JP4854458B2 - Medical multi-lumen tube - Google Patents

Description

  The present invention relates to a medical multi-lumen tube.

  Conventionally, when a stenosis or occlusion occurs in a blood vessel such as a blood vessel, or when a blood vessel is occluded by a thrombus, the stenosis or occlusion site of the blood vessel is expanded to improve blood flow on the peripheral side of the blood vessel. For this purpose, angioplasty (PTA: Percutaneous Transluminal Coronary Angioplasty) is generally performed. In addition, stents and other devices for maintaining the state of the expanded stenosis have been widely used in recent years.

  PTCA has been almost technically established as a revascularization since clinical application, but at the same time, lesions that are difficult to perform with balloon, such as “chronic complete occlusion”, “calcified lesion”, “acute coronary occlusion”, “ Difficult cases such as “remote restenosis” have also been revealed.

  Various devices have been developed to compensate for these problems. The tube that is the basis of the configuration of the catheter device is divided into a single lumen having a single lumen and a multi-lumen tube having a plurality of lumens.

  Multi-lumen tubes are formed so as not to communicate with each other, so multiple devices and procedures with various functions such as guide wire insertion, balloon inflation, drug solution injection, thrombus aspiration, pulverization wire, etc. are selected and performed with a single tube I can do it.

  The ability to use multiple devices and multiple procedures with a single catheter shortens the treatment time and further reduces the number of puncture holes, thereby reducing the burden on the patient.

As a method of braiding into a multi-lumen, Patent Document 1 (flexible tube) reinforces the inner tube on the outer surface of the inner tube having a plurality of lumens along the axial direction of the inner tube. A catheter tube is disclosed in which an outer layer is formed and an outer tube is formed outside the inner tube through the reinforcing outer layer. Specifically, as shown in FIG. 7, an inner tube 701 and an outer tube 702 and a reinforcing material layer 703 are provided between them. The inner tube 701 has a plurality of lumens 704.
Japanese Patent Laid-Open No. 2001-321445

An object of the present invention is to provide a medical multi-lumen tube having higher rigidity while maintaining flexibility.

The medical multi-lumen tube has the following characteristics.
(A) a first inner tube made of a first resin made of polytetrafluoroethylene ;
(B) an outer layer made of polyamide elastomer and having a Shore D hardness of 25 to 40, which covers the first inner layer pipe (a);
(C) one or more second inner layer tubes disposed in the outer layer (b);
Equipped with a,
At least a part of the one or more second inner layer pipes (c) is made of a second resin harder than the first resin .
This medical multi-lumen tube achieves better rigidity.
As another feature, the second resin is polyimide. The overall rigidity of the medical multi-lumen tube can be further enhanced by the effect of polyimide, which is a highly rigid material.
As another feature, the medical multi-lumen tube further includes a braided layer (d) between the first inner layer tube (a) and the outer layer (b). Due to the effect of the braided layer, better indentation and kink resistance can be obtained.

As another feature, the medical multi-lumen tube is manufactured as follows.
That is, the second inner layer pipe (c) covered with a polyamide elastomer is disposed on a braided tube in which the braided layer (d) covering the first inner layer pipe (a) is further covered with a polyamide elastomer, A heat shrink tube is further covered from above, and it is formed by applying heat to the covered heat shrink tube.
    Or
  It is formed by subjecting the first inner layer pipe (a) and the second inner layer pipe (c) covered with the braided layer (d) to melt coating extrusion.

As another feature, in the medical multi-lumen tube, an inner diameter of at least a part of the second inner layer tube included in the one or more second inner layer tubes (c) is the first inner layer tube (a). Is smaller than the inner diameter. Thereby, flexibility can be adjusted.
As another feature, in the medical multi-lumen tube, the second resin of the second inner layer tube smaller than the inner diameter of the first inner layer tube (a) is harder than the first resin. As a result, more excellent flexibility can be adjusted.
As another feature, in the medical multi-lumen tube, a cross section of at least a part of the second inner layer pipe included in the one or more second inner layer pipes (c) is elliptical. Thereby, by arranging the elliptical short axis so as to be directed toward the center of the multi-lumen tube, it is possible to reduce the outer diameter of the tube surrounding the first inner layer tube and the second inner layer tube.

  Other features of the present invention including the above features and their effects will become apparent from the following embodiments and drawings.

  The present invention provides a medical multi-lumen tube having better kink resistance.

1-1. Medical Multi-Lumen Tubes Tubes used for medical catheters are divided into single-lumen tubes having a single lumen and multi-lumen tubes having a plurality of lumens.

  Multi-lumen tubes are formed so as not to communicate with each other, so multiple devices and procedures with various functions such as guide wire insertion, balloon inflation, drug solution injection, thrombus aspiration, pulverization wire, etc. are selected and performed with a single tube I can do it.

  The ability to use multiple devices and multiple procedures with a single catheter shortens the treatment time and further reduces the number of puncture holes, thereby reducing the burden on the patient.

  For example, a catheter used for revascularization needs to follow the guide wire so that it can be smoothly inserted and pulled out along the guide wire leading to the blood vessel bent in a complex shape without damaging the inner wall of the blood vessel. It becomes.

1-2. Manufacturing Method In the present invention, the outer layer may be shrunk using a heat-shrinkable tube or may be coated by extrusion. Examples of the molding method will be described below.
As a method for shrinking the outer layer resin using a heat shrinkable tube, for example, a core material in which a silver plated annealed copper wire having a diameter of 1.10 mm is coated with polytetrafluoroethylene (PTFE) with a thickness of 0.030 mm is used on one side (left-handed) Is wound with 5 stainless steel wires (melting point 1400 ° C, diameter 0.030mm) arranged side by side, and the other side (right winding) is made of four polyethylene terephthalate fibers (melting point 273 ° C, diameter 0.030mm) An intermediate tube is produced by winding five stainless steel wires in a state where they are arranged side by side. Thereafter, a heat-shrinkable tube made of tetrafluoroethylene-hexafluoropropylene copolymer (FEP) is covered over the entire length of the intermediate tube. The entire length of the intermediate tube is heated with hot air of 290 ° C. to shrink, and after cooling, the heat shrinkable tube is removed. Thereafter, a polyamide elastomer (Pebax 4033) hollow tube molded with a resin that forms an outer layer by extrusion is separately covered, and a heat shrinkable tube is further covered thereon. The covered tube is shrunk in a heating furnace, and then the heat shrinkable tube is removed to obtain a braided tube. Then, a polyamide elastomer hollow tube (Pebax4033 inner diameter 0.42 mm inner diameter 0.0925) formed by extrusion molding through a polyimide tube (inner diameter 0.36 mm wall thickness 0.025 mm DF value (Dissipation Factor) ≦ 0.0035) and separately extruded. mm) is prepared, placed on the braided tube, and further covered with a heat shrinkable tube. It is obtained by shrinking the covered tube with a heat gun and then removing the heat shrinkable tube and the metal core.
Next, as an extrusion molding method, for example, after forming an intermediate tube in the same manner as the above-described shrink molding method, a member in which a stainless steel core material is passed through a polyimide tube (inner diameter 0.36 mm, wall thickness 0.025 mm, DF value ≦ 0.0035) is arranged. Polyamide elastomer (Pebax 4033) resin is melt coated and extruded to remove the metal core.

Hereinafter, each element constituting the “medical multi-lumen tube” of the present invention will be described with reference to embodiments.
2. First inner layer pipe (a) and first resin As a constituent material of “first inner layer pipe (a) made of first resin” constituting “medical multi-lumen tube” as an embodiment, for example, polytetrafluoroethylene , Fluoropolymers such as tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer, tetrafluoroethylene-hexafluoropropylene copolymer, ethylene-tetrafluoroethylene copolymer, polypropylene, polyethylene, ethylene-vinyl acetate copolymer, etc. And polyesters such as polyolefin, polyamide, polyethylene terephthalate, polybutylene terephthalate, etc., resins such as polyurethane, polyvinyl chloride, polystyrene resins, polyimides, or mixtures thereof. Polytetrafluoroethylene or tetrafluoroethylene-perfluoroalkyl vinyl ether from the standpoint that the finished product exhibits excellent lubricity with respect to the guide wire passing through the inner tube and obtains position adjustment with guide wire followability. It is preferable to comprise with a copolymer.
3. Outer layer (b)
Examples of the resin material forming the outer layer (b) constituting the “medical multi-lumen tube” as the embodiment include polyamide elastomer, polyester elastomer, polyurethane elastomer, polystyrene elastomer, fluorine elastomer, silicone rubber, latex rubber and the like. Resins such as various elastomers and combinations of two or more of these can be used.

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

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

As a material suitably used as an embodiment of the outer layer (b), a polyamide elastomer is preferable from the viewpoint of processability and flexibility. For example, Pebax manufactured by elf atochem is representative. Preferably, a Pebax grade with a Shore D hardness of 25-72, especially 40-55 is preferred.
4). Second inner layer tube (c) and second resin The second resin of the second inner layer tube (c) constituting the “medical multi-lumen tube” as the embodiment is, for example, polytetrafluoroethylene, tetrafluoroethylene-par Fluoro resin such as fluoroalkyl vinyl ether copolymer, tetrafluoroethylene-hexafluoropropylene copolymer, ethylene-tetrafluoroethylene copolymer, polyolefin such as polypropylene, polyethylene, ethylene-vinyl acetate copolymer, polyamide, polyethylene Polyesters such as terephthalate and polybutylene terephthalate, polyurethane, polyvinyl chloride, polystyrene resins, resins such as polyimide, polyamideimide, polyetheretherketone, and mixtures thereof, stainless steel, nickel And ruthenium alloys. A polyimide having good adhesion by fixed bonding is suitable for Pebax, which is a suitable material for the outer layer (b).

  The concept that “at least a part of the one or more second inner pipes (c) is made of a second resin harder than the first resin” is that the Shore hardness of the first resin is greater than the Shore hardness of the second resin. Also includes a high concept. However, the concept of “hard” here includes a case where it is determined as “hard” by another comparison standard other than Shore hardness, which is well known to those skilled in the art. For example, the state in which the first resin is polytetrafluoroethylene and the second resin is polyimide is that the “second at least part of the one or more second inner pipes (c) is harder than the first resin. It is included in the state of “made of resin”.

FIG. 1 shows a cross-sectional view of an example as an embodiment of the present invention. A first inner layer pipe 11 and a second inner layer pipe 12 and an outer layer 13 are provided.
Preferably, “the inner diameter of at least a part of the second inner layer pipe included in the one or more second inner layer pipes (c) is smaller than the inner diameter of the first inner layer pipe (a)” The inner diameter of the two inner layer tubes is 20 to 70%, or 30 to 60%, or 40 to 50%, or 1/2 (or 50%) of the inner diameter of the first inner layer tube (a).

The “plurality” in the “one or more second inner layer pipes (c)” is preferably 2, 3, 4, 5, 6, or 7.
For example, as shown in FIG. 2 as an embodiment of the present invention, the state in which the outer layer 23 is provided and the inner diameter of the second resin inner layer tube 22 is smaller than the inner diameter of the first resin inner layer tube 21 The inner diameter of at least a part of the second inner layer pipe included in the second inner layer pipe (c) is smaller than the inner diameter of the first inner layer pipe (a).
The concept that “the one or more second inner layer tubes (c) are embedded in the outer layer (b)” preferably includes the concept that the tube cross section is irregular. For example, a state where the completed tube cross section is not a perfect circle surrounding all the inner layer tubes is included in the concept of “anomaly”. Specifically, as shown in FIG. 3, the state in which the outer layer 33 is covered only around the first inner layer pipe 31 and the second inner layer pipe 32 is defined as “the one or more second inner layer pipes (c ) Is embedded in the outer layer (b).
FIG. 4 shows a cross-sectional view of an example as an embodiment of the present invention. A first inner layer tube 41 and an outer layer 43 are provided, and a second inner layer tube 42 having an elliptical cross section is provided.

  FIG. 5 shows a cross-sectional view of an example as an embodiment of the present invention. The first inner layer pipe 51 and the second inner layer pipe 52 are provided with an outer layer 53, and a braided layer 54 is provided between the outer layer 53.

FIG. 6 shows a cross-sectional view of an example as an embodiment of the present invention. The first inner layer pipe 61 and the outer layer 63 and a braided layer 64 are provided. Further, a plurality of second inner layer pipes 62 are provided.
Conventionally, in order to increase the rigidity of the entire medical multi-lumen, it has been common to change the material of the outer layer (b) (for example, Pebax) to a material having higher rigidity. In this regard, in the present embodiment, the material of the outer layer (b) is not changed, while the second resin constituting the second inner layer included in the second inner layer (c) is changed to a material having high rigidity. The rigidity of the multi-lumen as a whole is increased, and such an approach is brought about by the inventor's unique knowledge.
While increasing the rigidity as a whole, by changing the resin of the smaller one (ie, the second inner layer (c) instead of the outer layer (b)), the flexibility is maintained (flexibility is required) There is also an advantage that it is prevented).

5. Braided layer (d)
For example, catheters used for revascularization have torque transmission to ensure that the force applied at the base is reliably transmitted, and the operator's pushing force is reliably from the proximal side to the distal side to advance in the blood vessel. The pushability that can be transmitted to the device is also required. Therefore, a method is known in which a filament is wound around the inner layer tube as a reinforcing material layer in a coil shape or braided.

  The “braided layer (d)” constituting the “medical multi-lumen tube” as an embodiment is provided between the first inner tube (a) and the outer layer (b). Any material may be used as a constituent material of the striate constituting the “braided layer (d)” as long as it has a rigidity sufficient to obtain a sufficient reinforcing effect. For example, stainless steel, copper, tungsten, nickel , Titanium, piano wire, Ni-Ti alloy, Ni-Ti-Co alloy, Ni-Al alloy, Cu-Zn alloy, Cu-Zn-X alloy (for example, X = Be, Si, Sn, Al, Ga) Various metal materials such as superelastic alloy and amorphous alloy, polyester such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polymethylene terephthalate (PPT), polyolefin such as polyethylene and polypropylene, hard Polyvinyl chloride, polyamide, polyimide, polystyrene, thermoplastic polyurethane, polycarbonate -Bonate, ABS resin, acrylic resin, polymethyl methacrylate (PMMA), polyacetal (PA), polyarylate, polyoxymethylene (POM), high tension polyvinyl alcohol, fluororesin, polyvinylidene fluoride (PVdF), polytetrafluoroethylene, Polymer alloy, carbon fiber, glass containing any of these, such as ethylene-vinyl acetate saponified product (EVOH), polysulfone, polyethersulfone, polyetherketone, polyphenylene oxide, polyphenylene sulfide, aromatic polyaramide represented by Kevlar Fiber. Among these materials, in order to ensure the X-ray visibility of the X-ray opaque marker, the X-ray visibility is lower than that of the X-ray opaque marker, and it is excellent in processability and economy, and is toxic. Stainless steel is preferable because it is not present.

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

  The first inner layer pipe (a) covered with the braided layer preferably has a sufficient adherence force to the metal core wire. Further, in the subsequent step of coating the outer layer, a mechanical method (such as rubbing the surface with sandpaper or the like in a direction perpendicular to the axial direction) is applied to the surface of the first inner tube (a) for the purpose of increasing the adhesion force. Means) and / or a chemical method (use of a drug such as sodium naphthalene + dimethyl ether) and / or an electrical method such as plasma may be used to form irregularities or surface modification.

Example 1
As Example 1, the following medical multi-lumen tubes were prepared according to the above production method.

First inner layer pipe: PFA (wall thickness 0.03mm)
Second inner layer tube: Polyimide tube (inner diameter 0.36mm, wall thickness 0.025mm, DF value ≤ 0.0035)
Outer layer: Polyamide elastomer (Pebax 4033)
Braid: Stainless steel fine wire 0.1 * 0.03mm
Outer diameter: Short diameter: 1.3mm Long diameter: 1.7mm
Inner diameter: 1.1mm
The shape of the tube of Example 1 is substantially the same as that shown in FIG. The number of second inner layer tubes is 1, and the shape of the second inner layer tubes is circular. The inner diameter (0.36 mm) of the second inner layer pipe is smaller than the inner diameter (1.1 mm) of the first inner layer pipe, and the ratio of the inner diameter of the second inner layer pipe to the inner diameter of the first inner layer pipe is about 33%. .
(Comparative example)
As a comparative example, the following medical multi-lumen tube was prepared according to the above production method.

Inner tube: PFA (wall thickness 0.03mm)
Outer layer: Polyamide elastomer (Pebax 4033)
Braid: Stainless steel fine wire 0.1 * 0.03mm
Outer diameter: 1.3mm
Inner diameter: 1.1mm
(Bending stiffness test)
The bending stiffness was tested by the test method specified in JIS K 7171. Each prototype of the experimental example 1 and the comparative example was cut into fixed lengths, the load at the time of 1 mm deflection was measured by three-point bending, and this was defined as bending rigidity. The test was performed under the conditions of a test speed of 50 mm / min, a distance between support points of 20 mm, and a test temperature of 23 ° C. The results are as follows.

Example 1: 0.783 (N)
・ Comparative example: 0.477 (N)
As is apparent from the results of the bending test, Example 1 showed superior rigidity as compared with the comparative example.

FIG. 1 shows a cross-sectional view of a “medical multi-lumen tube” as an embodiment of the present invention. FIG. 2 shows a cross-sectional view of a tube as another embodiment. FIG. 3 shows a cross-sectional view of a tube as another embodiment. FIG. 4 shows a cross-sectional view of a tube as another embodiment. FIG. 5 shows a cross-sectional view of a tube as another embodiment. FIG. 6 shows a cross-sectional view of a tube as another embodiment. FIG. 7 is a sectional view showing an example of a tube according to the prior art.

Explanation of symbols

11 First resin inner layer tube 12 Second resin inner layer tube 13 Outer layer 21 First resin inner layer tube 22 Second resin inner layer tube 23 Outer layer 31 First resin inner layer tube 32 Second resin inner layer tube 33 Outer layer 41 First resin inner layer tube 42 Second 2 resin inner layer pipe 43 outer layer 51 first resin inner layer pipe 52 second resin inner layer pipe 53 outer layer 54 braid 61 first resin inner layer pipe 62 second resin inner layer pipe 63 outer layer 64 braid 701 inner layer pipe 702 outer layer 703 braid 704 lumen

Claims (7)

(A) a first inner tube made of a first resin made of polytetrafluoroethylene ;
(B) an outer layer made of polyamide elastomer and having a Shore D hardness of 25 to 40, which covers the first inner layer pipe (a);
(C) one or more second inner layer tubes disposed in the outer layer (b);
Equipped with a,
The medical multi-lumen tube, wherein at least a part of the one or more second inner layer pipes (c) is made of a second resin harder than the first resin. The medical multi-lumen tube according to claim 1, wherein the second resin is polyimide . A braided layer (d) is further provided between the first inner tube (a) and the outer layer (b);
The medical multi-lumen tube according to claim 2. The second inner layer pipe (c) covered with a polyamide elastomer is disposed on a braided tube in which the braided layer (d) covering the first inner layer pipe (a) is further covered with a polyamide elastomer, and above them. The heat shrinkable tube is further covered from and formed by applying heat to the covered heat shrinkable tube.
Or
Formed by melt coating extrusion of polyamide elastomer to the first inner layer pipe (a) and the second inner layer pipe (c) coated with the braided layer (d),
The medical multi-lumen tube according to claim 3 . The inner diameter of at least a part of the second inner layer pipe included in the one or more second inner layer pipes (c) is smaller than the inner diameter of the first inner layer pipe (a). Medical multi-lumen tube. The medical multi-lumen tube according to claim 5, wherein the second resin of the second inner layer pipe smaller than the inner diameter of the first inner layer pipe (a) is harder than the first resin . The medical multi-lumen tube according to any one of claims 1 to 6 , wherein a cross section of at least a part of the second inner layer pipe included in the one or more second inner layer pipes (c) is elliptical .

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