JP5212092B2 - Catheter manufacturing method - Google Patents

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. 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.
In such a manufacturing method, the deflection wire is pushed in from one end side and inserted in a state where the pressurized fluid is filled into the sub-lumen and the diameter thereof is expanded.

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 sub-lumen is kept to a very small diameter of 10 to several tens of μm or less.
Along with this, as a method of inserting an operation line for bending the distal end of the catheter into the sub-lumen, it is extremely difficult to push it in from one end side of the sub-lumen as described in Patent Document 2. ing. This is because it is difficult to uniformly and smoothly form the sub-lumen having a reduced diameter, and the buckling strength of the operation line is also the case of Euler buckling of a long cylinder with the free end as the column end, for example. This is because this decreases in proportion to the square of the wire diameter.
When the insertion performance of the operation line with respect to the sublumen is lowered, not only the insertion time is lengthened but also the quality of the catheter and the yield are deteriorated due to wear of the inner diameter of the sublumen and the operation line.

  The present invention has been made in view of the above-described problems, and provides a method for manufacturing a catheter in which an operation line can be suitably inserted into a sub-lumen regardless of the diameter of the catheter.

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
The resin material and the operation line, and the core wire for forming the main lumen and the operation line, with a clearance formed in the radial direction of the operation line, respectively, together with the core wire and the resin material, The operation line is extruded and molded.

  In the catheter manufacturing method of the present invention, as a more specific embodiment, the core wire, the resin material, and the operation line are used together with a liquid or solid filling material provided around the radial direction of the operation line. The clearance may be formed by extruding and molding.

  In the catheter manufacturing method of the present invention, as a more specific embodiment, the core wire, the resin material, and the operation line are extruded in a state where a gas is interposed around the radial direction of the operation line. The clearance may be formed by molding.

  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 operation line is extruded together with the resin material of the catheter at the time of extrusion forming the sublumen. At this time, since a clearance is provided between the resin material and the operation line, both are pushed out in a non-contact manner, so that the resin material that becomes the inner wall surface of the sub-lumen and the operation line come into contact with each other or the operation line is operated. The wire is not embedded in the resin material. This eliminates the need for a step of pushing the operation line from the one end side to the sub-lumen, so that the operation line is formed on the sub-molded catheter by a simple manufacturing method regardless of the diameter of the catheter. It can be made slidable with respect to.
Moreover, the main lumen and the sub-lumen are not communicated with each other by keeping the operation line and the core line in non-contact when the resin material is extruded. For this reason, in a formed catheter, when a medicine or the like is supplied through the main lumen or an optical system is inserted, they do 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.

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 production method according to the present invention (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 schematic longitudinal sectional view showing an example of a catheter 10 obtained by this method (hereinafter referred to as the catheter 10 of this 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.

The catheter 10 of the present embodiment is made of a resin material 12 and includes a main lumen 20 and a plurality of sub-lumens 30 having a smaller diameter than the main lumen 20. 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.
And the operation line 40 fixed to the distal end portion 15 of the catheter 10 is slidably inserted through 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 catheter 10 is made of a resin material, a tubular inner layer 21 having a main lumen 20 formed therein, a blade layer 50 formed by knitting wires 52 around the inner layer 21, and a resin material of the same or different type as the inner layer 21. And an outer layer 60 that is formed around the inner layer 21 and encloses the blade layer 50.
In the catheter 10 of the present embodiment, the sub-lumen 30 through which the operation lines 40 are inserted is formed inside the outer layer 60 and outside the blade layer 50.
The main body of the catheter 10 made of a resin material in which the main lumen 20 and the sublumen 30 are formed is referred to as a sheath 16.

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.
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 sublumen 30 is provided along the longitudinal direction of the catheter 10 (left-right direction in FIG. 1), and at least the proximal end 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. 3A is a schematic longitudinal sectional view showing the catheter 10 in a natural state, and FIG. It is a longitudinal cross-sectional schematic diagram which shows the catheter 10 of the pulled state. In the figure, only one of the three operation lines 40 in the catheter 10 of the present embodiment is illustrated.

The proximal end (proximal end) of the operation line 40 protrudes from the sub-lumen 30. In addition, an operation portion 70 is provided at the proximal end of the operation line 40 to bend the distal end portion 15 of the catheter 10 by individually pulling the plurality of operation lines 40.
In the catheter 10 of the present embodiment, when the proximal end 41 of the operation line 40 is pulled toward the proximal side (right side in the figure), a tensile force is applied to the distal end 15 of the catheter 10 via the marker 66. And the distal end portion 15 bends 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 is changed only by pulling the operation line 40 by the operation unit 70 without performing a torque operation to apply torque to the entire catheter 10 and direct the distal end portion 15 in a predetermined direction. It becomes possible to operate. For this reason, with respect to the catheter 10 of the present embodiment, for example, it is possible to enter the branching blood vessel in a desired direction.

On the other hand, when the proximal end 41 of the operation line 40 is pushed into the catheter 10, the operation line 40 is buckled and a pushing force is substantially applied to the distal end portion 15 of the catheter 10. Absent.
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.

<Manufacturing method>
Hereinafter, this method will be described.
FIG. 4 is a schematic configuration diagram of an apparatus 80 for manufacturing the catheter 10 used in the present method.
The manufacturing apparatus 80 includes an extruder 82, a sizing apparatus 84, and a take-up machine 86 arranged in series.
The extruder 82 includes a material supply unit 90 that inputs the resin material 12, and a die 92 that extrudes the resin material 12 together with the core wire 22 and the operation wire 40 and thins the resin material 12.

(First embodiment)
FIG. 5 is a schematic longitudinal sectional view showing the die 92 used in the manufacturing method according to the present embodiment, the resin material 12 extruded from the die 92, the core wire 22 and the operation line 40, and an enlargement of the circle V in FIG. It is sectional drawing. In addition, the inner layer 21 and the blade layer 50 (refer FIG. 1) are formed in the outer periphery of the core wire 22 so that it may mention later.

The method includes a main lumen 20 (see FIG. 1), a sub-lumen 30 having a smaller diameter than the main lumen 20, and an operation line 40 slidably inserted into the sub-lumen 30 and from the resin material 12. The manufacturing method of the catheter 10 which becomes.
And in this method, in the state which formed the clearance 42 in the radial direction of the operation line 40 between the resin material 12, the operation line 40, and the core wire 22 and the operation line 40 for forming the main lumen 20, respectively. The operation wire 40 is extruded together with the core wire 22 and the resin material 12, and the catheter 10 is molded.

Next, this method will be described in detail.
The sizing device 84 is a device that cools the catheter 10 extruded from the extruder 82 and adjusts the catheter 10 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 distal end of the catheter 10 that has been extruded from the extruder 82 and cooled by the sizing device 84 at a predetermined take-up speed.

  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, as shown in FIG. 5, the catheter 10 pushed out from the die 92 is pulled to the distal end side (left side in the figure), and this can be thinned to a predetermined diameter. it can.

A die 92 shown in FIG. 5 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 main hole 93 and the sub hole 94 extend over a predetermined length in the extrusion direction of the die 92. Further, three sub holes 94 are formed around the main hole 93 at intervals of 120 degrees (only one is shown in the figure).
The main lumen 20 and the sublumen 30 are formed in the catheter 10 by extruding the resin material 12 from the supply hole 95 in a state where the core wire 22 is inserted into the main hole 93 and the operation line 40 is inserted into the sub hole 94. Is done.
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.

Specifically, as the first step of the preliminary step, the inner layer 21 is formed around the core wire 22 by extrusion (first extrusion).
For the core wire 22, a metal material having high tensile strength and corrosion resistance, such as stainless steel (SUS), can be used.

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.

Further, in this method, the core wire 22 knitted around the blade layer 50 is extruded together with the resin material 12 and the operation wire 40.
That is, as a second extruding step as a preliminary step, the wire 52 is wound around the core wire 22 to which the inner layer 21 is applied.
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.

After the above preliminary process, the outer layer 60 (see FIG. 1) is formed around the blade layer 50 by extrusion molding (second extrusion molding) of the resin material 12 that is the main material of the catheter 10.
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.
In the present method, the clearance 42 is provided between the resin material 12 and the core wire 22 and the operation line 40 and the operation line 40 is pushed out, whereby the resin material 12 is pushed away by the clearance 42 and the sublumen 30 is formed.
The clearance 42 between the resin material 12 and the operation line 40 and the clearance 42 between the core line 22 and the operation line 40 may be equal to or different from each other.

  Since the operation line 40 of this method is extruded from the die 92 together with the resin material 12, heat resistance equal to or higher than the melting temperature of the resin material 12 is required. Specific materials include, for example, polyether ether ketone (PEEK), polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), polymer fiber such as PI or PTFE, or SUS, a corrosion-resistant coated steel wire. A metal wire such as titanium or a titanium alloy can be used.

Furthermore, in this method, as a post-process after the formation of the outer layer 60, a marker application process in which the marker 66 is clamped to the outer periphery of the tip and the tip of the operation line 40 is fixed to the marker 66, and extrusion molding (third extrusion) A hydrophilization step of forming a hydrophilic coat layer 64 on the outer periphery of the outer layer 60 is performed by molding.
For the coat layer 64, a hydrophilic material such as polyvinyl alcohol (PVA) or polyvinyl pyrrolidone can be used.

  Then, the main lumen 20 is formed by penetrating the core wire 22 from the extruded catheter 10. When pulling out the core wire 22, it is preferable to pull the both ends of the core wire 22 and reduce the diameter of the core wire 22.

  In this method, the clearance 42 is formed by extruding the core wire 22, the resin material 12, and the operation line 40 together with the liquid or solid filling material 44 provided around the radial direction of the operation line 40 to form the catheter 10. .

That is, in this method, since the filling material 44 exists around the operation line 40, the operation line 40 is not in contact with the resin material 12 and the core wire 22 during extrusion molding.
Further, since the filling material 44 is liquid or solid, even when the extruded catheter 10 is drawn and thinned by the take-up machine 86, the operation line 40 is prevented from coming into contact with the resin material 12 and the core wire 22. Is done.

More specifically, in this method, the filling material 44 is a water-soluble or solvent-soluble solid material, and the operation wire 40 previously coated with the filling material 44 is extruded together with the core wire 22 and the resin material 12 to form a catheter. 10 is molded.
Thereby, it is not necessary to continuously supply the liquid material to the sub-hole 94 at the time of the second extrusion molding, and the handling property of the manufacturing apparatus 80 is improved.

And this method includes the removal process which removes the filling material 44 from the catheter 10 extruded and shape | molded.
That is, in this method, in the extrusion molding (second extrusion molding) of the resin material 12 that is the main material of the catheter 10, the filling material 44 prevents contact between the resin material 12 and the operation line 40 and the sublumen 30. Form. Then, the operation line 40 is slidable with respect to the sub-lumen 30 by immersing the extruded catheter 10 in water or a solvent to remove the filling material 44.

  Various examples of the filling material 44 that is a water-soluble or solvent-soluble solid material can be used. Examples of the filling material 44 include polyvinyl alcohol (PVA), polyvinyl acetate partially saponified product, polyacrylic acid, polyacrylic acid, and the like. Biodegradable resins such as acrylamide, polyethylene oxide or starch can be used.

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 20 to 30 μm. The radius from the axial center of the catheter 10 to the center of the sublumen 30 can be about 300 to 350 μm, the inner diameter of the sublumen 30 can be 40 to 100 μm, and the thickness of the operation line 40 can be 30 to 60 μm. And the outermost diameter 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.

An example of specific molding conditions for obtaining the catheter 10 having the above dimensions is shown below.
Nylon elastomer is used as the resin material 12, and PVA is used as the filling material 44. The inner diameter of the circular nozzle 96 is 2.5 mm, the operation wire 40 is a round wire having a diameter of 40 μm, and the operation wire 40 is filled with a thickness of 20 μm. Material 44 is coated.
Then, the outer diameter of the outer diameter is determined by extruding and forming the catheter 10 while taking the distance between the nozzle 96 and the sizing device 84 to 200 to 500 mm, the cooling temperature by the sizing device 84 to room temperature, and the take-up speed to 10 to 20 m / sec. A catheter 10 having a diameter of 800 μm and an inner diameter of the sublumen 30 of 80 μm can be obtained.
Further, the molded catheter 10 is immersed in warm water, and the operation wire 40 is smoothly removed from the sub-lumen 30 by washing and removing the filling material 44 while sliding the operation wire 40 forward and backward with respect to the sub-lument 30. The sheath 16 slidably inserted can be obtained.
The catheter 10 can be manufactured by appropriately providing the coat layer 64, the marker 66, and the operation unit 70 on the sheath 16.

Various modifications are allowed for this embodiment.
For example, instead of covering the operation line 40 with the filling material 44 in advance, the filling material 44 may be a liquid material or a molten resin material, and the operation line 40 may be extruded into the filling material 44.
That is, in this method, the catheter 10 may be formed by co-extrusion of the filling material 44 including the operation line 40 and the resin material 12.
Here, the liquid material and the molten resin material are materials having a melting point lower than that of the resin material 12 and having fluidity at the extrusion molding (second extrusion molding) temperature of the resin material 12. It doesn't matter.

The melting point of the liquid material or molten resin material used for the filling material 44 is preferably lower than the melting point of the resin material 12 and higher than the cooling temperature by the sizing device 84.
The filling material 44 is extruded into the resin material 12 through the sub-hole 94 of the die 92 together with the operation line 40. Then, the filling material 44 is cooled and cured by the sizing device 84, and the filling material 44 is removed after adjusting the catheter 10 to a predetermined wire diameter.
In removing the filling material 44, the catheter 10 once cooled is heated to a temperature equal to or higher than the melting point of the filling material 44 and lower than the melting point of the resin material 12 to liquefy the filling material 44 in the sublumen 30. Remove.
In the case of such a modification, silicone oil can be used as an example of the liquid material, and paraffin having 20 to 40 carbon atoms can be used as an example of the molten resin material.

(Second embodiment)
FIG. 6 is a schematic longitudinal sectional view showing the die 92 used in the manufacturing method according to the present embodiment, the resin material 12 extruded from the die 92, the core wire 22 and the operation line 40.

In this method, the clearance 42 is formed by extruding the core wire 22, the resin material 12, and the operation line 40 and molding the catheter 10 with the gas 46 interposed around the radial direction of the operation line 40.
This method is different from the first embodiment in that a clearance 42 is formed around the radial direction of the operation line 40 using a gas 46 instead of the liquid or solid filling material 44.

Although the specific method of forming the clearance 42 with the gas 46 is not particularly limited, this method exemplifies a method using the tube 48 in which the operation line 40 is loosely inserted.
That is, in this method, the tube 48 having a melting point higher than that of the resin material 12 into which the operation line 40 is loosely inserted is extruded together with the core wire 22 and the resin material 12.

A heat-shrinkable resin material can be suitably used for the tube 48. An example of such a material is PTFE.
By making the tube 48 heat-shrinkable, the operation wire 40 is inserted into the tube 48 and then heated to adjust the inner diameter of the tube 48 as desired. The inner diameter of the tube 48 after the heating adjustment is made larger than the wire diameter of the operation wire 40.
And the gas 46 intervened between the resin material 12 and the operation line 40 by extruding the tube 48 through which the operation line 40 is inserted and heated and adjusted to the inside of the resin material 12 from the sub hole 94 of the die 92. The catheter 10 is extruded as it is.

In addition, as the catheter 10 is pulled out and thinned, the tube 48 is pressed by the resin material 12 to reduce the diameter. This is due to the fluidity and compressibility of the gas 46. When the heat shrink temperature of the tube 48 is equal to or lower than the extrusion temperature of the resin material 12, the heat shrink of the tube 48 proceeds and the tube 48 is further reduced in diameter.
For this reason, the inner diameter of the tube 48 in the catheter 10 whose wire diameter has been adjusted by the sizing device 84 is smaller than when it is supplied to the sub-hole 94 of the die 92. The inner diameter of the tube 48 in the molded catheter 10 corresponds to the inner diameter of the sub-lumen 30.
Therefore, the operation line 40 may be inserted into the tube 48 having a larger inner diameter than the sub-lumen 30 having a desired inner diameter in the formed catheter 10 and supplied to the die 92.

According to this embodiment, the tube 48 constitutes a part of the outer layer 60, and the gas 46 between the tube 48 and the operation line 40 constitutes the sub-lumen 30. For this reason, it is not necessary to remove the filling material 44 from the molded catheter 10 as in the first embodiment.
Further, by extruding these together with the resin material 12 in a state where the operation line 40 is covered with the tube 48, it is physically avoided that the operation line 40 and the resin material 12 come into direct contact. The sliding performance between the sub-lumen 30 and the operation line 40 is good.

Various modifications of the present embodiment are allowed.
For example, instead of using the tube 48, a gas material having a pressure higher than the atmospheric pressure may be blown around the radial direction of the operation line 40 as the gas 46.

That is, by blowing high-pressure gas into the sub-hole 94 of the indie 922, the sub-lumen 30 is not completely crushed in the catheter 10 drawn by the take-up machine 86 and thinned, and the gas around the operation line 40 46 can be held.
As the gaseous material, in addition to air, an inert gas such as nitrogen may be used.

  In the present embodiment using the tube 48 in which the operation line 40 is loosely inserted, high-pressure gas may be blown into the tube 48 extruded together with the resin material 12 to prevent the sub-lumen 30 from being crushed.

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 first or second embodiment, the sub-lumen 30 is formed outside the blade layer 50, but the present 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 manufactured through an extrusion process, a knitting process, and an outer layer forming process.
In the extrusion process, the core wire 22, the resin material 12, and the operation wire 40 are extruded together.
In the knitting process, the blade layer 50 is knitted around the extruded catheter 10.
In the outer layer forming step, an outer layer 60 made of the same or different kind of resin material as the resin material 12 is formed around the catheter 10 in which the blade layer 50 is knitted.

In the extrusion process, the operation line 40 is extruded together with the resin material 12, whereby the sub-lumen 30 is formed inside the inner layer 21.
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 where the sublumen 30 is formed, and the tip of the operation line 40 is fixed. Further, a hydrophilic coat layer 64 may be formed around the outer layer 60.

In the first or second embodiment, the flexibility of the catheter 10 is adjusted in multiple stages from the proximal end PE side to the distal end DE side by adjusting the take-up speed of the take-up machine 86 or continuously. Can be increased.
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 the first or second embodiment, as shown in FIGS. 5 and 6, the sub-hole 94 is provided in the base end surface (right end surface in the drawing) of the die 92 and the operation line 40 is supplied. However, the present invention is not limited to this. For example, the auxiliary hole 94 may be provided on the side of the out die 921, and the operation line 40 may be extruded together with the resin material 12 together with the filling material 44, the tube 48, or the gas 46, and the catheter 10 may be molded.

It is a longitudinal cross-sectional schematic diagram 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. It is a schematic block diagram of the manufacturing apparatus of a catheter. It is a longitudinal cross-sectional schematic diagram which shows the die | dye used with the manufacturing method concerning 1st embodiment, the resin material extruded from a die | dye, a core wire, and an operation line. It is a longitudinal cross-sectional schematic diagram which shows the die | dye used with the manufacturing method concerning 2nd embodiment, the resin material extruded from a die | dye, a core wire, and an operation line.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Catheter 12 Resin material 15 Distal end part 17 Proximal end part 20 Main lumen 21 Inner layer 22 Core wire 30 Sublumen 40 Operation line 42 Clearance 44 Filling material 46 Gas 48 Tube 50 Blade layer 60 Outer layer 64 Coat layer 66 Marker 70 Operation part 80 Production equipment 82 Extruder 84 Sizing equipment 86 Take-out machine 90 Material supply part 92 Die 921 Out die 922 Indie 93 Main hole 94 Sub hole 95 Supply hole 96 Nozzle

Claims (10)

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,
The resin material and the operation line, and a core wire for forming the main lumen and the operation line, with a clearance formed in the radial direction of the operation line, respectively, together with the core wire and the resin material, A method for producing a catheter, characterized by extruding an operation line.   2. The clearance is formed by extruding and molding the core wire, the resin material, and the operation line together with a liquid or solid filling material provided around the radial direction of the operation line. A method for producing the catheter according to 1.   The method for manufacturing a catheter according to claim 2, wherein the filling material is a liquid material or a molten resin material, and the operation line is pushed out into the filling material.   3. The filling material is a water-soluble or solvent-soluble solid material, and the operation line pre-coated with the filling material is extruded and molded together with the core wire and the resin material. Manufacturing method of the catheter.   The catheter manufacturing method according to any one of claims 2 to 4, further comprising a removing step of removing the filling material from the extruded catheter.   The clearance is formed by extruding and molding the core wire, the resin material, and the operation line in a state where a gas is interposed around the radial direction of the operation line. A method for manufacturing a catheter.   The catheter manufacturing method according to claim 6, wherein a gas material having a pressure higher than an atmospheric pressure is blown around the radial direction of the operation line as the gas.   The catheter manufacturing method according to claim 6, wherein a tube having a melting point higher than that of the resin material into which the operation line is loosely inserted is extruded together with the core wire and the resin material.   The method for manufacturing a catheter according to any one of claims 1 to 8, wherein the core wire having a blade layer knitted around is extruded together with the resin material and the operation line. An extrusion process for extruding the core wire, the resin material and the operation line together;
A knitting step of knitting a blade layer around the extruded catheter;
An outer layer forming step of forming an outer layer made of the same or different kind of resin material as the resin material around the catheter in which the blade layer is knitted,
A method for producing a catheter according to claim 1, comprising:

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