JP2020080930A - Catheter and manufacturing method of catheter - Google Patents

Abstract

To provide a catheter that prevents its peripheral diameter from becoming thick even when a radiopacity marker is attached to the catheter around which a metal wire is wound.SOLUTION: A catheter 100 formed by winding a metal wire around it includes: a melting part 12a formed by melting part of the metal wire; a radiopacity marker attaching part 12b formed at the melting part and formed in a recessed shape deeper than at least the thickness of a radiopacity marker 15; and the radiopacity marker attached to the radiopacity marker attaching part.SELECTED DRAWING: Figure 2

Description

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

Various catheters made of a coil body or catheters in which a metal wire is wound in a coil shape on a resin cylindrical member forming an inner layer lumen have been proposed.

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

Such catheters may be fitted with radiopaque markers on the outer circumference of the catheter to identify 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 in that the portion to which the X-ray opaque marker is attached has a larger outer peripheral diameter than other portions. ..

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

JP, 2017-42222, A

Therefore, the present invention has been made in view of the above-described problems, and the outer diameter is increased even when the radiopaque marker is attached to the catheter around which the metal wire is wound. Not intended to provide a catheter.

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

The catheter of the present invention is
In a catheter formed by winding a metal wire,
A fusion portion formed by melting a part of the metal wire,
An X-ray opaque marker attachment portion formed in the fusion portion and formed in a concave shape deeper than at least the thickness of the X-ray opaque marker;
The X-ray opaque marker attached to the X-ray opaque marker attachment part;
It is characterized by having.

According to the catheter of the present invention, the portion to which the X-ray opaque marker is attached is formed in a concave shape deeper than the X-ray opaque marker. Therefore, even when the X-ray opaque marker is attached, the outer circumference of the catheter is large. The catheter having the same thickness can be obtained even at the site where the radiopaque marker is attached. In addition, since the portion for producing the X-ray opaque marker attachment portion is integrated by melting the metal wire, the X-ray opaque marker attachment portion is formed without fraying the metal wire even if it is formed in a concave shape. be able to.

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

By making the concave shape of the X-ray opaque marker mounting portion into a size that allows the X-ray opaque marker to just fit in, the surface is flat when the X-ray opaque marker is attached to the X-ray opaque marker mounting portion. Therefore, the catheter having a more uniform thickness can be obtained.

Further, in the catheter according to the present invention, the periphery of the X-ray opaque marker attached to the X-ray opaque marker attaching portion is repaired with a repair material so as to have the same thickness as the outer peripheral surface. It may be a feature.

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

Further, the catheter according to the present invention may be characterized in that a metal wire is further wound around the outer peripheral side of the radiopaque marker.

By further winding the metal wire on the outer peripheral side, the outer peripheral thickness can be made uniform.

Further, 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 a drug 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, for example, as a catheter used for Optical Coherence Tomography and the like.

The present invention also provides a method for producing a catheter having a radiopaque marker,
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 the X-ray opaque marker to the melted fused portion by metal working;
An X-ray opaque marker attaching step of attaching an X-ray opaque marker to the X-ray opaque marker attaching portion;
There is provided a method for producing a catheter, which comprises:

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

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

Furthermore, in the method for producing a catheter according to the present invention,
After the step of attaching the X-ray opaque marker, there may be a repair step of repairing the periphery of the X-ray opaque marker with a repair material.

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

According to the catheter of the present invention, it is possible to manufacture a catheter having a radiopaque marker without causing a region having the radiopaque marker to become thick.

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 first embodiment. 2A is an enlarged schematic side view showing the AA portion of FIG. 1 of the catheter 100 according to the first embodiment, and FIG. 2B is a 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. 5A is a side view showing a catheter 100a according to the second embodiment, FIG. 5B is a side view showing a catheter 90 which is a source of the catheter 100a according to the second embodiment, and FIG. It is a side view which shows a part of process at the time of producing the catheter 100a concerning embodiment. FIG. 6 is a sectional view showing a catheter 100b according to the third embodiment. FIG. 7 is a sectional view showing a catheter 100c according to the fourth embodiment. FIG. 8 is a sectional view showing a catheter 100d according to the fifth embodiment. FIG. 9 is a sectional view showing a catheter 100e according to the sixth embodiment. FIG. 10A is a sectional view showing a state in which the conventional catheter 100f is inserted into the drive shaft, and FIG. 10B is a sectional view showing a state in which the catheter 100e according to the sixth embodiment is inserted into the drive shaft.

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. 2 is an enlarged schematic side view of a portion AA which is a part of the catheter 100 of FIG. ..

As shown in FIG. 1, the catheter device 110 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. It is possible to appropriately add components other than the tip portion 50 and the hand operation portion 200. Various members are attached to the tip 50 according to the intended use. For example, a flexible plastic tip may be attached or a pressure sensor for measuring blood pressure may be attached to improve vascular progression. Of course, the form of the tip portion 50 is not particularly limited, and the hand operation unit 200 may have any form.

As shown in FIG. 1, the catheter 100 is a member mainly for moving the distal end portion 50 to the operation region, and is formed in an elongated linear shape. As shown in FIG. 2, the catheter 100 according to the present embodiment is made of a metal wire 12 whose outer circumference is spirally or coiled, and is formed in a tubular shape with a hollow center. There is. In the first embodiment, the metal wires 12 wound in a spiral shape or a coil shape are wound so as to be adjacent to each other without a gap. The thickness of the metal wire 12 is not particularly limited, but it is preferable to use a wire having a thickness of about 10 μm to 100 μm. Further, the metal wire 12 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 12 is not particularly limited. Suitably, for example, tungsten, tantalum, cobalt, rhodium, titanium, alloys thereof, stainless steel, nickel alloys or molybdenum alloys are used.

In this way, the catheter 100 made of the metal wire 12 is attached with one or more radiopaque markers 15 at arbitrary positions so that the position can be easily confirmed under fluoroscopy. .. The X-ray opaque marker 15 is made of a material that can be imaged by X-ray, such as platinum, gold or palladium. Of course, it is not limited to these. These X-ray opaque markers 15 are usually attached to the outer circumference of the catheter 100 by being wound 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 portion. If a part of the catheter 100 is formed thick, the thick part may be caught in the lumen when the catheter 100 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, a fused portion 12a is formed by melting and integrating the metal wire 12 with a width wider than at least the width of the attached X-ray opaque marker 15, and the fused portion 12a is formed. Is formed to have a depth equal to or greater than the thickness of the X-ray opaque marker 15 by cutting or polishing, metal working by melting with a chemical, etc., to have a concave shape equal to or deeper than the thickness of the X-ray opaque marker 15. The X-ray opaque marker mounting portion 12b is formed, and the X-ray opaque marker 15 is wound around the X-ray opaque marker mounting portion 12b. As a result, the outer circumference of the catheter 100 at the site where the radiopaque marker 15 is attached does not become thick. As shown in FIG. 2, the concave shape of the X-ray opaque marker attaching portion 12b has the same cross-sectional shape as the X-ray opaque marker 15 and the concave X-ray opaque marker attaching portion 12b. It is preferable to manufacture it as described above. By using such an X-ray opaque marker attachment portion 12b, the surface of the fusion portion 12a and the surface of the X-ray opaque marker 15 are flush with each other, so that the catheter 100 having a more uniform thickness can be manufactured. You can The form of the X-ray opaque marker attaching portion 12b is not limited, and as shown in FIG. 3, a gentle X-ray opaque marker attaching portion 12b larger than the X-ray opaque marker 15 may be formed. When such a gentle X-ray opaque marker attachment portion 12b is formed, as shown in FIG. 4, in order to eliminate the step formed by the X-ray opaque marker 15, the X-ray opaque marker 15 is removed. It is advisable to fill the periphery with a repair material 16 such as resin to form a uniform thickness. Further, the fusion zone 12a needs to be made wider than at least the width of the X-ray opaque marker 15 to be attached, but the width is preferably as narrow as possible. This is because the melted portion is hard 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 and integrated into the fused portion 12a when the concave radiopaque marker attachment portion 12b is manufactured is to bend the metal wire 12 when the catheter 100 is manufactured to form a cylindrical shape. Since the metal wire 12 itself is manufactured in a shape, there is a possibility that tension is applied to the metal wire 12 itself. Therefore, if the metal wire 12 is made into a concave shape by cutting or the like as it is, the metal wire 12 may be broken and frayed. Therefore, by fusing the portion to which the X-ray opaque marker 15 is attached and the vicinity thereof to form an integrated fused portion 12a, fraying is prevented and tension of the metal wire 12 is eliminated.

The catheter 100 described above is manufactured as follows.
(1) Melting Step A part 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 the metal wire 12 in a predetermined range is integrated.
(2) X-ray opaque marker attachment portion manufacturing step The fusion portion 12a is cut or polished, and a concave X-ray opaque marker attachment portion 12b is produced by melting with a chemical or the like.
(3) X-ray opaque marker attaching step The X-ray opaque marker 15 is attached so as to be wound around the X-ray opaque marker attaching 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 X-ray opaque marker 15 by filling the area around the X-ray opaque marker 15 with putty. Say it.
In this way, the catheter 100 can be manufactured.

(Second embodiment)
A catheter 100a according to the 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 marker 15 is attached to the catheter 100 according to the first embodiment are provided with intervals as shown in FIG. 5B. It is different in that it is wound so as to 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 manufactured. Therefore, as shown in FIG. 5C, when the metal wire 12 is melted, the coil-shaped metal wire of the catheter 100a is temporarily pressured from both sides so as not to form a gap between the metal wires 12 The portion 12d is brought into a state of being melted and then cured in this state. By doing so, the melted portion can be made into the melted portion 12a in the same state as in the first embodiment. The subsequent manufacturing method is similar to 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 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 the catheter 100a in which the portion to which the transparent marker 15 is attached does not become thick.

(Third Embodiment)
A catheter 100b according to the third embodiment is shown in FIG. The catheter 100b according to the third embodiment is different from the catheter 100 according to the first embodiment in that another metal wire 13 is further wound around the outer circumference. The other configurations are similar to those of the first embodiment, and thus the description thereof is omitted.

The catheter 100b according to the third embodiment is manufactured by the method for manufacturing the catheter 100 according to the first embodiment, and then by winding another metal wire 13 to add a metal wire winding step. To be done. By further winding the metal wire 13 around the outer circumference in this way, the entire outer peripheral surface is formed of the metal wire 13, so that the surface condition does not change in thickness in all longitudinal directions, and the catheter with high uniformity is obtained. Can be

Further, even when the X-ray opaque marker attaching portion 12b having a gentle concave shape as shown in FIG. 2B is formed, it is smooth by winding the metal wire 13 from the outer periphery without repairing with the repair material 16. The outer peripheral surface can be Therefore, the repair process can be omitted.

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

The catheter 100c according to the fourth embodiment may be manufactured by inserting the resin tube 40 after the catheter 100 is manufactured by the same method as that of the first embodiment. After winding 12, the metal may be melted to form the fused portion 12a, and the concave X-ray opaque marker attachment portion 12b may be produced.

By providing the resin tube 40 inside, the core lumen 41 is formed in the center. The core lumen 41 can be used for passing a guide wire (not shown) or injecting a drug solution depending on the intended use of the catheter 100. The material of the resin tube 40 is not particularly limited, but for example, when it is used to pass a guide wire, polytetrafluoroethylene or the like having high slidability with the guide wire may be used. The resin tube 40 does not necessarily have to be a single resin layer. For example, a material that is resistant to liquids such as chemicals and blood is used on the inner peripheral side, and the resin tube 40 is arranged around the outer peripheral side. 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 formed.

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

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

The outer resin layer 70 constitutes the outermost layer of the catheter 100d, protects the inside of the catheter 100d and prevents the metal wire 12 from being exposed to the outside, and melts at the time of molding to be integrated with the metal wire 12. It has the function of fixing the position. The resin material of the outer resin layer 70 is not particularly limited. Any resin may be used as long as it has appropriate flexibility and can protect the outside. Preferably, polyamide or the like can be used.

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

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

(Sixth Embodiment)
A catheter 100e according to the sixth embodiment is shown in FIG. In the catheter 100e according to the sixth embodiment, the core material 80 is inserted in the inner layer as compared with the first embodiment. The configuration other than this is the same as that of the first embodiment, and thus the description thereof is omitted.

Examples of the core material 80 include a guide wire, a metal wire that can be used as an atherectomy catheter, an optical fiber used for an Optical Coherence Tomography (optical coherence tomography) catheter, and a signal wire used for an ultrasonic catheter. Of course, it is not limited to these.

In particular, an atherectomy catheter or a catheter for optical coherence tomography is used by rotating the core material at a high speed, and thus can be more preferably used. For example, a catheter for optical coherence tomography takes an image while rotating a lens portion, which is inserted into the drive shaft 95 and provided at the tip, at high speed. Therefore, when the radiopaque marker 15 or the like is attached to the outer circumference of the catheter as in the conventional case, 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, vibration may occur when the catheter 100f rotates, or the lens portion at the tip may shake. Therefore, it is preferable to form the drive shaft 95 so that there is as little space as possible. According to the catheter of the present embodiment, as shown in FIG. 10B, the catheter 100e having the same thickness can be formed over the entire length, so that the occurrence of a gap can be reduced and the catheter 100e can be rotated. Can be reduced, and the possibility that the lens portion at the tip will shake can be reduced.

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

It is needless to say that the present invention is not limited to the above-described embodiments and can be implemented in various modes within the technical scope of the present invention.

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

12...Metal wire, 12a...fusion part, 12b...X-ray opaque marker attachment part, 12d...adhesion part, 13...metal wire, 15...X-ray opaque marker, 40...resin tube, 41...core lumen, 50 ... tip portion, 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 part, 200e... Catheter

Claims (10)

In a catheter formed by winding a metal wire,
A fusion portion formed by melting a part of the metal wire,
An X-ray opaque marker attachment portion formed in the fusion portion and formed in a concave shape deeper than at least the thickness of the X-ray opaque marker;
The X-ray opaque marker attached to the X-ray opaque marker attachment part;
A catheter comprising: The catheter according to claim 1, wherein the X-ray opaque marker attachment part is formed in a concave shape having the same cross-sectional shape as the cross-section of the X-ray opaque marker. 2. The X-ray opaque marker attached to the X-ray opaque marker attaching portion is repaired with a repair material so that the X-ray opaque marker has the same thickness as the outer peripheral surface. catheter. The catheter according to any one of claims 1 to 3, wherein a metal wire is further wound around the outer circumference of the radiopaque marker. The catheter according to any one of claims 1 to 4, wherein a resin tube is arranged on the inner peripheral side of the wound metal wire. The core material is arrange|positioned at the inner peripheral side of the said metal wire wound, The catheter of any one of Claim 1 to 5 characterized by the above-mentioned. In a method of making a catheter with a radiopaque marker,
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 the X-ray opaque marker to the molten fused portion by metal working;
An X-ray opaque marker attaching step of attaching the X-ray opaque marker to the X-ray opaque marker attaching portion;
A method for producing a catheter, comprising: After the radiopaque marker attaching step,
The method for producing a catheter according to claim 7, further comprising a metal wire winding step of winding another metal wire. The catheter manufacturing method according to claim 7, further comprising a repairing step of repairing a periphery of the X-ray opaque marker with a repair material after the X-ray opaque marker attaching step. After the repair process,
The method for producing a catheter according to claim 9, further comprising a metal wire winding step of winding a metal wire.

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