JP2010227138A - Method of manufacturing catheter - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a method of manufacturing a catheter capable of suitably inserting an operation wire to the sub lumen of recent years, whose diameter is made extremely small. <P>SOLUTION: In the method of manufacturing the catheter 10 including a main lumen 20, the sub lumen 30 of a diameter smaller than the main lumen 20 and the operation wire 40 slidably inserted to the sub lumen 30 and comprising a resin material, the sub lumen 30 is formed by pulling out a second core wire 24 whose diameter is reduced from a sheath 16 in which a first core wire and the second core wire 24 are embedded in the state of being separated from each other, and the operation wire 40 connected to the end part 26 of the second core wire 24 is inserted to the sub lumen 30. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

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

In recent years, there has been provided a catheter capable of manipulating the direction of entry into a body cavity by bending a distal end portion. As one of the modes for bending the distal end of the catheter, one in which a push / pull wire fixed to the distal end is operated on the proximal end side is known (see Patent Document 1 below).
The push / pull wire passes through a wire lumen having a diameter smaller than that of the main lumen through which the guide wire is inserted, and has a predetermined rigidity so that the distal end of the catheter can be bent when the wire is pushed. is doing. This document does not describe a specific method for inserting the push / pull wire into the wire lumen.

Further, in Patent Document 2 below, two wire lumens (sublumens) having a smaller diameter are provided around the central lumen (main lumen) so as to face each other by 180 degrees, and the inside of the sublumen is turned. A method for manufacturing a catheter through which a wire is inserted is described.
This document discloses a method of inserting a deflection wire from one end side in a state where a pressurized fluid is filled in the sublumen and the diameter of the submerged membrane is expanded (hereinafter sometimes referred to as a pressing method). Yes.

Special table 2007-507305 gazette JP 2006-192269 A

In recent years, the diameter of catheters has been reduced from the viewpoint of penetration into blood vessels and the like, and those having an outer diameter of 1 mm or less have been provided. In this case, from the viewpoint of securing the inner diameter of the main lumen that is used for the supply of drugs and the like and the insertion of the optical system, it is desired that the inner diameter of the sublumen be suppressed to an extremely small diameter of 10 to several tens of μm.
Accordingly, it is extremely difficult to perform the pushing method as described in Patent Document 2 when inserting an operation line for bending the distal end of the catheter through the sub-lumen. The first reason is that, as the diameter of the sub-lumen is reduced, it becomes difficult to form the sub-lumen uniformly and smoothly, and when the operation line is pushed into the sub-lumen, it is easily caught on the inner wall surface. The second reason is that the buckling strength is remarkably lowered by reducing the diameter of the operation line, and is easily buckled by the force pushed into the sub-lumen. For example, when the operation line is regarded as an oval cylinder, the Euler buckling strength with the column end as a free end decreases in proportion to the square of the wire diameter.
If the workability when pushing the operation line into the sub-lumen is reduced, not only the work man-hours are increased, but also the catheter quality and yield are deteriorated due to wear of the inner wall surface and the operation lines of the sub-lumen. Become.

  The present invention has been made in view of the above-described problems, and provides a method for manufacturing a catheter that allows an operation line to be suitably inserted into a sub-lumen having a very small diameter in recent years.

A method for manufacturing a catheter of the present invention includes a main lumen, a sub-lumen having a smaller diameter than the main lumen, and an operation line slidably inserted into the sub-lumen, and a method for manufacturing a catheter made of a resin material Because
A molding step in which a tubular body embedded with a first core wire and a second core wire having a smaller diameter than the first core wire are spaced apart from each other is formed from the resin material;
A diameter reducing step for reducing the diameter of the second core wire;
A drawing step of drawing the first core wire from the tubular body to form the main lumen;
An insertion step of drawing out the second core wire having a reduced diameter from the tubular body to form the sub-lumen, and inserting the operation line connected to an end of the second core wire into the sub-lumen;
including.

  In the catheter manufacturing method of the present invention, as a more specific embodiment, in the diameter reduction step, the second core wire is pulled by pulling both ends of the second core wire embedded in the tubular body. The diameter may be reduced.

In the catheter manufacturing method of the present invention, as a more specific embodiment, the second core wire is made of a metal material,
In the thinning step, the second core wire may be pulled and plastically deformed.

  In the catheter manufacturing method of the present invention, as a more specific embodiment, the operation line may be smaller in diameter than the second core wire that has been reduced in the diameter reduction step.

  In the catheter manufacturing method of the present invention, as a more specific embodiment, in the molding step, the tubular body may be molded by extruding the second core wire together with the resin material.

  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 this invention has described several process in order, the order of the description does not limit the order which performs several processes. For this reason, when implementing the 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 present invention is not limited to being executed at a timing at which a plurality of steps are individually different. 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 manufacturing method of the present invention, the second core wire embedded in the tubular main body is reduced in diameter and pulled out to form a sub-lumen, and the operation line connected to the end of the second core wire is used as the sub-lumen. Insert. As a result, the operation line is pulled by the second core line and inserted through the sub-lumen, so that the operation line does not buckle as in the conventional pushing method. In addition, the operation line is connected to the end of the second core wire and follows the second core wire pulled out from the tubular main body to enter the sub-lumen. It does not wear itself or the inner wall.
For this reason, the operation line can be easily inserted through the sub-lumen having a very small diameter in recent years.
Further, by separating the first core wire and the second core wire from each other in the tubular body formed in the forming step, the main lumen and the sub-lumen are not communicated with each other. For this reason, when a manufactured catheter or the like is supplied through the main lumen or inserted through the optical system, the manufactured catheter does not leak into the sublumen.
As described above, according to the catheter manufacturing method of the present invention, a high-quality catheter can be obtained with high throughput and yield.

It is a longitudinal cross-sectional view which shows an example of the catheter obtained by this method. It is II-II sectional drawing of FIG. It is a side view explaining operation | movement of a catheter, (a) is a longitudinal cross-sectional schematic diagram which shows the catheter of a natural state, (b) is a longitudinal cross-sectional schematic diagram which shows the catheter of the state which pulled the operation line. (A) is a schematic block diagram of the manufacturing apparatus of the sheath used for a formation process, (b) is the longitudinal cross-sectional view which cut the sheath shape | molded by the formation process in the longitudinal direction, (c) is a 2nd core wire. It is a longitudinal cross-sectional view which shows the state which gave the diameter reduction process to. (A) is a longitudinal cross-sectional view which shows the sheath after an extraction process, (b) is a longitudinal cross-sectional view which shows an insertion process, (c) is a longitudinal cross-sectional view which shows the sheath after an insertion process. It is a longitudinal cross-sectional view which shows the resin material extruded from a die | dye at a formation process, a 1st core wire, and a 2nd core wire.

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.
First, an outline of a catheter obtained by the manufacturing method according to the present embodiment (hereinafter sometimes referred to as the present method) will be described, and then the method will be described in detail.

<Catheter>
FIG. 1 is a longitudinal sectional view showing an example of a catheter 10 obtained by this method (hereinafter referred to as the catheter 10 of the present embodiment). The figure shows a cross section of the catheter 10 cut in the longitudinal direction. The left side of the figure corresponds to the distal end (tip) side of the catheter 10, and the right side corresponds to the proximal end (base end) side. However, in the figure, the proximal end side of the catheter 10 is not shown.
2 is a cross-sectional view (cross-sectional view) taken along the line II-II in FIG.

  In the catheter 10 of this embodiment, a main lumen 20 and a plurality of sub-lumens 30 having a smaller diameter than the main lumen 20 are formed inside a tubular main body (sheath 16) made of a resin material 12. The main lumen 20 and the sub-lumen 30 are provided separately from each other.

As shown in FIG. 2, in the catheter 10 of the present embodiment, a plurality of sublumens 30 are arranged in a distributed manner in the circumferential direction of the main lumen 20. Specifically, in the case of the catheter 10 of this embodiment, three sub-lumens 30 are arranged around the main lumen 20 at intervals of 120 degrees. Then, one operation line 40 fixed to the distal end portion 15 of the catheter 10 is slidably inserted into each of the three sub-lumens 30.
Here, the distal end portion 15 of the catheter 10 refers to a predetermined length region including the distal end DE of the catheter 10. Similarly, the proximal end portion 17 (see FIG. 3) of the catheter 10 refers to a predetermined length region including the proximal end PE of the catheter 10.

The sheath 16 of this embodiment includes a tubular inner layer 21 made of a resin material 12 and having a main lumen 20 formed therein, and an outer layer 60 made of the same or different kind of resin material as the inner layer 21 and formed around the inner layer 21. Are laminated.
A hydrophilic coat layer 64 formed as the outermost layer of the catheter 10 is laminated around the outer layer 60.

The coat layer 64 is formed of a hydrophilic resin material such as polyvinyl alcohol (PVA) or polyvinyl pyrrolidone, or is lubricated on the outer surface so that at least the outer surface is hydrophilic.
The coat layer 64 is provided in a partial length region on the distal end DE side of the sheath 16.

The catheter 10 of this embodiment includes a blade layer 50 formed by knitting wires 52 around the inner layer 21. The blade layer 50 is included in the outer layer 60.
In the catheter 10 of the present embodiment, the sublumens 30 through which the operation lines 40 are inserted are formed inside the outer layer 60 and outside the blade layer 50.

  The distal end 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 sub-lumen 30 of this embodiment is provided along the longitudinal direction of the catheter 10 (left-right direction in FIG. 1), and at least the proximal end portion 17 of the catheter 10 is open.
The distal end (distal end) of the operation line 40 is fixed to the distal end portion 15 of the catheter 10. A mode of fixing the tip of the operation line 40 to the distal end portion 15 is not particularly limited. For example, the tip of the operation line 40 may be fastened to the marker 66, welded to the distal end 15 of the sheath 16, or adhesively fixed to the marker 66 or the distal end 15 of the sheath 16 with an adhesive. May be.

  FIG. 3 is a side view for explaining the operation of the catheter 10 of the present embodiment. FIG. 4A is a schematic longitudinal sectional view showing the catheter 10 in a natural state, that is, in a state where the operation line 40 is not pulled. FIG. 2B is a schematic longitudinal sectional view showing the catheter 10 with the operation line 40 pulled. 3 shows only one of the three operation lines 40 in the catheter 10 of the present embodiment.

  The proximal end 41 of the operation line 40 protrudes proximally from the sub-lumen 30. In addition, on the proximal side of the operation line 40, an operation unit 70 that pulls the plurality of operation lines 40 individually and bends the distal end portion 15 of the catheter 10 is provided. Detailed illustration and description regarding the structure of the operation unit 70 are omitted.

In the catheter 10 of the present embodiment, when the proximal end 41 of the operation line 40 is pulled toward the base end side (the right side in the figure), a tensile force is applied to the distal end portion 15 of the catheter 10. When the tensile force is greater than or equal to a predetermined value, the distal end portion 15 bends from the axial center of the catheter 10 toward the sub-lumen 30 through which the operation line 40 is inserted.
By individually controlling the pulling lengths of the three operation lines 40, the distal end portion 15 of the catheter 10 can be bent in an arbitrary direction over 360 degrees. Thereby, the approach direction of the catheter 10 can be freely operated only by the pulling operation of the operation line 40 by the operation unit 70 without performing the torque operation for rotating the entire catheter 10. For this reason, the catheter 10 of this embodiment can be made to approach in a desired direction, for example with respect to body cavities, such as a branching blood vessel.

The operation line 40 is made of a very fine diameter wire material, and when the proximal end 41 is pushed into the sheath 16, the operation line 40 is buckled. For this reason, substantially no pushing force is applied to the distal end portion 15 of the catheter 10.
For this reason, even if the operator pushes the operation line 40 into the catheter 10, the operation line 40 does not come off the distal end portion 15 of the catheter 10 and protrude from the distal end DE. For this reason, when operating the catheter 10 inserted into the body cavity, the safety of the subject is ensured.

Here, typical dimensions of the catheter 10 obtained by this method will be described.
The radius of the main lumen 20 can be about 200 to 300 μm, the thickness of the inner layer 21 can be about 10 to 30 μm, the thickness of the outer layer 60 can be about 100 to 150 μm, and the thickness of the blade layer 50 can be about 20 to 30 μm. The radius from the axial center of the catheter 10 to the center of the sublumen 30 is about 300 to 350 μm, the inner diameter (diameter) of the sublumen 30 is about 40 to 100 μm, and the thickness of the operation line 40 is about 30 to 60 μm. be able to.
And the outermost diameter (radius) of the catheter 10 can be made into about 350-450 micrometers.
That is, the outer diameter of the catheter 10 of this embodiment is less than 1 mm in diameter, and can be inserted into blood vessels such as the celiac artery.

<Method for producing catheter>
Hereinafter, the manufacturing method (this method) of the catheter concerning this embodiment is demonstrated in detail.
This method includes a main lumen 20, a sub-lumen 30 having a smaller diameter than the main lumen 20, and an operation line 40 that is slidably inserted into the sub-lumen 30, and a method for manufacturing a catheter 10 made of the resin material 12. About.
And this method includes a shaping | molding process, a diameter reduction process, a drawing-out process, and an insertion process.
In the molding step, the tubular body (sheath 16) in which the first core wire 22 and the second core wire 24 having a smaller diameter than the first core wire 22 are embedded in a state of being separated from each other is molded by the resin material 12.
In the thinning step, the second core wire 24 is thinned.
In the drawing process, the main lumen 20 is formed by drawing the first core wire 22 from the tubular body (sheath 16).
In the insertion process, the second core wire 24 having a reduced diameter is pulled out from the tubular main body (sheath 16) to form the sub-lumen 30 and the operation line 40 connected to the end portion 26 of the second core wire 24 is connected to the sub-lumen 30. Insert.

  In the present invention, the timing at which the drawing step is performed is not particularly limited, and this may be performed before the diameter reduction step, or may be performed between the diameter reduction step and the insertion step, and further the insertion. You may perform after a process.

  However, in this method, an insertion process shall be performed after a drawing process. More specifically, in this method, a drawing process is performed between the diameter reducing process and the inserting process.

Hereafter, each process of this method is demonstrated still in detail using drawing.
Fig.4 (a) is a schematic block diagram of the manufacturing apparatus 80 of the sheath 16 used for a formation process. FIG. 4B is a longitudinal sectional view of the sheath 16 formed by the forming process cut in the longitudinal direction. FIG. 4C is a longitudinal sectional view showing a state in which the diameter reduction process is performed on the second core wire 24.

Fig.5 (a) is a longitudinal cross-sectional view which shows the sheath 16 after a drawing-out process. FIG. 5B is a longitudinal sectional view showing the insertion process. FIG. 4C is a longitudinal sectional view showing the sheath 16 after the insertion process.
FIG. 6 is a longitudinal sectional view showing the resin material 12, the first core wire 22 and the second core wire 24 extruded from the die 92 in the molding process, and is an enlarged sectional view of a circle VI shown in FIG. 4 (a).

(Molding process)
4A includes an extruder 82, a sizing device 84, and a take-up device 86 arranged in series.
The extruder 82 includes a material supply unit 90 that inputs the resin material 12 of the outer layer 60 constituting the sheath 16, and a die 92 that extrudes the resin material 12 to make it thin.
The sizing device 84 is a device that cools the sheath 16 extruded from the extruder 82 and adjusts the sheath 16 to a predetermined diameter, and a water tank can be used as an example.
The take-up machine 86 is composed of rollers 88 that run in opposition to each other, and is a device that takes out the tip of the sheath 16 that is pushed out of the extruder 82 and cooled by the sizing device 84 at a predetermined take-up speed.

In the molding step of this method, the second core wire 24 is extruded together with the resin material 12 to mold the tubular body (sheath 16).
More specifically, the manufacturing apparatus 80 used in this method extrudes at least the resin material 12, the first core wire 22, and the second core wire 24 from the die 92 to form the outer layer 60 in the sheath 16.
Thereby, as shown in FIG.4 (b), the 1st core wire 22 and the 2nd core wire 24 will penetrate and penetrate the outer layer 60 which consists of the resin material 12 in a longitudinal direction.

The first core wire 22 used in this method is a core (mandrel) formed in a columnar shape, and is a member that forms the main lumen 20 of the catheter 10 by being pulled out from the sheath 16 in the pulling process.
The second core wire 24 is a wire formed in a cylindrical shape having a smaller diameter than the first core wire 22, and is a member that forms the sublumen 30 of the catheter 10 by being pulled out from the sheath 16 in the insertion process. .

The diameter of the first core wire 22 corresponds to the inner diameter of the main lumen 20 of the catheter 10, and the radius is 300 to 350 μm (600 to 700 μm in terms of diameter).
The diameter of the second core wire 24 corresponds to the inner diameter of the sub-lumen 30 of the catheter 10, and the diameter is 40 to 100 μm.

  Although the material of the 1st core wire 22 and the 2nd core wire 24 is not specifically limited, A metal material can be used suitably from a high tensile strength and a corrosion resistant viewpoint. Specific examples include copper or copper alloys, alloy steels such as carbon steel and stainless steel (SUS), nickel or nickel alloys, and the like.

  The surface of the first core wire 22 may optionally be subjected to a mold release process. The mold release treatment may be performed by optical or chemical surface treatment in addition to the application of a release agent such as fluorine or silicon.

An inner layer 21 is provided around the first core wire 22.
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.

On the outer peripheral surface of the inner layer 21, a blade layer 50 formed by braiding wires 52 (see FIG. 1) is formed in a net-like manner.
For the wire 52, a fine wire of polymer fiber such as polyimide (PI), polyamide imide (PAI) or polyethylene terephthalate (PET) can be used in addition to a fine metal wire such as stainless steel 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.

In the molding step of this method, the outer layer 60 is formed around the blade layer 50 by extrusion molding of the resin material 12 that is the main material of the sheath 16. Thereby, the blade layer 50 is included in the outer layer 60 as shown in FIG.
As the resin material 12 constituting the outer layer 60, a thermoplastic polymer is widely used. Examples include PI, PAI, PET, polyethylene (PE), polyamide (PA), nylon elastomer, polyurethane (PU), ethylene-vinyl acetate resin (EVA), polyvinyl chloride (PVC), polypropylene (PP), etc. Can be used.

A die 92 shown in FIG. 6 is formed by combining an out die 921 and an in die 922.
A main hole 93 for forming the main lumen 20 and a sub hole 94 for forming the sub-lumen 30 are formed in the indie 922.
The out die 921 is a member that pushes out the nozzle 96 while holding the outer peripheral side surface of the resin material 12 supplied from the in die 922.
The main hole 93 and the sub hole 94 are formed over a predetermined length in the extrusion direction of the die 92 (left side of the figure).
Further, three sub holes 94 are formed around the main hole 93 at intervals of 120 degrees (only one is shown in the figure).

  Then, the resin material 12 is pushed out from the supply hole 95 in a state where the first core wire 22 around which the blade layer 50 and the inner layer 21 are attached is inserted into the main hole 93 and the second core wire 24 is inserted into the sub hole 94. Thus, the outer layer 60 made of the resin material 12 is formed on the surface of the blade layer 50 by coating.

  In the molding process, in addition to the take-up speed by the take-up machine 86, the cooling temperature in the sizing device 84 and the distance between the die 92 and the sizing device 84 can be adjusted. Then, by adjusting these parameters, as shown in FIG. 4 (a), the sheath 16 pushed out from the die 92 is pulled toward the distal end side (left side in the figure), and this is adjusted to a predetermined diameter. It can be thinned.

  Here, in the molding step of the present method, the outer core 60 is extruded by providing a radial clearance between the second core wire 24 and the resin material 12, thereby allowing the second core wire 24 and the resin material 12 to adhere to each other. prevent. Accordingly, the second core wire 24 is prevented from coming into close contact with the inner wall surface of the sub-lumen 30 in the diameter reduction process and the insertion process, which will be described later, and good insertion of the operation line 40 is achieved.

In the molding step of this method, the tubular body (sheath 16) is molded by extruding the resin material while blowing the gas material around the radial direction of the second core wire 24.
More specifically, as shown in FIG. 6, an air flow F having a pressure higher than the atmospheric pressure is blown into the sub-hole 94 of the indie 922. Thereby, it is suppressed that the outer layer 60 is joined to the second core wire 24 inside the sheath 16 that is drawn and thinned by the take-up machine 86 (see FIG. 4A). Further, by setting the total pressure of the airflow F to a predetermined value or higher, the gas 46 can be held around the second core wire 24 inside the sheath 16 sized by the sizing device 84.
As the gaseous material, in addition to air, an inert gas such as nitrogen may be used.

(Thinning process)
In the diameter reduction process shown in FIG. 4C, the diameter of the second core wire 24 inserted through the sheath 16 created in the molding process is reduced. Various specific methods for reducing the diameter can be employed.

  As an example of the diameter reducing step, in this method, the second core wire 24 is reduced in diameter by pulling both end portions 25 and 26 of the second core wire 24 embedded in the tubular main body (sheath 16).

  More specifically, in the diameter reduction step of this method, the diameter is reduced by pulling the second core wire 24 made of a metal material and plastically deforming it.

In the diameter reduction process, as shown by an arrow in FIG. 4C, the end portions 25 and 26 of the second core wire 24 are pulled in opposite directions.
For this reason, as shown to the same figure (b), it is good to expose the edge parts 25 and 26 of the 2nd core wire 24 from the both ends of the longitudinal direction of the sheath 16 shape | molded by the formation process, respectively.
The second core wire 24 can be pulled by attaching a chuck jig (not shown) to the end portions 25 and 26.
Thereby, according to the Poisson's ratio of the 2nd core wire 24, the 2nd core wire 24 shrinks | reduces to a radial direction and makes it thin.

In addition, it is good to perform a diameter reduction process in the state which hold | maintained the both ends of the 1st core wire 22 with the holder (not shown). Therefore, at the time of the diameter reduction process, it is preferable to leave the first core wire 22 while being inserted through the sheath 16 and to project both ends of the first core wire 22 in the longitudinal direction from the sheath 16.
As a result, the sheath 16 is in close contact with the large-diameter first core wire 22, and prevents the sheath 16 from following and stretching when the both ends 25 and 26 of the second core wire 24 are pulled. can do.

  On the other hand, in the sheath 16 (outer layer 60) cooled and hardened by the sizing device 84, holes corresponding to the outer diameter of the second core wire 24 before the diameter reduction is formed as the sub-lumen 30. For this reason, the thinned second core wire 24 is loosely inserted into the sub-lumen 30.

The diameter reduction ratio of the second core wire 24 in the thinning process is not particularly limited as long as the second core wire 24 is not pulled and fractured, and the second core wire 24 is thinned to the extent that it can be removed from the sub-lumen 30. .
Further, by thinning the second core wire 24 plastically as in this method, the wire diameter of the second core wire 24 does not recover to the initial diameter when the tensile force is pulled by the chuck jig. Thereby, in the insertion process mentioned later, it is not necessary to apply tensile force to the both ends of the 2nd core wire 24, and it is excellent in workability | operativity.

In addition, as another example of the diameter reducing step in the present method, the second core wire 24 may be thermally contracted.
That is, the second core wire 24 is made of a material having a larger linear expansion coefficient than the tubular main body (sheath 16), and the second core wire 24 is thermally contracted with respect to the tubular main body (sheath 16) in the diameter reduction step. The two-core wire 24 may be thinned.

  More specifically, the sheath 16 and the second core wire 24 are thermally contracted by further cooling the entire sheath 16 to a room temperature from the molding temperature in the sizing device 84, and the difference between the two is used to make the sheath. 16 and the second core wire 24 may be separated from each other.

(Drawing process)
In the drawing process, the main lumen 20 is formed by drawing the first core wire 22 from the tubular body (sheath 16). FIG. 5A shows the sheath 16 after the drawing process.

  As described above, in this method, the first core wire 22 is subjected to a mold release treatment, so that the interface strength between the first core wire 22 and the inner layer 21 is the interface strength between the blade layer 50 or the inner layer 21 and the outer layer 60. Can be made smaller. Thus, by shearing the first core wire 22 in the longitudinal direction with respect to the sheath 16, the blade layer 50 and the inner layer 21 can be left inside the sheath 16, and the first core wire 22 can be pulled out of the sheath 16.

  As shown in the figure, a main lumen 20 is formed in the sheath 16 from which the first core wire 22 has been pulled out.

As shown in the figure, an operation line 40 is connected to the end portion 26 of the second core wire 24.
The timing for connecting the operation wire 40 to the second core wire 24 may be before or after the drawing step.

The operation wire 40 has a smaller diameter than the second core wire 24 that has been thinned in the thinning step.
Moreover, regarding the connection between the operation line 40 and the end portion 26 of the second core wire 24, it is preferable to connect the two with an adhesive, for example. Thereby, the end portions of the second core wire 24 and the operation wire 40 are abutted against each other, and the operation wire 40 does not protrude beyond the outer diameter of the second core wire 24 in the radial direction. For this reason, the operation line 40 is smoothly inserted into the sub-lumen 30.

Examples of the material of the operation line 40 used in this method include polyether ether ketone (PEEK), polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), polymer fibers such as PI or PTFE, SUS, and corrosion resistance. A flexible metal wire such as a steel wire, titanium or a titanium alloy can be used.
The operation line 40 used in this method has a very small diameter of 30 to 60 μm as described above.

(Insertion process)
In the insertion step shown in FIG. 5 (b), the second core wire 24 having a reduced diameter is pulled out of the sheath 16 to form the sub-lumen 30, and the operation line 40 connected to the second core wire 24 is turned into the sub-lumen 30. Insert.

  In this method, the operation line 40 can be drawn into the sub-lumen 30 by using the thinned second core wire 24 like a sewing needle. As a result, it is possible to easily insert the operation wire 40 having a small diameter and flexibility into the sub-lumen 30 without using the conventional pushing method.

  Here, by pulling out the first core wire 22 from the sheath 16 prior to the diameter reduction process, the pressure that the second core wire 24 and the operation line 40 are subjected to in the radial direction from the outer layer 60 in the insertion process is reduced. Sex is good.

FIG. 4C shows a state in which the second core wire 24 is completely pulled out from the sheath 16 and the inside of the sub-lumen 30 is replaced with the operation wire 40 from the second core wire 24.
The operation line 40 is inserted from the distal end 15 to the proximal end 17 of the sheath 16.

(Other processes)
In this method, as a process after insertion of the operation line 40, a marker attaching process for pressing the marker 66 to the outer periphery of the distal end portion of the sheath 16 and fixing the distal end of the operation line 40 to the marker 66, and an outer periphery of the outer layer 60. A hydrophilization step for forming the hydrophilic coat layer 64 is performed.
As described above, the catheter 10 of the present embodiment can be obtained.

  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.

  In the said embodiment, although the aspect which extrudes both the 1st core wire 22 and the 2nd core wire 24 with the resin material 12 in the formation process of the outer layer 60 was illustrated, this invention is not limited to this. For example, the resin material 12 may be applied and formed on the first core wire 22 and the second core wire 24 held by the jig, or the resin material 12 previously formed into a tape (ribbon) shape may be used as the first core wire 22. Alternatively, the outer layer 60 may be formed by wrapping around the second core wire 24.

Moreover, in this method, although the method of pushing out the resin material 12 while blowing the airflow F around the 2nd core wire 24 was illustrated, this invention is not limited to this. Instead of spraying the air flow F, a water-soluble or solvent-soluble solid or liquid filling material may be extruded together with the resin material 12 in a state of being deposited around the second core wire 24. Then, the filling material can be removed from the molded sheath 16 by washing or the like, and a clearance can be formed between the second core wire 24 and the sheath 16 (outer layer 60).
Thereby, the second core wire 24 can be prevented from adhering to the inner wall surface of the outer layer 60 in the diameter reducing step, and the second core wire 24 can be easily pulled out from the sheath 16 in the insertion step.

  Moreover, in the said embodiment, although the aspect which forms the sublumen 30 in the exterior of the blade layer 50 was illustrated, this invention is not limited to this. That is, the sub-lumen 30 may be formed in the inner layer 21 and the blade layer 50 may be provided around the sub-lumen 30.

  The catheter 10 according to the modified example can be formed through an extrusion process, a knitting process, and an outer layer forming process in the molding process. An example of the creation method is shown below.

In the extrusion process, the molding material of the inner layer 21 is extruded from the die 92 (see FIG. 6) together with the first core wire 22 and the second core wire 24. Thereby, the second core wire 24 is included in the inner layer 21.
In the knitting process, the blade layer 50 is knitted around the extruded inner layer 21.
In the outer layer forming step, an outer layer 60 made of the same or different resin material as the molding material of the inner layer 21 is formed around the catheter 10 in which the blade layer 50 is knitted.

By protecting the outer periphery of the sub-lumen 30 with the blade layer 50 as in this modification, even if an excessive tensile force is applied to the operation line 40 during operation, the operation line 40 penetrates the catheter 10 and is exposed to the outside. There is no end.
A marker 66 is optionally attached to the tip of the inner layer 21 on which the sublumen 30 is formed, and the tip of the operation line 40 is fixed. A hydrophilic coat layer 64 is preferably formed around the outer layer 60.

Further, in this method, the flexibility of the catheter 10 is adjusted from the proximal end PE side to the distal end DE side by adjusting the take-up speed by the take-up machine 86 (see FIG. 4A). It can be increased in multiple stages or continuously.
Thereby, it is possible to sufficiently obtain the bending strength of the catheter 10 at the proximal end portion 17 to which the bending moment is most loaded during the operation while sufficiently securing the flexibility at the distal end portion 15 of the catheter 10.

  Further, in this method, as shown in FIG. 6, the secondary hole 94 is provided in the base end surface (right end surface in the drawing) of the die 92 to push out the second core wire 24. However, the present invention is not limited to this. I can't. For example, the sub-hole 94 may be provided on the side of the out die 921 and the sheath 16 may be formed by extruding the second core wire 24 together with the resin material 12.

  Further, in the catheter 10 of the present embodiment, the three operation lines 40 are slidably inserted into the sub-lumen 30, but the present invention is not limited to this. One, two, or four or more operation lines 40 may be used. Further, the number of sub-lumens 30 may be the same as or different from the number of operation lines 40. That is, a plurality of operation lines 40 may be inserted into the sub-lumen 30, or the sub-lumen 30 in which the operation lines 40 are not inserted may be provided in the sheath 16.

DESCRIPTION OF SYMBOLS 10 Catheter 12 Resin material 15 Distal end part 16 Sheath 17 Proximal end part 20 Main lumen 21 Inner layer 22 First core wire 24 Second core wire 25, 26 End part 30 Sublumen 40 Operation line 41 Proximal end 46 Gas 50 Blade layer 52 Wire 60 Outer layer 64 Coat layer 66 Marker 70 Operation unit 80 Manufacturing device 82 Extruder 84 Sizing device 86 Take-out device 88 Roller 90 Material supply unit 92 Die DE Distal end PE Proximal end F Airflow

Claims (9)

A catheter comprising a main lumen, a sub-lumen having a smaller diameter than the main lumen, and an operation line slidably inserted through the sub-lumen, and a method of manufacturing a catheter made of a resin material,
A molding step in which a tubular body embedded with a first core wire and a second core wire having a smaller diameter than the first core wire are spaced apart from each other is formed from the resin material;
A diameter reducing step for reducing the diameter of the second core wire;
A drawing step of drawing the first core wire from the tubular body to form the main lumen;
An insertion step of drawing out the second core wire having a reduced diameter from the tubular body to form the sub-lumen, and inserting the operation line connected to an end of the second core wire into the sub-lumen;
The manufacturing method of the catheter containing this.   2. The catheter manufacturing method according to claim 1, wherein, in the thinning step, the second core wire is thinned by pulling both ends of the second core wire embedded in the tubular body. The second core wire is made of a metal material,
The method for producing a catheter according to claim 2, wherein, in the thinning step, the second core wire is pulled and plastically deformed.   The catheter manufacturing method according to any one of claims 1 to 3, wherein the insertion step is performed after the extraction step.   The method of manufacturing a catheter according to claim 4, wherein the drawing step is performed between the thinning step and the insertion step. The second core wire is made of a material having a larger linear expansion coefficient than the tubular body,
The catheter manufacturing method according to claim 1, wherein, in the thinning step, the second core wire is heat-shrinked with respect to the tubular body to reduce the diameter of the second core wire.   The method for producing a catheter according to any one of claims 1 to 6, wherein the operation line has a diameter smaller than that of the second core wire that has been reduced in the diameter reduction step.   The method for manufacturing a catheter according to any one of claims 1 to 7, wherein in the forming step, the tubular body is formed by extruding the second core wire together with the resin material.   The catheter manufacturing method according to claim 8, wherein, in the forming step, the tubular body is formed by extruding the resin material while blowing a gas material around the radial direction of the second core wire.

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