JP6088809B2 - CATHETER TUBE MANUFACTURING METHOD, CATHETER TUBE CONTINUOUS AND CATHETER TUBE PRODUCING CORE - Google Patents

Description

  The present invention relates to a method for producing a catheter tube used in a catheter used in a lumen such as a blood vessel or a body cavity, a continuous catheter tube, and a core wire for producing a catheter tube.

  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 that constitutes the catheter increases the inner and outer diameters on the proximal end side, thereby increasing the rigidity and providing sufficient pushability. By securing the characteristics and making the inner and outer diameters on the tip side thinner than the proximal 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 formed on a core wire in which a large-diameter portion and a small-diameter portion having different outer diameters are continuous at a predetermined interval. After forming a body and forming a plurality of catheter tubes as a continuous body on the same core wire, the continuous body is cut together with the core wire for each catheter tube, and the core wire is drawn and removed to obtain a catheter tube A method is described.

JP 2008-183226 A

  The core wire used in the method described in Patent Document 1 described above has symmetrically formed portions that are reduced in diameter from the large diameter portion toward the small diameter portion on both ends of the large diameter portion. The portion to be coated on the diameter portion is removed as an unnecessary portion. For this reason, a manufacturing cost becomes high and a large manufacturing area is needed.

  The present invention has been made to solve the above-described problems, and while continuously manufacturing a plurality of catheter tubes using the same core wire, unnecessary portions are reduced as much as possible to reduce manufacturing costs. Another object of the present invention is to provide a catheter tube manufacturing method, a catheter tube continuum, and a catheter tube manufacturing core wire capable of saving space in the manufacturing area.

A method of manufacturing a catheter tube that achieves the above-described object includes a large-diameter portion and a small-diameter portion having different outer diameters, provided on one end side of the large-diameter portion, and reduced in diameter from the large-diameter portion to the small-diameter portion. The first transition portion to be formed, and the first transition portion provided on the other end side of the large-diameter portion and formed by reducing the diameter from the large-diameter portion to another small-diameter portion and having an inclination angle with respect to the axis line continuously formed on the core wire in advance a predetermined interval unit structure is provided with a second transition portion is sized rather 90 degrees than the covering body forming step of forming a coating member covering the resin, the coating A cutting step of cutting a plurality of single tubes by cutting a tubular continuous body obtained on the core wire together with the core wires at predetermined positions of the large diameter portion and the small diameter portion after the body forming step; A core wire removing step for removing the core wire. It is a manufacturing method of the ether tube.

  In the manufacturing method of the catheter tube configured as described above, since the inclination angle of the second transition portion of the core wire is larger than that of the first transition portion, the length of the second transition portion in the axial direction is shortened. Unnecessary parts formed on the transition portion can be reduced as much as possible, thereby reducing the manufacturing cost and saving the manufacturing area.

  If the inclination angle of the second transition portion is 90 degrees, the length of the second transition portion in the axial direction can be minimized, and unnecessary portions formed on the second transition portion can be further reduced. Thus, the manufacturing cost can be reduced and the manufacturing area can be saved.

  After the covering body forming step, if it further comprises an outer layer covering body forming step for forming an outer layer covering body by coating a resin radially outward from the covering body, a multilayer structure composed of a plurality of layers is formed. A catheter tube can be efficiently manufactured using a continuous tubular body.

  After the covering body forming step, if it further includes a reinforcing body forming step for forming a reinforcing body made of a wire material on the radially outer side than on the covering body, the manufactured catheter tube according to the site. It can reinforce and can improve indentation property and kink resistance.

  If the shape of the outer peripheral surface of the first transition portion in the cross section along the axis of the core wire has a curve, the rigidity of the manufactured catheter tube changes smoothly and in an inclined manner along the axis. Therefore, it is possible to manufacture a catheter tube excellent in indentability and kink resistance.

A single tube, which is an intermediate body of a catheter tube, is a continuous body of catheter tubes in which a plurality of continuous tubes are formed on the same core wire, and a large-diameter portion and a small-diameter portion having different outer diameters, A first transition portion provided on one end side and formed by reducing the diameter from the large diameter portion to the small diameter portion, and another diameter on the other end side of the large diameter portion provided from the large diameter portion. a core wire unit structure comprising a second transition portion inclination angle relative to the axis is large rather 90 degrees than the first transition portion is continuously formed at predetermined intervals while being formed reduced in diameter to parts, Since the inclination angle of the second transition part of the core wire is larger than that of the first transition part, the second transition is performed in a continuous body of a catheter tube having a covering formed by coating a resin on the core wire. The length of the axial direction of the part is shortened, and a defect formed on the second transition part Such by site as much as possible to reduce the, it is possible to save the space of the reduced and manufacturing area of manufacturing cost.

  If the inclination angle of the second transition portion provided in the continuum is 90 degrees, the length of the second transition portion in the axial direction can be minimized, and it is unnecessary to be formed on the second transition portion. By reducing the number of parts, it is possible to reduce manufacturing costs and save space in the manufacturing area.

  If the continuous body further includes an outer layer covering body formed of a resin on the outer side in the radial direction than the covering body, a multi-layered catheter tube composed of a plurality of layers is integrated into a continuous tubular structure. It can be manufactured efficiently using the body.

  If the continuous body further includes a reinforcing body made of a wire between the covering body and the outer layer covering body, the catheter tube to be manufactured can be reinforced according to the part, and the pushability and kink resistance can be improved. Can be improved.

  If the shape of the outer peripheral surface of the first transition portion in the cross section along the axis of the core wire is formed with a curve, the continuous body has rigidity of the catheter tube manufactured by being drawn out from the core wire. Changes smoothly and inclined along the axis, local bending is suppressed, and a catheter tube excellent in pushability and kink resistance can be manufactured.

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 a figure for demonstrating the manufacturing method of the tube for catheters 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 ) Is a marker placement step, (E) is a cutting step, (F) is an outer layer covering body forming step, (G) is a core wire stretching step, (H) is a core wire removing step, and (I) is a hydrophilic covering body forming step. Show. 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 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. 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. 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 (FIG. 3C) for forming the reinforcing body 52 on at least part of the inner layer covering body 51, and the marker 19 is disposed on the reinforcing body 52 A marker placement step (FIG. 3D) to be performed, a cutting step (FIG. 3E) for cutting the continuous tube 65 of the catheter tube obtained after the marker placement step and cutting the single tube 61, and an outer layer covering 53 An outer layer covering body forming step (FIG. 3 (F)), a core wire extending step (FIG. 3 (G)) for extending the core wire 40, and a core wire removing step (FIG. 3) for removing the core wire 40 from each single tube 61. (H)) and covering the hydrophilic covering 54 Hydrophilic coating forming process has (Fig. 3 (I)) and, the. 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.

  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 unit structures 45 having first transition portions 43 and second transition portions 44 whose outer diameters gradually change in the axial direction of the core wire 40 are continuously arranged at predetermined intervals. . 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. The inclination angle X1 with respect to the axis of the first transition portion 43 formed on one end side of the large diameter portion 41 is smaller than the inclination angle X2 with respect to the axis of the second transition portion 44 formed on the other end side of the large diameter portion 41. . 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 first transition portion 43 is 50 mm, and the outer diameter D1 of the large diameter portion 41 is 0.55. Although 0.6 mm and the outer diameter D2 of the small diameter part 42 can be 0.45-0.50 mm, a dimension is not limited to this. Further, as an example, the inclination angle X1 of the first transition portion 43 can be set to 0.01 to 10 degrees, and the inclination angle X2 with respect to the axis of the second transition portion 44 can be set to 70 to 90 degrees. The angle X1 may be 3 degrees and the inclination angle X2 with respect to the axis of the second transition portion 44 may be 90 degrees, but the dimensions are not limited thereto.

  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. 3B, an inner layer covering 51 is formed on the core wire 40 (an inner layer covering step (covering 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 extrusion molding machine 100 as shown in FIG. 4, a thermoplastic resin layer (here, inner layer covering 51) 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. In addition, the supply roll 106 and the recovery roll 107 may not be provided as long as the core material W is directly received from the previous process of extrusion molding and the core material W coated with the thermoplastic resin is directly transferred to the subsequent process. .

  In the inner layer covering body forming step, the inner layer covering body 51 may be formed by dip molding, not by extrusion molding. If the method by dip molding is outlined, first, in a container 200 as shown in FIG. 5, 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 contained. 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, the radiopaque marker 19 is arranged on the reinforcing body 52 (marker arranging 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, not only can the position be observed from outside the body by X-rays, but also the length can be measured using the markers as scales.

  The tubular continuous body 60 including the inner layer covering body 51, the reinforcing body 52, and the marker 19 is obtained on the core wire 40 by the marker placement step. The configuration including the core wire 40 in the tubular continuous body 60 is referred to as a catheter tube continuous body 65.

  After the marker placement step, as shown in FIG. 3E, the catheter tube continuous body 65 having the core wire 40 and the tubular continuous body 60 is cut at a predetermined position (cutting step). The continuous body 65 of the catheter tube includes a first cutting portion 63 in a portion close to the second transition portion 44 of the large diameter portion 41 and a small diameter portion in proximity to the first cutting portion 63 with the second transition portion 44 interposed therebetween. And the second cutting part 64 on 42. 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 includes the second transition portion 44 and 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, a cutting blade is used to cut with a shearing machine or the like, but any cutting method may be used as long as it can cut the core wire 40 and the covering (the inner layer covering 51 and the reinforcing body 52). The cutting step may be performed at any stage after the marker placement step, for example, may be performed after the outer layer covering body forming step, or after the hydrophilic covering body forming step. May be.

  After the cutting step, as shown in FIG. 3 (F), the outer layer covering 53 is formed on the outer surface of the single tube 61 by covering at least part of the marker 19 and the reinforcing member 52 (outer layer covering). 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.

  When a thermoplastic resin is used as the material of the outer layer covering 53, the outer layer covering 53 can be extruded using the extrusion tube 100 as shown in FIG.

  Further, in the outer layer covering body forming step, the outer layer covering body 53 is not formed by extrusion molding, but the outer layer covering body 53 is formed using the container 200 as shown in FIG. Dip molding is also possible. In the outer layer covering body forming step, since the core material W is cut not corresponding to the continuous body but corresponding to the catheter tube 10, it is not inserted from the valve body 201, but is lowered from above and dipped (immersed). It can also be lifted after being let down.

  The method of forming the outer layer covering 53 in the outer 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 resin is dispersed in a diluent is sprayed. (Spray), application, printing, and the like, after attaching to the outer peripheral surface of the reinforcing body 52, the attached solution or dispersion is heated and dried with hot air or a heater, and depending on the material, it may be sintered. Thus, the outer layer covering 53 may be formed.

  Moreover, in order to form the outer layer covering 53 in the outer layer covering forming step, it is also possible to use a heat-shrinkable tube that contracts into a memorized shape by heating. The heat shrinkable tube is, for example, a fluorine resin. When using a heat-shrinkable tube, first, as shown in FIG. 6A, a tube body 70 having an inner diameter larger than the outer diameter of the single tube 61 is prepared, and the tube body 70 is covered with the single tube 61. Thereafter, as shown in FIG. 6 (B), a heat-shrinkable tube 71 is placed on the outer side. The tube body 70 is a material that becomes the outer layer covering body 53. Next, as shown in FIG. 6C, the heat shrinkable tube 71 is contracted while being heated or heated by hot air or a heater to soften or melt the tube 70, and the tube 70 is contracted by the contraction force of the heat shrinkable tube 71. Can be formed as an outer layer covering 53 by pressing the outer periphery of the reinforcing body 52 and the inner layer covering 51. As shown in FIG. 6D, the heat-shrinkable heat-shrinkable tube 71 is removed after the tube body 70 is formed as the outer layer covering body 53 around the outer periphery of the reinforcing body 52 and the inner layer covering body 51. In FIG. 6, there is one tube body 70 to be the outer layer covering body 53, but it may be divided into a plurality of parts in the axial direction, and in this case, each is formed with different materials, characteristics, or dimensions. Various designs are possible.

  In addition, you may remove a part of reinforcement body 52 before an outer layer covering body formation process. For example, in order to ensure the flexibility of the distal end portion of the catheter tube 10, a part of the distal end side of the reinforcing body 52 corresponding to the small diameter portion 42 can be removed.

  After the outer layer covering forming step, as shown in FIG. 3G, a part of the covering at both ends of the core wire 40 cut in the cutting step is removed, and a part of both ends of the core wire 40 is exposed. To the drawing machine and the whole core wire 40 is drawn (core wire drawing step). Thereafter, as shown in FIG. 3H, the core wire 40 is pulled out from the large diameter portion 41 side (core wire removing step). In addition, after extending | stretching until the core wire 40 fractures | ruptures in the small diameter part 42 with an extending | stretching machine, you may pull out the broken core wire 40 from the large diameter part 41 side and the both sides of the small diameter part 42. Further, the core wire 40 may be stretched and pulled out after the cutting step and before the outer layer covering body forming step.

  After the outer layer covering body forming step, as shown in FIG. 3I, a hydrophilic polymer is formed on a part corresponding to the small diameter part 42 and a part corresponding to the large diameter part 41 of the outer layer covering body 53. The substance (hydrophilic material) is coated to form the hydrophilic covering 54 (hydrophilic covering forming step). Thereby, the catheter tube 10 is completed. The hydrophilic covering 54 on the outer surface of the catheter tube 10 exhibits lubricity when contacted with a liquid such as blood or physiological saline, reduces the frictional resistance of the catheter tube 10, and is slidable. As a result, the operability of insertion is further improved, and 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. Therefore, the range in which the hydrophilic polymer substance in the longitudinal direction of the catheter tube 10 is applied is 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 to impart a hydrophilic polymer substance to the region excluding.

  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.

  The hydrophilic covering forming step may be performed after the outer layer covering forming step and before the core wire stretching step or the core wire removing step. The hydrophilic covering forming step may be performed after the hub 20 and the kink protector 30 are connected to the manufactured catheter tube 10.

  As described above, the catheter tube manufacturing method according to the present embodiment is provided on the one end side of the large-diameter portion 41 and the small-diameter portion 42 and the large-diameter portion 41 having different outer diameters. The first transition portion 43 formed with the diameter reduced to the portion 42 and the first transition portion 43 provided on the other end side of the large diameter portion 41 and formed with the diameter reduced from the large diameter portion 41, and the inclination angle X2 with respect to the axis is the first. An inner layer covering body 51 (covering body) is formed by coating a resin on a core wire 40 in which a unit structure 45 having a second transitioning section 44 larger than the inclination angle X1 of the transition section 43 is continuously formed in advance at a predetermined interval. After the inner layer covering body forming step (covering body forming step) and the inner layer covering body forming step, the tubular continuous body 60 obtained on the core wire 40 is placed at predetermined positions of the small diameter portion 42 and the large diameter portion 41. Cut together with the core wire 40 to cut out a plurality of single tubes 61 Having a cutting step, a core removing step of removing the core wire 40 from a single piece tube 61, the. Thus, since the inclination angle X2 of the second transition portion 44 of the core wire 40 is larger than the inclination angle X1 of the first transition portion 43, the length of the second transition portion 44 in the axial direction is shortened, and the second transition Unnecessary portions formed on the portion 44 can be reduced as much as possible, so that the manufacturing cost can be reduced and the manufacturing area can be saved.

  Moreover, since the inner layer covering body 51 and the reinforcing body 52 corresponding to the plurality of catheter tubes 10 are formed as the tubular continuous body 60 at a time, the productivity is excellent.

  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 to reduce the inner and outer diameters from the proximal side to the distal end side. When the intermediate stretching process is performed, the residual strain due to the hot stretching process is affected during hot melt processing such as when attaching a soft tip or contrast marker, and the inner and outer diameters in the vicinity of the melted part increase, resulting in poor dimensional accuracy. In particular, there is a problem 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. In addition, since the winding pitch of the reinforcing body 52 (interstitial distance in the case of braiding) does not increase due to stretching, the tip portion is excellent in flexibility and kink resistance.

  In addition, since the inclination angle X2 of the second transition portion 44 is 90 degrees, the length of the second transition portion 44 in the axial direction can be minimized, and unnecessary portions formed on the second transition portion 44 can be reduced. By reducing the manufacturing cost, the manufacturing cost can be reduced and the manufacturing area can be saved.

  Further, after the inner layer covering body forming step, the outer layer covering body forming step of forming the outer layer covering body 53 by coating the resin on the radially outer side of the inner layer covering body 51 is provided. The tube 10 can be efficiently manufactured using the tubular continuous body 60 that is integrally connected.

  Moreover, since it has the reinforcement body formation process which forms the reinforcement body 52 which consists of a wire after the inner layer covering body formation process, the manufactured tube 10 for catheters can be reinforced according to a site | part, and push-in property and kink resistance are improved. Can be improved.

  Further, since the shape of the outer peripheral surface of the first transition portion 43 in the cross section along the axis of the core wire 40 has a curve, the rigidity of the manufactured catheter tube 10 changes smoothly and in an inclined manner along the axis. Therefore, it is possible to manufacture the catheter tube 10 which is suppressed in bending and excellent in pushability and kink resistance.

  The continuous tube 65 for the catheter tube is provided on one end side of the large-diameter portion 41 and the small-diameter portion 42 and the large-diameter portion 41 having different outer diameters, and is reduced in diameter from the large-diameter portion 41 to the small-diameter portion 42. The first transition portion 43 to be formed and the other end of the large-diameter portion 41 are formed by reducing the diameter from the large-diameter portion 41, and the tilt angle X2 with respect to the axis is the tilt angle X1 of the first transition portion 43. A core wire 40 in which a unit structure 45 having a larger second transition portion 44 is continuously formed in advance at a predetermined interval, and an inner layer covering 51 (covering body) formed by covering the core wire 40 with a resin. Have. Thus, since the inclination angle X2 of the second transition portion 44 of the core 40 provided in the continuum 65 is larger than the inclination angle X1 of the first transition portion 43, the length of the second transition portion 44 in the axial direction is short. Thus, unnecessary portions formed on the second transition portion 44 can be reduced as much as possible, so that the manufacturing cost can be reduced and the manufacturing area can be saved.

  Further, a core wire 40 for manufacturing a catheter tube is provided on one end side of a large diameter portion 41 and a small diameter portion 42 having different outer diameters and the large diameter portion 41 and is reduced in diameter from the large diameter portion 41 to the small diameter portion 42. The first transition portion 43 is formed on the other end of the large-diameter portion 41 and is formed by reducing the diameter from the large-diameter portion 41, and the tilt angle X2 with respect to the axis is the tilt angle of the first transition portion 43 A unit structure 45 having a second transition portion 44 larger than X1 is continuously formed in advance at a predetermined interval. Thus, since the inclination angle X2 of the second transition portion 44 of the core wire 40 is larger than the inclination angle X1 of the first transition portion 43, the length of the second transition portion 44 in the axial direction is shortened, and the second transition portion. Unnecessary parts formed on 44 can be reduced as much as possible, so that the manufacturing cost can be reduced and the manufacturing area can be saved.

  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, in the present embodiment, each of the reinforcing body 52, the outer layer covering body 53, and the hydrophilic covering body 54 may not be provided.

  In the present embodiment, the marker 19 is disposed on the reinforcing body 52, but may be disposed between the inner layer covering body 51 and the reinforcing body 52, or may be disposed on the outer layer covering body 53. May be.

  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.

  Further, like the core wire 80 as a modified example shown in FIG. 7, the second transition portion 84 that is provided between the large-diameter portion 81 and the small-diameter portion 82 and is removed is an inclination of the first transition portion 83. The inclination angle X2 may be less than 90 degrees as long as the inclination angle X2 is larger than the angle X1. Even if the inclination angle X2 is less than 90 degrees, if the inclination angle X2 is larger than the inclination angle X1, the length of the excess tube removed after cutting is shortened compared to the case where the inclination angle X2 is equal to the inclination angle X1. (Refer to the surplus chives 62 in FIG. 3E), and cost reduction and space saving in the manufacturing area can be achieved.

  Moreover, at least a part of the shape of the outer peripheral surface of the first 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 modified example 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. 8, the inclination angle X1 of the outer peripheral surface of the first 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 maximum at the substantially central portion, and gradually decreases as the diameter portion 91 is further approached. 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.

Moreover, the 1st transition part 103 formed in the core wire 110 may be formed in multiple steps | paragraphs like the core wire 110 as another modification shown in FIG.

  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,
40, 80, 90, 110 core wires,
41, 81, 91 Large diameter part,
42, 82, 92 Small diameter part,
43, 83, 93, 103 first transition part,
44, 8 4 2nd transition part,
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,
X1 tilt angle of the first transition part,
X2 The inclination angle of the second transition part.

Claims (7)

A large-diameter portion and a small-diameter portion having different outer diameters, a first transition portion provided on one end side of the large-diameter portion and reduced in diameter from the large-diameter portion to the small-diameter portion, and the large-diameter portion of the second transition portion inclination angle relative to the axis is large rather 90 degrees than the first transition portion with provided on the other end side is formed by a reduced diameter to another diameter portion from said large diameter portion A unit structure provided with a covering body forming step of forming a covering body by coating a resin on a core wire continuously formed at a predetermined interval in advance;
A cutting step of cutting a plurality of single tubes by cutting the tubular continuous body obtained on the core wire together with the core wire at a predetermined position of the large diameter portion and the small diameter portion after the covering body forming step;
And a core wire removing step of removing the core wire from the single tube. The method for manufacturing a catheter tube according to claim 1 , further comprising an 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 covering body forming step. The manufacturing method of the catheter tube of Claim 1 or 2 which further has a reinforcement body formation process which forms the reinforcement body which consists of a wire in the radial direction outer side rather than the said covering body after the said covering body formation process. A single tube that is an intermediate body of a catheter tube is a continuous body of catheter tubes in which a plurality of continuous tubes are formed on the same core wire,
A large-diameter portion and a small-diameter portion having different outer diameters, a first transition portion provided on one end side of the large-diameter portion and reduced in diameter from the large-diameter portion to the small-diameter portion, and the large-diameter portion of the second transition portion inclination angle relative to the axis is large rather 90 degrees than the first transition portion with provided on the other end side is formed by a reduced diameter to another diameter portion from said large diameter portion The core structure provided with a core wire continuously formed at a predetermined interval in advance,
A continuous body of a catheter tube having a covering formed by coating a resin on the core wire. The continuous body of the catheter tube of Claim 4 which further has the outer-layer coating body formed with resin in the radial direction outer side rather than the said coating body. The continuous body of the tube for catheters of Claim 4 or 5 which further has the reinforcement body which consists of a wire in the radial direction outer side rather than the said covering body. A core wire for manufacturing a catheter tube that is continuously formed by coating a single tube that is an intermediate body of a catheter tube,
A large-diameter portion and a small-diameter portion having different outer diameters, a first transition portion provided on one end side of the large-diameter portion and reduced in diameter from the large-diameter portion to the small-diameter portion, and the large-diameter portion of the second transition portion inclination angle relative to the axis is large rather 90 degrees than the first transition portion with provided on the other end side is formed by a reduced diameter to another diameter portion from said large diameter portion The core wire in which the unit structure provided is continuously formed in advance at a predetermined interval.

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