HK1137675A1 - Handle for catheters - Google Patents

Abstract

The invention provides a handle for pipes, wherein an operation part can be easily stopped at any radial position, the operation force of the operation part can be in fine adjustment, and the ageing of fastening force is little changed once the fastening force is set. The handle for pipes has: a handle body (24); an button for operation (22) having a medial axle part (28) moved along the axial direction and freely installed in the axle hole of the handle body (24); a front end cover (44) positioned at the periphery of the medial axle part (28), freely moved along the axial direction, and rotationally bolt-jointed with the far end of the handle body (24) surrounding the axle core; an annular elastic component (42) between the far end of the handle body (24) and the far end of the front end cover (44) and positioned at the inner periphery of the front end cover (44) and the outer periphery of the medial axle part (28), in which the fastening force at the outer periphery of the medial axle part (28) is changed according to the axial bolt-jointed position relative to the front end cover (44) of the handle body (24); and ratchet feel endowing mechanisms (50, 54) installed between the front end cover (44) and the handle body (24) and endowing the ratchet feel according to the rotational pitch angle (theta).

Description

Catheter handle

Technical Field

The present invention relates to a catheter handle, and more particularly to a catheter handle capable of finely adjusting an operation force of an operation unit.

Background

Various catheters have been proposed as medical catheters. A catheter handle is usually provided on the proximal end side of the catheter. The catheter handle proposes various proposals depending on the kind of catheter.

For example, an operation portion of a catheter handle may be bent or stretched in order to operate a distal end portion of a catheter.

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

Depending on the method of using the catheter, the distal end of the catheter may be inserted into the body of a patient, and the distal end of the catheter may be bent to maintain its original shape. In such a case, it is necessary to brake the axial movement of the operation portion with respect to the catheter handle. Therefore, a structure has been proposed in which an annular elastic member such as an O-ring is attached between the outer periphery of the piston and the inner periphery of the cylinder, and the tightening force of the annular elastic member is adjusted by the amount of screwing of the screwing member, so that the operation portion of the catheter handle can be braked at an arbitrary position in the axial direction.

However, in the conventional handle, if the fastening force of the annular elastic member is increased in order to improve the braking performance, the movement operation of the operation portion of the handle becomes heavy from the beginning, and there is a problem that the operation is difficult. Further, in order to improve the operability, there is a problem that the fastening force of the annular elastic member is reduced, and the braking performance is reduced, and it is difficult to finely adjust the fastening strength.

In addition, in the conventional grip, after the fastening strength of the annular elastic member is set to an appropriate value, there is a risk that the fastening strength may be changed with time due to the elasticity of the elastic member. In order to prevent the aging change, it is also considered to fix the screwing position of the screwing member with an adhesive, but in this case, the fastening strength of the annular elastic member cannot be finely adjusted thereafter.

[ patent document 1] Japanese patent application laid-open No. 2003-319915

Disclosure of Invention

Problems to be solved by the invention

The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a catheter handle which can easily stop an operation portion at an arbitrary axial position, can finely adjust an operation force of the operation portion, and has little change over time in a fastening force after the fastening force is set.

Means for solving the problems

In order to achieve the above object, a catheter handle according to the present invention includes:

a handle body;

an operating portion having a middle shaft portion mounted in a shaft hole of the handle body to be freely movable in an axial direction;

a front end cover located on the periphery of the middle shaft part, freely moving along the axial direction and rotatably screwed on the far end of the handle body around a shaft core;

an annular elastic member disposed between the distal end of the handle body and the distal end of the front end cover, between the inner periphery of the front end cover and the outer periphery of the intermediate shaft, for changing a fastening force to the outer periphery of the intermediate shaft in accordance with a screw coupling position of the front end cover with respect to the handle body in the axial direction;

and a ratchet feeling imparting mechanism which is attached between the front end cover and the handle body and imparts a ratchet feeling in accordance with a rotational pitch angle of the front end cover with respect to the handle body around the shaft core.

Preferably, the click feeling imparting mechanism includes: a ratchet ring fixed to the inner periphery of the front end cover and having a circumferential recess and projection formed on the inner periphery thereof corresponding to the rotational pitch angle; and ratchet protrusions formed on the outer periphery of the handle body at intervals of plural times the rotational pitch angle in the outer peripheral direction of the handle body and engaged with the ratchet ring in a circumferentially concave-convex manner.

Preferably, the ratchet protrusions are formed three or more in the circumferential direction on the outer periphery of the handle body.

Alternatively, the click feeling imparting mechanism may include: a circumferential concave-convex portion that forms a concave-convex portion corresponding to the rotational pitch angle in the outer periphery of the handle body; and a ratchet ring fixed to the inner periphery of the cover, and having ratchet protrusions formed on the inner periphery thereof at intervals in the circumferential direction which are multiple times the rotational pitch angle, the ratchet protrusions engaging with the circumferential concave-convex portions.

In this case, it is preferable that the ratchet protrusion is formed in three or more in the circumferential direction on the inner periphery of the ratchet ring.

Preferably, the proximal end of the catheter tube is fixed to the distal end of the operation portion, a tapered surface having an outer diameter decreasing in the distal direction is formed on an outer peripheral surface of a middle shaft portion of the operation portion, and an inner peripheral surface of the annular elastic member is configured to be movable in the axial direction while being in contact with an outer peripheral surface of the tapered surface.

Effects of the invention

In the catheter handle according to the present invention, the distal end cover is screwed to the outer periphery of the handle body, and the fastening force of the annular elastic member to the outer peripheral surface of the central shaft portion can be adjusted by adjusting the screwing depth of the distal end cover. At this time, the click feeling imparting mechanism imparts the click feeling in accordance with the rotational pitch angle of the tip cover with respect to the handle body around the axial core.

Therefore, the fastening force of the annular elastic member can be appropriately secured, and the operation portion can be easily locked at any axial position. Further, the screwing depth of the front end cover with respect to the handle body can be readjusted, and the screwing of the front end cover can be stopped at a predetermined number of rotational pitch angles, thereby finely adjusting the operating force of the operating section. In addition, once the fastening force of the annular elastic member is set, the rotation of the front end cover relative to the handle body is limited by the ratchet feel providing mechanism, so that the fastening force is less likely to change with time.

Drawings

Fig. 1 is an overall perspective view of a catheter according to an embodiment of the present invention.

Fig. 2 is a sectional view of a main portion of the catheter handle shown in fig. 1.

Fig. 3 is a sectional view further showing a main portion of fig. 2.

Fig. 4 is a cross-sectional view taken along line IV-IV shown in fig. 3.

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.

Description of the symbols

2.. the front end is deflectable toward the operating catheter 4.. the catheter tube 20.. the catheter use handle 22.. the operating button 24.. the handle body 28.. the middle shaft portion 30.. the operating wire 40.. the tapered surface 42.. the O-ring 50.. the ratchet use ring 52, 52a.. the circumferential direction protrusions 54, 54a.. the ratchet use protrusion

Detailed Description

The present invention will be described below with reference to embodiments shown in the drawings.

As shown in fig. 1, the tip according to an embodiment of the present invention is biased toward the catheter 2, for example, for diagnosing or treating arrhythmia, and a tip piece 10 and a plurality of intermediate rings 12 are attached to the distal end of a catheter tube (tube member) 4. The distal end piece 10 and the intermediate ring 12 function as electrodes and are connected and fixed to the catheter tube 4 by, for example, adhesion with an adhesive.

A handle body 20 is mounted to the proximal end of the catheter tube 4. The lead wires are respectively pulled through the catheter tube 4 and the handle body 20, and the tip ends of the lead wires are electrically connected to the tip piece 10 and the intermediate ring 12 constituting the electrode. The proximal ends of these wires are connected to a connector 21 fixed to the rear end of the handle body 20 shown in fig. 2. An operation button 22 for performing a deflecting operation (swing operation) of the distal end portion of the catheter tube 4 is attached to the handle body 20.

The catheter tube 4 may be formed of a hollow tube member or a tube member having the same properties in the axial direction, and preferably has a distal end portion having relatively good flexibility and a proximal end portion integrally formed in the axial direction with respect to the distal end portion and having relatively rigidity with respect to the distal end portion. In fig. 1, the length of the catheter tube 4 is shown to be short, but actually, it is about several times to several tens times longer than the axial length of the handle body 20.

The catheter tube 4 is made of synthetic resin such as polyolefin, polyamide, polyether polyamide, or polyurethane. The outer diameter of the pipe fitting 4 is generally about 0.6 to 3mm, and the inner diameter thereof is about 0.5 to 2.5 mm. The lead wires connected to the tip end piece 10 and the intermediate ring 12 constituting the electrode shown in fig. 1 are insulated from the axial lumen of the catheter tube 4.

The tip piece 10 and the intermediate ring 12 shown in fig. 1 are made of a metal having high conductivity, such as aluminum, copper, stainless steel, gold, or platinum. In order to have a good contrast against X-rays, it is preferable that the tip piece 10 and the intermediate ring 12 be made of platinum or the like. The outer diameters of the distal end piece 10 and the intermediate ring 12 are not particularly limited, but are preferably about the same as the outer diameter of the conduit tube 4, and are usually about 0.5 to 3 mm.

A swinging head member is housed inside the catheter tube 4 near the distal end thereof. The swing head member is not particularly limited, and is formed of, for example, a leaf spring. The distal end of the operation wire 30 shown in fig. 2 to 4 is connected and fixed to the leaf spring as the head swing member.

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

The proximal end of the manipulation wire 30 is fixed to a wire tension adjuster 32 as shown in fig. 2 after the tension of the manipulation wire 30 is adjusted in the present embodiment. The wire tensioning device 32 is mounted freely movable in the axial direction inside the handle body 24 of the handle 20. The tension of the operation wire 30 can be adjusted by fixing the wire tension adjuster 32 at a predetermined axial position inside the handle body 24.

As shown in FIG. 2, the proximal end of the catheter tube 4 is secured to the operating button 22 and the central shaft portion 28 by a sleeve 26. The operation button 22 and the middle shaft portion 28 correspond to an operation portion. The intermediate shaft portion 28 is inserted into a shaft hole 25 formed in the handle body 24, and is axially movable relative to the handle body 24.

The operator grasps the grip body 24 with one hand and operates the operation button 22 with the fingers of the one hand, so that the intermediate shaft portion 28 is operated movably in the axial direction relative to the grip body 24. Since the intermediate shaft portion 28 is fixedly attached to the proximal end of the catheter tube 4, when the intermediate shaft portion 28 is moved in the axial direction relative to the handle body 24, the proximal end of the catheter tube 4 is moved in the axial direction relative to the operation wire 30. The distal end of the operation wire 30 is fixed to a swinging member provided near the distal end of the catheter tube 4, and the proximal end of the operation wire 30 is fixed to a wire tension adjuster 32 fixed to the handle 20.

When the intermediate 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 held and fixed to the wire tension adjuster 32. In this case, by the operation of the middle shaft portion 28, tension is applied to the operation wire 30, and a compressive force is applied to the catheter tube 4 in the axial direction. Further, since the axial lengths of the operation wire 30 and the catheter tube 4 are almost constant, 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 yaw operation as indicated by an arrow a.

That is, the distal end of the catheter 2 can be moved in a meandering manner in the a direction by operating the operation button 22 of the handle 20 shown in fig. 1 in the axial direction X. Further, when the handle body 20 is rotated around the axis, the direction of the catheter 2 in the a direction can be freely set in a state of 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 whose outer diameter decreases toward the distal end side of the handle body 24. Preferably, the axial length of the tapered surface 40 is equal to or longer than the axial length of the range in which the operation knob 22 is relatively movable in the axial direction with respect to the handle body 24. Specifically, the axial length of the tapered surface 40 is preferably 5 to 20 mm. The cone inclination angle of the conical surface 40 is preferably 0.1-2.0 degrees relative to the axis.

The maximum outer diameter of the tapered surface 40 is smaller than or equal to the inner diameter of the shaft hole 25 shown in fig. 2, and determines that the operation cylinder 28 is movable in the axial direction X inside the shaft hole 25. The axial length of the operation cylinder 28 is preferably 40 to 80mm 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 24a of the handle body 24, and a female screw portion 52 is formed on the inner periphery of the distal end cover 44. The male screw portion 51 and the female screw portion 52 are screwed. The inner diameter of distal end 44a of distal end cover 44 is smaller than the inner diameter of the inner circumference of distal end cover 44 on which female screw portion 52 is formed. An O-ring groove 46 is formed between the inner periphery of the female threaded portion 52 and the outer periphery of the intermediate shaft portion 28 between the distal end 24a of the handle body 24 and the distal end 44a of the front end cap 44.

An O-ring 42 as an annular elastic member is fitted in the O-ring groove 46, and washers 41 and 43 are fitted to both sides in the axial direction. By screwing the male screw portion 51 of the handle body 24 into the female screw portion 52 of the front end cover 44, the axial length of the O-ring groove 46 is adjusted, the O-ring 42 is deformed in the axial direction, and the fastening force of the O-ring 42 to the tapered surface 40 of the center shaft portion 28 is changed.

The O-ring 42 is made of rubber such as silicone rubber, nitrile rubber, or fluororubber, or synthetic resin. The gaskets 41 and 43 are preferably made of fluororesin, metal, or the like.

Fig. 3 is a sectional view showing a main portion of fig. 2. As shown in fig. 3, a ratchet ring 50 is fixed to the inner periphery of the cylindrical portion 44b near the proximal end of the distal end cover 44 by screwing. That is, as shown in fig. 3, the ratchet ring 50 is an annular member having an outer diameter substantially equal to the inner diameter of the cylindrical portion 44b, and a male thread engageable with a female thread provided on the inner periphery of the cylindrical portion 44b is formed on the outer peripheral portion thereof. The ratchet ring 50 may be integrated with the inner peripheral surface of the tip cover 44 by means other than screwing. For example, the ratchet ring 50 may be bonded to the inner peripheral surface of the tip cover 44 or integrally formed by injection molding.

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

Further, on the outer peripheral surface of the handle body 24 positioned on the inner peripheral side of the ring 50, ratchet protrusions 54 that mesh with the circumferential direction concavities and convexities 52 are formed at intervals of multiple times the rotational pitch angle θ in the circumferential direction. In the embodiment shown in fig. 4, four ratchet projections 54 are integrally formed on the outer peripheral surface of the handle body 24 at intervals of 90 degrees in the circumferential direction along the outer peripheral surface of the handle body 24. The ratchet ring 50 and the ratchet protrusion 54 correspond to a ratchet feeling imparting mechanism.

Next, a method of using the distal end deflectable operation catheter 2 according to the present embodiment will be described. The operator grips the grip main body 24 with one hand and operates the operation button 22 with the fingers of the one hand, and as shown in fig. 2, operates the operation button 22 in the pull-away direction from the distal end of the distal end cover 44. In this case, since the middle shaft portion 28 is fixedly attached to the proximal end of the catheter tube 4, the catheter tube 4 is relatively moved in the axial direction with respect to the operation wire 30. As a result, as shown in fig. 1, the distal end portion of the catheter tube 4 changes from the linear state to the bent state as indicated by arrow a.

In the present embodiment, the intermediate shaft portion 28 moves in the distal end direction with respect to the handle body 24, and the O-ring 42 moves in the axial direction with respect to the intermediate shaft portion 28 from the side where the outer diameter of the tapered surface 40 is small to the side where the outer diameter is large. That is, in this case, the force in the direction in which the O-ring 42 expands in the circumferential direction increases in accordance with the movement. In addition, since the inner diameter of the annular groove 46 is constant, the interval between the middle shaft portion 28 and the O-ring groove 46 is narrowed in response to the movement, the force with which the O-ring 42 presses the middle shaft portion 28 and the front end cover 44 is increased, and the frictional force of the O-ring 42 against the middle shaft portion 28 is increased.

When the intermediate shaft portion 28 is moved in the proximal-most 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 smallest with respect to the intermediate shaft portion 28. Therefore, in this case, since the interval between the center shaft portion 28 and the O-ring groove 46 is the widest, the force with which the O-ring 42 presses the center shaft portion 28 and the front end cover 44 is the smallest, and the frictional force of the O-ring 42 and the center shaft portion 28 is reduced. Therefore, at the initial stage of the movement of the operation knob 22 in the direction away from the axial direction with respect to the grip main body 24, the operation knob 22 is moved in the axial direction by a light force.

Even if the finger is separated from the operation knob 22, the O-ring 42 is in contact with the tapered surface 40 having a large outer diameter, and thus the operation knob 22 is not moved in the axial direction by the frictional force. Therefore, even if the finger is released from the operation button 22, the distal end of the catheter tube 4 shown in fig. 1 can be kept in a bent state.

In order to keep the distal end of the catheter tube 4 straight as shown in fig. 1, the operation button 22 may be moved axially against the frictional force of the tapered surface 40 and the O-ring 42. At this time, the O-ring 42 moves from the large outer diameter portion to the small outer diameter portion of the tapered surface 40, so that 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 cover 44 is screwed to the outer periphery of the handle body 24, and the fastening force of the O-ring 42 to the outer peripheral tapered surface 40 of the center shaft portion 28 can be adjusted by adjusting the screwing depth. At this time, the ratchet feeling (rattling sound and feeling) is given by the rotational pitch angle θ of the tip end cover 44 relative to the grip main body 24 about the axial center by the engagement of the ratchet convex portion 54 as the ratchet feeling giving mechanism and the circumferential concave-convex portion 52. Therefore, the operator can finely adjust the screwing depth of the tip cover 44 for each rotational pitch angle. That is, the worker can finely adjust the tightening force of the O-ring 42 according to the number of the click feeling.

Therefore, the fastening force of the O-ring 42 can be appropriately secured, and the operation button 22 can be easily stopped at any axial position. Further, the screwing depth of the distal end cover 44 to the handle body 24 can be adjusted again, the screwing of the distal end cover 44 can be stopped at a predetermined number of rotational pitch angles θ, and the tightening force of the O-ring 42, that is, the operation force of the fine adjustment operation button 22 can be finely adjusted. After the tightening force of the O-ring 42 is set, the rotation of the front end cover 44 relative to the handle body 24 is restricted by the engagement between the ratchet protrusion 54 and the circumferential direction protrusion 52, so that the tightening force of the tapered surface 40 of the O-ring 42 is less likely to change with time.

The present invention is not limited to the above-described embodiments, and various modifications are possible. For example, in the above-described embodiment, as shown in fig. 4, four ratchet projections 54 are formed at equal intervals in the circumferential direction on the outer periphery of the handle body 24, but as shown in fig. 5, three or another number of ratchet projections 54 may be formed at equal or unequal intervals in the circumferential direction. It is preferable that three or more ratchet protrusions 54 are formed at equal intervals on the outer peripheral surface of the handle body 24 in the circumferential direction. When three or more ratchet protrusions 54 are formed, rattling (rattling in a direction perpendicular to the axial direction) with respect to the middle shaft portion 28 (operation portion) of the handle body 24 can be reduced.

Alternatively, as shown in fig. 6, the circumferential projections and recesses 52a may be formed on the outer peripheral surface of the handle body 24 corresponding to the rotational pitch angle θ shown in fig. 4, and the ratchet ring 50 may have on its inner peripheral surface ratchet projections 54a which mesh with the circumferential projections and recesses 52a at intervals which are plural times the rotational pitch angle in the circumferential direction. The ratchet ring 50 and the ratchet protrusion 54 correspond to a ratchet feeling imparting mechanism.

The catheter handle according to the present invention is not limited to the catheter whose tip is biased in the illustrated embodiment, and may be applied to other catheters.

Claims (6)

1. A handle for a catheter, comprising:

a handle body;

an operating portion having a middle shaft portion which is movably mounted in an axial hole of the handle body in an axial direction;

a front end cover which is positioned on the periphery of the middle shaft part and is screwed on the far end of the handle body in a mode of freely rotating around a shaft core along axial movement;

an annular elastic member which is located between a distal end of the handle body and a distal end of the front end cover, between an inner periphery of the front end cover and an outer periphery of the middle shaft portion, and which changes a fastening force to an outer peripheral surface of the middle shaft portion in accordance with a screw coupling position of the front end cover with respect to an axial direction of the handle body;

and a ratchet feeling imparting mechanism which is attached between the front end cover and the handle body and imparts a ratchet feeling in accordance with a rotational pitch angle of the front end cover with respect to the handle body around an axis.

2. The handle for catheter of claim 1, wherein the ratcheting feel imparting mechanism comprises: a ratchet ring fixed to an inner periphery of the tip cover, the ratchet ring having a circumferential irregularity corresponding to the rotational pitch angle formed on the inner periphery thereof; and ratchet protrusions formed on the outer periphery of the handle body at intervals of plural times the rotational pitch angle in the outer peripheral direction of the handle body, and engaging with the circumferential protrusions and recesses of the ratchet ring.

3. The handle for catheter according to claim 2, wherein the ratchet protrusion is formed three or more in a circumferential direction on the outer periphery of the handle body.

4. The handle for catheter of claim 1, wherein the ratcheting feel imparting mechanism comprises: a circumferential concave-convex portion that forms a concave-convex portion corresponding to the rotational pitch angle in the outer periphery of the handle body; and a ratchet ring fixed to an inner periphery of the cover, wherein ratchet protrusions engaging with the circumferential concave-convex portions are formed on the inner periphery of the ratchet ring at intervals of plural times the rotational pitch angle in a circumferential direction.

5. The catheter handle according to claim 4, wherein the ratchet protrusion is formed three or more in a circumferential direction on an inner periphery of the ratchet ring.

6. The catheter handle according to any one of claims 1 to 5, wherein a proximal end of the catheter tube is fixed to a distal end of the operation portion, a tapered surface having an outer diameter that decreases in a distal direction is formed on an outer peripheral surface of a middle shaft portion of the operation portion, and an inner peripheral surface of the annular elastic member is configured to be movable in an axial direction while being in contact with an outer peripheral surface of the tapered surface.