JP2005334396A - Medical catheter tube and method for manufacturing it - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical catheter tube which has a high degree of freedom for adjusting and controlling rigidity and flexibility gradually and allows to set its states in accordance with various access routes, and also to provide a method for manufacturing the same. <P>SOLUTION: The medical catheter tube comprises an inner layer tube, a reinforcing material layer, and an outer layer tube. The medical catheter tube is characterized as follows: the reinforcing material layer is made of a filament body which is a strand having a cross section made of an arc and a chord or a strand having a polygonal cross section, such as pentagonal or less, with less than two pairs of parallel sides, and the longest side of the strand is wound around the inner layer tube so that the longest side contacts the inner layer tube; the outer layer tube is made of a resin tube whose Shore D hardness is changed by at least one step from a base section to a tip section of the catheter tube; and the tip section of the catheter tube does not have the reinforcing material layer. Because the medical catheter tube has the reinforcing material layer, the outer layer tube and such a configuration, the flexural rigidity of the medical catheter tube can be reduced gradually or continuously from the base section to the tip section. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a medical catheter tube having excellent position adjustability, torque transmission performance, kink resistance, high degree of freedom of adjustment of inclination control of rigidity and flexibility, tone setting property according to various access paths, and the like. It relates to a manufacturing method.

  A catheter tube is a hollow medical device that is inserted into a body cavity, tube, blood vessel, etc., for example, injection of a liquid such as a selective angiographic agent, suction of a thrombus, securing a passage of a blood vessel in an obstructed state, vasodilation It is usually used as a tube body. Such a catheter is required to have excellent operability so that it can be quickly and reliably inserted into a vascular system having a thin and complicated pattern.

  The operability of such a catheter tube will be described in detail. Position adjustment to ensure that the operator's operation is transmitted from the base to the distal end, such as insertion and withdrawal in the blood vessel, etc., and chemicals etc. are circulated inside The pressure resistance at the time of making it is required. Also, torque transmission to ensure that the rotational force applied at the base of the catheter tube is transmitted reliably, and push-in that allows the operator's pushing force to be reliably transmitted from the proximal side to the distal side to advance in the blood vessel Sex is also required. In addition, the guide tube followability and the outer surface of the catheter tube that the inner surface of the catheter tube is slidable so that the blood vessel bent into a complicated shape can be smoothly inserted and pulled along the preceding guide wire without damaging the inner wall of the blood vessel. Affinity for blood and tissues is required. In addition, even when the distal end of the catheter tube reaches the target position and the guide wire is pulled out, kink resistance that prevents the catheter tube from bending at the curved and bent portions of the blood vessel and the shape according to the blood vessel shape The flexibility of the tip to keep is required.

  In general, it is known that a structure and a configuration in which the base portion is relatively rigid and gradually becomes flexible toward the distal end portion should be used in order to provide such characteristics according to the requirements.

  In order to obtain a catheter tube having the above-mentioned characteristics, a method is known in which a linear tube is wound around an inner layer tube as a reinforcing material layer in a coil shape or braided, and then the outer layer is covered to form a catheter tube. It has been.

  Patent Document 1 has a catheter main body having a portion in which a flexible inner tube and an outer tube are joined via a reinforcing material layer as a wire wound around an inner layer tube as a reinforcing material layer. The reinforcing material layer is formed by forming a linear body in a lattice shape, and the inclination angle of the linear body with respect to the axis of the catheter body changes continuously or stepwise along the axial direction of the catheter body. Or a catheter tube that forms a region having a large bending stiffness and a region having a small bending stiffness by continuously or stepwise changing the spacing of the lattice points of the striate body in the axial direction of the catheter body. ing.

  However, this catheter tube can form a rigid base and a highly flexible tip, but the degree of freedom in controlling the rigidity and flexibility of the tilt is low. There is a need for a catheter tube having a relatively large inner and outer diameter, and the kink resistance is inferior when attempting to reduce the catheter tube wall thickness. Furthermore, there is no idea of setting the condition of the catheter tube according to various access routes.

  In addition, as a reinforcing material layer wound around the inner tube in a coil shape, as in Patent Document 2, a proximal end, a distal end, and a passage that defines a lumen extending between these ends are provided. A catheter tube with an elongate tubular member, the elongate tubular member having an inner tubular liner made of a first liner material coaxially with an outer tubular cover having a first cover material and one circumference. A catheter tube is disclosed that includes at least one first ribbon reinforcement wound helically and coaxially outside the inner tubular liner and covered by the outer tubular cover.

  However, even in this configuration, the degree of freedom in controlling the inclination of the rigidity and flexibility is low, and in addition, due to the elastic force of the ribbon reinforcing material, the cut end breaks through the inner tubular liner and the outer tubular cover, resulting in production. Inferior to sex. Furthermore, there is no idea of setting the condition of the catheter tube according to various access routes.

  Further, in Patent Document 3, there is provided a reinforcing material layer intervening portion in which a substantially cylindrical inner tube and an outer tube each having flexibility are fixed via a reinforcing material layer so that the inner tube is inside the outer tube. The reinforcing material layer includes one or a plurality of rectangular filaments having a tensile strength of 500 MPa to 2000 MPa, braided in a net shape, and each rectangular with respect to the axial direction of the inner tube. There is disclosed a flexible tube characterized by having a reinforcing material such that the angle formed by the filaments changes stepwise or continuously substantially along the axial direction.

  However, even with this catheter tube, a rigid base and a flexible tip can be formed, but the degree of freedom in controlling the rigidity and flexibility of the tilt is low. There is a need for a catheter tube having a particularly large inner and outer diameter, and the kink resistance is inferior when attempting to reduce the catheter tube wall thickness. Furthermore, there is no idea of setting the condition of the catheter tube according to various access routes.

  In addition, as disclosed in Patent Document 4, a catheter including a flexible tubular catheter body and a coil having a reinforcing effect embedded in the wall of the catheter body, A first region located on the most distal side of the catheter and a second region located on a proximal side relative to the first region, and the coil extends from the first region to the second region. In the second region, the coil is wound at a relatively large winding pitch over the entire length, and in the first region, the coil is adjacent to the adjacent windings over the entire length. The coil is wound at a small winding pitch, and the winding pitch of the coil is gradually decreased toward the distal end side, and the rigidity of the catheter in the first region is larger than that in the second region. Catheter tube, characterized by being configured such that fence is disclosed.

  However, this catheter tube can form a rigid base and a flexible tip and can maintain the balance of bending rigidity, but the catheter tube can be adjusted according to various access routes. There is no idea of doing.

  Further, in Patent Document 5, a metal braid is continuously coated over the entire outer periphery of a tube body made of a thermoplastic resin into which a metal core wire is inserted as a braided wire braid as a reinforcing material layer on an inner layer pipe. After the torque transmitting portion is continuously formed, a laser beam having a wavelength of 1.06 μm is irradiated from the outside to remove a part of the braid intermittently over the length direction of the tube body. A plurality of insertion tip portions having a constant width in the length direction are formed at predetermined intervals, and then the metal core wire is extracted, and then the tube body is divided into a plurality at the end portions of the insertion tip portions. Thus, a catheter tube manufacturing method is disclosed in which the insertion tip is continuously formed at the tip of the torque transmitting portion.

However, the process of intermittently removing a part of the braid by irradiating a laser beam having a wavelength of 1.06 μm along the length direction becomes very cumbersome. Furthermore, after continuously forming and forming a metal braid over the entire outer periphery of the tube body made of a thermoplastic resin into which the metal core wire in the subsequent process is inserted, the tube body is heated and softened, and the braid is thickened on the outer surface thereof. Even when the torque transmission part is continuously formed by biting in and fixing about 1/2 to 1/5 of the length, when elasticizing the braid by heating and softening the tube body, When the cut end is warped, problems such as metal braiding popping out on the tube surface occur, resulting in poor productivity. Furthermore, sufficient tilt control of rigidity and flexibility cannot be obtained. Furthermore, there is no idea of setting the condition of the catheter tube according to various access routes.
Patent 3310031 Japanese Patent No. 2672714 JP 2001-299922 A JP 2001-218851 A JP 2000-225194 A

An object of the present invention is to provide a medical catheter tube having excellent position adjustability, torque transmission performance, flexibility, kink resistance, pressure resistance, pushability, and the like, and to disclose a manufacturing method thereof.
In particular, since the medical catheter tube of the present invention is used in various affected areas, there are various access paths to the target site. Therefore, the medical catheter tube has a high degree of freedom in adjusting the inclination control of rigidity and flexibility. An object of the present invention is to provide a medical catheter tube capable of setting a tone according to various access paths and to disclose a manufacturing method thereof.

The present invention comprises an inner layer tube made of a resin tube that exhibits lubricity and flexibility, and a linear member that adjusts flexibility and further imparts kink resistance, torque transmission property, pushability, etc. is wound around the inner layer tube. A medical catheter tube in which an outer layer pipe made of a resin pipe covering the reinforcing layer and having flexibility is integrated,
The catheter tube has a base and a distal end;
The cross-sectional shape of the striate body forming the reinforcing material layer is a polygon with a pentagon or less and two parallel sides with less than two pairs of strands, or a strand composed of an arc and a chord,
The longest side is wound on the inner layer tube,
The outer tube is arranged such that the resin tube forming it from the base to the tip has a Shore D hardness of one or more stages,
It has a tip where no reinforcing material layer exists,
The present invention relates to a medical catheter tube characterized in that bending rigidity from a base portion to a distal end portion decreases stepwise or continuously due to the presence of the reinforcing material layer and the outer layer tube.

  Further, in the medical catheter tube of the present invention, the winding of the linear body forming the reinforcing material layer is fixed to the inner layer tube with the end portion being the strand itself, and the winding is at an equal inclination angle and / or the like. The inclination angle and / or the inclination angle and / or the distance change continuously and / or stepwise and / or have a folded portion.

The medical catheter tube of the present invention is
From the base part to the tip part, the arrangement of the Shore D hardness of the resin pipe forming the outer layer pipe is gradually reduced.

  Furthermore, the medical catheter tube of the present invention has a stepwise decrease in the winding of the strands forming the reinforcing material layer and the Shore D hardness of the resin tube forming the outer layer tube from the base to the tip. It is characterized by being able to set various tones.

Further, the distal end portion of the medical catheter tube of the present invention has an inner layer at a distal end portion where no reinforcing material layer is present and only the inner layer tube and the outer layer tube are joined, and at a position closer to the base portion than the distal end portion. It is present between the tube and the outer layer tube and has a radiopaque marker.

  Furthermore, the medical catheter tube of the present invention is characterized in that an inner layer tube and an outer layer tube are joined via a reinforcing material layer.

  The medical catheter tube of the present invention is made of a resin that exhibits lubricity with respect to a guide wire or the like through which an inner layer tube passes.

  Moreover, in the most advanced part of the medical catheter tube of the present invention, the outer diameter of the outer layer tube is changed and formed into a round shape or a tapered shape, and / or the inner and outer diameters of the inner layer tube are changed.

  In the medical catheter tube of the present invention, the outer tube is coated with a hydrophilic coating.

  Further, in the method for producing a medical catheter according to the present invention, the reinforcing material layer is formed on the outer periphery of the inner layer tube, and then the outer layer tube is covered to manufacture the catheter tube. Winding a linear body supplied from a linear body supply unit around the outer circumference of the inner layer pipe in a spiral manner, and changing a relative movement speed and / or a relative rotation speed between the inner layer pipe and the linear body supply unit; and By changing the relative movement direction of the inner layer tube and the striate body supply section, the inclination angle and the interval of the striatum with respect to the catheter tube axis can be continuously and / or along the axial direction of the catheter tube. It is characterized by being changed in stages and / or having a folded portion.

  In addition, in the method for manufacturing a medical catheter tube according to the present invention, a reinforcing material layer is formed on the outer periphery of the inner layer tube, and then the outer layer tube is coated to manufacture the catheter tube. When the shore D hardness of the resin pipe is arranged in one or more stages, and when the shore D hardness of the resin pipe is multistage, the shore D hardness arrangement is stepwise from the base to the tip. It is characterized by being arranged so as to be smaller and various tones can be set.

  Furthermore, in the method for manufacturing the medical catheter tube, when the reinforcing material layer is formed on the outer periphery of the inner layer tube and then the outer layer tube is coated to manufacture the catheter tube, the outer layer tube is a resin tube that forms the outer tube. Arranged so that the Shore D hardness is one or more steps, and when the Shore D hardness of the resin tube is multi-staged, arrange the Shore D hardness so that it gradually decreases from the base to the tip. Cover the tube with a shrink tube and heat it to integrate the inner layer tube, reinforcement layer, and outer layer tube, and further shape the leading edge into a round shape or taper shape, and then cool the shrink tube after cooling it. It features a method of peeling to obtain a medical catheter tube.

  Further, in the method for producing a medical catheter tube of the present invention, a reinforcing material layer is formed on the outer periphery of the inner layer tube, and then the outer layer tube is coated to manufacture the catheter tube. Arranged so that the Shore D hardness of the pipe is one or more steps, and when the Shore D hardness of the resin tube is multistage, arrange the Shore D hardness so that it gradually decreases from the base to the tip, The catheter is passed through an electric heater and / or a mold heated by high-frequency induction to integrate the inner layer tube, the reinforcing material layer, and the outer layer tube, and the most advanced portion is formed into a round shape or a tapered shape. It features a manufacturing method for obtaining a tube.

  Furthermore, in the method for manufacturing a medical catheter tube according to the present invention, a reinforcing material layer is formed on the outer periphery of the inner layer tube, and then the outer layer tube is coated to manufacture the catheter tube. The outer layer tube is formed by covering and extruding the structure having the reinforcing material layer formed thereon so that the Shore D hardness becomes one step or more, and when the Shore D hardness is multistage, the Shore D hardness is from the base to the tip. A manufacturing method for obtaining a medical catheter by forming the outer layer tube so as to gradually become smaller over the part, integrating the inner layer tube, the reinforcing material layer, and the outer layer tube, and further forming the leading edge into a round shape or a tapered shape. It is characterized by.

  By means for solving the above-mentioned problems, the present invention is capable of adjusting the position with excellent guide wire followability, torque transmission when the operator gives a rotational force, and continuous flexibility from the base to the tip. Changes in rigidity, high flexibility in flexibility, tone setting according to various access routes, kink resistance that does not cause bending even when complicated bending occurs, guide wire followability, production There is an effect of providing a medical catheter tube having the characteristics.

  The best mode and manufacturing method of the medical catheter tube of the present invention will be described below with reference to the drawings. These drawings schematically show the characteristics of the configuration of the present invention, and the length and diameter of each part are arbitrary as long as they can be suitably used as a medical catheter tube. ing.

  First, as shown in FIG. 1, an inner tube coated with a metal core wire is prepared. In FIG. 1, for the sake of convenience, the left side is the base and the right side is the tip.

  As a constituent material of the inner layer tube, for example, fluorine-based polytetrafluoroethylene, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer, tetrafluoroethylene-hexafluoropropylene copolymer, ethylene-tetrafluoroethylene copolymer, etc. Examples thereof include resins, polyolefins such as polypropylene, polyethylene, and ethylene-vinyl acetate copolymer, polyesters such as polyamide, polyethylene terephthalate, and polybutylene terephthalate, resins such as polyurethane, polyvinyl chloride, polystyrene resins, and polyimides, and mixtures thereof. However, from the viewpoint of obtaining excellent position-adjustability with a guide wire following property, the finished product exhibits excellent lubricity with respect to the guide wire or the like passing through the inner layer tube, or polytetrafluoroethylene or It is preferably made of a perfluoroalkyl vinyl ether copolymer - tetrafluoroethylene.

  It is preferable that the inner tube covered with the metal core wire has a sufficient adherence to the metal core wire. Further, in the process of coating the outer tube, the inner tube surface is mechanically applied to the inner tube surface with sandpaper or the like in the direction perpendicular to the axial direction in order to increase the adhesion between the inner tube and the outer tube. The surface may be modified or surface-modified by means such as rubbing) and / or chemical methods (use of drugs such as sodium naphthalene + dimethyl ether) and / or electrical methods such as plasma. Good.

  Moreover, you may process the front-end | tip part of an inner-layer pipe | tube with a mechanical or chemical means so that the outer diameter may become small gradually as it goes to the most advanced part.

  Next, as shown in FIGS. 2 and 3, the end of the striate body is fixed by covering with the striate body itself, and winding is started so that the striate body cannot be unwound from the base of the inner layer tube. Here, FIG. 2 is a schematic diagram when winding is started from the tip of the inner layer tube, and FIG. 3 is a schematic diagram when winding is started from the base of the inner layer tube. By winding so that the striate does not unwind and loosen with respect to such an inner layer pipe, problems such as idle rotation and displacement do not occur, and the striate body can be strongly wound around the inner layer pipe. .

  The cross-sectional shape of the striate body that forms the reinforcing material layer is a polygon that is a pentagon or less, and uses two strands whose parallel sides are less than two sets, or a strand that consists of an arc and a chord. 4 has a shape as shown in FIG. 4, and the longest side is wound in contact with the inner layer tube, so that the contact area between the striate body and the inner layer tube is increased. If you roll while giving, you can prevent it from unraveling and not loosening.

  Further, by forming the cross-sectional shape of the striate forming the reinforcing material layer as shown in FIG. 4, the inner layer, the reinforcing layer, and the outer layer pipe that may cause kinks when the outer layer pipe is covered in a later process. During this time, air and the like are not caught, and the three layers are firmly integrated.

  As a method for winding the reinforcing material layer, the following method can be adopted.

  That is, FIG. 5 shows a method in which the winding of the filament is started from the distal end portion of the inner layer tube, and reaches the base portion and terminates the winding (herein referred to as 0.5 reciprocating winding).

  FIG. 6 shows a method of starting winding from the base portion of the inner layer tube, reaching the tip portion, turning back there, and returning to the base portion again as shown in FIG. ).

  As shown in FIG. 8, the winding of the filament is started from the distal end portion of the inner layer tube, folded at the base portion, further wound toward the distal end portion as shown in FIG. 9, and folded again at a position not reaching the distal end. In this way, the winding reaches the base and terminates the winding (here, temporarily called 1.5 reciprocating winding).

  Winding is started from the base of the inner tube as shown in FIG. 11 and reaches the tip, where it is folded back to reach the base as shown in FIG. 12, and then folded back and wound in the direction of the tip as shown in FIG. This is a method of turning back at a position where it does not reach and then ending the winding by reaching the base as shown in FIG. 14 (referred to herein as two reciprocating windings).

  Winding is started from the tip of the inner layer tube as shown in FIG. 15, reaches the base and ends winding, and starts winding from the position where it does not reach the tip again as shown in FIG. This is a method of terminating the turn (here, tentatively referred to as multi-stage winding). 15 and 16 show a method in which the winding is performed in two stages, but this may be performed in more stages.

  In any of the methods listed here, each winding has an equal inclination angle and / or equal interval, and / or an inclination angle and / or interval that changes continuously and / or stepwise. Further, in any of the methods listed here, the interval between the filaments is indicated by a, and the inclination angle of the filaments is indicated by θ. As for the space | interval a of a filament, and the inclination | tilt angle (theta) of a filament, it is preferable that a is so small that it is near a front-end | tip part, and (theta) takes a big angle.

  Any material may be used as a constituent material of the striatum constituting the reinforcing layer as long as it has a rigidity sufficient to obtain a sufficient reinforcing effect. For example, stainless steel, copper, tungsten, platinum (Pt), gold , Pt—Ir alloy, Pt—W alloy, Pt—Ni alloy, nickel, titanium, piano wire, Ni—Ti alloy, Ni—Ti—Co alloy, Ni—Al alloy, Cu—Zn alloy, Cu—Zn—X Various metal materials such as superelastic alloys such as alloys (for example, X = Be, Si, Sn, Al, Ga) and amorphous alloys, for example, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polymethylene terephthalate Polyester such as (PPT), polyethylene, polyolefin such as polypropylene, rigid polyvinyl chloride, polyamide, Riimide, polystyrene, thermoplastic polyurethane, polycarbonate, ABS resin, acrylic resin, polymethyl methacrylate (PMMA), polyacetal (PA), polyarylate, polyoxymethylene (POM), high tension polyvinyl alcohol, fluororesin, polyvinylidene fluoride ( PVdF), polytetrafluoroethylene, ethylene-vinyl acetate saponified product (EVOH), polysulfone, polyethersulfone, polyetherketone, polyphenylene oxide, polyphenylene sulfide, aromatic polyaramid represented by Kevlar, etc. Examples thereof include polymer alloys, carbon fibers, and glass fibers. Of these materials, stainless steel is preferred for reasons such as workability, economy, and lack of toxicity.

  The filament may be either a single fiber or an aggregate of fibers (for example, a single fiber). In addition, the thickness of the striatum is such that a necessary and sufficient reinforcing effect is obtained in relation to its constituent materials. For example, in the case of using the above metal material, the diameter is preferably about 5 to 50 μm. . In addition, a linear body may be used by single, or may be used in the state which bundled multiple pieces.

  Here, even when any winding method is used, the linear body having a rigidity sufficient to obtain a sufficient reinforcing effect may have elasticity at the same time, so that this end prevents unwinding. For this purpose, it is preferable to cut the filament after winding and fixing a plastic metal wire such as aluminum, or to heat and shrink after covering the shrink tube, and then cutting the filament after fixing.

  The method of winding the filament for forming the reinforcing layer is to spirally wind the filament supplied from the filament supply unit on the outer periphery of the inner tube, and supply the inner tube and the linear member. By changing the relative position of the part to the left and right, and changing the relative moving speed and / or the relative rotational speed of the inner layer tube and the striate body supply part, the striate is along the axial direction of the catheter tube. This is done by changing the tilt angle and / or spacing of the body relative to the catheter tube axis continuously and / or stepwise.

  Further, the winding of the above-mentioned wire rod can be achieved by fixing the supply portion of the wire rod and rotating the inner tube covered with the metal core, or conversely, the wire core covered This can also be achieved by fixing the inner layer tube and rotating the supply portion of the filament. Furthermore, when performing winding, it is preferable to maintain a constant tension between the linear body and the inner layer pipe from the viewpoint of preventing displacement of the linear body wound around the inner layer pipe.

  Subsequently, a radiopaque marker is placed as shown in FIG. 17 (representing 0.5 reciprocating windings in the figure). In the case where the striatum forming the reinforcing material layer already has radiopacity, the first reciprocating tip can be used as a radiopaque marker. When a radiopaque marker is installed separately from the reinforcing material layer, the position is in contact with the reinforcing material layer, and the material, shape and means thereof are platinum (Pt), Pt-Ir alloy. , Pt-W alloy, Pt-Ni alloy, gold, silver or other wire is wound, or platinum (Pt), gold, Pt-Ir alloy, Pt-W alloy, Pt-Ni alloy, silver, etc. are arranged Or platinum (Pt), Pt—Ir alloy, Pt—W alloy, Pt—Ni alloy, gold, silver, etc. are arranged in a cylindrical shape, barium sulfate, bismuth oxide, bismuth subcarbonate, tungstic acid A resin tube in which powders such as bismuth and bismuth-oxychloride are kneaded may be disposed.

  Next, when using a wire body that does not have radiopacity as the striatum forming the reinforcing material layer, is it caulked to fix the radiopaque marker as shown in FIG. And / or bonded to the inner layer tube, bonded to the reinforcing material layer, welded, welded, and / or a plastic metal wire such as aluminum (round line or corner in contact with a radiopaque marker) It is preferable to form a structure by winding and fixing the wire.

  Further, as shown in FIG. 19, an outer layer tube is arranged from the base portion to the tip portion, and the resin tube forming the outer tube has one or more stages of Shore D hardness. Although FIG. 19 shows a state where four types of Shore D hardness are closely arranged, it is necessary to dispose the Shore D hardness gradually from the base portion to the tip portion. Those having a Shore D hardness of about 20 to 80 are preferably used. When only the outer layer pipe having one type of Shore D hardness is arranged, the outer layer pipe having one type of Shore D hardness may be divided into a plurality of pieces and arranged closely.

  In this way, the length and interval of winding of the reinforcing material, the inclination angle, the arrangement of the resin pipes with different Shore D and the setting of the length are combined, and the degree of freedom of adjustment of the inclination control of rigidity and flexibility is high and various. Tone setting according to various access routes is demonstrated. The term “tone” as used herein means that the position of the highly flexible region at the tip is different as shown in FIG. In FIG. 20, the straight line portion shows higher rigidity than the tip portion, but also shows that flexibility is secured at the same time. By being able to set various tones, in Fig. 20, the closer to No. 1 tone, the more sensitive the torque of the tip part is, and at the same time the higher the torque transmission capability, the closer to No. 5 tone, In addition to the matter of use such as easy access to the deep part, there is an advantage that the intention of the surgeon's surgical method is reflected and selected for various affected parts.

  As the material of the resin tube forming the outer tube, various elastomers such as polyamide elastomer, polyester elastomer, polyurethane elastomer, polystyrene elastomer, fluorine elastomer, silicone rubber, latex rubber, or a combination of two or more of these are used. Is possible.

  Here, the polyamide elastomer is, for example, nylon 6, nylon 64, nylon 66, nylon 610, nylon 612, nylon 46, nylon 9, nylon 11, nylon 12, N-alkoxymethyl modified nylon, hexamethylenediamine-isophthalic acid. Typical block copolymers include polycondensates, various aliphatic or aromatic polyamides such as metaxyloxydiamine-adipic acid polycondensate as hard segments, and polymers such as polyester and polyether as soft segments. In addition, a polymer alloy (polymer blend, graft polymerization, random polymerization, etc.) of the polyamide and a flexible resin, a softened polyamide with a plasticizer or the like, and a concept including a mixture thereof It is.

  The polyester elastomer is typically a block copolymer of a saturated polyester such as polyethylene terephthalate or polybutylene terephthalate and a polyether or polyester. In addition, the polymer alloy or the saturated polyester may be used as a plasticizer. It is a concept that includes a softened material and a mixture thereof.

  As a material suitably used, a polyamide elastomer is preferable from the viewpoint of processability and flexibility. For example, PEBAX manufactured by elf atochem is representative.

  Subsequently, the inner peripheral surface of the outer layer tube is the outer peripheral surface of the inner layer tube, and the striatum forming the reinforcing layer, in addition, the adjacent outer layer tubes having different Shore D hardnesses are closely bonded and integrated, For example: As shown in FIG. 21, the entire structure is covered with a shrink tube having a property of reducing its diameter when heated and heated and fused with a heater and / or heated and fused and integrated by applying high-frequency electromagnetic waves. The method can be suitably used. As a result, the inner layer tube, the reinforcing material layer, and the outer layer tube are tightly integrated with each other, and the leading end portion of the soft outer layer tube is shaped like a round shape by the softening of the resin and the shrinkage of the shrink tube. In addition, due to this shaping, the inner and outer diameters of the inner tube may be reduced when the metal core is pulled out as described later.

  When forming the outer layer tube, as shown in FIG. 19, the outer tube is formed from the base portion to the tip portion so that the resin tube forming the outer layer tube has one or more stages of Shore D hardness, and the resin tube has a large Shore D hardness. When setting the stage, the Shore D hardness is arranged so as to gradually decrease from the base portion to the tip portion, and then the whole is passed through a mold that can be heated by an electric heater and / or high-frequency induction, thereby forming an inner tube The reinforcing material layer and the outer layer tube can be integrated (not shown).

  In addition, when the outer layer tube is coated and extruded to the structure in the state of FIG. 18 so that the Shore D hardness is one or more steps, and when the Shore D hardness is multi-stepped, the Shore D hardness ranges from the base portion to the tip portion. It is also possible to adopt a method in which the outer layer tube is formed by covering and extruding so as to gradually become smaller, and the inner layer tube, the reinforcing material layer, and the outer layer tube are integrated (not shown). At this time, when coating a resin having a multi-stage, for example, three-stage Shore D hardness, three extruders are connected to one extrusion mold and controlled so as to achieve a target outer diameter, and the three are sequentially applied. The outer layer tube can be formed by operating and stopping the extruder of the table. In addition, three extruders are connected to a mold having a valve mechanism, and while continuously extruding, a resin having a different Shore D hardness is sequentially applied to the extrusion flow channel while covering and switching the outer tube. It can also be formed. In this way, when performing the covering extrusion, a large number of metal core portions of the structure in the state of FIG. 18 may be connected in series by a method such as welding.

  Further, when it is necessary to form the tip of the outer layer tube into a tapered shape or a tapered shape, the inner surface is coated with a non-stick coating typified by polytetrafluoroethylene as shown in FIG. 22 and can be heated with a heater. A mold is prepared, and the outermost tube endmost portion is inserted into the mold as shown in FIG. In FIGS. 22 and 23, the shrink tube shown in FIG. 21 is coated. However, the inner layer pipe, the reinforcing material layer, and the outer layer pipe described above are heated inside the mold that can be heated by an electric heater and / or high frequency induction. When the outer layer tube is coated and extruded so that the Shore D hardness becomes one or more steps on the structure that has been integrated by passing or the structure in the state of FIG. The outermost layer tube is formed by coating and extruding the outer layer tube so that the D hardness gradually decreases from the base to the tip, and the inner layer tube, the reinforcing material layer, and the outer layer tube are integrated, and the outermost layer tube most advanced part is a mold as shown in FIG. It is also possible to form into a tapered shape or a tapered shape using

  Next, the shrink tube is peeled off as shown in FIG. 24 and the metal core is pulled out as shown in FIG. 25 to obtain a catheter tube. Here, the base end can be cut into an inner layer, a reinforcing layer, and an outer layer by means such as a disk-shaped diamond cutter that rotates at high speed for shaping, and the base end cross section can be finished into a single plane (not shown).

  Further, although not shown here, the catheter tube surface is preferably covered with a hydrophilic (or water-soluble) polymer substance. As a result, when the outer surface of the catheter tube comes into contact with blood or saline, the friction coefficient is reduced and lubricity is imparted, and the slidability of the catheter tube is further improved. Followability, kink resistance and safety are further enhanced. 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 are preferable because a low coefficient of friction can be stably obtained.

  In addition, although not shown here, a hub having an appropriate shape is attached to the base end to obtain the medical catheter tube of the best form of interest.

In addition, when using it, it may be used as described above, and if necessary, a part of the medical catheter tube may be heated with a heater or the like in advance to form a curved portion.

  Hereinafter, specific examples of the medical catheter tube of the present invention will be described.

(Example 1)
The reinforcing material was wound by one reciprocating winding shown in FIGS. 6 and 7 to manufacture a medical catheter tube. The reinforcing material layer was produced using a winding machine. The outer layer tube was integrated using a shrink tube.
Total length of catheter tube: 1000 mm from the catheter base end.
Reinforcement material 1 reciprocating winding area: Up to a position of 998 mm from the catheter base end.
Marker installation area: 1 mm width from the catheter base end to a position of 998 mm to 999 mm is used.
The inner layer tube and the outer layer tube are only adhered at a position of 999 mm to 1000 mm from the base end.
Inner diameter of inner tube: 0.5mm
Outer diameter of inner layer tube: 0.6mm
Material composing inner layer tube: outer diameter of outer layer tube after completion of polytetrafluoroethylene catheter tube: 0.8 mm
Material constituting the outer tube: Pebax4033 (Shore D hardness 40D) manufactured by elf atochem
Wires constituting the reinforcing material layer: stainless steel (SUS304) cross-sectional regular triangle, one side length of 20 μm.

  A hub is attached to the proximal end portion of the catheter tube, and is fixed by winding it around a metal rod having a diameter of 3 mm from a position of 890 mm from the proximal end portion. Saline was immersed in warm water under constant temperature set in the vicinity, and physiological saline dyed with red food was injected from the hub using a syringe at a rate of 0.2 cc / min.

  As a result, it was confirmed that the physiological saline was continuously and stably released from the tip portion, and even when taken out from the warm water, no kinks were generated in the portion wound five times.

(Example 2)
The reinforcing material was wound by 1.5 reciprocating winding shown in FIGS. 8, 9, and 10 to manufacture a medical catheter tube. The reinforcing material layer was produced using a winding machine. The outer layer tube was integrated using a shrink tube.
Total length of catheter tube: 1000 mm from the catheter base end.
Reinforcement material 1 reciprocating winding area: Up to a position of 998 mm from the catheter base end.
Marker installation area: 1 mm width from the catheter base end to a position of 998 mm to 999 mm is used.
The inner layer tube and the outer layer tube are only adhered at a position of 999 mm to 1000 mm from the base end.
Inner diameter of inner tube: 0.6mm
Outer diameter of inner layer tube: 0.7mm
Material composing inner layer tube: outer diameter of outer layer tube after completion of polytetrafluoroethylene catheter tube: 0.9 mm
Base end region to 700 mm: Pebax 6333 (Shore D hardness 63D) manufactured by elf atochem
700mm to 900mm area from the base end: Pebax4033 (Shore D hardness 40D) manufactured by elf atochem
900 mm to 1000 mm area from the base end: Pebax 2533 (Shore D hardness 25D) manufactured by elf atochem
Wires constituting the reinforcing material layer: stainless steel (SUS304) cross section trapezoid, lower base length 20 μm, upper base length 10 μm, height 10 μm.

  A hub is attached to the proximal end portion of the catheter tube, and it is fixed by winding it around a metal rod having a diameter of 5 mm from a position of 650 mm from the proximal end portion, and the hub is attached to the proximal end portion so that the entire temperature of the catheter tube is 37 ° C. It was immersed in warm water under constant temperature set in the vicinity, and physiological saline dyed with red food was injected from the hub using a syringe at a rate of 0.8 cc / min.

  As a result, it was confirmed that the physiological saline was continuously and stably released from the tip portion, and even when taken out from the warm water, no kinks were generated in the portion wound five times.

(Comparative Example 1)
In Example 1, the inner layer tube and the outer layer tube were not changed in configuration, and a tube in which a reinforcing material layer was not provided by winding the filament was prepared.

  A hub is attached to the proximal end portion of the catheter tube, and is fixed by winding it around a metal rod having a diameter of 3 mm from a position of 890 mm from the proximal end portion. Saline was immersed in warm water under constant temperature set in the vicinity, and physiological saline dyed with red food was injected from the hub using a syringe at a rate of 0.2 cc / min.

  As a result, it was confirmed that the physiological saline was intermittently released from the tip only unstablely, and even when taken out from the warm water, kinks were generated at the portion wound five times.

(Comparative Example 2)
In Example 2, the inner layer tube and the outer layer tube were not changed in configuration, and a tube without a reinforcing material layer formed by winding the filament was prepared.

  A hub is attached to the proximal end of this catheter tube, and it is fixed by wrapping around a metal rod having a diameter of 5 mm from a position of 890 mm from the proximal end, and the hub is attached to the proximal end so that the entire temperature of the catheter tube is 37 ° C. It was immersed in warm water under constant temperature set in the vicinity, and physiological saline dyed with red food was injected from the hub using a syringe at a rate of 0.8 cc / min.

  As a result, it was confirmed that the physiological saline was intermittently released from the tip only unstablely, and even when taken out from the warm water, kinks were generated at the portion wound five times.

Schematic diagram of PTFE tube covered with metal cored bar Schematic diagram when starting winding of the filament from the tip of the inner tube Schematic diagram when starting winding of the filament from the base of the inner layer pipe Example of cross-section of striatum used in the present invention Schematic diagram when 0.5 reciprocating winding is formed Schematic diagram when the first stage is formed by one reciprocating winding Schematic diagram when forming the second stage of one reciprocating winding Schematic diagram when forming the first stage of 1.5 reciprocating winding Schematic diagram when forming the second stage of 1.5 reciprocating winding Schematic diagram when forming the third stage of 1.5 reciprocating winding Schematic diagram when forming the first stage of two reciprocating windings Schematic diagram when forming the second stage of two reciprocating windings Schematic diagram when forming the third stage of two reciprocating windings Schematic diagram when forming the 4th stage of 2 reciprocating windings Schematic diagram when forming the first stage of multi-stage winding Schematic diagram when forming the second stage of multi-stage winding Schematic diagram showing the placement of radiopaque markers in contact with the reinforcement layer Schematic showing that in order to fix a radiopaque marker, this is caulked, or / and a plastic metal wire such as aluminum is wound and fixed in contact with the radiopaque marker. Figure The schematic diagram which shows that the resin pipe which forms it from the base part to a front-end | tip part arrange | positions an outer layer pipe | tube which has one or more steps of Shore D hardness. Conceptual diagram of the condition of the medical catheter tube of the present invention The schematic diagram which shows covering with the shrink tube which has a property which the diameter shrinks by heating, and heat-sealing the whole structure, and / or applying a high frequency electromagnetic wave, and heat-sealing. State-of-the-art part of cutting-edge mold and medical tube The most advanced part of a medical tube formed into a tapered shape by a shaping die The schematic diagram which shows that a shrink tube is peeled off, a structure is integrated, and the most advanced part is shape | molded by the round shape. FIG. 3 is a schematic view showing that a target catheter tube is completed by pulling out a metal core.

Explanation of symbols

a Streak interval θ Slope angle of the striate 1 X-ray opaque marker 2 Winding part of plastic metal wire such as aluminum for fixing the X-ray opaque marker 3 Constructing outer tube Outer layer resin pipe having the highest shore D hardness 4 Outer layer resin pipe having a high Shore D hardness among the outer layer pipes constituting 5 Outer layer resin pipe having a lower Shore D hardness among the outer layer pipes constituting 6 Outer resin tube with minimum Shore D hardness

Claims (14)

Inner layer tube made of a resin tube that exhibits lubricity and flexibility, and a reinforcing material obtained by winding a linear body on the inner layer tube that adjusts flexibility and further imparts kink resistance, torque transmission, pushability, etc. A medical catheter tube in which an outer layer pipe made of a resin pipe covering a layer and a reinforcing material layer and having flexibility is integrated,
The catheter tube has a base and a distal end;
The cross-sectional shape of the striate body forming the reinforcing material layer is a polygon with a pentagon or less and two parallel sides with less than two pairs of strands, or a strand consisting of an arc and a chord,
The longest side is wound on the inner layer tube,
The outer tube is arranged such that the resin tube forming it from the base to the tip has a Shore D hardness of one or more stages,
It has a tip where no reinforcing material layer exists,
A medical catheter tube characterized in that bending rigidity from a base portion to a distal end portion decreases stepwise or continuously due to the presence of the reinforcing material layer and the outer layer tube.   The winding of the striate body forming the reinforcing material layer is fixed to the inner layer tube with the strand itself at the end, and the winding is made at an equal inclination angle and / or at equal intervals, and / or continuously and / or The medical catheter tube according to claim 1, wherein the inclination angle and / or the interval changes stepwise and / or has a folded portion.   The medical catheter tube according to claim 1, wherein an array of Shore D hardnesses of the resin pipe forming the outer pipe is gradually reduced from the base portion to the distal end portion.   Various tunes can be set by gradually reducing the winding of the strands forming the reinforcing material layer and the Shore D hardness of the resin tube forming the outer layer tube from the base to the tip. The medical catheter tube according to claim 1, 2 or 3.   The tip part exists between the inner layer pipe and the outer layer pipe at a position closer to the base part than the most advanced part where the reinforcing material layer does not exist and only the inner layer pipe and the outer layer pipe are joined. The medical catheter tube according to claim 1, comprising a radiopaque marker.   6. The medical catheter tube according to claim 1, wherein the inner layer tube and the outer layer tube are joined via a reinforcing material layer.   The medical catheter tube according to claim 1, 2, 3, 4, 5, or 6, wherein the inner layer tube is made of a resin exhibiting lubricity with respect to a guide wire or the like passing through the inner layer tube.   The outer diameter of the outer layer tube is changed and formed into a round shape or a taper shape at the most distal portion, and / or the inner and outer diameters of the inner layer tube are changed. Medical catheter tube.   The medical catheter tube according to claim 1, wherein the outer tube is coated with a hydrophilic coating.   The method for manufacturing a catheter tube according to claim 1, wherein a reinforcing material layer is formed on the outer periphery of the inner layer tube, and then the outer layer tube is covered to manufacture the catheter tube. Spirally winding a striate body supplied from a striatum body supply unit on the outer periphery of the inner layer tube, and changing a relative movement speed and / or a relative rotation speed between the inner layer tube and the striatum body supply unit; And / or by changing the relative movement direction of the inner layer tube and the striate body supply unit, the inclination angle and the interval of the striate body with respect to the catheter tube axis are continuously and / or along the axial direction of the catheter tube. Alternatively, a method for producing a medical catheter tube, characterized by being changed stepwise and / or having a folded portion.   The catheter tube manufacturing method according to claim 1, wherein a reinforcing material layer is formed on the outer periphery of the inner layer tube, and then the outer layer tube is formed by covering the outer layer tube and manufacturing the catheter tube. When the Shore D hardness of the resin pipe is arranged in one or more stages, and when the Shore D hardness of the resin pipe is multistage, the Shore D hardness array is gradually increased from the base to the tip. A method for producing a medical catheter tube, wherein the medical catheter tube is arranged so as to be small and can be set in various ways.   The catheter tube manufacturing method according to claim 1, wherein a reinforcing material layer is formed on the outer periphery of the inner layer tube, and then the outer layer tube is formed by covering the outer layer tube and manufacturing the catheter tube. The resin tube is arranged so that the Shore D hardness is one or more steps, and when the Shore D hardness of the resin tube is multi-staged, the Shore D hardness is arranged so that it gradually decreases from the base to the tip. The whole was covered with a shrink tube, heated, the inner layer tube, the reinforcing material layer, and the outer layer tube were integrated, and the most advanced part was formed into a round shape or a tapered shape, and then the shrink tube was cooled. A method for producing a medical catheter tube by peeling it off later.   The catheter tube manufacturing method according to claim 1, wherein a reinforcing material layer is formed on the outer periphery of the inner layer tube, and then the outer layer tube is formed by covering the outer layer tube and manufacturing the catheter tube. The resin tube is arranged so that the Shore D hardness is one or more steps, and when the Shore D hardness of the resin tube is multi-staged, the Shore D hardness is arranged so that it gradually decreases from the base to the tip. , By passing through a die heated by an electric heater and / or high frequency induction, the inner tube, the reinforcing material layer and the outer tube are integrated, and the most advanced part is molded into a round shape or a tapered shape for medical use A manufacturing method for obtaining a catheter tube.   The method for manufacturing a catheter tube according to claim 1, wherein a reinforcing material layer is formed on the outer periphery of the inner layer tube, and then the outer layer tube is coated to manufacture the catheter tube. When the outer layer tube is formed by covering and extruding to a structure having a reinforcing material layer formed on the outer periphery so that the Shore D hardness is one or more steps, and when the Shore D hardness is multistage, the Shore D hardness is determined from the base. Manufacturing to obtain a medical catheter by forming the outer layer tube by covering and extruding so that it gradually decreases toward the tip, integrating the inner layer tube, the reinforcing material layer, and the outer layer tube, and further forming the leading edge into a round shape or a tapered shape Method.

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