WO2002004059A1

WO2002004059A1 - Medical guide wire, medical gadget, and medical gadget producing method

Info

Publication number: WO2002004059A1
Application number: PCT/JP2001/005819
Authority: WO
Inventors: Shuichi Miyazaki; Takashi Kawabata; Seiji Shimura
Original assignee: Japan Lifeline Co., Ltd
Priority date: 2000-07-06
Filing date: 2001-07-04
Publication date: 2002-01-17

Abstract

A medical guide wire comprising a core wire having a main core portion and a tip core portion having a mean outer diameter smaller than the mean outer diameter of the main core portion and usually made of metal, and a tip-side super-elastic coating layer covering at least a portion of the outer periphery of the tip core portion and made of super-elastic metal. The thickness of the super-elastic coating layer is 50 µm or less, and the coating layer is formed by sputtering.

Description

S ^ method for documentation guidewires, medical and medical devices

The present invention combats secret guidewires, medical devices and optional devices.漏 leak

For example, resin tubes are used in medical instruments such as custom catheters, but for medical use, thinner tubes are required. For this reason, there is a problem that the strength of the tube in the vehicle direction is reduced, and the push-in characteristics (pushability) are deteriorated. Therefore, it is key to form the catheter tube with gold J ^ tube.However, with a normal gold tube, it is necessary to insert the tube well into a meandering part such as a blood vessel, which lacks Mtt. Is difficult.

Therefore, it has been proposed that the tube constituting a catheter or the like is composed of a simple alloy such as a nickel-titanium alloy.

As for ^^ method of gold tube made of nickel-titanium alloy, etc., there is a method to bend the metal basket into a tube shape, seam weld the joint, and extend the length. . However, this male has a problem in that there is a limit to the thinness of the tube, and the strength of the shimyo becomes a problem, and the tube is vulnerable to bending.

It is also known to manufacture gold tubes by using a machine such as extrusion β and pultrusion. However, even with this method, there was a limit in reducing the thickness of the tube.

Although Sffi is known to form a metal thin film on a metal surface by using a plating method, the electrolytic plating method forms a metal film on a surface of a non-conductive material such as a synthetic resin. It is not possible. Also metal! An electroless plating method that can form a gold film on the surface of a metal material is also known, but a metal thin film can be used. The amount of metal that can be cut is limited, and an S5 \ -based gold film cannot be formed. On the other hand, there is a need to insert a catheter to a predetermined position in a blood vessel for examination. The catheter is highly flexible, and it is difficult for a caterpillar # ¾ insect to push it to a predetermined position inside a blood vessel. Therefore, a guide wire is inserted into the blood vessel in advance, and the catheter is guided to a predetermined position in the blood vessel along the guide wire.

A guide wire may be inserted into a meandering blood vessel so as not to damage the inner wall of the blood vessel. Also, in order to position the tip of the guide wire in the arterial blood vessel near the heart, the tip of the guide wire is often made to have a portion bent to R = 20 mm or less. If this ί is permanently changed, sending of the ¾ ^ becomes inconvenient. Therefore, it is important that the guide wire has excellent resilience, particularly at the distal end portion.

Therefore, as the guide wire in Agata, the length of the previous guide wire, hi 小さく, was made smaller than that of the other parts, and a coil spring was attached to the outer periphery of the tip to improve the flexibility of the tip. Guide wires have been proposed.

However, in such a conventional guidewire, since the guidewire and the coil spring are made of stainless steel, the elasticity of the joint is not sufficient, and a strong bend of R = 20 mm or less is inserted into the blood vessel. Have problems with their followability.

Further, in order to improve elasticity, the guide wire is also made of a superelastic metal such as a nickel-titanium alloy. However, if the entire guidewire is made of a simple metal, the elasticity of the guidewire is improved and the followability of the bend is improved. There is a problem in the pushing characteristics at the time of pushing in the blood vessel.

In order to solve these problems, some guidewires are made of stainless steel and the other end is made of a simple metal. However, it is difficult to join the stainless metal and the metallic metal, and the joining tends to be insufficient, and the strength at the joint becomes a problem. Also, depending on the state of the blood vessel of the patient using the guide wire, the shape of the tip of the guide wire may be previously bent into a substantially arc shape or L shape. However, it is difficult to bend the @ -metal because it is difficult to plasticize! Open invention

The present invention has been made in view of such circumstances, and has a method of manufacturing a medical device capable of freely controlling intellectual properties such as elasticity, rigidity, ®K, conductivity, and ionization tendency. This is the first purpose.

A second object of the present invention is to provide an E tool that easily follows a strongly bent portion of a living body such as a blood vessel and deforms so that it can be restored, and has excellent pushing characteristics.

A third object of the present invention is to provide a flexible body that has excellent elasticity and can easily follow a body cavity having a strongly bent portion so that the body can be restored to its original position. The purpose of the present invention is to provide a guide wire which is excellent in quality and easy to bend.

In order to achieve the first object, the method of the accessory according to the present invention includes a step of forming a metal thin film on a surface or an intermediate layer of a member constituting the accessory by sputtering. The metal thin film may be formed at least on the surface of the member or at least on the intermediate layer, and is not necessarily formed over the entire circumference.

The member constituting the accessory is not particularly limited, but is, for example, a synthetic resin, a metal, or a ceramic.

In order to achieve the second object, the accessory according to the present invention has an active metal thin film having a thickness of 50 m or less.

In the present invention, the fibrous metal is not particularly limited, and examples thereof include nickel titanium, iron-manganese-silicon, copper-aluminum-nickel, and amorphous metal. In the present invention, the term “comprehensiveness” means that the range of recoverable elasticity is large, for example, 1% to 10%, and that the temperature is 1% to 10%. Large elasticity. In addition, the superelastic metal has an elastic modulus in the superelastic region smaller than that of iron or stainless steel, and is excellent in flexibility.

According to the medical device Sit method according to the present invention, a composite structure of a thin film metal and a metal, It is possible to manufacture an optional tool consisting of a composite structure of any combination, such as a composite structure of a film metal and a ceramic, a composite structure of a thin film metal and a synthetic resin. Therefore, according to the present invention, according to the present invention, it is possible to manufacture an optional tool that can freely control the separation ttt such as elasticity, concealment, hardness, conductivity, and ionization tendency. Medical devices have an elastic metal film with a thickness of 5 or less, so they have excellent resilience and can easily follow even strongly bent parts and can be restored. In addition, the operating force of the accessory in the area of ¾¾¾ is excellently extended to the tip, and the push-in property is excellent.

In order to achieve the third object, the ugly guidewire according to the present invention includes:

The average length of the ^ Sff part and the part of the last name ^ part has a small average part i 平均

Self-tip; Covers at least the outer periphery of the Tato perimeter of the E part, and has a 'metal-headed Sffl monolithic' skin cover layer.

In the middle of the 1 ^ portion, the tiff also has a small-diameter portion with an average diameter smaller than the average outer diameter of the occupied portion.

The formed intermediate superelastic coating layer may be formed.

The method for forming the coating on the outer peripheral surface of the portion is not particularly limited, and examples thereof include a vapor deposition method and a sputtering method, and a sputtering method is preferable for forming a high quality conversion.

The guide wire according to the present invention preferably has a non-metallic biocompatible coating film integrally coated on the peripheral surface thereof. The biocompatible coating film is, for example, an olefin such as polyethylene. Examples of the coating film include, but are not limited to, polymers such as polyimide polymers and polyamide polymers, and siloxane polymers, and other commonly used polymers, etc. The coating film is not limited to polymers. It may be an unintentional coating film such as light carbon or carbon such as diamond-like carbon, but it is preferably non-metallic, ie, it is not a non-metallic biocompatible coating film: ^ In addition to the possibility of metal allergies due to elution of ions, the removal of metals causes a potential difference, This is because it is often. Biocompatible coating film Is not particularly limited, but is preferably from 0.1 to 10 m, and more preferably from 0.2 to 0.6 m. In the present invention, the entire outer surface of the guide wire may be covered with a plating film or the like, since metal ions such as gold and platinum are difficult to elute, and the outer surface of the plating film may be covered with a biocompatible coating film. May be.

It is preferable that a coil spring is mounted on the outer periphery of the tip side coating layer or the biocompatible coating film formed on the knitting tip portion along the direction of the vehicle fc¾ ″.

In the present invention, the core wire is usually made of metal. In the present invention, the term “normal metal” means a superelastic metal. Preferred normal metals are preferably plastic metals, such as stainless steel, gold, platinum, aluminum, steel, tungsten, tantalum, or alloys thereof. Superelastic metal is used.

In the medical guidewire according to the present invention, since the distal end of the core wire is covered with m metal, the core wire has excellent elasticity and can easily follow the inside of a body cavity having a strongly bent portion. ¾ changes to recoverable. In addition, since the base end of the core wire is composed of a part and is usually made of a metal such as stainless steel, the operating force of the flat part of the guide wire is satisfactorily ≤≤ to the tip of the wire, and the push-in characteristic is obtained. Excellent in nature.

Further, in the present invention, the distal end portion of the guide wire is not only made of the superelastic metal but has a distal end portion usually made of a metal. Depending on the use of the guidewire, the tip of the guidewire may be bent in advance into a substantially circular arc 开 e, but in the present invention, since the guidewire usually has a tip core portion made of metal, Bending by plastic shape is easy. Furthermore, since the present invention does not have a structure in which the main portion of gold is normally joined to the tip portion made of Na-metal, the strength of the joint does not matter.

In the middle of the core part, the average diameter of the part of the word ^ κ «

The guide wire according to the present invention, which forms the KM portion and the intermediate sheath made of a non-metallic material, "can provide a highly flexible guide wire even in the middle of the portion; Yes, in the body cavity where the guidewire is inserted The bent portion is not always located at the distal end portion of the guidewire, and a strong bent portion may be present even at the base end portion of the guidewire. As a guide wire to be inserted into such a body cavity, this guide wire can be used for the purpose. Brief description of 麵

Hereinafter, the present invention will be described based on an embodiment shown in FIG.

FIGS. 1A to 1C each show a method of a custom tool according to an embodiment of the present invention. FIG. 2 shows a method of manufacturing a custom tool according to an embodiment of the present invention. Schematic diagram of the device,

FIG. 3 is a cross-sectional view of a main part of a sputtering apparatus according to another example,

FIG. 4 is a schematic view of a sputter link apparatus according to still another example.

FIG. 5 is a schematic sectional view of a medical guidewire according to one embodiment of the present invention, FIG. 6 is a schematic view showing an example of use of the guidewire shown in FIG. 5,

7 and 8 are schematic cross-sectional views of a guide wire according to still another embodiment of the present invention. The best bear to bear the invention;

Hereinafter, the present invention will be described in detail based on embodiments shown in the drawings. As shown in FIG. 1A, in the present embodiment, the entire surface or the surface of the core material 100 constituting the accessory 120 is formed by a magnetron sputtering method, preferably a gold film having a thickness of 50 m or less. Form 60. The core material 100 is not particularly limited, but is made of, for example, metal, ceramics, synthetic resin, or the like. The shape of the cross section of the core material 100 is not particularly limited, and may be a circle, an ellipse, a polygon, or another shape. In this actual ft form, the core material 100 is formed of a rod having a circular cross section.

The length and length of the core material 100 are determined according to the intended use of the accessory 120. However, in the case of the ^^ fiber, the evening of the core material 100 may be hi 圣, and the evening under 0.1 mm] ¾ may be [圣].

A magnetron sputtering apparatus 70 shown in FIG. 2 is used to form a metal thin film 60 on the entire surface or the surface of the core material 100 by the magnetron sputtering method. In order to form the gold coating film 60 only on the “^” surface of the core material 100, magnetron sputtering may be performed after masking a part of the surface of the core material 100 with a resist film or the like. .

In a magnetron sputtering apparatus 70 shown in FIG. 2, a mounting table 76 on which a target 74 is set is disposed inside a _c & i 2 having a vacuum I 72. Magnetron magnets 78 and 80 for providing magnetic lines of force to the target 74 are arranged outside the vacuum processing package 72.

In addition, above the target 74 inside the vacuum chamber 112, the core member 100 is rotated by the rotation holder 82 so that the core member 100 is rotatably arranged around its axis. One end of 00 is held. By performing magnetron sputtering while rotating the core material 100 around the axis by the rotation holder 82, a gold film 60 is formed on the evening surface of the core material 100. You.

As the target 74, an alloy target may be used, or a plurality of different types of metal targets, each of which is different in the US, may be used. In the embodiment, a nickel-titanium alloy target or a combination of a nickel target and a titanium target is set on the mounting base 76.

The thickness of the gold film 60 formed on the outer peripheral surface of the core material 100 using the magnetron sputtering apparatus 70 shown in FIG. 2 is not particularly limited, but can be reduced to, for example, 50 m or less and 1 °. In the present embodiment, the gold film 60 is made of a simple metal made of a nickel-titanium alloy.

Specific applications of the medical device 120 of the embodiment are not particularly limited, but include, for example, a guide wire for guiding a balloon catheter, a snare-shaped wire, a guiding catheter, an electrode force sensor, a pacing electrode, and the like. It can be used for stents, thrombectomy baskets, ^ fJi †. Stapler needles (suturing machine needles), vascular clips, etc. The it method of the device according to the state is a ^ F example of »it¾¾ of the medical device according to the B ^ l real ftff state, and is used for snow. Except that the configuration of the cutter device is shown in FIG. 3, it is the same as the previous embodiment, and only different portions will be described.

As shown in FIG. 3, in the male according to the present embodiment, a pair of rotation-permissible seal devices 84 is provided on the side wall of the sputtering device facing the true & i 2, and the sieving devices 84 Through the process, the core material 100 is held inside the process 2. As shown in FIG. 3, the core material 100 is rotatably held by a sealing device 84 inside the processing 72, and is moved in the axial direction from right to left in the drawing. It is possible. The sealing device 84 is configured to be able to seal the inside of the processing board 72 irrespective of the rotational movement around the axis of the core material 100 and the movement in the fat direction. The core material 100 is moved in the axial direction while being rotated inside the process 72, and magnetron sputtering similar to that of the previous 15 ^ 1 embodiment is performed, so that the outer peripheral surface of the core material 100 is The gold film 60 shown in FIG. 1A can be formed in a fiber shape along the direction of the fat.

The other steps in the «square mode» are the same as in ^^ of the m 1 real style system, and the description is omitted.

Third form bear

製造 The method of manufacturing the tool according to the JF state is a modified IF example of the method of the medical tool according to the m1 actual lff state, except that a part of the sputtering apparatus used in the manufacturing method is shown in Fig. 4. It is similar to the front lightning sm i embodiment, and only different parts will be described.

As shown in FIG. 4, in the method according to the present invention, a supply roll 86 for the core material 100 and a take-up opening 8 8 are provided inside the truth chamber 72 of the sputtering apparatus. The rooster 5 is placed, and the core material 100 to be processed is positioned above the target 4 by the intermediate rolls 90 and 92. The supply roll 86 and the take-up roll 88 are held by a rotary support frame 94, respectively, are rotated in opposite directions by a drive motor 96, respectively, and are interposed between the intermediate holding rolls 90 and 92. 一部 A part of the held core material 100 is rotatable around its axis. Further, the core material 100 can be moved toward the vehicle from the supply roll 86 to the take-up opening 88.

Therefore, the core material 100 held between the intermediate holding rolls 90 and 92 is subjected to magnetron sputtering in a fiber-like manner, and gold 60 shown in FIG. Will be overturned.

The other steps in the i direction are the same as those in the m 1 real direction, and a description thereof will be omitted.

4th vertical bear

As shown in FIG. 1B, in this embodiment, a hollow synthetic resin tube having an inner portion formed along the body direction is used as the core material 100a. A gold film 60 preferably having a thickness of 50 m or less is formed on the entire surface of the core material 100a or on the entire peripheral surface thereof by the same magnetron sputtering method as in the knitting mode. Construct 0a.

The thickness, thickness, and length of the core material 100a made of a hollow synthetic resin tube are optimized according to the use of the medical device 100a.

The specific use of the medical device 120a of the embodiment is not particularly limited. For example, an endoscope having a tube member of a balloon catheter for IABP or a balloon catheter for PTCA, or a snare wire is used. ! ! Tubes for placement instruments, ophthalmic lacrimal ducts, guiding catheter tubing, microphone mouth catheter tubing, thin sheath introducer tubing, pacing electrode tubing, rotator atheroma It can be used for various kinds of tube members such as a tube member for a removal catheter, a tube for intravascular visual acuity, and a tube inside a sound wave.

Compared with the optional tube member made of synthetic resin, the optional tool 120a according to the ^ ffif state has a gold film 60 made of, for example, nickel-titanium on the outer peripheral surface of the tubular core material 100a. Because the tube is formed, the operating force from the proximal side of the tube satisfactorily satisfies the tip rule, and has excellent push-in characteristics (pushability) and excellent flexibility, and can be inserted into winding parts. It is possible. As shown in FIG. 1C, in the present embodiment, first, a polymer is vapor-deposited on the outer peripheral surface of a rod-shaped mandrel (not shown) having a circular cross section to form a core layer 10 Ob. Next, a metal thin film 60 preferably having a thickness of 50 m or less is formed on the entire surface of the core material layer 10Ob or by a magnetron sputtering method similar to the embodiment. After that, the outer periphery of the metal thin film 60 is again coated with a polymer by vapor deposition to form a tattoo skin layer 102, and the mandrel is pulled out to constitute a tool 12 Ob.

The diameter, thickness, and length of the core material layer 100b and the skin layer 102 are varied according to the use of the medical device 120b.

The specific use of the medical device 1 2 Ob in the embodiment is not particularly limited, but, for example, an endoscope having a tubing member of a balloon catheter for IABP or a balloon catheter for PTCA, and an endoscope having a snare wire Tube member for treatment instrument, lacrimal tube for ophthalmology, tube member for guiding catheter, tube member for microcatheter, tube member for thin sheath transducer, pacing electrode tube, rotator It can be used for various optional tube members such as a tube member for catheter removal for atheroma and a tube for intravascular ultrasound.

According to the 具 of the customary tool 1 2 Ob of the orientation, it is possible to use an extremely thin and flexible tube member having elasticity, strength, and flexibility. The Si tool 12 Ob is a synthetic tube member made of synthetic grease alone compared to a tube member because a metal thin film 60 made of, for example, nickel-titanium is formed in the intermediate layer of the tube member. The operating force from the hand side is transmitted well to the tip shell IJ, and it has excellent push-in efficiency (attachability) and excellent flexibility, and can be inserted into winding parts. As shown in Fig. 5, the guide wire 2 according to * ^ ¾f !! has a core part 5 and a tip of the average part M 圣, which has a small average height of the part 5; It has a core wire 4. ^ S portion 5 and tip of core wire 4; The cross section is integrally formed of a wire having a substantially circular shape. The material of the core wire 4 is not particularly limited, and examples thereof include metals such as stainless steel (for example, SUS316), gold, platinum, aluminum, tungsten, tantalum, and alloys thereof. The total length L1 of the core wire 4 varies depending on the purpose of use and is not particularly limited, but is, for example, 80 to 350 cm ^ Jg, and the axial length L2 of the tip of the core wire 4; For example, 5-5 O cm ^.

M 圣 of the main portion 5 of the core wire 4 may be uniform along the direction of the fat, or may be tapered toward the distal end. Although the average appendix of the part 5 is not particularly limited, it is about 0.15 to 0.90 marauder. Also, the evening W 圣 at the tip J ^ portion 7 may be uniform along the direction of the fat, or may be tapered toward the tip. The average の of the tip portion 7 is not particularly limited, but is preferably about 1 to 5 to 12 evening W 夕 with respect to the average of the portion 5.

Sphere or hemispherical Beaune 10 is in contact with the tip of core wire 4. The bow 10 is a part for minimizing damage to the inner wall of the body cavity when the guide wire 2 is inserted into a body cavity such as a blood vessel by making the tip of the guide wire 2 open. This bow 10 is made of a metal such as platinum, for example, and is joined to the tip of the tip portion 7 by means such as welding. The evening W 圣 of the ball portion 10 is preferably approximately 0.5 to 2 times the average outer diameter of the main portion 5.

Tip: The outer periphery of the portion 7 is covered with a metal thin film (coated mm) 6 made of metal. The gold listening film 6 is formed of a metal such as a Nikkenure titanium alloy. Reactive metal has a large recoverable elasticity range, for example, from 1% to 10%, and in the superelastic region, the force required for deformation I is almost constant even if the strain increases. Having. Also, the superelastic metal has extremely low stress in the cohesive region as compared with the elastic modulus of stainless steel, and is excellent in flexibility. Therefore, the distal end portion of the guide wire 2 covered with the gold JS¾ film 6 has the property of recovering its original shape upon stress release.

A core part having the same design as that of the present embodiment is formed using a conductive alloy, and stainless steel, platinum, and other ordinary metals are deposited on the surface by sputtering. Is also good. This: ^, with a guide wire of knitting style, to a certain extent ぃ properties are shown, but when the guide wire is bent in a blood vessel the surface is more distorted than inside, and It will be easier.

Although the thickness of the metal thin film 6 is not particularly limited, it is 1 to 100 m¾JK, preferably 1 to 50 m.By adjusting this thickness, the superelastic property of the guide wire 2 at the end can be adjusted. can do. The gold coating film 6 can be formed by a sputtering method. It is preferable to use the same magnetron sputtering as in the fine state.

The outer peripheral surface of the guide wire 2 is covered with a biocompatible coating film 8 in a manner of φΦ. Examples of the biocompatible coating film include, but are not particularly limited to, ordinary polymers used for applications such as olefins such as polyethylene, nitrogen-containing polymers such as polyimide and polyamide, and siloxane polymers. It is. Further, the coating film is not limited to the polymer, and may be a coating film of silicon carbide, carbon black such as light carbon or diamond-like carbon.

In the optional guide wire 2 according to the core embodiment, the tip core portion 7 of the core wire 4 is covered with the gold coating film 6 made of a superelastic metal, and thus has excellent elasticity at the beginning. Therefore, as shown in FIG. 6, when the guide wire 2 is inserted into the base of the foot: ^ «I pulse 22 The tip of the wire is easily deformed so that it can easily follow the inside of a blood vessel having a strongly bent portion near the tip of the wire. Further, the base end of the core wire 4 constituting the guide wire 2 is composed of the main portion 5 and is made of a normal metal such as stainless steel, so that the operating force of the guide wire 2 is good up to the distal end of the wire. The key is to push it in and it is particularly good. It is to be noted that a metal thin film made of an active metal may be provided in a portion where there is no difference in the input characteristics.

Further, in the machine-expanded state, the tip of the guide wire 2 has a tip core portion 7 which is refined with a normal metal rather than being made of only an S-metal. In the erect state, the outer periphery of the K «portion is covered with a gold coating made of a simple metal. Around the tatto It may be coated. Depending on the application of the guide wire 2, it is possible to pre-bend the 开 e at the end of the guide wire 2 into a substantially circular arc 开 e. ^ Mm n. Because of this, bending by plasticity is easy. Further, in the present embodiment, since the structure is not such that the main core portion of the normal gold S and the tip portion made of the non-ferrous metal are joined, the strength of the joined portion does not matter <as shown in FIG. In addition, the guide wire 2a for the application J is a modified example of the guide wire 2 shown in FIG. 5, and the common parts are denoted by the same reference numerals and description thereof is omitted.

In the guide wire 2a according to the embodiment, a coil spring 12 is provided along the direction of the vehicle fc¾ around the distal end portion 6a formed on the distal end core portion 7 and the outer periphery of the biocompatible coating film. The material of the coil springs 12 is the same as the material of the core wire 4, and is made of, for example, stainless steel 1. The coil / reseller is made of a metal having high X-ray absorption such as platinum. Can be made of

In the guide wire 2a according to the embodiment, by attaching the coil spring 12 to the tip of the wire 2a, the range of elasticity adjustment at the tip of the wire is widened and the diameter of the main part is large. The other effects of the guide wire 2a of the embodiment having the effect that the guide wire 2a becomes closer and the catheter is easy to slide are the same as those of the guide wire 2 shown in FIG. As shown in FIG. 8, the optional guide wire 2b according to the one-way system is a modification of the guide wire 2 shown in FIG. 5, and the common portions are denoted by the same reference numerals, and the description thereof is “^ Omitted.

In the guide wire 2b according to the square configuration, a fine core portion 7b having an average outer diameter smaller than the average outer diameter of the core portion 5b is formed in the middle of the portion 5b of the core wire 4b. On the outer periphery of the common part 7b, there is formed a mesenteric image 6b mounted on a table metal. The configuration of the guidewire 2b at the leading end is exactly the same as the guidewire 2 shown in FIG.

b evening w 圣 is less than "the average evening の of the part sb In this case, it may be substantially the same as the outer diameter of the tip; Stf portion 7, but may be slightly larger. Main; ^ The evening of the fine core part 7b is preferably 0.1 to 0.8 times @ «compared to ^ 圣 of the ^ part 5b.

The formation position of the small diameter portion 7b and the length in the direction of the vehicle fc¾ "are determined by the purpose of use of the guide wire 2b, and are not particularly limited. As U, the base position of the small diameter portion 7b is a wire. It is a position of length L3 = 200 to 500 from the base end of 2b, and its vehicle direction length L4 is, for example, about 200 to 500 bandits.

The thickness of the intermediate super-elastic coating layer 6b is not particularly limited, but is about 100 to 200 m. By adjusting this thickness, the special order in the middle of the 途中 | Can be adjusted. The coated layer 6 b is made of the same kind of metal as the metal forming the unit skin layer 6.

In the guide wire 2b according to the braided shape, in the middle of the ± JS¾ portion 5b, the small diameter of the average evening W 圣 smaller than the average outer diameter of the core material portion 5b¾ίί Intermediate superelastic SJf 6 b made of H metal is formed. Therefore, in the guide wire 2b according to the * ¾¾J state, the guide wire 2b having poor flexibility can be realized even in the middle of the main K portion 5b.

As shown in Fig. 6, in a body cavity such as a blood vessel into which a guidewire is inserted, a strongly bent portion is not always located only at the tip of the guidewire, and a strongly bent portion is formed even at the base of the guidewire. There is. This guide wire 2b can be used with care as a guide wire to be inserted into such a body cavity. Other functions and effects of the guide wire 2b of the present embodiment are the same as those of the guide wire 2 shown in FIG.

It should be noted that the present invention is not limited to the above-described embodiment, but can be variously changed within the scope of the present invention.

For example, in the embodiment described above, the superelastic characteristic ffi made of a nickel-titanium alloy is keyed to the gold thin-walled tube made of the Kinjo film 60. A medical device having a metal thin film can be manufactured in the same manner.

Claims

The scope of the claims

1. Core part and resident; S # part mean tip with small average outer diameter; core wire having part and usually made of metal;

An optional guide wire that covers at least the outer circumference of the part at the end of the skin, and has an Sf thigh covering layer formed of a metal.

2. In the middle of the lift Sii part, a small diameter part with an average diameter smaller than the average outer diameter of this part is formed. 2. The guide wire according to claim 1, wherein the formed intermediate superelastic coating is formed.

3. The medical guidewire according to claim 1, wherein the outer peripheral surface is coated with a biocompatible nonmetallic coating film.

4. The medical guidewire according to claim 1, wherein the thickness of the Iff! Self-tip rule superelastic coating is 50 m or less.

5. The medical guidewire according to claim 2, wherein the thickness of the ttfl intermediate layer is 50 m: under JI.

6. A tool having a super-elastic gold film having a thickness of 50 m or less.

7. The tool according to claim 6, wherein a self-metal thin film is formed on the outer periphery of the tubular core member.

8. The accessory according to claim 7, wherein the Itil tube-shaped core member is a hollow synthetic resin tube.

9. Manufacture of tools with a process of forming gold and films by sputtering on the surface or intermediate layer of the members that make up the listening tools ¾¾.

10. The method according to claim 9, wherein the metal thin film is formed by sputtering while rotating the member.

11. The male acid tool according to claim 9, wherein the thickness of the metal S film is 5 or less.

1 2. a step of forming a core layer on the outer peripheral surface of the rod-shaped mandrel; and a step of forming a gold layer on the outer peripheral surface of the braided core layer by sputtering. til the process of making the rod-shaped mandrel,

Have a tool it way.

13. The method according to claim 12, wherein the outer skin layer is formed on the outer periphery of the metal coating film, and then the mandrel is formed.

14. The method according to claim 12 or 13, wherein the core layer or the outer layer is made of a polymer fiber.

15. The manufacturing male of the optional tool according to any one of Items 9 to 14, wherein the gold film is a Taku's gold film.