JP6124563B2 - Catheter tube manufacturing method and catheter tube continuum - Google Patents

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, and a continuous body of catheter tubes.

  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 has a large inner and outer diameter on the proximal end side, thereby improving rigidity and providing sufficient pushability. The injection characteristic is secured, the inner and outer diameters on the distal end side are made thinner than the proximal end side, and it is made flexible to improve the reachability to the peripheral blood vessels and the followability to the guide wire.

  As a method for manufacturing such a catheter tube, for example, Patent Document 1 discloses that an inner layer is formed by coating a thermoplastic resin 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. A covering body is formed, a reinforcing body such as a metal wire or a resin fiber is formed on the inner layer covering body, and an outer layer covering body made of a thermoplastic resin is coated on the reinforcing body by extrusion molding. A method is described in which after 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 the core wire is pulled out and removed to produce a catheter tube.

JP 2008-183226 A

  However, in the method described in Patent Document 1 described above, a radiopaque marker for enabling observation of the catheter tube inserted into the lumen from outside the body is not provided.

  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 and a catheter tube continuum capable of efficiently placing markers on a plurality of catheter tubes. And

A method of manufacturing a catheter tube that achieves the above-described object includes a method of forming a covering by coating a resin on a core wire in which a large- diameter portion and a small-diameter portion having different outer diameters are continuously formed at predetermined intervals. After the body forming step, after the covering body forming step, a marker arranging step for arranging a plurality of radiopaque markers on the outside in the radial direction of the covering body, and after the marker arranging step, obtained on the core wire possess a cutting step of cutting a plurality of single tubes which the marker is provided in each of the are tubular continuum is cut together with the core, and the core wire removing step of removing the core from the single tube, the said marker placement step A marker is disposed at a position corresponding to at least the small-diameter portion of the large-diameter portion and the small-diameter portion, and in the cutting step, the tubular continuous body is arranged with the large-diameter portion and the small-diameter of the core wire. And cut at a predetermined position in a method for producing a plurality of said cut out single tube tube catheter.

  In the method for manufacturing a catheter tube configured as described above, after covering a core wire and arranging a plurality of markers, the markers are cut in order to cut out a plurality of single tubes each provided with a marker. It can be used as a mark for specifying the position, and the catheter tube can be efficiently manufactured while continuously manufacturing a plurality of catheter tubes using the same core wire. Furthermore, when placing a marker after cutting, it is necessary to reposition the single tube that has been cut out in order to place the marker. The number of times can be reduced, and the catheter tube can be manufactured more efficiently.

  The core wire is formed such that a large diameter portion and a small diameter portion having different outer diameters are continuously formed at a predetermined interval by a diameter reduction process, and the tubular continuous body is formed into a predetermined portion of the large diameter portion and the small diameter portion in the cutting step. If the plurality of the single tubes are cut out at the position, the catheter tubes having different diameters at the distal end side and the proximal end side can be efficiently manufactured while continuously forming a covering body on the core wire. .

In the marker placement step, if the marker is placed at a position corresponding to at least the narrow diameter portion of the large diameter portion and the small diameter portion, the marker is disposed at least at the distal end portion of the manufactured catheter tube, When inserted into a cavity or body cavity, the distal end portion of the catheter tube that is most demanded of observation can be easily observed. In the marker arranging step, if the marker is arranged at a position different from the position corresponding to the large diameter portion and corresponding to the small diameter portion, the marker is formed at the distal end portion of the manufactured catheter tube. Is placed and inserted into a lumen or body cavity, the distal end portion of the catheter tube having the highest demand for observation can be easily observed.

  If the core wire has a transition portion between which the outer diameter increases from the small diameter portion to the large diameter portion between the large diameter portion and the small diameter portion, the rigidity of the manufactured catheter tube is along the axis. Therefore, it is possible to manufacture a catheter tube having excellent pushability and kink resistance.

  If the shape of the outer peripheral surface of the 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 inclined along the axis, resulting in local bending. Is suppressed, and a catheter tube excellent in pushability and kink resistance can be manufactured.

  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 produced by using a continuous tubular body.

  If the catheter further includes a reinforcing body forming step for forming a reinforcing body made of a wire rod on the radially outer side of the covering body after the covering body forming step, the manufactured catheter tube is reinforced depending on the part. Indentation and kink resistance can be improved.

A continuum of catheter tube itself tube is an intermediate of the catheter tube is continuously more formed on the same core, different large-diameter portion and the small-diameter portion of the outer diameter in advance a predetermined interval A core wire formed continuously, a coating formed by coating a resin on the core wire, and an X-ray opaqueness disposed on the radially outer side of the coating corresponding to each of the single tubes possess a plurality of markers, said markers, if continuous body of the large diameter portion and the small-diameter portion of at least the small-diameter portion the catheter tube disposed in a position corresponding to the marker, single tube Therefore, the catheter tube can be efficiently manufactured while continuously manufacturing a plurality of catheter tubes using the same core wire. Furthermore, when placing a marker after cutting, it is necessary to reposition the cut out single tube in order to place the marker. However, since the marker has already been placed in the continuum before cutting, The number of positionings to be performed can be reduced, and the catheter tube can be manufactured more efficiently.

  If the core wire provided in the continuous body is formed such that a large diameter portion and a small diameter portion having different outer diameters are continuously formed at a predetermined interval, a catheter tube having a different diameter on the distal end side and the proximal end side. Can be cut out from a continuous continuous covering and efficiently manufactured.

If the marker provided in the continuous body is arranged at a position corresponding to at least the small diameter portion of the large diameter portion and the small diameter portion, the marker is disposed at least at the distal end portion of the manufactured catheter tube. Thus, when inserted into a lumen or body cavity, the distal end portion of the catheter tube having the highest observation demand can be easily observed. If the marker provided on the continuous body is arranged at a position different from the position corresponding to the large diameter portion and corresponding to the small diameter portion, the tip of the manufactured catheter tube When the marker is placed in the portion and inserted into the lumen or body cavity, the distal end portion of the catheter tube having the highest demand for observation can be easily observed.

  If the core wire provided in the continuum has a transition portion between the large diameter portion and the small diameter portion, the outer diameter of which extends from the small diameter portion toward the large diameter portion, the core wire is drawn out from the core wire. The rigidity of the catheter tube is changed smoothly and in an inclined manner along the axis, and local bending is suppressed, so that a catheter tube excellent in pushability and kink resistance can be manufactured.

  In the continuous body, if the shape of the outer peripheral surface of the transition portion in a cross section along the axis of the core wire has a curve, the rigidity of the catheter tube manufactured by being pulled out from the core wire is smooth and along the axis. The tube for catheter which changes in inclination and is suppressed in local bending and excellent in push-in property and kink resistance can be manufactured.

  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 continuous body in which a multi-layered catheter tube composed of a plurality of layers is integrally connected. Can be manufactured efficiently using

  If the continuous body further includes a reinforcing body made of a wire on the outer side in the radial direction than the covering body, the manufactured catheter tube can be reinforced according to the part, and the pushability and kink resistance are improved. Can be made.

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 marker. 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. 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 marker placement step for placing the marker 19 on the reinforcing body 52 (FIG. 3 (D)), a cutting step (FIG. 3 (E)) for cutting the tubular continuous body 60 obtained on the core wire 40 after the marker placement step and cutting the single tube 61, and forming the outer layer covering 53. Outer layer covering formation process (FIG. 3 (F)), core wire stretching process for stretching the core wire 40 (FIG. 3 (G)), and core wire removal process for removing the core wire 40 from each single tube 61 (FIG. 3 (H)) And a hydrophilic covering forming step for covering the hydrophilic covering 54 Figure 3 (I)), a has. 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 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 0.6 mm. The outer diameter D2 of the small diameter portion 42 can be 0.45 to 0.50 mm, but the dimensions are 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. 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. 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. 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 that is close to one end of the large diameter portion 41 and a first thin portion 42 that is close to the first cutting portion 63 across the transition portion 43. It cut | disconnects with the 2 cutting part 64. FIG. 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 addition, the large diameter part 41 and the small diameter part 42 of the core wire 40 can be set long so that the surplus tube 62 has the same shape as the single tube 61, and the surplus tube 62 can also be used as the single tube 61.

  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 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 may be extruded using the above-described extrusion molding machine 100 as shown in FIG. it can.

  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 by 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 tube distal end portion 12 of the catheter tube 10, a portion on 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 core wire removing step, as shown in FIG. 3 (I), a hydrophilic polymer substance (on the part corresponding to the small diameter part 42 and the part corresponding to the large diameter part 41 of the outer layer covering 53) is formed. A hydrophilic coating 54 is formed by coating the hydrophilic material (hydrophilic coating forming step). Thereby, the catheter tube 10 is completed. The hydrophilic covering 54 (hydrophilic layer 18) on the outer surface of the catheter tube 10 exhibits lubricity when in contact with a liquid such as blood or physiological saline, and the friction resistance of the catheter tube 10 is reduced. Further, the slidability is further improved. As a result, the operability of insertion is further improved, 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. 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 includes an inner layer covering body forming step (covering body forming step) in which an inner layer covering body 51 (covering body) is formed by coating a resin on the core wire 40. After the inner layer covering forming step, the marker arranging step of arranging a plurality of radiopaque markers 19 radially outside the inner layer covering 51, and after the marker arranging step, the core wire 40 is obtained. A cutting step of cutting the tubular continuous body 60 together with the core wire 40 to cut out a plurality of single tubes 61 each provided with a marker 19, and a core wire removing step of removing the core wires 40 from the single tube 61. Thus, after arranging the marker 19, a plurality of single tubes 61 each provided with the marker 19 are cut out, so that the marker 19 can be used as a mark for specifying the position to be cut in the cutting step. The catheter tube 10 can be efficiently manufactured while continuously manufacturing the catheter tube 10 using the same core wire 40. Further, when the marker 19 is arranged after cutting, it is necessary to position the cut-out single tube 61 again when the marker 19 is installed, but in this embodiment, the marker 19 is installed before cutting. The number of times of positioning for performing work can be reduced, and the catheter tube 10 can be manufactured more efficiently.

  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.

  Further, the core wire 40 has a large-diameter portion 41 and a small-diameter portion 42 having different outer diameters continuously formed in advance at a predetermined interval. In the cutting step, the tubular continuous body 60 is formed by the large-diameter portion 41 and the small-diameter portion. In order to cut out a plurality of single tubes 61 by cutting at a predetermined position 42, the tubular tube 60 is continuously connected to the catheter tube 10 having different inner and outer diameters at the tube base end portion 11 and the tube distal end portion 12. It can be efficiently manufactured while being formed on the core wire 40. The manufactured catheter tube 10 has a narrow tube distal end portion 12 as a proximal end side and a small diameter tube distal end portion 12 as a distal end side, thereby impairing the pushability and liquid feeding characteristics of the proximal end portion. The tip is flexible and has excellent guide wire tracking and kink resistance.

  Further, in the marker arrangement step, the marker 19 is arranged at a position corresponding to at least the small diameter portion 42 of the large diameter portion 41 and the small diameter portion 42, so that the marker 19 is at least on the tube tip portion 12 of the manufactured catheter tube 10. Is placed and inserted into the lumen or body cavity, it becomes possible to easily observe the distal end portion 12 of the tube that is most demanded of observation.

  Moreover, since the core wire 40 has the transition part 43 in which an outer diameter expands toward the large diameter part 41 from the small diameter part 42 between the large diameter part 41 and the small diameter part 42, the rigidity of the catheter tube 10 manufactured is manufactured. Changes smoothly and in an inclined manner along the axis of the catheter tube 10, local bending is suppressed, and the catheter tube 10 having excellent pushability and kink resistance can be manufactured.

  Moreover, since it has the outer layer covering body formation process which coat | covers resin to radial direction outer side than the inner layer covering body 51 and forms the outer layer covering body 53 after the inner layer covering body formation process, it has a multilayer structure consisting of a plurality of layers. The catheter tube 10 can be efficiently manufactured using the continuous tubular 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 material in the radial direction outer side from the inner layer coating body 51 after an inner layer coating body formation process, the manufactured tube 10 for catheters according to a site | part. It can reinforce and can improve indentation property and kink resistance.

  Further, the catheter tube continuous body 65 includes a core wire 40, an inner layer covering body 51 (covering body) obtained by coating the core wire 40 with a resin, and an inner layer covering body 51 corresponding to each single tube 61. And a plurality of radiopaque markers 19 arranged on the outer side in the radial direction than the marker 19, the marker 19 can be used as a mark for specifying a position to be cut to obtain the single tube 61. The catheter tube 10 can be efficiently manufactured while continuously manufacturing the plurality of catheter tubes 10 using the same core wire 40. Further, when the marker 19 is arranged after cutting, it is necessary to position the cut-out single tube 61 again in order to install the marker 19, but the marker 19 is already arranged in the continuous body 65 before cutting. Therefore, the number of positioning operations can be reduced, and the catheter tube 10 can be manufactured more 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, in this embodiment, the marker 19 is formed by winding a wire, but as shown in FIG. The marker 110 has a substantially cylindrical shape and has a slit in the cylinder axis direction, and the shape in a cross section orthogonal to the cylinder axis is a C-type. The marker 110 can be disposed by being plastically deformed so as to close the slit 111 after being attached to the cover on the core wire 40 from the outside in the radial direction of the core wire 40 via the slit 111.

  The core wire may be formed with a constant outer diameter without including the large diameter portion 41 and the small diameter portion 42. In this case, the marker may be cylindrical and attached so that the marker is inserted from the axial direction of the core wire.

  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. In addition, when arrange | positioning a marker on the outer layer covering 53, a cutting process will be performed after an outer layer covering formation process.

  Further, the reinforcing body 52 may not be provided between the inner layer covering body 51 and the outer layer covering body 53, and may be provided on the outer side in the radial direction of the outer layer covering body 53, for example. In addition, each of the reinforcing body 52, the outer layer covering body 53, and the hydrophilic covering body 54 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.

  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. 3D) to be removed after cutting is shortened, and the cost can be reduced and the manufacturing area can be saved.

  Moreover, 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, as 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. 8, 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.

  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,
19,110 markers,
40, 80, 90 core wires,
41, 81, 91 Large diameter part,
42, 82, 92 Small diameter part,
43, 83, 93 Transition section,
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 (10)

A covering body forming step of forming a covering body by coating a resin on a core wire in which a large diameter portion and a small diameter portion having different outer diameters are continuously formed at a predetermined interval ;
A marker placement step of placing a plurality of radiopaque markers on the radially outer side of the covering after the covering forming step;
After the marker placement step, a cutting step of cutting a tubular continuous body obtained on the core wire together with the core wire at a predetermined position to cut out a plurality of single tubes each provided with the marker;
Have a a core removing step of removing the core from the single tube,
In the marker arrangement step, a marker is arranged at a position corresponding to at least the small diameter portion of the large diameter portion and the small diameter portion,
In the cutting step, a method for manufacturing a catheter tube in which the tubular continuous body is cut at predetermined positions of the large-diameter portion and the small-diameter portion of the core wire to cut out a plurality of the single tubes . The method for manufacturing a catheter tube according to claim 1 , wherein, in the marker placement step, a marker is placed at a position different from a position corresponding to the large diameter portion and corresponding to the small diameter portion. The said core wire is a manufacturing method of the tube for catheters of Claim 1 or 2 which has the transition part which an outer diameter spreads toward a large diameter part from a small diameter part between the said large diameter part and a small diameter part. The method for manufacturing a catheter tube according to claim 3 , wherein the shape of the outer peripheral surface of the transition portion in a cross section along the axis of the core wire has a curve. Later than the covering member forming step, according to any one of claims 1 to 4, further comprising an outer layer covering body forming step of coating the resin radially outward than the covering member to form the outer layer covering body A method for producing a catheter tube. The catheter tube according to any one of claims 1 to 5 , 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. Production method. 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 core wire in which a large- diameter portion and a small-diameter portion having different outer diameters are continuously formed at predetermined intervals ;
A coated body formed by coating a resin on the core wire;
A plurality of radiopaque markers arranged on the radially outer side of the covering body corresponding to each of the single tubes ,
The marker is a continuous body of a catheter tube disposed at a position corresponding to at least the small diameter portion of the large diameter portion and the small diameter portion . The continuous body of catheter tubes according to claim 7 , wherein the marker is arranged at a position different from a position corresponding to the large diameter portion and corresponding to the small diameter portion. The continuous body of the catheter tube according to claim 7 or 8 , further comprising an outer layer covering body formed of a resin on a radially outer side than the covering body. The radially outward from the cover member, the continuum of the catheter tube according to any one of claims 7-9, further comprising a reinforcing member made of wire material.

Images