JPH0315914B2 - - Google Patents

Description

Detailed Description of the Invention [Industrial Application Field] The present invention relates to a guide wire that can guide medical instruments such as catheters, and the present invention relates to guide wires that can guide medical instruments such as catheters. The present invention also relates to a guide wire that can be introduced and placed in a predetermined site within a body cavity.

[Prior Art] Conventionally, a coiled guidewire made of stainless steel wire or piano wire, or a monofilament-shaped guidewire made of plastic has been used as a guidewire. All of the conventional guide wires mentioned above have a general metal material, such as stainless steel wire or piano wire, whose cross-sectional area gradually decreases from the main body toward the distal end in a part or the entire length of the guide wire. It has a main body with high rigidity and a relatively flexible tip.

The above-mentioned guide wire can be used to
It is inserted percutaneously into a blood vessel using an introducer needle, etc., and the tip opening of the catheter is inserted into the end of the main body of the guidewire located outside the body, and the catheter is used to insert the catheter into the blood vessel using the guidewire as a guide shaft. There are many things. Therefore, the main body portion of the guide wire is designed to be able to be smoothly inserted into a blood vessel against the resistance that occurs between the outer surface of the guide wire and the tissue, and to avoid the resistance that occurs between the outer surface of the guide wire and the inner surface of the catheter. It has a certain degree of rigidity to allow the catheter to be guided against resistance.

In addition, after the catheter is inserted into the blood vessel together with the guide wire, the distal end of the guide wire, which protrudes by a predetermined length from the distal opening of the catheter, is further inserted into the blood vessel in order to reach a predetermined vascular site. We need to get ahead and push forward. Therefore, the tip of a conventional guide wire is required to have good shape adaptability even in a tortuous blood vessel without damaging the blood vessel wall, and to be flexible enough to be inserted into complicated blood vessel branches.

[Problems to be Solved by the Invention] However, as mentioned above, the main body of the conventional guide wire is formed of a general metal material, and it undergoes plastic deformation when the displacement exceeds a certain level. can cause the guidewire to buckle or torsion, creating an irreversible deformation in the buckled or torsional region that creates significant resistance to catheter advancement. This makes it difficult to smoothly introduce the catheter. In addition, when guiding a catheter with the distal end curved in advance to facilitate insertion into a predetermined blood vessel site, the catheter is inserted into the guide wire and straightened, so the guide The resistance of the catheter to the wire when inserted into the crown increases, increasing the possibility that the buckling or torsional deformation described above will occur.

Additionally, as previously mentioned, conventional guidewires
The distal end portion is made of a general metal material or plastic, and if the displacement exceeds a certain level, irreversible plastic deformation occurs, impairing flexible blood vessel running to a predetermined blood vessel site. In addition, even if the tip of the guide wire reaches the specified blood vessel site, the tip has reduced rebound resilience due to plastic deformation, so when the tip of the catheter is advanced, bending stress on the catheter There is no resistance between the guidewire tip and the vessel wall necessary to keep the guidewire tip in place against the vascular site, and as a result, the guidewire tip is pulled out of the predetermined vascular site. This often results in failure to place the device in the appropriate location, and a large amount of procedure time. Also,
In order to prevent damage to the blood vessel wall and snags while running inside the blood vessel, some guidewires have their tips deformed into a J-shape, but the tips of these guidewires always remain straight when passing through the introducer needle. Many of them have the disadvantage that they do not restore to a perfect J-shape within the blood vessel and do not fully demonstrate their initial function.

SUMMARY OF THE INVENTION An object of the present invention is to provide a guide wire that allows a medical device such as a catheter to be introduced into a predetermined site within a body cavity reliably and easily.

More specifically, the object is to provide a guidewire whose main body does not buckle or twist during insertion and crown insertion.

Furthermore, it is an object of the present invention to provide a guide wire that can be restored to its original state even if it is buckled or torsionally deformed, and that does not affect insertion and crown insertion resistance.

A further object of the present invention is to provide a guidewire whose distal end has the flexibility to be inserted into complicated blood vessels and has good resilience against deformation.

Furthermore, the tip always has a moderate repulsion elasticity,
It is an object of the present invention to provide a guide wire whose tip remains in place when guiding the catheter.

[Means for Solving the Problems] The present invention provides a guidewire having a relatively rigid main body and a relatively flexible tip, in which at least a portion of the main body and the tip are made of amorphous metal. It was formed by

[Operation] A guide wire is inserted into a blood vessel or the like by hand manipulation applied to its main body, and its distal end is placed in front of a catheter inserted into the main body to guide the catheter or the like into a predetermined position inside the blood vessel or the like. This allows for guidance to the site.

Here, in the guide wire of the present invention, at least a portion of the main body portion and the distal end portion are formed of amorphous metal. Amorphous metal has nearly 30% higher tensile strength than piano wire, maintains elongation equal to or higher than that, and exhibits a wider range of elastic deformation, making it strong, flexible, and resilient. In addition, amorphous metal has high rigidity and good torque transmittance.

Therefore, when the main body of the guide wire is made of amorphous metal, the main body can be provided with a toughness that is resistant to buckling, high torque transmittance, and restorability, and can be used as a guide wire inside a blood vessel or the like. Insertion of the wire and insertion of a catheter or the like onto the outer surface of the guide wire can be carried out reliably and smoothly.

Furthermore, when the distal end of the guidewire is made of amorphous metal, the distal end can be provided with high flexibility and resilience, and the guidewire can be easily run to a predetermined site inside a blood vessel or the like. This makes it possible to improve the placement of the guide wire in the predetermined region. Here, the amorphous metal refers to a non-crystalline metal whose constituent atoms are arranged irregularly.

[Example] Fig. 1 is a front view showing a guide wire according to a first embodiment of the present invention, and Figs.
FIG. 3 is a cross-sectional view taken along line - -.

The guide wire 10 has a relatively rigid rod-shaped main body portion 11 and a relatively flexible rod-shaped tip portion 12, and has a tapered portion 13 between the two.

The guide wire 10 is entirely made of amorphous metal.

The combination of elements (alloy system) constituting amorphous metals is transition metal-metalloid system (Fe
-B, Ni-P, etc.), transition metal-transition metal system (Fe
−Zr, Ni−Zr, etc.), transition metals−rare earths (Co
−Gd, Ni−La, etc.), typical metals (Mg−Zn,
Ca-Al, etc.). In addition, above ~
There are also multiple combinations of these. Specific examples of amorphous metals include Fe-Si-B system, Co-Si
- B series or those in which Fe and Co are partially replaced with each other, or Cr, Mn, Mo,
It is possible to use a material in which Fe and Co are partially replaced with various elements such as Nb and Ta.

Table 1 shows the mechanical properties and other physical constants of amorphous metal in comparison with piano wire, which is the strongest of existing thin metal wires. The first characteristic is that amorphous metal has a tensile strength that is 10% higher in quenched materials and nearly 30% higher in drawn wire than piano wire, and maintains the same or higher elongation.
It can be said to be a material with extremely high toughness. Furthermore, it has been recognized that the elastic deformation region is considerably wider than that of piano wire (although Young's modulus is 25% lower).

The outer diameter of the main body 11 of the guide wire 10 is 0.1
2 mm, more preferably 0.45 to 1.15 mm, yield stress to 30 to 100 Kgf/mm ² , and restoring stress to 5 to 30 Kgf/mm ² . Further, the length of the main body portion 11 is preferably set in a range of 10 to 300 cm.

The outer diameter of the tip 12 of the guide wire 10 is 0.05
~1.5mm, more preferably 0.1~0.5mm (but not exceeding the outer diameter of the main body 11),
Yield stress 20~90Kgf/mm ² , restoring stress 2~25Kg
f/mm ² , bending load 0.1 to 10gf, restoring load 0.1
It is preferable to set it in the range of ~10gf. Further, the length of the tip portion 12 is 1 to 50 cm, more preferably,
It is best to set the distance between 2 and 30 cm.

Note that the restoring stresses of the main body portion 11 and the tip portion 12 of the guide wire 10 do not need to have the same value; rather, it is preferable to change them depending on the heat treatment conditions so as to obtain appropriate physical properties at an appropriate wire diameter. That is, the restoring stress of the main body part 11 is large, and the distal end part 12 is made flexible so that the main body part 1
It is preferable that the heat treatment of the tip portion 1 and the tip portion 12 be performed separately.

The most distal end 14 of the distal end 12 of the guidewire 10
is rounded to prevent penetration into the blood vessel wall. In addition, the tapered portion 13 has a cross-sectional area that is continuously reduced from the main body portion 11 toward the distal end portion 12, so that the change in rigidity at the connection portion between the main body portion 11 and the distal end portion 12 is gradual, and the connection This makes it possible to prevent the guide wire 10 from bending at the portion.

Note that the distal end of the distal end 12 of the guide wire 10 is not necessarily R-shaped, but has a spherical shape as shown at 15 in FIG. 5A, and a J shape as shown at 16 in FIG. 5B.
Even if it is possible to prevent penetration into the blood vessel wall by forming it into a letter shape, a coil shape as shown at 17 in Figure 5C, a ring shape as shown at 18 in Figure 5D, etc. good.

In addition, as shown in FIGS. 6A and 6B, the guide wire 10 can be inserted into a predetermined blood vessel site by bending its distal end portions 12A and 12B into a predetermined shape similar to blood vessel running and branching. can be carried out reliably and easily.

In addition, the guide wire 10 can be made more flexible by gradually tapering the distal end 12 toward the most distal end 14 .

Further, the connecting portion between the main body 11 and the distal end 12 of the guide wire 10 is not necessarily tapered, but has a cross-sectional shape that does not cause a significant change in cross-sectional area between the main body 11 and the distal end 12. It is sufficient if the body part 11 and the tip part 1
It may have an outer diameter intermediate between the two.

Next, the operation of the first embodiment will be explained.

The guide wire 10, as shown in FIG.
The blood vessel 10 is
0, and its tip is inserted into the main body 11.
This allows the catheter 101 to be guided to a predetermined site 102 inside the blood vessel 100 before the catheter 101 inserted into the blood vessel 100 .

Here, the guide wire 10 has both a main body portion 11 and a distal end portion 12 made of amorphous metal. Amorphous metal has nearly 30% higher tensile strength than piano wire, maintains elongation equal to or higher than that, and exhibits a wider range of elastic deformation, making it strong, flexible, and resilient. In addition, amorphous metal has high rigidity and good torque transmittance.

Therefore, the main body 11 of the guide wire 10
The guide wire 10 can be provided with toughness that is resistant to buckling, high torque transmittance, and restorability, and can be used to insert the guide wire 10 into a blood vessel or the like.
It is possible to reliably and smoothly insert a catheter or the like into the outer surface of the crown.

In addition, the distal end portion 12 of the guide wire 10 can have high flexibility and restorability, and allows the guide wire 10 to travel easily to a predetermined site inside a blood vessel or the like.
The indwelling property of 0 can be made good.

FIG. 7 is a front view showing a guide wire according to a second embodiment of the present invention.

The guide wire 20 consists of an inner core 21 and a covering portion 22, forming a main body portion 20A and a distal end portion 20B.

The inner core 21 of the guide wire 20 is substantially the same as the guide wire 10, and has a main body inner core part 21A and a distal inner core part 21B in a tapered part 2.
1C, and the entire guide wire is made of the same amorphous metal as the guide wire.

Further, the covering portion 22 of the guide wire 20 is
It consists of a main body side covering part 22A and a tip side covering part 22B, and is made of synthetic resin such as polyethylene, polyvinyl chloride, polyester, polypropylene, polyamide, polyurethane, polystyrene, fluororesin, silicone rubber, or their elastomers and composite materials. It is flexible and forms a smooth surface with no irregularities. Note that the covering portion 22 is
Anticoagulant properties can be obtained by coating with anticoagulants such as heparin and urokinase, or antithrombotic materials such as silicone rubber, urethane and silicone block copolymers (Abcosan), and hydroxyethyl methacrylate-styrene copolymers. It is possible to obtain low friction properties by using a resin having a low friction surface such as a fluororesin and by applying a lubricant such as silicone oil. In addition, the synthetic resin forming the covering portion 22 includes Ba, W,
By mixing an X-ray contrast agent made of a single metal or a compound such as Bi or Pb, it becomes possible to accurately confirm the position of the guide wire 20 within the blood vessel.

In the main body 20A of the guide wire 20, the outer diameter of the inner core 21A on the main body side is set in the range of 0.1 to 1.9 mm, more preferably 0.35 to 1.05 mm, and the yield stress is set to 30 mm.
It is preferable to set the restoring stress to 5 to 30 Kgf/mm ^{2 .} In addition, the main body side covering part 2
The outer diameter of 2A is 0.2 to 2 mm, more preferably 0.45
It is best to set it within the range of ~1.15mm. Further, the length of the main body portion 20A is preferably set in a range of 10 to 300 cm.

The distal end portion 20B of the guide wire 20 has an outer diameter of the distal inner core portion 21B set in the range of 0.05 to 1.5 mm, more preferably 0.1 to 0.5 mm, and has a yield stress of 20 mm.
It is preferable to set ^{the restoring stress to 2 to 25 Kgf/mm 2 ,} the bending load to 0.1 to 10 gf, and the restoring load to 0.1 to 10 gf. Further, the outer diameter of the inner core part on the distal end side does not have to be entirely the above-mentioned dimension, but may be a part of the outer diameter. Furthermore, the restoring stress of the main body and the tip of the guide wire 20 does not need to have the same value, but rather it is preferable to change it depending on the heat treatment conditions so as to obtain appropriate physical properties at an appropriate wire diameter. That is, it is preferable to separate the heat treatment of the main body and the tip so that the main body has a large restoring stress and the tip becomes flexible. Therefore, the strength can be increased without making the wire diameter of the inner core on the distal end side too thin. In addition, the tip side covering portion 2
The outer diameter of 2B is 0.07 to 2 mm, more preferably,
It is preferable to set it in the range of 0.12 to 1.10 mm. Further, the outer diameter of the tip portion including the covering portion does not have to be all the above-mentioned dimensions, and may be a portion thereof. Further, the length of the tip portion 20B is 1 to 50 cm, more preferably 2 cm.
It is best to set it within a range of ~30cm. It is also preferable that the outer diameter of the covering portion be the same at the tip and the main body.

Further, the covering portion 22 is usually melt-molded from the synthetic resin so as to be in close contact with the inner core 21, and the distal end portion 23 and the guide wire 20
It is similarly fixed on the side opposite to the distal end, that is, the proximal end 26. However, when the covering part 22 is formed of a hollow tube, in addition to the form in which the covering part 22 is tightly covered over the entire length, the distal end part 2 of the guide wire 20 is
It is also preferable to fix the inner core 21 at the proximal end 26 and the inner core 21 by adhesion or melt molding.
3 and the proximal end portion 26 or a suitable portion of the main body portion are not bonded or fixed to the inner core 21 over substantially the entire length, and therefore are not restrained by the inner core 21 when the guide wire 20 is bent. Freely moves relative to the inner core 21, especially the guide wire 20
This allows flexible deformation of the distal end portion 20B.
The covering portion in the present invention may be one in which the surface of the inner core 21 is coated with a coating thin film made of the synthetic resin. Also in this case, it is preferable that the covering portion is not fixed to at least the distal inner core portion 22B, so that the distal end portion 20B of the guide wire 20 can be deformed more flexibly.

Furthermore, the inner core of the guide wire 20 is not limited to being composed of a single wire, but may be composed of a plurality of parallel or twisted wires that exhibit the above function, that is, a gradual or continuous change in physical properties. It may be hot.

According to the guide wire 20, in the same manner as in the guide wire 10, a catheter or the like can be introduced reliably and easily into a predetermined site within a body cavity, and at the same time, by covering the inner core 21 with the covering portion 22, Even when the catheter, etc. to be guided has a large diameter, the inner core 21 can be made relatively small in diameter, and the bending rigidity can be kept within a certain range to obtain an outer diameter corresponding to the inner diameter of the catheter, etc. to be guided. , it becomes possible for a catheter or the like to expand the blood vessel wall etc. smoothly and without difficulty.

FIG. 8 is a front view showing a guide wire according to a third embodiment of the present invention, and FIG. 9 is a sectional view taken along the - line in FIG. 8.

The guide wire 30 is formed by integrating a main body side inner core part 31A and a distal end side inner core part 31B to form an inner core 31, and further covering the entire length of the inner core 31 with a spring 32. and a tip portion 30B. Note that a spring 32 is held at both ends of the inner core 31, and a guide wire 30 is held at both ends of the inner core 31.
A bulging portion 33 is provided by welding or the like to facilitate the entry of the body cavity into the body cavity.

The inner core 31 of the guide wire 30 is substantially the same as the guide wire 10, and has a main body side inner core portion 31A and a distal side inner core portion 31B connected to a tapered portion 3.
1C, and is entirely made of the same amorphous metal as the guide wire 10.

According to the guide wire 30, a catheter or the like can be reliably and easily introduced into a predetermined site within a body cavity in substantially the same manner as in the guide wire 10.

FIG. 10 is a sectional view showing a guide wire according to a fourth embodiment of the present invention.

The guide wire 40 differs from the guide wire 30 in that the entire outer surfaces of the spring 32 and the bulge 33 are coated with a synthetic resin coating 41 similar to that in the guide wire 20.

FIG. 11 is a front view showing a guide wire according to a fifth embodiment of the present invention, and FIG. 12 is a front view showing a guide wire according to a fifth embodiment of the present invention, and FIG.
It is a sectional view along a line.

The guide wire 50 is formed by integrating a main body side rod-shaped portion 51 and a distal end spring portion 52 by welding or the like to form a main body portion 50A and a distal end portion 50B. Note that a bulging portion 53 is provided at the tip of the spring portion 52 by welding or the like to facilitate entry of the guide wire 50 into the body cavity.

The main body side rod-shaped portion 51 of the guide wire 50 is
The entire guide wire 10 is made of the same amorphous metal as the guide wire 10.

According to the guide wire 50, the main body 50A is made of amorphous metal;
The main body portion 50A can be provided with toughness that is resistant to buckling, high torque transmittance, and restorability, and the guide wire 50 can be inserted into a blood vessel or the like.
A catheter or the like can be inserted into the outer surface of the guide wire 50 reliably and smoothly.

FIG. 13 is a sectional view showing a sixth embodiment of the present invention.

The guide wire 60 differs from the guide wire 50 in that the main body side rod-shaped portion 51 and the spring portion 5
2. Cover the entire outer surface of the bulge 53 with the guide wire 20
The reason is that it is covered with a synthetic resin covering part 61 similar to that in .

[Effects of the Invention] As described above, the present invention provides a guidewire having a relatively rigid body portion and a relatively flexible tip portion, in which at least a portion of the body portion and the tip portion are made of amorphous metal. It was formed by Therefore, a medical device such as a catheter can be reliably and easily introduced into a predetermined site within a body cavity.

Here, when the main body of the guide wire is formed of amorphous metal, the main body can have a tenacity that is resistant to buckling, high torque transmittance, and restorability, and the guide wire can be inserted into the inside of a blood vessel or the like. and inserting a catheter, etc. into the outer surface of the guide wire can be carried out reliably and smoothly.

Furthermore, when the distal end of the guidewire is made of amorphous metal, the distal end can be provided with high flexibility and resilience, and the guidewire can be easily run to a predetermined site inside a blood vessel or the like. This makes it possible to improve the placement of the guide wire in the predetermined region.

[Brief explanation of the drawing]

FIG. 1 is a front view showing a guide wire according to a first embodiment of the present invention, FIG. 2 is a sectional view taken along the line - in FIG. 1, and FIG. 3 is a sectional view taken along the line - in FIG. FIG. 4 is a cross-sectional view taken along the - line in FIG. 1, FIGS. 5A to D are front views showing the shape of the tip end of a guidewire according to a modification of the present invention, and FIGS. 6A and B.
7 is a front view showing the shape of the tip end of a guide wire according to a modified example of the present invention, FIG. 7 is a front view showing a guide wire according to a second embodiment of the present invention, and FIG. 8 is a front view showing a third embodiment of the present invention. A front view showing a guide wire according to
Figure 9 is a sectional view taken along the - line in Figure 8;
The figure is a sectional view showing a guide wire according to a fourth embodiment of the present invention, FIG. 11 is a front view showing a guide wire according to a fifth embodiment of the present invention, and FIG. 12 is a line XII-XII in FIG. FIG. 13 is a cross-sectional view showing a sixth embodiment of the present invention, and FIG. 14 is a schematic diagram showing how the guide wire according to the present invention is used. 10... Guide wire, 11... Main body, 12
...Tip portion, 13...Tapered portion, 20...Guide wire, 20A...Body portion, 20B...Tip portion,
21...Inner core, 21A...Inner core on main body side, 21B
...Tip-side inner core part, 22... Covering part, 30... Guide wire, 30A... Main body part, 30B... Tip part, 31... Inner core, 31A... Main body-side inner core part, 3
1B...Tip side inner core part, 31C...Tapered part, 4
0... Guide wire, 41... Covering part, 50...
Guide wire, 50A... Main body part, 50B... Tip part, 51... Main body side rod-shaped part, 52... Spring part, 60... Guide wire, 61... Covering part.

【table】

Claims (1)

[Scope of Claims] 1. A guidewire having a relatively rigid main body and a relatively flexible tip, in which at least a portion of the main body and the tip are made of amorphous metal. A guide wire characterized by: 2. The guide wire according to claim 1, which is formed by integrating a main body rod-shaped portion and a distal rod-shaped portion. 3. The guide wire according to claim 1, in which the main body side inner core part and the distal end side inner core part are integrated, and the entire length including both inner core parts is covered with a spring. 4. The guide wire according to claim 1, which is formed by integrating a main body side rod-shaped part and a distal end side spring part. 5. A guidewire according to any one of claims 1 to 4, the entire length of which is coated with resin, including the main body and the distal end. 6. The guide wire according to any one of claims 1 to 5, wherein the main body is made of amorphous metal. 7. The guide wire according to any one of claims 1 to 5, wherein the distal end portion is formed of an amorphous metal. 8. The guide wire according to any one of claims 1 to 5, wherein both the main body portion and the distal end portion are formed of amorphous metal. 9. The guide wire according to any one of claims 1 to 8, wherein the cross-sectional area of at least a portion of the distal end portion is smaller than the cross-sectional area of the main body portion. 10. The guide wire according to any one of claims 1 to 9, wherein the cross-sectional area between the main body and the distal end is continuously reduced from the main body toward the distal end.