JPH0229266A - Guide wire for catheter - Google Patents

Abstract

PURPOSE:To make it possible to surely transmit a torque and to curve a catheter in any direction with a small force by providing a braid member made of a hard material having a predetermined length, in the front end part of a catheter guide wire for introducing an curing or inspecting catheter. CONSTITUTION:During medical treatment of inspection, a guide wire as a leader for introducing a catheter into a desired part of a lumen of a blood vessel or the like, is inserted into the lumen of a blood vessel or the like. In this arrangement, the front end part 21 of a braid member 2 exists by a predetermined length in the forward extending direction of a wire member, and accordingly, a front half of the braid member 2 is urged to be slightly curved prior to the insertion of the guide wire into the lament of a blood vessel or the like. Further, during the insertion, a doctor gives a slight reciprocating torque to the base end of a wire member 1. Then, the torque is surely transmitted to the braid member 2 which is then made to enter into the blood vessel while meandering so as to search the meandering part of the lumen of the vessel or the like. Thereby it is possible to curve the braid member 2 in any direction by a small force.

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Application Field 1] The present invention is for introducing a therapeutic or testing catheter into a target site in a blood vessel, gastrointestinal tract, or trachea (hereinafter referred to as "inside the lumen of a blood vessel, etc."). This invention relates to a guide wire for catheters.

[Prior Art] When performing treatment or examination of areas where surgery is difficult, a guide wire for a catheter is inserted into a catheter after a doctor or the like bends its tip slightly. The rotational force reciprocated at the proximal end of the guidewire (
The doctor inserts the tube into the lumen of a blood vessel or the like by giving it a slight twist (twisting). The operating method is as follows:
Secure another part of the lumen of a blood vessel or the like away from the target part using the Seldingo method, etc., and insert the tip of the guide wire from here to remove the meandering or narrowed part of the lumen of the blood vessel or the like. The catheter is allowed to pass through the guide wire, or the guide wire is selectively advanced in a desired direction through a branch point, and when the target site is reached, the guide wire is pulled out, leaving the catheter behind.

Further, the guide wire may be left indwelled at the target site as an aid when expanding a balloon such as an expansion catheter. Note that the treatment or examination involves performing necessary procedures such as injecting a drug solution or an X-ray contrast agent through a catheter. After the procedure, the catheter is pulled out and pressure is applied to stop bleeding.

Therefore, the tip of the guide wire enters the lumen of a blood vessel while curving, using the twisting operation at the proximal end of the guide wire and the bending habit created in advance at the tip. It is the vital part of the guide wire that plays a leading role in guiding the guide wire to the desired branch tube after it enters the branch point of the lumen of the blood vessel, etc., and it must be able to reliably transmit rotational force (torsion). , flexibility with a weak waist, and bending strength in a certain curved state,
Requires sufficient safety and reliability.

If the torsion applied to the proximal end of the guidewire is not accurately transmitted to the distal end of the guidewire, it will be difficult to selectively enter the branch point of a lumen such as a blood vessel. If there is no bending strength in a curved state, it will be difficult to enter a winding part of a lumen such as a blood vessel.

However, conventional guide wires for catheters include a metal linear body such as stainless steel or piano wire, and a stainless steel or platinum wire that covers the vicinity of the tip of the linear body or over the entire length of the linear body.

Alternatively, it was constructed from a platinum alloy coil spring.

[Problems to be Solved by the Invention] When the distal end of the guide wire is composed of a coil spring, a) the twisting operation at the proximal end of the guide wire is not accurately transmitted to the coil spring; Selective approach operation at branch points is difficult.

b) When the coil spring is curved, a large gap will be created between the composition metal wires on the outside of the curve, and if the curve is made too large due to advancement of the guide wire, #1iJl of the curved coil wire and the coil wire will easily remain. This will make it very difficult to advance the guide wire from now on.

C) Furthermore, there is a risk of breakage of the metal wire of the coil spring.

There was a drawback.

The present invention has been devised in view of the above-mentioned points, and therefore can reliably transmit rotational force, can be bent greatly in any direction with a small force, and has extremely high bending resistance when bent to the limit. An object of the present invention is to provide a guide wire for a catheter, which has a guide wire tip portion having a guide wire tip.

[Means and effects for solving the problems] As shown in FIGS. 1 to 6, the catheter guide wire of the first invention of the present application has a braided body made of a hard material having a predetermined length at least in its distal end portion. 2.

The braided body 2 has the following characteristics in comparison with conventional coil springs in terms of twisting and bending.

a) Rotational force (torsion) can be transmitted while maintaining the curved state. The torque that can be transmitted is extremely large.

Coil springs can hardly transmit rotational force.

b) Limit - When curved into a cup, it will be supported by the tensile strength of the composition metal wire on the outside of the curve, and the bending strength is extremely large.Moreover, even if the braided body 2 is curved, the composition metal wire on the outside of the curve will There are no large gaps between the lines.

Therefore, according to the catheter guide wire of the present invention, the guide wire can be inserted into the lumen of a blood vessel or the like as a guide for introducing the catheter into the target site within the lumen of the blood vessel during treatment or examination. attitude<.

In this case, since the distal end portion 21 of the assembly 2 has a required length in the direction in which the distal end of the linear body extends, the guide wire is A slight bending tendency is given to the distal half of the braided body 2, and during insertion, the doctor applies a reciprocating rotational force (torsion) to the proximal end of the guide wire, that is, the proximal end of the linear body l. Give a little.

Then, the rotational force is reliably transmitted to the braided body 2. The braided body 2 to which the rotational force is applied is entered while curving to find a tortuous state in the lumen of a blood vessel or the like, as described above.

This is because the braided body 2 can be bent greatly in any direction with a small force, and can be easily restored when a bending force opposite to the bending direction is applied from the inner wall of the lumen of a blood vessel or the like as the guide wire advances. be.

In order to make the braided body 2 enter a desired branched pipe beyond the time when it enters a branching point of a lumen such as a blood vessel, the braided body 2 is externally observed using an X-ray contrast device, and the guide wire The proximal end of the braided body 2 is twisted by a required angle, and the bent side of the distal half of the braided body 2, which has been applied in advance when inserting the guide wire, is shifted in the direction of rotation with respect to the wire axis.
Point the tip of the guide wire in the direction of the desired branch tube and continue advancing the guide wire.

According to the present invention, it is easy and convenient to orient the tip of the two braided bodies 2 in the direction of a desired branch pipe, since rotational force can be reliably transmitted while the braided body 2 maintains its curved state as described above. can be done.

As shown in FIGS. 4 to 6, the catheter guide wire of the second invention of the present application includes a proximal core 111 and a distal core 112 that are formed separately. It is characterized in that it is provided with a connecting body 113 that connects the two by continuously covering the outer surface of the portion where the distal core 112 and the distal core 112 are connected.

The connecting body 113 includes a proximal core 111 and a distal core 112.
The proximal core 111 and the distal core 1
12 connections can be strongly secured.

Since the proximal core 111 and the distal core 112 are formed as separate bodies, the proximal core 111 can be made of, for example, a linear body with high tension to ensure the strength of the waist. However, by selecting a different material for the distal core 112, it is possible to ensure appropriate flexibility and weak stiffness at the distal end of the guidewire. Therefore, while the proximal core 111 can reliably transmit rotational force, the distal core 112 It can be bent to a large extent in any direction with a small amount of force, and it can ensure extremely high bending strength when bent to the limit.

As shown in FIGS. 4 and 5, the catheter guide wire of the third invention of the present application includes a proximal core 111 and a distal core 1 that are formed separately.
12, the proximal core 111 and the distal core 11.
A connecting body 113 is provided on the outer surface of the part where the two are connected to each other to connect the two by continuously coating the two, and a cylindrical braid made of a hard material with a predetermined length is provided at least at the distal end of the distal end core 112. The feature is that the body 2 is covered.

Since the configuration is a combination of the L-th invention and the above-mentioned second invention, the effects are also combined.

As shown in FIG. 6, the catheter guide wire of the fourth invention of the present application includes a proximal core 111 and a distal core 1 that are formed separately.
12, the proximal core 111 and the distal core 11.
A connecting body 113 is provided on the outer surface of the part where 2 and 2 are connected to each other to connect the two by continuously covering them, and a coil spring 2a of a predetermined length covers at least the tip portion of the tip side core 112. It is characterized by:

The effect is similar to that of the third invention.

[Example] The catheter guide wire of the present invention is shown as an example in FIGS. 1 to 6, respectively.

The embodiments shown in FIGS. 1 to 3 are examples of the first invention of the present application, and the embodiments shown in FIGS. 4 and 5 are common implementations of the first to third inventions of the present application. This is to show an example, and the embodiment shown in FIG. 6 shows an embodiment common to the first, second, and fourth inventions of the present application.

First, in the first embodiment shown in FIG. 1, a linear body 1 made of high-strength metal and an ultra-fine X-ray opaque metal wire are woven into a cylindrical shape, and the tip of the linear body 1 is woven from one end. Braided body 2 that covers the sides or the entire length and is fixed
The tip part 21 of the braided body 2 is formed into a smooth convex shape by heating and melting an ultra-fine metal wire that extends for a required length in the direction of extension of the tip of the linear body and forming the braided body 2. It is formed into a head piece shape having a curved surface 21a.

After fitting the braided body 2 woven into a cylindrical shape from ultra-fine X-ray opaque metal wire onto the tip 1a of the linear body l made of high-tensile strength metal, the brazing material 3 is infiltrated into the fitted part. The tips 21 of the braided body 2 are formed into a head piece shape having a smooth convex curved surface 21a by heating and melting the ultra-fine metal wires constituting the braided body 2, and at least The outer surface of the linear body 1 or the linear body 1 and the braided body 2 is coated with a synthetic resin film 4, and if necessary, a lubricating agent (no code) is coated on the outer surface of the synthetic resin. ing.

More specifically, the linear body 1 is made of stainless steel (preferably high-strength stainless steel for springs), piano wire (preferably nickel-plated or chrome-plated piano wire), or superelastic alloy (preferably).

Ni-Ti alloy, Cu-Al-Ni alloy, Cu-
It is a high-tensile metal wire made of (Zn-Al alloy) with a perfect circle in cross section, and is especially straight-processed, and its diameter and length vary depending on the purpose.

The diameter d is 0.2~t, 8mm (preferably 0.
25~1.01m), and the length of sentences is 30~3,
500 (preferably 50 to 3,000).

The purpose of performing the straightening process on the linear body 1 is to prevent the linear body 1 from bending easily, and also to prevent the tip of the braided body 2 from being inserted into the lumen of a blood vessel or the like when inserting the guide wire. This is to enable accurate transmission of operations performed at the proximal end of the guide wire (hand operation) to the distal end when manipulating the guide wire in the desired direction, pushing it in, or rotating it. This is to facilitate insertion.

The synthetic resin film 4 covering the linear body 1 or the linear body 1 and the braided body 2 is made of a thermoplastic synthetic resin (for example, fluororesin, thermoplastic polyurethane), and is, for example, dipping (resin liquid immersion and pulling up) A film can be formed to a uniform desired thickness by the method (method). In addition, in the case of materials other than fluororesin, it is preferable to coat the surface of the synthetic resin film 4 with a lubricity imparting agent in order to improve the slipperiness on the surface. The agent is, for example, a hydrophilic polymer substance or a derivative thereof that becomes slimy when it comes into contact with water, has a thickness of several microns to several hundred microns, and can reduce frictional resistance with the inner surface of the catheter or the wall of the blood vessel. . In this case, the synthetic resin II! J4 is selected from a substance having a reactive functional group, and the lubricity imparting agent is selected from a substance covalently bonded to the reactive functional group, thereby making it impossible for the lubricity imparting agent to separate or flow out. preferred for.

The braided body 2 has a diameter of several microns to several tens of microns.
Using a large number of ultra-fine X-ray opaque metal wires of one or several types of metal wires such as T, Pt alloy, Ag, Ag alloy, W, W alloy, or stainless steel, the outer diameter is approximately the same as the diameter of the linear body 1. It is woven into a cylindrical shape using a special machine so that it is even.

- The assembly 2 has a required length in the extending direction of the distal end of the linear body 1, and the length is preferably 0≦50 (m).

The convex curved surface 21a is not limited to a hemispherical surface, and may be in the shape of a bell or a bullet, as long as it smoothly closes the tip of the cylindrical braided body 2. The convex curved surface 21a is formed, for example, into a hemispherical shape, a bell shape, or a bullet shape by instantaneously melting the tip of the assembly 2 using a heating device and by the surface tension of the melted metal.

The braided body 2 has a distal end 21 that extends for a required length in the direction of extension of the distal end of the linear body, and is made by heating and melting an ultra-fine metal wire constituting the braided body 2 to form a smooth convex curved surface 21a. Since it is shaped like a head piece, it can be inserted into the lumen of a blood vessel or the like without damaging the wall of the blood vessel while curving to find the tortuous state of the lumen.

In the second embodiment shown in FIG. 2, the braided body 2 covers the entire length of the linear body 1, and the distal end portion 21 of the braided body 2 extends a required length in the direction in which the distal end of the linear body extends. Brazing material (no reference numeral) is infiltrated over the entire length of the linear body 1 or in spots to fix the braided body 2 to the linear body 1, and a synthetic resin film 4 is formed on the outside of the braided body 2. Furthermore, if necessary, the outer surface of the braided body 2 except for the tip part is coated with a lubricity imparting agent (no code).
This is different from the first embodiment described above. Note that the base end of the braided body 2 is heated and melted to cover and close the linear body 1 similarly to the distal end portion 21 .

In the third embodiment shown in FIG. 3, the distal end side 11 of the linear body 1 is passed inside the braided body 2 in a tapered shape that becomes smaller in diameter toward the distal end, and the braided body 2 has a convex curved surface 21a. Tip part 21 formed into a head piece shape
This is different from the first embodiment in that the wire body 1 extends close to the braided body 2 in that the distal end portion 1a of the distal end side 11 of the linear body 1 is fixed to the braided body 2 by penetrating the brazing material 5.

Note that, in this case, the tip end la on the tip side 11 of the linear body 1 extends to the tip end 21 of the braided body 2.

When processing the tip portion 21 into a convex shape, it may be melted and connected at the same time.

The distal end 11 of the filamentous body 1 is fixed inside the braided body 2 through the distal end thereof, so that the braided body 2 preferably has a moderate stiffness (straightness restorability). This is to have it. When the distal end portion 1a of the distal end side 11 terminates before the distal end portion 21 of the braided body 2, this is done in order to make it easier for the doctor to bend the distal end of the braided body 2 in advance when inserting the guide wire. be. And the tip side of the linear body l! The reason why the guidewire 1 is tapered to become smaller in diameter toward the tip is to increase the flexibility toward the tip of the guidewire. This is because it is preferable to enter along the winding inside the lumen of a blood vessel or the like.

In the fourth embodiment shown in FIG. 4, a linear body 1 made of high-strength metal and an ultra-fine X-ray opaque metal wire are woven into a cylindrical shape, and from one end to the tip side of the linear body 1. It consists of a braided body 2 that covers and is fixed, and a linear body l has approximately the same diameter and a proximal core (core material) 111 and a distal core 112 that are made of different metal materials. It has a coaxial multi-layer structure in which the distal core 112 is connected to the distal core +12 by a connecting body 113 made of a metal material different from these cores so as to enclose all of the distal core +12 and a part of the distal core +12. A part of the taper that becomes smaller in diameter toward the inside of the braided body 2 is passed through the convex curved surface 2 of the braided body
1a, and extends to or near the tip 21 formed in the shape of a head piece, and when the tip side 112a terminates before the tip 21 of the braided body 2, the tip side of the linear body 1 The tip end 112a of the core 112 is fixed to the braided body 2 through penetration of the brazing material 5.

The proximal core 111 is made of high-tensile stainless steel or piano wire to ensure the strength of the linear body 1 (ability to push the guide wire and torque transmission to the distal core 112). The distal end core 112 employs a Mi elastic alloy to ensure not only the flexibility of the braided body 2 at the distal end of the guide wire but also its weak stiffness. Suitable examples of the superelastic alloy include old-Ti alloy, Cu-Al-Ni alloy, and Cu-Zn-Al alloy.

Proximal core 111 and distal core 11 by connecting body 113
The crimp-bonded coating structure of No. 2 is used because it is difficult to connect the proximal core 111 and the distal core 112 by methods such as soldering, brazing, or welding. In other words, compared to the elastic elongation of normal metals, which is about 2%, superelastic alloys have an extremely high elastic elongation (6 to 6% for old i-based alloys).
8%), it is practically difficult to weld or braze with dissimilar metals, and even if welding or brazing is possible, the superelastic properties are lost due to the heat of welding or brazing. Therefore, high joint strength and superelasticity can be ensured by crimp-coating the end of the superelastic alloy with a stainless steel tube.

The connecting body 113 includes a proximal core 111 and a distal core 112.
The connecting body 113 is preferably made of stainless steel or the like.The connecting body 113 is preferably made of stainless steel or the like.

The production of the linear body 1 consisting of the proximal core 111, the distal core 112, and the connecting body 113 involves inserting a stainless steel wire as the proximal core 111 and a stainless steel wire as the distal core 111 within the inner diameter of the stainless steel pipe for the connecting body 113. After inserting a superelastic alloy as the core 112 to create a coaxial structure, (for example, insert the proximal core 111 into the inner diameter of a stainless steel pipe with an outer diameter of 0.5 ms and an inner diameter of 0.4 mm corresponding to the connecting body 113. 0.25m
The outer diameter of the stainless steel wire and the distal core 112 is 0.
After inserting the 25H superelastic alloy), the proximal core 111
The material is passed through a die from the side and drawn and drawn, and this process is performed in several stages to obtain the required outer diameter. Therefore, the connecting body 113 tightly adheres to the proximal core 111 and the distal core 112, and can strongly secure the connection between the proximal core 111 and the distal core 112.

The fifth embodiment shown in FIG.

Tip side core! The tip of the braided body 2 extends to the vicinity of the tip 21 of the braided body 2, as in the third embodiment shown in FIG.
This embodiment differs from the fourth embodiment shown in FIG. 4 in that the distal end portion 1a of the distal end side 11 of the linear body 1 is fixed to the braided body 2 by penetrating the brazing material 5.

The sixth embodiment shown in FIG. 6 differs from the fifth embodiment in that a coil spring 2a is used instead of the braided body.

The distal end of the distal core 112 extends to the vicinity of the distal end 21 of the coil spring 2a that covers the distal core 112, and the distal end of the distal core 112 of the linear body 1 extends to the vicinity of the distal end 21 of the coil spring 2a that covers the distal core 112. The brazing material 5 is infiltrated from the outside and fixed to the coil spring 2a.

Note that it is preferable to connect the distal end 21 of the coil spring 2a and the distal end of the distal core 112 with a safety wire, thereby suppressing elongation of the corresponding length of the coil spring 2a.

[Effects of the Invention] The catheter guide wire of the present invention described above has the following effects.

The catheter guide wire of the first invention has a braided body made of a hard material of a predetermined length at least at its distal end portion, so that the braided body has the following functions: a) ability to transmit rotational force while maintaining a curved state; and b ) It has the ability to bend greatly in any direction with a small force, and C) It has the ability to have an extremely large bending strength when curved into a cup. After giving a slight bending tendency to the side halves, rotational force ( When a doctor inserts the braided body into the lumen of a blood vessel while giving a slight twist (twist), the rotational force (twist) is reliably transmitted to the braided body, and the braided body will be able to maintain the tortuous state of the blood vessel, etc. You can approach it while curving as if looking for something. In addition, even when the 1-m braided body enters the branch point of a lumen such as a blood vessel and enters the desired branch pipe, the 1-m braided body can reliably transmit rotational force while maintaining its curved state. This can be done easily and favorably by giving a slight bend to the front half of the body.

That is, while observing the outside using an X-ray contrast device.

By twisting the base end of the linear body at a required angle, the rotational force (twisting) is reliably transmitted to the braided body, and the bending tendency of the distal half of the braided body, which has been applied in advance in response to the rotational force (twisting), is Using this, the tip of the braid can be directed very precisely toward the desired branch tube, thereby allowing the guidewire to advance into the desired branch tube.

In addition, in the catheter guide wire of the second invention, the proximal core and the distal core are abutted and the connecting portions of the two are connected in a tightly covered state by the connecting body, so that the connecting body connects the proximal core and the distal core. Strongly adheres to the side core,
A strong connection between the proximal core and the distal core can be ensured.

Since the proximal core and the distal core are formed separately, even if the proximal core is made of a linear body with high tensile strength to ensure stiffness, the distal core is By selecting a different material for the side core, the tip of the guidewire can be appropriately flexible and weak. Therefore, the proximal core can reliably transmit rotational force, and the distal core can transfer rotational force in any direction with a small force. It can also be curved to a large extent, ensuring extremely high bending strength when curved to the limit.

Furthermore, there is a catheter guide wire according to the third invention.

The proximal core and the distal core are abutted and the connecting portions of the two are tightly covered by a connecting body, and at least the distal end portion of the distal core is provided with a braided body made of a hard material of a predetermined length. In addition, the guide wire for a catheter according to the fourth aspect of the present invention is characterized in that the proximal core and the distal core are abutted, the connecting portions of the two are tightly covered by a connecting body, and at least the distal end portion of the distal core is provided with a predetermined shape. Since it is configured with a long coil spring.

By having both the effects of the first invention and the effects of the second invention described above, it is possible to provide a catheter guide wire with even better usability.

[Brief explanation of the drawing]

1 to 6 are cross-sectional views showing different embodiments of the catheter guide wire of the present invention. l... 113 ・ 2 ・ 0 2a * - Linear body.・Proximal side Fa, ＠ distal side core, ・Φ connection body. 0 braided body.・War coil spring,

Claims (5)

[Claims] (1) A guidewire for a catheter, characterized in that at least the distal end portion thereof is provided with a braided body made of a hard material having a predetermined length. (2) The braided body is a braided body of metal wire, and
The catheter guide wire according to claim 1, which has a cylindrical shape. (3) A proximal core and a distal core are formed separately, and the proximal core and the distal core are coated continuously on the outer surface of the part where they connect. A guide wire for a catheter, characterized in that it is provided with a connecting body. (4) A proximal core and a distal core are formed separately, and the proximal core and the distal core are coated continuously on the outer surface of the part where they connect. 1. A guide wire for a catheter, comprising a connecting body for connecting, and at least a distal end portion of the distal core is covered with a cylindrical braided body made of a hard material having a predetermined length. (5) A proximal core and a distal core are formed separately, and the proximal core and the distal core are coated continuously on the outer surface of the part where they connect. 1. A guide wire for a catheter, comprising a connecting body, and a coil spring of a predetermined length covering at least a distal end portion of the distal core.