JP3635965B2 - Method for manufacturing catheter tube - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a manufacturing method of a catheter tube to be used in medical institutions such as hospitals.
[0002]
[Prior art]
Conventionally, in a medical institution such as a hospital, a tube-like medical instrument called a catheter tube is used to inject a drug solution or a contrast medium from outside into a predetermined part of a patient's living body, or to take out a body fluid or the like in the living body. It is used.
[0003]
In general, since this catheter tube is inserted into a living body using blood vessels, urethra, etc., particularly during insertion, the catheter tube can be accurately inserted in the living body without damaging the blood vessel wall or organs on the way. In addition to high operability and safety that can reach a predetermined location, there are demands for injection of a drug solution and a contrast medium after insertion, smooth insertion, and the like.
[0004]
Therefore, the conventional catheter tube does not damage the blood vessel wall or organs, and it is easy to bend and has a flexible cap-like tube insertion tip, and the insertion tip is pushed into the living body to ensure a certain location. It is comprised from the tube-shaped torque transmission part reinforced in order to make it reach | attain.
[0005]
And as a manufacturing method of such a conventional catheter tube, first, a metal made of a corrosion-resistant metal strand over the entire outer periphery of a resin tube body into which a long and thin metal core wire having a circular cross section is inserted. After the braid is covered with a braiding machine, the tube body is passed through a high-temperature mold and softened by heating, so that the metal braid is digged into the outer surface of the tube body to reinforce the entire tube body. Next, this metal braid is removed intermittently with a predetermined width over the length of the tube body using a chemical removal method such as electricity or acid, or a mechanical removal method using a cutter, etc. Resin is collectively coated on the outer periphery by extrusion or the like, and then the metal core wire is stretched and pulled out from the tube body. After that, the tube body is divided into a plurality of parts from the end of the portion where the metal braid has been removed, so that the torque transmitting portion provided with the metal braid and the insertion tip having high elasticity after removing the metal braid are continuous. A plurality of catheter tubes formed in this way are manufactured simultaneously.
[0006]
[Problems to be solved by the invention]
By the way, in the manufacturing method as described above, since the metal braid is removed by a chemical removal method, a mechanical removal method, or the like, a large-scale apparatus is required and a large amount of removal work is required. There is a problem that it takes a long time. In addition, in the case of chemical removal by acid, a larger equipment processing step such as chemical treatment is required in terms of safety, and in the case of mechanical removal by a cutter or the like, the metal braid is fixed in advance. It is difficult to remove the metal wire from the remaining braided end during removal.
[0007]
In addition, a tube-shaped torque transmission part with a built-in metal braid and a tube-shaped insertion tip without a metal braid are manufactured separately, and the insertion tip is fused and bonded to the tip of this torque transmission part. A method of manufacturing by connecting with an agent or the like has also been proposed, but in the method of connecting different members to each other in this way, a stepped portion is generated in the connecting portion due to a slight mismatch of the inner diameter and outer diameter thereof. Further, if the connection area between the two is reduced, the connection strength is lowered, and the insertion tip may be separated and remain in the living body during the operation.
[0008]
The present invention has been made to effectively solve the above problems, its object is to provide a manufacturing how the novel catheter tube to manufacture excellent easy quality .
[0009]
[Means for Solving the Problems]
In order to solve the above-mentioned problems, the present invention is a method in which a metal braid is continuously coated over the entire outer periphery of a tube body made of a thermoplastic resin into which a metal core wire is inserted, and a torque transmission portion is continuously formed. In addition, a laser beam having a wavelength of 1.06 μm is irradiated from the outside thereof, and a part of the braid is intermittently removed along its length direction, and an insertion tip having a constant width along the length direction of the tube body. Are formed at a predetermined interval, and then the metal core wire is removed, and then the tube body is divided into a plurality at the end of each insertion tip, and the insertion tip is provided at the tip of the torque transmission portion. The part is formed continuously.
[0010]
As a result, the metal braid can be easily and reliably removed, which effectively eliminates problems such as unraveling the quality of the braid end as in the conventional mechanical type and the need for large-scale processing equipment as in the chemical method. It is possible to avoid it.
[0011]
DETAILED DESCRIPTION OF THE INVENTION
Next, a preferred embodiment for carrying out the present invention will be described with reference to the accompanying drawings.
[0012]
FIG. 1 is a partially cutaway side view showing an embodiment of a catheter tube 1 according to the present invention, FIG. 2A is a sectional view taken along line AA, and FIG. 2B is a sectional view taken along line BB. is there.
[0013]
As shown in the figure, this catheter tube 1 has a structure in which an insertion tip 3 having high elasticity is continuously formed at the tip of a reinforced tube-shaped torque transmitting portion 2.
[0014]
As shown in FIG. 1 and FIG. 2 (A), the torque transmission portion 2 covers a metal braid 6 made of a metal strand 5 on the outside of a tube body 4 made of a thermoplastic resin, and further on the outside. The coating layer 7 is formed from a thermoplastic resin, and the metal braid 6 reinforces the entire tube body 4 to improve crushing and bending resistance, thereby exhibiting good torque transmission.
[0015]
On the other hand, as shown in FIG. 1 and FIG. 2 (B), the insertion tip 3 has a structure that does not have the metal braid 6 like the torque transmission part 2 and exhibits good elasticity and flexibility. It is supposed to be.
[0016]
Therefore, in the catheter tube 1 of the present invention having such a structure, the insertion tip 3 of the torque transmission part 2 is continuous from the torque transmission part 2 and the inner diameter and the outer diameter thereof are completely matched. Therefore, it is possible to exhibit excellent operability and insertability.
[0017]
Next, a method for manufacturing the catheter tube 1 of the present invention having such a structure will be described.
[0018]
First, as shown in FIG. 3, a tube body 4 is formed by coating a thermoplastic resin on the metal core wire 8, and then, as shown in FIG. 4, the braiding machine extends over the entire outside of the tube body 4. (Not shown) is used to coat the metal braid 6. The material of the metal wire 5 constituting the metal braid 6 is not particularly specified, and a known metal wire 5 can be used, but is preferably a stainless steel, titanium-nickel alloy or titanium. Alloy systems and alloy systems such as tin are suitable. The diameter of the metal core wire 8 to be used is not particularly limited as long as the cross-sectional shape is circular. Further, the thickness of the tube body 4 and the metal braid 6 is the same.
[0019]
Next, after the tube body 4 is passed through a heated mold and melted and softened, the inner side of the metal braid 6 is bitten into the outer peripheral surface of the tube body 4 and fixed, and then the wavelength from the outside of the tube body 4 is increased. A part of the metal braid 6 is intermittently removed at a plurality of points by a predetermined length, that is, the length of the insertion tip 3 by irradiating a laser beam of 1.06 μm or by electric discharge machining as shown in FIG. State as shown. In addition to the method described above as a method for fixing the metal braid 6, there is also a method for fixing the metal braid 6 by performing, for example, a water dispersion type PTFE dispersion coating baking process.
[0020]
Thereafter, a coating layer (not shown) made of a thermoplastic resin or the like is further coated on the outside of the tube body 4 to cover the entire metal braid 6, and then the metal core wire 8 is expanded and contracted to be pulled out from the tube body 4. After that, the tube body 4 is divided at the end portions of the metal braid removal portions as shown in FIG. 6, so that the insertion tip portion 3 having high elasticity is continuously formed at the tip portion of the torque transmission portion 2. The formed catheter tube 1 of the present invention is obtained.
[0021]
Here, when a part of the metal braid 6 is removed by irradiating a laser beam having a wavelength of 1.06 μm, the thermoplastic resin constituting the tube body 4 and the coating layer 7 described above has characteristics such as workability and corrosion resistance. For example, polytetrafluoroethylene (PTFE), polyethylene tetrafluoroethylene (ETFE), polyfluoroalkoxy fluororesin (PFA), tetrafluoroethylene hexafluoropropylene copolymer (FEP), vinylidene fluoride (PVDF) and the like that are not colored are used. That is, an uncolored fluororesin easily transmits laser light having a wavelength of 1.06 μm, so that the influence on the resin due to absorption of the laser light is reduced. The reason why the laser beam having a wavelength of 1.06 μm is used is that the metal braid 6 absorbs the laser beam and the metal strand 5 is instantaneously melted and removed. A laser having a wavelength of 1.06 μm is generally called a YAG laser and is not particularly defined. Furthermore, although various metal conductors can be used for the metal core wire 8, a gold or silver plated conductor is preferable. That is, gold and silver almost reflect the laser beam having a wavelength of 1.06 μm, and therefore, it is possible to eliminate the influence on the conductor by the laser beam transmitted through the resin.
[0022]
On the other hand, when part of the metal braid 6 is removed by electric discharge machining, the thermoplastic resin constituting the tube body 4 does not need to consider the transmission of laser light as described above. In addition, known resins such as polyurethanes, polyamides, polyamide elastomers, and ethylene tetrafluoroethylene that have been widely used in the past, for example, may be used, but fluororesins such as PTFE are used. This is because the frictional resistance is very low, so that the metal core wire 8 can be easily pulled out and the lubricity of the inner surface can be greatly improved. In the case of electric discharge machining, as described above, in particular, the metal braid 6, specifically, about 1/2 to 1/5 of the outer diameter of the metal strand 5 constituting the metal braid 6 is a tube body. It is important to bite into the outer peripheral surface of 4 and fix it. That is, when the metal braid 6 is intermittently removed by electric discharge machining, the remaining metal braid 6 is prevented from being loosened from the end portion. Here, if the biting depth is deeper than ½ of the diameter of the metal strand 5, removal by electric discharge machining becomes difficult and the thermal influence on the resin by electric discharge machining becomes large. This is because if the depth is less than 5, the remaining braid 6 removed by electric discharge machining is easily peeled off from the end portion. Further, in the case of this electric discharge machining, after forming the metal braid 6 as described above, the PTFE dispersion having a concentration of 10 to 40 wt% is coated on the metal braid 6 without biting into the tube body 4 side. Then, the electric discharge machining may be performed after fixing the outer surface of the braid 6 to the tube body 4 side in a state where about 40 to 70% is exposed. In this case, when the exposure degree is 40% or less, it is difficult to remove by electric discharge machining as in the case of biting, and the thermal influence on the resin by electric discharge machining is increased, and this is more than 70%. This is because the degree of exposure is so large that the remaining braid 6 removed by electric discharge machining is easily peeled off from the end portion. Furthermore, the PTFE dispersion concentration of 10-50 is intended to facilitate control of the degree of exposure of the braid 6 for the purpose of fixing the braid 6, and it is sufficient if the concentration is less than 10 wt%. This is because it is necessary to repeat the coating process in order to obtain the fixed amount and the braid exposure amount, and when the concentration is higher than 50 wt%, the braid 6 is likely to be buried and sufficient exposure cannot be obtained. .
[0023]
And according to such a manufacturing method of the present invention, only the braid can be satisfactorily removed without adversely affecting the resin constituting the tube body, and at the same time, the braid is removed from the end from which the braid is removed. Since the constituent metal wires are not loosened, a high-quality catheter tube can be obtained easily and reliably. In addition, since the method of the present invention can be easily performed by using a commercially available YAG laser device or an electric discharge machining device that can be obtained relatively easily, conventional large-scale equipment and labor are not required. Further, productivity can be improved and manufacturing cost can be reduced at the same time.
[0024]
Although the method of the present invention is for a catheter tube, it can be easily and efficiently cut by using a YAG laser for cutting the shield wire of the micro coaxial cable.
[0025]
【Example】
Hereinafter, specific examples will be described in order to demonstrate the method of the present invention.
[0026]
(Example 1)
After producing a tube body having a thickness of 0.03 mm by repeatedly applying and baking a non-colored water-dispersed PTFE dispersion on a metal core wire made of silver-plated annealed copper wire having an outer diameter of 0.6φ, A braid is formed by braiding a metal strand 16 (one holding) made of SUS strand of φ 0.03 mm at a pitch of 2.5, and further, a water dispersion type PTFE dispersion coating and baking treatment is performed on the braid. A 200 m tube was prepared. Thereafter, a twin head Q-switched YAG laser (manufactured by NEC; SL475H / HF) was used to irradiate the tube body with laser light having a wavelength of 1.06 μm at regular intervals (repetition of braiding removal length 300 mm, non-removal length 2500 mm). However, the braid of the irradiation section can be completely removed, and there is no problem such as loosening at the end of the braid.
[0027]
(Example 2)
After producing a tube body by extruding and coating uncolored perfluoroalkoxy fluororesin (PAT) with a thickness of 0.05 mm on a metal core wire made of silver-plated annealed copper wire with an outer diameter of 0.6φ, the surface of this tube body A metal strand 16 (one holding) made of SUS strand having a diameter of 0.03 mm was braided at a pitch of 2.5 to coat the braid to form a tube body having a length of 200 m. Thereafter, a twin head Q-switched YAG laser (manufactured by NEC; SL475H / HF) was used to irradiate the tube body with laser light having a wavelength of 1.06 μm at regular intervals (repetition of braiding removal length 300 mm, non-removal length 2500 mm). However, as in Example 1, the braid of the irradiated portion could be completely removed, and there were no problems such as loosening at the end of the braid.
[0028]
(Comparative Example 1)
A tube body was manufactured by extruding and coating a perfluoroalkoxy fluororesin (PAT) colored in red on a metal core wire made of silver-plated annealed copper wire with an outer diameter of 0.6φ in a thickness of 0.05 mm. A metal strand 16 (one holding) made of SUS strand of φ 0.03 mm on the surface was braided at a pitch of 2.5 to form a tube body having a length of 200 m by covering the braid. Thereafter, a twin head Q-switched YAG laser (manufactured by NEC; SL475H / HF) was used to irradiate the tube body with laser light having a wavelength of 1.06 μm at regular intervals (repetition of braiding removal length 300 mm, non-removal length 2500 mm). However, although the braid of the irradiated part could be completely removed, the PAT resin constituting the tube body was also melted at the same time, and the metal strands were exposed.
[0029]
(Example 3)
A tube body is manufactured by coating a polyamide elastomer (PEBAX5533) with a thickness of 0.10 mm on a metal core wire made of silver-plated annealed copper wire with an outer diameter of 1.04φ, and then heated on the surface of the tube body at 200 ° C. A braid is formed by braiding a metal strand 16 (one holding) made of SUS strands of φ 0.04 mm at a pitch of 4.5, and 1/3 of the braid is bitten into the tube body to a length of 200 m. The tube body was made. Then, using an electric discharge machine, arc discharge was performed at a constant interval (repetition of braid removal length 300 mm, non-removal length 2500 mm) with respect to this tube body, and the braid of the discharge part can be completely removed. Moreover, there was no problem such as loosening at the end of the braid.
[0030]
(Example 4)
A 0.03 mm thick tube body was manufactured by repeating water-dispersed PTFE dispersion coating and baking on a metal core wire made of silver-plated annealed copper wire with an outer diameter of 1.40 φ, and then φ0.04 mm on the surface of this tube body A braid is formed by braiding a metal strand 16 (one piece) made of SUS strands at a pitch of 2.5, and further, a water dispersion type PTFE dispersion coating and baking treatment with a concentration of 30 wt% is performed on the braid. A tube body having a length of 200 m, in which about 60% of the braid was exposed, was prepared. Thereafter, as in Example 3, arc discharge was performed at a constant interval (repeated braiding removal length 300 mm, non-removal length 2500 mm) with respect to the tube body using an electric discharge machining apparatus. In addition, it was possible to remove them, and there were no problems such as loosening at the end of the braid.
[0031]
(Comparative Example 2)
A 0.03 mm thick tube body was manufactured by repeating water-dispersed PTFE dispersion coating and baking on a metal core wire made of silver-plated annealed copper wire with an outer diameter of 1.40 φ, and then φ0.04 mm on the surface of this tube body A braid is formed by braiding a metal strand 16 (one piece) made of SUS strands at a pitch of 2.5, and further, a water dispersion type PTFE dispersion coating and baking treatment of a concentration of 65 wt% is performed on the braid. A tube body having a length of 200 m with the braid exposed by about 20% was prepared. Thereafter, as in Example 3, arc discharge was performed at a constant interval (repeated braiding removal length 300 mm, non-removal length 2500 mm) with respect to the tube body using an electric discharge machining apparatus. When removed, the PTFE resin constituting the tube body was burned by the heat, and a hole was formed even in the metal core wire.
[0032]
(Comparative Example 3)
A 0.03mm-thick tube body is manufactured by coating a polyamide elastomer (PEBAX5533) on a metal core wire made of silver-plated annealed copper wire with an outer diameter of 1.40φ, and then the surface of the tube body is heated while being heated at 200 ° C. A braid is formed by braiding a metal strand 16 (1 piece) made of SUS strand of φ 0.04 mm at a pitch of 4.5, and the braid is bitten into the 1/10 tube body side to a length of 200 m. The tube body was made. Thereafter, as in Example 3, arc discharge was performed at a constant interval (repeated braiding removal length 300 mm, non-removal length 2500 mm) with respect to the tube body using an electric discharge machining apparatus. Although it could be removed, the metal strands were scattered from the remaining braid ends.
[0033]
【The invention's effect】
In short, according to the present invention, it is possible to satisfactorily remove only the braid without adversely affecting the resin constituting the tube body, and at the same time, the metal strand constituting the braid from the end from which the braid is removed. Since no loosening occurs, a high-quality catheter tube can be obtained easily and reliably. In addition, since the method of the present invention can be easily performed by using a commercially available YAG laser device or an electric discharge machining device that can be obtained relatively easily, conventional large-scale equipment and labor are not required. In addition, it is possible to exert excellent effects such as improvement in productivity and reduction in manufacturing cost at the same time.
[Brief description of the drawings]
FIG. 1 is a partially broken side view showing an embodiment of a catheter tube according to the present invention.
FIG. 2A is a cross-sectional view taken along line AA in FIG.
(B) is BB sectional drawing in FIG.
FIG. 3 is an overall schematic view showing a state in which a tube body is formed on a metal core wire.
4 is an overall schematic view showing a state in which a metal braid is formed on the entire tube body shown in FIG. 3; FIG.
5 is an overall schematic view showing a state in which a part of the metal braid of the tube body shown in FIG. 4 is intermittently removed. FIG.
6 is an overall schematic view showing a state where a catheter tube is obtained by dividing the tube body shown in FIG. 5 into a plurality of parts.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Catheter tube 2 Torque transmission part 3 Insertion front-end | tip part 4 Tube body 5 Metal strand 6 Metal braiding 7 Coating layer 8 Metal core wire

Claims (5)

A metal braid is continuously coated over the entire outer periphery of a tube body made of a thermoplastic resin into which a metal core wire is inserted to continuously form a torque transmitting portion, and then a laser beam having a wavelength of 1.06 μm from the outside. Is formed by intermittently removing a part of the braid over its length direction and forming a plurality of insertion tip portions with a constant width over the length direction of the tube body at a predetermined interval, Then, after extracting the metal core wire, the tube body is divided into a plurality at the end of each insertion tip, and the insertion tip is continuously formed at the tip of the torque transmitting portion. method of manufacturing features and to Luke tape ether tube.   Examples of the thermoplastic resin include polytetrafluoroethylene (PTFE), polyethylene tetrafluoroethylene (ETFE), polyfluoroalkoxy fluororesin (PFA), tetrafluoroethylene hexafluoropropylene copolymer (FEP), vinylidene fluoride ( 2. The method for producing a catheter tube according to claim 1, wherein any one of PVDF) is used.   After continuously coating and forming a metal braid over the entire outer periphery of the tube body made of the thermoplastic resin into which the metal core wire is inserted, the tube body is heated and softened, and the braid is formed on the outer surface of the braid. The tube body is formed by entraining and fixing about 2 to 1/5 to continuously form a torque transmitting portion, and then removing a part of the braid intermittently over the length direction by electric discharge machining. After forming a plurality of insertion tip portions having a constant width over the length direction, the metal core wire is extracted and the tube body is divided into a plurality at the end portions of the insertion tip portions. A catheter tube manufacturing method, wherein the insertion tip is continuously formed at the tip of the torque transmission portion.   After continuously forming the metal braid over the entire outer periphery of the tube body made of the thermoplastic resin into which the metal core wire is inserted, the metal braid is exposed on the metal braid by about 40 to 70% of its thickness. Thus, a PTFE dispersion with a concentration of 10 to 50 wt% is coated and fixed to form a torque transmitting portion continuously, and then a part of the braid is intermittently spread over its length by electric discharge machining. After removing and forming a plurality of insertion tips with a predetermined width across the length of the tube body at a predetermined interval, the metal core wire is pulled out and the tube body is attached at the end of each insertion tip. A method for manufacturing a catheter tube, characterized in that the insertion tip is continuously formed at the tip of the torque transmitting portion by being divided into a plurality of portions.   The method for producing a catheter tube according to any one of claims 1 to 4, wherein a conductor plated with gold or silver is used as the metal core wire.

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