JP2006158788A - Catheter tube for medical use and manufacturing method thereof - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a particularly thin catheter tube for medical use which has excellent flexibility, whose tip has proper X-ray visibility and which has condition setting property etc. corresponding to various access routes, and to provide a manufacturing method of the catheter tube. <P>SOLUTION: In the catheter tube for medical use and the manufacturing method thereof, a reinforcing material layer by braiding, a lubricant layer, an X-ray impermeable marker, and an outer layer tube are integrated, the braiding forming the reinforcing material layer consists of a synthetic resin strand and/or a metallic strand, the reinforcing material layer is covered with the lubricant layer, the lubricant layer is exposed from a gap of the reinforcing material layer, an inner hole is formed of the lubricant layer and the reinforcing material layer, the marker arranged at the tip and consisting of X-ray impermeable metal is flexible to flexural deformation, and flexural rigidity from a base part to the tip is reduced serially or continually. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a medical catheter tube that has a large inner hole and a small outer diameter, that is, is thin, and at the same time, a tip portion that can exhibit suitable X-ray visibility and excellent flexibility, and a method for manufacturing the same.

  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 Etc., and usually consists of 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, the catheter tube does not bend at the curved or bent portion of the blood vessel, and the blood vessel shape does not damage the blood vessel. The flexibility of the tip portion that maintains the corresponding shape 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 wire 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. ing.

As a coil for winding an element wire as a reinforcing material layer around an inner layer tube, Patent Document 1 has a catheter body having a portion where a flexible inner tube and an outer tube are joined via a reinforcing material layer, The reinforcing material layer is formed by forming a linear body in a lattice shape, and an 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. Alternatively, there is disclosed 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 striatum in the axial direction of the catheter body. Yes.
However, this catheter tube can form a rigid base and a flexible tip, but the degree of freedom of tilt control of the rigidity and flexibility is low, and the catheter tube can be adapted to various access routes. There is no idea of setting the tone. In addition, there is no special consideration for thinning, there is no specific description of the marker that gives X-ray visibility, and X-ray visibility is ensured simultaneously with the high flexibility of the catheter tip. There is no idea.

  In addition, as an element that winds a wire as a reinforcing material layer around an inner tube, as in Patent Document 2, an elongated body having a proximal end, a distal end, and a passage that defines a lumen extending between these ends. A catheter tube with a tubular member, the elongate tubular member having an inner tubular liner made of a first liner material coaxial 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. In addition, there is no special consideration for thinning, and for markers that give X-ray visibility, X-ray-impermeable granules are kneaded with resin and placed at the catheter tip, With this configuration, suitable X-ray visibility and high flexibility at the tip cannot be ensured.

  In addition, as disclosed in Patent Document 3, a catheter having a flexible tubular catheter body and a coil having a reinforcing effect embedded in a 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. In addition, this catheter tube is made of a metal wire that is all radiopaque and has no special consideration for making it thin, and the distal end portion has insufficient flexibility. Therefore, X-ray visibility becomes excessive, which may hinder the judgment of the operator during the operation.

  Furthermore, as a braid of a reinforcing material layer on an inner layer pipe, in Patent Document 4, a long shaft having a proximal region, a distal region, and a lumen extending therebetween, and this proximal region is an inner portion. Each having a smooth polymer layer, a reinforcing layer and an outer layer, each layer having a distal end, the reinforcing layer comprising a metal member and a blade having a plurality of polymer members, A vascular catheter having a plurality of monofilaments is disclosed.

  However, this catheter tube can form a rigid base and a flexible tip, but the rigidity and flexibility of the tilt control is low, and the condition of the catheter tube can be adjusted according to various access routes. There is no idea of setting. In addition, there is no special consideration for thinning, and the marker that gives X-ray visibility is a metal thin plate wrapped on the inner tube or caulked with a metal tube. If it takes, the high degree of flexibility of the catheter tip cannot be secured over the marker and its periphery.

  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. 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. A method of manufacturing a catheter tube 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 it with a laser beam having a wavelength of 1.06 μm becomes very troublesome. Furthermore, after continuously forming a metal braid covering 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 formed on the outer surface of the tube. 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, there is no special consideration for thinning, and 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.

  In addition, in Patent Document 6, a manifold, a proximal shaft portion connected to the manifold, a distal shaft portion that is more flexible than the proximal shaft portion and is coupled to the distal end of the proximal shaft portion, A fiber braid disposed around the shaft, the fiber braid being composed of a number of fibers disposed on the tip shaft and intersecting each other to form a pick, per inch A catheter configured to have about 70-120 picks is disclosed.

However, in this catheter tube, there is no idea that the expression of the rigid inclination is caused by the change of the pick interval and the arrangement of the hardness change of the outer layer resin, and sufficient inclination control of the rigidity and flexibility cannot be obtained. Moreover, there is no special consideration for thinning, and there is no idea of setting the condition of the catheter tube according to various access routes.
Patent 3310031 Japanese Patent No. 2672714 JP 2001-218851 A JP 2002-535049 A JP 2000-225194 A Japanese National Patent Publication No. 11-506369

  The present invention is advantageous in that it can provide a particularly thin catheter, and it is an object of the present invention to disclose a manufacturing method thereof. Since the medical catheter tube of the present invention is used in various affected areas, the access route to the target site is diverse, and thus 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 routes and to disclose a manufacturing method thereof.

Reinforcement layer made of braided wires that provide kink resistance, pressure resistance, torque transmission, indentation, etc., lubrication layer made of a resin that exhibits lubricity and flexibility, and has radiopacity A medical catheter tube in which a marker disposed by wrapping the metal on the lubricating layer, and an outer layer tube made of a flexible resin tube covering the lubricating layer and the marker, are integrated. A braid having a base, a tip, a leading edge, and an inner hole and forming a reinforcing material layer is made of a synthetic resin wire and / or a metal wire, a lubricating layer covers the reinforcing material layer, and further a reinforcing material The lubrication layer is exposed between the stitches of the layers, the inner hole is formed by the lubrication layer and the reinforcing material layer, and the marker made of a metal having radiopacity disposed at the tip portion is resistant to bending deformation. Have flexibility,
It is characterized by having a stiffening material layer and a cutting-edge part that does not have markers, and the bending rigidity from the base to the tip is reduced stepwise or continuously due to the presence of the outer tube and the stiffening material layer. The present invention relates to a medical catheter tube.

  In addition, according to the present invention, is a marker made of a metal having flexibility against bending deformation having radiopacity obtained by winding a radiopaque metal element wire on a lubricating layer in a coil shape? Alternatively, a medical catheter tube formed by using a resin in which a radiopaque metal thin plate having a cut line from both sides of a square is wound, or a resin kneaded with radiopaque metal powder is used. It is about.

The present invention relates to a medical catheter tube in which a synthetic resin wire forming a reinforcing material layer by braiding is made of a synthetic fiber having a molten liquid crystal polymer as an inner core and a flexible polymer as a sheath.
The present invention also relates to a medical catheter tube characterized in that the pick interval of the braid forming the reinforcing material layer changes continuously or stepwise from the base to the tip.

The present invention relates to a medical catheter tube characterized in that an array of Shore D hardnesses of a resin tube forming an outer tube is gradually reduced from a base portion to a distal end portion.
In the present invention, various tones are set by gradually decreasing the pick interval of the braid forming the reinforcing material layer and the Shore D hardness of the resin pipe forming the outer layer pipe from the base to the tip. It is related with the medical catheter tube characterized by being able to do.

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

  In addition, the present invention relates to a medical catheter tube that is formed in a round shape or a taper shape in which the outer diameter of the outer layer tube is changed at the most distal portion.

The present invention relates to a medical catheter tube in which an outer tube is coated with a hydrophilic coating.
Furthermore, in the method for producing a catheter tube of the present invention, the lubricating layer covers the reinforcing material layer formed by braiding, and the lubricating layer is exposed between the stitches of the reinforcing material layer, and the lubricating layer, the reinforcing material layer, An inner hole is formed by the above, and after placing a radiopaque marker having flexibility against bending deformation adjacent to the tip of the reinforcing material layer, the outer tube is covered, and a catheter tube is manufactured. A reinforcing material layer is formed by braiding a synthetic resin strand and / or a metal strand to the core wire, which is covered with a lubricating layer, an X-ray impermeable marker is disposed near the tip of the lubricating layer, and an outer layer The present invention relates to a method for producing a medical catheter, wherein a metal core wire is removed after covering a tube.

  The present invention also relates to a method of manufacturing a catheter tube, wherein a lubricating layer covers a reinforcing material layer formed by braiding, and the lubricating layer is exposed between the stitches of the reinforcing material layer. The lubricating layer and the reinforcing material layer When an X-ray impermeable marker having flexibility against bending deformation adjacent to the tip of the reinforcing material layer is further disposed, and then covering the outer layer tube to produce a catheter tube, The radiopaque marker is formed by winding a radiopaque metal element in a coil around the lubricating layer near the distal end of the catheter, or by winding a radiopaque metal sheet with slits on both sides of the square. The present invention relates to a method for producing a medical catheter tube characterized in that the flexibility of the distal end portion is secured by covering or further using a resin kneaded with radiopaque metal powder.

  The present invention also relates to a method of manufacturing a catheter tube, wherein a lubricating layer covers a reinforcing material layer formed by braiding, and the lubricating layer is exposed between the stitches of the reinforcing material layer. The lubricating layer and the reinforcing material layer When an X-ray impermeable marker having flexibility against bending deformation adjacent to the tip of the reinforcing material layer is further disposed, and then covering the outer layer tube to produce a catheter tube, The reinforcing material layer is formed by braiding the wire supplied from the wire supply unit on the outer periphery of the metal core wire, and changing the relative moving speed between the metal core wire and the wire supply unit continuously or stepwise. Thus, the present invention relates to a method for manufacturing a medical catheter tube, characterized in that the pick interval of the braid changes continuously or stepwise.

  Further, the present invention is a method of manufacturing a catheter tube, wherein a reinforcing material layer formed by braiding is covered with a lubricating layer, and the lubricating layer is exposed between the stitches of the reinforcing material layer, and the lubricating layer and the reinforcing material When an inner hole is formed by the layer and an X-ray impermeable marker having flexibility against bending deformation adjacent to the tip of the reinforcing material layer is disposed, the outer tube is covered and a catheter tube is manufactured. The outer layer pipe is arranged so that the arrangement of the Shore D hardness of the resin pipe forming the outer pipe is one or more stages. When the Shore D hardness of the resin pipe is multistage, the arrangement of the Shore D hardness is the base portion. The medical catheter is characterized in that it can be set in various steps by changing the pick of the braid forming the reinforcing material layer continuously or stepwise from the tip portion to the tip portion. Chu It relates to a manufacturing method to obtain the drive.

  The present invention also relates to a method of manufacturing a catheter tube, wherein a lubricating layer covers a reinforcing material layer formed by braiding, and the lubricating layer is exposed between the stitches of the reinforcing material layer. The lubricating layer and the reinforcing material layer When an X-ray impermeable marker having flexibility against bending deformation adjacent to the tip of the reinforcing material layer is further disposed, and then covering the outer layer tube to produce a catheter tube, The outer pipe is arranged so that the Shore D hardness of the resin pipe forming the outer pipe is one or more stages. When the Shore D hardness of the resin pipe is multistage, the Shore D hardness gradually increases from the base to the tip. Arranged to be small, covered with a shrink tube, heated to integrate the lubrication layer, reinforcing material layer, radiopaque marker and outer tube, and the leading edge is rounded or tapered On molded, a manufacturing method for obtaining a medical catheter tube peeled it after the shrink tube is cooled.

  The present invention also relates to a method of manufacturing a catheter tube, wherein a lubricating layer covers a reinforcing material layer formed by braiding, and the lubricating layer is exposed between the stitches of the reinforcing material layer. The lubricating layer and the reinforcing material layer When an X-ray impermeable marker having flexibility against bending deformation adjacent to the tip of the reinforcing material layer is further disposed, and then covering the outer layer tube to produce a catheter tube, The outer layer tube is formed by coating and extrusion so that the Shore D hardness becomes one step or more, and when the Shore D hardness is multistage, the Shore D hardness gradually decreases from the base to the tip. The outer layer tube is formed by covering and extruding, and the reinforcing material layer, lubricating layer, radiopaque marker and outer layer tube are integrated, and the most advanced part is formed into a round shape or a tapered shape, and a medical catheter. Manufacturing method to obtain about.

  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, flexibility and high flexibility of adjustment, tone setting according to various access routes, and kink resistance, pressure resistance, and guide wire tracking that do not bend even when complicated bending occurs There exists an effect which can provide the medical catheter tube which has productivity, productivity, etc. Furthermore, there is an effect that it is possible to provide a medical catheter tube capable of exhibiting a high degree of flexibility at the tip portion at the same time as appropriate X-ray visibility. The most important feature of the present invention is that a thin medical catheter tube can be provided.

  The best mode 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. FIG. 1 shows a flow chart of the manufacturing method, and the best mode of the present invention is shown according to this figure. In the present invention, changes can be appropriately made without departing from the scope of the present invention described in the claims.

  First, the metal core wire 1 is prepared as shown in FIG. This metal core wire is wound around a reel 2 and its outer diameter is substantially the same as the inner diameter of the catheter to be manufactured. The material is preferably a metal-plated copper wire or a stainless steel wire. In FIG. 2 and subsequent figures, for convenience, the left side is the base and the right side is the tip.

  Next, the reinforcing material layer 3 is formed by braiding the strands on the metal core wire as shown in FIG. The braiding is performed by a braiding machine. Although there are various forms such as 1 over 1 under and 2 over 2 under for the form of the braid, any form may be adopted as long as it is suitable as a reinforcing material layer of the catheter. One of the stitches is called a pick, and this pick interval is fine at the distal end of the catheter and rough at the base as shown in FIG. It becomes possible. FIG. 4 shows an enlarged schematic view of the braid. The stitch p in this figure is called a pick, and the stitch interval a is called a pick interval.

The smaller the pick interval, the more flexible, and the coarser, the more rigid. The number of braids and the number of striking can be selected as appropriate. The number is the number of strands included in one pick, and the number of hits represents the number of picks per round.
Further, as shown in FIG. 5, the number of strands as the reinforcing material layer may be appropriately arranged in the axial direction so as to suppress elongation when the catheter is pulled or to easily follow the complicated curve of the blood vessel. The arrangement of the strands in the axial direction can be expected to have an effect of further smoothing the inclination of rigidity and flexibility and improving the bursting resistance.

  As the element wire, a synthetic resin element wire and / or a metal element wire can be used. Particularly suitable as the synthetic resin strand is a molten liquid crystal polymer core 4 as shown in the conceptual cross-sectional view of FIG. 6 and a scanning photomicrograph, a molten liquid crystal polymer island (sheath) 5 and a flexible polymer sea ( (Sheath) 6 is covered. The molten liquid crystal polymer is made of polyarylate, and the flexible polymer is made of polyethylene naphthalate. The diameter of the synthetic resin strand preferably used is preferably 5 to 50 μm.

Other examples of synthetic resin wires include polyesters such as polyethylene terephthalate, polybutylene terephthalate and polymethylene terephthalate, polyolefins such as polyethylene and polypropylene, rigid polyvinyl chloride, polyamide, polyimide, polystyrene, heat Plastic polyurethane, polycarbonate, ABS resin, acrylic resin, polymethyl methacrylate, polyacetal, polyarylate, polyoxymethylene, high tension polyvinyl alcohol, fluororesin, polyvinylidene fluoride, polytetrafluoroethylene, ethylene-vinyl acetate saponified product, polysulfone, poly Aromatics such as ether sulfone, polyether ketone, polyphenylene oxide, polyphenylene sulfide, and Kevlar Riaramido like, polymer alloys containing any of these, carbon fibers and glass fibers and the like.
Examples of metal wires include stainless steel, copper, tungsten, nickel, titanium, piano wire, Ni—Ti alloy, Ni—Ti—Co alloy, Ni—Al alloy, Cu—Zn alloy, Cu—Zn—X alloy (for example, Various metal strands such as superelastic alloys such as X = Be, Si, Sn, Al, and Ga) and amorphous alloys are used. Of these materials, the visibility of the radiopaque marker to be placed later is improved. The use of stainless steel is preferred for reasons such as low visibility compared to radiopaque markers and sufficient workability, economy, and no toxicity in order to ensure sufficient. The metal strand is preferably about 5 to 50 μm in diameter.

The above-mentioned synthetic resin wires and metal wires may be used alone or as an assembly of strands (for example, twisted or bundled strands, or in parallel) But you can.
In the present invention, only a synthetic resin strand may be used, or only a metal strand may be used, but a synthetic resin strand and a metal strand may be used together.

Subsequently, as shown in FIG. 7, the lubricating layer 7 is formed on the metal core wire provided with the reinforcing material layer. For this coating, extrusion molding may be used as shown in FIG. 7, and although not shown in the figure, any means may be taken such as coating with a resin dispersion solution or resin solution and then drying. .
As a constituent material of this lubricating layer, for example, fluorine-based polytetrafluoroethylene, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer, tetrafluoroethylene-hexafluoropropylene copolymer, ethylene-tetrafluoroethylene copolymer, etc. Resin, polypropylene, polyethylene, polyolefins such as ethylene-vinyl acetate copolymer, polyamides, polyesters such as polyethylene terephthalate, polybutylene terephthalate, polyurethane, polyvinyl chloride, polystyrene resins, resins such as polyimide, and mixtures thereof. However, from the standpoint that the finished product exhibits excellent lubricity with respect to the guide wire passing through the lubrication layer and the reinforcing material layer and obtains position adjustment with guide wire followability, Styrene or a tetrafluoroethylene - perfluoroalkyl vinyl ether copolymer, or polypropylene, it is preferably made of polyethylene.

  The lubricating layer coated on the metal core wire provided with the reinforcing material layer preferably has a sufficient adherence force to the metal core wire and the reinforcing material layer. Furthermore, in the process of coating the outer tube, the mechanical and chemical methods (use of defluorinating agents such as sodium naphthalene + dimethyl ether) are applied to the surface of the lubricating layer in order to increase the adhesion between the lubricating layer and the outer tube. ), Irregularities may be formed or the surface may be modified by an electrical method such as plasma.

Further, the tip portion of the lubricating layer may be processed by mechanical or chemical means so that the outer diameter thereof gradually becomes smaller toward the most distal portion.
After the lubrication layer is formed, a bonding layer may be provided, although not shown here, in order to satisfactorily bond and fix the outer layer tube described later. This is also intended to block minute holes generated in the lubricating layer and increase the burst resistance, and 50 to 50% of flexible polyurethane, polyurethane dispersion or flexible adhesive is applied on the lubricating layer. It can be applied with a thickness of 5 μm or coated by spraying.

Subsequently, as shown in the flow chart of FIG. 1, any manufacturing method of the A process and the B process can be used. In the A process, the lubrication at a position corresponding to the boundary region between the distal end portion 8 and the base portion 9 of the catheter is performed as shown in FIG. The layer and the reinforcing material layer are removed so that the metal core wire 10 is exposed. On the other hand, although the B process is not shown, the removal operation of the lubricating layer and the reinforcing material layer as in the A process is not performed.
As shown in the flowchart of FIG. 1, any one of the manufacturing methods of the C process and the D process can be used. The C process will be described.
In the C process, the catheters are cut one by one as shown in FIG.

  FIG. 10 is an enlarged view of the distal end portion of the catheter, and 11 shows a metal core wire. A radiowire-impermeable metal wire marker 12 is formed on the metal core wire by a lubricating layer and a reinforcing material layer. Wind adjacent to the front of the structure. In addition, as shown in FIG. 11, the radiopaque metal wire marker 13 may be disposed on the tip of a structure including a lubricating layer and a reinforcing material layer. This winding may be either tight winding in which metal wires are in contact with each other or pitch winding in which metal wires are spaced from each other.

  12 shows an X-ray impermeable metal sheet marker 14 which is cut from both sides of a square having a shape as shown in FIG. 12, and an enlarged distal end portion of the catheter is shown in FIG. 13, and consists of a lubricating layer and a reinforcing material layer. Adjacent to the tip of the structure, it is wound around the metal core. Or you may arrange | position on the structure which consists of a lubrication layer and a reinforcing material layer like FIG.

  These radiopaque markers preferably have a diameter of 5 to 50 μm when a metal wire is used, and preferably have a thickness of 5 to 30 μm when a metal thin plate is used. In addition, these radiopaque markers can ensure appropriate flexibility both when a metal wire is used and when a metal thin plate is used. Further, the radiopaque marker may be appropriately fixed to the lubricating layer using an adhesive or the like. As for the material of the radiopaque marker, platinum (Pt), Pt—Ir alloy, Pt—W alloy, Pt—Ni alloy, gold, silver, etc. have high radiopacity and good X-ray visibility. A certain metal is preferably used.

  Although not shown here, a resin tube kneaded with X-ray-impermeable metal powder such as barium sulfate, bismuth oxide, bismuth carbonate, bismuth tungstate, bismuth-oxychloride, etc. is composed of a lubricating layer and a reinforcing material layer. You may arrange | position on the structure which adjoins the other end of a structure, or consists of a lubricating layer and a reinforcing material layer. As resin used here, the thing similar to what is used as an outer-layer pipe | tube mentioned later is preferable. In this arrangement, a resin tube kneaded with radiopaque metal powder may be arranged with a cut in the axial direction, or may be arranged while maintaining the tube form. The above is the C process.

  The D process is to attach a radiopaque marker without cutting the catheter. FIG. 15 shows the boundary region between the catheter base and the distal end. As shown in FIG. 16, the radiopaque metal wire marker 15 is wound around a structure composed of a lubricating layer and a reinforcing material layer at the distal end of the catheter. This winding may be either tight winding in which metal wires are in contact with each other or pitch winding in which metal wires are spaced from each other.

  Although not shown in the figure, as shown previously, a resin tube kneaded with radiopaque metal thin plate markers and radiopaque metal powder cut from both sides of a square is used as a lubricating layer at the tip of the catheter. You may arrange | position on the structure which consists of a reinforcing material layer. The shape, material, etc. of these radiopaque markers are the same as those already shown above. In order to fix these radiopaque markers, an adhesive having flexibility even after curing may be used as appropriate. The above is the D process.

  The E process is a process of making a catheter cut by the C process into a continuous body by welding a metal core wire. As shown in FIG. 17, the metal core wires of the catheters separated one by one are spot-welded to form a continuous body and wound on a reel. The above is the E process.

  Subsequently, the F process represents a step of covering the outer layer pipe with the structure formed of the lubricated layer and the reinforcing material layer. As an arrangement method of the outer layer pipe, as shown in FIG. 18, the resin pipes 16a and 16b serving as outer layer pipes are arranged from the base part to the tip part, and the resin pipe forming the outer pipe has one or more stages of Shore D hardness. At the distal end and the proximal end, a resin tube is disposed on the distal end side beyond the reinforcing material layer and the lubricating layer. Although FIG. 18 shows a state in which four types of Shore D hardness are closely arranged, it is necessary to arrange the Shore D hardness to gradually decrease from the base portion to the tip portion. That is, the Shore D hardness of the resin pipe serving as the outer pipe is 16a> 16b> 16c> 16d in FIG. 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. Further, if the resin pipes that are the outer pipes having different Shore D hardnesses are arranged so as to be shifted from the positions where the pick interval of the braid changes, the slopes of rigidity and flexibility can be changed gently. The above is the F process.

  The G process is another method of covering the outer pipe with the structure composed of the lubrication layer and the reinforcing material layer that have been cut. In this method, the outer layer pipe is produced by connecting a plurality of extruders to a single extrusion mold, and sequentially operating and stopping the plurality of extruders with resins having different Shore D hardnesses. A resin pipe whose D hardness changes stepwise is prepared, and this is arranged in a structure composed of a lubricating layer and a reinforcing material layer as shown in FIG. In addition, a plurality of extruders are connected to a mold having a valve mechanism, and while continuously extruding, resins having different Shore D hardnesses are sequentially introduced into and discharged from the extrusion flow path, and the Shore D hardness gradually increases. Alternatively, a resin pipe that changes to the above may be prepared, and this may be arranged in a structure including a lubricating layer and a reinforcing material layer as shown in FIG. At this time, it is necessary to arrange the outer layer tube so that it has a higher Shore D hardness as it approaches the proximal end portion and a lower Shore D hardness as it approaches the distal end side. The above is the G process.

  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, these polymer alloys and 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.

  The I process is a step of integrating the lubricating layer and the outer layer with a shrink tube. As shown in FIG. 20, the shrink tube 17 having the property of reducing its diameter by heating is disposed over the entire structure including the lubricating layer, the reinforcing material layer, and the outer layer tube. The shrink tube is preferably made of polytetrafluoroethylene or perfluoroethylene-propene copolymer.

After that, the shrink tube is heated with a heater to a temperature at which the tube contracts, or heated by applying high-frequency electromagnetic waves, and further, although not shown here, it is passed through a heating mold, and the lubricating layer, the reinforcing material layer, the outer layer tube Is integrated. At this time, the shrinkage of the shrink tube causes the tip of the resin tube that becomes the outer layer tube to be shaped into a round shape 18 as shown in FIG.
When forming the tip of the resin tube that becomes the outer layer tube into a taper shape, after shrinking the shrink tube, it is further contacted and heated as shown in FIG. 23 using a heating mold 19 as shown in FIG. The taper shape 20 is formed. Next, as shown in FIG. 24, the shrink tube is peeled, and the lubricating layer, the reinforcing material layer, and the outer layer tube at the distal end portion and the proximal end portion of the catheter are cut and adjusted as necessary. The above is the I process.

  The H process is a process in which the outer layer tube is continuously coated on the long connected catheter by switching extrusion. When the outer layer tube is coated and extruded so that the Shore D hardness becomes one step or more, and the Shore D hardness is multi-stepped. The outer layer tube is formed by covering and extruding so that the Shore D hardness gradually decreases from the base to the tip, and the lubricating layer, the reinforcing material layer, and the outer layer tube are integrated.

  At this time, when coating a resin having a multi-stage, for example, four-stage Shore D hardness, four extruders 22 are connected to one extrusion mold 21 as shown in FIG. While controlling, the four extruders can be sequentially operated and stopped to coat and form an outer layer pipe. Although not shown here, four extruders are connected to a mold having a valve mechanism, and while continuously extruding, resins having different Shore D hardnesses are sequentially switched into and out of the extrusion flow path. An outer tube can also be formed by coating.

  Thereafter, the catheters are cut one by one, the end of the lubrication layer or outer tube of the tip is adjusted, and the shrink tube 23 having the property of reducing its diameter by heating as shown in FIG. 26 is disposed only at the tip. To do. The shrink tube is preferably made of polytetrafluoroethylene or perfluoroethylene-propene copolymer.

  In the subsequent steps, as shown in the I process, the shrink tube is heated with a heater to a temperature at which the tube contracts, or heated by applying high frequency electromagnetic waves, and the lubricating layer, the reinforcing material layer, and the outer layer tube are integrated. To do. At this time, the shrinkage of the shrink tube causes the tip of the resin tube that becomes the outer layer tube to be shaped into a round shape 18 as shown in FIG. When forming the tip of the resin tube that becomes the outer layer tube into a taper shape, after shrinking the shrink tube, it is further contacted and heated as shown in FIG. 23 using a heating mold 19 as shown in FIG. The taper shape 20 is formed. After this shaping is completed, the shrink tube is removed. The above is the H process.

  Next, as a J process, it is preferable that the surface of the catheter tube is covered with a hydrophilic (or water-soluble) polymer substance (not shown). 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.

  As shown in FIG. 27, the metal core is pulled out, and the base end is cut into a single plane by cutting the lubricating layer, the reinforcing material layer, and the outer layer by means of a disk-shaped diamond cutter that rotates at a high speed for shaping. Finishing gives a catheter tube.

  This catheter tube combines the braided pick interval, the length of the equal pick interval portion, the arrangement of the resin pipes with different Shore D and the setting of the length, so that the degree of freedom of adjustment of the inclination control of rigidity and flexibility is high, and various Tone setting according to the access route 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. Or it can be expressed that the position where the bending strength changes is different. In FIG. 28, the straight line portion indicates that the rigidity is higher than that of the tip portion, but the flexibility is also ensured at the same time. By being able to set various tones, in Fig. 28, 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.

  When the lubricating layer is made of a fluorine-based resin such as polytetrafluoroethylene, the inner hole can be appropriately hydrophilized by an electric means such as plasma discharge treatment.

In addition, although not shown here, a hub having an appropriate shape is attached to the base end, so that the desired medical catheter tube of the best form can be obtained.
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 in advance with a heater or steam to form a curved portion.

Flow chart showing manufacturing method Metal core wire wound on reel Braided metal core wire to form a reinforcing material layer Pick and pick interval Example when the strands of reinforcing material are arranged in the axial direction Cross-sectional structure of strands suitably used as synthetic resin strands A state in which a lubricating layer is formed on the reinforcing material layer A state where the lubrication layer and the reinforcing material layer are removed at positions corresponding to the distal end and the base of the catheter. A state where the catheters are cut one by one An enlarged view of a state in which a radiopaque metal wire marker is disposed on a metal core wire at the distal end of the catheter An enlarged view of a state in which a radiopaque metal wire marker is disposed on the lubricating layer at the distal end of the catheter Radiopaque sheet metal marker with cuts from both sides of the square A state in which a radiopaque sheet metal marker with a cut from both sides of the square is placed on the metal core wire at the distal end of the catheter A state in which a radiopaque sheet metal marker with a cut from both sides of the square is placed on the lubricating layer at the distal end of the catheter Boundary region between catheter base and tip A state in which a radiopaque metal wire marker is wound around a structure composed of a lubricating layer and a reinforcing material layer at the distal end of the catheter. A state in which a metal core wire is welded to form a continuous catheter and wound on a reel A state in which resin tubes having four types of Shore D hardness as outer layers are arranged in close contact with each other A state in which an outer layer pipe whose Shore D hardness changes in stages is arranged Shrink tube placed Shrink tube shrinks, inner layer tube, reinforcing material layer, outer layer tube are integrated, and the resin tube tip that becomes the outer layer tube is rounded Tube mold tip and tip shaping heating mold The tip of the tube component is in contact with the tip shaping die and heated to form a taper. With the shrink tube removed The outer layer is formed by coating extrusion After cutting one by one, the shrink tube is placed at the tip Metal core wire is drawn and the base end cross section is finished Conceptual diagram representing tone

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Metal core wire 2 Reel 3 Reinforcement material layer 4 Core of molten liquid crystal polymer 5 Island (sheath) of molten liquid crystal polymer
6 Sea (sheath) of flexible polymer
DESCRIPTION OF SYMBOLS 7 Lubrication layer 8 Catheter tip part 9 Catheter base part 10 Metal core wire 11 Metal core wire 12 X-ray-impermeable metal wire marker 13 X-ray-impermeable metal wire marker 14 X-ray opacity cut from both sides of the rectangle Thin metal plate marker 15 X-ray opaque metal wire marker 16a Maximum Shore D hardness outer layer tube 16b High Shore D hardness outer layer tube 16c Low Shore D hardness outer layer tube 16d Minimum Shore D hardness outer layer tube 17 Shrink tube 18 Round shaped part DESCRIPTION OF SYMBOLS 19 Heating die 20 Heat-shaped taper-shaped front-end | tip part 21 Extrusion die 22 Extruder 23 Shrink tube

Claims (15)

Reinforcement layer made of braided wires that provide kink resistance, pressure resistance, torque transmission, indentation, etc., lubrication layer made of a resin that exhibits lubricity and flexibility, and has radiopacity A marker placed by covering the lubrication layer with a metal, a medical catheter tube in which an outer layer tube made of a resin tube covering the lubrication layer and the marker and having flexibility is integrated,
The catheter tube has a base, a distal end and a leading edge, and further an inner hole,
The braid forming the reinforcing material layer is made of synthetic resin wires and / or metal wires,
The lubricating layer covers the reinforcing material layer, and the lubricating layer is exposed from between the stitches of the reinforcing material layer, and an inner hole is formed by the lubricating layer and the reinforcing material layer,
A marker made of a metal having radiopacity arranged at the tip has flexibility with respect to bending deformation,
Reinforcing material layer, having a cutting-edge part with no markers,
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 an outer layer tube and a reinforcing material layer.   The marker made of a metal having flexibility against bending deformation having X-ray impermeability is obtained by winding an X-ray impermeable metal element on a lubricating layer in a coil shape or from both sides of a square. The medical catheter tube according to claim 1, wherein the medical catheter tube is formed by using a resin obtained by kneading a cut radiopaque metal thin plate or further kneading a radiopaque metal powder.   The medical catheter tube according to claim 1 or 2, wherein the synthetic resin wire forming the reinforcing material layer by braiding is made of a synthetic fiber having a molten liquid crystal polymer as an inner core and a flexible polymer as a sheath.   4. The medical catheter tube according to claim 1, wherein a pick interval of the braid forming the reinforcing material layer changes continuously or stepwise from the base to the tip.   The medical catheter tube according to claim 1, 2, 3, 4, wherein an array of Shore D hardnesses of the resin tube forming the outer layer tube is gradually reduced from the base portion to the distal end portion.   The pitch between the braids 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 can be reduced stepwise to set various tones. The medical catheter tube according to claim 1, 2, 3, 4, or 5.   The medical catheter tube according to claim 1, 2, 3, 4, 5, or 6, wherein the lubricating layer is made of a resin exhibiting lubricity with respect to a guide wire or the like passing through the lubricating layer.   The medical catheter tube according to claim 1, 2, 3, 4, 5, 6, or 7, wherein an outer diameter of the outer layer tube is changed at the most distal portion to be formed into a round shape or a tapered shape.   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 the lubricating layer covers the reinforcing material layer formed by braiding, and the lubricating layer is exposed from between the stitches of the reinforcing material layer, An inner hole is formed by the reinforcing material layer, and an X-ray impermeable marker having flexibility against bending deformation adjacent to the front side of the reinforcing material layer is disposed, and then the outer tube is covered to manufacture a catheter tube. In doing so, a reinforcing material layer is formed by braiding a synthetic resin wire and / or a metal wire on the metal core wire, which is covered with a lubricating layer, and an X-ray impermeable marker is placed near the tip of the lubricating layer. A method for producing a medical catheter, wherein the outer core tube is further covered, and then the metal core wire is removed.   The method for manufacturing a catheter tube according to claim 1, wherein the lubricating layer covers the reinforcing material layer formed by braiding, and the lubricating layer is exposed from between the stitches of the reinforcing material layer, An inner hole is formed by the reinforcing material layer, and an X-ray impermeable marker having flexibility against bending deformation adjacent to the front side of the reinforcing material layer is disposed, and then the outer tube is covered to manufacture a catheter tube. In doing so, the radiopaque marker is a radiopaque metal in which a radiopaque metal element wire is wound around the lubrication layer near the distal end of the catheter in the form of a coil or cut from both sides of the square. A medical catheter tube formed by covering a thin plate or by using a resin kneaded with a radiopaque metal powder and having a flexible distal end. Production method.   The method for manufacturing a catheter tube according to claim 1, wherein the lubricating layer covers the reinforcing material layer formed by braiding, and the lubricating layer is exposed from between the stitches of the reinforcing material layer, An inner hole is formed by the reinforcing material layer, and an X-ray impermeable marker having flexibility against bending deformation adjacent to the front side of the reinforcing material layer is disposed, and then the outer tube is covered to manufacture a catheter tube. In forming the reinforcing material layer, the wire supplied from the wire supply unit is braided on the outer periphery of the metal core wire, and the relative movement speed between the metal core wire and the wire supply unit is continuously or stepwise. A method of manufacturing a medical catheter tube, characterized in that the braid pick interval changes continuously or stepwise by changing.   The method for manufacturing a catheter tube according to claim 1, wherein the lubricating layer covers the reinforcing material layer formed by braiding, and the lubricating layer is exposed from between the stitches of the reinforcing material layer, An inner hole is formed by the reinforcing material layer, and an X-ray impermeable marker having flexibility against bending deformation adjacent to the front side of the reinforcing material layer is disposed, and then the outer tube is covered to manufacture a catheter tube. In this case, the outer layer pipe is arranged so that the arrangement of the Shore D hardness of the resin pipe forming the outer pipe is one or more stages, and when the Shore D hardness of the resin pipe is multistage, the arrangement of the Shore D hardness is Is characterized by being able to set various tone by changing the pick of the braid that forms the reinforcing material layer continuously or stepwise, in order to decrease gradually from the base to the tip Catete for Method of manufacturing a tube.   The method for manufacturing a catheter tube according to claim 1, wherein the lubricating layer covers the reinforcing material layer formed by braiding, and the lubricating layer is exposed from between the stitches of the reinforcing material layer, An inner hole is formed by the reinforcing material layer, and an X-ray impermeable marker having flexibility against bending deformation adjacent to the front side of the reinforcing material layer is disposed, and then the outer tube is covered to manufacture a catheter tube. In this case, the outer pipe is arranged so that the Shore D hardness of the resin pipe forming the outer pipe is one or more steps, and when the Shore D hardness of the resin pipe is multi-stage, the Shore D hardness is from the base to the tip. It is arranged so that it gradually becomes smaller over the part, the whole is covered with a shrink tube, heated, and the lubricating layer, reinforcing material layer, radiopaque marker and outer layer tube are integrated, and the most advanced part is rounded or Taper On molded into shape, the production method of obtaining a medical catheter tube peeled it after the shrink tube is cooled.   The method for manufacturing a catheter tube according to claim 1, wherein the lubricating layer covers the reinforcing material layer formed by braiding, and the lubricating layer is exposed from between the stitches of the reinforcing material layer, An inner hole is formed by the reinforcing material layer, and an X-ray impermeable marker having flexibility against bending deformation adjacent to the front side of the reinforcing material layer is disposed, and then the outer tube is covered to manufacture a catheter tube. In this case, the outer tube is formed by coating extrusion so that the Shore D hardness becomes one step or more, and when the Shore D hardness is multistage, the Shore D hardness gradually decreases from the base portion to the tip portion. The outer layer tube is formed by covering and extruding so that the reinforcing material layer, the lubrication layer, the radiopaque marker, and the outer layer tube are integrated, and the most advanced part is formed into a round shape or a tapered shape to form a medical catheter. Manufacturing method for obtaining the ether.

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