JP2010253125A - Catheter and method of manufacturing the catheter - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a catheter having various bending operability by a plurality of operation wires while obtaining precise operability and inserting property in a body cavity. <P>SOLUTION: A catheter 10 includes a sheath 16, operation wires 40a, 40b, a dial part 74, and a position adjusting mechanism 80. The sheath 16 has a main lumen and a sub-lumen with a diameter smaller than that of the main lumen, which are formed to pass through in the axial direction respectively. The operation wires 40a, 40b are slidably inserted into the sub-lumen respectively, and their tips are fixed to a distal end of the sheath 16. The dial part 74, which is mounted at a proximal end 17 of the sheath 16, is engaged with base ends 43 of the operation wires 40a, 40b respectively, so as to pull the operation wires 40a, 40b toward the sheath 16. The position adjusting mechanism 80 increases or decreases tensile strength of the operation wires 40a, 40b by relatively moving the dial part 74 and the sheath 16 in the axial direction of the sheath 16. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a catheter and a method for manufacturing the catheter.

  In recent years, a catheter has been provided in which a distal end portion of a sheath is bent by pulling an operation line inserted through the sheath so that an approach direction into a body cavity can be variably operated.

Regarding this type of technology, Patent Document 1 below pulls an operation line by a dial-type or slide-type operation unit to which a base end portion of one operation line (push / pull wire) inserted through a sheath is connected. A catheter to be manipulated is described.
Further, in Patent Documents 2 and 3 below, the sheath is formed by rotating a dial type operation unit (cam wheel) to which base ends of two operation lines (steering wires) inserted through the sheath are connected together. A catheter that can be bent in various orientations is described.

Special table 2007-507305 gazette Japanese Patent Laid-Open No. 07-59863 Japanese Patent Application Laid-Open No. 07-79993

  In the catheter, it is preferable to connect the operation line to the operation unit without any looseness or tension in the natural state. When the operation line is slack, a so-called “play” occurs in which the distal end portion of the sheath does not bend even when the operation portion is operated, and thus the bending operation of the catheter is delayed with respect to the operation. Further, if tension is applied to the operation line in a natural state, the catheter must be advanced into the body cavity with the distal end bent in advance in an unexpected direction.

  On the other hand, in recent years, there has been a demand for a catheter that can bend and operate a distal end portion even in a very fine body cavity such as a peripheral blood vessel. In such a catheter, since fine operability and penetration in a body cavity are required, it is necessary to avoid a delay in bending operation due to play of the operation line and bending in an unexpected direction.

  Here, as described in Patent Document 2, the catheter having a plurality of operation lines has an advantage that the bending operability of the distal end portion of the sheath is diversified. However, in the case of this type of catheter, it is difficult to connect the operation line to the operation unit without generating both slack and tension with respect to the plurality of operation lines.

  The present invention has been made in view of the above problems, and provides a catheter capable of obtaining fine operability and insertion in a body cavity while having various bending operability by a plurality of operation lines. To do.

The catheter of the present invention includes a sheath in which a main lumen and a plurality of sub-lumens having a diameter smaller than that of the main lumen are formed in the axial direction, respectively.
A plurality of operation lines that are slidably inserted into the plurality of sub-lumens, and whose distal ends are fixed to the distal end of the sheath;
An operation portion that is provided at a proximal end portion of the sheath, and that engages the proximal end portions of the plurality of operation lines, and pulls the operation line with respect to the sheath; and
A position adjustment mechanism that adjusts the tension of the operation line to increase or decrease by relatively moving the operation unit and the sheath in the axial direction of the sheath.

  In the catheter of the present invention, as a more specific embodiment, the proximal end portions of the first and second operation lines are engaged with the operation portion at different positions, and the traction operation is performed. Thus, the first and second operation lines may be pulled individually.

In the catheter of the present invention, as a more specific embodiment, when the operation portion is in the first state, the first operation line is pulled and tensioned, and the second operation line is relaxed. And
When the operation unit is in the second state, the first operation line may be relaxed and the second operation line may be pulled and tensioned.

Further, in the catheter of the present invention, as a more specific embodiment, the catheter further includes a main body portion that accommodates the proximal end portion of the sheath and to which the operation portion is fixed,
A proximal end of the sheath is attached to the position adjustment mechanism, and the position adjustment mechanism is screwed in the axial direction with respect to the main body portion,
The position adjusting mechanism may be screwed with respect to the main body portion, so that the operation portion, the operation line, and the sheath may be relatively moved in the axial direction.

Moreover, in the catheter of the present invention, as a more specific embodiment, the catheter further includes a connector that is fixed to the proximal end of the sheath and engages with the position adjusting mechanism,
The connector may move in the axial direction as the position adjusting mechanism is screwed relative to the main body.

In the catheter of the present invention, as a more specific embodiment, the sheath is formed of a resin material and a tubular inner layer in which the main lumen is formed, and a wire is knitted around the inner layer. A blade layer, and an outer layer made of the same or different kind of resin material as the inner layer and formed around the inner layer and enclosing the blade layer,
The sublumen may be formed inside the outer layer and outside the blade layer.

In the catheter of the present invention, as a more specific embodiment, the sublumen is formed by a hollow tube embedded in the outer layer,
A proximal end portion of the hollow tube may be branched from the sheath together with the operation line.

The catheter manufacturing method of the present invention includes a sheath in which a main lumen and a plurality of sub-lumens having a diameter smaller than that of the main lumen are formed in the axial direction, respectively.
First and second operation lines that are slidably inserted into the plurality of sub-lumens respectively, and whose tip is fixed to the distal end of the sheath;
Provided at the proximal end of the sheath, the proximal ends of the first and second operation lines are engaged, and the first operation line is pulled when the first operation line is in the first state. An operation portion that relaxes the second operation line and relaxes the first operation line to pull the second operation line when in a second state,
A first attachment that attaches the proximal end portion of the first operation line in a relaxed state inserted through the sub-lumen and having a distal end fixed to the distal end portion of the sheath to the operation portion in the second state. Process,
A dislocation step of pulling the first operation line with the operation portion to which the first operation line is attached as the first state;
In a state in which the first operation line is in tension, the proximal end portion of the second operation line in a relaxed state inserted through the sub-lumen and having a distal end fixed to the distal end portion of the sheath, A second attachment step for attaching to the operation section in the first state;
A tension adjusting step of setting the operating portion to a neutral state between the first state and the second state, and increasing or decreasing the tension of the first and second operating lines;
including.

In the catheter manufacturing method of the present invention, as a more specific embodiment, when the operation unit is in the neutral state, the first and second operation lines are both in tension.
In the tension adjusting step, both the tensions of the first and second operation lines may be removed.

  Note that the various components of the present invention do not have to be individually independent, that a plurality of components are formed as one member, and one component is formed of a plurality of members. It may be that a certain component is a part of another component, a part of a certain component overlaps a part of another component, and the like.

Moreover, although the manufacturing method of the catheter of this invention has described several process in order, the order of the description does not limit the order which performs several process. For this reason, when implementing the catheter manufacturing method of this invention, the order of the some process can be changed in the range which does not interfere in content.
Furthermore, the manufacturing method of the catheter of this invention is not limited to performing a several process at the timing which each differs. For this reason, another process may occur during execution of a certain process, or a part or all of the execution timing of a certain process and the execution timing of another process may overlap.

  According to the catheter and the manufacturing method thereof of the present invention, the operation portion and the sheath can be relatively moved in the axial direction by the position adjusting mechanism, and therefore, a plurality of both ends connected to the distal end portion and the operation portion of the sheath. The tension can be increased or decreased with respect to the operation line. For this reason, it is possible to obtain fine operability and insertion in the body cavity by eliminating slack and tension of the operation line while having various bending operability of the sheath by pulling operation of a plurality of operation lines. it can.

It is a side view showing an example of a catheter concerning an embodiment of the present invention. It is a longitudinal cross-sectional view of the distal end part of a catheter. FIG. 3 is a sectional view taken along line III-III in FIG. 2. It is a side view explaining the catheter of the state which pulled-operated the operation line. It is a longitudinal cross-sectional view of a catheter, (a) is a side view, (b) is a top view. FIG. 6 is an enlarged view of a region VI shown in FIG. 5. (A) is a side view which shows operation | movement of a position adjustment mechanism, (b) is the fragmentary longitudinal cross-sectional view. (A) is a side view which shows other operation | movement of a position adjustment mechanism, (b) is the fragmentary longitudinal cross-sectional view. (A)-(c) is a schematic diagram which shows the manufacturing method of a catheter.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same reference numerals are given to the same components, and the description will be omitted as appropriate.

FIG. 1 is a side view showing an example of a catheter 10 according to an embodiment of the present invention.
FIG. 2 is an enlarged cross-sectional view of the region II indicated by a broken line in FIG. 1, and is a vertical cross-sectional view of the distal end portion 15 of the catheter 10.
3 is a cross-sectional view (cross-sectional view) taken along the line III-III in FIG.
In the present embodiment, a cross-sectional view cut in the axial direction (longitudinal direction) of the catheter 10 is referred to as a vertical cross section, and a cross section cut in a direction orthogonal to the axial direction is referred to as a horizontal cross section.

First, the outline | summary of the catheter 10 of this embodiment is demonstrated.
The catheter 10 of the present embodiment includes a sheath 16, a plurality of operation lines 40 (40 a, 40 b), an operation unit (dial unit 74), and a position adjustment mechanism 80.
The sheath 16 is formed with a main lumen 20 and a plurality of sub-lumens 30 (30a, 30b) having a smaller diameter than the main lumen 20 in the axial direction.
The operation lines 40 a and 40 b are slidably inserted into the plurality of sub-lumens 30 a and 30 b, respectively, and the tip portion 41 is fixed to the distal end portion 15 of the sheath 16.
The operation portion (dial portion 74) is provided at the proximal end portion 17 of the sheath 16, and the proximal end portions 43 (see FIG. 5) of the plurality of operation lines 40a and 40b are engaged with each other, so that the operation line 40a. , 40b with respect to the sheath 16 is pulled.
The position adjustment mechanism 80 adjusts the tension of the operation lines 40 a and 40 b to increase or decrease by relatively moving the operation unit (dial unit 74) and the sheath 16 in the axial direction of the sheath 16.

The distal end portion 15 of the sheath 16 refers to a predetermined length region including the distal end DE of the sheath 16. The proximal end portion 17 of the sheath 16 refers to a predetermined length region including the proximal end PE (see FIG. 5) of the sheath 16, and includes a length region inserted into the operation mechanism 70. .
Similarly, the distal end portion 41 of the operation line 40 refers to a predetermined length region including the distal end of the operation line 40, and the proximal end portion 43 of the operation line 40 refers to a predetermined length including the proximal end of the operation line 40. This is the area.
Further, the proximal end side of the catheter 10 may be referred to as the rear side or the proximal end side, and the distal end side may be referred to as the front side or the distal end side.

Next, the catheter 10 of this embodiment will be described in detail.
Hereinafter, after describing the structure of the sheath 16 and the usage mode of the catheter 10, the structure of the operation mechanism 70 and the position adjusting mechanism 80, which are characteristic of the present embodiment, and the method for manufacturing the catheter 10 will be described.

<Sheath structure>
As shown in FIGS. 2 and 3, the sheath 16 of the present embodiment includes a tubular inner layer 21 made of a resin material and having a main lumen 20 formed therein, and a blade formed by knitting wires 52 around the inner layer 21. The layer 50 includes an outer layer 60 made of the same or different resin material as the inner layer 21 and formed around the inner layer 21 and enclosing the blade layer 50.
The sublumen 30 is formed inside the outer layer 60 and outside the blade layer 50.

The sheath 16 is a flexible tubular body that is inserted through the endoscope or directly into the body cavity.
Here, typical dimensions of the sheath 16 of the present embodiment will be described.
The outermost diameter of the sheath 16 is less than 1 mm in diameter, specifically about 700 to 900 μm.
The diameter of the main lumen 20 is about 400 to 600 μm, the thickness of the inner layer 21 is about 10 to 30 μm, the thickness of the outer layer 60 is about 100 to 150 μm, and the thickness of the blade layer 50 is 20 to 30 μm. Further, the radius from the axial center of the sheath 16 to the center of the sublumen 30 is about 300 to 350 μm, the inner diameter of the sublumen 30 is 40 to 100 μm, and the thickness of the operation line 40 is 30 to 60 μm.
The sheath 16 of the present embodiment has a size that can be inserted into a blood vessel such as a celiac artery and a peripheral blood vessel such as a hepatic artery branch and an internal carotid artery branch. Moreover, since the catheter 10 of this embodiment is operated freely by the pulling of the operation lines 40a and 40b, the sheath 16 can be advanced in a desired direction even in a branching blood vessel.

For example, a fluorine-based thermoplastic polymer material can be used for the inner layer 21. More specifically, polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), perfluoroalkoxy fluororesin (PFA), or the like can be used.
By using a fluorine-based resin for the inner layer 21, the delivery property when supplying a contrast medium or a drug solution to the affected area through the main lumen 20 of the catheter 10 is improved.

  A thermoplastic polymer is widely used for the outer layer 60. Examples include polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), nylon elastomer, polyurethane (PU), ethylene-vinyl acetate resin (EVA), poly Vinyl chloride (PVC) or polypropylene (PP) can be used.

As the wire 52 constituting the blade layer 50, a fine wire of polymer fiber such as PI, PAI or PET can be used in addition to a fine metal wire such as stainless steel (SUS) or nickel titanium alloy.
The cross-sectional shape of the wire 52 is not particularly limited, and may be a round line or a flat line.

The sub-lumens 30 a and 30 b are provided so as to penetrate the outer layer 60 along the main lumen 20.
In the catheter 10 of the present embodiment, the sub-lumens 30a and 30b are formed by the hollow tube 32 embedded in the outer layer 60.
That is, in the outer layer 60, two hollow tubes 32 into which the operation lines 40a and 40b are slidably inserted are extended in the axial direction and embedded.

  In addition, that the hollow tube 32 (sublumen 30) extends in the axial direction of the sheath 16 means that it has an axial component with respect to the sheath 16. That is, a part or all of the hollow tube 32 (sublumen 30) may be provided spirally with respect to the sheath 16, and may include a circumferential component together with an axial component.

  Hereinafter, the operation line 40a may be referred to as a first operation line, and the operation line 40b may be referred to as a second operation line.

  In the catheter 10 of the present embodiment, the two sub-lumens 30 a and 30 b through which the operation lines 40 a and 40 b are inserted are arranged to face the periphery of the main lumen 20.

  That is, in the present embodiment, the sub-lumen 30a and the sub-lumen 30b are formed to face each other by 180 degrees with the axis of the catheter 10 interposed therebetween. The operation line 40a is inserted through the sub-lumen 30a, and the operation line 40b is inserted through the sub-lumen 30b.

  By providing the hollow tube 32 (sub-lumen 30) outside the blade layer 50, the inside of the blade layer 50, that is, the main lumen 20 is protected against the sliding operation line 40 (40a, 40b). Further, as will be described later, when the hollow tube 32 is branched from the sheath 16 and guided to the dial portion 74, it is not necessary to pull out the hollow tube 32 from the inside of the blade layer 50, and it is not necessary to cut the blade layer 50.

  The hollow tube 32 can be extruded together with the resin material constituting the outer layer 60 and embedded in the outer layer 60. The material of the hollow tube 32 is superior in heat resistance to the resin material of the outer layer 60, and from the viewpoint of slidability with the operation wire 40, polyether ether ketone (PEEK), polysulfone (PSF), PTFE, PVDF, etc. The fluorine-based polymer material can be suitably used.

  Various methods can be used for inserting the operation line 40 into the sub-lumen 30. The operation line 40 may be inserted from one end side of the sheath 16 in which the hollow tube 32 is previously embedded. Alternatively, the sheath 16 may be formed by extruding the hollow tube 32 into which the operation line 40 has been inserted in advance together with the resin material of the outer layer 60.

Specific materials for the operation wire 40 include, for example, PEEK, polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), polymer fiber such as PI or PTFE, SUS, steel wire coated with corrosion resistance, titanium, and the like. Alternatively, a metal wire such as a titanium alloy can be used.
In addition, when heat resistance is not calculated | required in the operation line 40, such as when inserting the operation line 40 with respect to the sheath 16 by which the hollow tube 32 was embed | buried previously, in addition to said each material, PVDF, high density Polyethylene (HDPE) or polyester can also be used.

Around the outer layer 60, a hydrophilic coat layer 64 having an outer surface subjected to a lubrication treatment is optionally provided as the outermost layer of the catheter 10.
For the coat layer 64, a hydrophilic material such as polyvinyl alcohol (PVA) or polyvinyl pyrrolidone can be used.

  The distal end portion 15 of the catheter 10 is provided with a ring-shaped marker 66 made of a material that does not transmit radiation such as X-rays. Specifically, a metal material such as platinum can be used for the marker 66. The marker 66 of this embodiment is provided around the main lumen 20 and inside the outer layer 60.

  The distal end (distal end) 41 of the operation line 40 is fixed to the distal end 15 of the catheter 10. A mode in which the tip 41 of the operation line 40 is fixed to the distal end 15 is not particularly limited. For example, the tip 41 of the operating line 40 may be fastened to the marker 66, welded to the distal end 15 of the sheath 16, or the marker 66 or the distal end 15 of the sheath 16 with an adhesive. It may be bonded and fixed.

  The first operation line 40 a and the second operation line 40 b are individually pulled by the pulling operation of the dial unit 74.

  As shown in FIG. 2, in the first operation line 40 a and the second operation line 40 b, the tip portion 41 is fixed to the distal end portion 15 of the sheath 16. For this reason, by pulling the base end portion 43, a tensile force is applied to the sheath 16 at a position offset in the radial direction from the axial center, so that the distal end portion 15 bends in the offset direction.

<Usage of catheter>
FIG. 4 is a side view illustrating the catheter 10 in a state where the first operation line 40a and the second operation line 40b (both refer to FIG. 2) are pulled. FIG. 5A shows a first state in which the dial portion 74 is rotated clockwise in the drawing and the first operation line 40a is pulled. FIG. 5B shows a second state in which the dial portion 74 is rotated counterclockwise in the drawing and the second operation line 40b is pulled.
Hereinafter, with respect to the rotation direction of the dial portion 74, the clockwise rotation direction in the figure may be referred to as a forward direction and the counterclockwise rotation direction may be referred to as a reverse direction.

  The catheter 10 of this embodiment further includes a main body 72 that accommodates the proximal end portion 17 of the sheath 16 and to which a dial portion 74 (operation portion) is fixed.

  The catheter 10 of the present embodiment includes an indicator portion 75 that indicates that the dial portion 74 (operation portion) is in the first state, the second state, or the neutral state between the first state and the second state. It has more.

More specifically, the main body 72 is provided with a mark 76 indicating the reference position (zero point position) of the dial portion 74.
And the dial part 74 will be in a neutral state by making the index part 75 of the dial part 74 and the mark 76 of the main-body part 72 correspond (refer FIG. 1).
In the neutral state, both the first operation line 40a and the second operation line 40b are in a natural state, that is, a state in which they are not pulled, and the tension is zero.

  Then, when the dial portion 74 is rotated clockwise (in the positive direction) as shown in FIG. 4A based on the neutral state, the first operation line 40a is pulled. Then, when the dial portion 74 is rotated counterclockwise (in the reverse direction) as shown in FIG. 5B with the neutral state as a reference, the second operation line 40b is pulled.

  When the dial part (operation part) 74 is in the first state, the first operation line 40a is pulled and tensioned, and the second operation line 40b is relaxed. When the dial portion 74 is in the second state, the first operation line 40a is relaxed and the second operation line 40b is pulled and tensioned.

Here, the first operation line 40a is inserted upward in the figure inside the sheath 16 (see FIG. 2). Similarly, the second operation line 40b is inserted downward in the figure.
In the catheter 10 of the present embodiment, when the first operation line 40a or the second operation line 40b is pulled, a tensile force is applied to the distal end portion 15 of the sheath 16, and the operation line is inserted. The distal end 15 bends to the opposite side.
That is, in the catheter 10 of the present embodiment, when the dial portion 74 is rotated and the first operation line 40a is pulled toward the base end side (right direction in FIG. 4), the distal end portion 15 of the sheath 16 is shown in FIG. Bend upward. Further, when the second operation line 40b is pulled toward the proximal end side, the distal end portion 15 of the sheath 16 bends downward in the figure.
Here, the bending of the sheath 16 means that a part or all of the sheath 16 is bent or bent.

  Therefore, in a state where the first operation line 40a or the second operation line 40b is pulled and the distal end portion 15 is bent toward the operation line, the entire operation mechanism 70 is rotated in the right-handed direction around the axis. By rotating the torque by 90 degrees at the maximum in the left screw direction, the distal end portion 15 can be oriented in a desired direction.

  That is, according to the catheter 10 of the present embodiment, the distal end portion 15 can be bent in a desired direction while suppressing the torque rotation of the entire catheter 10 (operation mechanism 70) to 90 degrees or less. For this reason, the operator can orient | assign the distal end part 15 of the catheter 10 to a desired direction rapidly.

<Operation mechanism structure>
FIG. 5 is a longitudinal sectional view of the catheter 10 of the present embodiment. The figure (a) is a side view, and the figure (b) is a top view. FIG. 2B is a cross-sectional view taken along the line V-V shown in FIG.
FIG. 6 is an enlarged view of a region VI shown in FIG.

  The proximal end portion 17 of the sheath 16 is housed in the body portion 72 of the dial portion 74 so as to penetrate in the axial direction. The proximal end PE of the sheath 16 is located behind (to the right in FIG. 5) the main body 72 and the position adjusting mechanism 80.

  A folding tube 78 is attached to the distal end of the main body 72 in the axial direction. The folding tube 78 is a hollow tubular member, and the proximal end portion 17 of the sheath 16 is inserted into the folding tube 78. A break tube 78 is applied to the proximal end 17 of the sheath 16.

As shown in FIG. 6, the proximal end portion 33 of the hollow tube 32 branches off from the sheath 16 together with the operation line 40 inside the distal end side of the main body portion 72.
More specifically, a notch 62 is formed on the surface of the outer layer 60 at the proximal end 17 of the sheath 16 accommodated inside the main body 72. The hollow tube 32 is exposed to the outside from the outer layer 60 through the notch 62 and is branched outward in the radial direction of the sheath 16.
On the other hand, the sheath 16, that is, the outer layer 60, the blade layer 50, and the inner layer 21 are inserted in the axial direction so as to be slidable with respect to the main body 72 and extend to the rear of the main body 72 as shown in FIG.

The dial part (operation part) 74 of the present embodiment has a disk shape that is rotatably attached to the main body part 72. The dial portion 74 has a shaft portion 741 that is inserted into the main body portion 72, a drum portion 742 around which the first operation line 40 a and the second operation line 40 b are wound, and an enlarged diameter on the outer periphery of the drum portion 742. The flange portion 743 formed in this manner is integrally formed coaxially.
The flange portion 743 protrudes from the main body portion 72 in the width direction (vertical direction in FIG. 5). The operator can operate the dial portion 74 around the shaft portion 741 in the forward and reverse directions by rotating the circumferential surface of the flange portion 743 with the belly of the finger or the like.

  Grooves 79 (79a, 79b) are cut in the drum portion 742 so as to cut inward in the radial direction from the periphery. The groove portions 79 a and 79 b are formed at two places on the drum portion 742.

Inside the main body 72, guide rollers 77 (77a to 77d) for guiding the two hollow tubes 32 branched from the sheath 16 toward the dial part (operation part) 74 are provided.
The guide rollers 77a and 77b are rotation mechanisms that offset the hollow tube 32 from the sheath 16 in the axial direction of the dial portion 74 (upward in FIG. 6B). The guide rollers 77a and 77b are rotatably attached to the main body 72, and are parallel to each other. The rotation axes of the guide rollers 77 a and 77 b extend in a direction orthogonal to both the axial direction of the sheath 16 and the axial direction of the dial portion 74.

  The guide rollers 77 c and 77 d are rotational mechanisms that are provided opposite to each other in the radial direction of the dial portion 74 across the sheath 16 and guide the two hollow tubes 32 in the tangential direction of the drum portion 742. The guide rollers 77c and 77d are rotatably attached to the main body 72 and are parallel to each other. The rotation axes of the guide rollers 77 c and 77 d are orthogonal to the axial direction of the sheath 16 and are parallel to the axial direction of the dial portion 74.

  In the catheter 10 of the present embodiment, not only the operation line 40 (first and second operation lines 40a and 40b) but also the hollow tube 32 is branched from the sheath 16 and guided to the dial portion 74 by the guide roller 77. ing. As a result, the small-diameter operation line 40 is prevented from coming into direct contact with the guide roller 77 to wear and break.

The first operation line 40a and the second operation line 40b projecting from the base end portion 33 of the hollow tube 32 are wound around the drum portion 742 in opposite directions around the half circumference.
Specifically, as shown in FIG. 6A, the first operation line 40a is wound clockwise with respect to the upper half of the drum portion 742 from the distal end side toward the proximal end side. On the other hand, the second operation line 40 b is wound counterclockwise from the distal end side toward the proximal end side with respect to the lower half of the drum portion 742.

That is, the base end portions 43 of the first operation line 40a and the second operation line 40b are engaged with the dial unit 74 (operation unit) at different positions.
In the case of this embodiment, the first operation line 40 a and the second operation line 40 b are engaged with the drum portion 742 of the dial portion 74 at symmetrical positions with the sheath 16 interposed therebetween.

  In addition, as long as the dial part 74 can give tractive force with respect to the operation line 40, the aspect of engagement with the operation line 40 and the dial part 74 is not specifically limited. In the present embodiment, the base end 44 of the operation line 40 is fixed to the groove portion 79, and the base end portion 43 having a predetermined length is in contact with the periphery of the drum portion 742. However, instead of the present embodiment, the base end 44 of the operation line 40 may be fixed to the main body 72, and a traction force may be applied to the base end portion 43 of the operation line 40 by a dial part (cam) that rotates eccentrically.

  The base ends 44 of the first operation line 40a and the second operation line 40b are fixed to the groove portions 79a and 79b of the drum portion 742, respectively.

The flange portion 743 of the dial portion 74 prevents the first operation line 40a and the second operation line 40b wound around the drum portion 742 from being detached.
The flange portion 743 is provided with an index portion 75. In the case of the present embodiment, a pair of index portions 75 are provided at positions on the flange portion 743 facing each other by 180 degrees.
In the natural state of the catheter 10 shown in FIG. 5A, the pair of indicator portions 75 are in symmetrical positions with the sheath 16 in between. In the natural state of the catheter 10, the grooves 79 a and 79 b are also in symmetrical positions with the sheath 16 interposed therebetween.

When the dial portion 74 is rotated in the forward direction (clockwise) from this state, the circumferential length of the drum portion 742 from the guide roller 77c to the groove portion 79a increases, and the first operation line 40a is pulled to the proximal end side. Will be.
Conversely, when the dial portion 74 is rotated in the reverse direction (counterclockwise) from the natural state of FIG. 5A, the peripheral length of the drum portion 742 from the guide roller 77d to the groove portion 79b increases. The operation line 40b is pulled toward the base end side.

  Accordingly, as described above with reference to FIGS. 4A and 4B, the bending direction of the distal end portion 15 of the sheath 16 is selected by the rotation operation of the dial portion 74 in the forward / reverse direction.

In the present embodiment, since the translation direction of the dial part 74 is fixed with respect to the main body part 72, either the first operation line 40a or the second operation line 40b is selected by selecting the rotation direction of the dial part 74. Only one side is towed.
However, the present invention is not limited to this, and the first operation line 40a and the second operation line 40b may be pulled simultaneously.
Specifically, the dial part 74 may be attached to the main body part 72 so as to be rotatable and slidable in the axial direction. In other words, a long hole whose major axis is the axial direction is provided in the main body portion 72, and the dial portion 74 rotates and slides with respect to the main body portion 72 by mounting the shaft portion 741 of the dial portion 74 in the long hole. It becomes possible. Then, by sliding the dial portion 74, the first operation line 40a and the second operation line 40b can be pulled together.

<Position adjustment mechanism>
The position adjustment mechanism 80 of the present embodiment is a mechanism that relatively moves the dial portion 74 and the sheath 16 in the axial direction. In the present embodiment, a mechanism for moving the sheath 16 with respect to the main body 72 to which the dial portion 74 is fixed is exemplified as the position adjusting mechanism 80, but the present invention is not limited to this. While fixing the sheath 16 to the main body portion 72, the position adjusting mechanism 80 may be a mechanism that moves the dial portion 74 in the forward / backward direction with respect to the main body portion 72.

  As shown in FIG. 5, the catheter 10 of the present embodiment further includes a connector 90 to which the proximal end PE of the sheath 16 is fixed and engages with the position adjusting mechanism 80.

The connector 90 is a cylindrical member attached to the proximal end PE of the sheath 16, and an opening 92 is formed at the rear end. The tip of the connector 90 is closed except for the proximal end PE of the sheath 16.
A syringe (not shown) filled with a chemical solution or the like is attached to the opening 92. The chemical solution or the like supplied from the syringe to the sheath 16 is discharged from the distal end DE of the sheath 16 through the main lumen 20 of the sheath 16 (see FIGS. 2 and 3).

A proximal end PE of the sheath 16 is attached to the position adjustment mechanism 80. In the present embodiment, the proximal end PE of the sheath 16 is indirectly attached to the position adjustment mechanism 80 via the connector 90.
The position adjusting mechanism 80 is screwed in the axial direction with respect to the main body 72, and the position adjusting mechanism 80 is screwed with respect to the main body 72, so that the dial 74 and the operation lines 40a and 40b and the sheath. 16 is relatively moved in the axial direction.

Specifically, the position adjusting mechanism 80 according to the present embodiment includes a male screw portion 82 having a screw groove 86 threaded on the outer peripheral surface and a stopper portion 84 attached to the screw groove 86.
The male screw portion 82 includes a through hole 83 extending in the axial direction.
Both ends of the through hole 83 are open, and the distal end portion of the connector 90 and the proximal end PE of the sheath 16 are inserted therethrough.
A tapered portion 91 that is reduced in diameter toward the distal end side is formed at the distal end portion of the connector 90. The tapered portion 91 of the connector 90 is fitted and fixed to the through hole 83 of the male screw portion 82.

On the other hand, a female screw portion 81 extending in the axial direction is formed on the rear end portion of the main body portion 72.
The female screw portion 81 and the male screw portion 82 are screwed together.

  Then, when the position adjustment mechanism 80 is screwed relative to the main body 72, the connector 90 moves in the axial direction.

In the present embodiment, the position adjustment mechanism 80 screwed relative to the main body portion 72 means that the position adjustment mechanism 80 screwed into the main body portion 72 moves to at least one of the proximal end side and the distal end side. .
In the case of the present embodiment, the sheath 16 moves backward together with the connector 90 fitted in the through hole 83 by screwing the male screw portion 82 to the proximal end side with respect to the main body portion 72.

  FIG. 7A is a side view showing the operation of the position adjusting mechanism, and FIG. 7B is a partial vertical cross-sectional view of FIG.

  Compared with the position adjustment mechanism and connector (shown by broken lines in FIG. 7A) in FIG. 5, the catheter 10 shown in FIG. It is in the state screwed backward from 72 (right side in the figure).

  Here, the dial portion 74 is restricted from moving back and forth in the axial direction with respect to the main body portion 72. Accordingly, as shown in FIG. 5A, when the male screw portion 82 of the position adjusting mechanism 80 is screwed backward with respect to the main body portion 72, the proximal end PE of the sheath 16 (FIG. 5) is connected via the connector 90. Are pulled backwards. As a result, the dial portion 74 and the sheath 16 move relative to each other in the axial direction.

Then, as indicated by an arrow in FIG. 7B, the sheath 16 moves backward as a whole. Further, the hollow tube 32 branched from the sheath 16 and guided to the dial portion 74 by the guide rollers 77a to 77d also approaches the dial portion 74 as a whole.
On the other hand, the base ends 44 of the operation lines 40 a and 40 b are fixed to the groove portion 79 of the dial portion 74. Accordingly, when the distal end portion 15 (see FIG. 2) of the sheath 16 is retracted, the winding tension of the operation lines 40a and 40b to the dial portion 74 is reduced or loosened.

  In the present embodiment, the tension of the operation lines 40a and 40b is adjusted to increase or decrease by the position adjustment mechanism 80 from the predetermined reference state with respect to any one or more of the plurality of operation lines 40a and 40b. It means that the tension can be at least increased or decreased.

  In the catheter 10 of this embodiment, the position adjustment mechanism 80 is screwed relative to the main body portion 72 to adjust the tension of the operation lines 40a and 40b to increase or decrease, so that the relative movement between the dial portion 74 and the sheath 16 is achieved. Fine adjustment of the amount is possible.

In the catheter 10 of the present embodiment, it is possible to increase the tension with respect to the operation lines 40 a and 40 b in which the base end 44 is fixed to the dial portion 74.
FIG. 8A is a side view showing another operation of the position adjusting mechanism 80, and FIG. 8B is a partial longitudinal sectional view of the periphery of the dial portion 74 in FIG. 8A.

  Compared with the position adjustment mechanism and connector (shown by broken lines in FIG. 8A) in FIG. 5, the catheter 10 shown in FIG. It is in the state screwed forward from 72 (left side in the figure).

As shown in FIG. 8A, when the male screw portion 82 of the position adjusting mechanism 80 is screwed forward with respect to the main body portion 72, the connector 90 fitted and fixed to the male screw portion 82 together with the male screw portion 82. Advance.
Then, as shown in FIG. 5B, the sheath 16 to which the proximal end PE (see FIG. 5) is fixed with respect to the connector 90 and the hollow tube 32 branched from the sheath 16 are entirely connected to the catheter 10. Advance toward the tip side of the.

  On the other hand, since the proximal end 44 of the operation line 40a is fixed with respect to the groove 79 of the dial portion 74, the distal end portion 15 (see FIG. 2) of the sheath 16 advances, whereby the operation lines 40a and 40b are moved forward. In this case, winding tension to the dial portion 74 is generated or the tension is increased.

  As described above, in the catheter 10 of the present embodiment, the tension of the operation lines 40a and 40b is adjusted to increase and decrease by the operation of the position adjusting mechanism 80. For this reason, the operation lines 40a and 40b can be adjusted in a state where there is no slack and no tension, and “play” during the bending operation of the sheath 16 is suppressed, and the occurrence of unexpected bending of the sheath 16 is suppressed.

The stopper portion 84 of the position adjusting mechanism 80 is screwed into the thread groove 86 of the male screw portion 82, and is screwed with respect to the female screw portion 81 together with the male screw portion 82 (see FIG. 5).
Here, as shown in FIG. 8A, when the male screw portion 82 is advanced with respect to the main body portion 72 to increase the tension of the operation lines 40a and 40b, the male screw portion 82 has a predetermined advance length or more. The stopper portion 84 comes into contact with the rear end portion of the main body portion 72 by screwing. Thereby, the male screw part 82 is not accidentally screwed excessively and the operation lines 40a and 40b are not broken. Further, when the operator accidentally rotates the male screw portion 82 when the sheath 16 is inserted into the body cavity, the advancement of the male screw portion 82 is restricted by the stopper portion 84, so that the operation line 40 a is controlled. , 40b does not generate unexpected tension. For this reason, the unexpected bending | flexion does not arise in the distal end part 15 (refer FIG. 1, 2) of the sheath 16. FIG.

<Method for producing catheter>
FIGS. 9A to 9C are schematic views showing a method for manufacturing the catheter 10 (see FIGS. 1 and 2) of the present embodiment (hereinafter, sometimes referred to as the present method).

First, an outline of this method will be described.
The present method relates to a method for manufacturing the catheter 10 having the sheath 16, first and second operation lines 40 a and 40 b, and an operation part (dial part 74).
As described above, the sheath 16 is formed with a main lumen 20 and a plurality of sub-lumens 30 (30a, 30b) having a smaller diameter than the main lumen 20 in the axial direction.
The first and second operation lines 40 a and 40 b are slidably inserted into the plurality of sub-lumens 30 a and 30 b, respectively, and the distal end portion 41 is fixed to the distal end portion 15 of the sheath 16.
The operation portion (dial portion 74) is provided at the proximal end portion 17 of the sheath 16, and when the proximal end portions 43 of the first and second operation lines 40a and 40b are engaged with each other and are in the first state. The first operation line 40a is pulled to relax the second operation line 40b, and when in the second state, the first operation line 40a is relaxed to pull the second operation line 40b.

The method includes a first attachment step, a dislocation step, a second attachment step, and a tension adjustment step.
In the first attachment step, the proximal end portion 43 of the relaxed first operation line 40a inserted through the sub-lumen 30a and having the distal end portion fixed to the distal end portion 15 of the sheath 16 is operated in the second state. Attached to the part (dial part 74).
In the rearrangement step, the first operation line 40a is pulled with the dial portion 74 to which the first operation line 40a is attached as the first state.
In the second attachment step, the second operation line in a relaxed state in which the first operation line 40a is tensioned and the tip 41 is inserted into the sub-lumen 30 and the distal end portion 41 is fixed to the distal end 15 of the sheath 16. The base end portion 43 of 40b is attached to the dial portion 74 in the first state.
In the tension adjustment step, the dial portion 74 is set to a neutral state between the first state and the second state, and the tension of the first and second operation lines 40a and 40b is adjusted to increase or decrease.

Next, this method will be described in more detail.
Fig.9 (a) is explanatory drawing which shows a 1st attachment process.
In the first attachment step, one of the operation lines 40 inserted through the sub-lumen 30 which is the lumen of the hollow tube 32 branched from the sheath 16 is selected and attached to the dial portion 74.
In this method, the base end portion 43 (base end 44) of the first operation line 40a is fixed to the groove portion 79a.

The groove 79a is formed by cutting from the periphery of the drum portion 742 inward in the radial direction, and a hollow portion 791 is formed in the innermost portion.
A spherical bulging portion 45 is formed at the base end 44 of the first operation line 40a protruding from the hollow tube 32 by application of an adhesive or the like. The bulging portion 45 has a larger diameter than the width of the groove 79 a and a smaller diameter than the hollow portion 791.

  In the first attachment step, the dial portion 74 is arbitrarily rotated, and the groove portion 79a is brought close to the guide roller 77c. And the bulging part 45 of the base end 44 of the 1st operation line 40a which protruded from the hollow tube 32 is accommodated in the cavity part 791, and the 1st operation line 40a is latched with respect to the groove part 79a.

  The state of the dial portion 74 in FIG. 4A in which the groove 79a is close to the guide roller 77c corresponds to the second state shown in FIG. In the second state, since the first operation line 40a is in a relaxed state, the operation of hooking the first operation line 40a on the groove 79a can be easily performed.

Next, as shown by the arrow in FIG. 9A, the dial part 74 is rotated clockwise to perform the dislocation process.
The dislocation process is a process of bringing the groove 79b close to the guide roller 77d. In the shift step of the present method, the dial portion 74 is rotated clockwise by approximately 270 degrees.
By rotating the dial portion 74 clockwise in the shift step, the base end portion 43 of the first operation line 40a is wound around the drum portion 742.

The dial part 74 after the dislocation process is shown in FIG.
The state of the dial portion 74 in FIG. 5B where the groove 79b is close to the guide roller 77d corresponds to the first state shown in FIG. Since the second operation line 40b is in the relaxed state in the first state, the operation of hooking the second operation line 40b on the groove 79b can be easily performed.

FIG. 4B is an explanatory diagram showing the second attachment process.
In the second attachment step, the base end portion 43 (base end 44) of the second operation line 40b is fixed to the groove portion 79b.
A hollow portion 791 is formed in the innermost portion of the groove portion 79b in the same manner as the groove portion 79a.
In addition, a bulging portion 45 is also formed on the base end 44 of the second operation line 40b, similarly to the first operation line 40a.
In the second mounting step, the bulging portion 45 of the second operation line 40b is accommodated in the cavity 791, and the second operation line 40b is hooked on the groove 79b.

Next, the dial portion 74 is rotated counterclockwise as indicated by an arrow in FIG. 5B to bring the dial portion 74 into a neutral state.
The dial portion 74 in the neutral state is shown in FIG.

FIG. 4C is an explanatory diagram showing a tension adjustment process.
In the neutral state, the grooves 79a and 79b and the first and second operation lines 40a and 40b are both arranged at symmetrical positions with the sheath 16 in between.
The path length from the guide roller 77c to the groove 79a in the neutral state is longer than the path length in the second state. Similarly, the path length from the guide roller 77d to the groove 79b in the neutral state is longer than the path length in the first state.

Therefore, in this method, when the dial part (operation part) 74 is in a neutral state after the second attachment step, the first and second operation lines 40a and 40b are both in tension.
Then, in the tension adjustment step of the present method, the tensions (shown by the white arrows in the figure (c)) of the first and second operation lines 40a and 40b are both removed.

A specific tension adjusting step can be performed by operating the position adjusting mechanism 80.
That is, as described with reference to FIGS. 7A and 7B, in this method, the entire sheath 16 is pulled backward by screwing the position adjusting mechanism 80 backward with respect to the main body 72. Thus, the tension of the first and second operation lines 40a and 40b can be removed.

  In addition, removing the tension | tensile_strength of 1st and 2nd operation line 40a, 40b in this method includes removing a part of tension | tensile_strength which has arisen in the said operation line.

According to this method, after being hooked on the dial portion 74, the tension adjusting step is performed in a state where the first and second operation lines 40a and 40b are neutral and the respective tensions are made uniform. For this reason, the tension | tensile_strength of the 1st and 2nd operation lines 40a and 40b is removed equally, and the state from which the tension | tensile_strength of both operation lines becomes zero is realizable.
For this reason, according to this method, the operation line 40 can be connected to the operation part (dial part 74), without generating both slack and tension with respect to the plurality of operation lines 40.

  Moreover, when attaching the 2nd operation line 40b to the dial part 74, the base end of the 1st operation line 40a wound around the drum part 742 beforehand by making the 1st operation line 40a into a tension | tensile_strength state. The portion 43 is not dropped from the drum portion 742.

  The present invention is not limited to the above-described embodiment, and includes various modifications and improvements as long as the object of the present invention is achieved.

  For example, in the above embodiment, the mode in which the two operation lines 40 are inserted so as to face the periphery of the main lumen 20 has been described as an example, but the present invention is not limited to this.

  For example, instead of the present embodiment, three or more sub-lumens 30 may be arranged in a distributed manner in the circumferential direction of the main lumen 20, and the operation lines 40 may be inserted through the sub-lumens 30. More specifically, three sub-lumens 30 may be arranged around the main lumen 20 at intervals of 120 degrees.

  In this case, the operation unit may be a sphere instead of the disc-shaped dial unit 74 of the present embodiment. A spherical dial portion 74 is rotatably provided on the main body portion 72 via a bearing, and the base ends 44 of the three operation lines 40 are fixed to the dial portion 74 at different positions. Thereby, the three operation lines 40 can be pulled individually or at the same time.

  In the case of the catheter 10 including three or more operation lines 40, the distal end portion 15 of the sheath 16 can be arbitrarily oriented over 360 degrees by selecting the operation line 40 to be pulled and individually controlling the pulling length. Can be bent. As a result, the sheath 16 with respect to the body cavity can only be pulled by the operation mechanism 70 without pulling the distal end portion 15 in a predetermined direction by applying torque to the entire catheter 10. The approach direction can be freely controlled.

  Further, in the above embodiment, the sub-lumen 30 is formed inside the outer layer 60 and outside the blade layer 50, but the present invention is not limited to this, and the sub-lumen 30 is located on the inner peripheral side of the blade layer 50. You may form in.

DESCRIPTION OF SYMBOLS 10 Catheter 15 Distal end part 16 Sheath 17 Proximal end part 20 Main lumen 21 Inner layer 30 Sublumen 32 Hollow tube 33 Base end part 40 Operation line 40a (First) operation line 40b (Second) operation line 41 Front end portion 43 Base end portion 44 Base end 45 Swelling portion 50 Blade layer 52 Wire 60 Outer layer 62 Notch portion 64 Coat layer 66 Marker 70 Operating mechanism 72 Main body portion 74 Dial portion 741 Shaft portion 742 Drum portion 743 Flange portion 75 Index portion 76 Mark 77 Guide roller 78 Folding tube 79 Groove part 791 Cavity part 80 Position adjustment mechanism 81 Female thread part 82 Male thread part 83 Through hole 84 Stopper part 86 Screw groove 90 Connector 91 Taper part 92 Opening part DE Distal end PE Proximal end

Claims (9)

A sheath in which a main lumen and a plurality of sub-lumens having a smaller diameter than the main lumen are formed in the axial direction, respectively,
A plurality of operation lines that are slidably inserted into the plurality of sub-lumens, and whose distal ends are fixed to the distal end of the sheath;
An operation portion that is provided at a proximal end portion of the sheath, and that engages the proximal end portions of the plurality of operation lines, and pulls the operation line with respect to the sheath; and
A position adjustment mechanism that increases or decreases the tension of the operation line by relatively moving the operation unit and the sheath in the axial direction of the sheath.   Proximal end portions of the first and second operation lines are engaged with different positions with respect to the operation unit, and the first and second operation lines are individually pulled by the pulling operation. The catheter according to claim 1. When the operation unit is in the first state, the first operation line is pulled and tensioned, and the second operation line is relaxed,
The catheter according to claim 2, wherein when the operation unit is in the second state, the first operation line is relaxed and the second operation line is pulled and tensioned. Further comprising a main body portion that accommodates the proximal end portion of the sheath and to which the operation portion is fixed;
A proximal end of the sheath is attached to the position adjustment mechanism, and the position adjustment mechanism is screwed in the axial direction with respect to the main body portion,
4. The operation unit, the operation line, and the sheath move relative to each other in the axial direction when the position adjusting mechanism is screwed with respect to the main body. The catheter described. A connector that is secured to the proximal end of the sheath and engages the position adjustment mechanism;
The catheter according to claim 4, wherein the connector moves in the axial direction when the position adjusting mechanism is screwed relative to the main body. The sheath is made of a resin material and has a tubular inner layer in which the main lumen is formed; a blade layer formed by knitting wires around the inner layer; and the inner layer made of the same or different resin material as the inner layer An outer layer formed around the blade and enclosing the blade layer,
The catheter according to claim 4 or 5, wherein the sublumen is formed inside the outer layer and outside the blade layer. The sublumen is formed by a hollow tube embedded in the outer layer,
The catheter according to claim 6, wherein a proximal end portion of the hollow tube is branched from the sheath together with the operation line. A sheath in which a main lumen and a plurality of sub-lumens having a smaller diameter than the main lumen are formed in the axial direction, respectively,
First and second operation lines that are slidably inserted into the plurality of sub-lumens respectively, and whose tip is fixed to the distal end of the sheath;
Provided at the proximal end of the sheath, the proximal ends of the first and second operation lines are engaged, and the first operation line is pulled when the first operation line is in the first state. An operation portion that relaxes the second operation line and relaxes the first operation line to pull the second operation line when in a second state,
A first attachment that attaches the proximal end portion of the first operation line in a relaxed state inserted through the sub-lumen and having a distal end fixed to the distal end portion of the sheath to the operation portion in the second state. Process,
A dislocation step of pulling the first operation line with the operation portion to which the first operation line is attached as the first state;
In a state in which the first operation line is in tension, the proximal end portion of the second operation line in a relaxed state inserted through the sub-lumen and having a distal end fixed to the distal end portion of the sheath, A second attachment step for attaching to the operation section in the first state;
A tension adjusting step of setting the operating portion to a neutral state between the first state and the second state, and increasing or decreasing the tension of the first and second operating lines;
The manufacturing method of the catheter containing this. When the operation unit is in the neutral state, the first and second operation lines are both in tension,
The catheter manufacturing method according to claim 8, wherein in the tension adjustment step, the tensions of the first and second operation lines are both removed.

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