JP2007267963A - Core material for manufacturing catheter tube and its manufacturing method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To obtain a core material for manufacturing a catheter tube which stretches under a low load, hardly adheres to a resin, can be easily made straight, endures flaws, and is easy to manufacture, is suitable for use in manufacturing a catheter tube by extracting the core material after the cover layer of a resin is formed on the outside periphery of an inexpensive linear core material. <P>SOLUTION: The core material for manufacturing a catheter tube is formed of a wire whose basic material is an aluminum and having an aluminum oxide layer on the surface. Consequently, the aluminum is drawn into a long wire having a prescribed diameter (a), the wire material is softened by solution annealing (b), and successively is slightly hardened by aging (c) and then the surface hardness is increased by forming an aluminum oxide layer on the surface by anodic treatment (d). <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to the manufacture of a thin-walled, thin-diameter catheter tube that is introduced into a blood vessel or the like for treatment or examination, and in particular, after forming a resin coating layer on the outer periphery of a linear core material, the core material is pulled out. The present invention relates to a core material used for manufacturing a catheter tube and a manufacturing method thereof.

  As a method for manufacturing a thin or thin catheter tube for treatment or examination, for example, a copper wire is used as a core material, and a resin coating layer is formed on the outer periphery of the core material by extrusion or application, and then the core material is pulled out. A method of manufacturing a catheter tube is conventionally known (see, for example, Patent Documents 1 and 2).

  Conventionally, the core material used for manufacturing the catheter tube by this method has been generally silver-plated or tin-plated copper wire. The copper wire is soft and stretches with a low load to reduce its diameter, so that it is easy to pull out and easy to pull out by human power, and since it is soft, it is easy to produce straightness and is suitable as a core material for catheter tube production. However, since copper is unstable and easily oxidized, and oxidized copper is easily peeled off, if the core material is used as it is, oxidized copper may adhere to the inner surface of the coating layer that is a resin. In order to prevent this, Ag plating or tin plating is performed.

  More specifically, in this manufacturing method, after heat treatment and wire drawing are repeated using copper as a raw material to obtain a long wire (copper wire) having a predetermined wire diameter, the wire is subjected to predetermined conditions (temperature: 300 to 300). (400 ° C., time: about 10 min), and then the surface of the wire is subjected to silver plating or tin plating to obtain a silver plated copper wire or a tin plated copper wire. The diameter of the wire to be manufactured here is, for example, 0.46 mm, 0.76 mm, and 1.08 mm when the core material for manufacturing a guiding catheter for treatment is used. In the case of a core material, for example, it is 1.80 mm.

  Then, the silver-plated copper wire or tin-plated copper wire is used as a core material, and a resin is applied to the outer periphery thereof. The thickness of resin to apply is 20-30 micrometers, for example. The resin to be applied is PTFE (polytetrafluoroethylene), for example, in the case of a guiding catheter core, and is applied as a liquid by heating to about 400 ° C., and in the case of an angiographic catheter core, for example, nylon. And heated to about 200 ° C. and applied as a liquid.

  Then, a braided braided wire (round wire such as SUS or flat wire) is wound on the applied resin, and nylon (or urethane) is coated on the braided wire. The thickness of nylon (or urethane) to be applied is, for example, 50 to 60 μm.

  Thereafter, it is cut into a desired length while being straightened. The length to cut is 2 m, for example. Then, the resin at both ends of the cut core material is peeled off, one end is chucked and fixed, one end is pulled by human power, the core material is stretched to reduce the diameter, and the core material is pulled out by being peeled from the resin.

Japanese Patent Laid-Open No. 5-15601 JP-A-9-285545

  As described above, a resin coating layer is formed on the outer periphery of the core material, and then the core material used to manufacture the catheter tube by pulling the core material is conventionally made of silver-plated or tin-plated copper wire. Generally, the cost is high because silver plating or tin plating is required. Also, silver-plated copper wires and tin-plated copper wires are very soft and are easily scratched on the surface of the core material during handling. And since the scratch is concave, after the resin is applied to the core material, the inner surface of the catheter tube manufactured by removing the core material can form a convex bulge along the wound of the core material, which is a guide wire or the like. The problem of hindering smooth insertion arises.

  After forming a resin coating layer on the outer periphery of a linear core material, the present invention extends at a low load, hardly sticks to the resin, can be easily straightened, is not easily scratched, is easy to manufacture, and is inexpensive. Another object of the present invention is to provide a catheter tube manufacturing core material suitable for manufacturing a catheter tube by drawing out the core material, and a manufacturing method thereof.

  The core material for producing a catheter tube according to the present invention is a core material used for producing a catheter tube made of a resin by forming a resin coating layer on the outer periphery of a linear core material and then pulling out the core material. The base material is aluminum.

  This core material is made of aluminum and is soft and stretches with a low load. Therefore, it is easy to pull out, and since it is soft, straightness can be easily obtained. There are various methods for straight processing, such as rotary correction, roller correction, or solution treatment while applying tension. It can also be cut into a predetermined length while straightening. In addition, aluminum easily oxidizes, but the oxide is stable, hardly peeled off, and hardly adheres to the inner surface of the coating layer, which is a resin, when being pulled out. Therefore, Ag plating or the like is not necessary, manufacturing is simple, and the unit price is low.

  And this catheter tube manufacturing core material is good to form the aluminum oxide layer (alumina layer) on the surface. By forming the aluminum oxide layer on the surface of the core material using aluminum as a base material, the surface becomes hard (Hv450 to 500), and scratches are hardly scratched. The thickness of the aluminum oxide layer is about 5 to 10 μm. In this case, since the aluminum oxide layer is thin and stays on the extreme surface, the elongation (strength) is not affected.

  Further, the method for producing a core material for producing a catheter tube according to the present invention is used for producing a catheter tube made of resin by forming a resin coating layer on the outer periphery of a linear core material and then pulling out the core material. A method of manufacturing a wire material to be a core material, which is obtained by drawing aluminum into a wire material having a predetermined wire diameter, then subjecting the wire material to a solution treatment, and then anodizing the surface to form aluminum oxide A layer is formed. The treatment conditions for the solution treatment are preferably temperature: 450 to 520 ° C. and time: about 10 min. Moreover, sulfuric acid is suitable for the electrolyte solution used for anodizing treatment, for example.

  By this method, a core material for manufacturing a catheter tube having aluminum as a base material and an aluminum oxide layer on the surface can be easily manufactured.

  Moreover, in this manufacturing method, it is good to perform an aging treatment after the solution treatment. Aluminum is a very soft metal that tends to become hazy during handling. However, when it is aged after solution treatment, it becomes slightly harder and less likely to become habit, improving workability. The treatment conditions for the aging treatment are preferably temperature: 150 to 200 ° C. and time: 1 to 20 hours.

  As described above, according to the present invention, after the resin coating layer is formed on the outer periphery of the linear core material, the core material used for manufacturing the catheter tube by pulling the core material is stretched at a low load, and the resin It is difficult to stick, straightness can be easily achieved, manufacture is easy, and it can be made inexpensive. In particular, by forming an aluminum oxide layer on the surface of the core material, it can be made hard to be damaged. And, such a core material can be easily manufactured by solution treatment of an aluminum wire, and then anodizing treatment, and in particular, by aging treatment after solution treatment, it is difficult to get wrinkled, It can be made easy to handle.

  1 and 2 show an example of an embodiment of the present invention. FIG. 1 is an explanatory diagram (a) to (c) of a catheter tube manufacturing core material and a catheter tube manufacturing method using the core material, and FIG. 2 is an explanatory diagram of a manufacturing method of a catheter tube manufacturing core material.

  FIG. 1A shows a cross-sectional structure of a catheter tube manufacturing core material (hereinafter simply referred to as a core material) 1 of this embodiment. The core material 1 is made of an aluminum wire, and has an aluminum oxide layer (alumina layer) 1a on the surface. The diameter of the core material 1 is arbitrary, and in the case of a core material for manufacturing a guiding catheter for treatment, for example, 0.46 mm, 0.76 mm, and 1.08 mm, and an angiographic catheter for inspection is manufactured. In the case of the core material, for example, it is 1.80 mm. Moreover, the thickness of the aluminum oxide layer 1a is about 20-50 micrometers.

  As shown in FIG. 2, the core material 1 is manufactured by performing the processes a to d in the order of wire drawing, solution treatment, aging treatment, and anodizing treatment. The details of the manufacturing method are as follows.

  First, in step a of wire drawing, heat treatment and wire drawing (wire drawing) are repeated using aluminum as a raw material to produce a long wire having a predetermined wire diameter.

  In the solution treatment step b, the wire material having a predetermined wire diameter is subjected to a solution treatment under predetermined conditions (temperature: 450 to 520 ° C., time: about 10 min).

  Then, the wire material that has been softened by solution treatment is subjected to an aging treatment at a predetermined condition (temperature: 150 to 200 ° C., time: 1 to 20 hours) in the step c of the aging treatment.

  Thereafter, in step d of anodizing treatment, the wire is anodized in an electrolyte solution (for example, sulfuric acid) to form an aluminum oxide layer 1a having a thickness of 5 to 10 μm on the surface.

  The linear core material 1 manufactured in this manner is used to manufacture a catheter tube by forming a resin coating layer on the outer periphery and then withdrawing the core material 1. The details of the manufacturing method of the catheter tube are as follows.

  First, as shown in FIG. 1B, a resin is applied to the outer periphery of the core material 1 to form a resin coating layer 2a (inner layer). The thickness of the coating layer 2a (inner layer) is, for example, 20 to 30 μm. The resin to be applied is PTFE (polytetrafluoroethylene), for example, in the case of a guiding catheter core, and is applied as a liquid by heating to about 400 ° C., and in the case of an angiographic catheter core, for example, nylon. And heated to about 200 ° C. and applied as a liquid.

  Then, a braided blade wire 3 (round wire or flat wire such as SUS) is wound on the resin of the coating layer 2a (inner layer), and a resin (nylon or urethane) is applied on the blade wire 3, A coating layer 2b (outer layer) of resin (nylon or urethane) is formed. The thickness of the coating layer 2b (outer layer) is, for example, 50 to 60 μm.

  Then, it is straightened by a method such as rotary correction, roller correction, or a solution treatment while applying tension, and cut into a predetermined length (for example, 2 m) while straightening.

  Then, the resin of the covering layers 2a and 2b and the blade wire 3 at both ends of the cut core material 1 are peeled off, one end of the core material 1 is fixed by chucking, and the other end is pulled by human power, and the core material 1 is stretched and contracted. Diameter and pull out.

  In this way, a hollow catheter tube 4 made of the resin of the coating layers 2a and 2b and the blade wire 3 shown in FIG.

  In the core material 1 of this embodiment, the base material is aluminum, and since it is soft and stretches with a low load, it can be easily pulled out, and since it is soft, straightness can be easily obtained. Moreover, since the core material 1 has the aluminum oxide layer 1a on the surface, it is hard (Hv450-500) and is hard to be damaged. The aluminum oxide layer 1a remains on the pole surface and does not adversely affect the elongation (strength). Further, the aluminum oxide on the surface is difficult to peel off and hardly adheres to the inner surface of the coating layer 2a which is a resin when being pulled out. Further, although the core material 1 is aluminum, the core material 1 is slightly hard due to the aging treatment after the solution treatment, so that it is difficult to become habit and has good workability.

Table 1 shows the mechanical properties of aluminum (Al) and copper (Cu) related to tensile deformation and hardness after solution treatment. The solution treatment of aluminum was performed under the processing conditions of temperature: 450 to 520 ° C. and time: about 10 min. The solution treatment of copper was performed under the processing conditions of temperature: 300 to 400 ° C. and time: about 10 min. It is what I did.

  Aluminum after the solution treatment has an elongation at break: 20 to 30%, 0.2% proof stress: 50 to 100 MPa, strength at break: 150 to 200 MPa, hardness: Hv 80 to 90, and copper after the solution treatment has an elongation at break. : 40-60%, 0.2% proof stress: 250-300 MPa, breaking strength: 300-350 MPa, hardness: Hv 100-110. Aluminum after solution treatment has advantageous properties as a core material in that it has a 0.2% proof stress smaller than that of solution-treated copper, and can be pulled out and pulled out with a low load.

Table 2 shows the mechanical properties related to tensile deformation and hardness after further aging treatment of solution treated aluminum (Al). The aging treatment is performed under the treatment conditions of temperature: 150 to 200 ° C. and time: 1 to 20 hours.

  The aluminum after the aging treatment has elongation at break: 10 to 15%, 0.2% proof stress: 300 to 400 MPa, break strength: 400 to 500 MPa, and hardness: Hv 120 to 130. By aging the aluminum, it becomes a little harder, less wrinkled, and easier to handle. Moreover, although 0.2% yield strength of aluminum is increased by aging treatment, good pullability at low load is maintained to a degree that is slightly higher than 0.2% yield strength of copper after solution treatment.

  The aluminum after the aging treatment is formed with an aluminum oxide layer on the surface by anodic oxidation treatment, so that the surface hardness becomes Hv450 to 500 and is hardly scratched.

  As mentioned above, although an example of embodiment was demonstrated, this invention is not limited to this, It can implement in various aspects.

It is explanatory drawing (a)-(c) of the catheter tube manufacturing method using the core material for catheter tube manufacture of this Embodiment, and this core material. It is explanatory drawing of the manufacturing method of the core material for catheter tube manufacture of embodiment of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Core material for catheter tube production 1a Aluminum oxide layer 2a Coating layer (inner layer)
2b Coating layer (outer layer)
3 Braid wire 4 Catheter tube a Drawing process b Solution treatment process c Aging process d Anodizing process

Claims (4)

After forming a resin coating layer on the outer periphery of a linear core material, the core material is used to produce a catheter tube made of the resin by pulling out the core material, and the base material is aluminum. A core material for manufacturing a catheter tube. The core material for manufacturing a catheter tube according to claim 1, which has an aluminum oxide layer on the surface. A method for producing a wire material used as the core material, which is used to produce a catheter tube made of the resin by pulling out the core material after forming a resin coating layer on the outer periphery of a linear core material, comprising aluminum A wire having a predetermined wire diameter is drawn, and then the wire is subjected to a solution treatment, and then anodized to form an aluminum oxide layer on the surface. A method of manufacturing the material. 4. The method for producing a core material for manufacturing a catheter tube according to claim 3, wherein the aging treatment is performed after the solution treatment.

Images