JP2007202979A - Medical guiding catheter tube - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical guiding catheter tube, having backup force, kink resistance, and torque transmission performance, in which a guiding catheter tube has a small outer diameter, and a large inner diameter, achieving a thin thickness. <P>SOLUTION: The medical guiding catheter tube is provided with an inner layer tube, comprising inner layer resin, a reinforcement layer, formed on the inner layer tube, and comprising strands, a flexible part, comprising second resin, a transition part, comprising third resin, abutted on the flexible part, and a hand side part comprising fourth resin, abutted on the transition part, covering the reinforcing layer from the tip of the inner layer tube toward a base part in order, and a soft tip part comprising first resin, covering the tip part of the flexible part. Values R<SB>in</SB>and R<SB>out</SB>of a part covered with the flexible part, the transition part, and the hand side part are within a prescribed range. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a catheter assembly used by being inserted into a heart or a surrounding tissue, particularly, a coronary artery. More specifically, the present invention relates to a guiding catheter for introducing a treatment catheter such as an expansion catheter for PTCA, a microcatheter for injecting a drug or an embolic substance, and a stent delivery catheter into a target site of a blood vessel.

  For example, in percutaneous coronary angioplasty (PTCA), in order to treat a stenosis in a blood vessel, it is inserted into the blood vessel and the balloon is inflated to expand the stenosis, thereby improving blood flow at the peripheral side of the stenosis. A balloon catheter is used for illustration. In addition, a microcatheter for injecting an agent such as a contrast agent or a thrombolytic agent into a stenosis or delivering an embolic material to a blood vessel connected to the cancer tissue is used. Furthermore, a treatment catheter such as a delivery catheter for delivering a stent to the vascular stenosis is used.

  Since these balloon catheters, microcatheters, stent delivery catheters, etc. have small diameters (hereinafter referred to as “small diameter catheters”), the pushing force of the proximal end is reduced by buckling or bending. It is hard to be transmitted to.

  Thus, in general, in PTCA procedures, a guide wire is passed through these small diameter catheters. At this time, the guide wire is placed at the last position where it does not protrude from the tip (distal end) of the small-diameter catheter. Next, the thin catheter through the guide wire is passed through the guiding catheter, and at this time, the thin catheter is kept at a position where it does not protrude from the distal end of the guiding catheter. Then, the guiding catheter in which these three members are integrated is carried to the entrance of the affected area via a sheath introducer or the like.

  At this time, it is not carried along the guide wire, but is carried to the entrance of the affected area using the pushability of the guiding catheter and the bending of the tip. Then, a soft tip at the tip of the guiding catheter is pushed into the cavity of the affected part, and fixed so that the guiding catheter does not move. Then, only the guide wire is operated to advance to the target affected part or to pass through the affected part. Finally, along the guide wire, the small diameter catheter is brought to the affected area to treat the affected area.

  Inserting a guide wire before insertion of a thin catheter is difficult to suddenly insert the thin catheter into the affected area. First, the distal end of the guide wire is passed through the affected area, and the small catheter is inserted along the guide wire. It is because it is easy to insert.

  Also, when inserting a small diameter catheter, the guiding catheter is used because the distal end of the guiding catheter is positioned at the affected area such as the coronary artery entrance or around the cancer tissue, and then the small diameter catheter is placed in the coronary artery or around the cancer tissue. This is because the reaction force at the time of insertion of the small-diameter catheter into the affected part is received. Therefore, most guiding catheters have at least one bent portion in accordance with the blood vessel shape.

  In the guiding catheter, as in Patent Document 1, a braid made of metal and braided into a mesh is disposed between the first layer and the second layer that define the lumen of the tubular body of the guiding catheter tube. Some catheters provide radiopacity and twist resistance. However, this guiding catheter tube represents only a standard three-layer composite tube, and special considerations and ingenuity are required for the inner and outer diameters of the guiding catheter tube and the wall thickness. There is nothing.

Furthermore, the guiding catheter tube is joined with a flexible tip portion and a main body in a tapered shape as in Patent Document 2, and a wire is wound along the inner wall of the catheter in order to increase the strength of the catheter. There is something. Since this guiding catheter tube is made of a hard material inside the wire, it is easy to insert the balloon catheter smoothly into it, and the outside is made of a softer material than the inside. There is an advantage that it is less hurt. However, as in Patent Document 1, this also does not have special considerations or devices for the inner and outer diameters and thickness of the guiding catheter tube.
JP-A-10-43300 Japanese Patent Laid-Open No. 7-8563

  The inventor of the present invention independently studied the function and structure of a guiding catheter that can be suitably used in the above-described procedures of PTCA. As a result, the function and structure of the guiding catheter tube exemplified below, which is not considered in the techniques disclosed in Patent Documents 1 and 2, have been conceived.

  As described above, the guiding catheter tube can ensure the operability of the small-diameter catheter if the inner diameter is increased in order to allow the small-diameter catheter to pass therethrough. Further, since the guiding catheter tube is passed through the blood vessel, it is advantageous that the outer diameter is small. That is, the use of a thin guiding catheter tube having a small outer diameter and a large inner diameter is beneficial for both the patient and the patient in performing the procedure / treatment.

  Based on the above examination results, one of the objects of the present invention is to provide a thin guiding catheter tube having a small outer diameter and a large inner diameter, that is, a thin wall. Furthermore, one of the objects of the present invention is to provide a medical guiding catheter tube having a backup force, an anti-kink property and a torque transmission property while being thin as described above.

(1) One feature of the present invention is as follows:
(A) an inner tube made of an inner resin,
(B) a reinforcing material layer made of a strand formed on the inner layer pipe,
Covering the reinforcing material layer in order from the most advanced to the base of the inner layer tube,
(C-1) a flexible part made of the second resin,
(C-2) a transition portion made of a third resin that contacts the flexible portion;
(C-3) a proximal portion made of a fourth resin that contacts the transition portion;
(D) a soft tip portion made of a first resin that covers the tip of the flexible portion;
A medical guiding catheter comprising:
In the medical guiding catheter, the portion covered with the flexible portion, the transition portion, and the hand portion has a constant inner diameter R _in and a constant outer diameter R _out , and the R _in and R _out are the following:
(I) 1.830 mm ≦ R _in ≦ 4.0000 mm and (ii) 0.060 mm ≦ (R _out −R _in ) /2≦0.136 mm and (iii) 0.029 ≦ (R _out −R _in ) / R _out ≦ 0.130,
It is a medical guiding catheter tube characterized by satisfying the following equations.

  Therefore, a thin medical guiding catheter tube having a small outer diameter and a large inner diameter, that is, a thin medical diameter can be obtained. Moreover, the medical guiding catheter tube which has backup force, anti-kink property, and torque transmission property can be obtained according to the relationship between the inner diameter and the outer shape.

In the above equation, (R _out −R _in ) / 2 indicates the thickness of the guiding catheter tube, and (R _out −R _in ) / R _out indicates the ratio of the outer radius to the thickness of the guiding catheter tube. It is shown.
(2) In one embodiment of the present invention, the Shore D hardness of the first resin is the same as the Shore D hardness of the second resin, and the Shore D hardness of the first resin and the second resin Is less than or equal to the Shore D hardness of the third resin, and the Shore D hardness of the third resin is less than or equal to the Shore D hardness of the fourth resin,
A medical guiding catheter tube characterized by the above.

Therefore, in the length direction, the hardness change gradually changes from the most advanced to the base, and the pushing force and rotational force given by the base are smoothly transmitted to the most advanced part, and at the same time, an unnatural deformation force is given to the blood vessel. There is no. Furthermore, since the soft tip portion formed of the first resin is particularly flexible, the inner wall of the blood vessel is not damaged when the guiding catheter tube is inserted into the blood vessel.
(3) In one embodiment of the present invention, the first resin, the second resin, the third resin, the fourth resin, and the inner layer pipe are all polyamide-based elastomer resins. Therefore, it can be set as the medical guiding catheter tube which takes a flexible deformation | transformation along a complicated blood vessel path | route.
(4) In one embodiment of the present invention, the first resin further contains bismuth oxide, and the second resin, the third resin, and the fourth resin contain barium sulfate. To do. Therefore, when operating the guiding catheter tube under fluoroscopy, the soft tip portion constituted by the first resin containing the bismuth oxide can ensure particularly clear visibility, It becomes easy to grasp what path the flexible part, transition part, and hand part constituted by the second resin, the third resin, and the fourth resin containing barium sulfate follow in the blood vessel. .
(5) One embodiment of the present invention is further characterized in that the material of the wire forming the reinforcing material layer is a metal, and the cross section of the wire is rectangular. Therefore, it is possible to obtain a thin medical guiding catheter tube while having backup force, anti-kink property, and torque transmission property.
(6) One embodiment of the present invention is further characterized in that the outer diameters of the contact portion between the flexible portion and the transition portion and the contact portion between the transition portion and the proximal portion do not change. Therefore, when inserting the guiding catheter tube into the blood vessel, the inner wall of the blood vessel is not damaged and a smooth procedure can be achieved.
(7) One embodiment of the present invention has at least one bent portion in the axial direction of the medical guiding catheter tube. Therefore, it becomes easy to deliver the soft tip part of the guiding catheter tube to the affected part to be treated.
(8) In one embodiment of the present invention, the tip of the soft tip has a round shape. Therefore, when the medical guiding catheter tube is inserted into a blood vessel, the possibility of damaging the inner wall of the blood vessel can be significantly reduced.
(9) One embodiment of the present invention is further characterized in that the soft tip portion is tapered at a portion covering the tip of the flexible portion. Therefore, the possibility of damaging the inner wall of the blood vessel when the medical guiding catheter tube is inserted into the blood vessel by the portion forming the outer diameter R _out of the medical guiding catheter tube generated thereby can be significantly reduced.
(10) One embodiment of the present invention is characterized in that the inner surface and / or the outer surface is coated with a hydrophilic coating. Therefore, the insertion of the guiding catheter tube into the blood vessel is facilitated, and the insertion of the small-diameter catheter passing therethrough is facilitated.
(11) In one embodiment of the present invention, in order to reduce resistance to the inner wall of the blood vessel into which the medical guiding catheter tube is inserted and reduce the mobility of the medical guiding catheter tube, The outer surface is not coated with a hydrophilic coating. If the outer surface is not coated, there is an advantage that friction with the blood vessel occurs, and the guiding catheter tube cannot be moved carelessly during the procedure.
(12) In one embodiment of the present invention, the inner surface of the medical guiding catheter tube is further coated with silicone oil. Therefore, it becomes easy to insert a small-diameter catheter therethrough.

  Therefore, a thin medical guiding catheter tube having a small outer diameter and a large inner diameter, that is, a thin medical diameter can be obtained. Moreover, the medical guiding catheter tube which has backup force, anti-kink property, and torque transmission property can be obtained according to the relationship between the inner diameter and the outer shape.

  Other features and advantages of the present invention will become apparent from the description of the following embodiments.

  The best mode, structure and manufacturing method of a medical catheter tube as an embodiment 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. be able to.

FIG. 1 shows a flowchart of a manufacturing method, and the configuration and structure of a medical catheter tube as an embodiment of the present invention and a manufacturing method will be described with reference to this drawing. The form, structure, and manufacturing method of the present invention can be modified as appropriate without departing from the scope of the present invention described in the claims.
1. Preparation of metal core wire and formation of inner layer tube First, as shown in FIG. 2, a metal core wire (or metal core metal) 1 wound around a reel 2 is prepared. The outer diameter of the metal core wire is substantially the same as the inner diameter of a later-described catheter to be manufactured, and the material is preferably an annealed copper wire plated with a metal such as silver or nickel, or a stainless steel wire.

  Subsequently, as shown in FIG. 3, the inner layer tube 3 is formed by extrusion coating on the metal core wire using the extruder 4. The constituent material of the inner tube is preferably polyamide elastomer, polyester elastomer, polyurethane elastomer, polystyrene elastomer, fluorine-based elastomer, various elastomers such as silicone rubber, latex rubber, or a combination of two or more of these. Can be mentioned.

  Here, the “polyamide elastomer” includes, for example, nylon 6, nylon 64, nylon 66, nylon 610, nylon 612, nylon 46, nylon 9, nylon 11, nylon 12, N-alkoxymethyl-modified nylon, hexamethylene. A block copolymer having various aliphatic or aromatic polyamides such as diamine-isophthalic acid condensation polymer and metaxyloyldiamine-adipic acid condensation polymer as a hard segment and a polymer such as polyester or polyether as a soft segment. Typical examples are polymer alloys (polymer blend, graft polymerization, random polymerization, etc.) of the polyamide and a flexible resin, those obtained by softening the polyamide with a plasticizer, and mixtures thereof. It is a concept that also includes

  The above-mentioned “polyester elastomer” is typically a block copolymer of a saturated polyester such as polyethylene terephthalate or polybutylene terephthalate and a polyether or polyester. It is a concept including those softened with a plasticizer or the like, and also a mixture thereof.

  The material suitably used for the inner layer tube is preferably a polyamide elastomer from the viewpoint of processability and flexibility, and a typical example thereof is PEBAX manufactured by Arkema. Here, it is preferable to use PEBAX having a relatively hard Shore D hardness of about 70D so that the catheter has a small outer diameter and a large inner diameter at the same time.

  The “Shore D hardness” referred to in the present specification is a value measured with a durometer type D in accordance with ISO (International Organization for Standardization) 7619.

The inner tube coated with the metal core wire preferably has a sufficient adherence force to the metal core wire, and when the both ends of the metal core wire are pulled in the subsequent process, the outer diameter of the metal core wire is reduced, It is preferable that the inner layer tube is peeled off from the metal core wire so that the metal core wire comes out of the inner layer tube. For example, polyamide elastomer or PEBAX can be used as the constituent of the inner tube having such properties.
2. Formation of reinforcing material layer (braiding)
The metal core wire covering the inner layer pipe is set on the braiding machine 5 as shown in FIG. 4 to form a reinforcing material layer. The braiding machine 5 has a mechanism for braiding metal strands in the inner pipe circumferential direction. In this mechanism for braiding metal strands in the inner pipe circumferential direction, the rotating parts 6a and 6b rotate in opposite directions, and at the same time, the bobbin 7 attached to each of the rotating parts 6a and 6b covers the inner pipe. The braiding is performed by alternately repeating the action of approaching and leaving the metal core wire.

  Here, the number of bobbins of the rotating portions 6a and 6b is set to six as an example, but this results in twelve strikes (number of stitches (pick) of one round). This number of strikes can be set as appropriate depending on the number of bobbins used. The number of wires (the number of strands included in one stitch) can be appropriately set depending on how many strands are wound together around one bobbin. In order to obtain a guiding catheter tube that is thin but maintains characteristics such as backup force, anti-kink property, and torque transmission property, it is possible to adjust the number of strokes and the number of handles. The adjustment of the number of strokes and the number of hands, that is, the adjustment of the density of the strands is a technique well known to those skilled in the art.

  Here, the guiding catheter is generally required to have characteristics such as backup force, anti-kink property, and torque transmission property. In the prior art, in order to satisfy these characteristics, for example, by reducing the inner diameter, it has been necessary to make the wall thickness more than a certain thickness (see the comparative example described later). In other words, it is the common general knowledge of those skilled in the art that if the thickness is below a certain thickness, the specification of the backup force and the like is impaired.

  In this respect, the embodiment is necessary even though the guiding catheter is thinned as will be described later, thereby simultaneously improving the permeability to the blood vessel and the operability of the small-diameter catheter that is allowed to pass inside. One characteristic is that the above-mentioned characteristics (back-up force, anti-kink property, torque transmission property, etc.) are provided. One of the reasons why the embodiment achieves these advantageous effects is because the embodiment employs a method of forming a reinforcing material layer having the above-mentioned characteristics, which is not found in the prior art. The dimension range suitable for the guiding catheter tube of the embodiment of the present invention will be described later together with the examples.

  There are various forms of braiding of the metal wire, such as 1 over 1 under and 2 over 2 under, but any form may be adopted as long as it is suitable as a reinforcing material layer for the catheter. In addition, the metal wire may be formed in a coil shape instead of a braid according to the dimensions required for the guiding catheter.

  Although the strand used for braiding is illustrated as embodiment, it is preferable that it is a metal from a viewpoint of intensity | strength. As the metal wire constituting the braid, stainless steel, C—Mn—Si—PS—Cr—Mo—Ni—Fe—X (X═Au, Os, Pd, Re, Ta, Ir, Ru) alloy, C—Mn—Si—PS—Cr—Mo—Ni—X (X═Au, Os, Pd, Re, Ta, Ir, Ru) alloy, copper, nickel, titanium, piano wire, Co—Cr alloy, Ni-Ti alloys, Ni-Ti-Co alloys, Ni-Al alloys, Cu-Zn alloys, Cu-Zn-X alloys (for example, X = Be, Si, Sn, Al, Ga), amorphous alloys The use of stainless steel is preferable because various metal strands such as the above can be used, and there are no workability, economical efficiency, and no toxicity. As the stainless steel wire, any stainless steel such as martensite, ferrite, two-phase, and austenite may be used, but a heat-treated stainless steel wire called an annealed wire or a spring wire is preferably used. .

  For the purpose of obtaining a thinner guide catheter tube, the metal wire preferably has a rectangular cross section.

  As shown in FIG. 5, the rectangular cross section of the metal strand preferably has a width of about 0.05 to 0.10 mm and a thickness of about 0.01 to 0.05 mm. The metal element wire may be a metal element alone or an assembly of element wires.

Subsequently, the inner layer pipes braided with metal wires are cut one by one as shown in FIG.
3. Outer tube disposed further to the inner tube which is braided with metal wire, a resin outer layer (or a resin tube), respectively, formed proximal portion, a transition portion, the flexible portion (or hand part), according to the "Fourth resin" The tube 7c, the tube 7b made of "third resin", and the tube 7a made of "second resin" are covered as shown in FIG.

  Here, it is preferable to use tubes having the same inner and outer diameters as the tube 4c made of "fourth resin", the tube 7b made of "third resin", and the tube 7a made of "second resin".

  In FIG. 7 and subsequent figures, for the sake of convenience, the left 7c is used as a hand portion, the middle 7b is used as a transition portion, and the right 7a is used as a flexible portion.

  The fourth resin, the third resin, and the second resin tube each change stepwise from a high portion to a low Shore D hardness from the hand portion to the hand portion. That is, in FIG. 7, the resin tube whose Shore D hardness increases in the order of 7a <7b <7c is arranged.

  Examples of the resin forming the resin outer layer include polyamide elastomers, polyester elastomers, polyurethane elastomers, polystyrene elastomers, fluorine-based elastomers, various elastomers such as silicone rubber and latex rubber, or combinations of two or more thereof. Can be mentioned.

  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. -Representative examples are block copolymers with various aliphatic or aromatic polyamides such as isophthalic acid polycondensate and metaxyloyldiamine-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 a mixture thereof. It is a concept that also includes

  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 are plasticized. It is a concept including those softened with an agent or the like, and also a mixture thereof.

  A material suitably used for the resin outer layer is preferably a polyamide elastomer from the viewpoint of processability and flexibility, and examples thereof include PEBAX manufactured by Arkema.

  Furthermore, X-ray-impermeable metal compound particles are added to the tube 7c made of the fourth resin, the tube 7b made of the third resin, and the tube 7a made of the second resin, which form the hand portion, the transition portion, and the flexible portion. It is desirable that Specifically, the material is not particularly limited as long as the material exhibits radiopacity, but heavy metal compounds that are radiopaque and stable for a long time can be given. More specifically, barium sulfate, bismuth compounds, tungsten compounds, platinum, gold, silver, tantalum, and the like can be given. Here, grasping the route of the tube 7c made of the fourth resin, the tube 7b made of the third resin, and the tube 7a made of the second resin, which form the hand portion, the transition portion, and the flexible portion, in the blood vessel In order to facilitate this, it is preferable that barium sulfate is added.

More specifically, the tube 7c made of the fourth resin forming the hand portion has PEBAX having a Shore D hardness of about 70D and barium sulfate of about 40 wt%, and the tube 7b made of the third resin forming the transition portion has a Shore D hardness of about 60D. It is desirable to add about 40 wt% of barium sulfate to PEBAX and add about 40 wt% of barium sulfate to PEBAX having a Shore D hardness of about 40D in the tube 7a made of the second resin forming the flexible part, and obtain a tube by extrusion molding. At this time, the barium sulfate has an average particle diameter of preferably 1 to 100 μm, and particularly preferably an average particle diameter of 1 to 10 μm.
4). Shrink tube tightening and removal / metal core wire removal Subsequently, as shown in FIG. 8, the resin outer layer (resin tube) disposed is covered with a shrink tube 8 having a property of reducing its diameter by heating. The shrink tube is preferably made of polytetrafluoroethylene or perfluoroethylene-propene copolymer.

  Thereafter, by heating with a heater to a temperature at which the shrink tube 8 contracts, or by applying high-frequency electromagnetic waves, the inner tube, the braid with a metal wire, respectively, a hand part, a transition part, a flexible part, The tube made of the fourth resin, the tube made of the third resin, and the tube made of the second resin are integrated.

Subsequently, after the integration as described above, the shrink tube is peeled off, the metal cored bar is extended from both ends to reduce the diameter, the adhesion to the inner layer pipe is peeled off, and the metal cored bar is removed.
5. Mandrel insertion / Flexible part tip molding / Soft tip part placement / Soft tip shrink tube tightening Further, the mandrel 9 is inserted into the flexible part (see the tube 7a in FIG. 7) as shown in FIG. To form a taper shape. The tip of the flexible part in FIG. 9 shows an example of the “taper shape” of the present invention. By having a tapered shape, when the portion forming the outer diameter R _out of the medical guiding catheter tube inserting the medical guiding catheter tube into the blood vessel, significantly likely to injure the blood vessel inner wall reduction Can be made.

Subsequently, the soft tip portion 10 is inserted into the mandrel 9 and the flexible portion as shown in FIG. 10, and the shrink tube 11 is placed on the mandrel 9 and heated as shown in FIG. 11, and the soft tip portion 10 and the flexible portion tip are integrated. In order to give flexibility, the soft tip is a “first resin” having the same hardness as the second resin (see the tube 7a in FIG. 7), that is, PEBAX having a Shore D hardness of about 40D. It is preferable to use a tube obtained by extrusion molding by adding about 50 wt% of bismuth oxide, which can provide visibility more clearly.
6). Shrink tube removal, soft tip end molding, mandrel removal After this, the shrink tube 11 is peeled off, the tip of the soft tip portion is heated or given a round shape by means such as a cutter or a router, and the mandrel 9 is pulled out, A medical guiding catheter tube is obtained. The tip of the soft tip portion 10 in FIG. 12 shows an example of the “R shape” of the present invention. By having the round shape, the possibility of damaging the inner wall of the blood vessel when the medical guiding catheter tube is inserted into the blood vessel can be significantly reduced. In addition, giving a round shape is not limited to after the shrink tube 11 is peeled off as described above, but may be processed into a round shape in advance before being inserted into the mandrel 9 and the flexible portion.

At this time, the tube inner diameter R _in and the tube outer diameter R _out are defined as shown in FIG. When using a medical guiding catheter tube, the metal core wire is removed.

Note that the lengths in the axial direction of the soft tip portion, the flexible portion, the transition portion, and the hand portion described above may be the same or different.
7). Hydrophilic coating or non-coating Although not shown, after the shrink tube 11 is peeled off, the inner surface and / or outer surface of the medical guiding catheter tube may be coated with a hydrophilic (or water-soluble) polymer substance. . When the outer surface is coated, when the outer surface of the catheter tube comes into contact with blood or physiological saline, the friction coefficient is reduced and lubricity is imparted, and the slidability of the catheter tube is further improved. As a result, pushability, followability, kink resistance and safety are further enhanced. When the inner surface is coated, insertion of a small diameter catheter through the guiding catheter is facilitated.

  Examples of the “hydrophilic (or water-soluble) polymer substance” include the following natural or synthetic polymer substances and 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.

  On the other hand, when the outer surface is not coated as described above, there is an advantage that friction with a blood vessel occurs and the medical guiding catheter tube cannot be moved carelessly during the procedure. The presence or absence of the hydrophilic coating and the selection of the inner surface and / or the outer surface as the coating target can be appropriately selected depending on the function required for the medical guiding catheter tube.

In addition, since the inner surface of the medical guiding catheter tube is coated with silicone oil, it is easy to insert a small-diameter catheter therethrough. This inner surface coating can be employed with or without the outer surface hydrophilic coating.
8). Although not shown here, a hub having an appropriate shape to serve as the handle of the medical catheter is attached to the end of the proximal portion, so that the desired medical catheter tube of the best form can be obtained.

  In use, a bent portion can be formed by heating a part of the medical guiding catheter tube with a heater or steam in advance. The bent portion preferably has a shape corresponding to the state of the blood vessel into which the medical guiding catheter is inserted.

  A metal cored bar having a diameter of 1.83 mm wound on a reel was coated and extruded with PEBAX7033 to a thickness of 0.025 mm using an extruder to produce an inner layer tube. Next, an element wire (cross-sectional thickness 0.035 mm, width 0.100 mm) made of SUS304 was braided using the braiding machine 5 illustrated in FIG. 4 described above. At the time of this braiding, the number of strands was 24 and the number of striking was eight.

  Next, cut to the required length, and cover with PEBAX tubes to which barium sulfate is added, corresponding to the above-mentioned hand portion, transition portion, and flexible portion (see 7c, 7b, 7a and description thereof in FIG. 6), and the whole. Was covered with a shrink tube, heated with a heater, and integrated.

  Thereafter, the shrink tube was peeled off, and both ends of the metal core were pulled to remove the metal core. Thereafter, a mandrel was inserted into the tip, and the tip of the flexible part was formed into a taper shape using a router.

  Furthermore, the soft tip part containing bismuth oxide corresponding to the above-mentioned soft tip part 10 was covered on the front-end | tip of a flexible part, and the shrink tube was further covered, and it heated. After cooling, the shrink tube was peeled off, the mandrel was peeled off, and a guiding catheter tube was obtained.

The inside diameter R _in of this guiding catheter tube was 1.83 mm as measured with a pin gauge. More flexible section, the flexible section, the outer diameter of the transition section is measured to the outer diameter R _out by a laser outer diameter measuring device, it was constant at 2.10 mm.

Comparative example

The inner diameter R _in the medical guiding catheter five other products having substantially the same outer diameter as in Example pin gauge, and the outer diameter R _out measured by a laser outer diameter measuring instrument. The measurement results are shown in Table 1.

The wall thickness can be obtained by an arithmetic expression (R _out −R _in ) / 2 based on the measured R _out and R _in .

The ratio of the outer radius to the wall thickness of the guiding catheter tube (abbreviated as wall thickness / outer radius ratio) is expressed by (R _out −R _in ) / R _out .

In addition, the dimension range requested | required by this specification is as follows.
(I) Inner diameter: 1.830 mm ≦ R _in ≦ 4.0000 mm and (ii) Wall thickness: 0.060 mm ≦ (R _out −R _in ) /2≦0.136 mm and (iii) Ratio of outer radius to wall thickness : 0.029 ≦ (R _out −R _in ) / R _out ≦ 0.130

以上のように、内径Ｒ_in、外径Ｒ_outを測定すると上記条件を満たすものは本実施例のみであった。

As described above, when the inner diameter R _in and the outer diameter R _out are measured, only the present example satisfies the above conditions.

  The inner diameter of the guiding catheter may be determined within the above range (i) based on the diameter of the small-diameter catheter that is passed through the guiding catheter. Adjustment of the inner diameter in the range of (i) can be performed, for example, by setting the metal core wire illustrated in FIG. 2 to a desired outer diameter. Adjustment of the thickness of the guiding catheter within the range of (ii) can be performed by the manufacturing method described in the embodiment.

  As described above, it is possible to form a thinner guiding catheter than the comparative example by adopting the reinforcing material layer forming method based on the inventor's unique knowledge of the present application described in the embodiment. It became. Therefore, by adopting the dimensions in the above ranges (i) to (iii) that are not adopted in the comparative example, the “medical guiding catheter tube” included in the scope of the present invention is thin, but is backed up. It has the characteristics of having strength, anti-kink property, and torque transmission property.

FIG. 1 is a flowchart showing a method for manufacturing a medical catheter tube as an embodiment of the present invention. FIG. 2 shows a state of the metal core wire wound around the reel. FIG. 3 shows a state where the inner layer pipe is continuously coated by an extruder. FIG. 4 shows a state in which a reinforcing material layer is formed by braiding metal strands in the circumferential direction of the inner layer pipe with a braiding machine. FIG. 5 shows a state of a rectangular cross section of the metal strand. FIG. 6 shows the inner pipes cut one by one braided with metal strands. FIG. 7 shows a state in which a tube made of a fourth resin, a tube made of a third resin, and a tube made of a second resin are covered with an inner layer tube braided with metal wires. FIG. 8 shows the state shown in FIG. 7 covered with a shrink tube. FIG. 9 shows a state where the mandrel is inserted into the flexible part. FIG. 10 shows a state in which a soft tip is inserted into the mandrel and the flexible part. FIG. 11 shows the state shown in FIG. 10 covered with a shrink tube. FIG. 12 is a diagram illustrating a method for defining the tube inner diameter R _in and the tube outer diameter R _out of the medical guiding catheter tube as the embodiment.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Metal core wire 2 Reel 3 Inner layer pipe 4 Extruder 5 Braiding machine 6a, 6b Rotating part of the mechanism part to braid 7 Bobbin 7a Tube 7b by 2nd resin 7c Tube 7c by 3rd resin 8 Shrink tube 9 Mandrel 10 Soft tip 11 shrink tube

Claims (12)

(A) an inner tube made of an inner resin,
(B) a reinforcing material layer made of a strand formed on the inner layer pipe,
Covering the reinforcing material layer in order from the most advanced to the base of the inner layer tube,
(C-1) a flexible part made of the second resin,
(C-2) a transition portion made of a third resin that contacts the flexible portion;
(C-3) a proximal portion made of a fourth resin that contacts the transition portion;
(D) a soft tip portion made of a first resin that covers the tip of the flexible portion;
A medical guiding catheter comprising:
In the medical guiding catheter, the portion covered with the flexible portion, the transition portion, and the hand portion has a constant inner diameter R _in and a constant outer diameter R _out , and the R _in and R _out are the following:
(I) 1.830 mm ≦ R _in ≦ 4.0000 mm and (ii) 0.060 mm ≦ (R _out −R _in ) /2≦0.136 mm and (iii) 0.029 ≦ (R _out −R _in ) / R _out ≦ 0.130,
A medical guiding catheter tube characterized by satisfying the following formulas. The Shore D hardness of the first resin is the same as the Shore D hardness of the second resin, and the Shore D hardness of the first resin and the second resin is less than or equal to the Shore D hardness of the third resin, and The Shore D hardness of the third resin is less than or equal to the Shore D hardness of the fourth resin;
The medical guiding catheter tube according to claim 1.   3. The medical guiding catheter tube according to claim 1, wherein all of the first resin, the second resin, the third resin, the fourth resin, and the inner layer tube are polyamide-based elastomer resins.   The medical guide according to any one of claims 1 to 3, wherein the first resin contains bismuth oxide, and the second resin, the third resin, and the fourth resin contain barium sulfate. Ding catheter tube.   The medical guiding catheter tube according to any one of claims 1 to 4, wherein a material of the wire forming the reinforcing material layer is a metal, and a cross section of the wire is rectangular.   The medical guiding according to any one of claims 1 to 5, wherein an outer diameter of the contact portion between the flexible portion and the transition portion and a contact portion between the transition portion and the proximal portion does not change. Catheter tube.   The medical guiding catheter tube according to any one of claims 1 to 6, wherein the medical guiding catheter tube has at least one bent portion in an axial direction.   The medical guiding catheter tube according to any one of claims 1 to 7, wherein a tip of the soft tip portion has a round shape.   The medical guiding catheter tube according to any one of claims 1 to 8, wherein a portion of the soft tip portion covering the tip of the flexible portion is tapered.   The medical guiding catheter tube according to any one of claims 1 to 9, wherein an inner surface and / or an outer surface of the medical guiding catheter tube are coated with a hydrophilic coating.   The outer surface of the medical guiding catheter tube is not hydrophilically coated to reduce resistance to the inner wall of the blood vessel into which the medical guiding catheter tube is inserted, thereby reducing the mobility of the tube. A medical guiding catheter tube according to any one of claims 1 to 9. The medical guiding catheter tube according to any one of claims 1 to 11, wherein an inner surface of the medical guiding catheter tube is coated with silicone oil.

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