WO2020208906A1 - Guide wire - Google Patents

Abstract

The purpose of the present invention is to provide a guide wire that is capable of preventing a core shaft from deforming excessively. The guide wire 1 is provided with: a core shaft 11 having an expanding diameter portion 11k having a diameter expanding toward the terminal end; a coil body 21 disposed so as to cover at least the leading end of the core shaft 11; a leading end fixed portion 31 fixed to the leading end of the coil body 21; and a radio-opaque marker portion 41 which is disposed at the leading end of the core shaft 11. In the long axis direction of the core shaft 11, the marker portion 41 is separated from the leading end fixed portion 31.

Description

Guide wire

The present invention relates to a guide wire.

For example, when inserting a medical device such as a catheter into a blood vessel, a guide wire for guiding to the site where the medical device is treated is inserted in advance.

Such a guide wire is required to have flexibility at the tip so that it can smoothly proceed in a curved blood vessel. On the other hand, in order to prevent the U-shaped bending of the tip of the guide wire, which may occur due to this flexibility, from excessively developing toward the proximal end, for example, a tapered or stepped shape in the middle of the core shaft. A technique for increasing the rigidity by providing an enlarged diameter portion has been proposed (see, for example, Patent Document 1).

U.S. Pat. No. 5,345,945

However, when the conventional guide wire as described above is used, when the bending reaches the enlarged diameter portion, the core shaft tends to be plastically bent due to a large change in rigidity, and the operator uses the bent guide wire. If it is pushed in without recognition, it may press the inner wall of the blood vessel.

The present invention has been made based on the above circumstances, and an object of the present invention is to provide a guide wire capable of preventing the core shaft from being excessively deformed.

Some aspects of this disclosure include
(1) A core shaft having a diameter-expanded portion that expands in the direction of the base end,
A coil body arranged so as to cover at least the tip of the core shaft,
The tip fixing portion fixed to the tip of the coil body and the tip fixing portion
A radiation-impermeable marker portion arranged at the tip of the core shaft is provided.
A guide wire in which the marker portion and the tip fixing portion are separated from each other in the long axis direction of the core shaft.
(2) The guide wire according to (1) above, wherein the tip shape of the marker portion is a curved surface shape that protrudes toward the tip direction.
(3) The guide wire according to (1) or (2) above, wherein the coil body is not fixed to the marker portion.
(4) The item according to any one of (1) to (3) above, wherein the coil body is not fixed to the tip of the core shaft and is fixed to a portion other than the tip of the core shaft. The guide wire, and (5) the guide wire according to any one of (1) to (4), wherein the enlarged diameter portion has a tapered shape or a stepped shape.
Is.

In the present specification, the "tip direction" means a direction along the long axis direction of the guide wire and a direction in which the tip fixing portion is located with respect to the coil body. The "base end direction" means a direction along the long axis direction of the guide wire and a direction opposite to the tip end direction. Further, the "tip" indicates an end portion in the distal end direction of any member or portion, and the "base end" indicates an end portion in the proximal end direction of any member or portion.

The present invention can provide a guide wire capable of preventing the core shaft from being excessively deformed.

It is a schematic side view which shows the 1st Embodiment. It is a partially enlarged schematic side view which shows an example of the shape of the marker part in 1st Embodiment. It is a partially enlarged schematic side view which shows an example of the shape of the marker part in 1st Embodiment. It is a partially enlarged schematic side view which shows an example of the shape of the marker part in 1st Embodiment. It is a schematic side view which shows the use state of FIG. It is a schematic side view which shows the use state of FIG. It is a schematic side view which shows the modification of the 1st Embodiment. It is a schematic side view which shows the 2nd Embodiment. It is a schematic side view which shows the modification of the 2nd Embodiment. It is a schematic side view which shows the 3rd Embodiment.

The guide wire has a core shaft having a diameter-expanded portion that expands in the direction of the proximal end, a coil body arranged so as to cover at least the tip of the core shaft, and a tip fixed to the tip of the coil body. A portion and a radiation-impermeable marker portion arranged at the tip of the core shaft are provided, and the marker portion and the tip fixing portion are separated from each other in the long axis direction of the core shaft.

Hereinafter, the first to third embodiments will be described with reference to the drawings, but the present invention is not limited to the embodiments described in the drawings. Further, the dimensions of the guide wire shown in the drawings are the dimensions shown for facilitating the understanding of the implementation contents, and do not correspond to the actual dimensions.

[First Embodiment]
FIG. 1 is a schematic side view showing the first embodiment. As shown in FIG. 1, the guide wire 1 is roughly composed of a core shaft 11, a coil body 21, a tip fixing portion 31, and a marker portion 41.

The core shaft 11 is a shaft having a diameter-expanded portion 11k that expands in diameter toward the base end. The shape of the enlarged diameter portion 11k in the guide wire 1 is stepped. The guide wire 1 has a diameter-expanded portion 11k provided at one position in the major axis direction of the core shaft 11, and the core shaft 11 has a small diameter portion 11a having a constant outer diameter located in the tip direction of the diameter-expanded portion 11k. It is composed of a large diameter portion 11b which is located in the proximal direction of the enlarged diameter portion 11k and has an outer diameter larger than the outer diameter of the small diameter portion 11a.

The shape of the enlarged diameter portion is such that the outer diameter of the base end (corresponding to the outer diameter of the large diameter portion 11b in the guide wire 1) is larger than the outer diameter of the tip (corresponding to the outer diameter of the small diameter portion 11a in the guide wire 1). If it is also large, the shape in the middle in the long axis direction is not particularly limited.

The dimensions of the core shaft 11 in the major axis direction are usually 1,800 to 3,000 mm in total length and 5 mm to 100 mm in the small diameter portion 11a. The outer diameter of the core shaft 11 is usually 0.03 mm to 0.1 mm for the small diameter portion 11a and 0.25 mm to 0.46 mm for the large diameter portion 11b.

As a material constituting the core shaft 11, from the viewpoint of ensuring the flexibility of the guide wire 1 and imparting antithrombotic properties and biocompatibility, for example, stainless steel such as SUS304 and superelasticity such as Ni—Ti alloy. An alloy or the like can be used.

The coil body 21 is a coil-shaped (spiral-shaped) member arranged so as to cover at least the tip of the core shaft 11. The coil body 21 is, for example, one formed by winding a wire 21a into a coil shape (see FIG. 1), one formed by slitting a cylindrical member or the like (not shown), and the like. Can be adopted. When the wire 21a is used for the coil body 21, one or a plurality of single wires, or one or a plurality of stranded wires can be used as the wire 21a. However, the single wire means one single wire, and the stranded wire means a bundle of wires formed by twisting a plurality of single wires in advance.

The diameter of the wire 21a (single wire or stranded wire) constituting the coil body 21 is usually 0.01 to 0.10 mm.

As the wire rod constituting the coil body 21, from the viewpoint of ensuring the flexibility of the guide wire 1 and imparting antithrombotic properties and biocompatibility, for example, stainless steel such as SUS316; superelasticity such as Ni—Ti alloy. Alloy; A radiation-impermeable metal such as platinum or tungsten can be used.

The base end of the coil body 21 can be joined to, for example, the step portion (diameter expansion portion 11k) of the core shaft 11. On the other hand, the tip of the coil body 21 can be joined to, for example, the tip fixing portion 31 described later. As a method of joining the coil body 21 to the core shaft 11 and the tip fixing portion 31, for example, a brazing method using a brazing material can be adopted. Examples of the brazing material include metal brazing materials such as Sn—Pb alloy, Pb-Ag alloy, Sn—Ag alloy, and Au—Sn alloy.

It is preferable that the coil body 21 is not fixed to the tip of the core shaft 11 and is fixed to a portion other than the tip of the core shaft 11. Specific examples of such an embodiment include a guide wire 1 (see FIG. 1) in which only the base end of the coil body 21 is joined to the core shaft 11 at the joint portion 21b. As described above, the coil body 21 is not fixed to the tip of the core shaft 11 and is fixed to a portion other than the tip of the core shaft 11, so that the coil body 21 and the tip of the core shaft 11 are fixed to each other. Since it is not provided, a sudden change in rigidity at the tip of the core shaft 11 in the long axis direction can be suppressed, and plastic deformation or breakage can be further prevented.

The tip fixing portion 31 is a portion fixed to the tip of the coil body 21. Specifically, the tip fixing portion 31 can be formed so as to have a substantially hemispherical shape in which the tip portion is curved in a convex shape toward the tip direction, for example. For example, the tip of the coil body 21 is joined to the base end of the tip fixing portion 31.

The tip fixing portion 31 can be formed, for example, by melting and molding a part of a member constituting the guide wire 1 such as the coil body 21, or by melting and molding a brazing material. Examples of the brazing material include those similar to those described in the method of joining the coil body 21.

The marker portion 41 is a radiation opaque member arranged at the tip of the core shaft 11. The marker portion 41 is arranged so as to be separated from the tip fixing portion 31 in the long axis direction of the core shaft 11. The shape of the marker portion 41 is not particularly limited as long as the effect of the present invention is not impaired, and for example, a curved marker portion 411 (see FIG. 2A) protruding toward the tip end and a substantially columnar marker portion 412 (FIG. 2A). (See 2B), a substantially disk-shaped marker portion 413 (see FIG. 2C), and the like can be adopted.

Among these, it is preferable that the shape of the marker portion 41 is formed so that the tip shape is a curved surface shape that protrudes toward the tip direction. Specific examples of such a curved marker portion 41 include a substantially hemispherical marker portion 411 (see FIG. 2A) having a curved surface in the tip direction. As a result, when the tip end portion of the guide wire 1 is bent, the coil body 21 can be smoothly bent without being caught by the marker portion 41.

Examples of the radiation-impermeable material constituting the marker portion 41 include gold, platinum, tungsten, and alloys containing these elements (for example, platinum-nickel alloy). The material constituting the marker portion 41 is, for example, a mixture of a radiation-permeable material and a radiation-impermeable material, a material obtained by coating the surface of a radiation-permeable material with a radiation-impermeable material, and the like. It may be a combination of a permeable material and a radiation opaque material.

As a method of joining the marker portion 41 and the core shaft 11, for example, the same method as described in the method of joining the coil body 21 can be mentioned. It is preferable that the marker portion 41 is not fixed to the coil body 21. Since the marker portion 41 is not fixed to the coil body 21 in this way, the coil body 21 can be smoothly bent without being restrained by the marker portion 41.

Next, the usage mode of the guide wire 1 will be described. First, the guide wire 1 is inserted into the blood vessel from the tip thereof, and the guide wire 1 exposed to the outside of the body is operated to push the tip portion forward. At that time, the guide wire 1 is usually inserted into the blood vessel after intentionally bending a part of the tip portion of the guide wire 1 in advance so that the blood vessel can be easily selected, for example, at the branch portion of the blood vessel. .. Such bending may also occur at random as the guide wire 1 travels through the blood vessel.

Here, the degree of bending of the tip of the guide wire 1 differs depending on the degree of bending force. For example, when the bending force is small, as shown in FIG. 3A, only the tip end portion of the coil body 21 can be bent without bending the small diameter portion 11a of the core shaft 11. This is because the rigidity of the guide wire 1 in the long axis direction increases at the tip of the small diameter portion 11a of the core shaft 11 (the rigidity increases sharply toward the proximal end direction). When the bending force becomes large, as shown in FIG. 3B, both the tip end portion of the coil body 21 and the small diameter portion 11a of the core shaft 11 corresponding to the tip end portion can be bent. Therefore, when the bending force is small, it is possible to prevent the bending of the tip of the guide wire 1 from extending beyond the tip of the small diameter portion 11a toward the proximal end. Further, when the bending of the tip of the guide wire 1 exceeds the tip of the small diameter portion 11a, the position of the marker portion 41 is grasped under irradiation to prevent the small diameter portion 11a of the core shaft 11 from being excessively bent. can do. As a result, it is possible to prevent the core shaft 11 from being plastically deformed due to the bending of the core shaft 11 extending to the enlarged diameter portion 11k.

Next, after the tip of the guide wire 1 reaches the site to be treated, the base end of the guide wire 1 is inserted into the lumen from the tip of a medical device (not shown) such as a catheter, and the base end of the medical device is inserted. After protruding from, the medical device is pushed along the guide wire 1. Then, after reaching the site to be treated by the medical device, various treatments are performed using the medical device. Then, after the above procedure is completed, the series of procedures is completed by pulling out the medical device and the guide wire 1 from the blood vessel.

As described above, since the guide wire 1 has the above configuration, it can be visually recognized by the marker unit 41 whether or not the guide wire 1 is bent in the proximal direction beyond the tip of the core shaft 11. Therefore, it is possible to prevent the core shaft 11 from being excessively deformed (for example, plastic deformation or breakage of the core shaft 11) while observing the bent state of the small diameter portion 11a using the marker portion 41 as a clue. ..

In the first embodiment described above, the guide wire 1 having one enlarged diameter portion 11k composed of the small diameter portion 11a and the large diameter portion 11b has been described, but there may be a plurality of enlarged diameter portions. For example, it may be a guide wire 1m1 (see FIG. 4) having two enlarged diameter portions 11km11 and 11km12 and having a core shaft 11m1 in which the outer diameters of the small diameter portions 11am11 and 11am12 are changed stepwise.

[Second Embodiment]
FIG. 5 is a schematic side view showing the second embodiment. As shown in FIG. 5, the guide wire 2 is roughly composed of a core shaft 12, a coil body 21, a tip fixing portion 31, and a marker portion 41. The guide wire 2 is different from the first embodiment in that the core shaft 12 is provided. Since the configurations of the coil body 21, the tip fixing portion 31, and the marker portion 41 are the same as those of the first embodiment, the same parts are designated by the same reference numerals and detailed description thereof will be omitted. To do. Further, since the configuration of the core shaft 12 shown below is the same as that of the first embodiment, detailed description thereof will be omitted.

The core shaft 12 is a shaft having a diameter-expanded portion 12k that expands in diameter toward the base end. The shape of the enlarged diameter portion 12k of the core shaft 12 in the guide wire 2 is tapered (the enlarged diameter portion 12k is also referred to as “tapered portion 12a”). In the guide wire 2, the tapered portion 12a is provided at one position in the major axis direction of the core shaft 12, the tip of the tapered portion 12a coincides with the tip of the core shaft 12, and the base end of the tapered portion 12a has an outer diameter. It is continuous with a certain large diameter portion 12b.

The base end of the coil body 21 is joined to the tapered portion 12a of the core shaft 12 at the joining portion 21b.

As described above, in the guide wire 2, the shape of the enlarged diameter portion 12k of the core shaft 12 is tapered. Therefore, it is possible to prevent the core shaft 12 from being excessively deformed while observing the degree of bending of the marker portion 41 as a clue.

In the second embodiment described above, the guide wire 2 composed of the tapered portion 12a and the large diameter portion 12b has been described, but the guide wire 2 has a plurality of enlarged diameter portions and the outer diameter is directed toward the proximal end. It may be a guide wire having a core shaft that changes stepwise. Examples of such a guide wire include a tapered portion 12 am21 (diameter-expanded portion 12 km21) whose diameter increases in a tapered shape from the tip of the core shaft 12 m2 toward the proximal end, a small diameter portion 12 cm2 having a constant outer diameter, and a tapered portion. Examples thereof include a guide wire 2m2 (see FIG. 6) having a core shaft 12m2 composed of a tapered portion 12am22 (diameter expanding portion 12km22) for expanding the diameter and a large diameter portion 12bm2 having a constant outer diameter.

[Third Embodiment]
FIG. 7 is a schematic side view showing a third embodiment. As shown in FIG. 7, the guide wire 3 is roughly composed of a core shaft 12, a coil body 21, an inner coil body 51, a tip fixing portion 31, and a marker portion 43. The guide wire 3 is different from the second embodiment in that it includes an inner coil body 51 and a marker portion 43. Since the configurations of the core shaft 12, the coil body 21, and the tip fixing portion 31 are the same as those of the second embodiment, the same parts are designated by the same reference numerals and detailed description thereof will be omitted. To do. Further, since the configurations of the inner coil body 51 and the marker portion 43 shown below are the same as those of the second embodiment, detailed description thereof will be omitted.

The inner coil body 51 is a coil-shaped (spiral-shaped) member provided inside the coil body 21 and arranged so as to cover at least the tip of the core shaft 12. The inner coil body 51 is, for example, one formed by winding a wire 51a into a coil shape (see FIG. 7), one formed by slitting a cylindrical member or the like (not shown), and the like. Can be adopted. When the wire 51a is used for the inner coil body 51, one or a plurality of single wires, or one or a plurality of stranded wires can be used as the wire 51a.

The diameter of the wire 51a (single wire or stranded wire) constituting the inner coil body 51 is usually 0.01 to 0.10 mm.

As the wire rod constituting the inner coil body 51, for example, the same material as the coil body 21 described above is adopted from the viewpoint of ensuring the flexibility of the guide wire 3 and imparting antithrombotic property and biocompatibility. be able to.

The base end of the inner coil body 51 can be joined to the enlarged diameter portion 12k (tapered portion 12a) of the core shaft 12 at the joining portion 51b, for example. On the other hand, the tip of the inner coil body 51 can be joined to, for example, the tip fixing portion 31.

The marker portion 43 is a radiation opaque member arranged at the tip of the core shaft 12. The marker portion 43 is arranged so as to be separated from the tip fixing portion 31 in the long axis direction of the core shaft 12. The shape of the marker portion 43 in the guide wire 3 is a substantially 1/4 spherical shape. One plane 43a of the two planes forming the substantially 1/4 spherical shape is joined to the tip of the core shaft 12, and the other plane 43b is arranged so as to be in contact with the inner circumference of the inner coil body 51.

As described above, since the marker portion 43 of the guide wire 3 has a substantially 1/4 spherical shape, the guide wire can be brought into contact with the inner circumference of the inner coil body 51 by the other plane 43b described above. Directivity (the coil body 21 and the inner coil body 51 can be easily bent toward the side along the curved surface 43c of the marker portion 43) can be imparted in the bending direction of 3. Further, since the guide wire 3 includes the inner coil body 51, the rigidity change of the guide wire 3 in the long axis direction can be formed in more stages.

It should be noted that the present invention is not limited to the configuration of the above-described embodiment, but is indicated by the scope of claims, and is intended to include all modifications within the meaning and scope equivalent to the scope of claims. Will be done.

For example, in the above-described embodiment, the guide wires 1 to 3 having the diameter-expanded portions 11k and 12k in which the core shafts 11 and 12 unilaterally expand in diameter from the tip end toward the proximal end direction have been described, but the effect of the present invention has been described. A guide wire having a portion of the core shaft whose diameter is reduced toward the proximal end may be used as long as the above is not impaired.

Further, the inner coil body 51 described above in the third embodiment is an arbitrary component. Although not shown, the present invention is, for example, a guide wire having no inner coil body 51, or a guide wire having the guide wires 1 and 2 of the first and second embodiments further provided with an inner coil body. You may.

1 to 3, 1m1, 2m2 Guide wire 11, 12, 11m1, 12m2 Core shaft 11k, 12k, 11km11, 11km12, 12km21, 12km22 Enlarged part 21 Coil body 31 Tip fixing part 41, 411, 412, 413, 43 Marker part

Claims (5)

A core shaft having a diameter-expanded portion that expands toward the base end,
A coil body arranged so as to cover at least the tip of the core shaft,
The tip fixing portion fixed to the tip of the coil body and the tip fixing portion
A radiation-impermeable marker portion arranged at the tip of the core shaft is provided.
A guide wire in which the marker portion and the tip fixing portion are separated from each other in the long axis direction of the core shaft. The guide wire according to claim 1, wherein the tip shape of the marker portion is a curved surface shape that protrudes toward the tip direction. The guide wire according to claim 1 or 2, wherein the coil body is not fixed to the marker portion. The guide wire according to any one of claims 1 to 3, wherein the coil body is not fixed to the tip of the core shaft and is fixed to a portion other than the tip of the core shaft. The guide wire according to any one of claims 1 to 4, wherein the shape of the enlarged diameter portion is tapered or stepped.

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