CN103354753A

CN103354753A - Guide wire for medical use

Info

Publication number: CN103354753A
Application number: CN2012800080607A
Authority: CN
Inventors: 河崎浩范
Original assignee: Japan Lifeline Co Ltd
Current assignee: Japan Lifeline Co Ltd
Priority date: 2011-03-30
Filing date: 2012-01-16
Publication date: 2013-10-16
Anticipated expiration: 2032-01-16
Also published as: TW201247258A; CN103354753B; JP2012205793A; JP5605949B2; WO2012132498A1; TWI552778B; HK1188746A1

Abstract

A guide wire for medical use is provided with a coil spring (20) mounted on a distal end side small diameter part (11) of a core wire (10) formed of austenitic stainless steel with a tensile strength of 2600 to 3000 MPa. The coil spring (20) has a tip end side small diameter part (21), a first taper part (22), a middle diameter part (23), a second taper part (24) and a back end side large diameter part (25). A closely coiled portion (201) is formed by the tip end side small diameter part (21), first taper part (22), middle diameter part (23) and second taper part (24), and a loosely coiled portion (202) is formed by the back end side large diameter part (25). The tip end portion of the tip end side small diameter part (21), the back end portion of the second taper part (24) and the back end portion of the back end side large diameter part (25) are affixed to the outer periphery of the distal end side small diameter part (11) of the core wire (10). This guide wire is capable of passing through even constricted areas, has high flexural rigidity, and also has exceptional push-in properties, torque conveyance properties and shape stability properties.

Description

Guide wire for medical use

Technical field

The present invention relates to be equipped with in the periphery of the distolateral minor diameter part of amphi position of heart yearn the guide wire for medical use of disc spring.

Background technology

Be used for the pliability that seal wire that medical apparatus and instruments with conduit etc. guides to the endoceliac assigned position of blood vessel etc. requires the amphi position end.

Thus, known following seal wire, it makes the external diameter of amphi position end of heart yearn less than the external diameter of peri position end, and in the periphery of the amphi position end of heart yearn (the distolateral minor diameter part of amphi position) disc spring is installed, realize the flexual raising (for example, with reference to patent documentation 1) of amphi position end.

For the periphery of the distolateral minor diameter part of amphi position that disc spring is installed in heart yearn, usually, respectively leading section and the rearward end of disc spring are fixed on the heart yearn by scolder.

Recently, expectation realizes patient's invasive and realizes the miniaturization of medical apparatus and instruments.

Brought the requirement to the thin footpath of seal wire, the inventor has researched and developed the seal wire with external diameter (0.010 inch) thinner than in the past seal wire (external diameter is 0.014 inch) thereupon.

If adopt 0.010 inch seal wire, then can bring huge contribution to the miniaturization of the medical instruments of conduit etc.

And, according to this seal wire, for example, entering the CTO(chronic total occlusion) operability during microchannel in the pathological changes also has and becomes to a certain degree good.

But the bending rigidity (anti-kinking) of the seal wire in thin footpath is low, and embedability is also poor.

From such situation, the inventor proposes and has researched and developed a kind of seal wire, its periphery at the distolateral minor diameter part of amphi position of heart yearn is equipped with disc spring, wherein, the coil outer diameter of the front of disc spring is 0.010 inch, and the external diameter of the peri position end of the coil outer diameter of the rear end side of disc spring and heart yearn all is 0.014 inch (with reference to patent documentation 2).

The prior art document

Patent documentation

Patent documentation 1: TOHKEMY 2003-299739 communique

Patent documentation 2: No. 4354525 communique of Japan Patent

Summary of the invention

The problem that invention will solve

On the microchannel in the CTO pathological changes, there to be the position than 0.010 inch little aperture, in order in such microchannel, interting, to need further path of seal wire (coil outer diameter of disc spring).

On the other hand, in the disc spring that consists of seal wire, in the different situation of the coil outer diameter of front and rear end side, there are the following problems, that is, and and when interting the narrow positions of microchannel etc., at the part generation stress concentration that coil directly changes, kinking easily occurs in this part.In addition, have that the seal wire of the disc spring that coil outer diameter significantly changes is not talkative to have a good embedability.

In addition, seal wire requires to have good moment of torsion transitivity (being delivered to well amphi position at the distolateral rotation torque of peri position distolateral).If the moment of torsion transitivity is insufficient, then in vessel branch is selected, to the difficult that advances of the blood vessel as target, workability is inserted in infringement.

But there are the tendency of moment of torsion transitivity variation in the seal wire in thin footpath, the seal wire with disc spring that coil outer diameter significantly changes.

In addition, even seal wire requires also to be difficult to occur permanent deformation (shape retention) by in the full of twists and turns blood vessel and when crooked.When permanent deformation occurs in manual operations, by the rotation that operation is on hand carried out, can occur to rise and fall etc., after endovascular operation difficult.

The present invention makes in view of above situation.

The first purpose of the present invention provides a kind of guide wire for medical use, and the little narrow positions in the aperture that the seal wire in the past can not intert also can be interted, bending rigidity (anti-kinking) height, and embedability might as well.

The second purpose of the present invention provides a kind of guide wire for medical use, and it has good moment of torsion transitivity, even by in the full of twists and turns blood vessel, also be difficult to occur permanent deformation, shape retention is good.

Be used for solving the technical scheme of problem

(1) guide wire for medical use of the present invention is characterized in that, has:

Heart yearn, it is that the austenitic stainless steel of 2600～3000MPa consists of by hot strength, and has the distolateral large-diameter portion of peri position and the external diameter amphi position distolateral minor diameter part less than the distolateral large-diameter portion of described peri position;

Disc spring, it is installed on the periphery of the distolateral minor diameter part of amphi position of described heart yearn vertically, is fixed on the described heart yearn at leading section and rearward end at least,

Be that the periphery of the bar of 3mm is reeled under the state of a circle along diameter at the distolateral minor diameter part of the amphi position that makes the described heart yearn that is fixed with described disc spring, make the tensile load effect of 150gf after 10 seconds, the warpage angle of the fore-end that produces by reeling is less than 25 °.

(2) in guide wire for medical use of the present invention, preferably have:

Heart yearn, it is that the austenitic stainless steel of 2600～3000MPa consists of by hot strength, and to have external diameter be the distolateral large-diameter portion of peri position and the external diameter amphi position distolateral minor diameter part less than the distolateral large-diameter portion of described peri position more than 0.012 inch;

Disc spring, it is installed on the periphery of the distolateral minor diameter part of amphi position of described heart yearn vertically, and the thick volume that is divided and divide continuously with described dense curling part and had greater than 2.0 times coil-span of coil wire diameter by the dense curling part of 1.1～2.0 times coil-span with coil wire diameter partly consists of

Described disc spring has:

The front minor diameter part, it has the coil outer diameter below 0.008 inch;

Central diameter section, it has the coil outer diameter larger than the coil outer diameter of described front minor diameter part;

The rear end side large-diameter portion, it is more than 0.012 inch and has the large coil outer diameter of coil outer diameter than described central diameter section;

The first tapered portion, it is between described front minor diameter part and described central diameter section;

The second tapered portion, its between described central diameter section and described rear end side large-diameter portion,

Having consisted of length by described front minor diameter part, described the first tapered portion, described central diameter section and described the second tapered portion is that the described dense curling part of 5.5～110mm divides, and has consisted of described distant curling part by described rear end side large-diameter portion and divide,

The rear end part of the rear end part of the fore-end of described front minor diameter part, the second tapered portion and described rear end side large-diameter portion is fixed on by scolder on the periphery of the distolateral minor diameter part of amphi position of described heart yearn,

Be that the periphery of the bar of 3mm is reeled under the state of a circle along diameter at the distolateral minor diameter part of the amphi position that makes the described heart yearn that is fixed with described disc spring, make after the tensile load effect 10 seconds of 150gf, the warpage angle of the fore-end that produces by reeling [below be also referred to as " crooked custom angle (bent げ addiction angle) (θ) ")] is less than 25 °.

According to such guide wire for medical use, it is front minor diameter part below 0.008 inch that the disc spring that consists of it has coil outer diameter, thereby the little narrow positions in the aperture that the seal wire in the past can not intert also can be interted, can use the treatment of the narrow zone that seal wire in the past can not carry out (for example, the following microchannel of the 250 μ m of the aperture in the CTO pathological changes).

In addition, it is rear end side large-diameter portion more than 0.012 inch that this disc spring has coil outer diameter, and front minor diameter part, central diameter section, rear end side large-diameter portion and coil outer diameter change interimly, thereby the bending rigidity of seal wire with this disc spring is high, and embedability might as well.

In addition, the fore-end of front minor diameter part, the rear end part of the rear end part of the second tapered portion and rear end side large-diameter portion is fixed on by scolder on the periphery of the distolateral minor diameter part of amphi position of described heart yearn, thus, can reliably disc spring be fixed on the distolateral minor diameter part of amphi position of heart yearn, and front minor diameter part (except fore-end), the first tapered portion, central diameter section and the second tapered portion (except rear end part) are not fixed on the periphery of the distolateral minor diameter part of amphi position of heart yearn by scolder, thereby the front end area that can guarantee fully disc spring is the flexibility during dense curling part divides, and can also repair in this zone.

In addition, because the dense curling part that has consisted of disc spring by front minor diameter part, the first tapered portion, central diameter section and the second tapered portion divides, so be that dense curling part divides and can manifest good radiography (observability) in the front end area of disc spring.

In addition, the resistance when disc spring is inserted narrow positions is different because of coil outer diameter, thereby can follow the phasic Chang of coil outer diameter to change (sense of touch) assurance disc spring to the intubating length of narrow positions by inserting resistance.

In addition, be that the high-intensity austenitic stainless steel of 2600～3000MPa consists of heart yearn by hot strength, and be accustomed to angle (θ) less than 25 ° as the bending of seal wire, thus, this guide wire for medical use has good moment of torsion transitivity, in the time of in passing through full of twists and turns blood vessel, also is difficult to occur permanent deformation, shape retention (for example, the retentivity of finishing shape) is good.

(3) in guide wire for medical use of the present invention, the external diameter of the distolateral large-diameter portion of peri position of preferred described heart yearn is more than 0.014 inch, the coil outer diameter of the front minor diameter part of described disc spring is below 0.008 inch, the coil outer diameter of described central diameter section is 0.009～0.011 inch, and the coil outer diameter of described rear end side large-diameter portion is more than 0.014 inch.

(4) in addition, in this guide wire for medical use, the coil outer diameter of preferred described front minor diameter part is 0.5～0.9 with respect to the ratio of the coil outer diameter of described central diameter section, the length of described the first tapered portion is 0.5～10mm, the coil outer diameter of described rear end side large-diameter portion is 1.1～2.3 with respect to the ratio of the coil outer diameter of described central diameter section, and the length of described the second tapered portion is 0.5～10mm.

(5) in guide wire for medical use of the present invention, the fore-end of preferred described front minor diameter part is fixed on the described heart yearn by containing gold solder, is 0.1～0.5mm by the length that contains the hard straight part of the formed front end of gold solder.

Here, " contain gold solder " and comprise Au solder and the Au scolder of Au-Sn class scolder, Au-Ge class scolder, Au-Si class scolder, Au-In class scolder, Au-Sb class scolder etc.

In addition, " front end hard straight part " refers to the fore-end of disc spring (seal wire) that can not free bend because of the scolder that is impregnated into coil inside, in the situation that form the front end tip by scolder, this front end tip also becomes hard directly partly the part of front end.

In addition, " length of the hard straight part of front end " refers to that front end from seal wire is to axial length the rear end of the scolder that is impregnated into coil inside, seal wire.

Contain gold solder as the scolder use that is fixed on for the fore-end (leading section of disc spring) with the front minor diameter part on the heart yearn, thus, no matter whether the length of the hard straight part of front end is 0.1～0.5mm short like this (fixed area of scolder is narrow), can both obtain disc spring to the structure of the constant intensity of heart yearn fully high (fracture strength than the distolateral minor diameter part of amphi position of heart yearn is high), even to the heart yearn effect tensile force of the state that inserts disc spring, heart yearn can not be pulled out yet.

And because the length of the hard straight part of front end is that 0.1～0.5mm is short like this, so can shorten trim length (the bending length of front end) (making 0.7mm following), its result during operation in carrying out the microchannel, can reduce frictional resistance fully.

(6) in addition, in this guide wire for medical use, preferably at the front minor diameter part of described disc spring, contain gold solder and from front end, in the scope suitable with 1～4 spacing, be impregnated into coil inside.

Here, for example, from front end, in the scope suitable with 3 spacings, be impregnated into coil inside and refer to, the rear end that is impregnated into the scolder of coil inside be positioned at from front end contact with the coil of the 3rd circle and with the situation of the 4th discontiguous position of coil of enclosing.

(7) in guide wire for medical use of the present invention, preferably be filled with resin in the inside of described disc spring, and be formed with the resin bed of described resin in the periphery of described disc spring, on the surface of described resin bed, form the hydrophilic resin layer stackedly, be formed with the hydrophobic resin layer on the surface of described heart yearn.

By at the inside of disc spring potting resin, especially improved the integraty of heart yearn and disc spring, thus, can further improve moment of torsion transitivity, the operability of seal wire.

In addition, across the resin bed of the resin identical with the material that is filled into disc spring inside, form the hydrophilic resin layer in the periphery of disc spring stackedly, thus the hydrophilic resin layer can be fixed reliably, stably manifest the lubricity of hydrophilic resin.

In addition, form the hydrophobic resin layer by the surface at heart yearn, can prevent that patient's blood from causing allergy with the Metal Contact that consists of heart yearn, in addition, can prevent adhering to of Hemostatic Oral Liquid etc. reliably by the hydrophobic resin layer.In addition, can also manifest lubricity with respect to other medical apparatus and instruments.

(8) in guide wire for medical use of the present invention, preferably have:

Wherein,

The external diameter of the distolateral large-diameter portion of peri position of described heart yearn and the coil outer diameter of described disc spring all are below 0.012 inch,

The leading section of described disc spring is fixed on the described heart yearn by containing gold solder,

Length by the hard straight part of front end that contains the gold solder generation is 0.1～0.5mm,

Crooked custom angle (θ) is less than 25 °.

(9) in guide wire for medical use of the present invention, preferably have:

Disc spring, it is installed on the periphery of the distolateral minor diameter part of amphi position of described heart yearn vertically, and have front minor diameter part, rear end side large-diameter portion and a tapered portion between described front minor diameter part and described rear end side large-diameter portion that coil outer diameter is larger than described front minor diameter part, at least be fixed on the described heart yearn at leading section and rearward end

Wherein,

The length of the front minor diameter part of described disc spring is 5～100mm, and coil outer diameter is below 0.012 inch,

Crooked custom angle (θ) is less than 25 °.

The effect of invention

According to guide wire for medical use of the present invention, the little narrow positions in the aperture that the seal wire in the past can not intert also can be interted.

The bending rigidity of guide wire for medical use of the present invention (anti-kinking) height, embedability might as well.

Guide wire for medical use of the present invention has good moment of torsion transitivity, and in vessel branch was selected, the insertion workability of easily advancing to the blood vessel that becomes target was good.

Even guide wire for medical use bending of the present invention also is difficult to occur permanent deformation, shape retention is good.

Description of drawings

Fig. 1 is the side view of biopsy cavity marker devices of the first embodiment of expression seal wire of the present invention.

Fig. 2 is the side view figure of size (be used for explanation) of biopsy cavity marker devices of the first embodiment of expression seal wire of the present invention.

Fig. 3 is the partial enlarged drawing of Fig. 1, and Fig. 3 (A) is A part details drawing, and Fig. 3 (B) is B part details drawing, and Fig. 3 (C) is C part details drawing, (D) is D part details drawing.

Fig. 4 is the state of finishing has been carried out in expression to the leading section of seal wire side view.

Fig. 5 is the key diagram that the assay method of angle (θ) is accustomed in the bending of seal wire.

Fig. 6 is the side view in partial cross-section of the second embodiment of expression seal wire of the present invention.

Fig. 7 is the side view in partial cross-section (figure that is used for the explanation size) of the second embodiment of expression seal wire of the present invention.

Fig. 8 is the partial enlarged drawing of Fig. 6, and Fig. 8 (A) is A part details drawing, and Fig. 8 (B) is B part details drawing, and Fig. 8 (C) is C part details drawing.

Fig. 9 is the side view in partial cross-section of the 3rd embodiment of expression seal wire of the present invention.

Figure 10 is the side view in partial cross-section (figure that is used for the explanation size) of the 3rd embodiment of expression seal wire of the present invention.

Figure 11 is the partial enlarged drawing of Fig. 9, and Figure 11 (A) is A part details drawing, and Figure 11 (B) is B part details drawing, and Figure 11 (C) is C part details drawing.

Figure 12 is that expression is for the key diagram of the analog that the moment of torsion transitivity of seal wire is tested.

Figure 13 is the line chart of the moment of torsion transitivity of expression seal wire.

The specific embodiment

The＜the first embodiment＞

The guide wire for medical use of the present embodiment of Fig. 1～shown in Figure 3 is following guide wire for medical use, it has heart yearn 10 and disc spring 20, described heart yearn 10 is that the austenitic stainless steel of 2600～3000MPa consists of by hot strength, and to have external diameter be the distolateral large-diameter portion 13 of peri position more than 0.012 inch, the distolateral minor diameter part 11 of amphi position that external diameter is less than the distolateral large-diameter portion of peri position 13, tapered portion 12 between the distolateral large-diameter portion 13 of peri position and the distolateral minor diameter part 11 of amphi position, described disc spring 20 by on the periphery of the distolateral minor diameter part 11 of the amphi position that is installed in vertically heart yearn 10 and the dense curling part with coil-span of 1.1～2.0 times of coil wire diameter divide 201, consist of with the thick volume part 202 of dividing 201 continuously with dense curling part and have above 2.0 times coil-span of coil wire diameter.Disc spring 20 has: have the coil outer diameter (D below 0.008 inch ₂₁) front minor diameter part 21; Has the coil outer diameter (D than front minor diameter part 21 ₂₁) large coil outer diameter (D ₂₃) central diameter section 23; Have more than 0.012 inch and than the coil outer diameter (D of central diameter section 23 ₂₃) large coil outer diameter (D ₂₅) rear end side large-diameter portion 25; The first tapered portion 22 between front minor diameter part 21 and central diameter section 23; The second tapered portion 24 between central diameter section 23 and rear end side large-diameter portion 25.Consisted of length (L by front minor diameter part 21, the first tapered portion 22, central diameter section 23 and the second tapered portion 24 ₂₁+ L ₂₂+ L ₂₃+ L ₂₄) be that the dense curling part of 5.5～110mm divides 201, and consisted of distant curling part by rear end side large-diameter portion 25 and divided 202, the fore-end of front minor diameter part 21, the rear end part of the rear end part of the second tapered portion 24 and rear end side large-diameter portion 25 is respectively by Au-Sn class scolder 31, Au-Sn class scolder 32 and Ag-Sn class scolder 33 are fixed on the periphery of the distolateral minor diameter part 11 of amphi position of heart yearn 10, under the distolateral minor diameter part 11 of the amphi position of the heart yearn 10 that will be fixed with disc spring 20 is reeled a state that encloses along the periphery of the bar of diameter 3mm, make the tensile load effect of 150gf in the time of 10 seconds, the warpage angle of the fore-end that produces by reeling (permanent deformation i.e. crooked custom angle (θ)) is less than 25 °.

The seal wire of present embodiment has heart yearn 10 and disc spring 20.

Heart yearn 10 has the distolateral minor diameter part 11 of amphi position from taper to peri position direction hole enlargement ground that processed by, to tapered portion 12 and the distolateral large-diameter portion 13 of peri position of peri position direction hole enlargement.

The distolateral minor diameter part 11 of amphi position, tapered portion 12 and the distolateral large-diameter portion 13 of peri position are made of integratedly same wire rod (for example pole parts).

The cross section of the distolateral large-diameter portion 13 of tapered portion 12 and peri position is circular.

The distolateral cross section of the peri position of the distolateral minor diameter part 11 of amphi position is circular, also can become by compressed wire tabularly but the amphi position of the distolateral minor diameter part 11 of amphi position is distolateral, and the cross section in this situation is essentially rectangular.

Heart yearn 10 is high-intensity austenitic stainless steel (for example SUS304, the SUS316) formation of 2600～3000MPa by hot strength.

Because hot strength is that the elastic limit of high-intensity austenitic stainless steel of 2600～3000MPa is also high, in its seal wire as the present embodiment of heart yearn, be difficult to occur the permanent deformation that is caused by bending.

Heart yearn 10 can be made as follows, namely, wire rod to austenitic stainless steel is implemented Wire Drawing, make the wire rod with regulation wire diameter, intensity, then implemented after the straight rectification, cut into specific length and make bar, then, under 300～500 ℃ of temperature, the treatment conditions of 0.5～4 hour time, implement Ageing Treatment.

Here, " Ageing Treatment " is to remove (minimizing) to become fluctuating that residual stress in the part of the distolateral minor diameter part 11 of amphi position prevents that amphi position is distolateral etc. and implement for purpose.

In the situation that aging temperature less than 300 ℃ or greater than 500 ℃, obtains having the heart yearn 10 of the above hot strength of 2600MPa and obtains having the seal wire difficult of being accustomed to angle (θ) less than 25 ° bending.

In addition, the Ageing Treatment time just can not be removed residual stress fully less than 0.5 hour.On the other hand, even surpass 4 hours processing, can not obtain and corresponding effect of time.

Outer peripheral face at heart yearn 10 is formed with not shown hydrophobic resin layer.

As the resin that consists of the hydrophobic resin layer, adopt the resin as medical use, can use to have hydrophobic material, can enumerate the fluorine-type resin of PTFE etc. as preferred resin.

Total length (the L of seal wire shown in Figure 2 ₁) be for example 1500～3000mm, can illustration 1780mm as a preferred example.

External diameter (the D of the distolateral large-diameter portion 13 of the peri position of heart yearn 10 ₁) be more than 0.012 inch (0.305mm), be preferably more than 0.014 inch (0.356mm), can illustration 0.014 inch as a preferred example.

, be not particularly limited as long as less than the internal diameter of disc spring 20 as the maximum outside diameter of the distolateral minor diameter part 11 of amphi position, but be preferably the external diameter (D of the distolateral large-diameter portion 13 of peri position ₁) about 1/5～3/5.

The distolateral minor diameter part 11 of amphi position also can be towards front undergauge continuously, also can interim ground undergauge.

The disc spring 20 that consists of seal wire is made of 1 wire rod, and is installed in vertically the periphery of the distolateral minor diameter part 11 of amphi position of heart yearn 10.

The external diameter (coil wire diameter) that consists of the wire rod of disc spring 20 is not particularly limited, but is preferably 30～90 μ m, can enumerate 50 μ m as a preferred example.

Can enumerate the good material (not transmission of X ray material) of the radiography to X ray of platinum, White gold alloy (such as Pt/W=92/8), gold, gold-copper alloy, tungsten, tantalum etc. as the material of disc spring 20.

Disc spring 20 is made of front minor diameter part 21, the first tapered portion 22, central diameter section 23, the second tapered portion 24 and rear end side large-diameter portion 25.

The dense curling part that front minor diameter part 21, the first tapered portion 22, central diameter section 23 and the second tapered portion 24 have consisted of disc spring 20 divides 201.The dense curling part of disc spring 20 divides 201(front minor diameter part 21, the first tapered portion 22, central diameter section 23 and the second tapered portion 24) and front end described later tip become not regional transmission of X ray.

The distant curling part that rear end side large-diameter portion 25 has consisted of disc spring 20 divides 202.

It is 1.1～2.0 times of coil wire diameter that the dense curling part of front divides coil-span in 201, can enumerate 1.5 times as a preferred example.

In 1.1 times the situation of coil-span less than the coil wire diameter, damage this regional flexibility.On the other hand, surpass in 2.0 times the situation of coil wire diameter in coil-span, in this zone, can not manifest good radiography.

The distant curling part of rear end side divides coil-span in 202 greater than 2.0 times of coil wire diameter, can enumerate 3.0 times as a preferred example.

Like this, in front and rear end side, changing by making coil-span, is that dense curling part divides in 201 in front end area, can manifest good radiography (observability).

Adopt same spacing in the whole zone of disc spring in the situation that spread all over, regional transmission is not elongated owing to X ray, so cause observability to reduce.

In Fig. 2, the length (L of disc spring 20 ₂) for for example 30～800mm, be preferably 100～200mm, can enumerate 165mm as a preferred example.

Length (the L of front minor diameter part 21 ₂₁) be 0.5～100mm, be preferably 3～15mm, can enumerate 8.5mm as a preferred example.

Length (the L of the first tapered portion 22 ₂₂) be preferably 0.5～10mm, can enumerate 1.5mm as a preferred example.

Length (the L of central diameter section 23 ₂₃) be 0.5～150mm, be preferably 10～50mm, can enumerate 28.5mm as a preferred example.

Length (the L of the second tapered portion 24 ₂₄) be preferably 0.5～10mm, can enumerate 1.5mm as a preferred example.

Length (the L of rear end side large-diameter portion 25 ₂₅) be can enumerate 125mm as a preferred example by for example 85～154.5mm.

The dense curling part of disc spring 20 divides length in 201 namely from the front end of front minor diameter part 21 to the length (L the rear end of the second tapered portion 24 ₂₁+ L ₂₂+ L ₂₃+ L ₂₄) be generally 5.5～110mm, be preferably 10.5～80mm, can enumerate 40.0mm(8.5mm+1.5mm+28.5mm+1.5mm as a preferred example).

This length (L ₂₁+ L ₂₂+ L ₂₃+ L ₂₄) be more than the 5.5mm, thus, to nearly all microchannel, (running through) dense curling part from the front end of front minor diameter part 21 to the rear end of the second tapered portion 24 that can intert divides 201.

In addition, this length (L ₂₁+ L ₂₂+ L ₂₃+ L ₂₄) be below the 110mm, thus, can fully guarantee to help to improve the length (L of the rear end side large-diameter portion 25 of bending rigidity and embedability ₂₅).

Length (L from the front end of seal wire to the rear end of disc spring 20 ₃+ L ₂) be can enumerate 165.2mm(0.2mm+165mm as a preferred example by for example 30～800mm).

Length (L from the front end of seal wire to the rear end of the second tapered portion 24 ₃+ L ₂₁+ L ₂₂+ L ₂₃+ L ₂₄) be can enumerate 40.2mm(0.2mm+8.5mm+1.5mm+28.5mm+1.5mm as a preferred example by for example 10～50mm).

Coil outer diameter (D in the front minor diameter part 21 of disc spring 20 ₂₁) be generally below 0.008 inch (0.203mm), can enumerate 0.0078 inch as a preferred example.Coil outer diameter (the D of front minor diameter part 21 ₂₁) be below 0.008 inch, thus, in seal wire in the past, even in the little narrow positions in the aperture that can not intert, also can intert, also can carry out the treatment in impracticable narrow zone (for example, the following microchannel of the 250 μ m of the aperture in the CTO pathological changes) when the seal wire that uses in the past.

Coil outer diameter (D in the central diameter section 23 of disc spring 20 ₂₃) than the coil outer diameter (D in the front minor diameter part 21 ₂₁) large, be preferably 0.009～0.011 inch (0.229～0.279mm), can enumerate 0.010 inch (0.254mm) as a preferred example.

Between front minor diameter part 21 and rear end side large-diameter portion 25, there is central diameter section 23, thus, front minor diameter part 21, central diameter section 23, rear end side large-diameter portion 25 and coil outer diameter change interimly, do not have coil outer diameter part jumpy (the easily part of kinking).

Coil outer diameter (D in the rear end side large-diameter portion 25 of disc spring 20 ₂₅) than the coil outer diameter (D in the central diameter section 23 ₂₃) large, be generally more than 0.012 inch, be preferably more than 0.014 inch (0.356mm), can enumerate 0.014 inch as a preferred example.

Coil outer diameter (the D of rear end side large-diameter portion 25 ₂₅) be more than 0.012 inch, and front minor diameter part 21, central diameter section 23, rear end side large-diameter portion 25 and coil outer diameter change interimly, and thus, the bending rigidity of seal wire of present embodiment with such disc spring 20 is high, and embedability might as well.

In disc spring 20, the coil outer diameter of front minor diameter part 21 is with respect to the ratio (D of the coil outer diameter of central diameter section 23 ₂₁/ D ₂₃) be the length (L of the 0.5～0.9, first tapered portion 22 ₂₂) be preferably 0.5～10mm.

Ratio (D at coil outer diameter ₂₁/ D ₂₃) less than in 0.5 the situation, and/or in the situation of length less than 0.5mm of the first tapered portion 22, exist the bending rigidity of seal wire to reduce, kinking occurs near the first tapered portion 22, or the problem of infringement embedability.

On the other hand, at this than (D ₂₁/ D ₂₃) greater than in 0.9 the situation and/or in the situation of length greater than 10mm of the first tapered portion 22, existence can not realize the problem of the path of front minor diameter part 21 fully.

Ratio (the D of coil outer diameter ₂₁/ D ₂₃) the preferred example of conduct can enumerate 0.78(0.0078 inch/0.010 inch).

In addition, in disc spring 20, the coil outer diameter of rear end side large-diameter portion 25 is with respect to the ratio (D of the coil outer diameter of central diameter section 23 ₂₅/ D ₂₃) be the length (L of the 1.1～2.3, second tapered portion 24 ₂₄) be preferably 0.5～10mm.

At the coil outer diameter of the rear end side large-diameter portion 25 ratio (D with respect to the coil outer diameter of central diameter section 23 ₂₅/ D ₂₃) greater than in 2.3 the situation and/or in the situation of the length of the second tapered portion 24 less than 0.5mm, exist the bending rigidity of seal wire to reduce, kinking occurs near the second tapered portion 24, or the problem of infringement embedability.

On the other hand, at this than (D ₂₁/ D ₂₃) less than in 1.1 the situation and/or in the situation of length greater than 10mm of the second tapered portion 24, can not realize fully the path of central diameter section 23 and front minor diameter part 21.

Ratio (the D of coil outer diameter ₂₅/ D ₂₃) the preferred example of conduct can enumerate 1.4(0.014 inch/0.010 inch).

The rear end part of the fore-end of the front minor diameter part 21 of the disc spring 20 of the seal wire of present embodiment, the rear end part of the second tapered portion 24 and rear end side large-diameter portion 25 is fixed on respectively the periphery of the distolateral minor diameter part 11 of amphi position of heart yearn 10 by scolder.

Shown in Fig. 1 and Fig. 3 (A), the leading section of disc spring 20 is that the fore-end of front minor diameter part 21 is fixed on the heart yearn 10 by Au-Sn class scolder 31.

Namely, Au-Sn class scolder 31 is impregnated into the inside of the leading section (fore-end of front minor diameter part 21) of disc spring 20, and with the distolateral minor diameter part 11 of heart yearn 10(amphi position) periphery contact, thus, the leading section of disc spring 20 is fixed on the distolateral minor diameter part 11 of heart yearn 10(amphi position) on.

Shown in Fig. 3 (A), Au-Sn class scolder 31 is impregnated into coil inside in the scope suitable with 3 spacings of disc spring 20.

In addition, at the leading section of disc spring 20, the Au-Sn class scolder 31 of the inside by not being impregnated into disc spring 20 has formed roughly hemispheric front end tip.

Thus, leading section at the seal wire of present embodiment, be formed with by the hard straight part of Au-Sn class scolder 31 formed front ends (because of Au-Sn class 31 scolders that are impregnated into coil inside can not free bend disc spring 20(front minor diameter part 21) fore-end and the front end tip that is formed by Au-Sn class scolder 31, by the formed firmly directly part of these two parts).

The length of the hard straight part of this front end (length from the front end of seal wire to the rear end of the Au-Sn class scolder 31 that is impregnated into coil inside) (L ₄) be 0.1～0.5mm, be preferably 0.3～0.4mm.

The length of the hard straight part of front end is more than the 0.1mm, thus, can guarantee fully the bed knife of 20 pairs of heart yearns 10 of disc spring.

In addition, the length of the hard straight part of front end is below the 0.5mm, thus, can make trim length (length of outer side (L described later ₅₂)) be below the 0.7mm.

In the seal wire of present embodiment, for the length that makes the hard straight part of front end is 0.1～0.5mm, preferred Au-Sn class scolder is impregnated into coil inside in the scope suitable with 1～4 spacing of disc spring.

The employed Au-Sn class of the seal wire of present embodiment scolder for example is made of the alloy of Au75～80 quality % and Sn25～20 quality %.

Use Au-Sn class scolder fixedly rustless steel and platinum (alloy), thus, compare with the situation of fixing by normally used Ag-Sn class scolder, obtain the bed knife (hot strength) about 2.5 times.

Thus, length in the hard straight part of front end is (scope of soaking into of scolder is 1～3 times situation of coil-span) in the short like this situation of 0.1～0.5mm, also can improve fully the constant intensity of 20 pairs of heart yearns 10 of disc spring, specifically, can further improve the tensile break strength of the distolateral minor diameter part 11 of amphi position of heart yearn 10.Thus, even between disc spring 20 and heart yearn 10, act on tensile force, can prevent that also heart yearn 10 is pulled out.

In addition, Au-Sn class scolder is compared with Ag-Sn class scolder, and radiography is better.

And Au-Sn class scolder is compared with Ag-Sn class scolder, and is also better to the corrosion resistance of blood and body fluid.

In addition, replace Au-Sn class scolder by using other scolders that contain gold, also can bring into play the effect identical with the situation of using Au-Sn class scolder.

As the gold solder that contains beyond the Au-Sn class scolder, can enumerate Au solder and the Au scolder of Au-Ge class scolder, Au-Si class scolder, Au-In class scolder, Au-Sb class scolder etc.

Shown in Fig. 1 and Fig. 3 (B), the first tapered portion 22 of disc spring 20 and the boundary member between the central diameter section 23 are not fixed on the heart yearn 10 by scolder.

Thus, from front minor diameter part 21(except fore-end) to the second tapered portion 24(except rear end part) zone (front end area of disc spring), do not exist because of the formed hard straight part of scolder, thereby can guarantee fully the flexibility of the seal wire in this zone.

Shown in Fig. 1 and Fig. 3 (C), the rear end part of the second tapered portion 24 of disc spring 20 is fixed on the heart yearn 10 by Au-Sn class scolder 32.

That is, Au-Sn class scolder 32 is impregnated into the inside of the rear end part of the second tapered portion 24, and with the distolateral minor diameter part 11 of heart yearn 10(amphi position) periphery contact, thus, the rear end part of the second tapered portion 24 is fixed on the distolateral minor diameter part 11 of heart yearn 10(amphi position) on.

Shown in Fig. 1 and Fig. 3 (D), the rearward end of disc spring 20 is that the rear end part of rear end side large-diameter portion 25 is fixed on the heart yearn 10 by Ag-Sn class scolder 33.

Namely, Ag-Sn class scolder 33 is impregnated into the inside of the rearward end (rear end part of rear end side large-diameter portion 25) of disc spring 20, and with the distolateral minor diameter part 11 of heart yearn 10(amphi position) periphery contact, thus, the rearward end of disc spring 20 is fixed on the distolateral minor diameter part 11 of heart yearn 10(amphi position) on.

In the distolateral minor diameter part 11 of the amphi position of heart yearn 10, the external diameter of the part that the rear end side large-diameter portion 25 of disc spring 20 is fixed is larger (comparatively speaking than the external diameter of the part (amphi position end) that the front minor diameter part 21 of disc spring 20 is fixed, fixed-area is large), thus the bed knife Ag-Sn class scolder less than Au-Sn class scolder can be used.

Such as Fig. 1～shown in Figure 3, the seal wire of present embodiment is when the inside of disc spring 20 (the unsoaked inside of scolder) fills hardening resin 40, and the resin bed 40A by this hardening resin 40 covers that the periphery of disc spring 20 and front end tip form.

And, on the surface of this resin bed 40A, formed hydrophilic resin layer 50 stackedly.

Fill hardening resin 40 by the inside to disc spring 20, especially improve the integraty (interlock) of heart yearn 10 and disc spring 20.Thus, can further improve the moment of torsion transitivity of seal wire, be passed to reliably the amphi position end of the disc spring 20 that becomes one with the distolateral minor diameter part 11 of amphi position from the rotation torque of distolateral large-diameter portion 13 transmission of the peri position of heart yearn 10.

In addition since under resin bed 40A(coating) be formed with hydrophilic resin layer 50 in the periphery of disc spring 20, so this hydrophilic resin layer 50 can be firmly fixed, stably manifest the lubricity of hydrophilic resin.

Here, as the inside that is filled into disc spring 20 and consist of to cover the hardening resin 40 of resin bed 40A of the periphery of disc spring 20, preferably use the material that concerning disc spring 20 and hydrophilic resin both sides, all has good cementability, specifically, can the illustration polyurethane acrylate resin, the ray hardening resin of polyurethane resin, organic siliconresin, epoxy resin, acrylic resin, nylon resin etc. or hardening thing of thermosetting resin etc.

Thickness as the resin bed 40A of the periphery that covers disc spring 20 and front end tip for example adopts 1～100 μ m, is preferably 3～10 μ m.

As having consisted of the resin of stratification at the lip-deep hydrophilic resin layer 50 of resin bed 40A, can use all employed materials in medical instruments field.

As the thickness of hydrophilic resin layer 50, for example adopt 1～30 μ m, be preferably 3～19 μ m.

As the filling of hardening resin 40, the formation method of resin bed 40A and the stratification method of hydrophilic resin 50, for example can be listed below method, namely, impregnated in hardening resin by the disc spring 20 that will be installed on the heart yearn 10, hardening resin is filled in the inside of disc spring 20, and the surface at disc spring 20 forms resin bed, by making its thermmohardening or photo-hardening make hardening resin 40(resin bed 40A), then, be coated with hydrophilic resin on the surface of resin bed 40A by suitable method.

According to the seal wire of present embodiment, the disc spring 20 that consists of it has coil outer diameter (D ₂₁) be the front minor diameter part 21 below 0.008 inch, thereby the little narrow positions in aperture that in the past the seal wire of also can interting can not intert, can use the treatment of the narrow zone that seal wire in the past can not carry out (for example, the following microchannel of the 250 μ m of the aperture in the CTO pathological changes).

In addition, disc spring 20 has coil outer diameter (D ₂₅) be the rear end side large-diameter portion more than 0.012 inch, and the coil outer diameter of front minor diameter part 21, central diameter section 23, rear end side large-diameter portion 25 changes (coil outer diameter is non-to be changed sharp) interimly, thus, the bending rigidity of seal wire of present embodiment with such disc spring 20 is high, and embedability and moment of torsion transitivity might as well.

In addition, in disc spring 20, the coil outer diameter of front minor diameter part 21 is with respect to the ratio (D of the coil outer diameter of central diameter section 23 ₂₁/ D ₂₃) be the length (L of the 0.5～0.9, first tapered portion 22 ₂₂) be 0.5～10mm, and the coil outer diameter of rear end side large-diameter portion 25 is with respect to the ratio (D of the coil outer diameter of central diameter section 23 ₂₅/ D ₂₃) be the length (L of the 1.1～2.3, second tapered portion 24 ₂₄) be 0.5～10mm, thus, can balance manifest well the raising effect of the path (expansion of the disease that can treat) of front minor diameter part 21 and bending rigidity, embedability, moment of torsion transitivity.

In addition, the dense curling part that has been made of disc spring 20 front minor diameter part 21, the first tapered portion 22, central diameter section 23 and the second tapered portion 24 divides 201, thereby is that dense curling part divides and can manifest good radiography (observability) in 201 in the front end area of disc spring 20.

In addition, seal wire is different because of the difference of the coil outer diameter of disc spring 20 to the insertion resistance of narrow positions, thereby the operator can follow the variation of coil outer diameter and changes (sense of touch) and hold the seal wire of present embodiment to the intubating length of narrow positions based on inserting resistance.

In addition, owing to be filled with hardening resin 40 in the inside of disc spring 20, thus can improve the integraty (interlock) of heart yearn 10 and disc spring 20, thus moment of torsion transitivity, the operability of seal wire can further be improved.

In addition, across the resin bed 40A of hardening resin 40, form hydrophilic resin layer 50 in the periphery of disc spring 20 stackedly, thereby can stably manifest the lubricity of hydrophilic resin.

In addition, used Au-Sn class scolder as the scolder that is fixed on the heart yearn 10 for the leading section (fore-end of front minor diameter part 21) with disc spring 20, thereby no matter whether the length of the hard straight part of front end is that 0.1～0.5mm is short like this, disc spring is all fully high to the constant intensity of heart yearn (the distolateral minor diameter part 11 of amphi position), even act on tensile force between disc spring 20 and heart yearn 10, heart yearn 10 can not be pulled out yet.

And because the length of the hard straight part of front end is that 0.1～0.5mm is short like this, so can shorten trim length, its result during operation in carrying out the microchannel, can reduce frictional resistance fully.In addition, can also use the treatment of the narrow zone that seal wire in the past can not carry out.

Fig. 4 (A) is illustrated in the scope suitable with 2 spacings of the front minor diameter part (0.0078 inch of coil wire diameter 50 μ m, coil-span 75 μ m, coil outer diameter) of disc spring, and Au-Sn class scolder is soaked into the state that the leading section of the seal wire of the present embodiment that forms has carried out finishing.The length of the hard straight part of the front end of this seal wire is 0.25mm, the inside length (L of trim length ₅₁) be 0.35mm, length of outer side (L ₅₂) be 0.40mm.

Fig. 4 (B) is illustrated in the scope suitable with 6 spacings of the leading section (0.010 inch of coil wire diameter 50 μ m, coil-span 75 μ m, coil outer diameter) of disc spring, and Ag-Sn class scolder is soaked into the state that the leading section of the seal wire that forms has carried out finishing.The length of the hard straight part of the front end of this seal wire is 0.60mm, the inside length (L of trim length ₅₁) be 0.70mm, length of outer side (L ₅₂) be 0.75mm.

The bending custom angle (θ) of the seal wire of present embodiment is less than 25 °, preferably less than 10 °.

Here, " crooked custom angle (θ) " is determined as described below.Namely, shown in Fig. 5 (1), with chuck C fixedly seal wire G front end (specifically, from comprising the front end tip in the part about 2mm the interior front end), will be from the front end of this seal wire G approximately (part of long degree ≒ 9.5mm ≒ 3.14 * 3mm) hangs down after the periphery of the bar R of diameter 3mm is reeled a circle, and the counterweight W of (lower end) installation 150g applies tensile load in its back-end between the position of 5mm to the position of 14.5mm from front end.After 10 seconds, take off counterweight W, to the seal wire G from chuck C and bar R release, shown in Fig. 5 (2), the warpage angle (the tangent line angulations of the front and back at coiling position) of the fore-end that produces reeling is as crooked custom angle (θ).This bending custom angle (θ) is less, the more difficult permanent deformation that causes.

Because crooked custom angle (θ) is even also be difficult to occur permanent deformation less than the seal wire bending of 25 ° present embodiment, shape retention is good, so the operability by in the such full of twists and turns blood vessel of coronary artery the time is good.

In addition, so good shape retention (causing the difficulty of permanent deformation when crooked) high hot strength (2600～3000MPa) of helping significantly the constituent material of heart yearn 10 to have.

According to the seal wire of present embodiment, the narrow positions of microchannel that the aperture that in the past the seal wire of can also interting can not intert is little etc.

The bending rigidity of the seal wire of present embodiment (anti-kinking) height, embedability is also good, has good moment of torsion transitivity (moment on hand easily is delivered to front end), thereby in vessel branch is selected, easily advance to the blood vessel that becomes target, operability is good.

In addition, even the seal wire of present embodiment is crooked by time in the full of twists and turns blood vessel, also be difficult to occur permanent deformation, shape retention is good.

The＜the second embodiment＞

Seal wire shown in Figure 6 has heart yearn 10 and disc spring 20B.

Heart yearn 10 has the distolateral minor diameter part 11 of amphi position from taper to peri position direction hole enlargement ground that processed by, to the distolateral large-diameter portion 13 of tapered portion 12, the peri position of the hole enlargement of peri position direction.

The distolateral minor diameter part 11 of amphi position, tapered portion 12 and the distolateral large-diameter portion 13 of peri position are made of integratedly same wire rod (for example, pole parts).

The distolateral cross section of the peri position of the distolateral minor diameter part 11 of amphi position is circular, also can compressed wire forms tabularly but the amphi position of the distolateral minor diameter part 11 of amphi position is distolateral, and the cross section in this situation is essentially rectangular.

Hot strength is that the elastic limit of high-intensity austenitic stainless steel of 2600～3000MPa is also high, thereby in its seal wire as the present embodiment of heart yearn, is difficult to occur the permanent deformation that causes because of bending.

In addition, the outer peripheral face at heart yearn 10 has formed the hydrophobic resin layer.

Resin as consisting of the hydrophobic resin layer adopts medical resin, can use all to have hydrophobic material, can enumerate the fluorine-type resin of PTFE etc. as preferred resin.

As shown in Figure 7, the total length (L of seal wire 1 ₁) be can enumerate 1780mm as a preferred example by for example 1500～3000mm.

In addition, the external diameter (D of the distolateral large-diameter portion 13 of peri position ₁) be generally below 0.012 inch (0.305mm), be preferably below 0.010 inch (0.254mm), more preferably 0.006～0.010 inch, can enumerate 0.010 inch as a preferred example.

External diameter (the D of the distolateral large-diameter portion 13 of peri position ₁) be below 0.012 inch, thus, help the miniaturization of the medical apparatus and instruments of conduit of using with seal wire of the present invention etc., and then help invasive.

As the maximum outside diameter of the distolateral minor diameter part 11 of amphi position, as long as less than the internal diameter of disc spring 20B, be not particularly limited, but the external diameter (D of the distolateral large-diameter portion 13 of employing peri position ₁) about 1/5～3/5.

The disc spring 20B that consists of seal wire 1 is installed in the periphery of the distolateral minor diameter part 11 of amphi position of heart yearn 10 vertically.

Disc spring 20B is made of 1 wire rod, and to be 1.0～1.8 times front dense curling part 21B of coil wire diameter and coil-span by coil-span consist of greater than 1.8 times rear end side distant curling part 22B of coil wire diameter, consisted of not regional transmission of X ray by front dense curling part 21B and front end described later tip.

Coil-span among the front dense curling part 21B is 1.0～1.8 times of coil wire diameter, can enumerate 1.0 times as a preferred example.

Coil-span among the rear end side distant curling part 22B is 1.8～2.5 times of coil wire diameter, can enumerate 2.0 times as a preferred example.

Like this, in front and rear end side, change by making coil-span, can manifest good radiography (observability) at front dense curling part 21B.

Adopt same spacing in the disc spring Zone Full in the situation that spread all over, X ray not regional transmission is elongated, thereby causes observability to reduce.

In Fig. 7, the length (L of disc spring 20B ₂) be can enumerate 115mm as a preferred example by for example 30～800mm.

Length (the L of front dense curling part 21B ₂₁) be can enumerate 30mm as a preferred example by for example 10～50mm.

Length (the L of rear end side distant curling part 22B ₂₂) be can enumerate 85mm as a preferred example by for example 20～750mm.

Length (L from the front end of seal wire 1 to the rear end of disc spring 20B ₃+ L ₂) be can enumerate 115.2mm as a preferred example by for example 30～800mm.

Length (L from the front end of seal wire 1 to the rear end of front dense curling part 21B ₃+ L ₂₁) be can enumerate 30.2mm as a preferred example by for example 10～50mm.

Coil outer diameter (the D of disc spring 20B ₂) be generally below 0.012 inch (0.305mm), be preferably below 0.010 inch (0.254mm), more preferably 0.006～0.010 inch, can enumerate 0.010 inch as a preferred example.

External diameter (the D of the distolateral large-diameter portion 13 of the peri position of heart yearn 10 ₁) be below 0.012 inch, and the coil outer diameter (D of disc spring 20B ₂) also be below 0.012 inch, thus, the operability when entering the microchannel (for example, the lubricity in the microchannel) is good.

The external diameter that consists of the wire rod of disc spring 20B is not particularly limited, but is preferably 30～90 μ m, can enumerate 60 μ m as a preferred example.

As the material of disc spring 20B, can enumerate the good material (not transmission of X ray material) of the radiography with respect to X ray of platinum, White gold alloy (such as Pt/W=92/8), gold, gold-copper alloy, tungsten, tantalum etc.

Leading section, rearward end and the pars intermedia of the disc spring 20B of the seal wire of present embodiment (boundary member between front dense curling part 21B and the rear end side distant curling part 22B) is fixed on the periphery of the distolateral minor diameter part 11 of amphi position of heart yearn 10 by scolder respectively.

Shown in Fig. 6 and Fig. 8 (A), the leading section of disc spring 20B is fixed on the heart yearn 10 by Au-Sn class scolder 31.

That is, Au-Sn class scolder 31 is impregnated into the inside of disc spring 20B, this Au-Sn class scolder 31 and the distolateral minor diameter part 11 of heart yearn 10(amphi position) periphery contact, thus, the leading section of disc spring 20B is fixed on the distolateral minor diameter part 11 of heart yearn 10(amphi position) on.

Shown in Fig. 8 (A), Au-Sn class scolder 31 is impregnated into coil inside in the scope suitable with 2 spacings of disc spring 20B.

In addition, at the leading section of disc spring 20B, the Au-Sn class scolder 31 of the inside by not being impregnated into disc spring 20B has formed roughly hemispheric front end tip.

Thus, the leading section of the seal wire 1 of present embodiment formed the hard straight part of the front end that is produced by Au-Sn class scolder 31 (because of the Au-Sn class scolder 31 that is impregnated into coil inside can not free bend the fore-end of disc spring 20B and the front end tip that is formed by Au-Sn class scolder 31, the firmly directly part that is produced by these two parts).

The length of the hard straight part of this front end (length from the front end of seal wire 1 to the rear end of the Au-Sn class scolder 31 that is impregnated into coil inside) (L ₄) be about 0.3～0.4mm.

In seal wire of the present invention, the length of the hard straight part of front end is 0.1～0.5mm.

In the situation of length less than 0.1mm of the hard straight part of front end, can not guarantee fully that disc spring is to the bed knife of heart yearn.

On the other hand, in the situation of length greater than 0.5mm of the hard straight part of front end, trim length (length of outer side (L described later ₅₂)) can not be for below the 0.7mm.

In seal wire of the present invention, for the length that makes the hard straight part of front end becomes 0.1～0.5mm, coil-span in the leading section of preferred disc spring is 1.0～1.8 times of coil wire diameter, and Au-Sn class scolder is impregnated into coil inside in the scope suitable with 1～3 spacing of disc spring.

Guide wire for medical use of the present invention is characterised in that, is fixed on scolder on the heart yearn as being used for leading section with disc spring, uses Au-Sn class scolder.

The Au-Sn class scolder that uses among the present invention for example is made of the alloy of Au75～80 quality % and Sn25～20 quality %.

Use Au-Sn class scolder fixedly rustless steel and platinum (alloy), thus, compare with the situation of fixing by Ag-Sn class scolder, can access the bed knife (hot strength) about 2.5 times.

Thus, even the length in the hard straight part of front end is (scope of soaking into of scolder is 1～3 times situation of coil-span) in the short like this situation of 0.1～0.5mm, also can improve fully disc spring 20B to the constant intensity of heart yearn 10, specifically, can further improve the tensile break strength of the distolateral minor diameter part 11 of amphi position of heart yearn 10.Thus, even between disc spring 20B and heart yearn 10, act on tensile force, can prevent that also heart yearn 10 is pulled out.

Shown in Fig. 6 and Fig. 8 (B), comprise the front dense curling part 21B of disc spring 20B and the borderline region between the rear end side distant curling part 22B and be fixed on the heart yearn 10 by Au-Sn class scolder 32 at interior pars intermedia.

That is, Au-Sn class scolder 32 is impregnated into the inside of disc spring 20B, this Au-Sn class scolder 32 and the distolateral minor diameter part 11 of heart yearn 10(amphi position) periphery contact, thus, the pars intermedia of disc spring 20B is fixed on the distolateral minor diameter part 11 of heart yearn 10(amphi position) on.

Borderline region between front dense curling part 21B and the rear end side distant curling part 22B easily causes stress concentration, and the Au-Sn class scolder large by bed knife fixedly comprises this borderline region at interior pars intermedia, can further improve the constant intensity of disc spring 20B.

Shown in Fig. 6 and Fig. 8 (C), the rearward end of disc spring 20B is fixed on the heart yearn 10 by Ag-Sn class scolder 33.

That is, Ag-Sn class scolder 33 is impregnated into the inside of disc spring 20B, this Ag-Sn class scolder 33 and the distolateral minor diameter part 11 of heart yearn 10(amphi position) periphery contact, thus, the rearward end of disc spring 20B is fixed on the distolateral minor diameter part 11 of heart yearn 10(amphi position) on.

At the distolateral minor diameter part 11 of the amphi position of heart yearn 10, the external diameter of the part that the rearward end of disc spring 20B is fixed is larger (comparatively speaking than the external diameter of the part (amphi position end) that the leading section of disc spring 20B is fixed, fixed-area is large), thus the bed knife Ag-Sn class scolder less than Au-Sn class scolder can be used.

Such as Fig. 6～shown in Figure 8, the seal wire 1 of present embodiment is to have filled hardening resin 40 in the inside of disc spring 20B, and the resin bed 40A by this hardening resin 40 covers, and the periphery of disc spring 20B and front end tip form.

Be filled with hardening resin 40 in the inside of disc spring 20B, thus, heart yearn 10 and disc spring 20B become one, especially improve the moment of torsion transitivity of seal wire, be delivered to reliably the amphi position end of the disc spring 20B that becomes one with the distolateral minor diameter part 11 of amphi position from the rotation torque of distolateral large-diameter portion 13 transmission of the peri position of heart yearn 10.

In addition, coating under resin bed 40A() periphery at disc spring 20B forms hydrophilic resin layer 50, thereby this hydrophilic resin layer 50 can be firmly fixed, and stably manifests the lubricity of hydrophilic resin.

Here, as the inside that is filled in disc spring 20B and consisted of the hardening resin 40 of the resin bed 40A of the periphery that covers disc spring 20B, the material that preferably disc spring 20B and hydrophilic resin both sides is had good cementability, specifically, can the illustration polyurethane acrylate resin, the ray hardening resin of polyurethane resin, organic siliconresin, epoxy resin, acrylic resin, nylon resin etc. or hardening thing of thermosetting resin etc.

Thickness as the resin bed 40A of the periphery that covers disc spring 20B and front end tip adopts for example 1～100 μ m, is preferably 3～10 μ m.

As having consisted of the resin of stratification at the lip-deep hydrophilic resin layer of resin bed 40A, can all use the material that uses in the medical instruments field.

Thickness as hydrophilic resin layer 50 adopts for example 1～30 μ m, is preferably 3～19 μ m.

As the filling of hardening resin 40, the formation method of resin bed 40A and the stratification method of hydrophilic resin 50, for example can be listed below method, namely, the disc spring 20B that is installed on the heart yearn 10 be impregnated in hardening resin, thus, hardening resin is filled into the inside of disc spring 20B, and the surface at disc spring 20B forms resin bed, by making its thermmohardening or photo-hardening make hardening resin 40(resin bed 40A), then, be coated with hydrophilic resin on the surface of resin bed 40A by suitable method.

Seal wire 1 according to present embodiment, used Au-Sn class scolder as the scolder that is fixed on the heart yearn 10 for the leading section with disc spring 20B, thereby no matter whether the external diameter of the distolateral large-diameter portion 13 of peri position of heart yearn 10 is whether length thin like this below 0.012 inch, the hard straight part of front end is that 0.3～0.4mm is short like this, disc spring is all high fully to the constant intensity of heart yearn (the distolateral minor diameter part 11 of amphi position), even effect has tensile force between disc spring 20B and heart yearn 10, heart yearn 10 can not be pulled out yet.

And because the length of the hard straight part of front end is that 0.3～0.4mm is short like this, so can shorten trim length, its result during operation in carrying out the microchannel, can reduce frictional resistance fully.In addition, can also use treatment in the narrow zone that seal wire in the past can not carry out.

In addition, owing to being filled with hardening resin 40 in the inside of disc spring 20B, so heart yearn 10 and disc spring 20B are become one, especially can improve moment of torsion transitivity, the operability of seal wire 1.

In addition, across the resin bed 40A of hardening resin 40, at the periphery stratification hydrophilic resin layer 50 of disc spring 20B, thereby can stably manifest the lubricity of hydrophilic resin.

In addition, owing to disc spring 20B is made of front dense curling part 21B and rear end side distant curling part 22B, so in front dense curling part 21B, can manifest good radiography (observability).

Crooked custom angle (θ) is even also be difficult to occur permanent deformation less than the seal wire bending of 25 ° present embodiment, and shape retention is good, thereby the operability by in the such full of twists and turns blood vessel of coronary artery the time is good.

The bending rigidity of the seal wire of present embodiment (anti-kinking) height, embedability has good moment of torsion transitivity, thereby in vessel branch is selected, easily advances to the blood vessel that becomes target, and operability is good.In addition, even the seal wire of present embodiment also is difficult to occur permanent deformation crooked by time in the full of twists and turns blood vessel, shape retention is good.

The＜the three embodiment＞

Seal wire shown in Figure 9 has heart yearn 10 and disc spring 20C.

The distolateral cross section of the peri position of the distolateral minor diameter part 11 of amphi position is circular, also can adopt tabular that compressed wire forms but the amphi position of the distolateral minor diameter part 11 of amphi position is distolateral, and the cross section in this situation is essentially rectangular.

In addition, the outer peripheral face at heart yearn 10 is formed with not shown hydrophobic resin layer.

Resin as consisting of the hydrophobic resin layer uses medical resin, also can use all to have hydrophobic material, can enumerate the fluorine-type resin of PTFE etc. as preferred resin.

As shown in figure 10, the total length (L of seal wire ₁) be can enumerate 1780mm as a preferred example by for example 1500～3000mm.

External diameter (the D of the distolateral large-diameter portion 13 of the peri position of heart yearn 10 ₁) be preferably more than 0.014 inch (0.356mm), can enumerate 0.014 inch as a preferred example.

As the maximum outside diameter of the distolateral minor diameter part 11 of amphi position, as long as less than the internal diameter of disc spring 20C, be not particularly limited, but be preferably the external diameter (D of the distolateral large-diameter portion 13 of peri position ₁) about 1/5～3/5.

The disc spring 20C that consists of seal wire is made of 1 wire rod, is installed in vertically on the periphery of the distolateral minor diameter part 11 of amphi position of heart yearn 10.

Disc spring 20C is made of front minor diameter part 21C, tapered portion 22C and rear end side large-diameter portion 23C.

In the present embodiment, front minor diameter part 21C and tapered portion 22C divide 201 to form by the front dense curling part, and rear end side large-diameter portion 23C divides 202 to form by the rear end side distant curling part.And, divide 201(front minor diameter part 21C and tapered portion 22C by the front dense curling part) and front end described later tip consisted of not regional transmission of X ray.

It is 1.0～1.8 times of coil wire diameter that the front dense curling part divides coil-span in 201, can enumerate 1.3 times as a preferred example.

It is 1.8～3.0 times of coil wire diameter that the rear end side distant curling part divides coil-span in 202, can enumerate 3.0 times as a preferred example.

Like this, in front and rear end side, coil-span is changed, thus, divide 201 can manifest good radiography (observability) at the front dense curling part.

Adopt same spacing in the disc spring Zone Full in the situation that spread all over, regional transmission is not elongated owing to X ray, so cause the reduction of observability.

In Figure 10, the length (L of disc spring 20C ₂) for for example 30～800mm, be preferably 100～200mm, can enumerate 165mm as a preferred example.

Length (the L of front minor diameter part 21C ₂₁) be 5～100mm, be preferably 10～70mm, can enumerate 38.5mm as a preferred example.

Length (the L of front minor diameter part 21C ₂₁) be more than the 5mm, thus, to nearly all microchannel, can both intert front minor diameter part 21C.

Length (the L of front minor diameter part 21C ₂₁) be below the 100mm, thus, can fully guarantee to help to improve the length of the rear end side large-diameter portion 23C of bending rigidity, moment of torsion transitivity.

Length (the L of tapered portion 22C ₂₂) be can enumerate 1.5mm as a preferred example by for example 0.5～10mm.

Length (the L of rear end side large-diameter portion 23C ₂₃) be can enumerate 125mm as a preferred example by for example 85～154.5mm.

Length (L from the front end of seal wire to the rear end of disc spring 20C ₃+ L ₂) be can enumerate 165.2mm as a preferred example by for example 30～800mm.

Length (L from the front end of seal wire to the rear end of tapered portion 22C ₃+ L ₂₁+ L ₂₂) be can enumerate 40.2mm as a preferred example by for example 10～50mm.

Coil outer diameter (D among the front minor diameter part 21C of disc spring 20C ₂₁) be generally below 0.012 inch (0.305mm), be preferably below 0.010 inch (0.254mm), more preferably 0.006～0.010 inch, can enumerate 0.010 inch as a preferred example.

Coil outer diameter (the D of front minor diameter part 21C ₂₁) be below 0.012 inch, thus, the operability when entering the microchannel (for example, the lubricity in the microchannel) is good.

Coil outer diameter (D among the rear end side large-diameter portion 23C of disc spring 20C ₂₃) be preferably more than 0.014 inch (0.356mm), can enumerate 0.014 inch as a preferred example.

Coil outer diameter (the D of rear end side large-diameter portion 23C ₂₃) be more than 0.014 inch, thus, given sufficient bending rigidity (being pressed into transitivity during insertion, the conveying function of equipment after inserting) to seal wire, in addition, the moment of torsion transitivity of this seal wire (seal wire of present embodiment) is also good.

Ratio (D as the coil outer diameter of rear end side large-diameter portion 23C and front minor diameter part 21C ₂₃/ D ₂₁) be preferably 1.1～2.3, can enumerate 1.4 as a preferred example.

The external diameter that consists of the wire rod of disc spring 20C is not particularly limited, but is preferably 30～90 μ m, can enumerate 60 μ m as a preferred example.

As the material of disc spring 20C, can enumerate the good material (not transmission of X ray material) of the radiography with respect to X ray of platinum, White gold alloy (such as Pt/W=92/8), gold, gold-copper alloy, tungsten, tantalum etc.

Front minor diameter part 21C, the tapered portion 22C of the disc spring 20C of the seal wire of present embodiment and rear end side large-diameter portion 23C are fixed on respectively the periphery of the distolateral minor diameter part 11 of amphi position of heart yearn 10 by scolder.

Shown in Fig. 9 and Figure 11 (A), the leading section of disc spring 20C is that the fore-end of front minor diameter part 21C is fixed on the heart yearn 10 by Au-Sn class scolder 31.

Namely, Au-Sn class scolder 31 is impregnated into the inside of the leading section (fore-end of front minor diameter part 21C) of disc spring 20C, and with the distolateral minor diameter part 11 of heart yearn 10(amphi position) periphery contact, thus, the leading section of disc spring 20C is fixed on the distolateral minor diameter part 11 of heart yearn 10(amphi position) on.

Shown in Figure 11 (A), Au-Sn class scolder 31 is impregnated into coil inside in the scope suitable with roughly 2 spacings of disc spring 20C.

In addition, at the leading section of disc spring 20C, the Au-Sn class scolder 31 of the inside by not being impregnated into disc spring 20C has formed roughly hemispheric front end tip.

Thus, the leading section of the seal wire of present embodiment formed the hard straight part of the front end that is produced by Au-Sn class scolder 31 (because of the Au-Sn class scolder 31 that is impregnated into coil inside can not free bend disc spring 20C(front minor diameter part 21C) fore-end and the front end tip that is formed by Au-Sn class scolder 31, the firmly directly part that is formed by these two parts).

The length of the hard straight part of this front end (length from the front end of seal wire to the rear end of the Au-Sn class scolder 31 that is impregnated into coil inside) (L ₄) be about 0.3～0.4mm.

On the other hand, in the situation of length greater than 0.5mm of the hard straight part of front end, trim length (length of outer side (L described later ₅₂)) can not become below the 0.7mm.

In seal wire of the present invention, for the length that makes the hard straight part of front end becomes 0.1～0.5mm, coil-span among the front minor diameter part 21C of preferred disc spring is 1.0～1.8 times of coil wire diameter, and Au-Sn class scolder is impregnated into coil inside in the scope suitable with 1～3 spacing of disc spring.

Guide wire for medical use of the present invention has following characteristics, and the scolder as being fixed on for the front minor diameter part with disc spring on the heart yearn uses Au-Sn class scolder.

By using Au-Sn class scolder fixedly rustless steel and platinum (alloy), compare with the situation of fixing by Ag-Sn class scolder, can obtain the bed knife (hot strength) about 2.5 times.

Thus, even the length in the hard straight part of front end is (scope of soaking into of scolder is 1～3 times situation of coil-span) in the short like this situation of 0.1～0.5mm, also can fully improve disc spring 20C to the constant intensity of heart yearn 10, specifically, can further improve the tensile break strength of the distolateral minor diameter part 11 of amphi position of heart yearn 10.Thus, even between disc spring 20C and heart yearn 10, act on tensile force, can prevent that also heart yearn 10 is pulled out.

In addition, Au-Sn class scolder is compared with Ag-Sn class scolder, and radiography is good.

And Au-Sn class scolder is compared with Ag-Sn class scolder, might as well to the corrosion resistance of blood and body fluid.

Shown in Fig. 9 and Figure 11 (B), the rear end part of the tapered portion 22C of disc spring 20C is fixed on the heart yearn 10 by Au-Sn class scolder 32.

That is, Au-Sn class scolder 32 is impregnated into the inside of the rear end part of tapered portion 22C, and with the distolateral minor diameter part 11 of heart yearn 10(amphi position) periphery contact, thus, the rear end part of tapered portion 22C is fixed on the distolateral minor diameter part 11 of heart yearn 10(amphi position) on.

Shown in Fig. 9 and Figure 11 (C), the rearward end of disc spring 20C is that the rear end part of rear end side large-diameter portion 23C is fixed on the heart yearn 10 by Ag-Sn class scolder 33.

Namely, Ag-Sn class scolder 33 is impregnated into the inside of the rearward end (rear end part of rear end side large-diameter portion 23C) of disc spring 20C, and with the distolateral minor diameter part 11 of heart yearn 10(amphi position) periphery contact, thus, the rearward end of disc spring 20C is fixed on the distolateral minor diameter part 11 of heart yearn 10(amphi position) on.

At the distolateral minor diameter part 11 of the amphi position of heart yearn 10, the external diameter of the part that the rear end side large-diameter portion 23C of disc spring 20C is fixed is larger (comparatively speaking than the external diameter of the part (amphi position end) that the front minor diameter part 21C of disc spring 20C is fixed, fixed-area is large), thus the bed knife Ag-Sn class scolder less than Au-Sn class scolder can be used.

Such as Fig. 9～shown in Figure 11, the seal wire of present embodiment is that (the unsoaked inside of scolder) is filled with hardening resin 40 in the inside of disc spring 20C, and the resin bed 40A by this hardening resin 40 covers, and the periphery of disc spring 20C and front end tip form.

Fill hardening resin 40 by the inside at disc spring 20C, especially improve the integraty (interlock) of heart yearn 10 and disc spring 20C.Thus, further improve the moment of torsion transitivity of seal wire, be delivered to reliably the amphi position end of the disc spring 20C that becomes one with the distolateral minor diameter part 11 of amphi position from the rotation torque of distolateral large-diameter portion 13 transmission of the peri position of heart yearn 10.

In addition, coating under resin bed 40A(), be formed with hydrophilic resin layer 50 in the periphery of disc spring 20C, thereby this hydrophilic resin layer 50 can be firmly fixed, and stably manifests the lubricity of hydrophilic resin.

Here, the material that preferably disc spring 20C and hydrophilic resin both sides is had good cementability as the inside that is filled into disc spring 20C and the hardening resin 40 that consisted of the resin bed 40A of the periphery that covers disc spring 20C, specifically, can the illustration polyurethane acrylate resin, the ray hardening resin of polyurethane resin, organic siliconresin, epoxy resin, acrylic resin, nylon resin etc. or hardening thing of thermosetting resin etc.

Thickness as the resin bed 40A of the periphery that covers disc spring 20C and front end tip adopts for example 1～100 μ m, is preferably 3～10 μ m.

As having consisted of the resin of stratification at the lip-deep hydrophilic resin layer 50 of resin bed 40A, can use the material that uses in whole medical instruments field.

As the filling of hardening resin 40, the formation method of resin bed 40A and the stratification method of hydrophilic resin 50, for example can be listed below method, the disc spring 20C that is installed on the heart yearn 10 be impregnated in hardening resin, thus, hardening resin is filled into the inside of disc spring 20C, and the surface at disc spring 20C forms resin bed, by making its thermmohardening or photo-hardening make hardening resin 40(resin bed 40A), then, be coated with hydrophilic resin on the surface of resin bed 40A by suitable method.

The outer periderm resin of the tapered portion 22C of disc spring 20C (resin bed 40A and hydrophilic resin layer 50) covers, and thus, forms the taper as the seal wire shape.

Here, the starting point of this taper is in the distolateral (T of Figure 10 of amphi position of the front end of tapered portion 22C ₁Shown position), the terminal point of this taper is in the distolateral (T of Figure 10 of peri position of the rear end of tapered portion 22C ₂Shown position).That is, less than the angle of taper of tapered portion 22C as the angle of taper of the taper of seal wire shape, this taper length (L ₅) than the length (L of tapered portion 22C ₂₂) long.

Like this, by cover tapered portion 22C with resin, make as the conical by its shape of seal wire gentlyer than the taper of tapered portion 22C, thus, can carry out more swimmingly the update of seal wire.

In Figure 10, at the length (L of tapered portion 22C ₂₂) be for example in the situation about 1.5mm, the length (L of the taper of seal wire ₅) be preferably about 5～6mm.

Seal wire according to present embodiment, use Au-Sn class scolder as the scolder that is fixed on for the leading section (fore-end of front minor diameter part 21C) with disc spring 20C on the heart yearn 10, thereby no matter whether the length of the hard straight part of front end is that 0.3～0.4mm is short like this, disc spring is all high fully to the constant intensity of heart yearn (the distolateral minor diameter part 11 of amphi position), even act on tensile force between disc spring 20C and heart yearn 10, heart yearn 10 can not be pulled out yet.

And because the length of the hard straight part of front end is that 0.3～0.4mm is short like this, so can shorten trim length, its result during operation in carrying out the microchannel, can fully reduce frictional resistance.In addition, can also use treatment in the narrow zone that seal wire in the past can not carry out.

In addition, the coil outer diameter (D of the front minor diameter part 21C of disc spring 20C ₂₁) be thin footpath such below 0.012 inch, thus, the operability when entering the microchannel (for example, the lubricity in the microchannel) is good.

And, the external diameter (D of the distolateral large-diameter portion 13 of the peri position of heart yearn 10 ₁) and the coil outer diameter (D of rear end side large-diameter portion 23C ₂₃) all be more than 0.014 inch, thus, give sufficient bending rigidity (being pressed into transitivity during insertion, the conveying function of equipment after inserting) to seal wire, the moment of torsion transitivity of this seal wire (seal wire of present embodiment) might as well.

In addition, owing to filled hardening resin 40 in the inside of disc spring 20C, thus can improve the integraty (interlock) of heart yearn 10 and disc spring 20C, and can further improve moment of torsion transitivity, the operability of seal wire.

In addition, across the resin bed 40A of hardening resin 40, form hydrophilic resin layer 50 in the periphery of disc spring 20C stackedly, thereby can stably manifest the lubricity of hydrophilic resin.

In addition, disc spring 20C by the front dense curling part that consists of front minor diameter part 21C and tapered portion 22C divide 201 and the rear end side distant curling part that consists of rear end side large-diameter portion 23C divide 202 to form, thereby divided the 201 front minor diameter part 21C that consists of and tapered portion 22C by the front dense curling part, manifest good radiography (observability).

The bending rigidity of the seal wire of present embodiment (anti-kinking) height, embedability has good moment of torsion transitivity, thereby in vessel branch is selected, easily advances good operability to the blood vessel that becomes target.In addition, even the seal wire of present embodiment also is difficult to occur permanent deformation crooked by time in the full of twists and turns blood vessel, shape retention is good.

Embodiment

＜embodiment 1＞

Consisted of by the austenitic stainless steel (SUS304) of having implemented with hot strength Ageing Treatment, that have 2800MPa of 300～500 ℃ and 0.5～4 hour, disc spring 20 is installed in the heart yearn that heart yearn 10(with following shape (size) is covered by PTFE) the distolateral minor diameter part 11 of amphi position on, make the seal wire of the present invention of the structure of 6 Fig. 1～as shown in Figure 3.

(1) the distolateral large-diameter portion 13 of peri position:

External diameter: 0.014 inch (0.356mm)

Length: 1665mm

(2) tapered portion 12:

Maximum outside diameter: 0.014 inch

Minimum outer diameter: 0.008 inch

Length: 70mm

(3) the distolateral minor diameter part 11 of amphi position:

Continuous conical by its shape

Maximum outside diameter: 0.008 inch

Minimum outer diameter: 0.0017 inch

Length: 165mm

Here, be the platinum wire rod formation of 50 μ m as disc spring 20 by external diameter (coil wire diameter), use following material, that is, and the coil outer diameter (D of front minor diameter part 21 ₂₁) be 0.0078 inch, length (L ₂₁) be 8.5mm, the length (L of the first tapered portion 22 ₂₂) be 1.5mm, the coil outer diameter (D of central diameter section 23 ₂₃) be 0.010 inch, length (L ₂₃) be 28.5mm, the length (L of the second tapered portion 24 ₂₄) be 1.5mm, the coil outer diameter (D of rear end side large-diameter portion 25 ₂₅) be 0.014 inch, length (L ₂₅) be 125mm, it is 1.5 times of 75 μ m(coil wire diameters that the dense curling part that is made of front minor diameter part 21, the first tapered portion 22, central diameter section 23 and the second tapered portion 24 divides 201 coil-span, coil sow discord the distance be 25 μ m), the coil-span of the thick volume part 202 that is made of rear end side large-diameter portion 25 is 3 times of 150 μ m(coil wire diameters, coil to sow discord distance be 100 μ m).

In addition, the fore-end of the front minor diameter part 21 of disc spring 20 and the rear end part of the second tapered portion use Au-Sn class scolder to be fixed on the heart yearn 10, and the rear end part of rear end side large-diameter portion 25 uses Ag-Sn class scolder to be fixed on the heart yearn 10.

In each 6 seal wires, the spacing number (being abbreviated as " spacing number " in table 1) that is impregnated into the suitable coil in the zone (length) of coil inside with scolder is to count arbitrarily in 1～4.The length of the hard straight part of formed front end is as shown in table 1 thus.

In addition, after being installed in disc spring on the heart yearn, hardening resin (polyurethane acrylate resin) is filled into the inside of disc spring, and form the resin bed of hardening resin in the periphery of disc spring, and on the surface of this resin bed, form the hydrophilic resin layer that is consisted of by poly(ethylene oxide) stackedly.

＜comparative example 1＞

As disc spring by consisting of take lower member: consisted of as the platinum wire rod of 50 μ m by external diameter, the front minor diameter part of coil outer diameter as 0.0078 inch, length as 38.5mm; The length continuous with this front minor diameter part is the tapered portion of 1.5mm; With this tapered portion continuous, coil outer diameter is that 0.014 inch, length are the rear end side large-diameter portion of 125mm.Coil-span during the dense curling part that use is made of front minor diameter part and tapered portion divides is 75 μ m, and the coil-span in the thick volume part that is made of the rear end side large-diameter portion is the material of 150 μ m, and the fore-end of the front minor diameter part of this disc spring and the rear end part of tapered portion be fixed on the heart yearn with Au-Sn class scolder, and the rear end part of rear end side large-diameter portion is fixed on the heart yearn with Ag-Sn class scolder, in addition, identical with embodiment 1, will be by the front minor diameter part thereby made 6, the disc spring that tapered portion and rear end side large-diameter portion consist of is installed in the seal wire of the relatively usefulness that forms on the distolateral minor diameter part of amphi position of heart yearn.

＜comparative example 2＞

As the parts of heart yearn use by austenitic rustless steel (SUS304) formation of the hot strength with 2400MPa, identical with embodiment 1 in addition, thus made 6 relatively seal wires of usefulness.

(2) the front end load of seal wire:

About each seal wire that is obtained by embodiment 1 and comparative example 1, under the state that makes front end tip and electronic balance butt, (deflection: maximum load 0.5mm) when having measured the part deflection that makes 10mm from front end.If this maximum load (being denoted as " front end load " in table 1) is in the scope of 0.5～1.0gf, can say that then the fore-end of seal wire has good bending rigidity and flexibility concurrently.The result as described in Table 1.

(3) minimum trim length and the stationarity of seal wire:

By the seal wire that embodiment 1 and comparative example 1 obtain, measured minimum trim length (minimum length that can bend) about each.

The mensuration of minimum trim length is about inside length (L shown in Figure 4 ₅₁) and length of outer side (L ₅₂) carry out.

In addition, tensile force is acted between disc spring and the heart yearn, observe fracture location and assess stationarity.Assessing benchmark is, will be denoted as " zero " in the situation of the distolateral minor diameter part fracture of the amphi position of heart yearn, and situation about will peel off between disc spring or the distolateral minor diameter part of amphi position and scolder is denoted as " * ".In the situation that even if one " * " arranged, can not be as product.The result is illustrated in the following table 1 in the lump.

[table 1]

(4) crooked custom angle (θ):

About each seal wire that is obtained by embodiment 1 and comparative example 2, measured crooked custom angle (θ) by said method, the bending custom angle (θ) of the seal wire of comparative example 2 (6) is 26～30 °, and the bending of the seal wire of embodiment 1 (6) custom angle (θ) is 7～10 °, all being very little, is the good material of shape retention that is difficult to occur permanent deformation.

(5) moment of torsion transitivity:

With each seal wire that is obtained by embodiment 1 and comparative example 2 inside of anchor clamps coronarius of people of having inserted simulation shown in Figure 12, make the peri position end (side on hand) of seal wire reverse the degree of side angle on hand 720 degree of rotation regulation by motor, check the front end anglec of rotation (torsion angle) that the amphi position end (front end) of this seal wire is located.The result as shown in figure 13.Near theoretical straight line shown in Figure 13, the moment of torsion transitivity is better, and operability is better.If the moment of torsion transitivity is good, then the moment of side easily is delivered to front end on hand, in vessel branch is selected, easily to become target blood vessel advance, insert workability and improve.

The explanation of Reference numeral

10 heart yearns

The distolateral minor diameter part of 11 amphi positions

12 tapered portion

The distolateral large-diameter portion of 13 peri positions

20 disc springs

21 front minor diameter parts

22 first tapered portion

23 central diameter sections

24 second tapered portion

25 rear end side large-diameter portions

201 dense curling parts divide

202 distant curling parts divide

31 Au-Sn class scolders

32 Au-Sn class scolders

33 Ag-Sn class scolders

40 hardening resins

The 40A resin bed

50 hydrophilic resin layers

Claims

1. guide wire for medical use is characterized in that having:

2. guide wire for medical use as claimed in claim 1 is characterized in that, has:

Disc spring, it is installed on the periphery of the distolateral minor diameter part of amphi position of described heart yearn vertically, and divided and thick volume part consists of by dense curling part, described dense curling part divides 1.1～2.0 times coil-span with coil wire diameter, described thick volume part is divided continuously with described dense curling part and is had a coil-span of 2.0 times greater than the coil wire diameter

Described disc spring has:

The front minor diameter part, it has the coil outer diameter below 0.008 inch;

Be that the periphery of the bar of 3mm is reeled under the state of a circle along diameter at the distolateral minor diameter part of the amphi position that makes the described heart yearn that is fixed with described disc spring, make after the tensile load effect 10 seconds of 150gf, the warpage angle of the fore-end that produces by reeling is less than 25 °.

3. guide wire for medical use as claimed in claim 2 is characterized in that,

The external diameter of the distolateral large-diameter portion of peri position of described heart yearn is more than 0.014 inch,

The coil outer diameter of the front minor diameter part of described disc spring is below 0.008 inch,

The coil outer diameter of described central diameter section is 0.009～0.011 inch,

The coil outer diameter of described rear end side large-diameter portion is more than 0.014 inch.

4. guide wire for medical use as claimed in claim 3 is characterized in that,

The coil outer diameter of described front minor diameter part is 0.5～0.9 with respect to the ratio of the coil outer diameter of described central diameter section, and the length of described the first tapered portion is 0.5～10mm,

The coil outer diameter of described rear end side large-diameter portion is 1.1～2.3 with respect to the ratio of the coil outer diameter of described central diameter section, and the length of described the second tapered portion is 0.5～10mm.

5. such as each described guide wire for medical use in the claim 1～4, it is characterized in that,

The fore-end of described front minor diameter part is fixed on the described heart yearn by containing gold solder,

Be 0.1～0.5mm by the length that contains the hard straight part of front end that gold solder produces.

6. guide wire for medical use as claimed in claim 5 is characterized in that, at the front minor diameter part of described disc spring, contains gold solder and be impregnated into coil inside in the scope suitable with 1～4 spacing from front end.

7. such as each described guide wire for medical use in the claim 1～4, it is characterized in that,

Inside at described disc spring is filled with resin, and is formed with the resin bed of described resin in the periphery of described disc spring, forms the hydrophilic resin layer on the surface of described resin bed stackedly,

Surface at described heart yearn forms the hydrophobic resin layer.

8. guide wire for medical use as claimed in claim 1 is characterized in that,

Be 0.1～0.5mm by the length that contains the hard straight part of the formed front end of gold solder.

9. guide wire for medical use as claimed in claim 1 is characterized in that,

Described disc spring has front minor diameter part, rear end side large-diameter portion and the tapered portion between described front minor diameter part and described rear end side large-diameter portion that coil outer diameter is larger than described front minor diameter part,