JP4308782B2 - Medical guide wire and manufacturing method thereof. - Google Patents

Description

  The present invention relates to a medical guide wire used for guiding a catheter or the like for examining or treating a state of a blood vessel or the like, and a manufacturing method thereof.

  A medical guide wire is inserted into a blood vessel in order to inspect the state of an affected part in a blood vessel of a human body or treat the affected part, and the inserted guide wire is a catheter for injecting an X-ray contrast medium. It is used as a guide member when inserting a balloon catheter or a stent for enlarging a stenotic site.

  As such a medical guide wire, use is made of a core wire whose tip is reduced in diameter and made flexible by fixing an outer sheath made of a coil spring, synthetic resin or the like to the core wire tip. Has been. Furthermore, in order to confirm the insertion position of the guide wire and catheter in the blood vessel and to measure the length of stenotic lesions in the blood vessel, it has been proposed to form a scale portion made of a radiopaque marker portion at the distal end portion of the guide wire. ing.

For example, in Japanese Patent No. 3517786 (Patent Document 1) and Japanese Patent Application Laid-Open No. 8-112356 (Patent Document 2), a coil body is wound around the outer periphery of the core wire tip, and the coil body is spaced at regular intervals. It is disclosed that a radiopaque marker portion is formed at the position. Japanese Patent Application Publication No. 2004-516049 (Patent Document 3) discloses that a coiled radiopaque marker member is mounted inside the coil body at the tip of the guide wire.
Japanese Patent No. 3517786 JP-A-8-112356 Japanese translation of PCT publication No. 2004-516049

  However, the conventional medical guide wire has a configuration in which a marker portion having the same form is provided on the same member, and there is a technical problem that it is difficult to measure the stenosis lesion length of the blood vessel with high accuracy. In addition, if the interval between the marker portions (scale intervals) is decreased in order to increase the measurement accuracy, the flexibility of the distal end portion of the guide wire is impaired, and the followability of the wire at the sudden bending change portion of the blood vessel is reduced, resulting in a deep portion. Inconveniences such as insertion become difficult.

  The present invention has been made in view of such a technical problem, and an object of the present invention is medical treatment capable of easily and accurately measuring the length of a stenotic lesion without impairing the flexibility of the guide wire. An object guide wire and a manufacturing method thereof are provided.

In order to achieve the above object, the medical guidewire according to the present invention is a medical guidewire having a core wire having a tip diameter-reduced portion and an exterior portion made of a coil spring that encloses the tip diameter-reduced portion. A ring-shaped radiopaque marker portion that wraps the outer peripheral portion at regular intervals in the length direction is provided at the reduced diameter portion of the tip, and the radiopacity that is fixed to the core wire by brazing or the like at regular intervals in the length direction. A marker portion is provided, and the marker of the radiopaque marker portion of the tip reduced diameter portion and the marker of the radiopaque marker portion of the exterior portion are alternately arranged in the length direction, and the radiopaque marker of the tip reduced diameter portion Forming an equally-spaced graduation section with equal intervals of a plurality of marker intervals or a plurality of marker intervals of the radiopaque marker portion of the exterior portion, and the length of each marker portion in the direction perpendicular to the axis The difference, or characterized by scale display by the fluoroscopic image by using the brightness difference.

In order to achieve the above object, the method for producing a medical guide wire according to the present invention includes a step of reducing the diameter of the core wire tip and a step of forming a ring-shaped radiopaque marker portion on the outer periphery of the core wire tip. And a step of fitting a coil spring to the tip end portion of the core wire, a step of forming a radiopaque marker portion to be fixed to the core wire on the coil spring portion, and an interval between the radiopaque marker portions of the coil spring, One or a plurality of radiopaque marker portions at the tip of the core wire are alternately arranged, and one-half of the interval of the radiopaque markers of the coil spring or a one-multiple interval are equally spaced. And a step of forming an equally spaced scale portion.

According to the medical guide wire of the present invention, without impairing the flexibility of the gas guide wire, the medical guide wire is provided a measurement of the stenotic lesion length as possible out be performed easily at high precision.

According to the medical guide wire production method of the present invention, without impairing the flexibility of the gas guide wire, a manufacturing method of the medical guide wire is provided for the measurement of the stenotic lesion length as possible out be performed easily at high precision The

  Embodiments of the present invention will be specifically described below with reference to the drawings. Note that the same reference numerals denote the same or corresponding parts throughout the drawings. FIG. 1 is a schematic longitudinal sectional view showing a first embodiment of a medical guide wire according to the present invention, and FIG. 2 is a transverse sectional view taken along line 2-2 in FIG. 1 and 2, the medical guide wire 100 has a structure in which the distal end portion 11 of the core wire 10 is reduced in diameter and the periphery of the distal reduced diameter portion 11 is covered with a coil spring 50. Reference numeral 12 denotes a base portion of the core wire 10. As the core wire 10, for example, a stainless steel wire or a nickel titanium alloy wire having a diameter of 0.34 mm and a length of about 1.5 m to 3 m is used, and the reduced diameter portion 11 has a length from the proximal end to the distal end, for example. Is reduced to a diameter of 0.142 mm at about 110 mm to 150 mm, and further reduced to a tapered shape within a range of about 40 to 50 mm at the tip.

The coil spring 50 as an exterior portion wound around the outer peripheral portion of the tip reduced diameter portion 11 is formed by, for example, winding a thin metal wire in a coil shape with a winding diameter of about 0.34 mm, and its front end portion It is secured by brazing or the like to the core wire 10 in and the rear end. In the present embodiment, the radiospherical material hemispherical member 13 is fixed to the tip of the core wire tip reduced diameter portion 11 by brazing or the like, and the tip of the coil spring 50 is brazed to the hemispherical member 13. It is fixed by attaching.

FIG. 3 is an explanatory view schematically showing an embodiment of a scale portion including a marker portion 15 formed on the core wire 10 and a marker portion 55 formed on the coil spring 50 in the medical guide wire of FIGS. 1 and 2. 4 is an explanatory view schematically showing another embodiment of the scale portion in the medical guide wire of FIGS. 1 and 2. FIG. 3 and 4, the core wire 10 is formed of a radiolucent wire such as a stainless steel wire or a nickel titanium alloy wire, and the coil spring 50 is a radiolucent wire such as a stainless steel wire or a nickel titanium alloy wire. It is formed with. Therefore, a radiopaque marker portion 15 having a width of about 0.5 mm to 2.0 mm at positions at regular intervals in the length direction (for example, a position with a pitch of 10 mm) is provided on the outer periphery of the reduced diameter portion 11 of the core wire. Is formed. The marker unit 15 forms a scale display (mark) by shading on a radioscopic image.

  As shown in FIG. 3, the marker portion 15 can be formed by gold plating in a ring shape surrounding the outer periphery of the tip reduced diameter portion 11 or vapor deposition of gold-platinum molten metal. Alternatively, as shown in FIG. 4, the marker portion 15 is brazed with a radiopaque coil made of a thin wire such as gold, platinum, tungsten, tantalum, rhenium, an alloy thereof, or a gold-nickel chrome alloy, to the reduced diameter portion 11. You may form by the method of adhering by etc.

  1 to 4, the coil spring 50 is formed with a radiopaque marker portion 55 having a width of about 0.5 mm to 2.0 mm at the same interval (for example, 10 mm pitch) as the marker portion 15 of the reduced diameter portion 11. Has been. The marker portion 55 also forms a scale display (mark) by shading on the radioscopic image. The marker portion 55 can be formed by brazing a radiopaque material such as gold, platinum, tungsten, tantalum, rhenium, an alloy thereof, or a gold-nickel chrome alloy to the surface of the coil spring 50.

  The marker portion 15 of the tip diameter-reduced portion 11 and the marker portion 55 of the coil spring 50 are each formed at a constant pitch interval (for example, 10 mm). In the assembled state as the guide wire 100, the marker portion 15 of the tip diameter-reduced portion 11 and the marker portion 55 of the coil spring 50 are alternately arranged at equal intervals in the length direction, so that the pitch is ½. Scale portions with an interval (for example, 5 mm) are formed.

  FIG. 5 is an explanatory view schematically showing another example of the arrangement of the marker portions of the equally spaced scale portions (equally spaced marker portions) in the present invention. In the present invention, the marker portions 15 of the tip diameter-reduced portion 11 and the marker portions 55 (65) of the exterior portion 50 (60) are alternately arranged at equal intervals in the length direction (equally spaced marker portions). 3), as shown in FIG. 3, not only a configuration in which the marker portion 15 of the tip reduced diameter portion and the marker portion 55 (65) of the exterior portion are alternately arranged one by one, but also the marker portion of the tip reduced diameter portion and A configuration in which one or a plurality of marker portions of the exterior portion are alternately arranged is also included. For example, as shown in FIG. 5, a plurality (two) of marker portions 15 formed on the tip diameter-reduced portion 11 between marker portions 55 (65) formed at predetermined intervals on the exterior portion 50 (60). The structure which arrange | positions by equal intervals is also included.

  According to 1st Embodiment demonstrated in FIGS. 1-5, while providing the marker parts 15 and 55 of a fixed space | interval in both the core wire 10 and the exterior part 50, in the state of a guide wire, these marker parts 15, Since the scales 55 are alternately arranged at equal intervals, the marker portions 15 and 55 are used in combination when measuring the position and length of a stenotic lesion by inserting into a blood vessel such as a coronary artery. By doing so, the following effects can be obtained.

  First, use the “difference in length” or “difference in brightness” due to the difference in length (diameter) in the direction perpendicular to the axis of each marker portion 15 on the core wire 10 and each marker portion 55 of the exterior portion 50. As a result, it is possible to visually recognize an image of a radioscopic marker similar to that of the measurement measure, and it is possible to easily and accurately measure a stenotic lesion. This “difference between long and short” causes a “lightness difference between light and shade” on a radioscopic image if the radiopaque material has the same form. This is due to the volume difference of the radiopaque material forming the marker portions 15 and 55.

  That is, in the present embodiment, unlike the conventional equally spaced markers of the same form, the short marker portion 15 and the long marker portion 55 formed on two different members of the core wire 10 and the coil 50 are used in combination. The scale part which consists of the marker part on another member can be formed. Therefore, the measurement interval can be reduced (a plurality of parts) without any reduction in the flexibility of the distal end portion of the guide wire 100, and more accurate under the sense of a measurement measure having long and short scales. It is possible to easily measure a stenotic lesion length.

  Secondly, by using a marker portion formed on a separate member in combination, the measurement accuracy can be reduced by maintaining the flexibility of the coil spring 50 as it is, and the interval between the radiopaque marker portions is reduced to a plurality. Therefore, it is possible to improve the length measurement accuracy by reducing the length measurement interval without impairing the followability of the wire at the sudden bending change portion of the blood vessel and the deep insertion property at the bent lesion portion. be able to. This is because the coil spring 50 is a kind of torsion spring, and its displacement angle is proportional to the number of coil turns, and the flexibility decreases as the interval between the marker portions 55 decreases. According to this embodiment, brazing is performed. This is because the scale interval can be reduced without reducing the interval between the marker portions 55.

  FIG. 6 is a schematic longitudinal sectional view showing a second embodiment of the medical guide wire according to the present invention, and FIG. 7 is a transverse sectional view taken along line 7-7 in FIG. In the present embodiment, an exterior portion that covers the outer periphery of the tip diameter-reduced portion 11 of the core wire 10 is formed with a synthetic resin coating. 6 and 7, an exterior portion (covering portion) 60 made of a radiolucent synthetic resin is integrally formed around the tip reduced diameter portion 11 of the core wire 10. The illustrated resin coating 60 is formed in a region including a part or the whole of the base portion 12 of the core wire 10 including the tip reduced diameter portion 11. The surface of the resin coating (synthetic resin) 60 is covered with a thin film layer 61 of a hydrophilic polymer. Moreover, the front-end | tip part 62 of the synthetic resin 60 is formed in the hemispherical shape.

  6 and 7, the outer peripheral portion of the tip diameter-reduced portion 11 of the core wire is not exposed to radiation having a width of about 0.5 mm to 2.0 mm at a constant interval of 10 mm, for example, as in the first embodiment. A transparent marker portion 15 is formed. As shown in FIGS. 3 and 4, the marker portion 15 is also gold-plated, gold-platinum molten metal is deposited, or gold, platinum, tungsten, tantalum, rhenium, or an alloy thereof or a gold-nickel-chrome alloy. The radiopaque coil such as can be formed by a method such as fixing by brazing.

  In FIG. 6, a radiation having a width of about 0.5 mm to 2.0 mm at a constant interval (for example, 10 mm pitch) in the length direction on the outer periphery of the synthetic resin 60 which is an exterior portion covering the reduced diameter portion 11. An opaque marker portion 65 is formed. The marker portion 65 also forms a scale display (mark) by shading on the radioscopic image. The marker portion 65 is formed of a radiopaque plating layer such as gold, platinum, tungsten, tantalum, rhenium, an alloy thereof, or a gold nickel chrome alloy.

  And the marker part 15 of the tip diameter-reduced part 11 of the core wire 10 and the marker part 65 of the synthetic resin 60 are alternately arranged at equal intervals in the length direction, so that the light and dark (long and short) mark parts are alternately arranged. Arranged scale parts are formed. Also in the present embodiment, the configuration of the equally spaced scale portions (equally spaced marker portions) in which the marker portions 15 of the tip diameter-reduced portion 11 and the marker portions 65 of the exterior portion 60 are alternately arranged at equal intervals in the length direction is as follows. The marker portion 15 of the tip diameter-reduced portion 11 and the marker portion 65 of the exterior portion (synthetic resin) 60 may be alternately arranged one by one or plural. For example, as shown in FIG. A configuration in which a plurality (two) of marker portions 15 formed on the tip reduced diameter portion 11 are arranged at equal intervals between the marker portions 65 formed at intervals is also included in the range.

  That is, also in this embodiment, by using together the marker portions 15 and 65 formed on different members, the scale interval is decreased (by a plurality) to improve the measurement accuracy of the stenosis lesion length. A measuring length measure is constructed. As described above, the second embodiment shown in FIGS. 6 and 7 is provided with an exterior portion made of the above synthetic resin 60 in place of the coil spring 50 and the hemispherical member 13 in the first embodiment. This embodiment is different from the first embodiment and has substantially the same configuration in other points.

  FIG. 8 is a schematic longitudinal sectional view showing an example in which a part of the second embodiment of FIGS. 6 and 7 is changed. The embodiment of FIG. 8 has an inner portion of the synthetic resin 60 in the configuration of FIG. 6 and has a predetermined length (for example, Lc = about 30 mm) around the tip region of the tip diameter-reduced portion 11. A coil spring 63 of radiopaque material is provided. The coil spring 63 forming the radiopaque portion is fixed to the tip reduced diameter portion 11 by means of brazing or bonding. This example is different from the second embodiment of FIGS. 6 and 7 in the above points, but has substantially the same configuration in other points.

Also in the second embodiment described above with reference to FIGS. 6 to 8, since the scale portion is formed by using the marker portions 15 and 65 provided on both the core wire 10 and the exterior portion 60, the coronary artery When measuring the position and length of a stenotic lesion such as the following, the following effects can be obtained.
First, as in the case of the first embodiment, the “difference in length” or “brightness” due to the difference in the length (diameter) of the marker portion 15 of the core wire 10 and the marker portion 65 of the exterior portion 60 in the direction perpendicular to the axis. By using the “difference”, it is possible to configure a scale that can easily and accurately measure the length of the stenotic lesion with the same feeling as the measurement measure when measuring the stenotic lesion on the radioscopic marker image. Therefore, according to the second embodiment, it is possible to more accurately measure the stenotic lesion length by reducing the length measurement interval (one / multiple) without reducing the flexibility of the distal end portion of the guide wire 100. It becomes.

  Second, the position of the marker portion 15 of the core wire 10 is confirmed by forming the synthetic resin 60 of the exterior portion by a manufacturing method such as extrusion molding of a transparent resin, dipping of a molten resin, and fitting of a shrinkable resin tube. However, the exterior marker portion 65 can be formed, and the scale portion can be formed more easily and accurately. In addition, the marker part 65 of the exterior part 60 can also be formed by a method in which a circular ring body or a coil body as shown in FIG. Moreover, in 2nd Embodiment, the smoothness of the surface of the guide wire 100 can be improved by coat | covering the thermoplastic resin, such as a polyurethane and a polyamide, on the whole outer surface of the synthetic resin 60 and the marker part 65. FIG. Further, a thin film of hydrophilic polymer such as polyvinyl pyrrolidone or polyethylene oxide may be formed on the outer surface.

  In the first embodiment and the second embodiment described above, all of the marker part of the core wire and the marker part of the exterior part are provided at fixed intervals, and one or more marker parts of these different forms are provided in the length direction or Although the case where a plurality of them are alternately arranged at equally spaced positions has been shown, this may be configured such that unequally spaced mark portions provided at different pitch positions as described below are added. Next, an embodiment in which such an unequal interval marker portion is added will be described.

  FIG. 9 shows a radiopaque non-opaque state on the right side (tip side) of the scale portion in which the marker portions 15 of the core wire 10 and the marker portions 55 (or 65) of the exterior portion 50 (or 60) are alternately arranged at equal intervals. It is explanatory drawing which shows the Example which added the equal interval marker part. In the embodiment of FIG. 9, unequally spaced marker portions 16 are provided at a pitch of 3 mm on the tip side of a scale in which marker portions provided on different members are alternately arranged at equal intervals of a 5 mm pitch. In the example shown in the figure, the unequal interval marker portion 16 is provided on the core wire 10, but this may be provided on the exterior portion. Further, the unequally spaced marker portions 16 may be provided on both sides of the front and rear ends.

  FIG. 10 shows a radiopaque structure on the left side (rear end side) of the scale portion in which the marker portions 15 of the core wire 10 and the marker portions 55 (or 65) of the exterior portion 50 (or 60) are alternately arranged at equal intervals. It is explanatory drawing which shows another Example which added the unequally spaced marker part. In the embodiment of FIG. 10, unequal interval marker portions 56 are provided at a pitch of 8 mm on the rear end side of the scale in which marker portions provided on different members are alternately arranged at equal intervals of 5 mm. In the illustrated example, the unequal interval marker portion 56 is provided in the exterior portion (the coil spring 50 or the synthetic resin 60), but this may be provided in the core wire 10. The unequal interval mark portions 56 may be provided on both sides of the front and rear ends.

  According to the configuration of the scale portion including the marker portions as shown in FIGS. 9 and 10, any one of the front and rear ends of the scale portions in which the radiopaque marker portions provided on different members are alternately arranged at equal intervals. Since the unevenly spaced portions 16 (or 56) are provided on the side or both sides, the following operational effects can be obtained in addition to the case of the first or second embodiment. First, by appropriately selecting the distance between unequal intervals, the length of a stenotic lesion such as a coronary artery can be easily and accurately measured, and the comparison between the length of a stenotic lesion and a commercially available stent length can be easily confirmed. This allows the selection of the optimal length stent to be made accurately and quickly.

  Here, the stent is a metal cylindrical mesh body, and is used to prevent clogging of the blood vessel by placing it on the inner wall surface of the blood vessel while expanding the blood vessel from the inside using a balloon catheter. There are five types of dimensions of stents currently on the market, for example, an outer diameter of about 2 mm and lengths (stent lengths) of 8, 13, 18, 23, and 33 mm. Therefore, when the pitch of the scale part of the equally spaced part is 5 mm, by adding a 3 mm or 8 mm non-uniformly spaced part as shown in FIG. 9 or FIG. Therefore, the stent length and the lesion length can be easily and accurately compared with each other.

  That is, by using the equally-spaced scale portion and the non-uniformly spaced portion together, it is possible to quickly select a stent having a length optimal for the lesion length from a variety of commercially available stent lengths, and to perform a quick medical procedure. It becomes possible. For example, if it is confirmed that the length of the lesion matches the length of the 3 mm non-uniformly spaced part and the 3 equally spaced scales, the optimal stent length of 18 mm can be selected quickly and accurately. can do.

  Second, by speeding up the comparison between the lesion length and the commercially available stent length, the burden on the patient can be reduced and safety can be improved. That is, in recent years, since the rate of restenosis after placing a stent in a stenotic lesion is as high as about 30%, use of a drug-eluting stent (DES) is becoming widespread. In this type of stent, a first layer of a hydrophilic coating as a therapeutic substance is provided on a base material, and a second layer of a hydrophobic coating is provided on the outer side of the stent. It has a structure that gradually releases therapeutic drugs. In such a stent, when it is rubbed with the inside of a blood vessel such as a calcified lesion during introduction of the stent, a crack occurs in the coating layer on the outer surface of the stent, and even in a normal site as the indwelling time increases. The drug may elute and may cause side effects. Therefore, when using a drug-eluting stent, the rapid placement of the stent is particularly required, so the above-mentioned unequal interval portion is extremely effective for the determination of the optimum stent by comparing with the lesion length. It is.

  FIG. 11 shows still another example in which an unequal interval portion 58 is provided at the center portion of the scale portion where the marker portion 15 of the core wire 10 and the marker portion 55 (or 65) of the exterior portion 50 (or 60) are alternately arranged at equal intervals. It is explanatory drawing which shows the Example. In the embodiment of FIG. 11, an equidistant portion of 8 mm is provided at the center, and a marker portion provided at a constant interval (10 mm pitch) on each of the different members on both sides is used in combination to alternately equidistant the pitch of 5 mm. The scale part arranged at is formed. In the embodiment of FIG. 11, the unequal spacing portion 58 at the center is formed between the two marker portions 55 (or 65) provided in the exterior portion, but the two marker portions are core wires. Any one of the marker portion 15 and the marker portion 55 (65) of the exterior portion may be selected as appropriate.

  By arranging the marker portions at regular intervals around the unequal interval portion as shown in FIG. 11 (usually symmetrically in the front-and-rear direction), the following operational effects can be obtained. That is, it becomes possible to measure the length of lesions at a plurality of locations of a stenotic lesion in a coronary artery almost simultaneously. In addition, it is possible to confirm the comparison between the lesion length and various stent lengths at the same time as measuring the lesion lengths at a plurality of locations, and it is possible to easily determine the selection of the optimum stent when measuring at a plurality of locations.

  FIG. 12 is a schematic longitudinal sectional view showing a third embodiment of the medical guide wire according to the present invention. In FIG. 12, a range of a predetermined length from the distal end of the coil spring 50 that is the exterior portion of the reduced diameter portion 11 of the core wire 10 is formed by a radiation opaque portion 51, and a predetermined length from the rear end of the radiation opaque portion 51. The range is a radiation transmission part 52 having no marker part, and the marker part 15 and the marker part 55 as shown in FIG. 1 or 5 are alternately arranged at equal intervals on the rear side of the radiation transmission part 52. A scaled portion is formed.

  In one example of the third embodiment, the distance L1 from the distal end of the guide wire 100 (the distal end of the hemispherical member 13) to the rear end of the radiation opaque portion 51 of the coil spring is selected to be about 30 mm. The distance L2 from the tip of the wire 100 to the rear end of the radiation transmitting portion 52 was selected to be about 50 mm. In addition, the marker portions 15 provided at regular intervals (for example, 10 mm pitch) on the tip diameter-reduced portion 11 and the marker portions 55 provided at regular intervals (for example, 10 mm pitch) on the exterior portion 50 are alternately arranged at equal intervals. The length L3 of the scaled portion was selected to be about 75 mm. That is, in this embodiment, the tip of the coil spring 50 is made of a radiopaque coil, and the scale is composed of the marker portions 15 and 55 arranged at equal intervals in the range of about 50 mm to about 125 mm from the tip of the guide wire 100. The part is formed. The width of the marker portions 15 and 55 is selected to be about 0.5 mm to about 2.0 mm.

  In the third embodiment shown in FIG. 12, the case where the exterior part is the coil spring 50 is shown, but this is similarly applied to the case where the exterior part is the synthetic resin 60 as shown in FIGS. 6 to 8. It is possible. The configuration in that case is included in the third embodiment as an example. And since the structure in that case can be easily and clearly understood from the combination of the second embodiment of FIGS. 6 to 8 and the third embodiment of FIG. 12, the detailed description with reference to the drawings will be omitted. Omitted.

  According to the third embodiment described above, the following operational effects can be obtained in addition to the operational effects of the first embodiment or the second embodiment described above. That is, according to the third embodiment, the structure of the coil spring 50 is such that the front end portion is the radiation opaque coil 51 and the rear side portion is the radiation transparent coil and the region near the rear end of the radiation transparent coil. Since the marker portion 55 (or 65) for forming the equally-spaced scale portion is provided in combination with the core wire marker portion 15, the following operational effects can be obtained.

First, by using the radiopaque coil 51 at the length L1 of the tip, the tip position when measuring the lesion length can be easily confirmed, and the anchor effect when inserted into the deep blood vessel deep portion Thus, it is possible to suppress and stabilize the fluctuation of the wire of the scale portion L3 for measuring the length of the lesion caused by blood flow, thereby facilitating the measurement.
Second, a scale portion composed of long and short (or light and dark) marker portions 55 (65) and 15 is formed within a range of a distance L2 (for example, 50 mm) from the tip of the guide wire to a length L3 (for example, 75 mm). Therefore, when performing examination treatment of a stenotic lesion part that often occurs at a blood vessel bifurcation, it can be applied to most of the stenotic lesion parts that occur in the left and right coronary arteries. And the boundary position and pinpoint of a stenosis lesion part are made by making the width | variety of each marker part 15 and 55 (65) into 0.5 mm-2.0 mm as mentioned above, More preferably, it is 0.5 mm-1.6 mm. Can be aligned.

  The medical guide wire according to the embodiment described above can be manufactured by a manufacturing method including the following steps. That is, in the case where the exterior portion covering the tip diameter-reduced portion 11 of the core wire 10 is formed by the coil spring 50, the step of reducing the diameter of the core wire tip portion 11 and the radiation opaqueness to the outer peripheral portion of the core wire tip portion 11 A step of forming a marker portion 15, a step of fitting a coil spring 50 to the core wire tip 11, a step of forming a radiopaque marker portion 55 in the coil spring 50, and a marker of the core wire tip And a step of forming a scale portion by alternately arranging one or a plurality of marker portions 55 of the coil spring and a plurality of marker portions 55 of the coil spring at equal intervals.

  On the other hand, when the exterior portion covering the tip diameter-reduced portion 11 of the core wire 10 is formed of the synthetic resin 60, the step of reducing the diameter of the tip portion 11 of the core wire 10 and the radiation on the outer peripheral portion of the core wire tip portion 11 are performed. A step of forming the opaque marker portion 15, a step of covering at least the core wire tip 11 of the core wire 10 with the synthetic resin 60, and a step of forming 65 a radiopaque marker portion on the outer peripheral portion of the synthetic resin 60. And a step of forming a scale portion by alternately arranging one or a plurality of marker portions 65 of the core wire tip portion and the synthetic resin marker portions 65 at equal intervals. it can.

  In the means for forming the radiopaque portion in the core wire 10 described above, as the radiopaque material, gold, platinum, silver, tantalum, tungsten, rhenium, or an alloy thereof is used, and the radiopaque structure. Examples of the thin film include a cylindrical ring, a coil spring, and a thin film. Examples of the formation of the thin film include plating methods such as electroplating and hot dipping, and vapor phase film forming methods such as vapor deposition, sputtering, and ion plating. The film thickness is preferably 20 μm to 50 μm from the viewpoint of ensuring contrast, and a large number of markers may be simultaneously formed at fixed intervals by a masking method.

  Further, as described above, the width of the radiopaque marker portion is preferably about 0.5 mm to about 2.0 mm, more preferably 0.5 mm to 1.6 mm. The reason is that the lesion boundary is pinpointed. In that case, a radiopaque coil having a wire diameter of 20 μm may be formed, cut to a width of about 0.5 mm to 2.0 mm, and fixed to the core wire 10 by brazing, caulking, bonding, or the like (FIG. 4). .

  In the means for forming the radiopaque portion in the exterior portion made of the coil spring 50 or the synthetic resin 60, the material of the radiopaque material is the same as that of the core wire 10, and the radiopaque structure is as described above. The thin film layer may be formed by a vapor phase film forming method such as vapor deposition, sputtering, or ion plating, or a ball-shaped brazing material such as gold or silver solder may be used. A structure in which the core wire 10 and the coil spring 50 are fixed (coupled) with a brazing material may be used. In this case, the proposed structure that does not reduce the flexibility of the coil spring 50 is very effective. Further, the width of the radiopaque marker portions of the exterior portions 50 and 60 and the function and effect thereof are the same as those of the core wire 10 described above.

As apparent from the above description, according to the medical guide wire and a method for producing a medical guide wire according to the present invention, without impairing the flexibility of the gas guide wire, carried out easily with high precision measurement of the stenotic lesion length Medical guidewires and methods for manufacturing medical guidewires that can be provided are provided.

It is a typical longitudinal section showing a 1st embodiment of a medical guide wire by the present invention. It is a cross-sectional view along line 2-2 in FIG. It is explanatory drawing which shows typically one Example of the scale part which consists of the marker part formed in a core wire and the marker part formed in a coil spring in the medical guide wire of FIG. It is explanatory drawing which shows typically another Example of the scale part which consists of the marker part formed in a core wire and the marker part formed in a coil spring in the medical guide wire of FIG. It is explanatory drawing which shows typically another one example of arrangement | positioning of the marker part of the equally-spaced scale part in this invention. It is a typical longitudinal section showing a 2nd embodiment of a medical guide wire by the present invention. It is a cross-sectional view along line 7-7 in FIG. It is a typical longitudinal cross-sectional view which shows the Example which changed a part of 2nd Embodiment of FIG.6 and FIG.7. It is explanatory drawing which shows the Example which added the radiopaque unequal-interval marker part to the front end side of the scale part which arrange | positioned the marker part of a core wire, and the marker part of an exterior part alternately at equal intervals. It is explanatory drawing which shows another Example which added the radiopaque unequal-interval marker part to the rear end side of the scale part which arrange | positioned the marker part of a core wire, and the marker part of an exterior part alternately at equal intervals. It is explanatory drawing which shows another Example which provided the unequal space | interval part in the center part of the scale part which arrange | positions the marker part of a core wire, and the marker part of an exterior part alternately at equal intervals. It is a typical longitudinal section showing a 3rd embodiment of a medical guide wire by the present invention.

Explanation of symbols

10 Core wire 11 Reduced tip (core wire tip)
12 Base part 13 Hemispherical member 15 Marker part (radiation opaque marker part of core wire)
50 Coil spring (exterior)
51 Radiopaque parts (coil springs)
52 Radiation transmission part (coil spring)
55 Marker part (coil spring radiopaque marker part)
60 Synthetic resin (exterior part)
61 Hydrophilic polymer 63 Radiation opaque part (coil spring)
65 Marker part (Radiopaque marker part of synthetic resin)
100 Medical guidewire

Claims (6)

In a medical guide wire having a core wire having a tip diameter-reduced portion and an exterior portion made of a coil spring covering the tip diameter-reduced portion,
A ring-shaped radiopaque marker portion that wraps the outer peripheral portion at regular intervals in the length direction is provided at the reduced diameter portion of the tip, and the radiopacity that is fixed to the core wire by brazing or the like at regular intervals in the length direction. Provide a marker,
The marker of the radiopaque marker part of the tip reduced diameter part and the marker of the radiopaque marker part of the exterior part are alternately arranged in the length direction,
Forming an equally-spaced graduation portion with equal intervals of a marker interval of the radiopaque marker portion of the tip reduced diameter portion or a marker interval of the radiopaque marker portion of the exterior portion;
A medical guide wire characterized in that a scale is displayed on a radioscopic image similar to a length measurement measure by using a difference in length or brightness in the direction perpendicular to the axis of each marker portion. The medical guidewire according to claim 1,
Between the markers of the radiopaque marker portion of the exterior portion, a plurality of radiopaque marker portions of the reduced diameter portion are alternately arranged in the length direction, and the marker of the radiopaque marker portion of the exterior portion is arranged. A medical guide wire characterized in that an equal interval scale portion having an equal interval of one half of the interval is formed. The medical guidewire according to claim 1 or 2,
The equally-spaced scale portion and an unequally-spaced portion formed by disposing radiopaque marker portions at intervals different from the equally-spaced one side or both sides of the front-rear end of the equally-spaced scale portion. Provided,
A medical guide wire characterized in that the comparison between the length of a stenotic lesion and the length of a commercially available stent is speeded up. The medical guidewire according to claim 1 or 2,
Providing the equal interval scale part and an unequal interval part formed by disposing a radiopaque marker part at an interval different from the equal interval at the central part in the length direction of the equal interval scale part;
A medical guidewire characterized in that the lesion length at a plurality of stenotic lesions can be simultaneously measured by using a symmetrical marker arrangement with the unequal interval portion as the center. The medical guide wire according to any one of claims 1 to 4,
A radiation opaque portion formed in a range of a predetermined length from the front end of the exterior portion, and a radiation transparent portion of a scale-free portion formed in a range of a predetermined length from the rear end of the radiation opaque portion of the exterior portion And having
The equally-spaced scale portion using the radiopaque marker portion of the reduced diameter tip portion and the radiopaque marker portion of the exterior portion in combination with the radiolucent portion 50 mm to 125 mm from the distal end of the medical guide wire Formed,
A medical guide wire, wherein the marker has a width of 0.5 mm to 2 mm. A process of reducing the diameter of the tip of the core wire;
Forming a ring-shaped radiopaque marker portion on the outer periphery of the core wire tip, and
A step of fitting a coil spring to the core wire tip,
Forming a radiopaque marker portion to be fixed to the core wire in the coil spring portion;
One or a plurality of radiopaque marker portions at the tip of the core wire are alternately arranged in the interval between the radiopaque marker portions of the coil spring, and the interval between the radiopaque marker portions of the coil spring is two minutes. A step of forming an equally-spaced scale portion having an equal interval of 1 or a plurality of intervals;
A method for producing a medical guide wire, comprising:

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