JP7282355B2 - CATHETER AND CATHETER MAKING METHOD - Google Patents

Description

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

Various catheters made of a coiled body or catheters in which a metal wire is coiled around a resin tubular member forming an inner layer lumen have been proposed.

For example, the right holder proposes a catheter having an inner resin layer, a reinforcing metal wire arranged around the outer circumference of the inner resin layer, and an outer resin layer arranged around the outer circumference of the reinforcing metal wire. (Patent Document 1).

Such catheters are sometimes fitted with radiopaque markers around the circumference of the catheter to confirm the position of the catheter when it is inserted into the body during surgery. However, when the X-ray opaque marker is attached to the outer peripheral side of the reinforcing metal wire, there is a problem that the outer diameter of the part where the X-ray opaque marker is attached becomes larger than the other parts. .

If a part of the catheter is formed thick, there is a possibility that the catheter may not advance smoothly when advancing through a lumen such as a blood vessel.

JP 2017-42222 A

Therefore, the present invention has been made in view of the above problems, and is intended to prevent the outer diameter from increasing even when an X-ray opaque marker is attached to a catheter wound with a metal wire. It aims to provide a catheter that does not

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

The catheter of the present invention is
In a catheter formed by winding a metal wire,
a melted portion formed by melting a portion of the metal wire;
a radiopaque marker mounting portion formed in the fusion zone and formed in a concave shape at least deeper than the thickness of the radiopaque marker;
the radiopaque marker attached to the radiopaque marker mounting portion;
characterized by comprising

According to the catheter of the present invention, since the portion where the X-ray opaque marker is attached is formed in a concave shape that is deeper than the X-ray opaque marker, the circumference of the catheter is thick even when the X-ray opaque marker is attached. Therefore, the catheter can be made to have the same thickness even at the site where the X-ray opaque marker is attached. In addition, since the portion where the X-ray opaque marker mounting portion is to be fabricated is integrated by melting the metal wire, the metal wire does not fray even when the concave shape is formed, thereby forming the X-ray opaque marker mounting portion. be able to.

Further, in the catheter according to the present invention, the radiopaque marker mounting portion may be formed in a concave shape having the same cross-sectional shape as the cross section of the radiopaque marker. .

By making the concave form of the radiopaque marker attachment portion to a size that the radiopaque marker can just fit into, the surface is flush when the radiopaque marker is attached to the radiopaque marker attachment portion. Therefore, a catheter having a more uniform thickness can be obtained.

Further, in the catheter according to the present invention, the circumference of the radiopaque marker attached to the radiopaque marker attaching portion is repaired with a repair material so as to have the same thickness as the outer peripheral surface. It may be characterized.

By repairing with the repair material, it is not necessary to make the concave form the same shape as the cross section of the radiopaque marker, and after forming the concave shape larger than the radiopaque marker and attaching the radiopaque marker , can be repaired to have the same thickness as the surrounding outer peripheral surface.

Furthermore, in the catheter according to the present invention, a metal wire may be further wound around the outer circumference of the X-ray opaque marker.

By further winding the metal wire around the outer circumference, the thickness of the outer circumference can be made uniform.

Furthermore, in the catheter according to the present invention, a resin tube may be arranged on the inner peripheral side of the wound metal wire.

By adopting such a configuration, a catheter having a core lumen in the center can be obtained, and a catheter that can be used for injecting drugs or the like can be obtained.

Furthermore, in the catheter according to the present invention, a core material may be arranged on the inner peripheral side of the wound metal wire.

By adopting such a configuration, it can be suitably used as a catheter for use in, for example, Optical Coherence Tomography.

The present invention also provides a method of making a catheter having radiopaque markers, comprising:
a melting step of melting a part of the metal wire of the catheter formed by winding the metal wire with a laser;
an X-ray opaque marker attaching portion producing step of producing a concave X-ray opaque marker attaching portion for attaching an X-ray opaque marker by metal processing the melted melted portion;
a radiopaque marker attaching step of attaching a radiopaque marker to the radiopaque marker attachment portion;
A method of making a catheter is provided, comprising:

By adopting such a manufacturing method, a catheter having the effects described above can be manufactured.

Furthermore, in the method for fabricating a catheter according to the present invention,
After the radiopaque marker attachment step,
It may be characterized by having a metal wire winding step of winding another metal wire.

Furthermore, in the method for fabricating a catheter according to the present invention,
After the radio-opaque marker mounting step, a repairing step of repairing the periphery of the radio-opaque marker with a repair material may be provided.

Furthermore, in the method for fabricating a catheter according to the present invention,
After the repair process,
Furthermore, it may be characterized by having a metal wire winding step of winding a metal wire.

According to the catheter according to the present invention, it is possible to manufacture a catheter having radiopaque markers without thickening the region having the radiopaque markers.

FIG. 1 is a schematic side view of a catheter device 110 having a catheter 100 and a handheld portion 200 according to a first embodiment. FIG. 2A is an enlarged schematic side view of the catheter 100 according to the first embodiment taken along line AA of FIG. 1, and FIG. 2B is a cross-sectional view. FIG. 3 is a side view showing another example of the catheter 100 according to the first embodiment. FIG. 4 is a cross-sectional view showing another example of the catheter 100 according to the first embodiment. FIG. 5A is a side view showing a catheter 100a according to the second embodiment, FIG. 5B is a side view showing a catheter 90 from which the catheter 100a according to the second embodiment is based, and FIG. FIG. 4A is a side view showing a part of a process for manufacturing a catheter 100a according to an embodiment; FIG. 6 is a cross-sectional view showing a catheter 100b according to the third embodiment. FIG. 7 is a cross-sectional view showing a catheter 100c according to the fourth embodiment. FIG. 8 is a cross-sectional view showing a catheter 100d according to the fifth embodiment. FIG. 9 is a cross-sectional view showing a catheter 100e according to the sixth embodiment. FIG. 10A is a cross-sectional view showing a state in which a conventional catheter 100f is inserted into a drive shaft, and FIG. 10B is a cross-sectional view showing a state in which a catheter 100e according to the sixth embodiment is inserted into the drive shaft.

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 a catheter 100 according to the first embodiment, and FIG. 2 is an enlarged schematic side view of section AA, which is part of the catheter 100 of FIG. .

A catheter device 110 according to the first embodiment, as shown in FIG. 1, includes a catheter 100, a distal end portion 50 at its distal end, and a hand operation portion 200 at its proximal end side. Additional components other than the distal end portion 50 and the handheld operation portion 200 can be added as appropriate. 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 of the handheld operation portion 200 may be adopted.

As shown in FIG. 1, the catheter 100 is a member mainly for moving the distal end portion 50 to an operation area, and is formed in a long and thin line. As shown in FIG. 2, the catheter 100 according to the present embodiment is made of a metal wire 12 whose outer circumference is wound in a spiral or coil shape, and is formed into a tubular shape with a hollow center. there is In the first embodiment, the spirally or coiled metal wires 12 are wound adjacent to each other without gaps. The thickness of the metal wire 12 is not particularly limited, but preferably about 10 μm to 100 μm. Moreover, the metal wire 12 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 12 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.

One or more X-ray opaque markers 15 are attached at arbitrary positions to the catheter 100 thus fabricated by the metal wire 12 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 radiopaque markers 15 are typically attached to the circumference of the catheter 100 by wrapping them around like a band. However, when it is wound around the outer circumference of the metal wire 12, there is a problem that the outer circumference becomes thick only at that part. If a portion of the catheter 100 is thickened, there is a risk that the thickened portion may get caught in the lumen when the catheter 100 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 metal wire 12 is melted and integrated with a width wider than at least the width of the X-ray opaque marker 15 to be attached to form a fusion portion 12a. is formed into a concave shape equal to or deeper than the thickness of the X-ray opaque marker 15 by metal processing such as cutting, polishing, or melting with chemicals so that the depth is equal to or greater than the thickness of the X-ray opaque marker 15 An X-ray opaque marker mounting portion 12b is formed, and an X-ray opaque marker 15 is wound around the X-ray opaque marker mounting portion 12b. As a result, the circumference of the catheter 100 at the site where the X-ray opaque marker 15 is attached does not become thicker. As shown in FIG. 2, the radio-opaque marker mounting portion 12b has a concave form in which the cross-sectional shape of the radio-opaque marker 15 is the same as the cross-sectional shape of the concave radio-opaque marker mounting portion 12b. It is preferable to make Since the surface of the fusion zone 12a and the surface of the X-ray-opaque marker 15 are flush with the X-ray-opaque marker mounting portion 12b, the catheter 100 having a more uniform thickness can be manufactured. can be done. The shape of the X-ray opaque marker mounting portion 12b is not limited, and as shown in FIG. When such a gentle X-ray-opaque marker mounting portion 12b is formed, as shown in FIG. It is preferable to fill the periphery with a repair material 16 such as resin to form a uniform thickness. Also, the fusion zone 12a must be made wider than at least the width of the X-ray opaque marker 15 to be attached, but the width should be as narrow as possible. This is because the melted portion becomes difficult to bend. Preferably, the width of the fusion zone formed on both sides of the X-ray opaque marker 15 should be within 1 mm.

The reason why the metal wire 12 is melted to form the melted portion 12a when the concave X-ray opaque marker mounting portion 12b is produced is that the metal wire 12 is curved when the catheter 100 is produced to form a cylindrical shape. There is a possibility that the metal wire 12 itself is tensioned to some extent because it is manufactured in a shape. Therefore, if the metal wire 12 is formed into a concave shape by cutting or the like in the state of the metal wire 12, the metal wire 12 may be cut and frayed. Therefore, fraying is prevented and the tension of the metal wire 12 is eliminated by forming a melted portion 12a by melting and integrating the portion to which the X-ray opaque marker 15 is attached and the vicinity thereof.

The catheter 100 described above is manufactured as follows.
(1) Melting Step A portion of the metal wire 12 of the catheter 100 formed by winding the metal wire 12 is melted by a laser to produce a melted portion 12a in which a predetermined range of the metal wire 12 is integrated.
(2) X-ray opaque marker mounting portion manufacturing step The X-ray opaque marker mounting portion 12b having a concave shape is manufactured by cutting, polishing, or melting the melted portion 12a with a chemical.
(3) X-ray opaque marker attachment step The X-ray opaque marker 15 is attached by winding it around the radio-opaque marker attachment portion 12b formed in a concave shape.
(4) Repair process If necessary, a repair material 16 made of resin or the like is used to repair the area around the X-ray opaque marker 15 by filling it with putty. make it
Thus, the catheter 100 can be produced.

(Second embodiment)
A catheter 100a according to a second embodiment is shown in FIG. 5A. In the catheter 100a according to the second embodiment, the metal wires 12 of the catheter 90 before the radiopaque markers 15 are attached to the catheter 100 according to the first embodiment are spaced apart as shown in FIG. 5B. It is different in that it is wound so that it can be

In the case of such a catheter 100a, even if the metal wire 12 is melted as it is, the melted portion 12a for forming the concave portion cannot be produced. Therefore, as shown in FIG. 5C, when the metal wire 12 is melted, pressure is applied to the coiled metal wire of the catheter 100a from both sides once so that the metal wires 12 are in close contact with each other so that no gap is formed. The state of the portion 12d is obtained, and after being melted in this state, it is cured. By doing so, the melted portion 12a can be produced in the same state as in the first embodiment. The manufacturing method thereafter is the same as that of the first embodiment.

Even if the catheter 100a manufactured in this manner is formed into a concave shape by cutting or the like in the same manner as in the first embodiment, the metal wire 12 does not fray and the X-ray opaque marker attachment portion 12b can be manufactured. It is possible to manufacture a catheter 100a in which the site to which the permeation marker 15 is attached does not become thicker.

(Third embodiment)
A catheter 100b according to a third embodiment is shown in FIG. A catheter 100b according to the third embodiment differs from the catheter 100 according to the first embodiment in that another metal wire 13 is wound around the outer periphery. Since other configurations are the same as those of the first embodiment, description thereof is omitted.

The catheter 100b according to the third embodiment is manufactured by adding a metal wire winding step by further winding another metal wire 13 after being manufactured by the method for manufacturing the catheter 100 according to the first embodiment. be done. By further winding the metal wire 13 around the outer periphery in this way, the entire outer peripheral surface is formed of the metal wire 13, so that the thickness of the surface does not change in the entire longitudinal direction, and the catheter has a high uniformity. can be

Moreover, even when the X-ray opaque marker mounting portion 12b is formed in a gentle concave shape as shown in FIG. outer peripheral surface. Therefore, the repair process can be omitted.

(Fourth embodiment)
A catheter 100c according to a fourth embodiment is shown in FIG. A catheter 100c according to the fourth embodiment differs from the catheter 100 according to the first embodiment in that a resin tube 40 is inserted in the inner layer. Since other points are the same as those of the first embodiment, description thereof is omitted.

The catheter 100c according to the fourth embodiment may be manufactured by inserting the resin tube 40 after manufacturing the catheter 100 by the same method as in the first embodiment, or by inserting the metal wire into the resin tube 40 in advance. After winding 12, the metal may be melted to create a welded portion 12a and a concave radiopaque marker mounting portion 12b.

A core lumen 41 is formed in the center by providing a resin tube 40 inside. The core lumen 41 can be used for passing a guide wire (not shown) or for injecting a drug solution depending on the intended use of the catheter 100 . Although the material of the resin tube 40 is not particularly limited, for example, if it is used for passing a guide wire, polytetrafluoroethylene or the like having high slidability with respect to the guide wire may be used. In addition, the resin tube 40 does not necessarily have to be a single layer of resin. It may be formed in a two-layer structure by using a material having high adhesion and compatibility with the metal wire 12 to be applied.

Also, the resin tube 40 may be used in combination with the second embodiment and the third embodiment.

(Fifth embodiment)
A catheter 100d according to a fifth embodiment is shown in FIG. A catheter 100d according to the fifth embodiment differs from the catheter 100 according to the first embodiment in that an outer resin layer 70 is formed. Since other points are the same as those of the first embodiment, description thereof is omitted.

The outer resin layer 70 constitutes the outermost layer of the catheter 100d, protects the inside of the catheter 100d, prevents the metal wire 12 from being exposed to the outside, and is melted during molding to be integrated with the metal wire 12 so that these It has the function of fixing the position. The resin material of the outer resin layer 70 is not particularly limited. Any resin that has appropriate flexibility and can protect the outside may be used. Polyamide or the like can be preferably used.

By providing such an outer resin layer 70, the thickness of the outer peripheral surface of the catheter 100d can be made uniform.

Note that the outer resin layer 70 may be used in combination with the second to fourth embodiments.

(Sixth embodiment)
A catheter 100e according to a sixth embodiment is shown in FIG. A catheter 100e according to the sixth embodiment has a core material 80 inserted in the inner layer, unlike the first embodiment. Since the configuration other than this is the same as that of the first embodiment, description thereof is omitted.

Examples of the core material 80 include guide wires, metal wires usable as atherectomy catheters, optical fibers used in optical coherence tomography catheters, signal wires used in ultrasound catheters, and the like. Of course, it is not limited to these.

In particular, atherectomy catheters and optical coherence tomography catheters are used with the core material rotated at high speed, so they can be used more preferably. For example, a catheter for optical coherence tomography is inserted into the drive shaft 95 and images are captured while a lens portion provided at the tip is rotated at high speed. Therefore, if the X-ray opaque marker 15 or the like is attached to the outer circumference of the catheter as in the conventional art, a gap is formed between the catheter 100f and the inner wall of the lumen of the drive shaft 95 as shown in FIG. 10A. It will be. If there is a gap, when the catheter 100f rotates, there is a possibility that vibration will occur or the lens portion at the tip will shake. Therefore, it is preferable to form the gap with respect to the drive shaft 95 as little as possible. According to the catheter according to the present embodiment, as shown in FIG. 10B, the catheter 100e can have the same thickness over the entire length. Vibration can be reduced, and the possibility of blurring of the lens portion at the tip can be reduced.

This sixth embodiment may be used in combination with the second through third and fourth through fifth embodiments.

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 12... Metal wire, 12a... Melting part, 12b... X-ray opaque marker mounting part, 12d... Adhesion part, 13... Metal wire, 15... X-ray opaque marker, 40... Resin tube, 41... Core lumen, 50 Tip part 70 Outer resin layer 80 Core material 90 Catheter 95 Drive shaft 100 Catheter 100a Catheter 100b Catheter 100c Catheter 100d Catheter 100e Catheter 100f Catheter 110 Catheter device 200 Hand operation unit 200e Catheter

Claims (10)

In a catheter formed by winding the metal wires so that they are spaced apart ,
A portion of the coil-shaped metal wire in a portion other than the tip portion is once pressed from both sides to be in close contact with each other so that no gap is formed between the metal wires. a melted portion formed by melting to a width wider than the width of the transmission marker;
a radiopaque marker mounting portion formed in the fusion zone and formed in a concave shape at least deeper than the thickness of the radiopaque marker;
the radiopaque marker attached to the radiopaque marker mounting portion;
A catheter comprising: 2. The catheter according to claim 1, wherein said X-ray opaque marker mounting portion is formed in a concave shape having the same cross-sectional shape as that of said X-ray opaque marker. 2. The apparatus according to claim 1, wherein the periphery of said radiopaque marker attached to said radiopaque marker mounting portion is repaired with a repair material so as to have the same thickness as the outer peripheral surface. catheter. 4. The catheter according to any one of claims 1 to 3, further comprising a metal wire wound around the outer periphery of the X-ray opaque marker. 5. The catheter according to any one of claims 1 to 4, wherein a resin tube is arranged inside the wound metal wire. 6. The catheter according to any one of claims 1 to 5, wherein a core material is arranged on the inner peripheral side of the wound metal wire. A method of making a catheter having a radiopaque marker comprising:
A portion of the coil-shaped metal wire in a portion other than the distal end portion of the catheter, which is formed by winding the metal wires at intervals, is once pressed from both sides, and each of the metal wires is pulled. a melting step of forming a melted portion by melting a portion of the metal wire with a laser so as to have a width wider than at least the width of the radiopaque marker to be attached while being in close contact with no gap between them ;
an X-ray opaque marker attachment portion producing step of fabricating a concave X-ray opaque marker attachment portion for attaching the X-ray opaque marker by metal processing the melted molten portion;
a radiopaque marker attaching step of attaching the radiopaque marker to the radiopaque marker attachment portion;
A method of making a catheter, comprising: After the radiopaque marker attachment step,
8. The method of manufacturing a catheter according to claim 7, further comprising a metal wire winding step of winding another metal wire. 8. The method of manufacturing a catheter according to claim 7, further comprising a repairing step of repairing the periphery of the radiopaque marker with a repair material after the radiopaque marker attaching step. After the repair process,
10. The method of manufacturing a catheter according to claim 9, further comprising a step of winding a metal wire.

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