WO2007013545A1

WO2007013545A1 - Medical catheter tube and process for producing the same

Info

Publication number: WO2007013545A1
Application number: PCT/JP2006/314853
Authority: WO
Inventors: Takahiro Murata; Tsuyoshi Mihayashi; Takeshi Kikuchi
Original assignee: Kaneka Corporation
Priority date: 2005-07-28
Filing date: 2006-07-27
Publication date: 2007-02-01
Also published as: JPWO2007013545A1; KR20080025038A; JP4553010B2; KR101314714B1

Abstract

A medical catheter tube comprising an inner layer tube, a synthetic resin wire disposed along the direction of axis line of the medical catheter tube on at least part of the inner layer tube, a reinforcing material layer of braided metal wires provided so as to cover the synthetic resin wire, and a resin external layer. Further, there is provided a process for producing a medical catheter tube, comprising preparing an inner layer tube; disposing a synthetic resin wire on the base and distal end portion of medical catheter tube along the direction of axis line thereof; so as to cover the same, braiding metal wires, thereby forming a reinforcing material layer; and covering the reinforcing material layer with a resin external layer.

Description

Specification

Medical catheter tube and manufacturing method thereof

Technical field

[0001] The present invention has excellent flexibility, position adjustment, torque transmission, kink resistance, pressure resistance, high degree of freedom of adjustment of inclination control of rigidity and flexibility, and tone setting according to various access routes The present invention relates to a medical catheter tube having the above and the manufacturing method thereof.

[0002] In particular, the present invention exhibits excellent flexibility at the same time as the X-ray visibility suitable for the distal end portion, and the operator does not deteriorate and position adjustment is not deteriorated in the process of repeatedly pushing and pulling. The present invention relates to a medical catheter tube and a method for manufacturing the same.

Background art

[0003] 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 contrast agent, suction of a thrombus, securing a passage of a blood vessel in an obstructed state, Used for vasodilation and the like, and usually consists of a tube body. Such a catheter is required to have excellent operability so that it can be quickly and surely inserted into a vascular system having a thin and complicated pattern.

[0004] The operability of such a catheter tube will be described in detail. Position adjustment for ensuring that the operation of the operator is transmitted from the base to the distal end, such as insertion and withdrawal in the blood vessel, etc. Etc., pressure resistance is required when circulating such as. This position adjustment requires the property that the force taper does not stretch. In addition, torque transmission to ensure that the rotational force generated at the base of the catheter tube is transmitted, and the pushing force of the practitioner is reliably transmitted from the proximal end to the distal end to advance the blood vessel. The pushability that can be done is also required. Furthermore, 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 out along the preceding guide wire without damaging the inner wall of the vessel. Affinity for blood and tissues is required. Even if the tip of the catheter tube reaches the target position and the guide wire is pulled out, kink resistance that does not cause the catheter tube to bend at the bent or bent portion of the blood vessel and the blood vessel without damaging the blood vessel Shape according to shape The tip must be flexible enough to maintain

[0005] It is generally known that in order to provide such characteristics according to demands, it is preferable to have a structure and configuration in which the base is relatively rigid and gradually becomes flexible toward the tip.

[0006] In order to obtain a catheter tube having the characteristics described above, a wire is wound around the 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. The method is known.

[0007] Patent Document 1 discloses that a wire is wound around an inner layer tube as a reinforcing material layer in a coil shape. In Patent Document 1, a catheter having a portion in which a flexible inner tube and an outer tube are joined via a reinforcing material layer. The reinforcing material layer has a linear body formed in a lattice shape, and the inclination angle of the linear body with respect to the axis of the catheter body is continuous along the axial direction of the catheter body. Alternatively, the region where the bending stiffness is increased and the region where the bending stiffness is decreased by changing the interval of the lattice points of the filaments in the axial direction of the catheter body continuously or in steps are changed. A forming catheter tube is disclosed.

[0008] However, in this configuration, the reinforcing material layer is only wound in a coil shape on the inner tube, and when the catheter is pushed in and repeatedly pulled out, the position of the catheter is reduced and the position adjustability is lowered. , I don't care about things.

[0009] Further, as disclosed in Patent Document 2, a passage that defines a proximal end, a distal end, and a lumen extending between these ends, as a coil in which an element wire is wound around an inner layer tube as a reinforcing material layer. An 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; A catheter tube is disclosed having at least one first ribbon stiffener having a circumference and spirally and coaxially wound around the outer tubular liner and covered by the outer tubular cover. Yes.

[0010] However, in this configuration, with regard to the marker that gives X-ray visibility in this configuration, an X-ray-impermeable granule kneaded with rosin is placed at the catheter tip. Good X-ray visibility and high flexibility cannot be secured. In this configuration, the reinforcement layer is There is no consideration for the fact that when the catheter is pushed in and pulled out repeatedly, the position of the catheter is reduced and the position adjustment is reduced.

[0011] As described in Patent Document 3, a catheter having a flexible tubular catheter body and a coil having a reinforcing effect embedded in the wall of the catheter body. The catheter body includes a first region located on the most distal side of the catheter, and a second region located on the proximal side of the first region, and the coil includes the first region. Extending in the second region, in which the coil is wound at a relatively large winding pitch over its entire length, and in the first region, the coil is adjacent over its entire length. The windings are wound at a relatively small winding pitch that separates the windings, and the winding pitch of the coil gradually decreases toward the tip side, and the first region is larger than the second region. Catheter in one area Catheter tube, characterized by being configured to sexual force S decreases so is disclosed.

[0012] However, this catheter tube can form a rigid base portion and a highly flexible distal end portion, and can maintain a balance of flexural rigidity. However, according to various access paths. When setting the condition of the catheter tube, there is no idea. In addition, this catheter tube has all the reinforcing coils that are X-ray-impermeable metal wire force, and the distal end portion is not sufficiently flexible. In addition, the X-ray visibility becomes excessive, so that the operation is performed during the operation. May interfere with the judgment of the person. Furthermore, there is no consideration for the catheter extending when the catheter is pushed in and pulled out repeatedly.

[0013] As a method for braiding a reinforcing material layer on an inner layer pipe, Patent Document 4 discloses a long shaft having a proximal region, a distal region, and a lumen extending therebetween. The proximal region has an inner smooth polymer layer, a reinforcing layer and an outer layer, each layer has a distal end, and the reinforcing layer comprises a metal member and a blade having a plurality of polymer members. And vascular catheters, each polymer member comprising a plurality of monofilaments.

[0014] Although this catheter tube has an assembly of monofilaments in the axial direction and consideration is given to elongation, the monofilament used is made of liquid crystal polymer and braided (braided). Fraying associated with the fibrillation occurs and the productivity is immediately inferior.

[0015] Further, since the aggregate of monofilaments arranged in the axial direction has a structure woven between the strands to be braided, it is necessary to use a special braiding machine. In particular, the insertion resistance of the guide wire that causes the catheter inner hole surface to become uneven or immediately conducting may increase. In addition, when both the axially arranged and braided ones are monofilaments, the entire catheter may be too soft and may not have sufficient kink resistance.

Patent Document 1: Japanese Patent Laid-Open No. 06-134034

Patent Document 2: Japanese Patent Publication No. 09-501094

Patent Document 3: Japanese Patent Laid-Open No. 2001-218851

Patent Document 4: Japanese Translation of Special Publication 2002-535049

Disclosure of the invention

Problems to be solved by the invention

[0016] The present invention provides a medical catheter tube having excellent position adjustment, torque transmission, flexibility, kink resistance, pressure resistance, pushability, X-ray visibility, and the like, and a method for manufacturing the same. It is to be disclosed.

[0017] The present invention provides a medical catheter tube that is stretched in the process of being repeatedly pushed and pulled out by an operator in particular and does not deteriorate the position adjustability, and to disclose a manufacturing method thereof.

Means for solving the problem

[0018] In summary, the present invention provides:

(1) A medical force tube

An inner tube,

A reinforcing material layer in which a synthetic resin wire is disposed in the axial direction of the medical catheter tube on at least a part of the inner tube, and a metal wire is braided so as to cover it.

A resin outer layer covering the inner layer pipe and the reinforcing material layer;

A medical catheter tube comprising:

(2) The catheter tube has a base portion, an intermediate portion, and a distal end portion from the proximal side toward the distal side. Has a marker part and a soft part,

The synthetic resin wire has a synthetic fiber force having a structure in which a molten liquid crystal polymer is used as a core, and a sheath made of an island of the molten liquid crystal polymer and a sea of a flexible polymer covers the core. In this case, a radiopaque metal covers the inner layer tube to form a marker, and the Shore D hardness from the base part to the tip part of the resin material of the outer layer of the resin is stepwise or continuously. The medical catheter tube according to (1), which is smaller;

(3) The resin outer layer includes at least a first resin outer layer, a second resin outer layer, and a third resin outer layer.In the soft part, the inner layer tube is covered with at least the first resin outer layer,

In the marker portion, the inner layer pipe is covered with the reinforcing material layer, the reinforcing material layer is covered with a marker, and further covered with the first resin outer layer,

At the tip, the inner layer tube is covered with the reinforcing material layer, the reinforcing material layer is covered with the first outer resin layer,

In the intermediate portion, the inner layer pipe is covered with a reinforcing material layer, and the reinforcing material layer is covered with at least a second resin outer layer,

At the base, the inner layer tube is covered with a reinforcing material layer, the reinforcing material layer is covered with at least a third resin outer layer,

Here, the Shore D hardness of the resin material of the first resin outer layer is smaller than the Shore D hardness of the resin material of the second resin outer layer and

The medical catheter tube according to (2), wherein the Shore D hardness of the resin material of the second outer layer resin is smaller than the Shore D hardness of the resin material of the third resin outer layer;

(4) The medical catheter tube according to (3), wherein the first resin outer layer, the second resin outer layer, and the third resin outer layer covering the catheter tube have the same or different lengths in the axial direction;

(5) The thickness of the first resin outer layer covering the catheter tube is thinner than the thickness of the second resin outer layer The wall thickness of the second resin outer layer is thinner than the thickness of the third resin outer layer (4) The described medical catheter tube;

(6) The medical catheter tube according to the above (5), wherein the vagina of the inner tube is made of greaves exhibiting lubricity with respect to the guide wire passing through the lumen; (7) The medical catheter tube according to the above (6), wherein the resin exhibiting lubricity with respect to the guide wire is a fluorinated resin.

(8) The medical catheter tube according to the above (7), wherein the outer diameter of the soft part is changed and is formed into a round shape or a tapered shape;

(9) The medical catheter tube according to any one of the above (1) to (8), wherein the outer layer of the resin is coated with a hydrophilic coating;

(10) A method of manufacturing a medical catheter tube,

Prepare the inner tube,

A synthetic resin wire is disposed on at least a part of the inner layer tube in the axial direction of the base portion and the distal end portion of the medical catheter tube, and a reinforcing material layer is formed by braiding the metal wire so as to cover it. ,

Covering the reinforcing material layer with a resin outer layer;

A manufacturing method comprising:

(11) Hand side force The method for producing a medical catheter tube according to (10) above, which has a base portion, an intermediate portion, a tip portion, a marker portion, and a soft portion in a distal direction,

Preparing at least a first resin outer tube, a second resin outer tube, and a third resin outer tube for the resin outer layer;

In the soft part and the marker part, the inner layer tube is covered with a reinforcing material layer, and the reinforcing material layer is covered with at least a first resin outer layer tube;

At the tip, the inner layer tube is covered with a reinforcing material layer, and the reinforcing material layer is covered with at least a first resin outer layer tube;

Covering the inner layer tube with a reinforcing material layer at the intermediate portion and covering the reinforcing material layer with at least a second outer resin tube;

At the base, the inner tube is covered with a reinforcing material layer, and the reinforcing material layer is covered with at least a third resin outer layer tube;

Here, the first, second and third resin outer layer pipes are covered with a shrink tube, heat-condensed and integrated, and then the shrink tube is peeled off. In the soft part, the first resin outer layer pipe and the reinforcing material layer of the part corresponding to the soft part are once removed to expose the inner layer pipe,

In the marker portion, the first outer resin outer tube is removed leaving the reinforcing material layer to expose the reinforcing material layer, and the inner tube corresponding to the marker portion and the reinforcing material layer are impermeable to X-rays. Cover with metal, cover the inner tube corresponding to the radiopaque metal and soft part with the first resin outer layer tube, then cover with the shrink tube and heat shrink to make it integral, and then peel off the shrink tube. And forming a marker part and a soft part;

Here, the Shore D hardness of the material of the first resin outer layer tube is smaller than the Shore D hardness of the material of the second resin outer layer tube, and

The method for producing a medical catheter tube according to (10) above, wherein the Shore D hardness of the material of the second resin outer layer tube is smaller than the Shore D hardness of the material of the third resin outer layer tube;

(12) The method for producing a medical catheter tube according to (11), wherein the first resin outer layer tube, the second resin outer layer tube, and the third resin outer layer tube have the same or different length in the catheter tube axial direction;

(13) The thickness of the first resin outer layer tube covering the catheter tube is thinner than the thickness of the second resin outer layer tube. The wall thickness of the second resin outer layer tube is the wall thickness of the third resin outer layer tube. A method for producing a medical catheter tube as described in (12) above;

(14) The method for producing a medical catheter tube according to (13), wherein the soft portion is formed into a round shape or a tapered shape.

I will provide a.

The invention's effect

By means for solving the above-mentioned problems, the present invention is capable of adjusting the position with excellent guide wire followability, transmitting torque applied at the base of the catheter tube, transmitting torque and pushing, and from the base to the tip. There is a continuous change in flexibility between the parts, rigidity and high flexibility of adjustment, tone setting according to various access routes, and kink resistance that does not bend even when complicated bending occurs , Pressure resistance, guide wire followability, productivity, X-ray visibility, etc. There are fruits.

[0020] In particular, the present invention has an effect of providing a medical catheter tube that does not deteriorate its position adjustability due to stretching in the process of being repeatedly pushed and pulled out by an operator.

Brief Description of Drawings

FIG. 1 is a flowchart showing a manufacturing process of a medical catheter of the present invention.

FIG. 2 is a schematic view of a metal core wire wound around a reel.

FIG. 3 is a schematic explanatory diagram for continuously forming an inner layer pipe by an extruder.

FIG. 4 is a schematic explanatory view of forming a reinforcing material layer by arranging reinforcing material wires in the axial direction of the inner layer pipe by a braiding machine and further braiding in the circumferential direction of the inner layer pipe.

FIG. 5 is a schematic diagram of a cross-sectional structure of a strand preferably used as a synthetic resin strand.

FIG. 6 is a schematic view showing a state where tubes are cut one by one.

FIG. 7 is a schematic view showing a state in which the resin tubes having different Shore D hardnesses as outer layers are arranged in close contact with each other.

FIG. 8 is a schematic view showing a state where the whole is covered with a shrink tube.

FIG. 9 is a schematic view showing a state in which the distal end portion of the catheter tube is enlarged and a radiopaque metal tube marker is further arranged.

FIG. 10 is a schematic view showing a state in which a radiopaque metallic wire marker is wound around the distal end of the catheter tube.

FIG. 11 is a schematic diagram showing a radiopaque sheet metal marker with cuts on both sides of a square.

FIG. 12 is a schematic view showing a state in which a radiopaque metal thin plate marker having cuts on both sides of a square is placed at the tip of a force tail tube.

FIG. 13 is a schematic view showing a state in which a resin tube kneaded with radiopaque metal powder is disposed at the distal end of a catheter tube.

FIG. 14 is a schematic view showing a state in which the first rosin outer layer tube is arranged.

FIG. 15 is a schematic view showing a state in which the first resin outer tube is covered with a shrink tube.

[Fig.16] Shrink tube contracts, inner layer tube, X-ray opaque metal force Schematic which shows the state which the car and the 1st resin outer-layer pipe | tube integrated, and the soft part was shaped in the round shape.

FIG. 17 is a schematic diagram showing a heating mold used for soft part shaping and the tip of a catheter tube.

FIG. 18 is a schematic view showing a state where the distal end of the catheter tube is brought into contact with a soft part shaping die and heated.

FIG. 19 is a schematic view of a medical catheter tube showing a state where a metal core wire is drawn and a base end cross section is finished.

FIG. 20 is a schematic diagram showing the condition of a catheter tube.

Explanation of symbols

1 Metal core wire

2 reel

3 Inner layer pipe

4 Extruder

5 Braiding machine

6 Wire supply unit for supplying synthetic resin wires

7 Mechanism for braiding metal strands

8a Rotating part

8b rotating part

9 Bobbin

10 Molten liquid crystal polymer composing core

11 Molten liquid crystal polymer islands that make up the sheath

12 Sea of flexible polymer composing the sheath

13 Resin outer layer

13a High Shore D hardness outer tube

13b Medium Shore D hardness outer layer tube

13c Low Shore D hardness outer tube

14 Shrink tube

15 First resin outer layer 16 Tip of reinforcement layer

17 Inner layer pipe

18 Metal cored bar

19 Radiopaque metal tube

20 X-ray opaque metal strand

21 X-ray opaque metal sheet with cuts on both sides of the square

22 X-ray opaque metal sheet with cuts on both sides of the wrapped square

23 Resin tube kneaded with radiopaque metal powder

24 Absorbent tube with kneaded X-ray opaque metal powder

25 Do not cut! /, A resin tube kneaded with x-ray impermeable metal powder

26 First resin outer tube

27 Shrink tube

28 Soft part shaped like a round shape

29 Heating mold

30 Soft part shaped like a taper

31 Synthetic resin wire

32 Metal wire

33 Reinforcement layer

34 Medical catheter tube

35 base

36 Middle part

37 Tip

38 Marker section

39 Soft part

BEST MODE FOR CARRYING OUT THE INVENTION

The best mode of the medical catheter tube of the present invention and its manufacturing method 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 of each part is preferably used as a medical catheter tube. Any device can be used as long as it can be used. FIG. 1 shows a flowchart of the manufacturing method, and the configuration of the embodiment of the present invention and the manufacturing method will be described with reference to this figure. The form of the present invention 'structure and manufacturing method can be modified as appropriate without departing from the scope of the present invention described in the claims.

[0024] First, an inner layer pipe is prepared as follows.

Prepare metal core wire 1 as shown in Fig.2. This metal core wire is wound around the reel 2, and the outer diameter thereof 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, the left side is the base and the right side is the tip for convenience.

Subsequently, as shown in FIG. 3, the inner layer tube 3 is formed by forming the resin that becomes the inner layer tube on the metal core wire 1 by extrusion coating using the extruder 4.

[0026] The constituent material of the inner tube is not particularly limited as long as it is a resin. Examples of the material for the inner layer tube include polytetrafluoroethylene, tetrafluoroethylene perfluoroalkyl alkyl ether, tetrafluoroethylene hexafluoropropylene copolymer, and ethylene-tetrafluoroethylene. Fluorine-based resins such as copolymers, Polyolefins such as polypropylene, polyethylene, ethylene acetate butyl copolymer, polyesters such as polyamide, polyethylene terephthalate, and polybutylene terephthalate, polyurethanes, polyvinyl chloride, polystyrene-based resins, Resin such as polyimide, and mixtures thereof are listed, but from the standpoint of obtaining position adjustment with guide wire followability, the finished product exhibits excellent lubricity with respect to the guide wire passing through the inner tube, etc. Polytetrafluoroethylene or te It is preferable to configure a fluorine-based 榭脂 such rough Ruo ii ethylene per full O b vinyl ether copolymer. When polytetrafluoroethylene is used, it is baked after undergoing treatment such as drying of the additive.

[0027] In addition, the inner layer tube covered with the metal core wire is sufficiently covered so that the inner layer tube does not lose the metal core wire force unless the metal core wire is stretched by stretching both ends of the metal core wire. It is preferable to have adhesion. Further, in the process of coating the outer tube, the chemical method is used to increase the adhesion between the inner tube and the outer tube, and the use of a defluorinating agent such as thorium naphthalene + dimethyl ether), Z or plasma Within by electrical means such as Concavities and convexities may be formed on the layer tube, or the surface may be modified.

[0028] Subsequently, a reinforcing material layer is formed on at least a part of the inner layer pipe.

First, the metal core wire covered with the inner tube 3 is set in the braiding machine 5 as shown in FIG. The braiding machine 5 includes a strand supply section 6 for supplying a synthetic resin strand 31 in the axial direction of the inner layer pipe 3 and a mechanism section 7 for braiding a metal strand 32 in the circumferential direction of the inner layer pipe 3. The mechanical part 7 braiding the metal strand 32 in the circumferential direction of the inner layer pipe 3 is a metal in which the two rotating parts 8a and 8b rotate in opposite directions, and at the same time, the bobbin 9 attached thereto covers the inner layer pipe 3 Braiding is performed by alternately repeating the movement toward and away from the core wire.

[0029] The synthetic resin wire 31 is arranged in the axial direction of the inner layer tube 3 (that is, the axial direction of the base portion and the distal end portion of the medical catheter tube), so that it is flexible when used as a catheter. It increases the pushability without losing force, and stretches in the process of repeatedly pulling out! / It functions as an anti-elongation material so that the position adjustability does not deteriorate.

[0030] It is preferable to use a synthetic resin wire having a circular cross section, and a plurality of synthetic resin wires are assembled in a flat state (a state where synthetic resin wires are arranged side by side). It is preferable to place it on the inner tube. At this time, the number of synthetic resin strands is preferably 2 to 10 aggregates. Furthermore, it is preferable that 1 to 4 aggregates of the synthetic resin wires in a flat state are arranged on the inner pipe.

[0031] Particularly suitable as the synthetic resin strand is a molten liquid crystal polymer core 10 as shown in the schematic cross-sectional view of Fig. 5 (a), a molten liquid crystal polymer island 11 and a flexible polymer sea 12. The sheath which consists of has the structure which covered the said core. Figure 5 (b) shows a scanning micrograph of this part. The molten liquid crystal polymer is made of polyarylate, and the flexible polymer is made of polyethylene naphthalate. Since such a synthetic resin strand has a structure in which the core of the molten liquid crystal polymer is covered with a sheath, the core of the molten liquid crystal polymer does not fibrillate and become fluffy during processing. The synthetic resin strand having such a structure is composed of a die that melts and extrudes a molten liquid crystal polymer corresponding to a core portion, and a molten liquid crystal polymer and a flexible polymer that are arranged coaxially and correspond to a sheath portion. It can be obtained by spinning each polymer while extruding it from a die that melts and extrudes the mixture. Preferably the diameter of the synthetic resin strand used suitably is 5-50 It is preferable to use a μm one.

[0032] Other examples of synthetic resin wires include polyesters such as polyethylene terephthalate, polybutylene terephthalate and polymethylene terephthalate, polyolefins such as polyethylene and polypropylene, rigid polychlorinated butyl, Polyamide, Polyimide, Polystyrene, Thermoplastic polyurethane, Polycarbonate, ABS resin, Acrylic resin, Polymethylmethalate, Polyacetal, Polyarylate, Polyoxymethylene, High-tensile polybulal alcohol, Fluorine resin, Polyvinyl fluoride Fragrance typified by redene, polytetrafluoroethylene, ethylene acetate saponification, polysulfone, polyethersulfone, polyether ketone, polyphenylene oxide, polyphenylene sulfide, and Kevlar Such as polyaramid, Porimaaroi containing any of these, carbon fiber and glass fiber.

[0033] The braiding of the metal strand in the circumferential direction of the catheter plays a role of giving pressure resistance and providing kink resistance.

[0034] There are various forms of the braid, such as 1 over 1 under and 2 over 2 under, but if it is suitable as a reinforcing material layer for the catheter, take the form of deviation.

[0035] The metal wire constituting the braid includes stainless steel, C—Mn—Si—P—S—Cr—Mo

Ni—Fe— X (X = Au, Os, Pd, Re, Ta, Ir, Ru) alloy, C Mn— Si— P— S— Cr — Mo— Ni— X (X = Au, Os, Pd, Re , Ta, Ir, Ru) alloy, copper, nickel, titanium, piano wire, Co-Cr alloy, Ni-Ti alloy, Ni-Ti-Co alloy, Ni-Al alloy, Cu-Zn alloy, Cu-Zn — Various metal strands such as alloys such as X alloys (for example, X = Be, Si, Sn, Al, Ga), amorphous alloys, etc. are used. Of these materials, X-ray opaque markers to be placed later In order to ensure sufficient visibility, it is preferable to use stainless steel because it is less visible than an X-ray impermeable marker and because it is not workable, economical or toxic. This stainless steel wire may be martensitic, ferritic, two-phase, austenitic, or other stainless steel, but heat-treated stainless steel, commonly called annealed wire or panel wire, is used. Wire is preferably used. The metal strand is preferably about 5 to 50 μm in diameter. [0036] The metal element wire may be used alone, or an assembly of element wires may be used. As the aggregate, for example, one obtained by knitting a plurality of strands in a string shape can be mentioned.

[0037] In the medical catheter tube of the present invention, since the reinforcing material layer made of the synthetic resin wire and the metal wire is formed on the inner tube as described above, the flexibility is not lost. The pushability is increased, and the process of stretching is repeated in the process of repeated pulling, so that the position adjustability does not deteriorate. In addition, pressure resistance and kink resistance can be imparted. This is because the melted liquid crystal polymer used in the present invention has an inner core, and the tensile strength of the synthetic resin wire having a structure in which the melted liquid crystal polymer island and the seam sheath of the flexible polymer cover the inner core is high. Moreover, this is due to the synergistic effect of the high elastic modulus of the metal strands.

The reinforcing material layer is arranged on at least a part of the inner layer pipe, preferably on the entire surface.

[0038] Subsequently, the inner tube and the reinforcing material layer are covered with the outer resin layer. First, the tube on which the reinforcing material layer is formed is cut to a desired length. In Fig. 6, the reinforcing material layer is formed over the entire length of the tube, but when the reinforcing material layer is formed on at least a part of the tube, the inner layer pipe is exposed in the remaining part.

[0039] Examples of the coating method with the outer resin layer include a method in which a outer resin tube that can cover the reinforcing material layer is disposed on the reinforcing material layer. As the arrangement method of the outer resin tube, a plurality of different outer resin tubes with different hardnesses are prepared in advance by extrusion molding. A method is preferred in which a fat outer layer pipe is arranged, these fat outer pipes are covered with a shrink tube, and the inner layer, the reinforcing material layer, and the outer fat layer are integrated.

[0040] For example, the outer tube is a resin tube, a first resin outer layer tube covering the soft portion of the catheter tube, the marker portion and the tip end portion, a second resin outer layer tube covering the middle portion, and a third tube covering the base portion. A tube having a Shore D hardness of at least three or more stages is arranged as a fat outer layer tube. Fig. 7 shows an example of an outer-layered resin tube (outer-layer tube) 13a, 13b, and 13c, which have three types of Shore D hardness, placed in close contact with each other. It is necessary to arrange so that the Shore D hardness is low. The length of each of the outer tube can be adjusted to the same force or different appropriate length. it can. The parts that require a high degree of flexibility for use as a catheter are the soft part, the marker part, and the distal end part, and the first resin from the viewpoint of ensuring torque transmission and pushability to the intermediate force base part. It is preferable that the length of the outer layer tube, the length of the second resin outer layer tube, and the length of the third resin outer layer tube are different. Furthermore, the thickness of the first resin outer layer pipe is preferably thinner than the thickness of the second resin outer layer pipe. The thickness of the second resin outer layer pipe is preferably smaller than the thickness of the third resin outer layer pipe. This is because the soft part, the marker part, and the tip part of the catheter tube are smaller in diameter and flexible, and at the same time, reachability of the lesioned part is ensured, and the middle part and the base part are rigid and have excellent torque transmission properties. It is. By these things, various tone which will be described later can be set. That is, it is preferable that the Shore D hardness of the material of the resin pipe used as the outer layer pipe is set so that 13a>13b> 13c in FIG. Those having a Shore D hardness of about 20 to 80 are preferably used. The Shore D hardness referred to in this specification is a value measured in accordance with ISO 7619 for a durometer type D.

[0041] It is preferable that there is a very strong space between the structure in which the reinforcing material layer is braided on the inner pipe and the resin pipe serving as the outer pipe. If so, the outer pipe is arranged. There are few drools only in the wires that become the reinforcing layer. This spacing means that the reinforcing material layer tends to loosen from the inner layer pipe due to the restoring force due to the high modulus of elasticity of the metal strands that make up the braid. Any interval that can be maintained is acceptable.

[0042] As the material of the resin pipe forming the outer pipe, polyamide elastomer, polyester elastomer, polyurethane elastomer, polystyrene elastomer, fluorine-based elastomer, various elastomers such as silicone rubber, latex rubber, or the like are used. A combination of two or more of these can be used. The resin tube used as the outer layer tube can be adjusted in hardness by mixing elastomers with different Shore D hardness and extrusion molding.

[0043] 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, hexame. Typical examples are block copolymers with various aliphatic or aromatic polyamides such as tylenediamine, isophthalic acid polycondensate, and metaxyloyldiamin adipic acid polycondensate as hard segments and polymers such as polyester and polyether as soft segments. In addition, the polyamide and the flexible resin Remalloy (polymer blend, graft polymerization, random polymerization, etc.), and those obtained by softening the polyamide with a plasticizer or the like, Sarakuko is a concept including these mixtures.

[0044] 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 above saturated polyesters may be used. Softened with a plasticizer or the like, Sarako is a concept that includes these mixtures.

A material suitably used is preferably a polyamide elastomer from the viewpoint of processability and flexibility, and a representative example thereof is PEBAX manufactured by Arkema.

[0045] The resin outer layer tube can be fixed to the inner layer tube and the reinforcing material layer by using a shrink tube or the like having a property of reducing its diameter when heated. By using a shrink tube, the outer resin tube is heated to reach a deformation temperature, and the inner tube and the reinforcing material layer are tightened with a uniform force. Further, the reinforcing material layer is the inner tube or the outer resin tube. Niku! /, If you put it together, there is an advantage!

For example, as shown in FIG. 8, the entire outer resin tube 13a to 13c is covered with the shrink tube 14. The shrink tube is preferably made of polytetrafluoroethylene or perfluoroethylene propene copolymer! /.

[0047] Thereafter, a heating force and a high-frequency electromagnetic wave are applied to a temperature at which the shrink tube contracts, and heating is performed, and the inner tube, the reinforcing material layer, and the outer tube are integrated by shrinking the shrink tube.

Next, the marker portion and the soft portion are formed as follows. That is, the shrink tube covering the entire catheter tube is peeled off, and a part of the reinforcing material layer and a portion of the first resin outer layer (specifically, the first resin outer tube) corresponding to the soft portion of the catheter tube are further removed. Remove and leave the inner tube exposed. In addition, the marker portion is made such that the reinforcing material layer is exposed by removing a part of the first resin outer layer while leaving the reinforcing material layer.

[0049] Next, a force indicating the arrangement method of the marker that also has a radiopaque metallic force FIG. 9 is an enlarged view of the distal end portion of the force tail tube. The tip is 16, the inner tube is 17, and the metal core is 18.

[0050] The radiopaque metal tube 19 is a complementary metal marker having radiopacity. The reinforcing material layer 33 is disposed adjacent to the reinforcing material layer 33 on the strong material layer 33 or the inner layer pipe 17. The X-ray impermeable metal tube 19 is preferably fixed on the reinforcing material layer 33. When using a radiopaque metal tube, the thickness is preferably 5 to 60 m.

Further, as a metal marker having radiopacity, the radiopaque metal element wire 20 may be wound in a coil shape as shown in FIG. When the X-ray opaque metal strand is used, the diameter is preferably 5 to 60 μm. There is no particular limitation on the number of times of winding.

[0052] As a metal marker having radiopacity, a radiopaque thin metal plate 21 having a cut line from both sides of a square having a shape as shown in Fig. 11 may be used. Fig. 12 shows an enlarged view of the tip of the catheter tube, but it is wrapped around the reinforcing material layer 33 like a radiopaque thin metal plate 22 and placed. When the metal thin plate 22 is used, the thickness is preferably 5 to 60 μm. This metal sheet is to be cut to ensure suitable flexibility.

[0053] As a material of the X-ray impermeable metal tube, the metal element wire, and the metal thin plate, a tungsten-based metal, a platinum-based metal, or a gold-based metal can be used. Tungsten metal is pure tungsten, W—45Mo alloy, W—5Mo—5Ni (Co, Fe) alloy, W—Re alloy, W—ThO

2 alloys, and alloys of tungsten and copper, carbon, etc. The platinum-based metal refers to gold and alloys of platinum and tungsten, rhodium, iridium, osmium, palladium, ruthenium, and the like. Gold-based metal refers to pure gold or an alloy of gold and copper, silver, rhodium, iridium, osmium, palladium, norrenium.

As shown in FIG. 13, as a metal marker having radiopacity, barium sulfate, bismuth oxide, bismuth subcarbonate, bismuth tungstate, bismuth monochloride, tungsten, gold, A resin tube 23 kneaded with radiopaque metal powder such as platinum may be disposed on the reinforcing material layer 33. The resin used here is preferably the same as that used as the first outer layer resin tube used for the soft part and the marker part. In this arrangement, a resin tube kneaded with X-ray-impermeable metal powder may be arranged with a cut in the axial direction as shown in 24, or a cut in the axial direction as shown in 25. You can also place it in the tube shape! / ヽ. The thickness of the resin tube kneaded with the radiopaque metal powder is preferably 5 to 60 m. [0055] Next, as shown in FIG. 14, a flexible first rosin outer layer tube 26 is newly disposed on the metal marker (X-ray impermeable metal tube) 19 and the inner layer tube 17 having radiopacity. To do.

[0056] Further, the periphery of the re-positioned flexible first resin outer tube 26 is covered with a shrink tube 27 having the property of reducing its diameter by heating as shown in FIG.

[0057] After this, the shrink tube 27 is heated by a heater to a temperature at which the tube contracts, is heated by applying a high frequency electromagnetic wave, the inner layer tube, the X-ray impermeable metal marker, the first resin outer layer tube Are integrated to form the marker portion 38 and the soft portion 39.

At this time, the shrinkage of the shrink tube 27 causes the soft portion 39 to be shaped into a round shape 28 as shown in FIG. When shaping the soft part 39 into a tapered shape, shrink the shrink tube 27 and then use a heating mold 29 as shown in FIG. 17 to contact and heat as shown in FIG. Let it shape. In order to more reliably shape the soft part into the round shape, it is possible to contact and heat the inside of the heating die 29 to the round shape. Here, the rounded shape is a curved shape in which the outer diameter of the end portion of the soft portion 39 of the tube decreases as it approaches the distal end, and the cross-sectional shape in the tube radial direction of the reduced diameter portion has a predetermined radius. State.

[0059] However, it is not shown in the figure, but after the shrink tube is peeled off, the surface of the catheter tube (specifically, the outer layer of the resin) is covered with a hydrophilic (or water-soluble) polymer substance. It is preferable to perform sex coating. 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. Furthermore, 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 high molecular weight materials (for example, hydroxypropyl cellulose), polyethylene oxide based polymer materials (polyethylene glycol), maleic anhydride based polymeric materials (for example, methyl vinyl ether maleic anhydride copolymer, maleic anhydride). Acid copolymers), acrylamide polymer materials (eg, polyacrylamide), and water-soluble nylon are preferred because they have a stable low coefficient of friction.

[0060] Finally, the metal core is pulled out, and the base end is a disk-shaped die that rotates at a high speed for shaping. A medical catheter tube 34 shown in FIG. 19 is obtained by cutting the inner layer, the reinforcing layer, and the outer layer with a means such as a diamond cutter and finishing the base end cross section into a single plane.

[0061] The medical catheter tube 34 has an inner layer tube 17 and a synthetic resin wire 31 disposed on at least a part of the inner layer tube 17 in the axial direction of the tube, and covers the metal wire 3 2 is provided with a reinforcing material layer 33 braided 2 and a resin outer layer 13.

The medical catheter tube 34 has a base part 35, an intermediate part 36, a tip part 37, a marker part 38, and a soft part 39 from the proximal side toward the distal side.

[0062] As the synthetic resin wire 31, a synthetic fiber having a structure in which a molten liquid crystal polymer is a core, and an island of a molten liquid crystal polymer and a sea sheath of a flexible polymer covers the core is used. In the marker portion 38, a radiopaque metal covers the inner layer tube 17 to form a marker, and the Shore D hardness of the resin material of the outer resin layer 13 from the base part to the tip part By making the diameter gradually or continuously small, the tip part exhibits excellent flexibility at the same time as suitable X-ray visibility, and the operator stretches in the process of pushing and pulling repeatedly. Therefore, the position of the position adjustment is not lowered, and the medical catheter tube is excellent in physical properties.

[0063] In the soft part 39, the inner layer pipe 17 is covered with at least a resin pipe 13c which is the first resin outer layer,

In the marker portion 38, the marker is covered with a resin tube 13c, which is the first resin outer layer, and in the tip portion 37, the inner layer tube 17 is covered with the reinforcing material layer 33, and the reinforcing material layer 33 is covered with the first reinforcing material layer 33. It is covered with a grease tube 13c that is an outer layer of fat,

In the intermediate part 36, the inner layer pipe 17 is covered with a reinforcing material layer 33, and the reinforcing material layer 33 is covered with at least a resin pipe 13b which is the second outer resin layer,

In the base portion 35, the inner layer pipe is covered with the reinforcing material layer 33, and the reinforcing material layer 33 is covered with the resin pipe 13a which is at least the third resin outer layer.

[0064] By setting the Shore D hardness of the resin material of the outer layer tubes 13a to 13c to 13a> 13b> 13c, the distal end portion can be made a more flexible catheter.

[0065] In the medical catheter tube, by setting the lengths of the outer layer tubes 13a to 13c having different Shore D, a high degree of freedom of adjustment of inclination control of rigidity and flexibility and various access processes are possible. The tone setting according to the road is demonstrated. The tone here means that the position of the highly flexible region at the tip is different as shown in FIG. It can also be expressed that the position where the bending strength changes is different. In FIG. 20, the straight portion shows higher rigidity than the tip portion, but shows that flexibility is secured at the same time. By being able to set various tones, in Fig. 20, the closer the tone is to No. 1, the more sensitive the state of the tip part is. In addition to the matters of use such as easy access to the depths and depths, the intention of the surgeon's surgical method for the various affected areas is reflected and can be selected.

[0066] Further, when the inner layer tube is made of a fluorine-based resin such as polytetrafluoroethylene, the inner hole is appropriately hydrophilized by an electric means such as plasma discharge treatment. be able to. In addition, it is preferable because it exhibits excellent lubricity with respect to the guide wire passing through the lumen of the inner tube.

[0067] In addition, although not shown here, an optimally shaped medical catheter tube can be obtained by attaching a hub having an appropriate shape to the base end.

[0068] In addition, when used, it may be used as described above. If necessary, a part of the medical catheter tube is heated in advance with a heater or steam to form a curved portion. Say it with a word.

[0069] Further, a medical catheter can be produced by a known method using the medical catheter tube of the present invention.

Applicability of invention

[0070] The medical catheter tube of the present invention is suitably used for a catheter used for medical purposes, more specifically, an infusion catheter capable of administering a therapeutic substance to a local site.

Claims

The scope of the claims

[1] Medical force tube

An inner tube,

A medical catheter tube comprising:

[2] The catheter tube has a base portion, an intermediate portion, a tip portion, a marker portion, and a soft portion from the proximal side toward the distal side,

The synthetic resin wire has a synthetic fiber force having a structure in which a molten liquid crystal polymer is used as a core, and a sheath made of an island of the molten liquid crystal polymer and a sea of a flexible polymer covers the core. In this case, a radiopaque metal covers the inner layer tube to form a marker, and the Shore D hardness from the base part to the tip part of the resin material of the outer layer of the resin is stepwise or continuously. The medical catheter tube according to claim 1, wherein the medical catheter tube is small.

[3] The resin outer layer includes at least a first resin outer layer, a second resin outer layer, and a third resin outer layer, and in the soft part, the inner layer tube is covered with at least the first resin outer layer,

3. The medical catheter tube according to claim 2, wherein the Shore D hardness of the resin material of the second outer layer resin is smaller than the Shore D hardness of the resin material of the third resin outer layer.

4. The medical catheter tube according to claim 3, wherein the first resin outer layer, the second resin outer layer, and the third resin outer layer covering the catheter tube have the same or different lengths in the axial direction.

[5] The thickness of the first resin outer layer covering the catheter tube is thinner than the thickness of the second resin outer layer. The wall thickness of the second resin outer layer is thinner than the thickness of the third resin outer layer. Item 5. A medical catheter tube according to Item 4.

6. The medical catheter tube according to claim 5, wherein the vagina of the inner tube is made of greaves exhibiting lubricity with respect to the guide wire passing through the lumen.

7. The medical catheter tube according to claim 6, wherein the resin exhibiting lubricity with respect to the guide wire is a fluorinated resin.

[8] The medical catheter tube according to [7], wherein the outer diameter of the soft portion is changed and is formed into a round shape or a tapered shape.

[9] The medical catheter tube according to any one of claims 1 to 8, wherein the outer layer of the resin is coated with a hydrophilic coating.

[10] A method of manufacturing a medical catheter tube,

Prepare the inner tube,

Covering the reinforcing material layer with a resin outer layer;

Manufacturing method.

[11] The method for producing a medical catheter tube according to claim 10, further comprising a base portion, an intermediate portion, a tip portion, a marker portion, and a soft portion from the proximal side toward the distal side.

At the tip, the inner tube is covered with a reinforcing material layer, and the reinforcing material layer is at least the first outer resin layer. Cover with tube;

Here, the first, second and third resin outer layer pipes are covered with a shrink tube, heat-condensed and integrated, and then the shrink tube is peeled off.

In the soft part, the first resin outer layer pipe and the reinforcing material layer of the part corresponding to the soft part are once removed to expose the inner layer pipe,

11. The method for producing a medical catheter tube according to claim 10, wherein the Shore D hardness of the material of the second resin outer layer tube is smaller than the Shore D hardness of the material of the third resin outer layer tube.

[12] The manufacturing of the medical catheter tube according to claim 11, wherein the lengths of the first resin outer layer tube, the second resin outer layer tube, and the third resin outer layer tube in the axial direction of the catheter tube are the same or different. Method.

[13] The wall thickness of the first resin outer layer tube covering the catheter tube is thinner than the wall thickness of the second resin outer layer tube. The wall thickness of the second resin outer layer tube is the wall thickness of the third resin outer layer tube. 13. The method for producing a medical catheter tube according to claim 12, wherein the method is thinner.

14. The method for producing a medical catheter tube according to claim 13, wherein the soft part is formed into a round shape or a tapered shape.