WO2020153013A1 - Catheter and method for manufacturing catheter - Google Patents

Abstract

[Problem] To provide a catheter in which the outer circumference diameter thereof is not made large even when radiopaque markers are attached to a catheter having a metal wire wound therearound. [Solution] A catheter 100 according to the present invention has a metal wire 10 wound around the outer circumference of an inner tube 20, with gaps between turns of the metal wire, in the form of spirals or coils with gaps therebetween. This catheter 100 is characterized in that radiopaque markers 15 are wound in gaps between a portion of the wound metal wire and a portion adjacent thereto.

Description

Catheter and method of making catheter

The present invention relates to a catheter and a method for manufacturing the catheter.

A radiopaque marker is attached to the outer circumference of the catheter to grasp the position of the catheter when it is inserted into the body during surgery.

As a catheter having a radiopaque marker attached, for example, a metal marker is attached to the outer circumference of a catheter tube, and a pair of fixed tubes having a tapered outer circumference is attached to both sides of the metal marker. There has been proposed a catheter formed so that no step is 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 it is possible to provide a catheter with improved blood vessel permeability by eliminating the step.

However, even if there is no step in the catheter, if a part thicker than the surroundings is formed, there is a problem that it cannot be moved smoothly because it gets caught in the lumen when the catheter is advanced or taken out. .. Therefore, there is a demand for a catheter that is formed with a constant thickness without providing a thick portion, even if it is a part.

On the other hand, various catheters have been proposed in which a metal wire is wound around the inner tube in a coil shape. When an X-ray opaque marker is attached to the outer peripheral side of a catheter around which such a metal wire is wound, the outer diameter of the portion to which the X-ray opaque marker is attached inevitably becomes larger than other portions. There was a problem.

Moreover, in many cases, a catheter formed by winding a metal wire around the outer circumference of such an inner tube is flexible and bendable in order to ensure followability when advancing inside a lumen such as a blood vessel. However, when the X-ray opaque marker is attached, there is a problem that the bendability of the portion to which the X-ray opaque marker is attached deteriorates and the lumen followability deteriorates.

JP-A-2002-143316

Therefore, the present invention has been made in view of the above-mentioned problems, and the outer diameter does not become thick even when the radiopaque marker is attached to the catheter on which the metal wire is wound. It is also an object of the present invention to provide a catheter capable of suppressing deterioration of bending performance as much as possible.

The present invention has adopted the following means in order to achieve the above object.

The catheter according to the present invention,
In a catheter in which a metal wire is wound around the outer circumference of the inner tube in a spiral shape or a coil shape at intervals,
An X-ray opaque marker is wound in a gap between the wound metal wire and an adjacent metal wire.

According to the catheter of the present invention, since the X-ray opaque marker is directly wound around the inner tube between the metal wires which are spirally or wound, the X-ray is provided on the outer peripheral side of the metal wire. It is possible to prevent the portion where the X-ray opaque marker is attached from becoming thicker as compared with the case where the opaque marker is attached.

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, it is possible to prevent the position of the metal wire from being displaced due to the resin wire, and since the resin wire is also arranged between the metal wires, the X wound around the outer circumference side thereof The line opaque marker can also be prevented from slipping by coming into contact with the resin line.

Further, 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, since the outer circumference of the X-ray opaque marker is arranged on the inner circumference side of the outer circumference of the metal wire, it is possible to reliably prevent the portion to which the X-ray opaque marker is attached from becoming thick. can do.

Further, in the catheter according to the present invention, the X-ray opaque marker may be characterized in that a plurality of windings are provided between metal wires.

By adopting such a configuration, the area occupied by the X-ray opaque marker can be increased, so that the portion that can be visually recognized by the X-ray becomes larger, so that the visibility is enhanced and the insertion position of the catheter can be easily recognized. Can be

Furthermore, the catheter according to the present invention may be characterized in that the metal wire and the X-ray opaque marker are coated with a resin on the outer circumference thereof.

By adopting such a configuration, the positions of the radiopaque marker and the metal line can be fixed, and the possibility that the radiopaque marker will fall off can be reduced.

Furthermore, the production method for producing a catheter having a radiopaque marker according to the present invention is
(1) Metal wire winding step of winding a metal wire around the outer circumference of the inner tube (2) X-ray between the metal wire and the metal wire at an arbitrary position of the inner tube around which the metal wire is wound Adhere one end of the opaque marker to the inner tube, wind 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 attaching process by attaching to X-ray opaque marker to inner tube (3) After covering with a resin-made covering tube, heat shrink to cover the metal wire and X-ray opaque marker with the covering tube A resin coating step of coating is included.

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

According to the catheter of the present invention, it is possible to provide a catheter that reduces or prevents the region having the radiopaque marker from becoming thick even if the catheter has the radiopaque marker attached.

FIG. 1 is a schematic side view of a catheter device 110 having a catheter 100 and a hand operation unit 200 according to the embodiment. 2A is an enlarged side schematic view showing a portion AA of FIG. 1 in the catheter 100 according to the embodiment, and FIG. 2B is a sectional view taken along the line BB of FIG. 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 cross-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 circumference 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 the catheter 100 according to the first embodiment, and FIG. 2A is an enlarged schematic side view of a portion AA which is a part of the catheter 100 of FIG. 2B is a sectional view taken along line BB of FIG. 2A.

As shown in FIG. 1, a catheter device 110 including the catheter 100 according to the first embodiment includes a catheter 100, a distal end portion 50 at a distal end thereof, and a hand operation portion 200 at a proximal end side thereof. .. Various members are attached to the tip portion 50 depending on the intended use. For example, a flexible plastic tip or a pressure sensor for measuring blood pressure can be attached to improve vascular progression. Of course, the shape of the tip portion 50 is not particularly limited, and any shape may be adopted as the hand operation portion 200. It is possible to appropriately add components other than the tip portion 50 and the hand operation portion 200.

As shown in FIG. 1, the catheter 100 is a member mainly for moving the distal end portion 50 to the surgical region and is formed in an elongated linear shape. As shown in FIG. 2, in the catheter 100 according to the present embodiment, the metal wire 10 is spirally or coiled around the outer circumference of the inner tube 20. The metal wire 10 wound in a spiral shape or a coil shape is wound so as to leave a space α between adjacent metal wires 10 so as to ensure flexibility in order to improve the followability in the lumen of the catheter 100. It has been turned. The interval α between the adjacent metal wires 10 is not limited, but is preferably set to 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 a wire 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 a flat wire may be used. The type of metal material forming the metal wire 10 is not particularly limited. Suitably, for example, tungsten, tantalum, cobalt, rhodium, titanium, alloys thereof, stainless steel, nickel alloys or molybdenum alloys are used.

The catheter 100 wound with the metal wire 10 in this manner is attached with an X-ray opaque marker 15 at one or more arbitrary positions so that the position can be easily confirmed under X-ray fluoroscopy. As the X-ray opaque marker 15, a material that can be imaged by X-ray, for example, platinum, gold or palladium is used. Of course, it is not limited to these. These X-ray opaque markers 15 are usually attached to the outer circumference of the catheter by winding them like bands. However, when the metal wire is wound around the outer circumference, there is a problem that the outer circumference becomes thick only at that portion. If a part of the catheter is formed thick, there is a risk that the thickened part may be 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 X-ray opaque marker 15 to be attached is attached by winding a linear wire formed in a gap between the metal wire 10 and an adjacent metal wire. Has been. That is, the metal wire 10 is directly wound around the inner tube 20 at a pitch substantially similar to the winding pitch of the metal wire 10 so as to be arranged 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 X-ray opaque markers 15 may be provided in parallel as shown in FIG. 2 or may be one as shown in FIG. When winding a plurality of radiopaque markers 15, a plurality of radiopaque markers 15 may be wound without a gap between the metal wires 10 as shown in FIG. As shown in, a gap may be provided between the respective X-ray opaque markers 15. By providing the gap, the flexibility of the catheter 100 can be ensured even in the region around which the radiopaque marker 15 is wound. As for the thickness of the X-ray opaque marker 15, it is preferable to use the same thickness having the same diameter as the cross-sectional diameter of the metal wire 10 or a thin one having a diameter shorter than the cross-sectional diameter of the metal wire 10. By using the X-ray opaque marker 15 thinner than the metal wire 10, the X-ray opaque marker 15 is not located outside the outer periphery of the metal wire 10 and the X-ray opaque marker 15 is attached. It is possible to prevent the outer circumference of the catheter 100 at a different portion from becoming thick. 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, and a flat line shape are used. be able to.

Further, as shown in FIG. 5, when the metal wire 10 is wound around the inner tube 20 in a spiral or coil shape, the metal wire 10 and the resin wire 30 made of resin may be braided. Positioning of the metal wire 10 can be prevented by braiding with the resin wire 30. Further, the X-ray opaque marker 15 can also be made hard to be displaced by the resin wire 30. The resin wire 30 is preferably thinner than the metal wire 10 and the X-ray opaque marker 15. By using the resin wire 30 that is thinner than the metal line 10 and the X-ray opaque marker 15, it is possible to exert the function of preventing positional deviation without hindering the arrangement of the metal line 10 and the X-ray opaque marker 15. ..

In the catheter 100 having the metal wire 10 and the radiopaque marker 15 wound in this way, the outer layer may be optionally covered with a resin as shown in FIG. As the resin coating layer 40, polyamide, polyolefin, polyester, fluorine resin, or the like can be used. The coating can be formed by covering the outer peripheral surface of the portion to which the radiopaque marker 15 is attached with a heat-shrinkable tube and then applying heat to shrink the tube.

A method for manufacturing the above catheter 100 will be described.
(1) Metal Wire Winding Step The metal wire 10 is wound around the inner tube 20 in a spiral shape or a coil shape, and the catheter 100 in which the metal wire 10 is wound around the outer peripheral side of the inner tube 20 is manufactured. In this case, when the resin wire 30 is braided, the metal wire 10 and the resin wire 30 can be simultaneously braided and wound.

(2) X-ray opaque marker attaching step The X-ray opaque marker 15 is wound around a gap between the metal wire 10 and the adjacent metal wire 10 at an arbitrary position of the catheter 100 around which the metal wire 10 is wound. When winding the X-ray opaque marker 15, the end portion of the X-ray opaque marker 15 is adhered to the inner tube 20 with an adhesive. When it is confirmed that one end of the X-ray opaque marker 15 is bonded, the X-ray opaque marker 15 is wound along the gap of the metal wire 10. The number of rotations for winding is not limited, but it is preferably about 1 to 5 rotations. When the winding is completed, the other end of the radiopaque marker 15 is finally attached to the inner tube 20 with an adhesive.

(3) X-ray opaque marker fixing step Before providing the next resin coating layer 40, a step of arbitrarily fixing the X-ray opaque marker 15 to the inner tube 20 or the metal wire 10 may be performed. As a fixing method, a method of welding the adjacent metal wire 10 with a laser or the like, a method of fixing the X-ray opaque marker 15 by plating, and in the case of a braid of the metal wire 10 and the resin wire 30, heat is applied. Therefore, a method of integrally fixing the resin wire 30 and the X-ray opaque marker 15 and the like 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 agent that has fixed the X-ray opaque marker 15 may be removed using an adhesive removing agent. .. Removing the adhesive can reduce the likelihood that the adhesive will elute during use of the catheter.

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

Needless to say, the present invention is not limited to the above-described embodiments and can be carried out in various modes within the technical scope of the present invention.

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

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 (6)

In a catheter in which a metal wire is wound around the outer circumference of the inner tube in a spiral shape or a coil shape at intervals,
A catheter characterized in that a radiopaque marker is wound in a gap between the wound metal wire and an adjacent metal wire. The catheter according to claim 1, wherein the metal wire is braided with a resin wire made of resin. The catheter according to claim 1 or 2, wherein the radiopaque marker has a diameter smaller than that of the metal wire. The catheter according to any one of claims 1 to 3, wherein the radiopaque marker is wound a plurality of times between the metal wires. The catheter according to any one of claims 1 to 4, wherein the metal wire and the X-ray opaque marker are coated with resin on their outer circumferences. In a production method for producing a catheter having a radiopaque marker,
(1) Metal wire winding step of winding a metal wire around the outer circumference of the inner tube (2) X-ray between the metal wire and the metal wire at an arbitrary position of the inner tube around which the metal wire is wound Adhere one end of the opaque marker to the inner tube, wind 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 attaching process by attaching to X-ray opaque marker to inner tube (3) After covering with a resin-made covering tube, heat shrink to cover the metal wire and X-ray opaque marker with the covering tube A method for producing a catheter having an X-ray opaque marker, which comprises a resin coating step of coating.

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