JP2005144104A - Medical guide wire superior in operability - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To improve operability and safety, by controlling a tip shape (an angle, a width, the tip straight line part length and the tip curve part length) of a medical guide wire. <P>SOLUTION: A tip angle of the medical guide wire defined in this invention is controlled in 10 to 120 degrees. A width dimension of a curve part at the tip part is set to 3 mm to 10 mm. The length of the tip curve part is set to 5 mm to 10 mm. The length of the tip straight line part is set to less than 10 mm. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a medical guide wire used to introduce a catheter or an introduce circuit used for treatment or examination into a target site of a blood vessel.

  A medical guide wire is used to introduce a catheter or an introductory circuit into a blood vessel and place it in an affected area when performing diagnosis or treatment. Therefore, the medical guide wire needs to be shaped with a tip that can be pushed in following the shape of the blood vessel without damaging the blood vessel in the branching or meandering blood vessel. In recent years, the introduction port of a catheter into a blood vessel is shifting from a femoral (thigh) to a brachial (upper arm) or a radial (wrist), and this demand is increasing.

  In order to allow the guide wire to be advanced to a desired position on the heart, the tip of the commercially available guide wire is shaped (shaped). Furthermore, the tip shape becomes an important element in terms of function as the doctor shape (reshape) with the fingers in accordance with the shape of the bifurcation at the clinical site.

  In recent years, the tip of the wire used to push the brachial or radial toward the heart has been used in the J-shaped standard in order to prevent entry (meandering) into the branch vessel during insertion. Tend to be.

An inserter is used as an insertion assisting instrument when a medical guide wire having a curved tip is inserted into an introduction needle, catheter or sheath. In particular, in order to insert a J-type wire into an introduction needle, a catheter, or a sheath, insertion is extremely difficult without an inserter.
When inserting a J-type wire into an introduction needle, catheter or sheath, an inserter is required as described above, and its structure has been improved to improve the insertion property into the inserter while correcting the curved portion of the wire. Is disclosed in Patent Document 1.

2. Description of the Related Art Conventionally, a guide wire having a curved tip portion with a guide wire having a diameter of about 0.4 mm and having a tip angle defined by the present invention is also known as a treatment guide wire. Since this guide wire has a small diameter, the X-ray visibility is low, and it is necessary to improve visibility such as attaching a gold coil wire to the tip, which is structurally completely different from the guide wire of the present invention. There is also a problem that it is easy to bend into a blood vessel other than the intended purpose because it is thin and easily bent. Furthermore, as a core wire for a medical guide wire, stainless steel or a nickel titanium alloy is mainly used practically, but in recent years, a super elastic nickel titanium alloy has become mainstream. (Patent Document 2, Patent Document 3, Patent Document 4).
JP-A-7-155382 Japanese Patent Publication No.2-245550 JP-B-2-24548 Japanese Patent Publication No.2-245549

  The distal end of the medical guide wire is shaped into a J type, a double angle type, or an angle type. Among these, when a guide wire is introduced from a brachial or a radial, a medical guide wire having a J-shaped tip cannot often be pushed into a blood vessel smoothly.

  During the operation, the guide wire may be frequently pulled out of the sheath. In the case of a J-type wire, an auxiliary instrument such as an inserter must be used every time the wire is inserted into the sheath. There is a problem that imposes unnecessary work and time on doctors.

  Moreover, when the superelastic nickel titanium-type alloy of patent documents 2-4 is used for a core wire metal, it has the fault that the tip shape shaping by J type or the present invention is very difficult. In addition, it has been pointed out that there is a drawback that the tip cannot be shaped by a doctor at the clinical site. In order to remedy this drawback, a guide wire (Japanese Patent Laid-Open No. 10-146390) has been proposed in which a metal coil is brought into close contact with the tip to improve the tip shape.

  Based on the above various findings, the present inventors have intensively studied to complete the present invention. The purpose of the present invention is to introduce a guide wire from the radial or radial toward the heart. Compared to the J-type wire used for the guide wire, it is a guide wire having a tip shape that allows a guide wire to be introduced smoothly, and is required when inserting a wire into an introduction needle, catheter, or sheath It is an object of the present invention to provide a medical guide wire used for an angiography or an introducer excellent in operability, which does not require an extra auxiliary device such as an inserter.

  This will be explained in more detail. The ease of insertion of the introducer indwelling needle or catheter into the connector when the guide wire is inserted into the blood vessel, the push resistance to the blood vessel during the movement to the treatment site, and the treatment site. The size of misentry into the branch blood vessels is important as the performance of the guide wire, and it is to provide a guide wire with an excellent balance of these performances.

Means to solve the problem

  That is, the present invention is a medical guide wire comprising a metal core wire whose surface is coated with a resin and having a distal end portion that is bent in a smooth curved shape, and an angle formed by a direction extension line of the distal end portion and a wire base line is formed. 10 to 120 degrees, preferably 20 to 90 degrees, more preferably 30 to 80 degrees, most preferably 40 to 70 degrees, the length of the curved portion is 5 mm or more and less than 10 mm, the width dimension of the curved portion is 5 mm or more and less than 10 mm, It is a medical guide wire used for a beak type angiography or an introducer characterized in that the length of the distal straight portion is less than 10 mm.

  The present invention is also a medical guide wire comprising a metal core wire whose surface is coated with a resin and having a distal end portion that is bent into a smooth curved shape, and the diameter of the guide wire including the resin layer is 0.46 to 1. A medical guide wire used for a beak type angiography or introducer, characterized in that the angle formed between the direction extension line of the tip and the wire base line is 10 to 120 degrees.

The invention's effect

  A guide wire having a tip shaped to a diameter and an angle defined in the present invention has a higher effect (in a tendency) to suppress meandering to a blood vessel bifurcation than a conventional shaped wire. The load at the time of pushing in and the resistance at the time of pulling out were small compared to the J-type wire, and the surface of the blood vessel was hardly damaged and the operability was good. Furthermore, the conventional J-type wire requires an inserter when introduced into the introduction needle, sheath, or catheter, but the guide wire according to the present invention is unnecessary and the operability can be improved.

BEST MODE FOR CARRYING OUT THE INVENTION

  In the present invention, the core wire is made of metal to enable the guide wire tip shape to be smoothly operated without meandering to a branching blood vessel in the middle of introduction into the heart and with a small resistance value when pushing and withdrawing. High function with excellent operability, with the tip bent in a smooth curved shape coated with resin on the surface, and the angle formed by the direction extension line of the tip and the wire base line is shaped in the range of 10 to 120 degrees It is a medical guide wire.

  The angle is the angle α defined in FIG. 1, and α is 10 to 120 degrees, preferably 20 to 90 degrees, more preferably 30 to 80 degrees, and most preferably 40 to 70 degrees. In the present invention, a wire having a tip bent at the above angle is referred to as a beak type. In FIG. 1, the horizontal line in the state where the wire 1 is placed horizontally without applying force is the wire base line 2, and the angle formed by the intersection with the directional extension line 3 of the distal end in a state where the distal end portion 4 is erected vertically is α And When α is 10 to 120 degrees, preferably 20 to 90 degrees, more preferably 30 to 80 degrees, and most preferably 40 to 70 degrees, it can be easily inserted into an introducer indwelling needle or catheter connector without using an inserter. In addition, there is a tendency that erroneous entry into the branch blood vessels is improved in a well-balanced manner. At a relatively small angle of 10 to 30 degrees, it can be inserted into the introducer indwelling needle or catheter connector without using an inserter, but compared to the one with a large α (α is 40 to 120 degrees). Therefore, the insertability tends to decrease. On the other hand, at a relatively large angle of 70 to 120 degrees, the insertability is good, but the function of preventing erroneous entry tends to decrease. Therefore, the tip angle may be set to 10 to 120 degrees according to the required performance.

  The definition of the extension line in the tip direction will be described in more detail. The direction extension line of the portion existing in the direction of the base line from the leading edge of the curved portion in the smoothly bent tip portion, and the tip portion being a straight line It is a straight direction extension line. If the leading edge is not a straight line, the line connecting the leading edge and the line center point at a point of 3 mm toward the curved line is the tip direction line, and the extension line is the tip direction extension line. That is, in the present invention, since the tip straight portion is included, the direction extension line in the definition means a direction extension line of the tip straight portion.

Further, the entire length of the curved end portion of the guide wire of the present invention is a length L from the point A where the base line begins to bend to the most advanced portion B, and the width of the curved portion is indicated by R in the figure. In the guide wire of the present invention, L is 5 mm or more and less than 10 mm, R is 5 to 10 mm, and the length of the tip straight portion is less than 10 mm. More specifically, when α is 10 to 120 degrees and the length of the tip straight portion is 4 to 8 mm, R is 5 to 9 mm, more preferably when the length of the tip straight portion is 5 to 7 mm, R is 6 to 9 mm. . On the other hand, when α is 40 degrees to 70 degrees and the length of the tip straight line portion is 2 to 5 mm, R is 2 to 9 mm.
The tip shape will be described in more detail below. The tip shape referred to in the present invention is determined by the tip angle α, the length C of the tip straight portion, and the length L of the tip curve portion. FIG. 1 shows a base line on the base side of the guide wire 1, and 4 is a straight portion at the tip of the wire. The length of this portion is the length C of the tip straight portion. In addition, when the most distal portion B of the wire is bent from the baseline 3 to the inside or outside of the curve, as shown by the upper right chain line in FIG. 1, the baseline until the wire starts to bend with respect to the baseline 3 from the most distal B. The length in the direction parallel to 3 is defined as the length C of the tip straight portion. In the present invention, the most important of these elements is the tip angle α.

  The metal used for the guide wire core wire of the present invention is a metal usually used for the application, such as a nickel titanium alloy, a copper alloy, an aluminum alloy, or stainless steel. Further, the diameter of the guide wire used in the present invention is 0.46 to 1.02 mm (0.018 to 0.040 inch), preferably 0.56 mm to 1.02 mm (0.022 to 0.040 inch), More preferably, it is 0.64 mm to 1.02 mm (0.025 to 0.040 inch), and most preferably 0.89 mm to 1.02 mm (0.035 to 0.040 inch). When the diameter is 0.46 mm or less, even in the tip shape defined in the present invention, the probability of erroneous entry into the branch vessel increases due to excessive tip flexibility.

  The bending load indicating the flexibility of the guide wire at the curved end of the guide wire (the bending load when the center point of 14 mm between the fulcrums is pushed by 0.8 mm) is 0.5N to 0.01N, preferably 0.4N. It is -0.03N, More preferably, it is 0.03N-0.05N, Most preferably, it is 0.2N-0.07N.

  As described above, it goes without saying that the flexibility of the guide wire is greatly influenced by the diameter including the resin layer, but the diameter of the metal used for the core wire and the tip shape processing (the diameter of the metal core wire is the tip). Further accurate control is possible by factors such as a taper shape gradually becoming smaller toward the surface, temperature control in thermal processing, and the like. In more detail, the required physical characteristics of the tip of the guide wire include rapid shape change in the blood vessel (returning speed from the stretched state to the beak-type tip shape), workability (shape according to the target shape). It is desirable to optimize the spring rigidity of the distal curve portion in terms of pushability, etc., and to have flexibility that does not damage the blood vessel wall. Therefore, regarding the tip shape of the guide wire, the taper processing method of the tip of the metal core wire and the setting of the heat treatment conditions for tip shaping become important together with the guide wire shape including the resin layer.

  Below, it explains in detail about the shape and tip shape processing method of nickel titanium system beak type guide wire core metal. The diameter of the core wire of the curved portion used in the present invention is 0.01 to 0.4 mm, preferably 0.03 to 0.3 mm, more preferably 0.05 to 0.2 mm, most preferably 0.08 to. 0.15 mm. The total length of the guide wire of the present invention is about 1500 to 2300 mm, and the diameter of the core wire in the base line portion is 0.3 to 0.9 mm. The operability of the wire is further improved by making the point of 100 to 200 mm from the tip of the curved portion toward the base and the diameter of the core wire from the middle point toward the tip.

Conventionally, a generally used guide wire has a starting point of a curved portion at a tip of about 30 mm, and the diameter on the core wire base side is tapered from about 0.2 mm toward the tip. It has a diameter of 1 mm. Moreover, the thing of the fixed diameter whose diameter from 30 mm of front-end | tips is about 0.1 mm can also be used.
The taper of the curved portion may be a continuous or stepped taper structure such as one step, two steps, or three steps. It is experimentally determined at which position of the curved portion the taper stage is provided. The diameter of the metal core wire in the most advanced part is 0.01 to 0.20 mm, preferably 0.03 to 0.15 mm, more preferably 0.04 to 0.12 mm, most preferably 0.05 to 0.10 mm. is there. In order to reduce damage to the blood vessel wall, it is desirable to reduce the rigidity by reducing the diameter of the metal core wire at the most distal end.

  In order to give flexibility to the most advanced part, it is possible to reduce the diameter of the metal core wire in the most advanced part. However, in this case, it is pointed out that the processability to the final product becomes difficult. As this solution, a structure in which the most straight line portion is deformed into a flat shape (rectangular cross section or oval shape) so that the stress of the guide wire is reduced is preferable. It was possible to freely control the elastic modulus (10 to 90% of the round wire) by processing a round guide wire having a diameter of 0.1 mm at the most advanced portion 6 mm into a flat cross section.

  2 to 4 are partial enlarged views showing an example in which the tip curve portion is flattened, and FIGS. 5A and 5B are cross sections taken along lines XX and YY in FIGS. Each figure is shown. FIG. 2 shows the entire curved portion L that has been flattened. The metal core wire 1 having a perfect cross-section and a diameter of 0.1 mm is unidirectionally moved from the state shown in FIG. 5A to the direction shown in FIG. 5B. The cross section is flattened with a thickness of 0.01 to 0.27 mm (preferably 0.08 mm). Further, FIG. 3 shows the center portion of the curved portion L that has been flattened in the same manner as described above. Further, FIG. 4 shows a shape obtained by flattening the tip of the curved portion L in the same manner as described above. Thus, by performing flattening, the flexibility and workability of the guide wire tip are improved.

  The rigidity (flexibility) of the tip curve part can be controlled by the heat treatment temperature when shaping the tip when the core wire metal is a nickel titanium alloy in addition to controlling the diameter of the guide wire tip as described above. It is already known. That is, by setting the temperature at the time of shaping the guide wire tip to 400 to 550 degrees for a predetermined time, the setting and rigidity of the target angle α can be easily performed. When the tip curve part is shaped under the above-mentioned conditions, in the case of a nickel titanium alloy, all the superelastic functions are given regardless of work hardening type, wire drawing type, cooling wire drawing type, etc. The rigidity tends to be relatively large.

  Therefore, it is difficult to shape the tip with a thin wire having a core wire diameter of 0.1 mm or less at the tip portion or a small wire with R of the curved portion being 4 mm or less. Therefore, the performance of the tip portions of various beak-type guide wires is determined by the combination of the shape of the metal core wire at the tip portion of the guide wire (tip portion diameter, taper processing, flattening processing) and heat treatment conditions.

  A preferred metal is a nickel-titanium-based alloy having a property of being excellent in introduction property that hardly causes permanent distortion. More preferably, the nickel-titanium-based alloy is easy to shape or reshape the tip, and hardly causes permanent deformation, and is a work hardening type (Japanese Patent Publication No. 6-83726), a wire drawing type (Japanese National Standard Hei 5- No. 508559), or a metal that is subjected to mechanical straightening without heat treatment after the cold wire drawing and does not show martensitic transformation in stress induction (Japanese Patent Laid-Open No. 2000-140124).

  Among these, particularly preferred is that the tip is shaped or reshaped easily, and is not easily deformed. Further, it is excellent in pushability, torque transmission, and reinsertability. This is a nickel-titanium alloy that is mechanically straightened and does not show martensitic transformation in the stress induction.

  FIG. 6 is a side view showing the shape of a conventional guide wire called a J-shaped wire. The angle α defined in the present invention is 0 ± 5 degrees, that is, the wire base line 5 and the distal direction extension line 6 are almost the same. Parallel. Comparing the J-type wire and the wire of the present invention, when pushed into a silicone tube of a blood vessel model with an inner diameter of 3 mm, the wire of the present invention has a smooth insertion operation and little variation, and the maximum pushing force of the J-type wire Of 1/10 or less. Further, the pull-out resistance of the guide wire obtained by the present invention was about a quarter of that of the J-type wire. From the above model experiment, it is shown that the guide wire obtained by the present invention can be easily pushed to the target affected part without damaging the blood vessel as compared with the J-type wire and can be safely recovered after the treatment.

  FIG. 7 is a side view showing a conventional guide wire called an angle-type wire, in which the angle α defined by the present invention (the angle formed by the base line 7 and the distal direction extension line 8) is 120 degrees or more. When an angle-type wire is pushed into a blood vessel model branched at right angles with a silicone tube, it is easy to meander into the branch blood vessel, and in particular, when a wire is introduced from a brachial or a radial, introduction is difficult. On the other hand, since the guide wire obtained by the present invention suppresses the meandering described above, it has been clarified that the wire of the present invention has preferable performance.

  Furthermore, using a 4 French guiding catheter, the pushability and pull-out resistance of the wire obtained according to the present invention and the J-shaped wire were examined and showed the same tendency, and the tip was shaped at an angle defined by the present invention. Medical guidewires were found to be excellent in operability.

  Nickel titanium alloy, copper alloy, aluminum alloy or stainless steel is used as the core wire of the guide wire, but the guide wire adapts to the blood vessel shape without damaging the blood vessel in the branching / meandering blood vessel. In order to push in, flexibility and shape restoration are required. In recent years, catheters have been pushed into peripheral blood vessels, and the demand has been increasing. Conventionally, stainless steel wire has been mainly used as a guide wire core, but if it passes through a meandering blood vessel, it will be permanently deformed and will remain deformed, and it will not be able to be pushed into the peripheral blood vessel, and reinsertion There was a problem that could not be done.

  As a material for coating the metal of the core wire, polyurethane, polyamide elastomer, polyester elastomer, polyolefin elastomer, or fluorine-based material or a polymer thereof is the main component because of the ease of coating and the need to provide a lubricating function. A flexible polymer such as a polymer alloy is used. The polymer coating material is flexible to the extent that it does not hinder the bending of the core metal such as a resin, and the outer surface is a smooth surface substantially free of irregularities. In the polymer coating material, fine powders such as tungsten, bismuth, and barium can be mixed as an X-ray contrast material.

  The surface of the polymer covering the metal of the core wire is coated with a hydrophilic polymer in order to reduce the frictional resistance with the inner surface of the catheter and blood vessels and to exhibit good slidability. As the hydrophilic polymer, those having a hydrophilic group such as a hydroxyl group, an amide group, an amino group, a carboxylic acid group, a carboxylic acid group, a sulfonic acid group, a sulfonic acid group, and / or a pyrrolidone group are preferable. Specifically, vinyl ether-maleic anhydride copolymer, vinyl ether-maleic anhydride copolymer salt, polyether, polyacrylate, polyvinylpyrrolidone, or the like is used.

  A straight 0.89 mm nickel-titanium alloy (0.5 mm in diameter) coated with medical grade urethane that has been subjected to mechanical straightening processing on the metal of the core wire and does not exhibit stress relaxation martensite transformation. Using a guide wire lubricated with pyrrolidone, first, about 7 mm of the tip is bent so that the angle between the extension line in the tip direction and the wire base line is 90 degrees, and further along a circular arc with a radius of 1.5 mm. A guide wire was created by shaping so that the angle of the tip shape of FIG. The width R of the curved portion was 6.3 mm, the length L of the curved portion was 7.2 mm, and the length C of the tip straight portion was 4.1 mm. In addition, the diameter including the urethane coating at the tip was 0.8 mm, and the diameter of the alloy wire of the core wire was 0.1 mm. As a result of measuring the indentation length and the resistance value three times when the obtained guide wire was pushed into a silicone tube having a diameter of 3 mm as a blood vessel model at a speed of 500 mm / min, the load at the time of pushing was constant at an average of 0.02 N It was confirmed that it was able to proceed smoothly through the tube. Furthermore, as a result of measuring the resistance value when pulling out the guide wire from the tube, the average resistance value when pulling out is 0.02N, and the difference between the maximum and minimum resistance values is smaller than when pushing, and the guide wire is smoothly pulled. It was possible to recover from within the tube.

Comparative Example 1

  A guide wire was formed by shaping in the same manner as in Example 1 so that the angle of the tip shape of FIG. 1 implemented in the present invention along an arc having a radius of 1.5 mm was 0 ± 5 degrees. The width R of the curved portion was 5.3 mm, the length L of the curved portion was 8.8 mm, and the length C of the tip straight portion was 4.1 mm. In addition, the diameter including the urethane coating at the tip was 0.8 mm, and the diameter of the alloy wire of the core wire was 0.1 mm. When the resistance at the time of indentation was measured by the same method as in Example 5, the average resistance value of the drawn characters was 0.1 N, which was higher than that of the present invention at 0.1 N.

  A straight 0.89 mm nickel-titanium alloy (0.5 mm in diameter) coated with medical grade urethane that has been subjected to mechanical straightening processing on the metal of the core wire and does not exhibit stress relaxation martensite transformation. Using a guide wire lubricated with pyrrolidone, first, about 9 mm of the tip is bent so that the angle between the extension line in the tip direction and the wire base line is 90 degrees, and further, along the arc having a radius of 2.0 mm A guide wire was created by shaping so that the angle of the tip shape of FIG. The width R of the curved portion was 6.9 mm, the length L of the curved portion was 9.1 mm, and the length C of the straight end portion was 3.7 mm. In addition, the diameter including the urethane coating at the tip was 0.8 mm, and the diameter of the alloy wire of the core wire was 0.1 mm. As a result of measuring the indentation length and the resistance value three times when the obtained guide wire was pushed into a silicone tube having a diameter of 3 mm, which is a blood vessel model, at a speed of 500 mm / min, the load during pushing was constant at an average of 0.035 N It was confirmed that it was able to proceed smoothly through the tube. Furthermore, as a result of measuring the resistance value when pulling out the guide wire from the tube, the average resistance value when pulling out is 0.033N, and the difference between the maximum and minimum resistance values is smaller than when pushing, and the guide wire is smoothly pulled. It was possible to recover from within the tube.

  A straight 0.89 mm nickel-titanium alloy (0.5 mm in diameter) coated with medical grade urethane that has been subjected to mechanical straightening processing on the metal of the core wire and does not exhibit stress relaxation martensite transformation. Using a guide wire lubricated with pyrrolidone, first, the tip portion of about 9.4 mm is bent so that the angle between the extension line in the tip direction and the wire base line is 90 degrees, and further along an arc having a radius of 2.0 mm. The guide wire was created by shaping so that the angle of the tip shape of FIG. The width R of the curved portion was 8.0 mm, the length L of the curved portion was 9.3 mm, and the length C of the tip straight portion was 4.6 mm. In addition, the diameter including the urethane coating at the tip was 0.8 mm, and the diameter of the alloy wire of the core wire was 0.1 mm. As a result of measuring the indentation length and the resistance value three times when the obtained guide wire was pushed into a silicone tube having a diameter of 3 mm as a blood vessel model at a speed of 500 mm / min, the load at the time of pushing was constant at an average of 0.030 N It was confirmed that it was able to proceed smoothly through the tube. Furthermore, as a result of measuring the resistance value when pulling out the guide wire from the tube, the average resistance value when pulling out is 0.029N, and the difference between the maximum and minimum resistance values is smaller than when pushing, and the guide wire is smoothly pulled. It was possible to recover from within the tube.

Comparative Example 2

  A guide wire was formed by shaping in the same manner as in Example 6 so that the angle of the tip shape of FIG. 1 carried out in the present invention along a circular arc with a radius of 2.0 mm was 0 ± 5 degrees. The width R of the curved portion was 6.6 mm, the length L of the curved portion was 9.8 mm, and the length C of the tip straight portion was 3.7 mm. In addition, the diameter including the urethane coating at the tip was 0.8 mm, and the diameter of the alloy wire of the core wire was 0.1 mm. When the resistance at the time of indentation was measured by the same method as in Example 6, the average resistance value of the drawn characters was 0.15 N, which was higher than that of the present invention.

  Using the same guide wire obtained from the present invention as in Example 1, the silicone tube was replaced with a 4-French catheter and the indentation resistance was measured three times. As a result, the average load during indentation was 0.06 N. As a result of measuring the resistance value at the time of pulling out from the catheter three times, the average resistance value at the time of pulling out was 0.08 N, and the variation was small.

Comparative Example 3

  Using the same J-type guide wire as in Comparative Example 1, the silicone tube was replaced with a 4-French catheter, and the indentation resistance was measured three times. As a result, the average load during indentation was 0.12 N. Compared to the wire obtained in the above, there was a large tendency, and the variation was also large. The average resistance value at the time of drawing was 0.14N, which was found to be larger than that of the wire obtained in the present invention in Example 4.

  When a T-shaped coronary artery branch model blood vessel was created with a silicone tube having a diameter of 3 mm and the guide wire obtained by the present invention in Example 1 was pushed in, it was not introduced into the branch part.

Comparative Example 4

  When a conventional guide wire having a tip angle defined by the present invention shaped to 135 degrees is pushed into a silicone tube in the same manner as in Example 5, the tip is shaped to an angle defined by the present invention of 60 degrees. Compared with the guide wire, the probability of being erroneously introduced into the branching portion was large.

  A guide wire having a distal end shaped at an angle of 70 degrees as defined in the present invention could be introduced without using an inserter in a sheath or catheter.

Comparative Example 5

  A guide wire having a J-shaped tip is extremely difficult to introduce into a sheath or catheter when the inserter is not used.

Industrial applicability

  The guide wire of the present invention can be used as a guide wire for contrast or introduction of the brain, abdomen and the like in addition to the coronary artery.

It is a side view which shows the shape of an example of the guide wire obtained by this invention. It is the elements on larger scale which show the example at the time of flattening the front-end | tip curve part. It is the same figure of another example. It is the same figure of another example. (A) and (b) are the XX line and the YY line sectional drawing in FIG. 2 thru | or FIG. 3, respectively. It is a side view which shows the shape of the conventional J-type wire. It is a side view which shows the shape of the conventional angle type guide wire.

Explanation of symbols

1 Guide wire 2, 5, 7 Base line 3, 6, 8 direction extension line 4 Wire tip A Curve start point B Most advanced part R Curve part width

Claims (6)

  A medical guide wire comprising a metal core wire whose surface is coated with a resin and having a distal end portion that is bent in a smooth curved shape, and an angle formed between a direction extension line of the distal end portion and a wire base line is 10 to 120 degrees. Yes, for a beak type angiography or introducer characterized in that the length of the curved portion is 5 mm or more and less than 10 mm, the width of the curved portion is 3 mm or more and less than 10 mm, and the length of the straight end portion is less than 10 mm. Medical guide wire.   The medical guide wire according to claim 1, wherein an angle formed by a direction extension line of the distal end portion and a wire base line is 20 to 90 degrees.   The medical guide wire according to claim 1 or 2, wherein an angle formed by a direction extension line of the distal end portion and a wire base line is 30 to 80 degrees.   The medical guide wire according to claim 1 or 2, wherein an angle formed by a direction extension line of the distal end portion and a wire base line is 40 to 70 degrees.   A medical guide wire comprising a metal core wire whose surface is coated with a resin and having a distal end portion which is bent into a smooth curved shape, and the diameter of the guide wire including the resin layer is 0.46 to 1.02 mm. Item 5. A medical guide wire used for the beak-type angiography or introducer according to Item 1, 2, 3 or 4.   The medical guidewire according to claim 1, 2, 3, 4, or 5, wherein the metal core wire is a Ni-Ti alloy.

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