JP2014100337A - Catheter tube manufacturing method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a catheter tube manufacturing method capable of efficiently manufacturing catheter tubes whose diameters are varied according to portions.SOLUTION: A catheter tube manufacturing method for a catheter tube 10 comprises: an internal coat layer body forming step of forming an internal coat layer body 51 by applying a coat of a resin onto a unit core wire 47 which has a large diameter part 41 and a small diameter part 42 of different external diameters already been formed; a joining step, following the internal coat layer body forming step, of joining a plurality of unit core wires arranged in a radial line direction; an intermediate step, following the joining step, of disposing another member on or applying predetermined processing to a structure obtained on a core wire 40 formed by joining of the unit core wires 47; a cutting step, following the intermediate step, of cutting, together with the core wire 40, the structure obtained on the core wire 40, at a predetermined position of the large diameter part 41 and small diameter part 42 of the core wire 40, into a plurality of discrete tubes 61; and a core wire removing step of removing the core wire 40 from the discrete tubes 61.

Description

  The present invention relates to a method for manufacturing a catheter tube used for a catheter used in a lumen such as a blood vessel or a body cavity.

  In recent years, treatment in a lumen such as a blood vessel or a body cavity using a catheter has been actively performed for the reason that surgical invasion is very low. For example, catheters that are selectively introduced into complex branched blood vessels in the body are typically selectively pushed along a guide wire that is pre-introduced into the blood vessel to provide therapeutic drugs and diagnostics. The contrast agent for use is distributed from the proximal side (base end side) to the distal end side. For this reason, the long catheter tube constituting the catheter increases the rigidity of the proximal end by increasing the inner and outer diameters on the proximal end side, while maintaining sufficient pushability (pushability). By ensuring the injection characteristics and making the inner and outer diameters on the distal end side thinner than the proximal end side and making it flexible, the reachability to the peripheral blood vessels and the followability to the guide wire are enhanced.

  As a method for manufacturing such a catheter tube, for example, in Patent Document 1, a thermoplastic resin is coated and molded on a core wire in which a large diameter portion and a small diameter portion are continuous at a predetermined interval, and a plurality of catheter tubes are used. A method is described in which a tube is formed as a continuous body on the same core wire, the continuous body is cut together with the core wire for each catheter tube, and then the core wire is pulled out and removed to produce a catheter tube.

JP 2008-183226 A

  In the method described in Patent Document 1 described above, a plurality of catheter tubes are formed as a continuous body on the same core wire, and finally the core wire is cut. When the core wire is cut, it is formed on the core wire after cutting. When it is desired to perform processing or treatment on each catheter tube to be processed, it is necessary to carry out processing one by one, and the manufacturing efficiency is lowered.

  The present invention has been made to solve the above-described problems, and an object of the present invention is to provide a catheter tube manufacturing method capable of efficiently manufacturing catheter tubes having different diameters depending on the site.

  A manufacturing method of a catheter tube that achieves the above-described object includes a covering body forming step of forming a covering body by coating a resin on a unit core wire in which a large diameter portion and a small diameter portion having different outer diameters are formed in advance, After the covering body forming step, a joining step of arranging a plurality of the unit core wires in the axial direction and joining them, and a structure obtained on the core wire formed by joining the unit core wires after the joining step, An intermediate step of arranging a member or performing a predetermined treatment, and after the intermediate step, a structure obtained on the core wire is cut together with the core wire at a predetermined position of the large diameter portion and the small diameter portion of the core wire. It is the manufacturing method of the tube for catheters which has the cutting process which cuts out a some single tube, and the core wire removal process which removes the said core wire from the said single tube.

  In the method for manufacturing a catheter tube configured as described above, after forming a covering on a unit core wire having a large diameter portion and a small diameter portion, the unit core wires are aligned and joined in the axial direction, and the unit core wires are joined. Since the intermediate step is performed using the core wire, the intermediate step can be efficiently performed using the continuous core wires, and the catheter tube having a different diameter depending on the part can be efficiently manufactured.

  In the covering body forming step, a resin is coated on the core wire on which the unit core wires are continuously formed to form a covering body, after the covering body forming step and before the joining step, If it has further the parting process which divides the said core wire for every said unit core wire, after forming a covering efficiently using the core wire which a unit core wire continues continuously, a core wire is parted and a unit core wire is obtained. be able to.

  By further including a reinforcing body forming step for forming a reinforcing body made of a wire material on the radially outer side of the covering body after the covering body forming step and before the dividing step, the unit core wire Can be obtained by efficiently forming a reinforcing body using a continuous core wire, and then dividing the core wire to obtain a unit core wire. Alternatively, if a reinforcing body forming step for forming a reinforcing body made of a wire rod is formed on the radially outer side of the covering body after the dividing step, the unit core wire is divided without being continuously connected. Since a reinforcing body can be formed every time, it is possible to form a reinforcing body using various methods, and it is possible to form reinforcing bodies of more various materials, characteristics, or shapes, and the degree of freedom in design is improved. .

  If it further includes an outer layer covering body forming step of forming an outer layer covering body by coating a resin radially outside of the covering body after the dividing step and before the joining step, Since the outer layer covering is formed for each unit core wire that is divided instead of the continuous core wires, the outer layer covering can be formed by using various methods, and the outer layer coverings of various materials, characteristics, or shapes can be formed. The body can be formed, and the degree of freedom in design is improved.

  If the intermediate step includes an outer layer covering body forming step in which an outer layer covering body is formed by coating a resin on the outer side in the radial direction from the covering body, a continuous core wire is formed by joining unit core wires. Thus, the outer layer covering can be formed efficiently.

  If the intermediate step includes a hydrophilic covering forming step of forming a hydrophilic covering by coating a hydrophilic material radially outside the covering, the unit core wires are continuously joined. A hydrophilic covering can be efficiently formed using a continuous core wire.

  If the intermediate step has an end portion forming step for giving a predetermined shape to a portion constituting the end portion in the catheter tube, a unit core wire is joined and continuously used. The shape of the end of the catheter tube can be formed efficiently.

It is a top view which shows a catheter. It is sectional drawing which shows the tube for catheters manufactured by the manufacturing method of the tube for catheters concerning embodiment. It is the schematic for demonstrating the manufacturing method of the catheter tube which concerns on embodiment to process order, (A) is a core wire preparation process, (B) is an inner layer covering body formation process, (C) is a reinforcement body formation process, ( D) shows a reinforcing body removing step, (E) shows a marker placement step, (F) shows a dividing step, and (G) shows an outer layer covering forming step. It is the schematic for demonstrating the manufacturing method of the catheter tube which concerns on embodiment to process order, (A) is a joining process, (B) is an edge part formation process, (C) is a hydrophilic covering body formation process, ( D) shows a base end connecting member attaching step, (E) shows a cutting step, and (F) shows a core wire drawing step and a core wire removing step. It is the schematic for demonstrating the method of forming a layer by extrusion molding. It is the schematic for demonstrating the method of forming a layer by dip molding. It is the schematic for demonstrating the method of forming a layer using a heat contraction tube. It is the schematic for demonstrating the method of coat | covering a hydrophilic coating body by dip molding. It is a top view which shows the modification of a core wire. It is a top view which shows the other modification of a core wire.

  Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

  A catheter tube 10 manufactured by the catheter tube manufacturing method according to the present embodiment is inserted into a blood vessel, bile duct, trachea, esophagus, urethra, or other living body lumen or body cavity as shown in FIG. It is used for the catheter 1 for performing treatment and diagnosis. The catheter 1 includes a long catheter tube 10, a hub 20 connected to the proximal end of the catheter tube 10, and a kink protector 30 provided at a connection portion between the catheter tube 10 and the hub 20. ing. In this specification, the side to be inserted into the lumen is referred to as “tip” or “tip side”, and the proximal side to be operated is referred to as “base end” or “base end side”.

  As shown in FIGS. 1 and 2, the catheter tube 10 is a tubular member having flexibility, a tube base end portion 11 having a predetermined outer diameter and an inner diameter, and an outer diameter smaller than the tube base end portion 11. And a tube transition portion 13 in which the outer diameter and the inner diameter gradually change in the axial direction between the tube proximal end portion 11 and the tube distal end portion 12. The catheter tube 10 has a lumen 14 formed from the proximal end to the distal end. The lumen 14 functions as a guide wire lumen, for example, and the guide wire is inserted when the catheter 1 is inserted into the living body lumen. The lumen 14 can also be used as a passage for a chemical solution, an embolic material, a contrast medium, or the like.

  The catheter tube 10 is composed of a plurality of layers, an inner layer 15 constituting the innermost layer, a reinforcing layer 16 formed outside the inner layer 15, and an outer layer formed outside the inner layer 15 and the reinforcing layer 16. 17, a hydrophilic layer 18 that covers the outer side of the outer layer 17, and a marker 19. The distal end side of the tube distal end portion 12 is removed from the reinforcing layer 16 in order to ensure flexibility on the distal end side of the catheter tube 10. The most distal end portion 12A is formed on the distal end side of the tube distal end portion 12, the most proximal end portion 11A is formed on the proximal end side of the tube proximal end portion 11, and the most distal end portion 12A of the tube distal end portion 12 is In order to reduce the influence on the living tissue as much as possible when it is inserted into the living body lumen or body cavity, it is rounded into a curved shape. Further, taper processing may be performed instead of R processing. In addition, the structure and material of the inner layer 15, the reinforcement layer 16, the outer layer 17, and the hydrophilic layer 18 are demonstrated in detail by the manufacturing method mentioned later.

  In the hub 20, the proximal end portion of the catheter tube 10 is fixed in a liquid-tight manner by an adhesive, heat fusion, a stopper (not shown) or the like. The hub 20 functions as an insertion port for a guide wire into the lumen 14, an injection port for a drug solution, an embolic material, a contrast medium, etc. into the lumen 14, and also functions as a grip portion when operating the catheter 1. To do. Although the material of the hub 20 is not particularly limited, for example, a thermoplastic resin such as polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer can be suitably used.

  The kink protector 30 is made of an elastic material provided so as to surround the circumference of the catheter tube 10, and suppresses kinking of the catheter tube 10 at a connection portion between the catheter tube 10 and the hub 20. As a material for the kink protector 30, for example, natural rubber, silicone resin, or the like can be preferably used.

  Next, a method for manufacturing the catheter tube 10 according to the present embodiment will be described. The catheter tube 10 includes a core wire preparation step (FIG. 3A) for preparing a long core wire 40, and an inner layer cover body formation step (cover body formation) for forming an inner layer cover body 51 (cover body) on the core wire 40. Step) (FIG. 3B), a reinforcing body forming step for forming the reinforcing body 52 on the inner layer covering body 51 (FIG. 3C), and a reinforcing body removing step for removing a part of the reinforcing body 52 (FIG. 3 (D)), a marker placement step (FIG. 3 (E)) for placing the marker 19 on the reinforcing body 52, and a structure for dividing the structure obtained on the core wire 40 at a predetermined position of the core wire 40. Step (FIG. 3 (F)), outer layer covering body forming step (FIG. 3 (G)) in which the reinforcing body 52 and the inner layer covering body 51 are integrally covered to form the outer layer covering body 53, and the core wire 40 is divided. A joining step (FIG. 4 (A)) for joining the unit core wires 47 thus formed, and a catheter. End forming step (FIG. 4B) for imparting the shapes of the most distal end portion 12 </ b> A and the most proximal end portion 11 </ b> A, and a hydrophilic covering forming step for covering the hydrophilic covering 54 (FIG. 4). (C)), a base end connecting member mounting step (FIG. 4D) for mounting the hub 20 (base end connecting member), and a structure obtained on the core wire 40 is cut at a predetermined position of the core wire 40. A cutting step (FIG. 4 (E)) for cutting out the single tube 61, a core wire drawing step (FIG. 4 (F)) for drawing the core wire 40, and a core wire removing step (FIG. F)). The inner layer covering body 51, the reinforcing body 52, the outer layer covering body 53, and the hydrophilic covering body 54 formed on the core wire 40 are finally the inner layer 15, the reinforcing layer 16, the outer layer 17, and the hydrophilic layer 18 of the catheter tube 10. It becomes.

  A process performed after the joining process (FIG. 4A) and before the cutting process (FIG. 4E) is generally referred to as an intermediate process. An intermediate process is a process of arrange | positioning another member or giving a predetermined process to the structure obtained on the core wire 40 after the unit core wire 47 is joined.

  As shown in FIG. 3 (A), the core wire preparation step is performed by mechanical processing such as drawing, drawing, or the like using a cutting die, cutting, polishing, grinding, forging, welding, split die, or chemical processing such as etching. , A step of processing to have the large-diameter portion 41, the small-diameter portion 42, and the transition portion 43, or a step of preparing the core wire 40 subjected to the above-described processing by purchase or the like.

  The core wire 40 prepared in the core wire preparation step includes a large diameter portion 41 having a predetermined outer diameter, a small diameter portion 42 having an outer diameter smaller than the large diameter portion 41, and between the large diameter portion 41 and the small diameter portion 42. A plurality of transition portions 43 whose outer diameters gradually change in the axial direction of the core wire 40 are arranged side by side. The ratio of the outer diameter D1 of the large diameter portion 41 to the outer diameter D2 of the small diameter portion 42 (D1 / D2) is preferably more than 1.00 and 1.31 or less, more preferably 1.30 or less. More preferably 1.22 or less. The ratio (D1 / D2) is greater than 1. When the ratio (D1 / D2) is 1.31 or less, not only the small-diameter portion 42 but also the large-diameter portion 41 is satisfactorily stretched in the core wire stretching step, and the thinning of only the small-diameter portion 42 is suppressed. The core wire 40 can be removed well in the removing step, and the catheter tube 10 that can withstand actual use can be manufactured. If the ratio (D1 / D2) is 1.22 or less, the thinning of only the small-diameter portion 42 is more reliably suppressed, and the core wire 40 can be more reliably removed in the core wire removing step. The catheter tube 10 can be manufactured. As an example, the length L1 of the large diameter portion 41 is 1800 mm, the length L2 of the small diameter portion 42 is 150 mm, the length L3 of the transition portion 43 is 50 mm, and the outer diameter D1 of the large diameter portion 41 is 0.55 to. Although the outer diameter D2 of 6 mm and the thin diameter part 42 can be 0.45-0.50 mm, a dimension is not limited to this.

  The material of the core wire 40 can be a metal such as a copper wire or a stainless steel soft wire, or a resin strand such as polyamide (PA), and the cross section is not limited to a circle, but can be any shape such as an ellipse, a semicircle, a polygon, etc. It can be made into the shape. The core wire 40 as described above can be easily prepared by purchase or the like.

  After the core wire preparation step, as shown in FIG. 3 (B), an inner layer covering 51 is formed on the core wire 40 (inner layer covering forming step). As the material of the inner layer covering 51, a thermoplastic resin, a thermosetting resin, or the like can be applied, and a low friction material such as a fluorine-based resin or high-density polyethylene (HDPE) is preferable.

  The inner layer covering 51 may be mixed with a radiopaque material. When the inner layer covering 51 is formed of a low friction material such as a fluororesin, the outer surface of the inner layer covering 51 is roughened by chemical etching or the like so that other materials can be covered on the outer side. It is preferable to perform the treatment.

  When a thermoplastic resin is used as the material of the inner layer covering 51, it can be extruded at a predetermined take-up speed at a predetermined molding temperature (die temperature) with an extruder. Thereby, the extrusion molding (inner layer covering 51) of substantially the same thickness can be obtained. As an example, the outer diameter of the inner layer covering 51 in the portion corresponding to the large diameter portion 41 is 0.57 to 0.76 mm, and the outer diameter of the inner layer covering 51 in the portion corresponding to the small diameter portion 42 is 0.47 to 0. 0.53 mm, but the dimensions are not limited to this. In addition, by adjusting the take-up speed, the wall thickness can be changed according to the part.

  An outline of the extrusion molding method is as follows. Using a general extruder 100 as shown in FIG. 5, a thermoplastic resin layer (here, inner layer covering 51) is formed on the core material W (here, the core wire 40). ). The extrusion molding machine 100 includes an extruder 101 for extruding the heated and melted material, a mold 103 for extruding the resin extruded from the extruder 101 from the extrusion port 102, and a position passing through the mold 103 at the center of the extrusion port 102. A take-up machine 105 for picking up the core material W to be wound, a supply roll 106 for supplying the core material W to the mold 103 while the core material W is wound and held, and a recovery for recovering the core material W that has been extruded. A roll 107. When extruding a material onto the core material W, the material heated and melted by the extruder 101 is supplied to the mold 103, and sent from the supply roll 106 to take out the core material W located at the extrusion port 102. The material is continuously supplied from the extrusion port 102 onto the core material W while being taken up by 105, and the material is coated on the core material W. The core material W coated with the material is wound around the collection roll 107 and collected after the coated material is solidified. By changing the take-up speed by the take-up machine 105, the outer diameter of the extruded product can be arbitrarily changed. If the core material W is directly received from the previous process and the core material W coated with the thermoplastic resin is directly transferred to the subsequent process, the supply roll 106 and the recovery roll 107 may not be provided. In the extrusion molding of the inner layer covering 51, when a fluororesin (such as PTFE) is used as the resin, it is possible to extrude a mixture of resin powder with a fluorolubricant as an auxiliary agent.

  In the inner layer covering body forming step, the inner layer covering body 51 may be formed by dip molding, not by extrusion molding. The method by dip molding will be outlined. First, in a container 200 as shown in FIG. 6, a solution R in which a resin as a material is dissolved in a solvent or a dispersion R in which a dispersion R is dispersed in a diluent is accommodated. Supply roll on which the core material W is wound and held via a flexible valve body 201 through which the core material W (here, the core wire 40) can be inserted while maintaining liquid tightness. The core material W is supplied from 202, and the core material W is inserted into the container 200 from below. Then, after the core material W is dipped (immersed) in the solution R or dispersion R in the container 200, the core 200 is pulled out above the container 200. As a result, the solution R or dispersion R is adhered to the outer peripheral surface of the core material W, and the solution R or dispersion R adhered to the core material W is heated and dried with hot air, a heater, etc. When the dispersion R is used, the inner layer covering 51 is formed by further sintering. The core material W coated with the material is wound around the collection roll 203 and collected after the coated material is solidified. As the solvent and diluent, those usually used can be applied. By changing the pulling speed from the container 200, the film thickness of the solution R or the dispersion R attached to the core material W can be arbitrarily changed, and the thickness of the inner layer covering 51 can be arbitrarily changed. The film thickness is determined by the interaction of the density, surface tension, viscosity, gravity and pulling speed of the solution R or dispersion R. When the pulling speed from the container 200 is decreased, the solution R attached to the core W is reduced. Alternatively, the film thickness of the dispersion R can be increased, and when the pulling rate is increased, the film thickness of the solution R or the dispersion R attached to the core material W can be decreased. For example, the film thickness of the part corresponding to the small diameter part 42 can be made thinner than the large diameter part 41, and the film thickness of the part corresponding to the transition part 43 can be gradually changed.

  Also, if the viscosity of the solution R or dispersion R is high, the coating thickness tends to be non-uniform, so the viscosity is set low enough to make the coating film thickness uniform, and dip molding is repeated multiple times. Thus, the coating thickness can be gradually increased, and the coating thickness can be controlled with high accuracy. When the dip molding is repeatedly performed, the recovery roll 203 from which the core material W coated with the material is recovered can be moved below the container 200 to be the supply roll 202, and the dip molding can be performed again. When the dip molding is repeated, it is preferable to dry and sinter the solution R or the dispersion R by heating with hot air or a heater every time.

  Further, when the dip molding is repeated a plurality of times, it is preferable that the dip molding is performed at least once in the opposite direction, rather than the dip molding by pulling up in the same direction of the core wire 40, more preferably once. It is preferable to perform dip molding while changing the direction one by one. By dipping from the opposite direction at least once, the film thickness can be made uniform by suppressing the unevenness of the film thickness depending on the pulling direction. The thickness deviation can be suppressed to the maximum and the film thickness can be made more uniform. In particular, in the core wire 40 whose outer diameter changes, the thickness 40 depending on the pulling direction is likely to occur in the portion where the outer diameter changes, so the core wire 40 in which the large diameter portion 41 and the small diameter portion 42 are formed. When the dip molding is performed, the dip molding is performed at least once from the opposite direction, so that a high effect can be achieved in making the film thickness uniform.

  In addition, although it can dry and sinter for every step of dip forming, it can also be dried and sintered after dip forming continuously several times without drying and sintering. Thus, the thickness in a desired part can be finely set by carrying out the dip molding continuously several times without drying and sintering.

  Further, when the dip molding is repeatedly performed, the number of repetitions can be changed according to the portion of the core wire 40. As an example of a method for this purpose, the portion where the number of repetitions is to be increased is pulled up, the solution R or dispersion R coated on the portion is dried and sintered, and then the core wire 40 that has moved upward is moved downward. And the part where the number of repetitions is to be increased is immersed in the solution R or the dispersion R. Thereafter, the core wire 40 is again moved upward, and the part where the number of repetitions is desired to be increased is again pulled up, so that the solution R or the dispersion R can be further coated. By repeating this, dip molding can be performed a desired number of repetitions according to the site. In this way, the number of repetitions of dip molding can be set as appropriate according to the site while switching the moving direction of the core wire 40. Therefore, for example, the number of repetitions of dip molding can be set so that transition portion> large diameter portion> small diameter portion or large diameter portion> transition portion> small diameter portion. A> B means that the number of repetitions in A is larger than the number of repetitions in B. Of these, it is preferable to perform dip molding so that the number of repetitions is maximized at the transition portion, because the thickness at the transition portion can be variably changed. Even in this method, drying and sintering can be performed for each step of dip molding, but drying and sintering may be performed after dip molding multiple times in succession without drying and sintering. .

  In addition, the core 40 is not moved, but the depth is changed by changing the amount H of the solution R or dispersion R shown in FIG. (Downward) can also be adjusted.

  In addition, the core material W is lifted from the container 200 while being rotated about the axis of the core material W, so that centrifugal force is applied to the solution R or dispersion R coated on the core material W to be coated. Can be arbitrarily changed. That is, the higher the rotational speed of the core material W, the greater the centrifugal force that acts, so that the film thickness of the solution R or dispersion R coated on the core material W can be reduced. The slower the centrifugal force acting, the more the film thickness of the solution R or dispersion R coated on the core material W can be increased. For example, by increasing the rotational speed at the time of pulling up the small diameter portion 42 rather than at the time of pulling up the large diameter portion 41, the film thickness covered by the small diameter portion 42 is changed to the film thickness covered by the large diameter portion 41. Can be made thinner. And when pulling up the transition part 43, the film thickness in the transition part 43 is changed smoothly and incline between the large diameter part 41 and the small diameter part 42 by changing the rotational speed of the core wire 40 gradually. be able to. Thereby, the distal end side of the manufactured catheter tube 10 can be made more flexible than the proximal end side. In addition, the larger the outer diameter of the core wire 40, the greater the centrifugal force that acts. Therefore, in order to make the film thickness of the solution R or dispersion R to be coated constant, the rotational speed is adjusted at the portion where the outer diameter changes. It is also possible to do.

  In the present embodiment, since the core material W is supplied from the supply roll 202 and is recovered by the recovery roll 203, the supply roll 202 and the recovery roll 203 can be rotated about the axis of the core material W in the container 200. However, the configuration of the apparatus is not limited as long as the core material W in the container 200 can be rotated.

  Further, when the core material W is pulled up from the container 200 while rotating, if a mixture of particles, fibers, and the like is mixed in the solution R or the dispersion R, the mixture can be oriented.

  When the dip forming is repeated a plurality of times while rotating, it is preferable to perform the dip forming while rotating the core wire 40 in the same direction each time instead of rotating at least once. It is preferable to perform dip molding while reversing the direction. By performing dip molding while rotating in reverse at least once, the film thickness can be made uniform by suppressing the deviation of film thickness depending on the rotation direction, and by rotating the rotation direction by changing the rotation direction one by one. The film thickness deviation depending on the thickness can be suppressed to the maximum, and the film thickness can be made more uniform.

  When it is desired to reduce the film thickness of the solution R or the dispersion R coated on the core material W, it is necessary to slow the pulling speed if it is controlled by the pulling speed. If it is controlled by speed, it can be adjusted by increasing the rotational speed without slowing the pulling speed, so that the manufacturing time can be shortened.

  Thus, the viscosity of the solution R or the dispersion R, the pulling speed, the pulling direction, the pulling site, the liquid amount of the solution R or the dispersion R (depth in the container 200), the number of repetitions of dip molding, the rotation speed, and By adjusting the rotation direction, the coating thickness and manufacturing time of the inner layer covering 51 to be coated can be controlled with high accuracy.

  In addition, if the inner layer covering 51 can be dip-molded, the container 200 does not have to be as described above. For example, the core material W is not inserted through the bottom of the container 200 but from above the container. May be dipped (immersed) in the solution R or the dispersion R, and the core material W may be curved and pulled up again. Further, after the solution R or the dispersion R is attached to the outer peripheral surface of the core material W, the amount of the solution R or the dispersion R to be attached is regulated by passing through a die (not shown) having a predetermined inner diameter. Thus, the outer diameter of the inner layer covering 51 can be adjusted. Further, if the core material W is directly received from the previous process and the core material W coated with the material is directly transferred to the subsequent process, the supply roll 202 and the recovery roll 203 around which the core material W is wound are not provided. May be.

  Further, the method for forming the inner layer covering 51 in the inner layer covering forming step is not limited to extrusion molding or dip molding. For example, a solution in which a resin is dissolved in a solvent or a dispersion in which a dispersion is dispersed in a diluent is sprayed. (Spray), application, printing, etc., after attaching to the core wire 40, the solution or dispersion attached to the core wire 40 is heated and dried with hot air or a heater, and depending on the material, it may be sintered. The inner layer covering 51 may be formed.

  After the inner layer covering body forming step, as shown in FIG. 3C, the reinforcing body 52 is formed so as to cover at least a part on the inner layer covering body 51 (reinforcing body forming step).

  The reinforcing body 52 is formed on the inner layer covering body 51 by continuously winding a strand with a braid having a predetermined interstitial distance. The reinforcing body 52 may be wound with strands while changing the winding direction, such as horizontal winding in the same direction, right-hand winding, left-hand winding, etc., and the winding pitch, interstitial distance, inclination angle with respect to the circumferential direction, etc. The configuration may be changed, and the configuration is not particularly limited.

  As the strands used for the reinforcing body 52, metal wires such as platinum (Pt) / tungsten (W), resin fibers, carbon fibers, glass fibers and the like can be applied, or a plurality of these strands may be used in combination. .

  After the reinforcing body forming step, as shown in FIG. 3D, a part of the reinforcing body 52 at a portion corresponding to the small diameter portion 42 is removed (reinforcing body removing step). The parts to be removed are set at predetermined intervals corresponding to the distal end side to which the flexibility of the tube distal end portions 12 of the plurality of catheter tubes 10 to be finally produced is desired. The removal of the reinforcing body 52 can be performed by electrochemical treatment using electrolysis, chemical treatment using chemicals such as acid, mechanical treatment using a cutter, or optical treatment using a laser. In addition, the site | part to remove may remove not only the site | part corresponding to the front end side of the tube front-end | tip part 12 of the tube 10 for catheters finally manufactured but another site | part.

  After the reinforcing body forming step, as shown in FIG. 3E, the radiopaque marker 19 is placed on the inner layer covering 51 (marker placing step). The marker 19 is arranged by winding a wire formed of a material containing an X-ray opaque material from a radially outer side of the core wire 40 around a portion corresponding to the small diameter portion 42. Thus, by arranging the marker 19 from the outside in the radial direction of the core wire 40, even if the target to which the marker 19 is attached has a continuous shape before being cut, it can be easily arranged. As the material of the marker 19, a material in which an X-ray contrast agent such as metal powder of platinum, gold, silver, tungsten, or an alloy thereof, barium sulfate, bismuth oxide, or a coupling compound thereof is kneaded can be applied. The outer diameter of the wire constituting the marker 19 is, for example, about 30 to 50 μm, but is not particularly limited as long as it has radiopacity.

  In the present embodiment, only one marker 19 is provided in a portion corresponding to the small diameter portion 42, but a plurality of markers 19 may be provided in the small diameter portion 42. In addition, the marker 19 may not be provided in the portion corresponding to the small diameter portion 42, and one or a plurality of markers may be provided in the portion corresponding to the large diameter portion 41. Moreover, a marker may be provided on both the small diameter portion 42 and the large diameter portion 41. By providing a plurality of markers, it becomes possible not only to observe the position by X-rays from outside the body, but also to measure the length using the markers as scales.

  After the marker installation step, as shown in FIG. 3 (F), the structure obtained on the core wire 40 is cut together with the core wire 40 at a predetermined dividing portion 46 of the core wire 40 (cutting step). The dividing part 46 is provided in a range corresponding to a later-described surplus tube 62 (see FIG. 4E) to be finally removed. Thus, the core wire 40 is cut into a plurality of unit core wires 47 each having a large diameter portion 41 and a small diameter portion 42.

  In the dividing step, cutting is performed with a cutting blade by a shearing machine or the like, for example, but any cutting method may be used as long as the core wire 40 and the tubular continuous body 60 can be cut.

  After the dividing step, as shown in FIG. 3G, on the outer surface of the structure formed on each unit core wire 47, at least a part of the marker 19 and the reinforcing body 52 is coated to cover the outer layer. The body 53 is formed (outer layer covering body forming step). As an example, the outer diameter of the outer layer covering 53 in a portion corresponding to the large diameter portion 41 is 0.8 mm to 1.1 mm, and the outer diameter of the outer layer covering 53 in a portion corresponding to the small diameter portion 42 is 0.6 mm to 1. 0.0 mm. The outer diameter of the outer layer covering 53 at the portion corresponding to the transition portion 43 gradually changes and is 0.6 mm to 1.1 mm. The dimensions are not limited to this.

  The material of the outer layer covering 53 is, for example, polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, etc. A thermoplastic resin such as a polyamide, a polyester elastomer, a polyamide elastomer, a polyurethane, a polyurethane elastomer, polyimide, a fluororesin, or a mixture thereof, or a thermosetting resin such as an epoxy resin can be applied. The outer layer covering 53 may be mixed with a radiopaque material.

  In the outer layer covering forming process, first, as shown in FIG. 7A, a plurality of (this embodiment) are divided in the axial direction on the radially outer side of each unit core wire 47 to form one cylindrical shape as a whole. Then, three covering members 70A, 70B, and 70C are covered. The covering members 70 </ b> A, 70 </ b> B, 70 </ b> C are materials that become the outer layer covering 53. Since the continuous core wires 40 are cut into a plurality of unit core wires 47 by the dividing step, each of the unit core wires 47 can be easily covered with the covering members 70A, 70B, and 70C. The covering members 70 </ b> A, 70 </ b> B, 70 </ b> C have an inner diameter larger than the outer diameter of the single tube 61, and can be easily put on the single tube 61. By forming the outer layer covering 53 using the plurality of covering members 70A, 70B, and 70C, it becomes possible to easily vary the respective materials, shapes, and characteristics, and it is possible to manufacture various catheter tubes 10. Become.

  Next, as shown in FIG. 7B, the shape memorized by heating the coating members 70A, 70B, 70C on the radially outer side so as to cover the coating members 70A, 70B, 70C. A shrinkable heat shrinkable tube 71 is placed. The heat shrinkable tube 71 is, for example, a fluorine resin.

  Next, as shown in FIG. 7C, the heat-shrinkable tube 71 is contracted while being heated or heated by a heat source (not shown) such as hot air or a heater to soften or melt the covering members 70A, 70B, 70C. The covering members 70A, 70B, and 70C are pressed by the contraction force of the heat-shrinkable tube 71, and the covering members 70A, 70B, and 70C are brought into close contact with and bonded to the outer periphery of the reinforcing body 52 and the inner layer covering body 51. The covering member 70A, the covering member 70B, and the covering member 70C to be combined are joined together.

  Thereafter, the heat-shrinkable tube 71 that was heat-shrinked was formed around the outer periphery of the reinforcing body 52 and the inner-layer covering body 51 with the covering members 70A, 70B, and 70C as the outer-layer covering body 53, as shown in FIG. It will be removed later.

  In the outer layer covering body forming step, the outer layer covering body 53 is not formed using the heat shrinkable tube 71, but the above-described extrusion molding machine 100 as shown in FIG. The outer layer covering body 53 can also be extruded by using the core material W as a configuration in which the reinforcing body 52 is covered (see FIG. 3F).

  In the outer layer covering body forming step, the above-described container 200 as shown in FIG. 6 is used, and the core wire 40 is covered with the inner layer covering body 51 and the reinforcing body 52 (see FIG. 3F). As W, the outer layer covering 53 can be dip-molded.

  Further, the method of forming the outer layer covering 53 in the outer layer covering forming step is not limited to the method using the heat shrinkable tube 71, extrusion molding, and dip molding. For example, in a solution or diluent in which a resin is dissolved in a solvent. The dispersion liquid dispersed in is adhered to the outer peripheral surfaces of the inner layer covering body 51 and the reinforcing body 52 by a known method such as spraying, coating, and printing, and then the adhered solution or dispersion liquid is heated with hot air or a heater. For example, the outer layer covering 53 may be formed by heating and drying by means of, for example, and sintering depending on the material.

  After the outer layer covering body forming step, as shown in FIG. 4A, a plurality of unit core wires 47 are aligned in the axial direction and joined to form the core wire 40 again (joining step). The joining can be performed by butt welding using a spot welding machine or the like. Note that welding is not necessary as long as joining is possible.

  After the joining step, as shown in FIG. 4B, shapes corresponding to the most distal end portion 12A and the most proximal end portion 11A of the catheter tube 10 are imparted to the inner layer covering body 51 and the outer layer covering body 53 ( End forming step). The shape imparting portion 55 corresponding to the most distal portion 12A of the inner layer covering 51 and the outer layer covering 53 is formed by the upper die M1 and the lower die M2 in which cavities corresponding to the curved shape of the most distal portion 12A are formed. A curved surface shape similar to that of the portion 12A is transferred. The inner layer covering body 51 and the outer layer covering body 53 are preferably completely divided in the axial direction at the shape imparting portion 55 when the upper mold M1 and the lower mold M2 reach the core wire 40. Good.

  Further, in the shape imparting portion 56 corresponding to the most proximal end portion 11A of the inner layer covering body 51, the reinforcing body 52, and the outer layer covering body 53, an upper mold M3 in which a cavity corresponding to the end face shape of the most proximal end portion 11A is formed. And the end face shape similar to the most proximal end portion 11A is transferred by the lower mold M4. The inner layer covering body 51, the reinforcing body 52, and the outer layer covering body 53 are preferably completely divided in the axial direction at the shape imparting portion 56 when the upper mold M3 and the lower mold M4 reach the core wire 40, but are completely divided. It does not have to be done.

  After the edge forming step, as shown in FIG. 4C, the outer covering 53 is covered with a hydrophilic polymer substance (hydrophilic material) to form a hydrophilic covering 54 (hydrophilic covering). Body formation step). The hydrophilic covering 54 finally constitutes the hydrophilic layer 18 (see FIG. 2) on the outer surface of the catheter tube 10. The hydrophilic layer 18 exhibits lubricity when contacted with a liquid such as blood or physiological saline, reduces the frictional resistance of the catheter tube 10, and further improves the slidability. And the pushability, followability, kink resistance and safety are further improved.

  Further, when inserting the catheter tube 10 into a blood vessel, it is necessary to operate the catheter tube 10 by holding the proximal end side of the catheter tube 10 in a hand. For this reason, if the base end side of the catheter tube 10 slips when held by hand, the operability is lowered, which is not preferable. For this reason, the range in which the hydrophilic layer 18 in the longitudinal direction of the catheter tube 10 is provided excludes a predetermined length (for example, about 150 to 500 mm) from the proximal end of the catheter tube 10 toward the distal end. It is preferable that it is a region. Therefore, the hydrophilic covering 54 covered on the outer peripheral surface of the outer covering 53 is covered on a part of the outer covering 53 so that the hydrophilic layer 18 is provided in the above range. Specifically, a plurality of coating ranges B corresponding to a part of the large-diameter portion 41 and the small-diameter portion 42 are provided at predetermined intervals along the axial direction of the core wire 40, and these coating ranges B are hydrophilicly coated. Form body 54.

  Examples of the hydrophilic polymer substance include the following natural or synthetic polymer substances or derivatives thereof. In particular, cellulosic polymer materials (eg, hydroxypropyl cellulose), polyethylene oxide polymer materials (polyethylene glycol), maleic anhydride polymer materials (eg, maleic anhydride such as methyl vinyl ether maleic anhydride copolymer) Copolymers), acrylamide polymer substances (for example, polyacrylamide), and water-soluble nylon (for example, AQ-nylon P-70 manufactured by Toray Industries, Inc.) are preferable because a low friction coefficient can be stably obtained. Among these, a maleic anhydride polymer material is more preferably used. Further, the derivative of the polymer substance is not limited to a water-soluble derivative, and there is no particular limitation as long as the polymer substance has a basic configuration, and even if it is insolubilized, the molecular chain has a degree of freedom. As long as it has water and contains water.

  In order to fix such a hydrophilic polymer substance to the outer surface of the catheter tube 10, it is covalently bonded to a reactive functional group present or introduced in the outer layer covering 53 or on the surface of the outer layer covering 53. It is preferable to carry out. Thereby, a continuous lubricating surface can be obtained.

  The reactive functional group present in or introduced into the outer layer covering 53 or on the surface thereof may be any one that reacts with the hydrophilic polymer substance and is fixed by being bonded or cross-linked, such as a diazonium group. , Azide group, isocyanate group, acid chloride group, acid anhydride group, imino carbonate group, amino group, carboxyl group, epoxy group, hydroxyl group, aldehyde group, and the like. Among these, as the reactive functional group, an isocyanate group, an amino group, an aldehyde group, and an epoxy group are more preferable.

  In the hydrophilic covering forming step, the hydrophilic covering 54 can be formed by dip molding using the core W as a structure in which the inner layer covering 51, the reinforcing body 52, and the outer covering 53 are coated on the core wire 40. . In dip molding, the apparatus 300 shown in FIG. 8 can be used. The apparatus 300 collects the container 301 containing a solution R2 in which a hydrophilic polymer material is dissolved in a solvent, the supply roll 302 for supplying the core W, and the core W coated with the hydrophilic covering 54. And a collection roll 303. The core material W extends downward from the supply roll 302, curves in a U shape at the lower end, extends upward, and reaches the recovery roll 303. Examples of the solvent that can be used include dimethylformamide, dimethyl sulfoxide, and tetrahydrofuran.

  When the core material W is coated with the hydrophilic coating 54, when the core material W is not immersed in the solution R 2 and the recovery roll 303 is stopped and the core material W is supplied from the supply roll 302, the coating range B After positioning the core material W at a position where only the material R2 is immersed in the solution R2, the supply by the supply roll 302 and the recovery by the recovery roll 303 are stopped and the core material W is fixed (see the one-dot chain line in FIG. 8). Next, the coating area B is immersed in the solution R2 by supplying the core material W from the supply roll 302 in a state where the collection roll 303 is stopped. After a predetermined time has passed, the supply roll 302 is stopped, the core material W is wound up by the collection roll 303, and the core material W is pulled up from the solution R2. The solution R2 attached to the core material W is naturally dried or dried by heating with hot air, a heater, or the like, and the hydrophilic covering 54 is covered only in the covering range B. Thereafter, in order to coat the hydrophilic coating 54 in the next coating range B provided at a predetermined interval, the supply roll 302 and the recovery roll 303 are operated so that only the coating range B can be immersed in the solution R2. After the core material W is moved to position the core material W, the supply by the supply roll 302 and the recovery by the recovery roll 303 are stopped to fix the core material W. Thereafter, by repeating the above steps, the core material W can be coated with the hydrophilic covering 54 at a predetermined interval. As long as the hydrophilic covering 54 can be formed, the forming method is not limited. For example, the hydrophilic covering 54 may be coated by a known method such as spraying, spraying, coating, printing, or the like.

  The hydrophilic covering forming step may be performed after the proximal connecting member attaching step, the cutting step, the core wire stretching step, or the core wire removing step.

  After the hydrophilic covering body forming step, as shown in FIG. 4D, the hub 20 is attached to a portion corresponding to the large diameter portion 41 of the outer layer covering body 53 (base end connecting member attaching step). In the hub 20, the hub split members 20 </ b> A and 20 </ b> B that are divided into two in the circumferential direction are arranged so as to cover the shape imparting portion 56 corresponding to the most proximal end portion 11 </ b> A of the outer layer covering 53. , 20B are bonded to each other by heat fusion, an adhesive, or a fastener, and arranged on the outer layer covering 53. Thereby, the tubular continuous body 60 including the inner layer covering body 51, the reinforcing body 52, the marker 19, the outer layer covering body 53, the hydrophilic covering body 54, and the hub 20 is formed on the core wire 40. The configuration including the core wire 40 in the tubular continuous body 60 is referred to as a catheter tube continuous body 65. Note that the hub may be formed in a C-shaped cross section having a slit extending in the axial direction, for example, without being provided in two parts. In the case of such a shape, a hub is put on the outer layer covering body 53 through a slit from the outside in the radial direction of the outer layer covering body 53, and then, it is bonded by heat fusion, an adhesive, or a fastener so as to close the slit. it can.

  The kink protector 30 (base end connecting member) may also be mounted on the outer layer covering 53 by the same method as the hub 20 in the base end connecting member mounting step.

  After the proximal end connecting member mounting step, as shown in FIG. 4E, the tubular continuous body 60 formed on the core wire 40 is cut together with the core wire 40 at a predetermined position (cutting step). The tubular continuous body 60 includes a first cutting portion 63 close to one end of the large diameter portion 41 and a second cutting portion on the small diameter portion 42 close to the first cutting portion 63 across the transition portion 43. 64 and cut. Thereby, the single tube 61 from which the large diameter part 41 is cut long and the surplus tube 62 from which the large diameter part 41 is cut short are formed. The single tube 61 corresponds to one catheter tube 10 and is an intermediate body before reaching the catheter tube 10. The surplus tube 62 is removed as an unnecessary portion. As an example, in the single tube 61, the length of the portion corresponding to the large diameter portion 41 of the core wire 40 is 1600 mm, and the length of the portion corresponding to the small diameter portion 42 of the core wire 40 is 100 mm.

  In the cutting step, for example, the cutting is performed with a cutting blade by a shearing machine or the like, but any cutting method may be used as long as the core wire 40 and the tubular continuous body 60 can be cut.

  After the cutting step, as shown in FIG. 4 (F), both ends of the single tube 61 cut out in the cutting step are fixed to a drawing machine, and the entire core wire 40 is drawn (core wire drawing step). Then, after the core wire 40 is stretched by the stretching machine until it breaks at the small diameter portion 42, the broken core wire 40 is pulled out from the large diameter portion 41 side and both sides of the small diameter portion 42. At this time, since the shapes corresponding to the most distal end portion 12A and the most proximal end portion 11A are already provided to the shape imparting portions 55 and 56, unnecessary coverings on both ends of the core wire 40 in the single tube 61 are provided. 66A and 66B can be removed together with the core wire 40. In particular, the shape imparting portion 56 is located inside the hub 20 (see FIG. 4D), but at least one of the inner layer covering body 51, the reinforcing body 52, and the outer layer covering body 53 is already present in the shape imparting portion 56. Since the portion is cut, it is possible to easily pull out the unnecessary covering 66B partially disposed inside the hub 20 only by extending the core wire 40. Thereby, manufacture of the tube 10 for catheters is completed.

  As described above, in the method for manufacturing the catheter tube 10 according to the present embodiment, the resin is coated on the unit core wire 47 in which the large-diameter portion 41 and the small-diameter portion 42 having different outer diameters are formed in advance, thereby coating the inner layer. From the inner layer covering body forming step (covering body forming step) for forming the body 51 (covering body), the joining step of joining the unit core wires 47 side by side in the axial direction, and the joining step after the inner layer covering body forming step. After that, another member (hydrophilic covering 54, hub 20, etc.) is arranged on the structure obtained on the core wire 40 to which the unit core wire 47 is joined, or predetermined processing (the most advanced portion 12A and the most basic). An intermediate step for applying the shape of the end portion 11A, and the structure obtained on the core wire 40 after the intermediate step together with the core wire 40 at predetermined positions of the large diameter portion 41 and the small diameter portion 42 of the core wire 40 Cut multiple single tubes 6 Having a cutting step of cutting a core wire removal step of removing the core wire 40 from a single piece tube 61, the. Thus, in this manufacturing method, after forming the inner layer covering 51 on the unit core wire 47 including the large diameter portion 41 and the small diameter portion 42, the unit core wires 47 are joined side by side in the axial direction, and the unit core wire 47 is joined. Since the intermediate process is performed using the formed core wire 40, the intermediate process can be efficiently performed using the continuous core wire 40, and the diameter of the catheter differs depending on the large diameter portion 41 and the small diameter portion 42. The tube 10 can be manufactured efficiently.

  The manufactured catheter tube 10 has a large-diameter tube proximal end portion 11 as the proximal end side and a small-diameter tube distal end portion 12 as the distal end side, thereby impairing the proximal end pushability and liquid feeding characteristics. The tip side becomes flexible without any problems, and the guide wire followability and kink resistance are excellent.

  In addition, as a method of manufacturing a catheter tube, a hot stretching process is generally performed in which a tube is subjected to a hot stretching process, and the inner and outer diameters are reduced from the proximal end side to the distal end side. When hot-stretching is performed, residual strain due to hot-stretching is affected during hot-melt processing, such as when attaching a soft tip or contrast marker, and the inner and outer diameters near the melted part become thicker, resulting in poor dimensional accuracy. As a result, there are problems such as a decrease in yield. On the other hand, according to the manufacturing method according to the present embodiment, since the hot stretching process is not performed, there is no distortion due to stretching, the workability is improved, and as a result, the cost is reduced. Further, since the winding pitch of the reinforcing body 52 (interstitial distance in the case of a braid) does not increase due to stretching, the distal end side is excellent in flexibility and kink resistance.

  Further, in the inner layer covering body forming step, the core wire 40 on which the unit core wires 47 are continuously formed is coated with a resin to form the inner layer covering body 51, which is later than the inner layer covering body forming step and after the joining step. Before, the core wire 40 is divided into unit core wires 47. Therefore, after the inner layer covering 51 is efficiently formed using the core wire 40 in which the unit core wires 47 are continuously connected, the core wire 40 is divided. Thus, the unit core wire 47 can be obtained.

  Moreover, since it has the reinforcement body formation process which forms the reinforcement body 52 which consists of a wire material in the radial direction outer side rather than the inner layer coating body 51 after the inner layer coating body formation process and before the cutting process, the unit core wire 47 After the reinforcing body 52 is efficiently formed using the core wire 40 continuously connected to each other, the core wire 40 can be divided to obtain the unit core wire 47.

  Moreover, since it has the outer layer covering body formation process which coat | covers resin to radial direction outer side rather than the inner layer covering body 51 and forms the outer layer covering body 53 after a division | segmentation process and before a joining process, it is continuous. The outer layer covering 53 can be formed for each of the unit core wires 47 that are separated from the core wire 40 that is continuous with the core wire 40, and the outer layer covering 53 can be formed using various methods. It becomes possible to form the outer layer covering 53 having a shape, and the degree of freedom in design is improved.

  Further, since the intermediate process includes a hydrophilic covering forming process in which the hydrophilic covering 54 is formed by coating the hydrophilic material on the outer side in the radial direction with respect to the inner covering 51, the continuous core wire 40 is used. Thus, the hydrophilic covering 54 can be formed efficiently.

  In addition, since the intermediate process includes an end portion forming step for giving a predetermined shape to the most distal end portion 12A and the most proximal end portion 11A constituting the end portion in the catheter tube 10, the core wire 40 that is continuously connected is used. Thus, the shape of the end of the catheter tube 10 can be formed efficiently.

  Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, instead of cutting the core wire 40 into a plurality of unit core wires 47 by a dividing step, a unit core wire 47 in a state of being divided in advance is prepared, and after the inner layer covering 51 is coated on the unit core wire 47, the unit The core wire 47 may be joined.

  Further, in the joining step of joining the unit core wires 47, other members are arranged on the structure obtained on the core wire 40 to which the unit core wires 47 are joined after the joining step (FIG. 4A), As long as it is possible to provide a process (intermediate process) for performing a predetermined process, the process may be performed at any stage. These steps can be performed continuously and efficiently by arranging other members on the structure obtained on the core wire 40 to be joined or by performing a predetermined treatment.

  Moreover, as long as the dividing process which cut | disconnects the core wire 40 is before the joining process which joins the unit core wire 47, it may be performed in any step. However, it is preferable that some process having an advantage in using the unit core wire 47 rather than the continuous core wire 40 is provided between the dividing step and the joining step. For example, a step of forming a reinforcing body may be provided between the dividing step and the joining step. If a reinforcing body forming step for forming a reinforcing body made of a wire rod is formed on the radially outer side of the inner layer covering body after the dividing step, the unit core wires 47 that are divided without being continuously connected to the core wire 40. The reinforcing body can be formed in various ways, and the reinforcing body can be formed using various methods, so that it is possible to form the reinforcing bodies with more various materials, characteristics, or shapes, and the degree of freedom of design is improved. For example, each unit core wire 47 can be easily installed by covering a reinforcing body knitted in a cylindrical shape in advance from the axial direction, and workability can be improved.

  Moreover, the outer layer covering body formation process which coat | covers resin outside radial direction rather than the inner layer covering body 51, and forms the outer layer covering body 53 may be performed as an intermediate | middle process after a joining process. If it does in this way, the outer layer covering 53 can be efficiently formed using the continuous core wire 40.

  Further, a transition portion 83 between the large-diameter portion 81 and the small-diameter portion 82 may be provided only on one end side of the large-diameter portion 81 as in a core wire 80 as a modified example shown in FIG. Thereby, the length of the surplus tube (see the surplus tube 62 in FIG. 4E) removed after cutting is shortened, so that the cost can be reduced and the manufacturing area can be saved.

  Further, at least a part of the shape of the outer peripheral surface of the transition portion 93 in the cross section along the axis of the core wire 90 may be formed as a curve, like a core wire 90 as another modification shown in FIG. Thereby, the rigidity of the manufactured catheter tube changes smoothly and in an inclined manner along the axis, local bending is suppressed, and a catheter tube excellent in pushability and kink resistance can be manufactured. In FIG. 10, the inclination angle X of the outer peripheral surface of the transition portion 93 in the cross section along the axis of the core wire 90 gradually increases from the small diameter portion 92 toward the large diameter portion 91. It becomes the maximum, and gradually becomes smaller as it gets closer to the large-diameter portion 91. By adopting such a shape, the rigidity along the axis between the large-diameter portion 91 and the small-diameter portion 92 can be changed more smoothly and in an inclined manner, and the catheter is more excellent in pushability and kink resistance. Tubes can be manufactured.

  Further, a radiopaque marker may be arranged between the inner layer covering body 51 and the reinforcing body 52, or between the outer layer covering body 53 and the reinforcing body 52, or on the outer layer covering body 53. In addition, each of the reinforcing body 52, the outer layer covering body 53, the hydrophilic covering body 54, the marker 19, and the hub 20 may not be provided.

  Further, at least one of the inner layer covering 51 and the outer layer covering 53 may be irradiated with an electron beam or gamma ray to crosslink the material to increase the hardness. Further, at least one of the inner layer covering body 51 and the outer layer covering body 53 may be subjected to a softening process for reducing the hardness using an acid or an alkali.

  The cross-sectional shape of the catheter tube 10 in the cross section orthogonal to the axis may not be circular, and may be, for example, elliptical. Further, the lumen 14 in the catheter tube 10 may not have a circular cross-sectional shape in the axial orthogonal cross section, and may be, for example, an elliptical shape or a semicircular shape. The catheter tube 10 may be provided with a plurality of lumens.

1 catheter,
10 Catheter tube,
20 hub (proximal connecting member),
30 Anti-kink protector (base end connection member),
40, 80, 90 core wires,
41, 81, 91 Large diameter part,
42, 82, 92 Small diameter part,
43, 83, 93 Transition section,
46 Dividing part,
47 unit core wire,
51 Inner layer covering (covering body),
52 reinforcements,
53 outer layer covering,
54 hydrophilic covering,
60 tubular continuum,
61 Single tube,
63 1st cutting part,
64 second cutting part,
65 A continuum of catheter tubes,
D1 Outer diameter of the large diameter part,
D2 Outer diameter of small diameter part,
X Tilt angle.

Claims (7)

On a unit core wire in which a large diameter part and a small diameter part having different outer diameters are formed in advance, a covering body forming step of forming a covering body by coating a resin;
After the covering body forming step, a joining step of joining the unit core wires in the axial direction and joining them,
After the joining step, an intermediate step of placing another member on the structure obtained on the core wire to which the unit core wire is joined or performing a predetermined process,
After the intermediate step, the tubular continuum obtained on the core wire, a cutting step of cutting a plurality of single tubes by cutting together with the core wire at a predetermined position of the large diameter portion and the small diameter portion of the core wire;
And a core wire removing step of removing the core wire from the single tube. In the covering body forming step, a covering body is formed by coating a resin on a core wire on which the unit core wires are continuously formed,
The method for producing a catheter tube according to claim 1, further comprising a dividing step of dividing the core wire into the unit core wires after the covering body forming step and before the joining step.   3. The reinforcing body forming step according to claim 2, further comprising a reinforcing body forming step of forming a reinforcing body made of a wire material on a radially outer side of the covering body after the covering body forming step and before or after the dividing step. A method for producing a catheter tube.   4. The outer layer covering body forming step of forming an outer layer covering body by coating a resin on a radially outer side of the covering body after the dividing step and before the joining step. The manufacturing method of the tube for catheters of description.   The said intermediate | middle process has an outer-layer coating body formation process which coat | covers resin outside radial direction rather than the said coating body, and forms an outer-layer coating body, The manufacture of the catheter tube of any one of Claims 1-3. Method.   The catheter according to any one of claims 1 to 5, wherein the intermediate step includes a hydrophilic covering forming step of forming a hydrophilic covering by coating a hydrophilic material on a radially outer side than the covering. Tube manufacturing method.   The said intermediate | middle process is a manufacturing method of the catheter tube of any one of Claims 1-6 which has an edge part formation process which provides a predetermined shape to the site | part which comprises an edge part in the said tube for catheters.

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