JP2017176604A - Distal end movable catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To stabilize behavior of a deflection part of a distal end movable catheter.SOLUTION: An operation part provided at a proximal end of a catheter comprises: a rotary operation member rotatably held while being sandwiched by first and second holding parts 42a, 42b; and rotation regulation means 6, 7 for regulating the rotation of the rotary operation member by releasably pressing substantially central portions of the first and second holding parts in a direction of approaching each other. The rotary operation member comprises: a first rotary operation member 32 in which an arcuate groove is formed; first and second movable members 34a, 34b movably attached along the arcuate groove; and a second rotary operation member 33 integrally attached to the first rotary operation member in a state that the first and second movable members are accommodated in an interior space defined between an inner face of the first rotary operation member and itself. A support member whose distal end face comes into contact with an inner face of the second rotary operation member is provided on the inner face of the first rotary operation member.SELECTED DRAWING: Figure 21

Description

  The present invention relates to a catheter that is a medical treatment instrument used for performing various treatments, examinations, and the like, and in particular, relates to a steerable catheter that can freely deflect a distal end portion.

  For catheters (including electrode catheters, ablation catheters, and catheter sheaths) that are inserted through body cavities, lumens, blood vessels, and the like to target tissues such as various organs (for example, the heart). In order to facilitate access and the like, the direction of the distal end (tip) of the catheter inserted into the body is controlled by operating the operation unit provided on the proximal end (base end) side of the catheter disposed outside the body. A tip movable catheter that can be deflected by this is known (for example, see Patent Document 1 below).

  For example, the portion of the distal end portion of the catheter tube to be deflected (deflecting portion) is set to have a gradually lower hardness as it goes to the distal end, and 180 of a ring (pull ring) that is integrally inserted at the distal end. ° Connect each distal end of a pair of wires to opposite positions, pull one wire (first wire) and loosen the other wire (second wire) at each proximal end of the pair of wires. In this way, the orientation of the tube tip can be controlled.

  As an operation portion provided on the proximal end side of such a catheter tube, as disclosed in, for example, Patent Document 1 below, the operation portion is rotatable in a state where a substantially disk-shaped rotation operation member is sandwiched between a pair of holding members. In the known example, one of the wires is pulled and the other wire is loosened by rotating the rotating operation member clockwise or counterclockwise.

  That is, in this technique, the rotation operation member includes a first rotation operation member in which a pair of arc-shaped grooves are formed, a pair of fan-shaped members that can move (rotate) along each of the arc-shaped grooves, and the first A second rotation operation member that is integrally attached to the first rotation operation member so that the fan-shaped member is accommodated in an internal space defined between the inner surface of the rotation operation member; As the rotary operation member rotates, the fan-shaped member moves along the arc-shaped groove, and tensions one of the wires connected to the fan-shaped member and relaxes the other, thereby deflecting the deflecting portion of the catheter. I am doing so.

  Further, the rotation operation member and the pair of holding members are formed with through-holes around the rotation center of the rotation operation member so as to correspond to each other. In these through holes, a rotary shaft member having a flange portion at one end of a substantially cylindrical shaft portion and a female screw portion at the other end is inserted, and the male screw of the knob member having a male screw portion and a head portion The portion is screwed into the female screw portion of the rotating shaft member. By screwing the knob member into the rotation shaft member, the rotation operation member is pressed from both sides by the pair of holding members, and the rotation of the rotation operation member is restricted, and thus the shape of the distal end portion of the catheter tube is fixed. On the contrary, by loosening the screwing of the knob member to the rotating shaft member, the restriction of the rotation of the rotating operation member is released, and the shape of the deflection portion (tip portion) of the catheter tube can be arbitrarily changed. It has become.

Utility Model Registration No. 3162588

  As described above, as an operation of changing the deflection state of the deflection unit, the distal end portion of the catheter tube is formed in a desired shape by appropriately rotating the rotation operation member while loosening the screwing of the knob member to the rotation shaft member. After the adjustment, the knob member is screwed into the rotary shaft member, the rotation of the rotary operation member is restricted to fix the shape of the deflection portion of the catheter tube, and readjustment (or fine adjustment) is required. In this case, the screwing of the knob member with respect to the rotating shaft member is again loosened and the same operation is performed.

  However, at the time of readjustment after fixing the shape of the distal end portion of the catheter tube, an operation of once loosening screwing of the knob member into the rotating shaft member, adjusting the shape, and screwing the knob member into the rotating shaft member again. It is cumbersome to perform. Therefore, in actual use, although the rotation operation member does not rotate easily, the knob member is arranged on the rotation shaft so that the rotation of the rotation operation member is regulated to the extent that the rotation operation member is rotated when a force exceeding a predetermined value is applied. An operation to rotate the rotation operation member may be performed in a state where the degree of screwing into the member is adjusted, and the behavior of the deflection portion of the catheter tube may become unstable when such use is made. There was a problem.

  As a result of analyzing the problem when such an operation is performed, when the knob member is screwed into the rotating shaft member, a pressing force acts on the central portion of the rotating operation member, and the first rotating operation member or the second rotating operation is performed. It has been found that such a problem occurs because the member is deformed slightly inwardly and interferes with the fan-shaped member housed inside the first rotation operation member and the second rotation operation member.

  This invention is made | formed in view of such a point, and it aims at providing the tip movable catheter which can stabilize the behavior of the deflection | deviation part of a catheter tube.

The tip movable catheter according to the present invention is:
A catheter tube;
A first wire and a second wire each having a distal end connected in the vicinity of the distal end of the catheter tube;
An operation portion provided at the proximal end of the catheter tube,
The operation unit is
A first holding part and a second holding part;
A rotation operation member rotatably held by the first holding unit and the second holding unit in a state of being sandwiched between the first holding unit and the second holding unit;
A rotation restricting means for restricting the rotation of the rotation operation member by releasably pressing the first holding portion and the substantially central portion of the second holding portion in directions close to each other;
The rotation operation member is
A first rotation operation member having a substantially arc shape centered on the rotation center and having an arc-shaped groove having a first end and a second end;
A first movable member slidably fitted on the side of the arcuate groove close to the first end;
A second movable member slidably fitted on the side of the arcuate groove close to the second end,
In a state where the first movable member and the second movable member are accommodated in an internal space defined between the inner surface of the first rotational operation member, the first rotational operation member is integrally attached to the first rotational operation member. A two-rotation operation member,
The inner surface of one of the first rotation operation member and the second rotation operation member is pressed by at least the rotation restricting means in a direction in which the substantially central portions of the first holding portion and the second holding portion are close to each other. In the above, a support member is provided in which the front end surface is in contact with the other inner surface of the first rotation operation member and the second rotation operation member.

In the present invention,
The operation part includes a fixed operation member fixed to the first holding part and the second holding part,
The first holding portion has a first through hole at the center thereof,
The second holding portion has a second through hole corresponding to the first through hole at the center thereof,
The rotation operation member has a third through hole corresponding to the first through hole and the second through hole at the center thereof,
The rotation restricting means is
A flange portion larger than the second through hole is provided at one end portion of the substantially cylindrical shaft portion, and a female screw portion is provided at the other end portion. The female screw portion is connected to the third through hole via the second through hole. The inserted rotating shaft member;
A knob member having a head larger than the first through-hole at one end of the neck having a smaller diameter than the first through-hole, and a male screw part screwed into the female screw part of the rotary shaft member at the other end; With
The first rotation operation member and the second rotation operation member are attached to the fixed operation member so as to rotate by a predetermined angle in a first direction and a second direction opposite to the first direction,
The first movable member rotates in accordance with the rotation of the rotation operation member by contacting the first end when the rotation operation member is rotated in the first direction;
A proximal end of the first wire is connected to the first movable member so that the first wire is pulled when the first movable member is rotated in the first direction;
The second movable member rotates in accordance with the rotation of the rotation operation member by contacting the second end when the rotation operation member is rotated in the second direction,
The second movable member is configured such that a proximal end of the second wire is connected so that the second wire is pulled when the second movable member is rotated in the second direction. be able to.

  In the present invention, the support members may be a pair of members disposed at positions that face each other at approximately 180 degrees near the periphery of the third through hole.

  According to the distal movable catheter of the present invention, the distal end surface of the first rotary operation member and the second rotary operation member contacts the other inner surface of the first rotary operation member and the second rotary operation member. Since the supporting strut member is provided, the pressing force is applied to the central portion of the rotating operation member in a state where the rotation of the rotating operation member is restricted by the rotation restricting means (for example, the knob member is screwed into the rotating shaft member). Even if it acts, it is suppressed that the rotation operation member (the first rotation operation member or the second rotation operation member) is deformed inwardly by the support member, and the first member accommodated in the rotation operation member. Interference with the movable member or the second movable member is reduced. Thereby, the behavior of the distal end portion of the catheter tube can be stabilized.

It is a top view which shows the external appearance structure of the tip movable catheter of embodiment of this invention. 2A is a cross-sectional view taken along line AA in FIG. 1, and FIG. 2B is a cross-sectional view taken along line BB in FIG. It is a side view which decomposes | disassembles and shows the structure of the grip part and operation part of the tip movable catheter of embodiment of this invention. It is a top view of the grip front member or grip back member which comprises the grip part of the tip movable catheter of embodiment of this invention. It is a bottom view of the grip front member or grip back member which comprises the grip of the tip movable catheter of embodiment of this invention. It is a disassembled perspective view which shows the structure of the operation part of the tip movable catheter of embodiment of this invention. It is a top view of the state which removed the 2nd rotation operation member which shows the structure of the operation part of the tip movable catheter of embodiment of this invention. It is a rear view which shows the structure of the operation part of the tip movable catheter of embodiment of this invention. It is a top view which shows the fixed operation member which comprises the operation part of the tip movable catheter of embodiment of this invention. It is a rear view which shows the fixed operation member which comprises the operation part of the tip movable catheter of embodiment of this invention. It is a top view which shows the 1st rotation operation member which comprises the operation part of the tip movable catheter of embodiment of this invention. It is a rear view which shows the 1st rotation operation member which comprises the operation part of the tip movable catheter of embodiment of this invention. It is a bottom view which shows the 2nd rotation operation member which comprises the operation part of the tip movable catheter of embodiment of this invention. It is a front view which shows the 2nd rotation operation member which comprises the operation part of the tip movable catheter of embodiment of this invention. It is a top view which shows the 1st fan-shaped member which comprises the operation part of the tip movable catheter of embodiment of this invention. It is a rear view which shows the 1st fan-shaped member which comprises the operation part of the tip movable catheter of embodiment of this invention. It is a top view which shows the 2nd fan-shaped member which comprises the operation part of the tip movable catheter of embodiment of this invention. It is a rear view which shows the 2nd fan-shaped member which comprises the operation part of the tip movable catheter of embodiment of this invention. It is a figure which shows operation | movement of the operation part of the tip movable catheter of embodiment of this invention, and is a figure which shows the case where a rotation operation member is rotated in the 1st direction. It is a figure which shows operation | movement of the operation part of the tip movable catheter of embodiment of this invention, and is a figure which shows the case where a rotation operation member is rotated in the 2nd direction. It is sectional drawing of the operation part of the tip movable catheter of embodiment of this invention.

  Embodiments of the present invention will be specifically described below with reference to the drawings. The catheter sheath (tip movable sheath) as the tip movable catheter of this embodiment precedes, for example, an electrode catheter for detecting an electrocardiogram or an ablation catheter for cauterizing an affected part when performing catheter ablation. A catheter that is inserted and guides these electrode catheters, ablation catheters, and the like. Hereinafter, a catheter sheath will be described as an example of the distal movable catheter to which the present invention is applied. However, the present invention can also be applied to an electrode catheter, an ablation catheter, and other distal movable catheters.

  Catheter ablation is a treatment method for treating an arrhythmia occurring in the heart. An ablation catheter having a high-frequency electrode at its distal end is passed through a blood vessel to the myocardial tissue causing the arrhythmia in the heart. This is a treatment method in which the cardiac muscle tissue or its vicinity is cauterized at about 60 to 70 ° C. to cause coagulative necrosis, thereby interrupting the arrhythmia circuit.

  First, FIG. 1, FIG. 2 and FIG. 3 will be referred to. The catheter sheath 1 includes a sheath body 2 as a catheter tube, an operation portion 3, a grip portion 4, a pair of wires 5a and 5b, a knob member 6, and a rotary shaft member 7.

  The sheath body 2 is made of a hollow tube, and for example, a multilayer tube including a blade layer made of mesh-like stainless steel and a plurality of resin layers is used. A part of the distal end side of the sheath body 2 is a deflecting portion 21 whose direction can be arbitrarily deflected, and the deflecting portion 21 is set to have a lower hardness (flexibly) than the remaining portion, Further, the deflection portion 21 is set so that the hardness decreases gradually or step by step toward the tip. The main material of the sheath body 2 is not particularly limited as long as it has flexibility, but is preferably a thermoplastic resin or a thermoplastic elastomer, such as a polyether block amide copolymer. Polyamide elastomer, polyamide, polyimide, polyamideimide, polyethylene terephthalate, polyethylene, polypropylene, polyurethane, ethylene / vinyl acetate copolymer, polyvinyl chloride and the like are used.

  An insertion hole through which a portion on the proximal end side of the sheath body 2 is inserted is formed in the operation portion 3 and the grip portion 4 attached to the proximal end side of the sheath body 2. A sheath hub 49a is attached to the end. The sheath hub 49a has a lumen, and the sheath body 2 in the grip portion 4 is attached to the distal end side of the sheath hub 49a so that the lumen of the sheath hub 49a and the main lumen 22 of the sheath body 2 communicate with each other. It has been. A catheter insertion port having a hemostasis valve is formed on the proximal end side of the sheath hub 49a. When the catheter sheath 1 is used (procedure), the above-described electrode catheter or ablation catheter is inserted from the catheter insertion port of the sheath hub 49a and guided to the main lumen 22 of the sheath body 2 so that each distal end portion is treated. Guided to the myocardial tissue. Further, a side injection tube is formed on the side of the sheath hub 49a so as to protrude in a direction parallel to the plane when the catheter sheath 1 is placed on a plane, and a tube 49b is provided on the side injection tube. A three-way stopcock 49c is attached through. For example, a syringe or the like can be attached to the three-way stopcock 49c so that blood in the body can be sucked or a chemical solution can be sent into the body.

  As shown in FIG. 2A, the sheath body 2 is composed of a multilayer tube composed of a relatively thin inner layer 2a and a relatively thick outer layer 2b. The inner layer 2a is made of a slippery material such as fluororesin. Excellent resin is used. In addition, a pair of thin resin tubes formed of a resin having excellent slipperiness such as a fluororesin is embedded in the thick wall of the outer layer 2b of the sheath body 2 so that a pair of sublumens substantially parallel to the main lumen 22 are embedded. 23a and 23b are formed. The sub-lumens 23a and 23b are formed at positions opposed to each other by 180 degrees, and the first wire 5a and the second wire 5b made of metal such as stainless steel are inserted into the sub-lumens 23a and 23b, respectively. Yes. Further, an elliptical cylindrical blade layer (shown as a dotted line in FIG. 2A) is embedded outside the sub-lumens 23a and 23b within the thick wall of the outer layer 2b.

  2B, an annular pull ring (ring member) 24 is embedded in the outer layer 2b of the sheath body 2 at the distal end of the sheath body 2 (near the tip of the deflecting portion 21). The distal ends of the first wire 5a and the second wire 5b are connected and fixed at a position opposite to the proximal end side of the pull ring 24 at 180 degrees.

  Proximal ends of the first wire 5a and the second wire 5b are pulled out from a side hole provided in the sheath body 2 inside the operation portion 3 provided on the proximal end side of the sheath body 2, and the operation portion 3 is pulled out. (The fan-shaped members 34a and 34b of the rotation operation member 31 to be described later) are respectively connected. The operation section 3 is held by a holding section 42 (42a, 42b) provided on the tip (distal end) side of the grip section 4.

  As shown in FIGS. 3 to 5, the grip portion 4 includes a grip surface member 4 a and a grip back member 4 b that are substantially symmetrical with each other, and the operation portion 3 is held by the grip surface member 4 a at the holding portion 42 (42 a, 42 b). In addition, they are integrated with each other in a state of being held rotatably by being sandwiched between grip back members 4b. The sheath body 2 is guided to the inside from the distal end opening of the distal end portion 43 (43a, 43b) of the grip portion 4. The material of the grip part 4 is not particularly limited, but is preferably a thermoplastic resin. For example, polycarbonate, polyacetal, polyamide, polyethylene, polypropylene, ABS resin, polyethylene terephthalate, or the like is used. Through holes (first through holes and second through holes) 46a and 46b are formed at the center of the holding portion 42 (42a and 42b).

  As shown in FIGS. 6 to 8, the operation unit 3 includes a fixed operation member 31, rotation operation members 32 and 33 rotatably supported by the fixed operation member 31, and a first fan-shaped member (first movable member). 34a and a second fan-shaped member (second movable member) 34b.

  As shown in FIGS. 6, 9, and 10, the fixing operation member 31 includes a front communication portion 31a, a rear communication portion 31b, and a substantially annular edge portion 31c. The inner side of the edge portion 31c is a penetration portion, and the first protrusion 35a, the second protrusion 35b, and the third protrusion 35c that protrude toward the inner side (center of the edge portion 31c) are integrally formed on the inner surface of the edge portion 31c. Is formed. An inner portion of the edge portion 31c is an annular projecting portion 31d that slightly projects in an annular shape. The front communication part 31a and the rear communication part 31b are integrally formed with protrusions 31e and 31f for positioning when being held by the grip part 4, respectively. These protrusions 31e and 31f are respectively fitted into receiving holes 4e and 4f (see FIG. 4) formed inside the grip back member 4b of the grip portion 4, so that when the grip portion 4 holds the operation portion, This is for determining the position of 3.

  As shown in FIGS. 1, 6, 7, and 8, the rotation operation members 32 and 33 include a first rotation operation member 32 and a second rotation operation member 33. The first rotation operation member 32 and the second rotation operation member 33 are predetermined in a first direction (counterclockwise in FIG. 1) B1 and a second direction (clockwise in FIG. 1) B2 opposite to the first direction B1. The fixed operation member 31 is rotatably supported so as to be reciprocally rotated by an angle (approximately 120 degrees in the present embodiment).

  As shown in FIGS. 6, 11, and 12, the first rotation operation member 32 includes a substantially disc-shaped disc portion 32 a and a pair of divided gripping portions 32 b and 32 b on the left and right. The divided gripping portion 32b is formed with a concave portion 32c that fits into a convex portion 33c formed on the divided gripping portions 33b and 33b of the second rotation operation member 33 described later. The circular plate portion 32a is formed with a circular depressed portion 32d that is slightly depressed corresponding to the annular projecting portion 31d of the fixing operation member 31 described above.

  A through hole (third through hole) 32e is formed at the center of the circular depression 32d, and an annular protrusion 32f slightly protruding outward (downward in FIG. 12) is formed around the through hole 32e. Is formed. The circular recess 32d is formed with an arcuate groove 36 having a first arc 36a and a second end 36b, which is substantially arc-shaped around the center of the disc 32a. In the present embodiment, the arc-shaped groove 36 is formed over an angle range of approximately 240 degrees. An intermediate portion of the arc-shaped groove 36 is a wide portion 36c having a wide width with respect to a narrow portion on the side close to the first end portion 36a or the second end portion 36b. The wide portion 36c constitutes an introduction portion when a first fan-shaped member 34a and a second fan-shaped member 34b described later are loosely fitted.

  A pair of support members 32g and 32g are integrally provided on the inner surface (circular depression 32d) of the first rotation operation member 32. In the assembled state, the support members 32g and 32g are positioned so as not to interfere with the portion where the sheath body 2 is arranged and the fan-shaped members 34a and 34b at any rotation position when the rotation operation members 32 and 33 are rotated. Has been placed. In the present embodiment, the support members 32g and 32g are arranged at positions that oppose each other at approximately 180 degrees in the vicinity of the peripheral edge portion of the through hole 32e, and lines that connect the centers of the pair of divided gripping portions 32b and 32b on the left and right. (A line passing through the center of rotation) (see also FIGS. 19 and 20).

  In the present embodiment, the support members 32g and 32g are formed of rod-shaped (columnar) members having a substantially arc-shaped cross-sectional shape. The support members 32g and 32g are erected so that the longitudinal direction thereof is substantially perpendicular to the plate surface of the first rotation operation member 32 (the bottom surface of the circular recess 32d) (the direction of the rotation center axis). ing. The support members 32g and 32g are in a height (longitudinal dimension) integrated with a second rotation operation member 33 described later (the first rotation operation member 32 and the second rotation operation member 33 are not deformed by an external force). ), The tip end surface is set to face the inner surface of the second rotation operation member 32 with a slight gap.

  The support members 32g and 32g are not limited to rod-shaped (columnar) members having an arcuate cross section, and may be cylindrical, prismatic, or other shapes. Moreover, it may not be the thing of the same cross-sectional shape from a base end part to a front-end | tip part, The thing of truncated cone shape, a truncated pyramid shape, and another shape may be sufficient. Furthermore, although two support members 32g are used in the present embodiment, one or three or more support members may be used. Further, in the present embodiment, the pair of support members 32g and 32g are disposed at positions facing each other at approximately 180 degrees, but may be disposed in another angular positional relationship.

  As shown in FIGS. 6, 13, and 14, the second rotation operation member 33 includes a substantially disc-shaped disc portion 33 a and a pair of split gripping portions 33 b and 33 b that project left and right. The split gripping portion 33b is formed with a convex portion 33c that fits into the concave portion 32c formed in the split gripping portion 32b of the first rotation operation member 32 described above. In addition, a pair of window portions 33d and 33d are formed in the disc portion 33a. A through hole (third through hole) 33e is formed at the center of the disk portion 33a, and an annular protruding portion 33f that slightly protrudes outward (upper side in FIG. 14) is formed around the through hole 33e. Has been.

  The first rotation operation member 32 is disposed on one side (the rear surface in FIG. 6, the lower surface in FIG. 8) side of the fixed operation member 31, and the second rotation is performed on the other surface (front surface in FIG. 6, upper surface in FIG. 8) side. The operation member 33 is arranged, the fixed operation member 31 is sandwiched between the first rotation operation member 32 and the second rotation operation member 33, and the concave portion 32c provided in the divided grip portion 32b of the first rotation operation member 32 and the second The rotation operation members 32 and 33 are rotatably attached to the fixed operation member 31 by fitting the projections 33 c provided on the divided gripping portion 33 b of the rotation operation member 33. Thus, in the state where the first rotation operation member 32 and the second rotation operation member 33 are integrated with each other (when the first rotation operation member 32 and the second rotation operation member 33 are not deformed by an external force), the first rotation The front end surfaces of the support members 32g and 32g of the operation member 32 face the inner surface of the second rotation operation member 33 with a slight gap.

  As shown in FIGS. 6 and 15 to 18, the first fan-shaped member 34 a and the second fan-shaped member 34 b are formed in a symmetrical shape so as to be paired with each other, and have an outer large arc and an inner small arc. It has a substantially fan-like plate-like portion 37a and a substantially arc-shaped leg portion 37b slidably fitted in the arc-shaped groove 36 of the first rotating operation member 32 described above. The front end (the lower end in FIGS. 16 and 18) of the leg portion 37b is formed to be slightly wide to form a wide portion 37c, and the leg portion 37b is loosely fitted into the arc-shaped groove 36 so that the leg portion 37b can be removed from the arc-shaped groove 36. It is to be prevented. The outer large arc and the inner small arc of the first fan-shaped member 34a and the second fan-shaped member 34b are substantially concentric with the arc-shaped groove 36 in a state where the leg portions 37b are loosely fitted in the arc-shaped groove 36, respectively. Is formed. Grooves for guiding the wires 5a and 5b (first wire guide groove, second wire guide groove) in the large arc portion (first arc-shaped edge portion, second arc-shaped edge portion) outside the plate-like portion 37a. 37d is formed. Further, a pin hole 37f through which a headed pin 39 (see FIG. 7) for fixing the wires 5a and 5b is inserted and a head of the headed pin 39 are pressed against the plate-like portion 37a. A pair of screw holes 37e into which a pair of screws 38 (see FIG. 7) for fixing 39 are screwed are formed.

  In a state where the fixed operation member 31 is superimposed on the first rotation operation member 32, the wide portion 36 c of the arc-shaped groove 36 of the first rotation operation member 32 is formed with respect to the first rotation operation member 32 with respect to the fixed operation member 31. The leg member 37a (the wide portion 37c) of the first fan-shaped member 34a is inserted into the wide portion 36c by rotating the fixed operation member 31 so as to be positioned between the first projection 35a and the third projection 35c. By moving to the first end portion 36a side, the first fan-shaped member 34a is slidably fitted in a narrow portion of the arc-shaped groove 36 on the side close to the first end portion 36a.

  The first rotation operation member 32 is fixed to the fixed operation member 31, and the wide portion 36 c of the arc-shaped groove 36 of the first rotation operation member 32 is disposed between the second protrusion 35 b and the third protrusion 35 c of the fixed operation member 31. The second fan-shaped member 34b is rotated by being rotated so as to be positioned, and the leg part 37b (wide part 37c) of the second fan-shaped member 34b is inserted into the wide part 36c and moved to the second end 36b side. Is slidably fitted in a narrow portion on the side close to the second end portion 36 b of the arc-shaped groove 36.

  As shown in FIG. 7, the line passing through the pair of gripping portions 32b of the first rotary operation member 32 is substantially the same as the line passing through the center of the front communication portion 31a and the rear communication portion 31b of the fixed operation member 31. In a state set so as to be orthogonal (hereinafter sometimes referred to as a neutral state), the first end portion 36a of the arc-shaped groove 36 is set at a position overlapping the first protrusion 35a. Since the two end portions 36b are set at positions overlapping the second protrusions 35b, in this state, the first fan-shaped member 34a is formed into the arc-shaped groove 36 at a portion between the first protrusions 35a and the third protrusions 35c. The second fan-shaped member 34b is slidable along the arc-shaped groove 36 at a portion between the second protrusion 35b and the third protrusion 35c.

  When the operation unit 3 configured as described above is sandwiched and integrated between the holding portion 42a of the grip surface member 4a and the holding portion 42b of the grip back member 4b, the fixed operation member 31 is connected to the grip surface member 4a and the grip surface member 4a. While being fixed to the grip back member 4b, the annular protrusion 36a was loosely fitted in a circular recess (not shown) formed in the holding part 42a with a slight gap, and the annular protrusion 36b was formed in the holding part 42b. The rotary operation members 32 and 22 are rotatably held with respect to the grip part 4 (holding parts 42a and 42b) by loosely fitting in a circular recess (not shown) with a slight gap. .

  The material of the fixed operation member 31 and the rotation operation member (the first rotation operation member 32, the second rotation operation member 33) is not particularly limited, but is preferably a thermoplastic resin, for example, polycarbonate, polyacetal, polyamide Polyethylene, polypropylene, ABS resin, etc. are used.

  The sheath body 2 introduced from the distal end opening of the distal end portion 43 (43a, 43b) in a state where the operation portion 3 is sandwiched and assembled between the retaining portion 42a of the grip front member 4a and the retaining portion 42b of the grip back member 4b. The proximal end side passes through the front communication portion 31 a and the rear communication portion 31 b of the fixed operation member 31 and is guided to the sheath hub 4 a at the proximal end of the grip portion 4.

  Proximal ends of the first wire 5a and the second wire 5b are respectively drawn outward from the sheath body 2 in the distal end portion 43 of the grip portion 4, and as shown in FIG. 7, the front communication portion 31a of the fixing operation member 31. Led through. The proximal end of the first wire 5a passes between the groove 37d formed in the portion of the large arc side outside the first fan-shaped member 34a and the edge portion 31a of the fixed operation member 31, and has a diameter on the pin shaft. Is inserted into a through hole of a headed pin 39 having a through hole in the direction, and the headed pin 39 is fitted into the pin hole 37f to be connected and fixed to the first fan-shaped member 34a. The proximal end of the second wire 5b passes between a groove 37d formed in a portion of the large arc side outside the second fan-shaped member 34b and the edge 31a of the fixed operation member 31, and is diametrically connected to the pin shaft. Is inserted into the through hole of the headed pin 39 having a through hole in the direction, and the headed pin 39 is fitted into the pin hole 37f to be connected and fixed to the second fan-shaped member 34b. If the first wire 5a and the second wire 5b are wound around the pin shaft of the headed pin 39 and the winding length is adjusted, the effective length of the first wire 5a and the second wire 5b can be easily adjusted. Can do.

  As shown in FIG. 3 or FIG. 21, the rotation restricting means in this embodiment includes a knob member 6 and a rotating shaft member 7. The knob member 6 includes a head at one end of the neck portion 64 and a male screw portion 65 at the other end. The head is composed of a knob portion 61, a disc portion 62, and a circular protrusion 63. The neck portion 64 is set to have a smaller diameter than the through hole 46 a of the holding portion 42 a and is set to have a smaller diameter than the inner diameter of the female screw portion 73 of the rotating shaft member 7. The circular protrusion 63 has a larger outer diameter than the through hole 46a of the holding portion 42a, and can be loosely fitted in a circular recess (not shown) formed in the holding portion 42a with a slight gap. . The male screw portion 65 has an outer diameter slightly larger than the through hole 46a of the holding portion 42a, and has a thread that is screwed into the female screw portion 74 of the rotating shaft member 7. As the material of the knob member 6, for example, a metal such as aluminum or stainless steel, or a resin such as polycarbonate, polyacetal, polyamide, polyimide, polyethylene, polypropylene, ABS resin, or polyethylene terephthalate is used.

  The rotary shaft member 7 has a flange portion 72 at one end of a substantially cylindrical shaft portion 71 and a female screw portion 73 at the other end. The shaft portion 71 is formed to have a smaller diameter than the through hole 46b of the holding portion 42b. The flange portion 72 is formed in a substantially disc shape, and its outer diameter is set to be larger than the through hole 46b of the holding portion 42b, and a circular recessed portion (not shown) formed in the holding portion 42b. ) To be loosely fitted with a slight gap. The female screw portion 73 is formed in a substantially cylindrical shape, and has an outer diameter larger than that of the shaft portion 71 and slightly smaller than the through hole 46b of the holding portion 42b, and the through holes of the rotation operation members 32 and 33. 32e and 33e are formed to be loosely fitted with a slight gap.

  On the inner periphery of the female screw portion 73, a screw thread to which the male screw portion 64 of the knob member 6 is screwed is formed. The female thread portion 73 is formed with a slit portion (not shown) through which a portion on the proximal end side of the sheath body 2 passes when assembled. The width of the slit portion is set to such a size that it can pass in consideration of the outer shape of the sheath body 2. As a material of the rotating shaft member 7, for example, a metal such as aluminum or stainless steel is used.

  When assembling the grip portion 4 described above, from the state shown in FIG. 3, the operation portion 3 to which the proximal end side of the sheath body 2 is attached is changed to the holding portion 42 a of the grip front member 4 a and the holding portion of the grip back member 4 b. The operation unit 3 is integrated with the grip unit 4 in a state where the operation unit 3 is held by the grip unit 4. In FIG. 3, the side injection tube of the sheath hub 49a to which the tube 49b and the three-way stopcock 49c are attached is shown facing the grip back member 4b, but actually the catheter sheath 1 is placed on a plane. In this case, assembly is performed in a direction (front direction in the figure) which is horizontal with the plane. Then, as shown in FIG. 21, while inserting the female screw part 73 side of the rotating shaft member 7 from the through hole 46b of the grip part 4b, the male screw part 65 side of the knob member 6 is inserted from the through hole 46a of the grip part 4a. The assembly is completed by inserting and screwing the male screw portion 65 of the knob member 6 into the female screw portion 73 of the rotary shaft member 7 and screwing it to an appropriate position.

  In the neutral state shown in FIG. 1, both the first wire 5a and the second wire 5b are in a tension-free state (or in a state where the wire 2 is loosened almost uniformly), and the deflection portion 21 at the distal end of the sheath 2 is shown in FIG. It will be in the state extended straight. In this state, as shown in FIG. 7, the first fan-shaped member 34 a is in a state where the leg portion 37 b is in contact with the first protrusion 35 a inside the operation portion 3. Further, the leg part 37b of the second fan-shaped member 34b is in contact with the second protrusion 35b.

  When the first rotation operation member 32 is rotated in the first direction (the direction of the arrow B1 in FIG. 7) from this neutral state, the first end portion 36a of the arc-shaped groove 36 becomes the leg portion 37b of the first fan-shaped member 34a. When abutting and further rotating, the first fan-shaped member 34a rotates with the first rotation operating member 32 and can be rotated until it abuts on the third protrusion 35c as shown in FIG. The first wire 5a is pulled by the rotation of the first fan-shaped member 34a, and the deflection portion 21 at the tip is deflected as indicated by an arrow B3 in FIG. At this time, the second fan-shaped member 34b keeps its leg portion 37b in contact with the second protrusion 35b and stopped by the tensile force of the second wire 5b.

  On the other hand, when the first rotation operation member 32 is rotated in the second direction (the arrow B2 direction in FIG. 1), the second end portion 36b of the arc-shaped groove 36 comes into contact with the leg portion 37b of the second fan-shaped member 34b. When rotated, the second fan-shaped member 34b rotates together with the first rotation operation member 32 and can be rotated until it comes into contact with the third protrusion 35c as shown in FIG. The second wire 5b is pulled by the rotation of the second fan-shaped member 34b, and the deflection portion 21 at the tip is deflected as shown by an arrow B4 in FIG. At this time, the first fan-like member 34a keeps its leg 37b in contact with the first protrusion 35a and stopped by the tensile force of the first wire 5a.

  When it is desired to fix the shape of the deflecting portion 21 in a state where the deflecting portion 21 at the tip of the sheath 2 is deflected, the knob member 6 is rotated clockwise by gripping the knob portion 61. The male screw portion 65 is screwed into the female screw portion 73 of the rotary shaft member 7, and the holding portion 42 a and the holding portion 42 b are brought closer to each other by the circular protrusion 63 of the knob member 6 and the flange portion 72 of the rotary shaft member 7. Accordingly, the rotary operation members 32 and 33 are firmly held between the holding portion 42a and the holding portion 42b. As a result, the rotation operation members 32 and 33 are fixed at the current angular position, and the shape of the deflection unit 21 at the distal end of the sheath body 2 is fixed.

  When it is desired to release the shape of the deflecting portion 21 at the distal end of the sheath body 2 (when it is desired to return to the neutral state or when the deflected state is to be readjusted), the knob 61 is gripped to reverse the above. By rotating the member 6 counterclockwise, the screwing of the male screw portion 65 of the knob member 6 into the female screw portion 73 of the rotary shaft member 7 is loosened, and the pressing of the holding portion 42a and the holding portion 42b toward each other is released. Then, the rotation operation members 32 and 33 are loosely held between the holding portion 42a and the holding portion 42b. As a result, the rotation operation members 32 and 33 can rotate, the shape of the deflection portion 21 at the distal end of the sheath body 2 is released from being fixed, and the rotation operation members 32 and 33 are held by holding the grip portions 32a and 33a. By rotating, the deflection state of the deflection unit 21 can be readjusted.

  In the case where it is desired to finely adjust the deflection state from the state in which the shape of the deflecting portion 21 at the tip of the sheath body 2 is fixed, the screwing of the knob member 6 with respect to the rotating shaft member 7 is not loosened (or the rotation operation members 32 and 33). This can be done by rotating the rotation operating members 32, 33 slightly loosened to the extent possible. In this case, in the prior art, the central portion of the second rotation operation member 33 is bent into a concave shape due to the screw member being pressed into the rotation shaft member 7, and the fan-shaped members 34a and 34b accommodated in the internal spaces are bent. Interfering with a part, the smooth movement along the arc-shaped groove 36 of the fan-shaped members 34a and 34b is obstructed, and the response of the deflecting portion 21 may be deteriorated or the behavior may be unstable.

  However, in the present embodiment, the support member 32g, 32g whose tip surface faces the inner surface of the second rotation operation member 33 with a slight gap is provided on the inner surface of the first rotation operation member 32. When the member 6 is pressed by screwing into the rotary shaft member 7, the first rotation operation member 32 and the second rotation operation member 33 are respectively bent inwardly, and the distal end surfaces of the support members 32g and 32g are subjected to the second rotation operation. It contacts the inner surface of the member 33. As a result, since the central portion of the second rotation operation member 33 is supported by the support members 32g and 32g, it is further prevented from being bent into a concave shape, and the fan-shaped members 34a and 34b accommodated in the internal spaces are suppressed. Interference with a part is prevented. As a result, the smooth movement along the arc-shaped groove 36 of the fan-shaped members 34a and 34b is not hindered, the responsiveness of the deflecting unit 21 can be prevented from deteriorating and the behavior can be prevented from becoming unstable. Can be improved.

  The embodiment described above is described for facilitating the understanding of the present invention, and is not described for limiting the present invention. Therefore, each element disclosed in the embodiment described above is intended to include all design changes and equivalents belonging to the technical scope of the present invention.

DESCRIPTION OF SYMBOLS 1 ... Catheter sheath 2 ... Sheath main body 21 ... Deflection part 22 ... Main lumen 3 ... Operation part 31 ... Fixed operation member 32 ... 1st rotation operation member (rotation operation member)
32g, 32g ... support member 33 ... second rotation operation member (rotation operation member)
34a ... 1st fan-shaped member (1st movable member)
34b ... 2nd fan-shaped member (2nd movable member)
35a ... 1st protrusion 35b ... 2nd protrusion 35c ... 3rd protrusion 36 ... Arc-shaped groove 36a ... 1st edge part 36b ... 2nd edge part 37b ... Leg part 4 ... Grip part 42 (42a, 42b) ... Holding part ( (First holding part, second holding part)
43 (43a, 43b) ... tips 5a, 5b ... wire 6 ... knob member (rotation restricting means)
61 ... knob portion 65 ... male screw portion 7 ... rotating shaft member (rotation restricting means)
72 ... Flange 73 ... Female thread

Claims (3)

A catheter tube;
A first wire and a second wire each having a distal end connected in the vicinity of the distal end of the catheter tube;
An operation portion provided at the proximal end of the catheter tube,
The operation unit is
A first holding part and a second holding part;
A rotation operation member rotatably held by the first holding unit and the second holding unit in a state of being sandwiched between the first holding unit and the second holding unit;
A rotation restricting means for restricting the rotation of the rotation operation member by releasably pressing the first holding portion and the substantially central portion of the second holding portion in directions close to each other;
The rotation operation member is
A first rotation operation member having a substantially arc shape centered on the rotation center and having an arc-shaped groove having a first end and a second end;
A first movable member slidably fitted on the side of the arcuate groove close to the first end;
A second movable member slidably fitted on the side of the arcuate groove close to the second end,
In a state where the first movable member and the second movable member are accommodated in an internal space defined between the inner surface of the first rotational operation member, the first rotational operation member is integrally attached to the first rotational operation member. A two-rotation operation member,
The inner surface of one of the first rotation operation member and the second rotation operation member is pressed by at least the rotation restricting means in a direction in which the substantially central portions of the first holding portion and the second holding portion are close to each other. A distal end movable catheter characterized by comprising a strut member whose tip surface abuts against the other inner surface of the first rotation operation member and the second rotation operation member. The operation part includes a fixed operation member fixed to the first holding part and the second holding part,
The first holding portion has a first through hole at the center thereof,
The second holding portion has a second through hole corresponding to the first through hole at the center thereof,
The rotation operation member has a third through hole corresponding to the first through hole and the second through hole at the center thereof,
The rotation restricting means is
A flange portion larger than the second through hole is provided at one end portion of the substantially cylindrical shaft portion, and a female screw portion is provided at the other end portion. The female screw portion is connected to the third through hole via the second through hole. The inserted rotating shaft member;
A knob member having a head larger than the first through-hole at one end of the neck having a smaller diameter than the first through-hole, and a male screw part screwed into the female screw part of the rotary shaft member at the other end; With
The first rotation operation member and the second rotation operation member are attached to the fixed operation member so as to rotate by a predetermined angle in a first direction and a second direction opposite to the first direction,
The first movable member rotates in accordance with the rotation of the rotation operation member by contacting the first end when the rotation operation member is rotated in the first direction;
A proximal end of the first wire is connected to the first movable member so that the first wire is pulled when the first movable member is rotated in the first direction;
The second movable member rotates in accordance with the rotation of the rotation operation member by contacting the second end when the rotation operation member is rotated in the second direction,
The proximal end of the second wire is connected to the second movable member so that the second wire is pulled when the second movable member is rotated in the second direction. A tip movable catheter.   3. The distal movable catheter according to claim 2, wherein the strut members are a pair of members disposed at positions that are substantially 180 degrees opposite each other in the vicinity of the periphery of the third through hole.

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