 is not required, and thus the sheath tube 28a is used. It is possible to improve the operability when controlling the direction of the tip of the.
Further, according to the configuration of the medical device 17 of the present embodiment, the distal end of the sheath tube 28a can be deflected in four directions. Furthermore, by combining deflections in four directions, it is possible to deflect in any direction of 360 degrees. For example, a cardiac catheter or the like to be inserted into the medical device 17 of the present configuration can be correctly placed at the target site more easily without rotating the medical device 17 of the present configuration itself.

  In the configuration of the medical device 17 of the present embodiment, the feed shaft (the first feed shaft 3, the second feed shaft 5, the third feed shaft 19, and the fourth feed shaft 21) and the moving member (the first feed shaft 3). Since the moving member 2, the second moving member 4, the third moving member 18, and the fourth moving member 20) have a one-to-one correspondence structure, the dimensional accuracy is good. As a result, it is possible to reduce the variation in the rotational force of the required first rotation operation unit (dial) 11 and second rotation operation unit (dial) 27 and stabilize the quality. Further, in the configuration of the medical device 17 of the present embodiment, it is not necessary to use a special member, so that the product cost can be suppressed.

  The details will be described below. As shown in FIGS. 15 and 16, the first case member 30a and the second case member 30b forming the handle case 30 are formed in a substantially semi-cylindrical shape. Here, the first case member 30a will be described, and the second case member 30b has the same configuration, so description thereof will be omitted. Similar to the first embodiment, the first case member 30a includes the first feed shaft housing recess 38, the second feed shaft housing recess 39, the bearing portions 38a and 38b, the bearing portions 39a and 39b, and the first feed shaft housing recess 39. A gear accommodating recess 40, a base end accommodating recess 41, and a bearing 42 are formed.

  The third feed shaft 19 is housed in the first case member 30a between the first feed shaft housing recess 38 and the second feed shaft housing recess 39. The feed shaft accommodating recess 43 is formed. Here, the third feed shaft accommodating recess 43 is formed in a substantially rectangular cross section orthogonal to the longitudinal direction so that the third moving member 18 can move. Bearing portions 43a and 43b that rotatably support the third feed shaft 19 are formed at the front end position and the base end side position of the third feed shaft accommodation recess 43. Further, the first case member 30a is located between the third feed shaft accommodating recess 43 and the first gear accommodating recess 40, and is engaged with the third gear 24 and the fourth gear 24. A second gear accommodating recess 44 for accommodating the gear 25 and the second main gear 26 (see FIGS. 11 and 12) is formed. Further, the first case member 30a is located between the first gear accommodating recess 40 and the second gear accommodating recess 44, and the gear shaft portion 26a of the second main gear 26 can be rotated. A bearing portion 45 that supports the bearing is formed. Further, the first case member 30a is formed with a distal end accommodation recess 47 which is located at the proximal end thereof and in which the distal end of the sheath hub 28b is non-rotatably accommodated.

  The second case member 30b forming the handle case 30 is also formed with a plurality of recesses and bearing portions similar to those of the first case member 30a. In particular, the second case member 30b is formed with a fourth feed shaft housing recess 46 in which the fourth feed shaft 21 is housed, at a position facing the third feed shaft housing recess 43. . Here, the fourth feed shaft accommodating recess 46 has a substantially rectangular cross section orthogonal to the longitudinal direction so that the fourth moving member 20 can move. Bearing portions 46a, 46b that rotatably support the fourth feed shaft 21 are formed at the front end position and the base end side position of the fourth feed shaft accommodation recess 46.

  As shown in FIGS. 10 to 12, 15, and 16, the first rotation operating portion 11 and the gear shaft portion 10a of the first main gear 10 have a first penetration through the common central axis thereof. A hole (not shown) is formed. Further, a second through hole (not shown) is formed in the second rotation operation part 27 and the gear shaft part 26a of the second main gear 26 so as to pass through a common central axis thereof. Then, after the gear shaft portion 26a integrated with the second rotation operation portion 27 is passed through the first through hole, the second main gear 26 is attached to the tip of the gear shaft portion 26a, whereby the first rotation operation is performed. The second rotation operation unit 27 can be rotatably integrated with the unit 11. Further, the sheath tube 28a of the sheath 28 can be passed through the second rotation operating portion 27 integrated with the first rotation operating portion 11 and the second through hole of the gear shaft portion 26a of the second main gear 26. it can.

  As shown in FIGS. 13 and 14, the sheath tube 28a has a first sub-lumen 28f and a second sub-lumen 28f separately from the main lumen 28e through which the dilator or the like is passed from the position immediately before the second main gear 26 to the tip portion. Sub-lumen 28g, third sub-lumen 28h, and fourth sub-lumen 28i are formed. Then, the first operating wire 6, the second operating wire 7, and the third operating wire 6, which are passed through the first sub-lumen 28f, the second sub-lumen 28g, the third sub-lumen 28h and the fourth sub-lumen 28i, respectively. One ends (tips) of the operation wire 22 and the fourth operation wire 23 are fixed to the wire joining ring 15 at the tip of the sheath tube 28a.

  As shown in FIG. 11, FIG. 12, FIG. 15, and FIG. 16, the third feed shaft 19 and the fourth feed shaft 21 are similar to the case of the first feed shaft 3 and the second feed shaft 5. , The male screws are wound in the opposite directions. Further, the third moving member 18 and the fourth moving member 20 are provided with female screws threadedly engaged with the third feed shaft 19 and the fourth feed shaft 21, respectively. As a result, the third feed shaft 19 and the fourth feed shaft 21 are rotated in the same direction so that the third moving member 18 and the fourth moving member 20 are respectively moved to the third feed shaft 19 and the fourth feed member 20. The axes 21 can be moved in opposite directions.

The medical device 17 is assembled as follows.
That is, as shown in FIGS. 11, 12, 15, and 16, first, the first feed shaft housing recess 38, the second feed shaft housing recess 39, and the third feed shaft housing recess 38 of the first case member 30a. The first feed shaft 3, the second feed shaft 5, and the third feed shaft 19 are rotatably housed in the feed shaft housing recesses 43, respectively. At this time, the first moving member 2, the second moving member 4, and the third moving member 18 respectively have a first feed shaft accommodation recess 38, a second feed shaft accommodation recess 39, and a third feed shaft accommodation recess 39. The feed shaft accommodating recess 43 is loosely fitted so as to be slidable. Then, the first rotation operation part 11, the first main gear 10, the second rotation operation part 27, and the second main gear 26 in the state of passing through the sheath tube 28a The base end part 11a is attached in a state of being housed in the base end part housing recess 41. At this time, the distal end portion of the sheath hub 28b is non-rotatably housed in the distal end housing recess 47, and the first main gear 10 is in a state of meshing with the first gear 8 and the second gear 9. Further, the second main gear 26 is in a state of meshing with the third gear 24. Next, the fourth feed shaft 21 is rotatably housed in the fourth feed shaft housing recess 46 of the second case member 30b. Next, as shown in FIG. 13, the other ends of the first operating wire 6, the second operating wire 7, the third operating wire 22 and the fourth operating wire 23 are respectively connected to the first moving member 2 and the second moving member 2. The moving member 4, the third moving member 18, and the fourth moving member 20 are fixed. Finally, the second case member 30b is assembled to the first case member 30a. At this time, the fourth gear 25 is in a state of meshing with the second main gear 26. In addition, the proximal end portion of the sheath tube 28a has a first feed shaft 3, a third feed shaft 19, a second feed shaft 5, and a fourth feed shaft that are arranged at intervals of approximately 90 degrees in the circumferential direction. It is arranged inside 21.
As described above, the medical device 17 shown in FIG. 10 is obtained.

  In the configuration of the medical device 17 of the present embodiment, the sheath tube 28a is arranged separately from the first feed shaft 3, the second feed shaft 5, the third feed shaft 19 and the fourth feed shaft 21. Therefore, the sheath tube 28a is easily passed through the handle portion 29, and the first operation wire 6, the second operation wire 7, the third operation wire 22, and the fourth operation wire 23 are also easily fixed.

(How to use medical equipment)
Next, a method of using the medical device according to the second embodiment of the present invention will be described with reference to FIGS.

The medical device 17 of the present embodiment is used, for example, when indwelling a cardiac catheter at a target site, as in the first embodiment. At this time, if necessary, the first rotation operation unit (dial) 11 and the second rotation operation unit (dial) 27 are rotated to deflect the distal end of the sheath tube 28a to adjust the placement position of the cardiac catheter. To do.
For example, as shown in FIG. 17, when the first rotation operation unit 11 is rotated in the forward rotation direction as in the first embodiment (see arrow I in FIG. 17), the first moving member 2 moves toward the base end. 17 (see arrow J in FIG. 17), the second moving member 4 moves toward the distal end (see arrow K in FIG. 17), and the distal end of the sheath tube 28a is deflected in the first direction (see FIG. 17). (See arrow L in FIG. 17).

  For example, as shown in FIG. 18, when the first rotation operating portion 11 is rotated in the reverse rotation direction as in the first embodiment (see the arrow M in FIG. 18), the second moving member 4 moves to the base end. 18 (see arrow N in FIG. 18), the first moving member 2 moves to the distal end side (see arrow O in FIG. 18), and the distal end of the sheath tube 28a is deflected in the second direction (see FIG. 18). (See arrow P in FIG. 18).

  For example, as shown in FIG. 19, when the handle case 30 is grasped by one hand and the second rotation operation section 27 is rotated in the forward rotation direction by the other hand (see arrow Q in FIG. 19), the second The third feed shaft 19 and the fourth feed shaft 21 rotate in the same direction via the main gear 26, the third gear 24, and the fourth gear 25. Then, the third moving member 18 moves to the base end side, and the fourth moving member 20 moves to the tip end side (see arrow R in FIG. 19). As a result, the third operation wire 22 is pulled toward the proximal end side, the fourth operation wire 23 is loosened, and the distal end of the sheath tube 28a is in the direction from the front side to the back side of the paper surface of FIG. 19 (a). It is deflected in the direction of 3 (see arrow S in FIG. 19).

  For example, as shown in FIG. 20, when the handle case 30 is grasped by one hand and the second rotation operation part 27 is rotated in the reverse rotation direction by the other hand (see arrow T in FIG. 20), Through the main gear 26, the third gear 24, and the fourth gear 25, the third feed shaft 19 and the fourth feed shaft 21 rotate in the opposite direction to the above. Then, the fourth moving member 20 moves to the base end side (see the arrow U in FIG. 20), and the third moving member 18 moves to the tip end side. As a result, the fourth operation wire 23 is pulled toward the proximal end side, the third operation wire 22 is loosened, and the distal end of the sheath tube 28a is in the direction from the back side of the paper surface of FIG. 20 (a) to the front side. It is deflected in the direction of 4 (see arrow V in FIG. 20). The third direction and the fourth direction are directions substantially orthogonal to the first direction and the second direction.

  As described above, since the placement position of the cardiac catheter can be adjusted, the cardiac catheter can be properly placed at the target site. Further, in the medical device 17 of the present embodiment, the distal end of the sheath tube 28a can be deflected in four directions, so that the heart catheter can be placed in the target site more easily and correctly.

  In the present embodiment, the case where the tube member is, for example, the introducer sheath 28 used when inserting the heart catheter from the blood vessel into the atrium or ventricle has been described as an example. However, the present invention is not necessarily limited to such a configuration. The tube member may be another tube member such as a catheter or an endoscopic tube as long as it has flexibility.

  Further, in the present embodiment, when the first rotation operation part 11 and the second rotation operation part 27 are rotated in the forward rotation direction and the reverse rotation direction, respectively, the curved shape of the distal end of the sheath tube 28a is almost the same. The case where the same shape is taken has been described as an example. However, the present invention is not necessarily limited to such a configuration. That is, the curved shape of the distal end of the sheath tube 28a is different depending on whether the second rotation operating portion 27 is rotated in the forward rotation direction or when the second rotation operating portion 27 is rotated in the reverse rotation direction. You may do it. With such a configuration, one sheath tube 28a can properly use four curves having different shapes, and it is possible to reach a large number of sites. In this case, the tensile resistances of the first to fourth operation wires 6, 7, 22, and 23 are considered to be different, but the number of teeth of the first to fourth gears 8, 9, 24, and 25, and the first to fourth gears By changing the pitch of the male threads of the fourth feed shafts 3, 5, 19, 21 it is easy to rotate the first and second rotary operation parts (dials) 11, 27 in the forward and reverse rotation directions. Controllability.

1,17 Medical device 2 First moving member 3 First feeding shaft 4 Second moving member 5 Second feeding shaft 6 First operating wire 7 Second operating wire 8 First gear 9 Second Gear 10 1st main gear 11 1st rotation operation part 11a Base end part 12,30 Handle case 12a, 30a 1st case member 12b, 30b 2nd case member 13,28 Introducer sheath 13a, 28a Sheath Tubes 13b, 28b Sheath hubs 13c, 28c Side ports 13d, 28d Dilator insertion ports 13e, 28e Main lumens 13f, 28f First sub-lumens 13g, 28g Second sub-lumens 14, 29 Handle portion 15 Wire joining ring 18 Third Moving member 19 third feed shaft 20 fourth moving member 21 fourth feed shaft 22 third operation wire 23 23 4th operation wire 24 3rd gear 25 4th gear 26 2nd main gear 26a Gear shaft part 27 2nd rotation operation part 28h 3rd sub-lumen 28i 4th sub-lumen 31, 38th 1 feed shaft accommodating recesses 31a, 31b, 32a, 32b, 35, 38a, 38b, 39a, 39b, 42, 43a, 43b, 45, 46a, 46b bearing portion 32, 39 second feed shaft accommodating recess 33 Gear accommodating recess 34, 41 Base end accommodating recess 36 Sheath tube accommodating recess 37, 47 Tip accommodating recess 40 First gear accommodating recess 43 Third feed shaft accommodating recess 44 Second gear accommodating recess Recess 46 Fourth feed shaft accommodating recess

Claims (4)

A tube member having flexibility,
A handle portion for controlling the direction of the tip of the tube member,
A first feed shaft on which the first moving member moves,
A second feed shaft on which the second moving member moves,
A first operating wire having one end fixed to the tip of the tube member and the other end fixed to the first moving member or a first other member interlocking with the first moving member;
A second operation wire having one end fixed to the tip of the tube member and the other end fixed to the second moving member or a second other member that works in conjunction with the second moving member;
A first gear fixed to the first feed shaft;
A second gear fixed to the second feed shaft;
A first main gear that is provided between the first gear and the second gear and that transmits a rotational driving force to the first gear and the second gear,
The handle portion has a first rotation operation portion that rotates the first main gear,
When the first rotation operation portion is rotated in the forward rotation direction, the first moving member moves to the proximal end side, so that the first operation wire causes the distal end of the tube member to move in the first direction. Biased to
When the first rotation operation portion is rotated in the reverse rotation direction opposite to the normal rotation direction, the second moving member moves to the proximal end side, so that the second operation wire moves to the tube member. The distal end of the device is deflected in a second direction opposite to the first direction.   The curved shape of the distal end of the tube member is different depending on whether the first rotation operation portion is rotated in the forward rotation direction or the first rotation operation portion is rotated in the reverse rotation direction. The medical device according to claim 1.   A first fixing portion to which the one end of the first operation wire is fixed and a second fixing portion to which the one end of the second operation wire is fixed are provided at positions facing each other. The medical device according to claim 1 or 2. A third feed shaft on which the third moving member moves,
A fourth feed shaft on which the fourth moving member moves,
A third operation wire having one end fixed to the tip of the tube member and the other end fixed to the third moving member or a third other member interlocking with the third moving member;
A fourth operation wire having one end fixed to the tip of the tube member and the other end fixed to the fourth moving member or a fourth other member interlocking with the fourth moving member;
A third gear fixed to the third feed shaft,
A fourth gear fixed to the fourth feed shaft,
A second main gear that is provided between the third gear and the fourth gear and that transmits a rotational driving force to the third gear and the fourth gear,
The handle portion further includes a second rotation operation portion that rotates the second main gear,
When the second rotation operation portion is rotated in the forward rotation direction, the third moving member moves to the proximal end side, so that the third operation wire moves the distal end of the tube member in the third direction. Biased to
When the second rotation operation unit is rotated in the reverse rotation direction opposite to the normal rotation direction, the fourth moving member moves to the proximal end side, so that the fourth operation wire moves toward the tube member. Deflecting the tip of the to a fourth direction opposite to the third direction,
The medical device according to any one of claims 1 to 3, wherein the third direction and the fourth direction are directions substantially orthogonal to the first direction and the second direction.