JPH0199571A - Guide wire - Google Patents

Abstract

PURPOSE:To enable sure and easy introduction of a catheter or the like in body cavities at specified regions, by forming a guide wire comprising the main body of relatively high rigidity and the tip of relative flexibility out of an amorphous metal at least in part of the main body and of the tip. CONSTITUTION:A guide wire 10 is inserted into a blood vessel 100 to introduce catheter 101 into the blood vessel 100 at a specified region 102. Hereupon, the guide wire 10 is formed out of an amorphous metal in both the main body 11 and the tip 12. An amorphous metal is stronger than a piano wire in tensile strength nearly by 30%, maintains an elongation of the same or more, and shows a wide elastic deformational region; therefore, the metal is sticky, flexible, and restorable. Another merit of an amorphous metal is high rigidity and good transmission of torque. Accordingly, the main body 11 of the guide wire 10 can be imported with stickiness to allow little buckling, with high transmission of torque, and with high restorability. As a result, insertion of guide wire 10 into blood vessels and fitting of a catheter or the like on the guide wire 10 can be executed surely and smoothly.

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 is inserted percutaneously into a blood vessel using an introducer needle, etc., as is typical when an angiography catheter is placed in a predetermined blood vessel site, and the catheter is inserted into the end of the main body of the guide wire outside the body. It is often used to insert a catheter into a blood vessel by inserting a crown through the tip opening of the catheter and using a guidewire as a guide shaft. 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 flexibility so that it can be easily adapted to the shape of a tortuous blood vessel without damaging the blood vessel wall, and can 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 plastic deformation occurs when the displacement exceeds a certain level. This may cause buckling or torsional deformation, and the buckled or torsional deformed portion becomes an irreversible deformed portion, which creates a large resistance to the advancement of the catheter and causes the catheter to become unrecoverable. This causes difficulty in smooth installation and operation. In addition, when guiding a catheter with the distal end curved in advance to facilitate insertion into a predetermined vascular site, the catheter is inserted into the kite wire and straightened.
Coronary insertion resistance of the catheter against the guide wire increases,
The possibility of the buckling or torsional deformation described above increases.

Furthermore, as mentioned above, the tip of a conventional guide wire is made of a general metal material or plastic, and when the displacement exceeds a certain level, it undergoes irreversible plastic deformation, allowing the blood vessel to travel flexibly to a predetermined vascular site. impair sexuality,
In addition, even when the tip of the guidewire 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, it resists the bending stress of the catheter. There is no resistance between the guidewire tip and the blood vessel wall necessary to keep the guidewire tip in place, 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, or a large amount of procedure time. In addition, in order to prevent damage to the blood vessel wall and to prevent the blood vessel from getting caught during self-travelling, there is a guidewire whose tip has been deformed into a three-letter shape. Because it is deformed into a straight line, it does not restore to a complete three-shape within the blood vessel,
Many of them have the disadvantage that they do not fully demonstrate their initial functions.

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 reliably and easily into a predetermined site within a body cavity.

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.

It is a further object of the present invention to provide a guide wire whose tip always has adequate resilience so that the tip remains in place when guiding the catheter.

[Means for Solving the Problems] The present invention provides a guidewire having a relatively rigid body and a relatively flexible tip, in which at least a portion of the 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, etc. inserted into the main body to guide the catheter, etc., into a predetermined position inside the blood vessel, etc. 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 a tensile strength nearly 30% higher than that of piano wire, maintains an elongation equal to or higher than that, and exhibits a wider elastic deformation range, so it has strong flexibility and resilience. 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 resilience that is resistant to buckling, high torque transmittance, and restorability, and the guide wire can be easily inserted into a blood vessel or the like. A catheter or the like can be inserted into the outer surface of the guide wire 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. , it is possible to improve the indwelling property of the guide wire at the predetermined site. 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. 2 to 4 are lines II-Il in Fig. 1 to I
It is a sectional view along the V-ff line.

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

The guide wire 10 is entirely made of amorphous metal.

Combinations of elements that make up amorphous metals (alloys)
As for transition metal-metalloid system (Fe-B, Xl-P
etc.), ■Transition metal-transition metal system (Fe-Zr, Ni
-Zr, etc.), ■Transition metal-rare earth system (G.

-Cd, Ni-La, etc.), ■ Typical metal system (Mg-Z
n, Ca-4 sentence, etc.). In addition, the above ■
There are also multiple combinations of ~■. Specific examples of amorphous metals include Fe-3i-B series, Go-9i-
B series or Fe of these things,! : Partially replace Ca with each other, or Cr, Mn, No, N
It is possible to use a material in which a part of Fe or Go is replaced with various elements such as b, Ta, etc.

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 is 10% cheaper than piano wire for quenched materials and 30% for drawn materials.
It can be said to be a material with extremely high toughness because it has a high tensile strength and maintains the same or higher elongation.

Furthermore, it has been recognized that the elastic deformation region is considerably wider than that of piano wire (although the Young's modulus is 25% lower).

The outer diameter of the main body 11 of the guide wire 10 is 0.1 to 2 m.
m, more preferably set in the range of 0.45 to 1.15+a+*, and the yield stress is set to 30 to 100 kgf/am2
．． The restoring stress is preferably set in the range of 5 to 30 kgf/*m2, and the length of one main body part 11 is 10 to 30 kgf/*m2.
It is preferable to set it within a range of 0 cm.

The outer diameter of the tip portion 12 of the guide wire 10 is 0.05~!
, 5 mm, more preferably in the range of 0.1 to 0.5 mm (but not exceeding the outer diameter of the main body 11),
The yield stress is 20 to 90 kgf/mm2. Restoration stress 2~
25kgf/arm2. Bending load from 0.1 to IQgF,
The restoring load is preferably set in the range of 0.1 to 10 gf, and the length of the tip 12 is preferably set in the range of 1 to 50 cm, more preferably 2 to 30 c++.

Note that the main body portion 11 and the distal end portion 12 of the guide wire 10
It is not necessary that the restoring stress of It is preferable that the heat treatment of the main body part 11 and the tip part 12 be performed separately so that the part 12 becomes flexible.

The most distal end 14 of the distal end 12 of the guide wire 10 is rounded to prevent it from penetrating the blood vessel wall. Also,
The tapered portion 13 has a cross-sectional area from the main body portion 11 to the tip portion 1.
2, the main body part 11 and the tip part 12
The change in rigidity at the connection portion with the guide wire 10 is made gentle, thereby making it possible to prevent the guide wire 10 from bending at the connection portion.

Note that the most distal end of the distal end 12 of the guide wire 10 is not necessarily R-shaped, but may be spherical as shown at 15 in FIG. 5(A) or three-shaped as shown at 16 in FIG. 5(B). , a coiled shape as shown at 17 in FIG. 5(C), and 1 in FIG. 5(D).
It may be formed into a ring shape as shown in 8 to prevent penetration into the blood vessel wall.

Further, as shown in FIGS. 6(A) and 6(B), the guide wire 10 has its distal ends 12A and 12B curved into a predetermined shape similar to a blood vessel running or branching.
Insertion into a predetermined vascular site can be performed reliably and easily.

Further, the guide wire 10 has a distal end portion 12 that gradually becomes smaller in diameter toward the distal end portion 14.
can be made more flexible.

Further, the main body portion 11 and the distal end portion 1 of the guide wire 10
2. Which connection portion does not necessarily have to be tapered, but may have a cross-sectional shape that does not cause a significant change in cross-sectional area between the main body portion 11 and the tip portion 12; The portion 12 may have an intermediate outer diameter.

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

As shown in FIG. 14, the guide wire 10 is inserted into the blood vessel 100 by hand manipulation applied to the main body 11, and the catheter is inserted with its distal end ahead of the catheter lot inserted into the main body 11. 101 as blood vessel lO
It is possible to guide it to a predetermined region 102 inside O.

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

Therefore, the main body 11 of the guide wire 10 can be provided with a toughness that is difficult to buckle, high torque transmittance, and restorability, and can be used for insertion of the guide wire 10 into a blood vessel or the like, a catheter on the outer surface of the guide wire 10, etc. Crown insertion can be carried out reliably and smoothly.

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. Good indwelling properties can be achieved.

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

The guide wire 20 includes 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 is formed by integrating a main body side inner core portion 21A and a distal side inner core portion 21B via a tapered portion 21C. The entire guide wire is made of the same amorphous metal as the guide wire.

The covering portion 22 of the guide wire 20 includes a main body side covering portion 22A and a distal end side covering portion 22B, and includes polyethylene, polyvinyl chloride, polyester, polypropylene, polyethylene, polyvinyl chloride, polyester, polypropylene, etc.
A flexible, smooth surface with no irregularities is formed using synthetic resins such as polyamide, polyurethane, polystyrene, fluororesin, silicone rubber, or their elastomers and composite materials. The coating portion 22 is anticoagulated by coating with an anticoagulant such as heparin or urokinase, or an antithrombotic material such as silicone rubber, a block copolymer of urethane and silicone (Abcosan), or a hydroxyethyl methacrylate-styrene copolymer. It is possible to obtain low friction properties by using a resin having a low friction surface such as a fluororesin and applying a lubricating liquid such as silicone oil. In addition, the synthetic resin forming the covering portion 22 contains Ba, W, and Bi.
By mixing an X-ray contrast agent made of a single metal or a compound such as Pb, the guide wire 2 in the blood vessel can be
The position of 0 can be confirmed accurately.

The main body part 20A of the guide wire 20 has one main body side inner core part 21.
The outer diameter of A is set in the range of 0.1 to 1.9111 m, more preferably 0.35 to 1.05 mm, and the yield stress is set in the range of 30 to 100 kgf/IIv12) The restoring stress is set in the range of 5 to 3.
The outer diameter of the main body side covering portion 22A is preferably set within the range of 0.2 to 2 m+a.
, more preferably in the range of 0.45 to 1.15 mm, and the length of the main body 20A is 10 to 1.15 mm.
300CI117) range.

The distal end portion 20B of the guide wire 20 is connected to the distal inner core portion 21.
The outer diameter of B is set in the range of 0.05 to 1.5+s, more preferably 0.1 to 0.5, and the yield stress is set to 20
~90kgf/m+s2. Restoration stress of 2 to 25 kgf/
m+*2. Bending load 0.1 to togr, restoring load 0
．． It is preferable to set the diameter in the range of 1 to 10 gF. Furthermore, the outer diameter of the inner core part on the distal end side does not have to be entirely the above-mentioned size, but may be a part of it. Furthermore, the restoring stress of the main body and 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. The restoring stress of the part is large, and it is preferable to separate the heat treatment of the main body part and the tip part so that the tip part becomes flexible.It is therefore possible to increase the strength without making the wire diameter of the inner core on the tip side too thin. can. Further, the outer diameter of the distal end side covering portion 22B is preferably set in the range of 0.12 to 1.10 ml1, more preferably from 0.07 to 211-2. In addition, the outer diameter of the tip part including the covering part does not have to be all the above-mentioned dimensions, it may be a part of the outer diameter, and
The length of 0B is 1~50cm, more preferably 2~30cm
It is preferable that the outer diameter of the covering portion is set to be within a range of cm. It is also preferable that the outer diameter of the covering portion be equal to that of the tip portion and the main body portion.

Further, the covering portion 22 is usually made of the synthetic resin.
It is melt-molded in close contact with the inner core 21, and is similarly fixed to the distal end 23 and the opposite end of the guide wire 20, that is, the proximal end 26. However, when the covering part 22 is formed of a hollow tube, in addition to the embodiment in which the covering part 22 is tightly covered over the entire length, the distal end part 23 and the proximal end part 26 of the guide wire 20 or an appropriate part of the main body part can be used. , it is also preferable to fix it to the inner core 21 by adhesion or melt molding. In this case, the distal end portion 23 and the proximal end portion 26 or an appropriate portion of the main body portion are fixed to each other over approximately the entire length,
It is not bonded or fixed to the inner core 21, and therefore, when the guide wire 20 is bent, it can freely move relative to the inner core 21 without being restrained by the inner core 21. Note that the covering portion in the present invention allows for a wide variety of deformations.
A thin coating film made of the synthetic resin described above may be applied. Also in this case, preferably the covering portion is not fixed to at least the distal inner core portion 22B,
It is preferable that the distal end portion 20B of the guide wire 20 be allowed to deform 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. You can.

According to the guide wire 20, the guide wire lO
When the catheter or the like to be guided is large in diameter, by covering the inner core 21 with the covering portion 22, the catheter or the like can be reliably and easily introduced into a predetermined site within the body cavity in the same way as in the case where the catheter or the like to be guided is large diameter. In addition, the inner core 21 has a relatively small diameter, the bending rigidity is kept within a certain range, and the outer diameter corresponds to the inner diameter of the catheter to be guided. It becomes possible to expand.

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 line IX--■ in FIG. 8.

The guide wire 30 has an inner core 31 formed by integrating a main body inner core part 31A and a distal inner core part 31B, and roughly covers the entire length of the inner core 31 with a spring 32. 30A and a tip portion 30B. In addition, inner core 3
1 has a bulging portion 33 at both ends that holds the spring 32 and facilitates the guide wire 30's entry into the body cavity.
is provided by welding etc.

The inner core 31 of the guide wire 30 is substantially the same as the guide wire IO, and is formed by integrating a main body side inner core portion 31A and a distal side inner core portion 31B via a tapered portion 31C. The entire guide wire 10 is made of the same amorphous metal as the guide wire 10.

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

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 sectional view taken along the line ■--■ in FIG. 11.

The guide wire 50 is formed by integrating a main body side rod-shaped part 51 and a distal end side spring part 52 by welding or the like, and the main body part 50
A and a tip portion 50B are formed. 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 rod-shaped portion 51 of the guide wire 50 is entirely formed of the same amorphous metal as that of the guide wire 10.

According to the guide wire 50, since the main body 50A is formed of an amorphous metal, the main body 50A can be provided with resilience that is resistant to buckling, high torque transmittance, and restorability, and can be used as a guide to the inside of a blood vessel or the like. Insertion of the wire 50 and insertion of a catheter or the like onto the outer surface of the guide wire 50 can be performed 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 entire outer surface of the main body side rod-shaped portion 51, spring portion 52) and bulging portion 53 is covered with a synthetic resin coating portion 61 similar to that in the guide wire 20. be.

[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 It is made of amorphous metal, and 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 an amorphous metal, the main body can have elasticity that is resistant to buckling, high torque transmittance, and restorability, and the guide wire 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 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. , it is possible to improve the indwelling property of the guide wire at the predetermined site.

[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.
The figure is a sectional view along the ■-■ line in Figure 1, and Figure 4 is the 1Uy
Cross-sectional views along the rtr-IV line of J, FIGS. 5(A) to (D
) is a front view showing the shape of the distal end of a guidewire according to a modification of the present invention, FIGS. 6(A) and 6(B) are front views showing the shape of the distal end of a guidewire according to a modification of the present invention, FIG. 7 is a front view showing a guide wire according to a second embodiment of the present invention, FIG. 8 is a front view showing a guide wire according to a third embodiment of the present invention, and FIG. 9 is a front view showing a guide wire according to a third embodiment of the present invention. 10 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 sectional view taken along line IX. is ■- in Figure 11
FIG. 13 is a cross-sectional view taken along the countersunk line, 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. DESCRIPTION OF SYMBOLS 10... Guide wire, 11... Main body part, 12... Tip part, 13... Taper part, 20... Guide wire, 20A... Main body part, 20B... Tip part, 21 ... Inner core, 21A... Main body side inner core part, 21B... Distal 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, 31B... Tip side inner core part, 31C... Taper part. 40... 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 .

Claims (10)

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