JP2009279096A - Catheter handle - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a catheter handle capable of easily stopping an operation section at an optional axial position, finely adjusting the operation force of the operation section, and, once setting a fastening force, showing a little deterioration over time in the fastening force. <P>SOLUTION: This catheter handle is provided with: a handle body 24; an operation knob 22 having a middle shaft section 28 axially movably attached in a shaft hole of the handle body 24; a tip cap 44 positioned at the periphery of the middle shaft section 28, axially movably rotating about a shaft core, and screwed to the distal end of the handle body 24; a ring-shaped elastic member 42 positioned at the inner periphery of the tip cap 44 and the periphery of the middle shaft section 28 between the distal end of the handle body 24 and the distal end of the tip cap 44, and having the fastening force to the peripheral face of the middle shaft section 28 changing according to the axial screwing position of the tip cap 44 with respect to the handle body 24; and clicking-sense application means 50 and 54, mounted between the tip cap 44 and the handle body 24, for applying the clicking sense according to a rotation pitch angle θ. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a catheter handle, and more particularly to a catheter handle that can finely adjust an operation force of an operation unit.

  Various catheters have been proposed as medical catheters. A catheter handle is usually provided on the proximal end side of the catheter. Various catheter handles have been proposed depending on the type of catheter.

  For example, there is a case where the distal end portion of the catheter is desired to be bent or extended by operating the operation portion of the catheter handle.

  As a catheter handle used in such a case, as shown in Patent Document 1 below, for example, a handle having a piston structure in which a drive member is incorporated in a long cylinder has been proposed. In this conventional handle, the distal end portion of the catheter can be bent or extended by moving the piston in the axial direction with respect to the cylinder.

  Depending on how the catheter is used, it may be desirable to insert the distal end of the catheter into the patient's body and maintain the shape while the distal end of the catheter is bent. In such a case, it is necessary to brake the axial movement of the operating portion with respect to the catheter handle. Therefore, a ring-shaped elastic member such as an O-ring is attached between the outer periphery of the piston and the inner periphery of the cylinder, the tightening force of the ring-shaped elastic member is adjusted by the screwing amount of the screwing member, and the catheter handle is operated. There has been proposed a structure in which the portion can be braked at an arbitrary position in the axial direction.

  However, in the conventional handle, if the tightening force of the ring-shaped elastic member is increased in order to improve the braking performance, there is a problem that the operation of moving the operation unit with respect to the handle becomes heavy from the beginning and is difficult to operate. Further, if the tightening force of the ring-shaped elastic member is reduced in order to improve the operability, there is a problem that the brake performance is lowered, and fine adjustment of the tightening strength is difficult.

Further, in the conventional handle, after the tightening strength of the ring-shaped elastic member is set to an appropriate value, the tightening strength may change over time due to the elasticity of the elastic member. In order to prevent the change over time, it is conceivable to fix the screwed position of the screwed member with an adhesive, but in that case, the tightening strength of the ring-shaped elastic member cannot be finely adjusted thereafter. End up.
JP 2003-319915 A

  The present invention has been made in view of such a situation, the operation unit can be easily stopped at any axial position, and the operation force of the operation unit can be finely adjusted, and the tightening force is once set. Later, it aims at providing the handle | steering_wheel for catheters with little temporal change of clamping force.

In order to achieve the above object, a catheter handle according to the present invention comprises:
The handle body,
An operation portion having a middle shaft portion which is mounted in the shaft hole of the handle body so as to be movable in the axial direction;
A tip cap located on the outer periphery of the middle shaft portion and rotated around the shaft core and screwed to the distal end of the handle body so as to be movable in the axial direction;
Between the distal end of the handle body and the distal end of the tip cap, the screw is positioned at the inner periphery of the tip cap on the outer periphery of the middle shaft portion, and is screwed in the axial direction of the tip cap with respect to the handle body In accordance with the ring-shaped elastic member that changes the tightening force to the outer peripheral surface of the central shaft portion,
Click feeling imparting means that is mounted between the tip cap and the handle main body and imparts a click feeling according to a rotation pitch angle around an axis of the tip cap with respect to the handle main body.

Preferably, the click feeling imparting means is
A ring for click which is fixed to the inner periphery of the tip cap and has a circumferential unevenness corresponding to the rotation pitch angle formed on the inner periphery;
On the outer periphery of the handle main body, there are formed click protrusions that are formed at intervals of a multiple of the rotation pitch angle along the outer periphery direction and mesh with the circumferential unevenness of the click ring.

  Preferably, three or more protrusions for click are formed on the outer periphery of the handle body along the circumferential direction.

Alternatively, the click feeling imparting means
On the outer periphery of the handle main body, a circumferential concavo-convex portion in which concavo-convex corresponding to the rotation pitch angle is formed,
A click ring fixed to the inner periphery of the cap and engaged with the circumferential concavo-convex portion, and having a click ring formed on the inner periphery at intervals of a multiple of the rotation pitch angle along the circumferential direction. It may be.

  In that case, preferably, three or more of the click convex portions are formed along the circumferential direction on the inner periphery of the click ring.

Preferably, the proximal end of the catheter tube is fixed to the distal end of the operation portion,
A tapered surface having a smaller outer diameter in the distal end direction is formed on the outer peripheral surface of the middle shaft portion of the operation portion,
The inner peripheral surface of the ring-shaped elastic member is in contact with the outer peripheral surface of the tapered surface so as to be movable in the axial direction.

  In the catheter handle according to the present invention, the fastening force of the ring-shaped elastic member to the outer peripheral surface of the central shaft portion is adjusted by screwing the tip cap onto the outer periphery of the handle main body and adjusting the screwing depth. Can do. In addition, at that time, the click feeling imparting means imparts a click feeling according to the rotation pitch angle around the axis of the tip cap with respect to the handle body.

  Therefore, the tightening force of the ring-shaped elastic member is properly maintained, and the operation unit can be easily stopped at an arbitrary axial position. In addition, the screwing depth of the tip cap with respect to the handle body can be readjusted, and the screwing of the tip cap can be stopped at a predetermined number of rotation pitch angles, and the operating force of the operating portion can be finely adjusted. Further, once the tightening force of the ring-shaped elastic member is set, the click feeling imparting means restricts the rotation of the tip cap with respect to the handle body, so that the tightening force hardly changes over time.

  Hereinafter, the present invention will be described based on embodiments shown in the drawings.

  As shown in FIG. 1, a tip deflection operable catheter 2 according to an embodiment of the present invention is used, for example, for diagnosis or treatment of arrhythmia in the heart, and a distal end portion of a catheter tube (tube member) 4. In addition, a tip 10 and a plurality of intermediate rings 12 are mounted. The tip 10 and the intermediate ring 12 function as electrodes, and are connected and fixed to the catheter tube 4 by bonding with an adhesive, for example.

  A handle 20 is attached to the proximal end of the catheter tube 4. Conductive wires are respectively passed through the catheter tube 4 and the handle 20, and the tips thereof are electrically connected to the tip 10 and the intermediate ring 12 constituting the electrodes. Further, the base ends of these conductive wires are connected to a connector 21 fixed to the rear end portion of the handle 20 shown in FIG. The handle 20 is provided with an operation knob 22 for performing a deflection movement operation (swing operation) of the distal end portion of the catheter tube 4.

  The catheter tube 4 is composed of a hollow tube member, and may be composed of a tube having the same characteristics along the axial direction. A proximal end portion that is integrally formed axially with the distal end portion and is relatively stiffer than the distal end portion. In FIG. 1, the length of the catheter tube 4 is shown to be short, but actually, it is several times to several tens of times longer than the axial length of the handle 20.

  The catheter tube 4 is made of a synthetic resin such as polyolefin, polyamide, polyether polyamide, or polyurethane. The outer diameter of the catheter tube 4 is generally about 0.6 to 3 mm, and the inner diameter is about 0.5 to 2.5 mm. Conductive wires connected to the distal tip 10 and the intermediate ring 12 constituting the electrode shown in FIG. 1 are insulated and passed through the axial lumen of the catheter tube 4.

  The tip 10 and the intermediate ring 12 shown in FIG. 1 are made of a metal having good electrical conductivity, such as aluminum, copper, stainless steel, gold, or platinum. It should be noted that the tip 10 and the intermediate ring 12 are preferably made of platinum or the like in order to provide a good contrast for X-rays. The outer diameters of the distal tip 10 and the intermediate ring 12 are not particularly limited, but are preferably about the same as the outer diameter of the catheter tube 4 and are usually about 0.5 to 3 mm.

  A swinging member is accommodated in the vicinity of the distal end of the catheter tube 4. The swinging member is not particularly limited, and is constituted by, for example, a leaf spring. The distal end of the operation wire 30 shown in FIGS. 2 to 4 is connected and fixed to the leaf spring as the swinging member.

  The outer diameter of the operation wire 30 is not particularly limited, but is preferably 0.01 to 0.3 mm, and more preferably 0.03 to 0.08 mm. The operation wire 30 is made of, for example, a Ni—Ti superelastic alloy, but is not necessarily made of metal. The operation wire 30 may be composed of, for example, a high-strength non-conductive wire.

  In the present embodiment, the proximal end of the operation wire 30 is fixed to the wire tension adjuster 32 as shown in FIG. 2 after adjusting the tension of the operation wire 30. The wire tension adjuster 32 is mounted in the handle body 24 of the handle 20 so as to be movable in the axial direction. By fixing the wire tension adjustment tool 32 at a predetermined axial position inside the handle body 24, the tension of the operation wire 30 can be adjusted.

  As shown in FIG. 2, the proximal end of the catheter tube 4 is fixed to the operation knob 22 and the middle shaft portion 28 via the sheath tube 26. The operation knob 22 and the middle shaft portion 28 correspond to the operation unit. The middle shaft portion 28 is inserted into a shaft hole 25 formed in the handle body 24 and is movable in the axial direction with respect to the handle body 24.

  The operator can hold the handle body 24 with one hand, operate the operation knob 22 with the finger of one hand, and move the middle shaft portion 28 relative to the handle body 24 in the axial direction. Since the middle shaft portion 28 is connected and fixed to the proximal end of the catheter tube 4, when the middle shaft portion 28 is moved in the axial direction with respect to the handle body 24, the catheter tube 4 is moved closer to the operation wire 30. The top end moves relative to the axial direction. The distal end of the operation wire 30 is fixed to a swinging member provided in the vicinity of the distal end of the catheter tube 4, and the proximal end of the operation wire 30 is fixed to the handle 20. It is fixed to.

  When the middle shaft portion 28 is moved to the distal end side, the proximal end of the catheter tube 4 is relatively moved to the distal end side while the proximal end of the operation wire 30 is fixed to the wire tension adjuster 32. In this case, the operation of the middle shaft portion 28 applies tension to the operation wire 30 and the catheter tube 4 is applied with a force compressing in the axial direction. Since the operation wire 30 and the catheter tube 4 hardly change in axial length, the catheter tube 4 and the operation wire 30 are bent. As a result, as shown in FIG. 1, the distal end portion of the catheter tube 4 performs a swing deflection operation as indicated by an arrow A.

  That is, the distal end of the catheter 2 can be bent and moved in the direction A by operating the operation knob 22 of the handle 20 shown in FIG. If the handle 20 is rotated around the axis, the direction in the A direction relative to the catheter 2 can be freely set while being inserted into the body cavity.

  In the present embodiment, as shown in FIG. 2, a tapered surface 40 is formed on the outer peripheral surface of the middle shaft portion 28. The tapered surface 40 is a tapered surface having an outer diameter that decreases toward the distal end side of the handle body 24. The axial length of the tapered surface 40 is preferably equal to or greater than the range length in which the operation knob 22 can move relative to the handle body 24 in the axial direction. Specifically, the axial length of the tapered surface 40 is preferably 5 to 20 mm. The taper inclination angle of the taper surface 40 is preferably an angle of 0.1 to 2.0 degrees with respect to the axis.

  The maximum outer diameter of the tapered surface 40 is equal to or smaller than the inner diameter of the shaft hole 25 shown in FIG. 2 and is determined so that the middle shaft portion 28 can move in the axial direction X within the shaft hole 25. The The axial length of the middle shaft portion 28 is preferably 40 to 80 mm longer than the axial length of the tapered surface 40.

  A male screw portion 51 is formed on the outer periphery of the distal end 24 a of the handle body 24, and a female screw portion 52 is formed on the inner periphery of the tip cap 44. The male screw part 51 and the female screw part 52 are screw-coupled. The inner diameter of the distal end 44a of the tip cap 44 is smaller than the inner diameter of the inner periphery of the tip cap 44 in which the female screw portion 52 is formed. An O-ring groove 46 is formed between the distal end 24 a of the handle body 24 and the distal end 44 a of the tip cap 44 and between the inner periphery of the female screw portion 52 and the outer periphery of the central shaft portion 28. The

  The O-ring groove 46 is provided with an O-ring 42 which is a ring-shaped elastic member and backup rings 41 and 43 on both sides in the axial direction. By screwing the male thread portion 51 of the handle body 24 into the female thread portion 52 of the tip cap 44, the axial length of the O-ring groove 46 is adjusted, the O-ring 42 is deformed in the axial direction, and the taper of the middle shaft portion 28 is achieved. The tightening force of the O-ring 42 against the surface 40 changes.

  The O-ring 42 is made of rubber such as silicone rubber, nitrile rubber, or fluorine rubber, or synthetic resin, for example. The backup rings 41 and 43 are preferably made of, for example, a fluororesin or a metal.

  FIG. 3 is a cross-sectional view showing a main part of FIG. As shown in FIG. 3, a click ring 50 is fixed to the inner periphery of the cylindrical portion 44b near the proximal end of the tip cap 44 by screwing. That is, as shown in FIG. 3, the click ring 50 is a member having a ring shape having an outer diameter substantially the same as the inner diameter of the cylindrical portion 44b, and is provided on the inner periphery of the cylindrical portion 44b. A male screw that can be coupled to the female screw is formed. The click ring 50 may be integrated with the inner peripheral surface of the tip cap 44 by means other than screwing. For example, the click ring 50 may be bonded to the inner peripheral surface of the tip cap 44 or may be integrally formed by injection molding.

  As shown in FIG. 4, circumferential irregularities 52 corresponding to the rotation pitch angle θ are formed on the inner peripheral surface of the click ring 50. The rotation pitch angle θ of the circumferential unevenness 52 is an angle around the axis between the convex portions of the adjacent concave and convex portions 52 or between the concave portions and the concave portions, and is preferably 5 to 10 degrees.

  Further, on the outer peripheral surface of the handle main body 24 located on the inner peripheral side of the ring 50, click convex portions 54 that mesh with the circumferential unevenness 52 are formed at intervals of a multiple of the rotation pitch angle θ along the circumferential direction. It is. In the embodiment shown in FIG. 4, four click protrusions 54 are integrally formed on the outer peripheral surface of the handle main body 24 at intervals of 90 degrees in the circumferential direction along the outer peripheral surface of the handle main body 24. The click ring 50 and the click projection 54 correspond to a click feeling imparting means.

  Next, the tip deflection operable catheter 2 according to the present embodiment will be described. The operator grasps the handle main body 24 with one hand, operates the operation knob 22 with the finger of one hand, and operates the handle 22 in a direction to separate it from the distal end of the tip cap 44 as shown in FIG. Suppose that In that case, since the middle shaft portion 28 is connected and fixed to the proximal end of the catheter tube 4, the catheter tube 4 moves in the axial direction relative to the operation wire 30. As a result, as shown in FIG. 1, the distal end portion of the catheter tube 4 is bent from a straight state as indicated by an arrow A.

  In addition, in the present embodiment, the O-ring 42 moves toward the distal end side with respect to the handle body 24, so that the O-ring 42 has a smaller outer diameter on the tapered surface 40 than the intermediate shaft portion 28. Move relative to the larger side in the axial direction. That is, in this case, the force in the direction of expanding the O-ring 42 in the circumferential direction increases according to the movement. Since the inner diameter of the O-ring groove 46 is not changed, the distance between the middle shaft portion 28 and the O-ring groove 46 becomes narrower according to the movement, and the force by which the O-ring 42 presses the middle shaft portion 28 and the tip cap 44. Becomes stronger, and the frictional force between the O-ring 42 and the middle shaft portion 28 increases.

  Further, when the middle shaft portion 28 is moved in the most proximal end direction with respect to the handle body 24, the O-ring 42 is positioned at a position where the outer diameter of the tapered surface 40 is the smallest relative to the middle shaft portion 28. positioned. Therefore, in this case, since the distance between the middle shaft portion 28 and the O-ring groove 46 is the largest, the force with which the O-ring 42 presses the middle shaft portion 28 and the tip cap 44 is the smallest. And the frictional force is reduced. Accordingly, at the initial stage of movement in which the operation knob 22 is moved in the direction away from the handle body 24 in the axial direction, the operation knob 22 moves in the axial direction with a light force.

  Even when the finger is released from the operation knob 22, the O-ring 42 contacts the tapered surface 40 having a large outer diameter, and the operation knob 22 does not move in the axial direction due to the frictional force. Therefore, even if the finger is released from the operation knob 22, the distal end portion of the catheter tube 4 shown in FIG. 1 can maintain a bent state.

  In order to make the distal end portion of the catheter tube 4 shown in FIG. 1 straight, the operation knob 22 may be moved in the axial direction against the frictional force between the tapered surface 40 and the O-ring 42. . At that time, since the O-ring 42 moves from a large outer diameter portion to a small outer diameter portion on the tapered surface 40, the frictional force between the tapered surface 40 and the O-ring 42 gradually decreases.

  In the catheter handle 20 according to the present embodiment, the distal end cap 44 is screwed to the outer periphery of the handle main body 24 and the screwing depth is adjusted, so that the O-ring 42 is fastened to the outer peripheral tapered surface 40 of the central shaft portion 28. The applied force can be adjusted. In addition, at this time, the click sensation (clicking) depends on the rotation pitch angle θ around the axis of the tip cap 44 with respect to the handle body 24 due to the engagement of the click convex portion 54 as the click sensation providing means and the circumferential concavo-convex portion 52. Sound and sensation). Therefore, the operator can finely adjust the screwing depth of the tip cap 44 for each rotation pitch angle. That is, the operator can finely adjust the tightening force of the O-ring 42 according to the number of click feelings.

  Therefore, the tightening force of the O-ring 42 is properly maintained, and the operation knob 22 can be easily stopped at an arbitrary axial position. Further, the screwing depth of the tip cap 44 with respect to the handle body 24 can be readjusted, and the screwing of the tip cap 44 can be stopped at a predetermined number of rotation pitch angles θ, and the tightening force of the O-ring 42 can be reduced. Adjustment, that is, fine adjustment of the operation force of the operation knob 22 can be performed. Further, once the tightening force of the O-ring 42 is set, the rotation of the tip cap 44 with respect to the handle main body 24 is restricted by the meshing of the click convex portion 54 and the circumferential unevenness 52, and therefore the taper of the O-ring 42. There is little change with time of the clamping force on the surface 40.

  The present invention is not limited to the above-described embodiment, and can be variously modified. For example, in the above-described embodiment, as shown in FIG. 4, four click convex portions 54 are formed at equal intervals along the circumferential direction on the outer periphery of the handle body 24, but as shown in FIG. 5, The click convex portions 54 may be formed at equal intervals or unequal intervals along the circumferential direction by three or other numbers. However, it is preferable to form three or more click convex portions 54 on the outer peripheral surface of the handle body 24 at equal intervals along the circumferential direction. When three or more click protrusions 54 are formed, the backlash of the central shaft portion 28 (operation portion) with respect to the handle body 24 (backlash in the direction perpendicular to the axial direction) can be reduced.

  Alternatively, as shown in FIG. 6, circumferential irregularities 52 a are formed on the outer peripheral surface of the handle body 24 corresponding to the rotational pitch angle θ shown in FIG. 4, and circumferential irregularities 52 a are formed on the inner peripheral surface of the click ring 50. The click convex portions 54a that mesh with each other may be formed at intervals of a multiple of the rotation pitch angle along the circumferential direction. The click ring 50 and the click projection 54 correspond to a click feeling imparting means.

  Furthermore, the catheter handle according to the present invention can be applied not only to the catheter capable of tip deflection operation of the illustrated embodiment but also to other catheters.

FIG. 1 is an overall perspective view of a catheter according to an embodiment of the present invention. FIG. 2 is a cross-sectional view of the main part of the catheter handle shown in FIG. FIG. 3 is a cross-sectional view showing a further essential part of FIG. 4 is a cross-sectional view taken along line IV-IV shown in FIG. FIG. 5 is a cross-sectional view corresponding to FIG. 4 of a catheter handle according to another embodiment of the present invention. FIG. 6 is a cross-sectional view corresponding to FIG. 4 of a catheter handle according to still another embodiment of the present invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 2 ... Tip deflection operation possible catheter 4 ... Catheter tube 20 ... Catheter handle 22 ... Operation knob 24 ... Handle main body 28 ... Middle shaft part 30 ... Operation wire 40 ... Tapered surface 42 ... O-ring 50 ... Click ring 52, 52a ... Circumferential unevenness 54, 54a ... Click convex part

Claims (6)

The handle body,
An operation portion having a middle shaft portion which is mounted in the shaft hole of the handle body so as to be movable in the axial direction;
A tip cap located on the outer periphery of the middle shaft portion and rotated around the shaft core and screwed to the distal end of the handle body so as to be movable in the axial direction;
Between the distal end of the handle body and the distal end of the tip cap, the screw is positioned at the inner periphery of the tip cap on the outer periphery of the middle shaft portion, and is screwed in the axial direction of the tip cap with respect to the handle body In accordance with the ring-shaped elastic member that changes the tightening force to the outer peripheral surface of the central shaft portion,
A catheter handle comprising: a click feeling imparting means that is mounted between the tip cap and the handle body and imparts a click feeling according to a rotation pitch angle around an axis of the tip cap with respect to the handle body. The click feeling imparting means is
A ring for click which is fixed to the inner periphery of the tip cap and has a circumferential unevenness corresponding to the rotation pitch angle formed on the inner periphery;
An outer periphery of the handle main body is formed with click convex portions formed at intervals of a plurality of times of the rotation pitch angle along the outer peripheral direction and meshing with the circumferential unevenness of the click ring. Item 2. The catheter handle according to Item 1.   The catheter handle according to claim 2, wherein three or more click convex portions are formed on an outer periphery of the handle main body along a circumferential direction. The click feeling imparting means is
On the outer periphery of the handle main body, a circumferential concavo-convex portion in which concavo-convex corresponding to the rotation pitch angle is formed,
A click ring fixed to the inner periphery of the cap and engaged with the circumferential concavo-convex portion, and having a click ring formed on the inner periphery at intervals of a multiple of the rotation pitch angle along the circumferential direction. The catheter handle according to claim 1, wherein:   The catheter handle according to claim 4, wherein three or more of the click convex portions are formed along the circumferential direction on the inner periphery of the click ring. The proximal end of the catheter tube is fixed to the distal end of the operation part,
A tapered surface having a smaller outer diameter in the distal end direction is formed on the outer peripheral surface of the middle shaft portion of the operation portion,
The catheter handle according to any one of claims 1 to 5, wherein an inner peripheral surface of the ring-shaped elastic member is in contact with an outer peripheral surface of the tapered surface and is movable in an axial direction.

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