JP7407490B2 - Catheter and catheter manufacturing method - Google Patents

Description

The present invention relates to a catheter and a method for making a catheter.

An X-ray opaque marker is attached to the outer circumference of the catheter in order to determine the position of the catheter when inserted into the body during surgery.

For example, a catheter equipped with an X-ray opaque marker may include a metal marker attached to the outer periphery of a catheter tube, and a pair of fixed tubes each having a tapered outer periphery attached to both sides of the metal marker. A catheter has been proposed in which a step is not formed between the fixed tube and the fixed tube, and between the fixed tube and the catheter tube (Patent Document 1).

According to such a catheter, there is an effect that by eliminating the step difference, it is possible to provide a catheter that improves blood vessel passage.

However, even if the catheter does not have a step, if a part of the catheter is thicker than the surrounding area, there is a problem in that when the catheter is advanced or removed, it gets caught in the lumen and cannot be moved smoothly. . Therefore, there is a demand for a catheter that is formed to have a constant thickness without providing even a partially thick portion.

On the other hand, various catheters have been proposed in which a metal wire is wound in a coil around the outer periphery of an inner tube. If an X-ray opaque marker is attached to the outer periphery of a catheter around which such a metal wire is wound, the outer diameter of the area where the X-ray opaque marker is attached will inevitably be larger than the other areas. There was a problem.

In addition, many of these catheters, which are made by winding a metal wire in a coil around the outer circumference of an inner tube, are formed so that they can be flexibly bent to ensure followability when moving through the lumen of a blood vessel. However, when an X-ray opaque marker is attached, there is a problem that the curvature of the portion to which the X-ray opaque marker is attached deteriorates, resulting in poor lumen followability.

Japanese Patent Application Publication No. 2002-143316

Therefore, the present invention has been made in view of the above problems, and even when an X-ray opaque marker is attached to a catheter around which a metal wire is wound, the outer diameter does not become thicker. It is an object of the present invention to provide a catheter that can suppress deterioration in bending performance as much as possible.

The present invention employs the following means to achieve the above object.

The catheter according to the present invention includes:
In a catheter in which a metal wire is wound spirally or coiled around the outer circumference of an inner tube at intervals,
The present invention is characterized in that an X-ray opaque marker is wound in a gap between the wound metal wire and an adjacent metal wire.

According to the catheter according to the present invention, since the X-ray opaque marker is wound spirally or directly around the inner tube between the metal wires, the X-ray Compared to the case where an opaque marker is attached, it is possible to prevent the portion to which the X-ray opaque marker is attached from becoming thicker.

Further, in the catheter according to the present invention, the metal wire may be braided with a resin wire made of resin.

By adopting such a configuration, the position of the metal wire can be made difficult to shift due to the resin wire, and since the resin wire is also placed between the metal wires, the X The line-opaque marker can also be made difficult to shift by coming into contact with the resin wire.

Furthermore, in the catheter according to the present invention, the X-ray opaque marker may have a diameter smaller than that of the metal wire.

By adopting such a configuration, the outer periphery of the X-ray opaque marker is placed closer to the inner periphery than the outer periphery of the metal wire, thereby reliably preventing the portion to which the X-ray opaque marker is attached from becoming thicker. can do.

Furthermore, in the catheter according to the present invention, the X-ray opaque marker may be wound around a plurality of metal wires.

By adopting such a configuration, the area occupied by the X-ray opaque marker can be increased, which increases the area that can be seen by X-rays, resulting in a catheter with high visibility and easy recognition of the insertion position of the catheter. It can be done.

Furthermore, the catheter according to the present invention may be characterized in that the outer periphery of the metal wire and the radiopaque marker is coated with resin.

By employing such a configuration, the positions of the X-ray opaque marker and the metal wire can be fixed, and the possibility that the X-ray opaque marker will fall off can be reduced.

Furthermore, the manufacturing method for manufacturing a catheter having an X-ray opaque marker according to the present invention includes:
(1) Metal wire winding process of winding the metal wire around the outer periphery of the inner tube (2) X-ray Glue one end of the opaque marker to the inner tube, wrap the X-ray opaque marker along the gap between the metal wires, and then attach the other end of the X-ray opaque marker to the inner tube. X-ray opaque marker installation process (3) After covering with a resin covering tube, heat shrink the metal wire and X-ray opaque marker to the inner tube. It is characterized by including a resin coating step of coating.

The above-mentioned catheter can be manufactured by such a method.

According to the catheter according to the present invention, it is possible to provide a catheter that reduces or prevents the portion having the X-ray opaque marker from becoming thicker, even if the catheter is equipped with an X-ray opaque marker.

FIG. 1 is a schematic side view of a catheter device 110 having a catheter 100 and a hand operation section 200 according to an embodiment. 2A is an enlarged schematic side view showing the section AA in FIG. 1 of the catheter 100 according to the embodiment, and FIG. 2B is a sectional view taken along BB in FIG. 1. FIG. 3 is a side view showing another example of the catheter 100 according to the embodiment. FIG. 4 is a side view showing yet another example of the catheter 100 according to the embodiment. FIG. 5 is a sectional view showing yet another example of the catheter 100 according to the embodiment. FIG. 6 is a side view showing a state in which the outer periphery of the catheter according to the embodiment is coated with resin.

Hereinafter, the catheter 100 according to the present invention will be described in detail with reference to the drawings.

(First embodiment)
FIG. 1 is a schematic side view of a catheter device 110 using a catheter 100 according to the first embodiment, and FIG. 2A is an enlarged side schematic view of a section AA, which is a part of the catheter 100 in FIG. , FIG. 2B is a sectional view taken along line BB in FIG. 2A.

As shown in FIG. 1, a catheter device 110 including a catheter 100 according to the first embodiment includes a catheter 100, a tip portion 50 at its distal end, and a hand operation portion 200 at its proximal end. . Various members are attached to the tip portion 50 depending on the intended use. For example, it can be fitted with a flexible plastic distal tip to improve vascular progress, or it can be fitted with a pressure sensor to measure blood pressure. Of course, the form of the tip portion 50 is not particularly limited, and any form may be adopted for the hand operation unit 200. Configurations other than the distal end portion 50 and the hand operation portion 200 can be added as appropriate.

As shown in FIG. 1, the catheter 100 is a member mainly for moving the distal end portion 50 to the surgical area, and is formed into an elongated linear shape. In the catheter 100 according to this embodiment, as shown in FIG. 2, a metal wire 10 is wound around the outer periphery of an inner tube 20 in a spiral or coil shape. The metal wires 10 wound in a spiral or coiled manner are wound so as to leave an interval α between adjacent metal wires 10 to ensure flexibility and improve followability within the lumen of the catheter 100. It's being passed around. Although the distance α between adjacent metal wires 10 is not limited, it is preferably set at about 0.5 mm to 1.5 mm. The thickness of the metal wire 10 is not particularly limited, but it is preferable to use one having a diameter of about 10 μm to 100 μm. Further, the metal wire 10 is not limited to a wire having a circular cross section, and may be a flat wire. The type of metal material that constitutes the metal wire 10 is not particularly limited. Suitably, for example, tungsten, tantalum, cobalt, rhodium, titanium, alloys thereof, stainless steel, nickel alloy, molybdenum alloy, etc. are used.

On the catheter 100 around which the metal wire 10 is wound in this way, one or more radiopaque markers 15 are attached at arbitrary positions so that the position can be easily confirmed under X-ray fluoroscopy. The X-ray opaque marker 15 is made of a material that can be contrasted with X-rays, such as platinum, gold, or palladium. Of course, it is not limited to these. These radiopaque markers 15 are usually attached by being wrapped around the outer circumference of the catheter like a band. However, when it is wrapped around the outer periphery of the metal wire, there is a problem in that the outer periphery becomes thicker only at that part. If a portion of the catheter is formed to be thick, there is a risk that the thickened portion may get caught in the lumen when the catheter is introduced into the body. Therefore, it is desirable that the thickness be as uniform as possible. Therefore, in the present invention, as shown in FIG. 2, the attached X-ray opaque marker 15 is attached by winding a linear shape in the gap between the metal wire 10 and the adjacent metal wire. It is being That is, it is directly wound around the inner tube 20 at substantially the same pitch as the winding pitch of the metal wire 10 so as to be disposed in the gap between the wound metal wires 10 . The number of X-ray opaque markers 15 is not particularly limited, and a plurality of markers may be provided in parallel as shown in FIG. 2, or one marker may be provided as shown in FIG. 3. Furthermore, when winding a plurality of X-ray opaque markers 15, the multiple X-ray opaque markers 15 may be wound without gaps between the metal wires 10 as shown in FIG. 2, or as shown in FIG. As shown in FIG. 2, the X-ray opaque markers 15 may be arranged with a gap between them. By providing a gap, flexibility of the catheter 100 can be ensured even in the region where the X-ray opaque marker 15 is wound. Further, it is preferable to use the X-ray opaque marker 15 having the same thickness as the cross-sectional diameter of the metal wire 10 or a thin marker having a diameter shorter than the cross-sectional diameter of the metal wire 10. By using the X-ray opaque marker 15 that is thinner than the metal wire 10, the X-ray opaque marker 15 is not positioned outside the outer periphery of the metal wire 10, and the X-ray opaque marker 15 can be attached. It is possible to prevent the outer periphery of the catheter 100 from becoming thicker at the portion where the catheter 100 is thickened. Note that the cross-sectional shape of the X-ray opaque marker 15 is not limited, and in addition to the circular cross-section shown in FIG. 2, various cross-sectional shapes such as an elliptical cross-section, a rectangular cross-section, a flat linear cross-section, etc. can be used. be able to.

Further, as shown in FIG. 5, when the metal wire 10 is wound spirally or coiled around the inner tube 20, the metal wire 10 and a resin wire 30 made of resin may be braided. By braiding it with the resin wire 30, it is possible to prevent the metal wire 10 from shifting. Further, the X-ray opaque marker 15 can also be made difficult to shift due to the resin wire 30. The resin wire 30 is preferably thinner than the metal wire 10 and the radiopaque marker 15. By using the resin wire 30 which is thinner than the metal wire 10 and the X-ray opaque marker 15, the positional shift prevention function can be exerted without hindering the arrangement of the metal wire 10 and the X-ray opaque marker 15. .

The outer layer of the catheter 100 in which the metal wire 10 and the radiopaque marker 15 are wound may optionally be coated with a resin, as shown in FIG. 6. As the resin coating layer 40, polyamide, polyolefin, polyester, fluororesin, etc. can be used. The covering can be formed by placing a heat-shrinkable tube over the outer peripheral surface of the area to which the radiopaque marker 15 is attached, and then applying heat to shrink the tube.

A method for manufacturing the catheter 100 described above will be explained.
(1) Metal wire winding step The metal wire 10 is wound around the inner tube 20 in a spiral or coil shape to produce a catheter 100 in which the metal wire 10 is wound around the outer circumference of the inner tube 20. If the resin wire 30 is to be braided at this time, it can be produced by simultaneously weaving and winding the metal wire 10 and the resin wire 30.

(2) Step of attaching an X-ray opaque marker An X-ray opaque marker 15 is wound around an arbitrary position of the catheter 100 around which the metal wire 10 is wound, in the gap between one metal wire 10 and an adjacent metal wire 10 . When wrapping the X-ray opaque marker 15, the end of the X-ray opaque marker 15 is adhered to the inner tube 20 with an adhesive. After confirming that one end of the X-ray opaque marker 15 is bonded, the X-ray opaque marker 15 is wound along the gap between the metal wires 10. The number of turns for winding is not limited, but is preferably about 1 to 5 turns. After winding is completed, the other end of the X-ray opaque marker 15 is finally adhered to the inner tube 20 with an adhesive.

(3) X-ray opaque marker fixing step Before providing the next resin coating layer 40, an optional step of fixing the X-ray opaque marker 15 to the inner tube 20 or metal wire 10 may be performed. Fixing methods include welding to adjacent metal wires 10 using a laser or the like, fixing the X-ray opaque marker 15 by plating, or applying heat if it is a braid of metal wires 10 and resin wires 30. Therefore, a method of integrating and fixing the resin wire 30 and the X-ray opaque marker 15 can be considered. Furthermore, after fixing the X-ray opaque marker 15 to the inner tube 20 or the metal wire 10 in this way, the adhesive that was fixing the X-ray opaque marker 15 may be removed using an adhesive remover. . Removing the adhesive can reduce the possibility of the adhesive leaching out during use of the catheter.

(4) Resin coating process After the X-ray opaque marker 15 has been fixed with adhesive in this way, or after it has been fixed in the (3) X-ray opaque marker fixing process, a resin coating tube is covered and heated. The catheter 100 in which the metal wire 10 and the radiopaque marker 15 are covered with the resin of the covering tube can be produced by heat-shrinking the covering tube.

It goes without saying that the present invention is not limited to the embodiments described above, and can be implemented in various forms as long as they fall within the technical scope of the present invention.

As shown in the embodiments described above, it can be used as a catheter.

DESCRIPTION OF SYMBOLS 10... Metal wire, 15... X-ray opaque marker, 20... Inner tube, 30... Resin wire, 40... Coating layer, 50... Tip part, 100... Catheter, 110... Catheter device, 200... Hand operation part

Claims (4)

In a catheter in which a metal wire is wound spirally or coiled around the outer circumference of an inner tube at intervals,
In the gap between the wound metal wire and an adjacent metal wire, one X-ray opaque marker having a diameter smaller than the cross-sectional diameter of the metal wire is placed at a pitch approximately equal to the winding pitch of the metal wire. A catheter characterized by being wound at a similar pitch. The catheter according to claim 1, wherein the metal wire is braided with a resin wire made of resin. The catheter according to claim 2, wherein the outer periphery of the metal wire and the radiopaque marker is coated with resin. A manufacturing method for manufacturing a catheter having an X-ray opaque marker according to any one of claims 1 to 3,
(1) Metal wire winding process of winding the metal wire around the outer periphery of the inner tube (2) X-ray Glue one end of the opaque marker to the inner tube, wrap the X-ray opaque marker along the gap between the metal wires, and then attach the other end of the X-ray opaque marker to the inner tube. X-ray opaque marker installation process (3) After covering with a resin covering tube, heat shrink the metal wire and X-ray opaque marker to the inner tube. 1. A method for manufacturing a catheter having an X-ray opaque marker, comprising the step of coating with a resin.

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