CN1846803A - Guide wire - Google Patents

Guide wire Download PDF

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Publication number
CN1846803A
CN1846803A CNA2006100724028A CN200610072402A CN1846803A CN 1846803 A CN1846803 A CN 1846803A CN A2006100724028 A CNA2006100724028 A CN A2006100724028A CN 200610072402 A CN200610072402 A CN 200610072402A CN 1846803 A CN1846803 A CN 1846803A
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CN
China
Prior art keywords
seal wire
wire portion
mentioned
external diameter
metal cladding
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Granted
Application number
CNA2006100724028A
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Chinese (zh)
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CN1846803B (en
Inventor
田野丰
梅野昭彦
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Terumo Corp
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Terumo Corp
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Priority claimed from JP2005150263A external-priority patent/JP4734029B2/en
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Publication of CN1846803A publication Critical patent/CN1846803A/en
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Publication of CN1846803B publication Critical patent/CN1846803B/en
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Abstract

The invention relates to a guide wire which can confirm the flexibility of front end with better operation, wherein the connect strength between first and second guide wires are be improved; it comprises a main body with the first guide wire part at the front end and the second guide wire part at the base of first guide wire; the outer circumference of front end of first guide wire has the coil with X-radio contrast; the base of first guide wire has constant valve of outer diameter along length direction; the front end of second guide wire is best formed by the taper that increasing from front end to base; the outer diameter of base of first guide wire is best the same as the front of second guide wire; the outer diameters of two guide wires via one end surface are welded; the circumference of connection part is best formed with metallic cover layer, to release the angle difference between the circumference of the base of first guide wire and the outer circumference of taper part.

Description

Seal wire
Technical field
The present invention relates to a kind of seal wire, relate in particular to employed seal wire when importing conduit (catheter) in the such body cavity of blood vessel and bile duct.
Background technology
For example as PTCA (Percutaneous Transluminal CoronaryAngioplasty: the percutaneous coronary revascularization), be difficult to carry out the treatment at operating position or will use conduit in the inspection that reduces treatment that infringement to human body is a purpose or cardiovascular radiography etc., seal wire is used for guide catheter.Be used for the seal wire of PTCA about this, during use, making under the front end of the seal wire state outstanding, seal wire near the balloon-like conduit is inserted into the angiostenosis portion at purpose position, is being guided to the leading section of ballon catheter near the angiostenosis portion by seal wire from the front end of balloon-like conduit.
In addition, in the pathological changes portion treatment of bile duct or ductus pancreaticus, also use seal wire near various therapeutic equipments being guided to bile duct, ductus pancreaticus pathological changes portion, the method for use for example has following several.
[1]ERCP(endoscopic?retrograde?cholangiopancreatography)
This is the method for X ray shooting, specifically is that endoscope is inserted into duodenal descender, with this endoscope in the top view vater's papilla, radiography intubate (cannula) is inserted bile duct, ductus pancreaticus, and the injection contrast agent.
[2]EST(endoscopic?sphincterotomy)
This is that the papillotome (papillotome) that will cut usefulness is inserted into the vater's papilla peristome, cuts the method that nipple expands about muscle with high frequency.
[3]EPBD(endoscopic?papillary?balloon?dilation)
This is via endoscope nipple to be expanded with balloon to open, and eliminates the method for cholelithiasis.
Need carry out the vascular bending complexity of PTCA, employed seal wire requires to possess when the balloon-like conduit is inserted blood vessel: the flexibility of doing to show when suitably crooked and restorative, be used for the transmission (these are generically and collectively referred to as " operability ") of the propelling that shows when operation with base end part is conveyed to front and moment of torsion, also have resistance to bend(ing) (folding song) or the like in addition.Among these characteristics, in order to obtain suitable flexibility, structurally, there is following mode to be used: promptly, the wire coil that can show flexibility when being bent is set around the very thin front end core of seal wire, or in order to give and flexibility and restorative super-elastic wires such as the core use Ni-Ti of seal wire or the like.
Past, adopt a core to constitute from cardinal extremity to the front end seal wire, in order to improve the operability of seal wire, this core adopts the higher material of spring rate more, but can cause the seal wire leading section to have the tendency of forfeiture flexibility to occur like this.In addition, in order to allow the leading section of seal wire obtain flexibility,, then can lose operability at the seal wire base end side if the material of core adopts the lower material of spring rate.Like this, the seal wire in past is difficult to have both simultaneously needed flexibility and operability.
In addition, crooked in body cavity owing to endoscope, and pliers work the reason seal wire of appearing on the stage and be bent, will be under the fixed state of contrast agent conduit be being exchanged etc., the above-mentioned seal wire that uses via the skill of endoscope armrest is under the harsh conditions and uses, so its torque transfer, propulsive force (propelling property: push ability) all can suffer damage.In addition, the difference of root a tree name unit equipment needs the seal wire that uses external diameter very little sometimes.But if external diameter is little, then the rigidity of seal wire can step-down, and torque transfer, propulsive force all can step-downs, can produce the problem that is difficult to various therapeutic equipments are guided to the purpose position.
In order to improve these unfavorable aspects, for example people have proposed a kind of like this seal wire, promptly, in core, use the Ni-Ti alloy wire, heat-treat with different conditions with base end side in its front, improve the flexibility of leading section and improve the rigidity (for example can with reference to the special fair 4-60675 communique of Japan) of base end side.
Yet, come flexibility controlled by carrying out such heat treatment that effect is limited after all, even sometimes obtained enough flexibilities, also can't obtain enough rigidity at base end side at leading section.
In addition, people have also proposed another seal wire, it comprises: be configured in flexual the 1st seal wire portion of having of front, be configured in the 2nd high seal wire portion of the rigidity of base end side and connect the 1st seal wire portion and the 2nd seal wire portion and have groove and the tubular connecting element of slit, the rigidity of link from front to base end side raise gradually (for example with reference to Japanese kokai publication hei 10-118005 communique).
Though such seal wire can dispose the seal wire portion with desired characteristic respectively on its front and base end side, but because it connects two seal wire portions by tubular connecting element, can't improve the bond strength of two seal wire portions so exist, be difficult to obtain the problem of enough torque transfer.In addition, the connection operation that also exists seal wire portion bothers the problem of this manufacture view.
Summary of the invention
The object of the present invention is to provide a kind of like this seal wire, can be when guaranteeing the leading section flexibility, operability is also good, and the bond strength between the 1st seal wire portion and the 2nd seal wire portion can be improved.
Above-mentioned purpose realizes the present invention by technical scheme as described below.
First scheme: a kind of seal wire, it has guidewire body, this guidewire body possesses the 1st seal wire portion and the 2nd seal wire portion that is configured in the wire of above-mentioned the 1st seal wire portion base end side of the wire of the front of being configured in, by the cardinal extremity of above-mentioned the 1st seal wire portion and the front end solder joints of above-mentioned the 2nd seal wire portion are constituted above-mentioned guidewire body, the base end part of above-mentioned the 1st seal wire portion along its length direction everywhere external diameter be essentially definite value, the leading section of the 2nd seal wire portion is by constituting to the tapering that the proximal direction external diameter increases gradually from its front end, the cardinal extremity external diameter of above-mentioned the 1st seal wire portion is identical with the front end external diameter of above-mentioned the 2nd seal wire portion, is formed with metal cladding on the composition surface peripheral part of above-mentioned the 1st seal wire portion and the 2nd seal wire portion.
Preferably above-mentioned metal cladding is made the form of the differential seat angle between above-mentioned the 1st seal wire portion base end part outer peripheral face and the above-mentioned tapering outer peripheral face that can ease up.
Make above-mentioned metal cladding preferably have the taper part that its outer radial proximal direction increases gradually, and the cone angle of this taper part is littler than the cone angle in above-mentioned tapering.
Above-mentioned the 1st seal wire portion adopts identical or congener metal material to constitute with above-mentioned the 2nd seal wire quality award from the ministry choosing.
Above-mentioned the 1st seal wire portion and the choosing of above-mentioned the 2nd seal wire quality award from the ministry adopt superelastic alloy to constitute respectively.
Preferably by to obtaining above-mentioned metal cladding by carrying out machining on the motlten metal solidfied material that welding produced between above-mentioned the 1st seal wire portion and above-mentioned the 2nd seal wire portion.
The average thickness of above-mentioned metal cladding is 1~100 μ m preferably.
The spiral coil that preferably has the part of front at least that covers above-mentioned the 1st seal wire portion.
On the leading section of above-mentioned the 1st seal wire portion, preferably has the radiography portion that possesses x-ray imaging.
On the periphery of above-mentioned the 1st seal wire portion and/or above-mentioned the 2nd seal wire portion, preferably be provided with the resin coating cap rock.
On the periphery of above-mentioned the 2nd seal wire portion, preferably be provided with the resin coating cap rock that constitutes by the resin material that can reduce friction.
On the periphery of above-mentioned the 1st seal wire portion, preferably be provided with the resin coating cap rock that constitutes by the material that is rich in flexibility.
Above-mentioned resin coating cap rock preferably is made of thermoplastic elastomer (TPE), silicones or fluororesin.
The front end of above-mentioned the 1st seal wire portion is preferably covered by above-mentioned resin coating cap rock and does not expose.
Preferably on the outer surface of front end at least of seal wire, apply with hydrophilic material.
Other schemes: a kind of seal wire, it has guidewire body, this guidewire body possesses wire the 1st seal wire portion of the front of being configured in and is configured in wire the 2nd seal wire portion of the base end side of above-mentioned the 1st seal wire portion, by the cardinal extremity of above-mentioned the 1st seal wire portion and the front end solder joints of above-mentioned the 2nd seal wire portion are constituted above-mentioned guidewire body; The front end external diameter of above-mentioned the 2nd seal wire portion is bigger than cardinal extremity external diameter the 2nd seal wire portion of above-mentioned the 1st seal wire portion, also is formed with metal cladding to be used for hiding the disconnected slope that is produced by their external diameter difference; Above-mentioned metal cladding is made of the motlten metal that welding produced between above-mentioned the 1st seal wire portion and above-mentioned the 2nd seal wire portion.
Preferably, above-mentioned motlten metal solidfied material obtains above-mentioned metal cladding by being carried out the machining shaping.
Make above-mentioned metal cladding preferably have the part that its thickness forward end direction reduces gradually.
The leading section of above-mentioned the 2nd seal wire portion preferably is made of the tapering that changes along its length direction external diameter.
Above-mentioned tapering is preferably the part that increases gradually to the cardinal extremity external diameter from front end.
Making above-mentioned metal cladding preferably have the taper part that its external diameter reduces gradually from the cardinal extremity forward end, is the cone angle in β, above-mentioned tapering when being α at the cone angle of this taper part, satisfies the relation of 0.5≤beta/alpha≤2.
Preferably make the base end part of above-mentioned the 1st seal wire portion roughly become definite value along its length direction external diameter everywhere.
Above-mentioned the 1st seal wire portion is made of identical or congener metal material with above-mentioned the 2nd seal wire quality award from the ministry choosing.
Above-mentioned the 1st seal wire portion and the choosing of above-mentioned the 2nd seal wire quality award from the ministry are made of superelastic alloy respectively.
The average thickness of above-mentioned metal cladding is 2~300 μ m preferably.
The spiral coil that preferably has the part of front at least that covers above-mentioned the 1st seal wire portion.
On the leading section of above-mentioned the 1st seal wire portion, preferably has the radiography portion that possesses x-ray imaging.
On the periphery of above-mentioned the 1st seal wire portion and/or above-mentioned the 2nd seal wire portion, preferably be provided with the resin coating cap rock.
On the periphery of above-mentioned the 2nd seal wire portion, preferably be provided with the resin coating cap rock that constitutes by the resin material that can reduce friction.
On the periphery of above-mentioned the 1st seal wire portion, preferably be provided with by the resin coating cap rock that material constituted that is rich in flexibility.
Above-mentioned resin coating cap rock preferably adopts thermoplastic elastomer (TPE), silicones or fluororesin to constitute.
The front end of above-mentioned the 1st seal wire portion is preferably covered by above-mentioned resin coating cap rock and does not expose.
Preferably on the outer surface of leading section at least of seal wire, apply with hydrophilic material.
The effect of invention is as follows, the guide wire of first scheme according to the present invention, by the 1st seal wire portion and the rigidity 2nd seal wire portion solder joints higher that will be rich in flexibility than the 1st seal wire portion, can access this seal wire of the following stated, owing to guaranteed enough flexibilities in the front of seal wire, thereby improved safety; Because the base end side at seal wire obtains enough rigidity, thereby propelling property, torque transfer and the property followed aspect performance are all excellent.For seal wire certainly needless to say, even the little seal wire of external diameter also can have been given play to above-mentioned effect with common external diameter.Thus, seal wire of the present invention for example in the conduit of bending, in the endoscope, all can bring into play good operability in the body cavity of blood vessel, bile duct, ductus pancreaticus etc.
In addition, because the inflexible difference of the 1st seal wire portion and the 2nd seal wire portion mainly is by due to the difference of seal wire portion external diameter, so two seal wire portions can constitute with identical or congener material.Can improve the bond strength between the 1st seal wire portion and the 2nd seal wire portion thus.Therefore, even in seal wire under the effect of bend tension iso-stress, the junction surface of the 1st seal wire portion and the 2nd seal wire portion can not break away from yet, and reliability is improved.
Especially, the 1st seal wire portion utilizes solder joints (connection) with the 2nd seal wire portion, by around this weld part, forming metal cladding, can further improve the bond strength of weld part, can transmit distortion moment of torsion and the propulsive force to the 1st seal wire portion more effectively from the 2nd seal wire portion.
In addition, make in the seal wire crooked and during distortion owing to around weld part, have metal cladding, so stress be dispersed to weld part around, avoided stress concentration to weld part.Thus, crooked twisting stress can transmission equably before and after the weld part, can effectively prevent suddenly bending (bending) or distortion etc.
In addition, if being set, metal cladding hides the disconnected slope that is produced by the external diameter difference between the 1st seal wire portion and the 2nd seal wire portion, when crooked and distortion action was on seal wire, stress was dispersed to weld part (the sloping portion of breaking) and, has avoided stress concentration to weld part on every side so.Thus, crooked and twisting stress can be transmitted equably in the weld part front and back, can effectively prevent suddenly bending (bending) or distortion etc.
And, if metal cladding is by obtaining carrying out the machining shaping by the motlten metal solidfied material that welding produced between the 1st seal wire portion and the 2nd seal wire portion, compare with the situation that forms metal cladding with other parts so, the more than manufacturing is more prone to, the bed knife of metal cladding in the 1st seal wire portion and the 2nd seal wire portion is also stronger, even also can not produce breakage when having over-drastic stress to have an effect.Especially, because metal cladding constitutes with the material of the 1st seal wire portion and/or the 2nd seal wire portion, so can be fixed in reliably in the 1st seal wire portion and the 2nd seal wire portion, can also easily be carried out shaping processing, guidewire body can be formed resemble the surface the continuous face on disconnected slope before and after weld part.
The guide wire of other schemes according to the present invention, by engaging than the 2nd higher seal wire portion of the 1st seal wire portion rigidity, even it is very soft that the seal wire that external diameter is little also can form front, the seal wire that the base end side rigidity is very high, so obtained enough propulsive forces and torque transfer, in the conduit of bending, in the endoscope, in the body cavity such as blood vessel, bile duct, ductus pancreaticus, all can bring into play good operability.
Be provided with the resin coating cap rock, when especially being provided with the resin coating cap rock that constitutes by the material of reducing friction, improving the sliding that waits the seal wire at place in the conduit, can allow the operability of seal wire become better.By reducing the resistance to sliding of seal wire, can avoid near the bending or twisting of bending or twisting, especially weld part of seal wire more effectively.
Periphery in the 1st seal wire portion is provided with under the tectal situation of resin that constitutes with the material that is rich in flexibility, especially cover the 1st seal wire portion front end with this resin coating cap rock and when it is not exposed, in in blood vessel etc., inserting, damage can be prevented more effectively, safety can be further improved blood vessel.
Description of drawings
Fig. 1 is the longitudinal sectional drawing of the embodiment of expression seal wire of the present invention.
Fig. 2 is near the longitudinal sectional drawing in junction surface that amplifies guidewire body in the expression seal wire of the present invention.
Fig. 3 is the longitudinal sectional drawing of other embodiment of expression seal wire of the present invention.
Fig. 4 is the longitudinal sectional drawing of other embodiment of expression seal wire of the present invention.
Fig. 5 is near the longitudinal sectional drawing in junction surface that amplifies guidewire body in the expression seal wire of the present invention.
Fig. 6 is near the longitudinal sectional drawing in junction surface that amplifies guidewire body in the expression seal wire of the present invention.
Fig. 7 is near the longitudinal sectional drawing in junction surface that amplifies guidewire body in the expression seal wire of the present invention.
Fig. 8 is the longitudinal sectional drawing of other embodiment of expression seal wire of the present invention.
Fig. 9 is near the longitudinal sectional drawing of other structure example of the junction surface of amplification expression guidewire body of the present invention.
Figure 10 is near the longitudinal sectional drawing of other structure example of the junction surface of amplification expression guidewire body of the present invention.
Figure 11 is near the longitudinal sectional drawing of other structure example of the junction surface of amplification expression guidewire body of the present invention.
Figure 12 is near the longitudinal sectional drawing of other structure example of the junction surface of amplification expression guidewire body of the present invention.
Figure 13 is the ideograph that makes use-case that is used to illustrate seal wire of the present invention.
Figure 14 is the ideograph that makes use-case that is used to illustrate seal wire of the present invention.
The specific embodiment
Preferred implementation shown in reference to the accompanying drawings is elaborated to seal wire of the present invention below.
Fig. 1 is the longitudinal sectional drawing of the embodiment of expression seal wire of the present invention; Fig. 2 will amplify the longitudinal sectional drawing that shows near the junction surface of guidewire body in the seal wire of the present invention.And for convenience of description, the right side among Fig. 1 and Fig. 2 is that " cardinal extremity ", left side are " front end ".In addition, in Fig. 1 and Fig. 2, for easy understanding, shortened the length on the guidewire length direction, and illustrated size on the seal wire thickness direction in the mode of exaggeration, the ratio of the size on the size on this length direction and the thickness direction is different with practical situation.
Seal wire 1 shown in Figure 1 is the conduit seal wire that is inserted into the interior intracavity use of conduit (also comprising endoscope), it has guidewire body 10 and spiral helicine coil 4, and wherein this guidewire body 10 is formed with the 2nd seal wire portion 3 solder joints (connection) that are configured in the 1st seal wire portion 2 base end sides by the 1st seal wire portion 2 that is configured in front.There is no particular limitation for the total length of seal wire 1, is preferably about 200~5000mm.
The 1st seal wire portion 2 is by having flexibility or elastic wire rod constitutes.There is no particular limitation for the length of the 1st seal wire portion 2, preferably about 20~1000mm.
In the present embodiment, the 1st seal wire portion 2 has the taper part that extreme direction reduces gradually before the constant part of external diameter and the outer radial (external diameter successively decrease portion).The latter can be that a place also can be more than two places, has place's external diameter portion 15 of successively decreasing in the illustrated embodiment.
By this external diameter portion 15 of successively decreasing is set, can allow rigidity (flexural rigidity, torsion rigidity) the forward end direction of the 1st seal wire portion 2 slowly reduce, thus, seal wire 1 leading section has good flexibility, improved the property followed, safety, and can also prevent that situation such as bending from occurring to blood vessel etc.
The successively decrease cone angle (external diameter slip) of portion 15 of external diameter both can be definite value in that seal wire is permanent along its length, also can alongst change.For example also can form repeatedly circulation shape repeatedly of cone angle (external diameter slip) bigger position and less position.
The base end side of the 1st seal wire portion 2 part (from the successively decrease base end side part of portion's 15 beginnings of external diameter), till the cardinal extremity of its external diameter to the 1 seal wire portion 2 all perseverance be definite value.
The front end of the 2nd seal wire portion 3 for example utilizes welding to be connected (binding) with the cardinal extremity of the 1st seal wire portion 2.The 2nd seal wire portion 3 is by having flexibility or elastic wire rod constitutes.Though there is no particular limitation for the length of the 2nd seal wire portion 3, about preferred 20~4800mm.
Be formed with from its front end (the 2nd seal wire portion 3 foremost) to tapering 16 that the proximal direction external diameter increases gradually at the leading section of the 2nd seal wire portion 3.And, than the tapering 16 of the 2nd seal wire portion 3 more by base end side, its along the guidewire length direction everywhere external diameter be roughly definite value.And the front end of the 2nd seal wire portion 3 (front end in tapering 16) external diameter is identical with the cardinal extremity external diameter of the 1st seal wire portion 2.
Thus, mean outside diameter by making the 1st seal wire portion 2 is littler than the mean outside diameter of the 2nd seal wire portion 3, therefore, the 1st seal wire portion 2 as the front of seal wire 1 is rich in flexibility, 3 rigidity of the 2nd seal wire portion as its base end side are higher, so can have both the flexibility of leading section and good operability (propelling property, torque transfer) simultaneously.And, owing to have tapering 16 on the leading section of the 2nd seal wire portion 3, so the physical characteristic that carries out the transition to the 1st seal wire portion 2 since the 2nd seal wire portion 3 especially elasticity is a smooth change, place, front and back at the junction surface (composition surface) 14 of two seal wire portions 2,3 can bring into play good propelling and torque transfer, and resistance to bend(ing) also is improved.
There is no particular limitation for the constituent material of the 1st seal wire portion 2 and the 2nd seal wire portion 3, for example can use rustless steel (for example full kind of SUS such as SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302), piano wire, cobalt respectively is various metal materials such as alloy, wherein especially preferably can show anelastic alloy (comprising superelastic alloy).More preferably superelastic alloy.
Superelastic alloy is soft and have restorative, be not easy residual crooked vestige, so by constitute the 1st seal wire portion 2 with superelastic alloy, seal wire 1 partly locates to obtain enough flexibilities and relative with bending restorative in its front, improved complicated bend, the property followed of the blood vessel of bending, obtained better operability, even repeatedly the 1st seal wire portion 2 is carried out bending, the distortion of bending, also because possessed restorative of the 1st seal wire portion 2 and can residual crooked vestige, so can avoid when using seal wire 1, residual down crooked vestige in the 1st seal wire portion 2, and cause the reduction of operability thus.
In the anelasticity alloy so long as stress application and after making it that big distortion take place, the material that can recover original form substantially that eliminates stress gets final product, comprise because the material of the stress-inflection curves of the Any shape caused of stretching, also comprise the material of the type that transition points such as As, Af, Ms, Mf can obviously be measured or can not obviously be measured.
Preferred composition as superelastic alloy can list: the Ni-Ti such as Ni-Ti alloy of 49~52 atom %Ni are Ni-Al alloy of the Cu-Zn alloy of alloy, 38.5~41.5 weight %Zn, the Cu-Zn-X alloy of 1~10 weight %X (X be among Be, Si, Sn, Al, the Ga at least a), 36~38 atom %Al etc.Wherein especially preferred is that above-mentioned Ni-Ti is an alloy.And Ni-Ti is that the superelastic alloy and the cohesive between the resin coating cap rock described later 8,9 of alloy representative is also very excellent.
Cobalt is the spring rate height of alloy during as seal wire, and has the elastic limit of appropriateness.Therefore, be that the seal wire torque transfer that constitutes of alloy is good with cobalt, can not produce problems such as vertical bending substantially.As cobalt is alloy, so long as comprised cobalt in the formation element, no matter use what kind of material all can, preferably be alloy (the Co base alloy: in the element that constitutes alloy of main component with the cobalt, the containing ratio of Co is maximum alloys with weight ratio), more preferably using Co-Ni-Cr is alloy.By using the alloy of composition like this, can allow above-mentioned effect more remarkable.In addition, so the alloy coefficient of elasticity of forming is high and also can form with the mode of cold forming under the situation with high resiliency limit, utilize the high resiliency limit, can reliably prevent vertical bending, and can realize minor diameterization, in the insertion of predetermined position, having both enough flexibilities and inflexible seal wire.
As Co-Ni-Cr is alloy, for example preferred: by the remaining part of 28~50wt%Co-10~30wt%Ni-10~30wt%Cr-is that alloy or its part that constitutes forming of Fe come metathetical alloy etc. with other element (substitutional element).Make and wherein contain substitutional element, can bring into play and the corresponding intrinsic effect of its kind.For example: can comprise from Ti, Nb, Ta, Be, Mo, select at least a as substitutional element, can seek further to improve the intensity of the 2nd seal wire portion 3 by the method.And under the situation that comprises the element outside Co, Ni, the Cr, its (all substitutional elements) amount is preferably below 30wt%.
In addition, the part of Co, Ni, Cr also can be used other element substitution.For example the part of Ni can be replaced with Mn.Thus, for example can seek further improvement to processability.In addition, the part of Cr can also be replaced with Mo and/or W.Thus, can seek further improvement to elastic limit.At Co-Ni-Cr is in the alloy, and the Co-Ni-Cr-Mo that preferably comprises Mo is an alloy.
Co-Ni-Cr is that the concrete composition of alloy for example can list: the remaining part of [1] 40wt%Co-22wt%Ni-25wt%Cr-2wt%Mn-0.17wt%C-0.03wt%Be-is Fe, [2] 40wt%Co-15wt%Ni-20wt%Cr-2wt%Mn-7wt%Mo-0.15wt%C-0.03wt%Be-remaining part is Fe, [3] the remaining part of 42wt%Co-13wt%Ni-20wt%Cr-1.6wt%Mn-2wt%Mo-2.8wt%W-0.2wt%C-0.04wt%Be-is Fe, [4] the remaining part of 45wt%Co-21wt%Ni-18wt%Cr-1wt%Mn-4wt%Mo-1wt%Ti-0.02wt%C-0. 3wt%Be-is Fe, [5] the remaining part of 34wt%Co-21wt%Ni-14wt%Cr-0.5wt%Mn-6wt%Mo-2.5wt%Nb-0.5wt%T a-is Fe etc.Said Co-Ni-Cr is that alloy is the notion that has comprised these alloys among the present invention.
Though the 1st seal wire portion 2 and the 2nd seal wire portion 3 can constitute with different materials, preferred metal material with identical or of the same type (in the alloy main metal material identical) constitutes.Thus, the bond strength of junction surface (weld part) 14 further improves, even the external diameter at junction surface 14 is little, also can not produce disengaging etc., can bring into play good torque transfer.
Under this situation, the 1st seal wire portion 2 and the 2nd seal wire portion 3 are that alloy constitutes with Ni-Ti respectively preferably.In addition, the 1st seal wire portion 2 and the 2nd seal wire portion 3 preferably constitute with superelastic alloy.Thus, can guarantee to have good flexibility, and can guarantee enough rigidity (bending rigidity, torsion rigidity) are partly arranged at the base end side of guidewire body 10 from the distolateral forward part in guidewire body 10 taperings 16.Thus, seal wire 1 can obtain good propelling and torque transfer, has guaranteed good operability, and has obtained good flexibility, restorative in front, has improved safety and to the property followed of blood vessel, bile duct, ductus pancreaticus.
Under the situation with the different materials formation, preferred the 1st seal wire portion 2 has identical element with the 2nd seal wire portion 3 in the 1st seal wire portion and the 2nd seal wire portion.For example the 1st seal wire portion 2 is that Ni-Ti is an alloy, and the 2nd seal wire portion 3 is rustless steels, and identical element is a nickel.By having identical element, improved weld strength.As other example, the 1st seal wire portion 2 is that Ni-Ti is an alloy, and the 2nd seal wire portion 3 is that Co-Ni-Cr is an alloy, and identical element is a nickel.The 1st seal wire portion 2 is preferably than the low material of the 2nd seal wire portion 3 spring rates.
On the 1st seal wire portion 2 leading section peripheries, dispose coil 4.This coil 4 is parts that wire rod (fine rule) coiling is formed for helical form, is provided with according to the mode partly of front at least of the 1st seal wire portion 2 of covering.In illustrated structure, the front of the 1st seal wire portion 2 is partly passed the approximate centre portion of coil 4 inboards.In addition, the part of the 1st seal wire portion 2 front is according to passing with the discontiguous mode of the inner surface of coil 4.Junction surface 14 is positioned at than the more close base end side of the cardinal extremity of coil 4 place.
And, in illustrated structure, though coil 4 is under the state that does not give external force, leave some spaces each other a little with the rotating wire rod of helical form, but also can be different with illustrated case, be configured under the state that does not give external force, and have no ground, space compact configuration between the rotating wire rod of helical form.
Coil 4 preferably constitutes with metal material.The metal material that constitutes coil 4 for example can list: rustless steel, superelastic alloy, cobalt are noble metal such as alloy and gold, platinum, tungsten or the alloy (for example platinum-iridium alloy) that comprises them etc.Especially by noble metal such can't the Transmission X ray material situation about constituting under, can make seal wire 1 obtain x-ray imaging, so under radioscopy, can confirm the position of leading section, and meanwhile insert in the organism, so comparatively preferred.In addition, coil 4 can also constitute its front and base end side with different materials.For example also can with X ray not the coil of the material of transmissive constitute front, the coil of material (rustless steel or the like) that can transmission with X ray comparatively speaking constitutes base end side.And, though the total length of coil 4 be not particularly limited, preferably about 5~500mm.
The base end part of coil 4 and leading section are secured in the 1st seal wire portion 2 with immobilization material 11 and 12 respectively.In addition, the pars intermedia of coil 4 (near front position) is secured in the 1st seal wire portion 2 with immobilization material 13.Immobilization material 11,12 and 13 usefulness scolding tin (wlding) constitute.And immobilization material 11,12 and 13 is not limited to scolding tin, can also be binding agent.In addition, the fixing means of coil 4 is not limited to utilize immobilization material to carry out, and for example can also use welding process.In addition, in order to prevent the damage to body cavity walls such as blood vessels, the front end face of immobilization material 12 preferably has toroidal.
In the present embodiment, covered so contact area is less by coil 4,, further improved the operability of seal wire 1 thus so can reduce resistance to sliding by being provided with such coil 4, the 1 seal wire portions 2.
And, under the situation of present embodiment, be circular wire rod though coil 4 has adopted cross section, be not limited to this, the cross section of wire rod for example can also be: oval, tetragon shapes such as (especially rectangles).
The 1st seal wire portion 2 that constitutes guidewire body 10 utilizes the welding mode to be connected, to fix with the 2nd seal wire portion 3.Seal wire 1 thus, rely on simple method to obtain high bond strength, so can transfer to the 1st seal wire portion 2 places effectively with distortion moment of torsion or the propulsive force from the 2nd seal wire portion 3 at 14 places, the junction surface of the 1st seal wire portion 2 and the 2nd seal wire portion 3 (weld part).
Do not limit as the welding process between the 1st seal wire portion 2 and the 2nd seal wire portion 3 is special, for example can list: friction welded, as to use laser point welding, opposite joint (butt seam) weldering etc. modes such as electric resistance welding, but, preferably adopt the mode of electric resistance welding from obtain high bond strength this respect in fairly simple mode.
As mentioned above, the cardinal extremity external diameter of the 1st seal wire portion 2 is identical with the front end of the 2nd seal wire portion 3 (front end in tapering 16) external diameter, therefore, and shape (circular) unanimity of the jointing end face of two seal wire portions 2,3.Therefore, when making it relative, can not produce disconnected slope because of the external diameter difference in two seal wire portions 2,3 of welding.
And two seal wire portions 2,3 utilize after the welding mode engages, and are formed with metal cladding 6 on the peripheral part at the junction surface 14 of two seal wire portions 2,3.Shape to metal cladding 6 describes below.
As shown in Figure 2, to be that external diameter is basic permanent be that the 1st seal wire portion 2 of definite value, the base end side at junction surface 14 are the taperings 16 in the 2nd seal wire portion 3 that increases gradually of outer radial proximal direction to the front at junction surface 14, and metal cladding 6 has covered above-mentioned two parts.And metal cladding 6 whole or a part of constitute the taper part 61 that the outer radial proximal direction increases gradually.
Here, the cone angle (the outer peripheral face angle of seal wire axis relatively) of establishing tapering 16 is that the cone angle of the taper part 61 of α, metal cladding 6 is β, then sets up the relation (with reference to figure 2) of α>β.That is, metal cladding 6 forms according to the mode of the differential seat angle between the outer peripheral face in the base end part outer peripheral face of the 1st seal wire portion 2 that can ease up and tapering 16.
By forming such metal cladding 6, the angle that 14 front and back, junction surface (front and base end side) locate suddenly of having eased up changes (variation in rigidity), can avoid or the stress concentration phenomenon at gentle weld part 14 places, can also allow and change from physical characteristic, especially rigidity and the uniform elastic ground of 3 to the 1st seal wire portions 2 of the 2nd seal wire portion, allow the place, 14 front and back, junction surface of two seal wire portions 2,3 give play to good propelling and torque transfer, resistance to bend(ing) also is improved.
Metal cladding 6 is made of motlten metal (fused mass) solidfied material that 2,3 weldings of two seal wire portions are produced.Therefore, the constituent material of metal cladding 6 comprises the formation metal of the 1st seal wire portion 2 and this two side of formation metal of the 2nd seal wire portion 3.Especially, such as mentioned above, under the 1st seal wire portion 2 and situation that the 2nd seal wire the portion identical or congener metal material of 3 usefulness constitutes, the constituent material of metal cladding 6 also has the metal identical with them and forms.
In addition, metal cladding 6 preferably carries out machining to above-mentioned motlten metal solidfied material and forms.Thus, can allow metal cladding 6 obtain desired shape and surface texture, can further improve propelling, torque transfer, the resistance to bend(ing) of seal wire 1.And, as machining, for example can cut, a kind of or two or more combinations among grinding, Laser Processing etc. carry out grinding.In addition, replace the mode of machining, perhaps after machining, can also carry out chemical treatments such as etching.
Though there is no particular limitation for the average thickness of metal cladding 6, preferably about 1~100 μ m, more preferably about 1~30 μ m.If the thickness of metal cladding 6 is thin excessively, the function of so above-mentioned metal cladding 6 possibly can't be not fully exerted, if thickness is blocked up, the variation of the physical characteristic (rigidity, elasticity etc.) between 2, the 2 seal wire portions 3 of the 1st seal wire portion possibly can't be carried out equably so.
Though the length for the guidewire length direction of metal cladding 6 is not particularly limited, preferably about 0.5~2.0mm, more preferably about 0.5~1.0mm.
Such metal cladding 6 for example forms in the following manner.
The 1st seal wire portion 2 and the 2nd seal wire portion 3 for example meet sb. at the airport by butt seam welding, when having applied predetermined voltage the cardinal extremity of the 1st seal wire portion 2 and the front end of the 2nd seal wire portion 3 are added press contacts.Add press contacts by this, form thin (for example about 0.01~50 μ m) melting layer, form junction surface 14 after this melting layer cooling curing, thus with the 1st seal wire portion 2 and 3 firm being joined together of the 2nd seal wire portion in contact portion.When carrying out this welding, (for example: the scope before and after the beginning of junction surface 14 about 0.2~8mm) form the bump of external diameter increase in the presumptive area that comprises junction surface 14.This bump is that the fused mass of the 1st seal wire portion 2 and the 2nd seal wire portion 3 solidifies the part that forms.
Appropriateness is removed and shaping (shape adjustments) by this fused mass bump is carried out, the metal cladding 6 that obtains having desired shape.As shaping methods, can list: bump is for example ground cut, the chemical treatment of the machining of grinding, Laser Processing etc. or etching etc.After carrying out machining, can also carry out polish etc. and be the chemical treatment of purpose.By shaping like this, can allow the outer peripheral face of metal cladding 6 become in fact along sliding face.
In the above description, though metal cladding 6 is to carry out shaping with the melting and solidification thing to the 1st seal wire portion 2 and the 2nd seal wire portion 3 to obtain, but be not limited to this, can also allow the melting and solidification thing become the residual convex of a part, or after being removed basically, resembling as described above the covering with other metal covering in its surface and constitute.In doing so, as other metal covering, can be with forming with the 1st seal wire portion 2 and the 2nd seal wire portion 3 congener materials.In addition, replace metal cladding 6, can also form cover layer made of plastic (resin coating cap rock).Certainly, also can constitute: whole or a part of cover layers made from plastics etc. of metal cladding 6 are covered.
Though the taper part 61 of metal cladding 6 is as shown in Figure 2, its outer radial proximal direction increases gradually with linear fashion, and taper part 61 also can be formed concave surface, perhaps is formed convex surface conversely.
As shown in Figure 1, guidewire body 10 has the whole or a part of resin coating cap rocks 8,9 of getting up that cover with its outer peripheral face (outer surface).In the illustrated embodiment, on the periphery of the 1st seal wire portion 2 and the 2nd seal wire portion 3, be respectively arranged with resin coating cap rock 8 and 9.
These resin coating cap rocks 8,9 form because of various purposes, and one of them example is: for by reducing the friction (resistance to sliding) of seal wire 1, improve sliding the operability of seal wire 1 is improved.
In addition, different with diagram, resin coating cap rock 8 or 9 can also be provided with according to the mode that covers metal cladding 6 peripheries.Thus, the external diameter of the guidewire body 10 of can further easing up changes (cone angle variation), further improves propelling, torque transfer, the resistance to bend(ing) of seal wire 1, can also improve the move operation of seal wire 1 length direction simultaneously.
For the friction (resistance to sliding) of seeking to reduce seal wire 1, resin coating cap rock 8,9 preferably constitutes with the material of reduced friction as described as follows.Thus, owing to the frictional resistance (resistance to sliding) that has reduced between the pipe inner wall that uses with seal wire 1 has improved sliding, allow the operability of the interior seal wire 1 of conduit become better.In addition, become lower, when seal wire 1 moves and/or rotates, can prevent the bending (bending) or the distortion of seal wire 1 effectively in conduit, especially near the crooked or distortion junction surface 14 by the resistance to sliding that makes seal wire 1.
As this material that can reduce friction, for example can list: the polyolefin of polyethylene, polypropylene etc., polrvinyl chloride, polyester (PET, PBT etc.), polyamide, polyimides, polyurethanes, polystyrene, Merlon, silicones, fluororesin (PTFE, ETFE etc.) or their composite.
When wherein especially using fluororesin (or contain its composite), can reduce the frictional resistance (resistance to sliding) between seal wire 1 and the pipe inner wall more effectively, improve sliding, make the operability of the seal wire 1 in the conduit better.In addition, by the way, when seal wire 1 moves and/or rotates, can also prevent the bending (bending) of seal wire 1 or near the crooked or distortion distortion, the especially weld part more effectively in conduit.
In addition, when using fluororesin (or contain its composite), by baking, blow method such as scrape, can carry out under the heated state, carry out the covering on guidewire body 10 resin material.Thus, can allow the cohesive between guidewire body 10 and the resin coating cap rock 8,9 good especially.
In addition, if resin cover layer 8,9 is made of silicones (or contain its composite), when forming resin coating cap rock 8,9 (on guidewire body 10, covering),, also can on guidewire body 10, form conscientiously and the resin coating cap rock 8,9 of good bond so even do not heat.That is, resin coating cap rock 8,9 constitute by silicones (composite that perhaps comprises it) situation under owing to can use the material etc. of reaction atherosclerotic type, so the formation of resin coating cap rock 8,9 can be carried out at ambient temperature.Thus, by at room temperature forming resin coating cap rock 8,9, not only can be easy apply can also be in fully keeping weld part 14 be operated seal wire under the state of bond strength between the 1st seal wire portion 2 and the 2nd seal wire portion 3.
In addition, the purpose that resin coating cap rock 8,9 (the especially resin coating cap rock of front) is set is the safety in order to improve in seal wire 1 being inserted blood vessel etc.For this purpose, resin coating cap rock 8, the 9 preferred materials (soft material, elastomeric material) that are rich in flexibility of using constitute.
As such material that is rich in flexibility, for example can list: the polyolefin of polyethylene, polypropylene etc., polrvinyl chloride, polyester (PET, PBT etc.), polyamide, polyimides, polyurethanes, polystyrene, silicones, polyurethane elastomer, polyester elastomer, polyamide elastomer, etc. the various elastomeric materials of thermoplastic elastomer (TPE), latex (latex) rubber, silicone rubber etc., or will make up the composite that obtains more than 2 kinds in above-mentioned each material.
Especially at resin coating cap rock the 8, the 9th, under the situation about constituting with above-mentioned thermoplastic elastomer (TPE) and various elastomeric material, owing to further improved the flexibility of seal wire 1 leading section, so when blood vessel etc. inserts, can prevent the injury to blood vessel etc. more effectively, safety is very high.
Such resin coating cap rock 8,9 can also be respectively the laminated body more than 2 layers.In addition, resin coating cap rock 8 and resin coating cap rock 9 both can constitute with commaterial, also can constitute with different materials.For example: the resin coating cap rock 8 that is positioned at seal wire 1 front is made of the above-mentioned material that is rich in flexibility (soft material, elastomeric material), and the resin coating cap rock 9 that is positioned at seal wire 1 base end side can constitute with the above-mentioned material that reduces friction.Thus, can have both raising sliding (operability) and the ambilateral benefit of raising safety.
There is no particular limitation for the thickness of resin coating cap rock 8,9, though can wait with due regard to according to formation purpose, constituent material or the formation method of resin coating cap rock 8,9, but usually both thickness (on average) of resin coating cap rock 8,9 is preferably about 1~100 μ m, is more preferably at about 1~30 μ m.If the thickness of resin cover layer 8,9 is thin excessively, then sometimes can't give full play to the formation purpose of resin coating cap rock 8,9, in addition, the phenomenon of peeling off of resin coating cap rock 8,9 might also can take place.In addition,, then might the physical characteristic of guidewire body 10 be exerted an influence, the phenomenon of peeling off of resin coating cap rock 8,9 sometimes also can take place in addition if the thickness of resin cover layer 8,9 is too thick.
And, in the present invention, on the outer peripheral face (surface) of guidewire body 10, can be used to improve resin coating cap rock 8,9 fusible processing (matsurface processing, chemical treatment, heat treatment), perhaps can also be provided with and to improve resin coating cap rock 8,9 fusible intermediate layers.
On the outer surface of leading section at least of seal wire 1, preferably apply with hydrophilic material.In the present embodiment, on the outer peripheral face of the seal wire 1 from seal wire 1 front end near the zone the cardinal extremity in tapering 16, apply with hydrophilic material.Thus, utilize hydrophilic material to carry out moistening and produced lubricity, reduced the friction (resistance to sliding) of seal wire 1, improved sliding.Therefore, improved the operability of seal wire 1.
As hydrophilic material, for example can list: cellulose family macromolecule material, poly(ethylene oxide) family macromolecule material, maleic anhydride family macromolecule material (for example maleic anhydride copolymer as ethylene methacrylic ether-maleic anhydride copolymer), acrylic amide polymer substance (for example block interpolymers of polyacrylamide, poly (glycidyl methacrylate), DMAA (PGMA-DMAA)), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone etc.
Such hydrophilic material owing to moistening (suction) brings into play lubricity, has reduced and with the frictional resistance (resistance to sliding) between the common pipe inner wall that uses of seal wire 1 as a rule.Thus, improved the sliding of seal wire 1, allowed the operability of the seal wire 1 in conduit become better.
Fig. 3 is the longitudinal sectional drawing of other embodiment of expression seal wire of the present invention.Below seal wire shown in Figure 3 being described, wherein omitted the explanation of the part identical with seal wire illustrated in figures 1 and 2, mainly is that the center describes with the difference.In addition, for convenience of description, with the right side among Fig. 3 be called " cardinal extremity ", the left side is called " front end ".In addition, in Fig. 3, for easy understanding, shortened the length on the guidewire length direction, and illustrated size on the seal wire thickness direction in the mode of exaggeration, the ratio of the length on the length on the length direction and the thickness direction is different with practical situation.
Seal wire 1 shown in Figure 3 is identical with seal wire 1 illustrated in figures 1 and 2 except not having coil 4.That is to say, seal wire 1 shown in Figure 3 has the 2nd seal wire portion 3 by the 1st seal wire portion 2 that will be configured in front and the base end side that is configured in the 1st seal wire portion 2 and utilizes guidewire body 10, the 1 seal wire portions 2 that solder joints (connection) forms and the peripheral part at the junction surface 14 between the 2nd seal wire portion 3 to be covered by metal cladding 6.
The front part (outer peripheral face of the 1st seal wire portion 2) of guidewire body 10 and base end side part (outer peripheral face of the 2nd seal wire portion 3) are covered by resin coating cap rock 8 and 9 respectively.
About the formation purpose of resin coating cap rock 8,9 and constituent material etc., identical with above-mentioned situation.In the present embodiment, the resin coating cap rock 8 that especially is positioned at seal wire 1 front preferably is made of the above-mentioned material (soft material, elastomeric material) that is rich in flexibility, and the resin coating cap rock 9 that is positioned at seal wire 1 base end side preferably is made of the above-mentioned material that reduces friction.Thus, can have both the double effects that improves sliding (operability) and improve safety.The object lesson of this situation can be listed below: resin coating cap rock 8 is made of polyurethanes, and resin coating cap rock 9 is made of fluororesin (PTFE, ETFE etc.).
As shown in Figure 3, the base end part of resin coating cap rock 8 is being terminal than the more close front end of the base end part of the 1st seal wire portion 2 place.The leading section of resin coating cap rock 9 is being terminal than the more close cardinal extremity of the leading section of the 2nd seal wire portion 3 place.The front end of the base end part of the 1st seal wire portion 2 and the 2nd seal wire portion 3 clips junction surface 14 and exposes outside.When seal wire is used for endoscope, because the base end part of resin coating cap rock 8 is different with the color of the 1st seal wire portion 2, so can identify the trend of seal wire.
The external diameter of resin coating cap rock 8 is identical with the external diameter of resin coating cap rock 9.
In addition, preferred resin cover layer 8 covers the front end of the 1st seal wire portion 2 and it is exposed, and the front end of preferred resin cover layer 8 is to have slick and sly shape.Like this, when body cavitys such as seal wire 1 insertion blood vessel, can prevent damage more effectively, improve safety its inwall.
In resin coating cap rock 8, be dispersed with the implant (particle) that constitutes by the material with radiography (material that above-mentioned X ray can't transmission etc.), can constitute radiography portion thus.
In addition, on the outer surface of leading section at least of seal wire 1, preferably apply with hydrophilic material.In the present embodiment, apply with hydrophilic material on the outer peripheral face of the seal wire 1 from the front end of seal wire 1 near the zone the cardinal extremity in tapering 16.Thus, utilize the moistening generation lubricity of hydrophilic material, reduced the friction (resistance to sliding) of seal wire 1, improved sliding.Therefore, improved the operability of seal wire 1.
In addition, hydrophilic material can also be only forms on the whole surface of the part of resin coating cap rock 8 outer surfaces or outer surface.And, also can be as the object lesson of hydrophilic material with as described above identical.
Fig. 4 is the longitudinal sectional drawing of other embodiment of expression seal wire of the present invention, and Fig. 5 will amplify the longitudinal sectional drawing that shows near the junction surface of guidewire body in the seal wire of the present invention.And, for convenience of description, the right side among Fig. 4 and Fig. 5 being called " cardinal extremity ", the left side is called " front end ".In addition, in Fig. 4 and Fig. 5 for easy understanding, shortened the length on the guidewire length direction, and illustrated size on the seal wire thickness direction in the mode of exaggeration, the length on its length direction and the ratio of the length on the thickness direction and practical situation are inequality.
Seal wire 1 as shown in Figure 4 is to insert the conduit seal wire that conduit (comprising endoscope) inner chamber uses, it has guidewire body 10 and spiral helicine coil 4, and wherein this guidewire body 10 is to form with the 2nd seal wire portion 3 solder joints (connection) that are disposed at the 1st seal wire portion 2 base end sides by the 1st seal wire portion 2 that will be disposed at front.The total length of seal wire 1, though be not particularly limited, preferably about 200~5000mm.
The 1st seal wire portion 2 is by having flexibility or elastic wire rod constitutes.Though the length of the 1st seal wire portion 2 is not particularly limited, preferably about 20~1000mm.
In the present embodiment, the 1st seal wire portion 2 has the part (external diameter successively decrease portion) of the taper that extreme direction reduces gradually before the constant part of its external diameter and the outer radial.The latter can be a place or more than two places, in the illustrated embodiment, has place's external diameter portion 15 of successively decreasing.
By such external diameter portion 15 of successively decreasing is set, rigidity (flexural rigidity, torsion rigidity) the forward end direction of the 1st seal wire portion 2 is reduced gradually, the result is that seal wire 1 obtains good flexibility at leading section, can improve the property followed, improve safety, and can prevent the generation of phenomenons such as bending blood vessel etc.
The successively decrease cone angle (external diameter slip) of portion 15 of external diameter can be to be definite value along the guidewire length direction is permanent, also can be to have the position that alongst changes.For example can be according to cone angle (external diameter slip) bigger place and less place are formed in a plurality of alternative repeatedly mutually modes.
The external diameter of the base end side of the 1st seal wire portion 2 part (from the external diameter part of portion 15 to base end side of successively decreasing) all is constant until the cardinal extremity of the 1st seal wire portion 2.
The front end utilization of the 2nd seal wire portion 3 is welded to connect (connection) to the cardinal extremity of the 1st seal wire portion 2.The 2nd seal wire portion 3 is by having flexibility or elastic wire rod constitutes.Though the length of the 2nd seal wire portion 3 is not particularly limited, preferably about 20~4800mm.
On the leading section of the 2nd seal wire portion 3, be formed with from its front end (the 2nd seal wire portion 3 foremost) to tapering 16 that the proximal direction external diameter increases gradually.And, from the tapering 16 of the 2nd seal wire portion 3 to base end side, its along the guidewire length direction everywhere external diameter be definite value substantially.
If establishing the external diameter of the 2nd seal wire portion 3 front ends (front end in tapering 16) is D2, the external diameter of the 1st seal wire portion 2 cardinal extremities is D1, then has the relation as D1<D2.Especially, D1/D2 is preferably about 0.2~0.98, more preferably about 0.5~0.9.By within such scope, owing to guaranteed the area at the junction surface 14 between the 1st seal wire portion 2 and the 2nd seal wire portion 3, thus obtained sufficient joint strength, and can also allow the 1st seal wire portion 2 become the seal wire that is rich in flexibility simultaneously.
The mean outside diameter of the 1st seal wire portion 2 is littler than the mean outside diameter of the 2nd seal wire portion 3.Thus, in seal wire 1, be rich in flexibility in the 1st seal wire portion 2 as its front, rigidity then relative in the 2nd seal wire portion 3 as base end side is higher, so can have both the flexibility of leading section and good operability (propelling property, torque transfer).
And, by on the leading section of the 2nd seal wire portion 3, having tapering 16, physical characteristic from 3 to the 1st seal wire portions 2 of the 2nd seal wire portion, especially elastic energy changes equably, place, 14 front and back, junction surface (composition surface) in two seal wire portions 2,3 can bring into play good propelling and torque transfer, has improved resistance to bend(ing).
The constituent material of the 1st seal wire portion 2 and the 2nd seal wire portion 3 is not particularly limited, respectively as described above, for example can use: rustless steel (for example full kind of SUS such as SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302), piano wire, cobalt be alloy, show anelastic alloy various metal materials such as (comprising superelastic alloy).Wherein especially preferably show anelastic alloy (comprising superelastic alloy), more preferably superelastic alloy.
Though the 1st seal wire portion 2 and the 2nd seal wire portion 3 also can constitute with different materials, preferably the metal material with identical or identical type (main metal material equates in the alloy) constitutes.Thus, make the bond strength at junction surface (weld part) 14 higher,, also can not produce break-off, can bring into play good torque transfer etc. even the external diameter at junction surface 14 is little.
At this moment, the 1st seal wire portion 2 and the 2nd seal wire portion 3 are that alloy constitutes by Ni-Ti respectively preferably.In addition, the 1st seal wire portion 2 and the 2nd seal wire portion 3 preferably are made of superelastic alloy respectively.Thus, can guarantee, and can also guarantee enough rigidity (flexural rigidity, torsion rigidity) in the base end side part of guidewire body 10 from the distolateral forward good flexibility in the tapering 16 of guidewire body 10.Thus, seal wire 1 is obtaining good propelling and torque transfer, when having guaranteed good operability, so obtain good flexibility at the front place, restoratively improved safety and to the property followed of blood vessel, bile duct, ductus pancreaticus.
Under the situation that the 1st seal wire portion 2 and the 2nd seal wire portion 3 are made of different materials, preferred the 1st seal wire portion 2 and the 2nd seal wire portion 3 have common element.For example the 1st seal wire portion 2 is that Ni-Ti is an alloy, and the 2nd seal wire portion 3 is rustless steels, and its common element is exactly a nickel so.By possessing common element, improved weld strength.As another example, the 1st seal wire portion 2 is that Ni-Ti is an alloy, and the 2nd seal wire portion 3 is that Co-Ni-Cr is an alloy, and so common element is exactly a nickel.The 1st seal wire portion 2 is preferably than the lower material of the 2nd seal wire portion 3 spring rates.
Configuration coil 4 on the 1st seal wire portion 2 leading section peripheries.This coil 4 is parts that wire rod (fine rule) is coiled to form with helical form.The mode partly of front at least according to the 1st seal wire portion 2 of covering is provided with.In illustrated structure, the front of the 1st seal wire portion 2 is partly inserted the approximate centre portion that connects coil 4 inboards.In addition, the front of the 1st seal wire portion 2 part is to pass with the discontiguous mode of the inner surface of coil 4.Junction surface 14 is positioned at than the more close base end side of the cardinal extremity of coil 4 place.
And, in illustrated structure, though coil 4 is under the state that does not give external force, leave some spaces each other a little with the rotating wire rod of shape in the shape of a spiral, but also can be different with illustrated case, be configured under the state that does not give external force, and have no ground, space compact configuration between the rotating wire rod of helical form.
Coil 4 preferably is made of metal material.The metal material that constitutes coil 4 for example can list: rustless steel, superelastic alloy, cobalt are noble metal such as alloy and gold, platinum, tungsten or the alloy (for example platinum-iridium alloy) that comprises them etc.Especially, with the such X ray of noble metal can't transmission material situation about constituting under, seal wire 1 has obtained x-ray imaging, thus can under radioscopy, confirm in organism, to insert in its leading section position, comparatively preferred.In addition, coil 4 can also constitute its front and base end side with different materials.For example: can also front with the X ray coil of transmission material not, base end side with X ray comparatively speaking can transmission the coil of material (rustless steel etc.) constitute respectively.And, though the total length of coil 4 be not particularly limited, preferably about 5~500mm.
The base end part of coil 4 and leading section are secured in the 1st seal wire portion 2 with immobilization material 11 and 12 respectively.In addition, the pars intermedia of coil 4 (near the position of front end) is fixed in the 1st seal wire portion 2 by immobilization material 13.Immobilization material 11,12 and 13 usefulness scolding tin (wlding) constitute.But immobilization material 11,12 and 13 is not limited to scolding tin, can also be binding agent.In addition, the fixing means of coil 4 is not limited to utilize immobilization material to carry out, and for example can also use welding process.In addition, in order to prevent that body cavity walls such as blood vessel are caused damage, the front end face of immobilization material 12 preferably has circular shape.
In the present embodiment, by being provided with such coil 4, therefore, the 1st seal wire portion 2 so can reduce resistance to sliding, has further improved the operability of seal wire 1 owing to covered so contact area is little by coil 4.
And, under the situation of present embodiment,, being not limited to this though the cross section of wire rod is circular in the coil 4, the cross section of wire rod for example can also be: ellipse, tetragon (especially rectangle) or the like shape.
The 1st seal wire portion 2 that constitutes guidewire body 10 utilizes welding manner to be connected, to fix with the 2nd seal wire portion 3.Seal wire 1 thus, can obtain high bond strength at 14 places, the junction surface of the 1st seal wire portion 2 and the 2nd seal wire portion 3 (weld part), so can will transfer to the 1st seal wire portion 2 places effectively from the distortion moment of torsion of the 2nd seal wire portion 3 and propulsive force etc. with simple method.
As the welding process between the 1st seal wire portion 2 and the 2nd seal wire portion 3, though there is no particular limitation, for example can list: the modes such as electric resistance welding of the crimping that rubs, the welding of use laser point, butt seam welding etc., but, preferably adopt the mode of electric resistance welding from obtain high bond strength this respect in fairly simple mode.
As mentioned above, the 1st seal wire portion 2 cardinal extremity outer diameter D, 1 to the 2 seal wire portion, 3 front ends (front end in tapering 16) outer diameter D 2 is little, therefore, in order to weld two seal wire portions 2,3 with it on time, because poor (below be called " external diameter is poor ") of outer diameter D 2 and D 1 produces and resolve slope 5.
And, after two seal wire portions, 2,3 usefulness weldings joint, on the peripheral part at two seal wire portion 2,3 junction surfaces 14, be formed with above-mentioned disconnected sloping 5 the metal cap rock 6 of covering.Shape to this metal cap rock 6 describes below.
As Fig. 5~shown in Figure 7, the front at junction surface 14 is basic permanent the 1st seal wire portions 2 of definite value that are of external diameter, the base end side at junction surface 14 is taperings 16 of the 2nd seal wire portion 3 that increases gradually of outer radial proximal direction, and what metal cap rock 6 will be caused by the external diameter difference between the top in the cardinal extremity of the 1st seal wire portion 2 and tapering 16 producing disconnected sloping 5 hides.
Metal cap rock 6 has taper part 61, and its external diameter reduces gradually from the cardinal extremity forward end.In the example of Fig. 5~Fig. 7, though metal cap rock 6 roughly integral body all constitute with taper part 61, also can partly form taper part 61.
Such metal cap rock 6 the thickness at taper part 61 places more the forward end direction reduce more gradually.Especially in the example of Fig. 5~Fig. 7, the thickness of metal cap rock 6 reduces at straight line on the direction of front end.
In addition, be β if establish the cone angle (the outer peripheral face angle of guidewire body 10 axis relatively) of the taper part 61 of metal cladding 6, the cone angle in the tapering 16 of the 2nd seal wire portion 3 is α, then preferably satisfies the relation of 0.5≤beta/alpha≤2, is more preferably the relation that satisfies 0.75≤beta/alpha≤1.25.When satisfying such relation, because β is the value that approaches α, so become littler to external diameter variation (minimizing) rate of the 1st seal wire portion 2 from the tapering 16 of the 2nd seal wire portion 3, so, from the physical characteristic of the 2nd seal wire portion 3 to the 1st seal wire portion 2 transition portions, especially uniform elastic ground changes, and the place, 14 front and back, junction surface (composition surface) of two seal wire portions 2,3 can bring into play good propelling or torque transfer, and resistance to bend(ing) also is improved.
In structure example shown in Figure 5, expressed the situation of β ≈ α.In structure example shown in Figure 6, expressed the situation of β>α.At this moment, preferred 1<beta/alpha≤2.In structure example shown in Figure 7, expressed the situation of β<α.At this moment, preferred 0.5≤beta/alpha<1.Wherein, in Fig. 6 and structure example shown in Figure 7, especially in the structure example shown in Figure 7, because being modes according to the differential seat angle between the 1st seal wire portion 2 base end part outer peripheral faces and tapering 16 outer peripheral faces that can ease up, metal cladding 6 forms, so can bring into play above-mentioned effect more significantly.
By forming such metal cladding 6,14 front places, the junction surface external diameter suddenly that eased up changes (disconnected slope 5), so can get rid of or ease up in the stress concentration phenomenon at weld part 14 places, and from the physical characteristic of the 2nd seal wire portion 3 to the 1st seal wire portion 2 transition portions, especially rigidity and elasticity change smoothly, the place, 14 front and back, junction surface of two seal wire portions 2,3 can give play to good propelling and torque transfer, and resistance to bend(ing) also is improved.
Metal cladding 6 is to be made of the motlten metal that welding produced (fused mass) solidfied material of two seal wire portions 2,3.Therefore, the constituent material of metal cladding 6 comprises at least one side in the formation metal of the formation metal of the 1st seal wire portion 2 and the 2nd seal wire portion 3 at least, has generally included the two.Especially as mentioned above such, under the 1st seal wire portion 2 and situation that the 2nd seal wire portion 3 is made of identical or congener metal material, the constituent material of metal cladding 6 also becomes the metal identical with them and forms.
In addition, metal cladding 6 is above-mentioned motlten metal solidfied material is carried out the machining shaping and to form the shape of Fig. 5 for example~as shown in Figure 7.Thus, can allow metal cladding 6 realize desired shape and surface texture, can further improve propelling, torque transfer, the resistance to bend(ing) of seal wire 1.And, as machining, for example can also be according to for example: grind cut, the one or more kinds of compound modes among grinding, Laser Processing or the like carry out.In addition, replace machining or after machining, can also carry out chemical treatments such as etching.
Metal cladding 6 preferably forms the not such surface of continuous face on disconnected slope by such shaping.That is to say that the base end part outer peripheral face of metal cladding 6 and the leading section outer peripheral face in tapering 16 constitute the not continuous face (with reference to figure 5) on disconnected slope.
Though the average thickness of metal cladding 6 is not particularly limited, preferably about 2~300 μ m, be more preferably at about 1~200 μ m, more further preferably about 1~100 μ m.As resolute sloping 5 excessive, then the thickness of metal cladding 6 has the tendency of increase, and under the 1st seal wire portion 2 situation different with the formation metal of the 2nd seal wire portion 3, the physical characteristic (rigidity, elasticity etc.) between two seal wire portions 2,3 might can't change equably.In addition, if the thickness of metal cladding 6 is thin excessively, might can't give full play to the function of above-mentioned metal cladding 6.
Though the length of metal cladding 6 on the guidewire length direction is not particularly limited, and preferably about 0.5~2.0mm, is more preferably at about 0.5~1.0mm.
Such metal cladding 6 for example forms in the following manner.
The 1st seal wire portion 2 and the 2nd seal wire portion 3 for example meet sb. at the airport by butt seam welding, make the cardinal extremity of the 1st seal wire portion 2 and the front end of the 2nd seal wire portion 3 add press contacts when being loaded predetermined voltage.Add press contacts by this, forming thin (for example about 0.01~50 μ m) melting layer on the contact portion, this melting layer cooling curing and form junction surface 14 firmly is joined together the 1st seal wire portion 2 and the 2nd seal wire portion 3.When carrying out this welding, the zone of 0.2~8mm left and right sides scope from the 14 beginning pro-extreme directions of junction surface (for example) accumulated fused mass in the inside on disconnected slope 5, and this fused mass solidifies, and the external diameter that has just in time increased the 1st seal wire portion 2 has formed bump.The fused mass curing of this bump the 1st seal wire portion 2 and/or the 2nd seal wire portion 3 forms.
Owing to exceeding outer diameter D 2, the bump of this fused mass forms.Therefore to moderately remove the part of this bump and carry out shaping (shape adjustments), can obtain the metal cladding 6 of desired shape as Fig. 5~as shown in Figure 7 by such mode.Can list as shaping methods: bump is for example ground cut, the chemical treatment of machining such as grinding, Laser Processing or etching etc.After carrying out machining, can also carry out with polish is the chemical treatment of purpose.Shaping through such can allow the outer peripheral face of metal cladding 6 become level and smooth in fact face.
And, the taper part 61 of metal cladding 6, though be as shown in Figure 5, its external diameter increases with linear fashion to proximal direction gradually from front end, taper part 61 both can form concave surface, perhaps also can form convex surface conversely.In addition, whole or a part of can also the constituting with the such cover layers such as resin of aftermentioned of metal cladding 6 covers.
As shown in Figure 4, guidewire body 10 has the whole or a part of resin coating cap rock 8,9 that covers its outer peripheral face (outer surface).In the illustrated embodiment, on the 1st seal wire portion 2 and the 2nd seal wire portion 3 peripheries, be respectively arranged with resin coating cap rock 8 and 9.
These resin coating cap rocks 8,9 can form for realizing various purposes, and one of them example is: by reducing the friction (resistance to sliding) of seal wire 1, improve sliding, the operability of seal wire 1 is improved.
In addition, different with diagram, resin coating cap rock 8 or 9 can also be provided with according to the mode of the periphery that covers metal cladding 6.So, the external diameter of the guidewire body 10 of can further easing up changes (variation of cone angle), further improves propelling, torque transfer, the resistance to bend(ing) of seal wire 1, can also improve the move operation on seal wire 1 length direction simultaneously.
In order to seek the reduction of seal wire 1 friction (resistance to sliding), resin coating cap rock 8, the 9 preferred materials that can reduce friction as described as follows of using constitute.Thus, owing to having reduced and, having improved sliding, allow the operability of conduit inner guide wire 1 become better with the frictional resistance (resistance to sliding) between the seal wire 1 common pipe inner wall that uses.In addition, by having reduced the resistance to sliding of seal wire 1, when seal wire 1 moves and/or rotates, can prevent the bending (bending) or the distortion of seal wire 1 more effectively in conduit, especially near the crooked or distortion junction surface 14.
As the material of such reduced friction, for example can list: the polyolefin of polyethylene, polypropylene etc., polrvinyl chloride, polyester (PET, PBT etc.), polyamide, polyimides, polyurethanes, polystyrene, Merlon, silicones, fluororesin (PTFE, ETFE etc.) or their composite.
Wherein especially under the situation of using fluororesin (or contain its composite), can reduce the frictional resistance (resistance to sliding) between seal wire 1 and the pipe inner wall more effectively, make sliding further improve, make the operability of the interior seal wire 1 of conduit better.In addition, by the way, when seal wire 1 moves and/or rotates, can also prevent the bending (bending) of seal wire 1 or near the crooked or distortion distortion, the especially weld part more effectively in conduit.
In addition, under the situation of using fluororesin (or contain its composite), by baking, blow method such as scrape, can carry out under the heated state, carry out covering to guidewire body 10 to resin material.Thus, can make the cohesive between guidewire body 10 and the resin coating cap rock 8,9 good especially.
In addition, if resin cover layer 8,9 usefulness silicones (or contain its composite) constitute, when forming resin coating cap rock 8,9 (covering on the guidewire body 10),, also can on guidewire body 10, form practical and firm adherent resin coating cap rock 8,9 so even do not heat.That is, under the situation that resin coating cap rock 8,9 is made of silicones (or contain its composite), owing to can use the material etc. of reaction atherosclerotic type, so the formation of resin coating cap rock 8,9 can be carried out at ambient temperature.Thus,, not only can apply easily, but also can be in fully keeping junction surface 14 seal wire be operated under the state of bond strength between the 1st seal wire portion 2 and the 2nd seal wire portion 3 by at room temperature forming resin coating cap rock 8,9.
In addition, the purpose that resin coating cap rock 8,9 (the especially resin coating cap rock 8 of front) is set is raising safety in seal wire 1 being inserted blood vessel etc. the time.For this purpose, resin coating cap rock 8, the 9 preferred materials (soft material, elastomeric material) that are rich in flexibility that adopt constitute.
Material that is rich in flexibility as such for example can list: the polyolefin of polyethylene, polypropylene etc., polrvinyl chloride, polyester (PET, PBT etc.), polyamide, polyimides, polyurethanes, polystyrene, silicones, polyurethane elastomer, polyester elastomer, polyamide elastomer, etc. thermoplastic elastomer (TPE), latex (latex) rubber, silicone rubber etc. various elastomeric materials or will make up the composite that obtains more than 2 kinds among them.
Especially under the situation that resin coating cap rock 8,9 is made of above-mentioned thermoplastic elastomer (TPE) or various elastomeric material, owing to further improved the flexibility of seal wire 1 leading section, so when blood vessel etc. inserts, can prevent the injury to blood vessel etc. more reliably, safety is very high.
Such resin coating cap rock 8,9 can also be respectively the laminated body more than 2 layers.In addition, resin coating cap rock 8 and resin coating cap rock 9 both can constitute with commaterial, also can constitute with different materials.For example: the resin coating cap rock 8 that is positioned at seal wire 1 front is made of the above-mentioned material that is rich in flexibility (soft material, elastomeric material), and the resin coating cap rock 9 that is positioned at seal wire 1 base end side can constitute with the above-mentioned material that reduces friction.Thus, can have both raising sliding (operability) and the ambilateral benefit of raising safety.
There is no particular limitation for the thickness of resin coating cap rock 8,9, though can wait with due regard to according to formation purpose, constituent material or the formation method of resin coating cap rock 8,9, but usually both thickness (on average) of resin coating cap rock 8,9 is preferably about 1~100 μ m, is more preferably at about 1~30 μ m.If the thickness of resin cover layer 8,9 is thin excessively, then often can't give full play to the formation purpose of resin coating cap rock 8,9, in addition, the phenomenon of peeling off of resin coating cap rock 8,9 sometimes also can take place.In addition,, might the physical characteristic of guidewire body 10 be exerted an influence, the phenomenon of peeling off of resin coating cap rock 8,9 might also can take place in addition if the thickness of resin cover layer 8,9 is blocked up.
And, in the present invention, on the outer peripheral face (surface) of guidewire body 10, can be used to improve the fusible processing (matsurface processing, chemical treatment, heat treatment) of resin coating cap rock 8,9, the fusible intermediate layer that can improve resin coating cap rock 8,9 perhaps can also be set.
On the outer surface of leading section at least of guidewire body 1, preferably apply with hydrophilic material.In the present embodiment, on the outer peripheral face of the seal wire 1 from seal wire 1 front end near the zone the cardinal extremity in tapering 16, apply with hydrophilic material.Thus, utilize the moistening lubricity that produced of hydrophilic material, reduced the friction (resistance to sliding) of seal wire 1, improved sliding.Therefore, improved the operability of seal wire 1.
As hydrophilic material, for example can list: cellulose family macromolecule material, ethylene oxide polymer substance, maleic anhydride family macromolecule material (for example maleic anhydride copolymer as ethylene methacrylic ether-maleic anhydride copolymer), acrylic amide polymer substance (for example block interpolymers of polyacrylamide, poly (glycidyl methacrylate), DMAA (PGMA-DMAA)), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone (polyvinyl pyrrolidone) or the like.
Such hydrophilic material as a rule, owing to moistening (suction) brings into play lubricity, reduced and and the common pipe inner wall that uses of seal wire 1 between frictional resistance (resistance to sliding).Thus, improved the sliding of seal wire 1, allowed the operability of the seal wire 1 in conduit become better.
Fig. 8 is the longitudinal sectional drawing of other embodiment of expression seal wire of the present invention.Below seal wire shown in Figure 8 is described, but the explanation of wherein having omitted the part identical with the seal wire of Fig. 4~shown in Figure 7 mainly is that the center describes with the difference.In addition, for convenience of description, with the right side among Fig. 3 be called " cardinal extremity ", the left side is called " front end ".In addition, in Fig. 8, for easy understanding, shortened the length on the guidewire length direction, and illustrated size on the seal wire thickness direction in the mode of exaggeration, the ratio of the length on the length on the length direction and the thickness direction is different with practical situation.
Seal wire 1 shown in Figure 8 is identical with the seal wire 1 of Fig. 4~shown in Figure 7 except not having coil 4.That is to say, seal wire 1 shown in Figure 8 has guidewire body 10, this guidewire body 10 by will being configured in front the 1st seal wire portion 2 and the 2nd seal wire portion 3 solder joints (connection) of the base end side that is configured in the 1st seal wire portion 2 form, what form on the junction surface 14 between the 1st seal wire portion 2 and the 2nd seal wire portion 3 disconnected sloping 5 hides by forming metal cladding 6.
The front part (outer peripheral face of the 1st seal wire portion 2) and the base end side part (outer peripheral face of the 2nd seal wire portion 3) of guidewire body 10 are covered by resin coating cap rock 8 and 9 respectively.
About the formation purpose of resin coating cap rock 8,9 and constituent material etc., identical with above-mentioned situation.In the present embodiment, the resin coating cap rock 8 that especially is positioned at seal wire 1 front preferably constitutes with the above-mentioned material (soft material, elastomeric material) that is rich in flexibility, and the resin coating cap rock 9 that is positioned at seal wire 1 base end side preferably is made of the above-mentioned material that reduces friction.Therefore, can have both the double effects that improves sliding (operability) and improve safety.Object lesson as this situation can be listed below: resin coating cap rock 8 is made of polyurethanes, and resin coating cap rock 9 is made of fluororesin (PTFE, ETFE etc.).
As shown in Figure 8, the base end part of resin coating cap rock 8 is being terminal than the more close front end of the base end part of the 1st seal wire portion 2 place.The leading section of resin coating cap rock 9 is being terminal than the more close cardinal extremity of the leading section of the 2nd seal wire portion 3 place.The front end of the base end part of the 1st seal wire portion 2 and the 2nd seal wire portion 3 clips junction surface 14 and exposes outside.When in endoscope, using seal wire, because the base end part of resin coating cap rock 8 is different with the color of the 1st seal wire portion 2, so can identify the trend of seal wire.
The external diameter of resin coating cap rock 8 is identical with the external diameter of resin coating cap rock 9.
In addition, preferred resin cover layer 8 covers the front end of the 1st seal wire portion 2 and does not make its situation about exposing, and the front end of resin coating cap rock 8 preferably has slick and sly shape.Like this, when body cavitys such as seal wire 1 insertion blood vessel, can prevent damage more effectively, improve safety body cavity walls.
Also can in resin coating cap rock 8, be dispersed with the implant (particle) that constitutes by the material with radiography (material that above-mentioned X ray can't transmission etc.), constitute radiography portion thus.
In addition, on the outer surface of leading section at least of seal wire 1, preferably apply with hydrophilic material.In the present embodiment, apply with hydrophilic material on the outer peripheral face of the seal wire 1 in from the front end of seal wire 1 near the zone the cardinal extremity in tapering 16.Thus, utilize the moistening generation lubricity of hydrophilic material, reduced the friction (resistance to sliding) of seal wire 1, improved sliding.Therefore, improved the operability of seal wire 1.
In addition, hydrophilic material can also be only forms on the whole surface of the part of resin coating cap rock 8 outer surfaces or outer surface.And, as the object lesson of hydrophilic material with as described above identical.
Fig. 9, Figure 10, Figure 11 and Figure 12 are respectively the longitudinal sectional drawings that amplifies near other structure example guidewire body 10 junction surfaces 14 in the expression seal wire 1.Below each structure example shown in these figure being described successively, but omit its explanation for the content identical with the seal wire shown in above-mentioned Fig. 4~Fig. 7, is that the center describes with the difference.In addition, for convenience of description, the right side among Fig. 9~Figure 12 is called " cardinal extremity ", the left side is called " front end ".In addition, in Fig. 9~Figure 12,, shortened the size on guidewire body 10 length directions for easy understanding, and illustrating the thickness of guidewire body 10 in the mode of exaggeration, the ratio and the practical situation of the size on the length on the length direction and the thickness direction are different.
In the guidewire body 10 shown in Figure 9, the base end part external diameter of the 1st seal wire portion 2 is constant, and the external diameter of the 2nd seal wire portion 3 leading sections is constant (not having tapering 16).And the outer diameter D 1 of the 1st seal wire portion 2 cardinal extremities is set forr a short time than the outer diameter D 2 of the 2nd seal wire portion 3 front ends.In addition structure is identical with the embodiment that describes according to above-mentioned Fig. 5~Fig. 7 or Fig. 8.
The 1st seal wire portion 2 base end part external diameters of guidewire body 10 as shown in figure 10 are constant, have on the 2nd seal wire portion 3 leading sections to compare the bigger part of external diameter with base end side.Particularly, has its external diameter on the leading section of the 2nd seal wire portion 3 towards tapering 17 that the front end direction increases gradually.The cardinal extremity outer diameter D 1 of the 1st seal wire portion 2 is set forr a short time than the front end outer diameter D 2 of the 2nd seal wire portion 3.The cardinal extremity outer diameter D 1 of the 1st seal wire portion 2 is set forr a short time than the base end side external diameter of the 2nd seal wire portion 3.The cardinal extremity outer diameter D 1 of the 1st seal wire portion 2 also can be set greatlyyer than the base end side external diameter of the 2nd seal wire portion 3.Metal cladding 6 be arranged on the 1st seal wire portion 2 base end parts around.The direction thickness of metal cladding 6 towards the 2nd seal wire portions 3 increases gradually.Its external diameter of direction of metal cladding 6 towards the 2nd seal wire portions 3 becomes big gradually.The maximum outside diameter part of metal cladding 6 is consistent with the maximum outside diameter part in tapering 17.The maximum outside diameter part of metal cladding 6 partly is positioned at 14 places, junction surface with the maximum outside diameter in tapering 17.
The base end part external diameter of the 1st seal wire portion 2 can also diminish gradually towards the direction of the 2nd seal wire portion 3.In addition structure be identical according to the illustrated embodiment of above-mentioned Fig. 5~Fig. 7 or Fig. 8.
Guidewire body 10 shown in Figure 11 has the leading section external diameter constant (not having tapering 16) of tapering 18, the 2 seal wire portions 3 that its outer radial proximal direction increases gradually on the base end part of the 1st seal wire portion 2.And the cardinal extremity outer diameter D 1 of the 1st seal wire portion 2 is set forr a short time than the front end outer diameter D 2 of the 2nd seal wire portion 3.In addition structure is with identical according to the illustrated embodiment of above-mentioned Fig. 5~Fig. 7 or Fig. 8.
Guidewire body 10 shown in Figure 12 further is welded to connect the 3rd seal wire portion 19 on the cardinal extremity of the 2nd seal wire portion 3 based on above-mentioned structure shown in Figure 9 (near the structure the 2, the 2nd seal wire portion 3 of the 1st seal wire portion and their junction surface 14 is identical).
The leading section external diameter of the base end part external diameter of the 2nd seal wire portion 3 and the 3rd seal wire portion 19 all is constant.And the cardinal extremity outer diameter D 3 of the 2nd seal wire portion 3 is set forr a short time than the front end outer diameter D 4 of the 3rd seal wire portion 19.The front end of the cardinal extremity of the 2nd seal wire portion 3 and the 3rd seal wire portion 19 utilizes welding to engage, form junction surface 14 thus, on the peripheral part at this junction surface 14, form metal cladding 6 as hereinbefore, in order to hide by the external diameter difference between outer diameter D 3 and the outer diameter D 4 caused producing disconnected sloping 5.
D2 and D3 can be the same or different.In addition, though diagram not, the 2nd seal wire portion 3 and the 3rd seal wire portion 19 at least one of them, locate for example can have and tapering 16 or 17 identical taperings in the place of needs.
Constituent material to the 3rd seal wire portion 19 is not particularly limited, and for example can list: rustless steel (for example full kind of SUS such as SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302), piano wire, cobalt be alloy, show the various metal materials of anelastic alloy (comprising superelastic alloy) etc.Wherein especially preferably show anelastic alloy (comprising superelastic alloy), more preferably superelastic alloy.
Though the 2nd seal wire portion 3 also can be made of different materials with the 3rd seal wire portion 19, preferably the metal material by identical or same kind (in the alloy main metal material identical) constitutes.Thus, allow the bond strength at the junction surface (weld part) 14 between the 2nd seal wire portion 3 and the 3rd seal wire portion 19 become higher, break-off can not take place, can bring into play better torque transfer.
At this moment, the 2nd seal wire portion 3 and the 3rd seal wire portion 19 preferably are made of above-mentioned superelastic alloy respectively, are that alloy constitutes with Ni-Ti more preferably wherein.Thus, can slowly allow flexibility increase towards the direction of guidewire body 10 leading sections (from the 3rd seal wire portion 19 to the 1st seal wire portion 2), the base end side part of guidewire body 10 especially in the 3rd seal wire portion 19, can also be guaranteed enough rigidity (flexural rigidity, torsion rigidity) simultaneously.Thus, the seal wire 1 that has used guidewire body shown in Figure 12 10 is having obtained good propelling and torque transfer when having guaranteed good operability, also obtained good flexibility, restorative in front, so also improved the property followed, safety to blood vessel, bile duct, ductus pancreaticus.
And for guidewire body shown in Figure 12 10, the structure except above-mentioned is with identical according to the illustrated embodiment of above-mentioned Fig. 5~Fig. 7 or Fig. 8.
In the present invention, any two the above structures among each embodiment shown in above-mentioned Fig. 4~Figure 12 can also be made up and implement.
Figure 13 and Figure 14 are respectively the figure of the user mode in expression is used in seal wire 1 of the present invention among the PTCA.
Among Figure 13 and Figure 14, symbol 40 is that aortic arch, symbol 50 are that right coronary artery, the symbol 60 of heart is that right coronary artery peristome, symbol 70 are angiostenosis portion (morbidity portions).In addition, symbol 30 is to be used for seal wire 1 is imported the guide catheter that right coronary artery is used effectively from the thigh tremulous pulse; Symbol 20 is that ballon catheter is used in the narrow expansion, has in its leading section office and can freely expand the balloon 201 that shrinks.Following operation is all carried out under radioscopy.
As shown in figure 13, make that the front end of seal wire 1 is outstanding from the front end of guide catheter 30, and be inserted in the right coronary artery 50 from right coronary artery peristome 60.And, advance seal wire 1, be inserted in the right coronary artery 50 from front end, its front end stops in the position that surpasses angiostenosis portion 70.Thus, guaranteed the path of guide catheter 20.And at this moment, the junction surface 14 of seal wire 1 (metal cladding 6) is positioned at the descending large artery trunks side (organism) of aortic arch.
Then, as shown in Figure 14, the feasible front end that inserts the ballon catheter 20 that connects from seal wire 1 base end side is given prominence to from the front end of guide catheter 30, and then it is moved on along seal wire 1, be inserted in the right coronary artery 50 from right coronary artery peristome 60, the position that arrives angiostenosis portion 70 at balloon 201 stops constantly.
Then, use fluid, make balloon 201 expand, and allow angiostenosis portion 70 expand from the base end side injection balloon expansion of ballon catheter 20.By such method, the cholesterol deposits such as (cholesterol) that is deposited in angiostenosis portion 70 blood vessel places is widened by physics, can eliminate blood flow and hinder.
More than, though seal wire of the present invention is illustrated, the invention is not restricted to this according to illustrated embodiment, the various piece that constitutes seal wire can also be replaced with the part of the arbitrary structures that can bring into play identical function.In addition, can also increase other component part arbitrarily.
In addition, the purposes of seal wire of the present invention is not limited to above-mentioned situation about being used in like that among the PTCA, for example can also be used in angiography and via maneuver of endoscope or the like.

Claims (13)

1, a kind of seal wire is characterized in that:
Has guidewire body, this guidewire body possesses wire the 1st seal wire portion of the front of being configured in and is configured in wire the 2nd seal wire portion of the base end side of above-mentioned the 1st seal wire portion, this guidewire body is that the front end solder joints with the cardinal extremity of above-mentioned the 1st seal wire portion and above-mentioned the 2nd seal wire portion forms
The base end part of above-mentioned the 1st seal wire portion along its length direction everywhere external diameter be roughly definite value, the leading section of the 2nd seal wire portion is by constituting to the tapering that the proximal direction external diameter increases gradually from its front end, the cardinal extremity external diameter of above-mentioned the 1st seal wire portion is identical with the front end external diameter of above-mentioned the 2nd seal wire portion
On the composition surface peripheral part of above-mentioned the 1st seal wire portion and the 2nd seal wire portion, be formed with metal cladding.
2, the seal wire of putting down in writing as claim 1 is by ease up differential seat angle between above-mentioned the 1st seal wire portion base end part outer peripheral face and the above-mentioned tapering outer peripheral face of above-mentioned metal cladding.
3, the seal wire of putting down in writing as claim 1, above-mentioned metal cladding have the taper part that its outer radial proximal direction increases gradually, and the cone angle of this taper part is littler than the cone angle in above-mentioned tapering.
4, the seal wire of putting down in writing as claim 1, above-mentioned the 1st seal wire portion is made of metalloid material identical or of the same race with above-mentioned the 2nd seal wire portion.
5, the seal wire of putting down in writing as claim 4, above-mentioned the 1st seal wire portion and above-mentioned the 2nd seal wire portion constitute with superelastic alloy respectively.
6, the seal wire of putting down in writing as claim 1, above-mentioned metal cladding is by obtaining carrying out machining by the motlten metal solidfied material that welding produced between above-mentioned the 1st seal wire portion and the 2nd seal wire portion.
7, the seal wire of putting down in writing as claim 1, the average thickness of above-mentioned metal cladding are 1~100 μ m.
8, a kind of seal wire is characterized in that:
Has guidewire body, this guidewire body possesses wire the 1st seal wire portion of the front of being configured in and is configured in wire the 2nd seal wire portion of above-mentioned the 1st seal wire portion base end side, this guidewire body is that the front end solder joints with the cardinal extremity of above-mentioned the 1st seal wire portion and above-mentioned the 2nd seal wire portion forms
The cardinal extremity external diameter of above-mentioned the 1st seal wire portion is bigger than the front end external diameter of above-mentioned the 2nd seal wire portion, also is formed with metal cladding being used for hiding the disconnected slope that is produced by their external diameter difference,
Above-mentioned metal cladding is made of the motlten metal that welding produced between above-mentioned the 1st seal wire portion and above-mentioned the 2nd seal wire portion.
9, the seal wire of putting down in writing as claim 8, above-mentioned metal cladding are that to carry out shaping resultant by above-mentioned motlten metal solidfied material being carried out machining.
10, the seal wire of putting down in writing as claim 8, above-mentioned metal cladding have the part that its thickness forward end direction reduces gradually.
11, the seal wire of putting down in writing as claim 8, the leading section of above-mentioned the 2nd seal wire portion is made of the tapering that changes along its length direction external diameter.
12, the seal wire of putting down in writing as claim 11, above-mentioned tapering are the parts that increases gradually to the cardinal extremity external diameter from front end.
13, the seal wire of putting down in writing as claim 12, above-mentioned metal cladding have the taper part that its external diameter reduces gradually from the cardinal extremity forward end, are the cone angle in β, above-mentioned tapering when being α at the cone angle of this taper part, satisfy the relation of 0.5≤beta/alpha≤2.
CN2006100724028A 2005-04-15 2006-04-11 Guide wire Expired - Fee Related CN1846803B (en)

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