JP7251765B2 - CATHETER AND CATHETER MAKING METHOD - Google Patents

Description

The present invention relates to catheters and methods of making catheters.

The catheter is fitted with radiopaque markers around the circumference of the catheter to track the position of the catheter when inserted into the body during surgery.

As a catheter attached with an X-ray opaque marker, for example, a metal marker is attached to the outer circumference of a catheter tube, and a pair of fixed tubes having tapered outer circumferences are attached to both sides of the metal marker. and the fixed tube, and between the fixed tube and the catheter tube, a catheter is proposed in which no step is formed (Patent Document 1).

According to such a catheter, there is an effect that it is possible to provide a catheter with improved vascular passageability by eliminating steps.

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 that the catheter may get caught in the lumen when advancing or removing it, making it impossible to move smoothly. . Therefore, there is a demand for a catheter formed with a constant thickness without providing a thick portion, even if only a part of it.

On the other hand, various catheters have been proposed in which a metal wire is coiled around the outer circumference of an inner tube. If a radiopaque marker is attached to the outer peripheral side of a catheter wrapped with such a metal wire, the outer diameter of the part attached with the radiopaque marker will inevitably become larger than the other parts. There was a problem.

In addition, many catheters made by winding a metal wire around the outer circumference of such an inner tube in a coil form are formed to be flexibly bendable in order to ensure followability when advancing through 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, resulting in poor lumen followability.

JP-A-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 wound with a metal wire, the outer diameter does not increase. It is an object of the present invention to provide a catheter capable of suppressing deterioration of bending performance as much as possible.

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

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

According to the catheter of the present invention, since the X-ray opaque marker is directly wound on the inner tube between the metal wires that are helically or wound, X-ray radiation is detected on the outer peripheral side of the metal wire. It is possible to prevent the portion to which the X-ray opaque marker is attached from becoming thicker than when the radiopaque marker is attached.

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, it is possible to prevent the position of the metal wire from shifting due to the resin wire, and since the resin wire is also arranged between the metal wires, the X wire is wound on the outer peripheral side of the metal wire. The line-opaque marker can also be made difficult to shift by contacting the resin line.

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 circumference of the X-ray opaque marker is arranged on the inner circumference side of the outer circumference of the metal wire, thereby reliably preventing the portion where the X-ray opaque marker is attached from becoming thicker. can do.

Further, in the catheter according to the present invention, the X-ray opaque marker may be wound multiple times 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 X-rays becomes larger, so that visibility is improved 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 metallic wire and the X-ray opaque marker are coated with a resin.

By adopting such a configuration, the positions of the X-ray opaque marker and the metal wire are fixed, and the possibility of the X-ray opaque marker falling off can be reduced.

Further, the fabrication method for fabricating a catheter having radiopaque markers according to the present invention comprises:
(1) A metal wire winding process of winding a metal wire around the outer circumference of an inner tube (2) An arbitrary position of an inner tube around which a metal wire is wound, and an X-ray is placed between the metal wires. One end of the radiopaque marker is adhered to the inner tube, the radiopaque marker is wound along the gap between the metal wires, and the other end of the radiopaque marker is attached to the inner tube. X-ray opaque marker attachment process to attach the X-ray opaque marker to the inner tube by adhering to the inner tube It is characterized by including a resin coating step of coating.

By such methods, the catheters described above can be made.

According to the catheter of the present invention, it is possible to provide a catheter that reduces or prevents thickening of the region having the X-ray opaque marker, even if the catheter is attached with the X-ray opaque marker.

FIG. 1 is a schematic side view of a catheter device 110 having a catheter 100 and a handheld portion 200 according to an embodiment. 2A is an enlarged schematic side view of the catheter 100 according to the embodiment, showing the AA portion of FIG. 1, and FIG. 2B is a cross-sectional view of the 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 of yet another example of the catheter 100 according to the embodiment. FIG. 5 is a cross-sectional view showing still 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.

The catheter 100 according to the present invention will be described in detail below 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 section AA, which is a part of the catheter 100 of FIG. 2B is a cross-sectional view taken along the line BB of FIG. 2A.

A catheter device 110 equipped with a catheter 100 according to the first embodiment, as shown in FIG. . Various members are attached to the distal end portion 50 according to the intended use. For example, a flexible plastic tip can be attached to improve vascular progression, or a pressure sensor can be attached to measure blood pressure. Of course, the shape of the distal end portion 50 is not particularly limited, and any shape may be adopted for the hand operation portion 200 . Additional components other than the distal end portion 50 and the handheld 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 operation area, and is formed in an elongated linear shape. In a catheter 100 according to this embodiment, as shown in FIG. 2, a metal wire 10 is wound spirally or coiled around the outer circumference of an inner tube 20 . The spirally or coiled metal wire 10 is wound so as to have an interval α between adjacent metal wires 10 so as to ensure flexibility in order to improve the followability of the catheter 100 in the lumen. being turned. The interval α between the adjacent metal wires 10 is not limited, but is preferably about 0.5 mm to 1.5 mm. Although the thickness of the metal wire 10 is not particularly limited, it is preferable to use a wire having a diameter of about 10 μm to 100 μm. Moreover, the metal wire 10 is not limited to one 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. Preferably, for example, tungsten, tantalum, cobalt, rhodium, titanium, alloys thereof, stainless steel, nickel alloys, molybdenum alloys, or the like is used.

The catheter 100 wound with the metal wire 10 in this way is attached with radiopaque markers 15 at one or more 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 imaged by X-rays, such as platinum, gold, or palladium. Of course, it is not limited to these. These radio-opaque markers 15 are typically attached to the circumference of the catheter in a band-like manner. However, when it is wound around the outer periphery of the metal wire, there is a problem that the outer periphery of that portion only becomes thicker. If a portion of the catheter is thickened, 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 to form the thickness as uniform as possible. Therefore, in the present invention, as shown in FIG. 2, the X-ray opaque marker 15 to be attached is formed in a linear shape in the gap between the metal wire 10 and the adjacent metal wire and is attached by winding it. It is That is, the metal wire 10 is wound directly around the inner tube 20 at a pitch substantially the same as the winding pitch of the metal wire 10 so as to be arranged in gaps 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 a single marker may be provided as shown in FIG. When a plurality of X-ray opaque markers 15 are wound, the plurality of X-ray opaque markers 15 may be wound without gaps between metal wires 10 as shown in FIG. , may be spaced between each radiopaque marker 15 as shown in FIG. By providing the gap, flexibility of the catheter 100 can be ensured even at the site where the X-ray opaque marker 15 is wound. In addition, it is preferable that the X-ray opaque marker 15 has the same thickness as the cross-sectional diameter of the metal wire 10 or a thin one having a smaller diameter 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 attached without being positioned outside the outer circumference of the metal wire 10. It is possible to prevent the outer circumference of the catheter 100 from becoming thicker at the site. The cross-sectional shape of the X-ray opaque marker 15 is not limited, and various cross-sectional shapes such as the circular cross-section shown in FIG. be able to.

Further, as shown in FIG. 5, when the metal wire 10 is spirally or coiledly wound around the inner tube 20, the metal wire 10 and the resin wire 30 made of resin may be braided. By braiding with the resin wire 30, the metal wire 10 can be prevented from being dislocated. Also, the position of the X-ray opaque marker 15 can be made difficult to shift by the resin wire 30 . The resin wire 30 is preferably thinner than the metal wire 10 and X-ray opaque marker 15 . By using the resin wire 30 thinner than the metal wire 10 and the X-ray opaque marker 15, it is possible to exhibit the positional deviation prevention function without hindering the arrangement of the metal wire 10 and the X-ray opaque marker 15. .

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

A method for manufacturing the catheter 100 described above will be described.
(1) Metal wire winding step The metal wire 10 is spirally or coiledly wound around the inner tube 20 to produce the catheter 100 in which the metal wire 10 is wound around the outer circumference of the inner tube 20 . At this time, when the resin wire 30 is braided, the metal wire 10 and the resin wire 30 can be wound while being woven at the same time.

(2) Radio-opaque Marker Attaching Step A radio-opaque marker 15 is wound at an arbitrary position on the catheter 100 around which the metal wire 10 is wound, in the gap between the metal wire 10 and the adjacent metal wire 10 . When winding 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 adhered, the X-ray opaque marker 15 is wound along the gap between the metal wires 10 . Although the number of rotations for winding is not limited, it is preferably about 1 to 5 rotations. After the 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) Radiopaque Marker Fixing Step A step of optionally fixing the radiopaque marker 15 to the inner tube 20 or the metal wire 10 may be performed before the coating layer 40 made of the resin is provided. As a fixing method, a method of welding the adjacent metal wires 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, applying heat. 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 fixing the X-ray opaque marker 15 may be removed using an adhesive remover. . Removal of the adhesive can reduce the likelihood of adhesive elution during catheter use.

(4) Resin Coating Process After the X-ray opaque marker 15 is thus fixed with an adhesive, or after it is fixed in the (3) X-ray opaque marker fixing process, a resin-made coating tube is put on it and heat is applied. A catheter 100 in which the metal wire 10 and the radiopaque marker 15 are coated with the resin of the coating tube can be produced by heat shrinking the coating tube.

It goes without saying that the present invention is by no means limited to the above-described embodiments, and can be embodied 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 (5)

A catheter in which a metal wire is wound in a spiral or coil shape at intervals around the outer circumference of an inner tube,
In the interstices between the wound metal wire and the adjacent metal wire, a plurality of radiopaque markers having a diameter smaller than the cross-sectional diameter of the metal wire are approximately the winding pitch of the metal wire. A catheter characterized by being wound in parallel with a similar pitch . The catheter according to claim 1, wherein the metal wire is braided with a resin wire made of resin. 3. The catheter according to claim 1, wherein the X-ray opaque marker is wound multiple times between the metal wires. The catheter according to any one of claims 1 to 3, wherein the metal wire and the X-ray opaque marker are coated with a resin. A fabrication method for fabricating a catheter having a radiopaque marker according to any one of claims 1 to 4, comprising:
(1) A metal wire winding process of winding a metal wire around the outer circumference of an inner tube (2) An arbitrary position of an inner tube around which a metal wire is wound, and an X-ray is placed between the metal wires. One end of the radiopaque marker is adhered to the inner tube, the radiopaque marker is wound along the gap between the metal wires, and the other end of the radiopaque marker is attached to the inner tube. X-ray opaque marker attachment process to attach the X-ray opaque marker to the inner tube by adhering to the inner tube 1. A manufacturing method for manufacturing a catheter having radiopaque markers, comprising: a coating resin coating step.

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