WO2013145893A1 - Medical guide wire - Google Patents

Medical guide wire Download PDF

Info

Publication number
WO2013145893A1
WO2013145893A1 PCT/JP2013/053077 JP2013053077W WO2013145893A1 WO 2013145893 A1 WO2013145893 A1 WO 2013145893A1 JP 2013053077 W JP2013053077 W JP 2013053077W WO 2013145893 A1 WO2013145893 A1 WO 2013145893A1
Authority
WO
WIPO (PCT)
Prior art keywords
end side
resin
coil spring
guide wire
rear end
Prior art date
Application number
PCT/JP2013/053077
Other languages
French (fr)
Japanese (ja)
Inventor
亮一 奥村
浩範 河崎
Original Assignee
日本ライフライン株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 日本ライフライン株式会社 filed Critical 日本ライフライン株式会社
Priority to CN201380004444.6A priority Critical patent/CN104023783B/en
Priority to KR1020147026779A priority patent/KR101844630B1/en
Publication of WO2013145893A1 publication Critical patent/WO2013145893A1/en
Priority to HK15101141.9A priority patent/HK1200746A1/en

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09058Basic structures of guide wires
    • A61M2025/09083Basic structures of guide wires having a coil around a core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09166Guide wires having radio-opaque features

Definitions

  • the present invention relates to a medical guide wire having a coil spring attached to the outer periphery of a small-diameter portion on the distal end side of a core wire.
  • a guide wire for guiding a medical device such as a catheter to a predetermined position in a body cavity such as a blood vessel requires flexibility and flexibility at the distal end. For this reason, the outer diameter of the distal end portion of the core wire is made smaller than the outer diameter of the proximal end portion, and a coil spring is attached to the outer periphery of the distal end portion (distal end side small diameter portion) of the core wire.
  • a guide wire intended to improve the flexibility of the distal end is known (see Patent Document 1).
  • the inside of the coil spring attached to the distal end portion of the core wire is filled with resin, and a resin layer made of the resin is formed on the outer periphery of the coil spring, and a hydrophilic resin layer is formed on the surface of the resin layer.
  • a laminated guide wire is introduced (see Patent Document 2). By forming the hydrophilic resin layer on the outer periphery of the coil spring, lubricity is imparted to the distal end portion of the guide wire, and the insertion property of the guide wire can be improved.
  • the operator can change the resistance (change) of the blood vessel site with which the distal end of the guide wire is in contact. Is grasped by feeling at hand.
  • the present invention has been made based on the above situation.
  • the object of the present invention is to have a good lubricity at the distal end and a good guide wire insertion property, but it is possible to sufficiently grasp information in the blood vessel as resistance (change) on the hand side.
  • An object of the present invention is to provide a medical guide wire that can be reliably pushed toward a target site.
  • Another object of the present invention is to provide a medical guide wire that can easily perform a shaping operation.
  • the medical guidewire of the present invention includes a core wire having a distal end side small diameter portion and a proximal end side large diameter portion having a larger outer diameter than the distal end side small diameter portion;
  • a medical guide wire having a coil spring attached to the outer periphery of the small-diameter portion on the distal end side of the core wire along the axial direction, and having a coil spring fixed to the core wire at least at the front end portion and the rear end portion;
  • the coil spring includes a close winding portion on the front end side having a coil pitch of 1.0 to 1.8 times the coil wire diameter, and a sparse winding on the rear end side having a coil pitch of 1.8 to 2.5 times the coil wire diameter.
  • the inside of the rear end side loosely wound portion is filled with resin, a resin layer made of the resin is formed on the outer periphery of the rear end side loosely wound portion, and a hydrophilic resin coating layer is laminated on the surface of the resin layer Formed, The outer periphery of the tip side densely wound portion is not covered with resin, and the constituent material (metal) of the coil spring is exposed.
  • the medical guide wire having such a configuration, the outer periphery of the distal-side densely wound portion is not covered with the resin, and the constituent material of the coil spring is exposed, so that the blood vessel into which the guide wire is inserted
  • the information inside can be fully grasped as resistance (change) on the hand side (excellent in information transmission).
  • the wire can be pushed forward reliably (excellent guide wire direction selectivity).
  • the core wire and the coil spring (rear end side loosely wound portion) can be integrated, and the torque transmission and operability of the guide wire can be integrated. Can be improved (excellent torque transmission).
  • a resin layer is formed on the outer periphery of the rear end side loosely wound portion, and a hydrophilic resin coating layer is laminated on the surface of the resin layer, thereby filling the inside of the rear end side loosely wound portion. Since the hydrophilic resin coating layer is laminated on the outer periphery of the rear end side loosely wound portion through the resin layer made of the same resin as the one, the hydrophilic resin coating layer is securely fixed, and the hydrophilic resin is preferably used. Lubricity can be stably expressed (excellent adhesion of the hydrophilic resin coating layer to the outer periphery of the rear end side loosely wound portion).
  • the distal end side closely wound portion is not filled with resin. According to such a configuration, it is possible to sufficiently ensure flexibility and flexibility in the front end side closely wound portion, and it is possible to easily perform a shaping operation in the coil spring (front end side closely wound portion).
  • an outer diameter (D 1 ) of the proximal end side large diameter portion of the core wire and a coil outer diameter (D 2 ) of the coil spring are 0.012 inches or less
  • the coil spring length (L 2 ) is 51 to 800 mm
  • the length (L 21 ) of the tip side densely wound portion is 1 to 50 mm
  • It is preferable that the length (L 22 ) of the rear end side loosely wound portion is 50 to 750 mm.
  • an intermediate portion including the front end side closely wound portion and the rear end side loosely wound portion of the coil spring is fixed to the core wire by solder.
  • a tip portion and an intermediate portion of the coil spring are fixed to the core wire with gold-containing solder.
  • the core wire is made of stainless steel.
  • the medical guidewire of the present invention has good lubricity at the distal end, and has good insertability, while sufficiently grasping information in the blood vessel as resistance (change) on the hand side. Can be pushed forward toward the target site. Further, since the resin is filled in the rear end side loosely wound portion, the torque transmission is excellent. In addition, according to the medical guide wire of the present invention including the distal end side tightly wound portion that is not filled with resin, the shaping operation can be further easily performed.
  • a guide wire 1 shown in FIGS. 1 and 2 includes a core wire 10 having a distal end side small diameter portion 11 and a proximal end side large diameter portion 14 having a larger outer diameter than the distal end side small diameter portion 11, and the core wire 10.
  • a medical guide wire having a coil spring 20 attached to the outer periphery of the distal end side small-diameter portion 11 along the axial direction and fixed to the core wire 10 at the front end portion, the intermediate portion, and the rear end portion,
  • the coil spring 20 includes a front end side closely wound portion 21 having a coil pitch of 1.0 to 1.8 times the coil wire diameter, and a rear end side having a coil pitch of 1.8 to 2.5 times the coil wire diameter.
  • the rear end side loosely wound portion 22 is filled with the cured resin 40, and a resin layer 40A made of the cured resin is formed on the outer periphery of the rear end side loosely wound portion 22 to form the resin.
  • Hydrophilic resin coating layer 50 on the surface of layer 40A On the other hand, the outer periphery of the tip side densely wound portion 21 is not covered with resin, and the constituent material of the coil spring 20 is exposed, and the inside of the tip side closely wound portion 21 is also filled with resin. Not a guide wire.
  • the guide wire 1 of the present embodiment has a core wire 10 and a coil spring 20.
  • the core wire 10 includes a distal end side small diameter portion 11 that is tapered so as to expand in the proximal direction, a tapered portion 13 that expands in the proximal direction, and a proximal end large diameter portion 14.
  • the distal end side small diameter portion 11, the taper portion 13, and the proximal end side large diameter portion 14 are integrally configured by the same wire (for example, a round bar member).
  • the cross section of the taper part 13 and the proximal end side large diameter part 14 is substantially circular.
  • the cross section on the proximal end side of the distal end side small diameter portion 11 is substantially circular, but the distal end side of the distal end side small diameter portion 11 may be formed into a plate shape by compressing the wire. In that case, the cross section is substantially rectangular.
  • the material of the core wire 10 is not particularly limited, and examples thereof include metals such as stainless steel (for example, SUS316, SUS304), gold, platinum, aluminum, tungsten, tantalum, and alloys thereof. Then, it is made of stainless steel.
  • a water repellent resin layer (not shown) is formed on the outer peripheral surface of the core wire 10.
  • the resin constituting the water-repellent resin layer any resin that is used for medical purposes and has water repellency can be used, and suitable resins include fluorine-based resins such as PTFE.
  • the total length (L 1 ) of the guide wire 1 shown in FIG. 2 is, for example, 1500 to 3000 mm, and is 1780 mm if a suitable example is shown.
  • the outer diameter (D 1 ) of the proximal end side large-diameter portion 14 is usually 0.012 inches (0.305 mm) or less, preferably 0.010 inches (0.254 mm) or less, more preferably 0. 0.006 to 0.010 inch, and a preferred example is 0.010 inch.
  • the medical instrument such as a catheter used with the guide wire of the present invention can be reduced in size and further reduced in invasiveness. Can contribute.
  • the maximum outer diameter of the distal end side small-diameter portion 11, is not particularly limited smaller than the inner diameter of the coil spring 20, the outer diameter of the proximal end side large-diameter portion 14 (D 1) 1/5 About 3/5.
  • the coil spring 20 constituting the guide wire 1 of the present embodiment is mounted on the outer periphery of the distal end side small diameter portion 11 of the core wire 10 along the axial direction.
  • the coil spring 20 is formed of a single wire, and has a closely wound end 21 with a coil pitch of 1.0 to 1.8 times the coil wire diameter, and a coil pitch of 1.8 to 2 of the coil wire diameter.
  • the rear end side sparsely wound portion 22 which is .5 times larger, and the tip side densely wound portion 21 and a tip which will be described later constitute an X-ray opaque region.
  • the coil pitch in the front end side densely wound portion 21 is 1.0 to 1.8 times the coil wire diameter, and is 1.0 times as a suitable example.
  • the coil pitch in the rear end side loosely wound portion 22 is 1.8 to 2.5 times the coil wire diameter, and is 2.0 times if a suitable example is shown.
  • good contrast visibility
  • the pitch is the same throughout the coil spring 20, the X-ray non-transparent region becomes long, and the visibility is lowered.
  • the coil outer diameter (D 2 ) of the coil spring 20 is usually 0.012 inch (0.305 mm) or less, preferably 0.010 inch (0.254 mm) or less, more preferably 0.006 to 0.010. Inches are 0.010 inches.
  • the outer diameter (D 1 ) of the proximal end side large diameter portion 14 of the core wire 10 is 0.012 inch or less and the coil outer diameter (D 2 ) of the coil spring 20 is also 0.012 inch or less,
  • the operability when accessing the microchannel is excellent.
  • the outer diameter of the wire constituting the coil spring 20 is not particularly limited, but is preferably 30 to 90 ⁇ m, and 60 ⁇ m is a preferable example.
  • the front end portion, the rear end portion, and the intermediate portion of the coil spring 20 are soldered 31 and 32, respectively. 33 is fixed to the outer periphery of the distal end side small diameter portion 11 of the core wire 10.
  • the tip of the coil spring 20 is fixed to the core wire 10 with solder 31. That is, the solder 31 penetrates into the coil spring 20, and the solder 31 comes into contact with the outer periphery of the core wire 10 (distal end side small diameter portion 11), whereby the tip of the coil spring 20 is fixed to the core wire 10. Yes.
  • a substantially hemispherical tip is formed by solder 31 that has not penetrated into the coil spring 20 at the tip of the coil spring 20.
  • the distal end portion of the guide wire is provided with a rigid end portion by the solder 31 (the distal end portion of the coil spring 20 that can no longer be freely bent by the solder 31 that has penetrated into the coil, and the distal end formed by the solder 31. A rigid part) is formed.
  • an intermediate portion including a boundary region between the front end side densely wound portion 21 and the rear end side loosely wound portion 22 of the coil spring 20 is fixed to the core wire 10 by the solder 32. That is, the solder 32 penetrates into the coil spring 20, and the solder 32 comes into contact with the outer periphery of the core wire 10 (distal end side small diameter portion 11), whereby the intermediate portion of the coil spring 20 is fixed to the core wire 10. Yes.
  • the rear end portion of the coil spring 20 is fixed to the core wire 10 with solder 33. That is, the solder 33 penetrates into the coil spring 20, and the solder 33 comes into contact with the outer periphery of the core wire 10 (distal end side small diameter portion 11), whereby the rear end portion of the coil spring 20 is fixed to the core wire 10. ing.
  • gold-containing solder As the solders 31 and 32 for fixing the tip part and the intermediate part of the coil spring 20 to the core wire 10 respectively.
  • gold-containing solder includes Au alloy solder such as Au—Sn solder, Au—Ge solder, Au—Si solder, Au—In solder, Au—Sb solder, and Au solder. It is.
  • examples of the solder 33 for fixing the rear end portion of the coil spring 20 to the core wire 10 include silver-based solder such as Ag—Sn.
  • the inside of the rear end side loosely wound portion 22 of the coil spring 20 is filled with the cured resin 40 and the outer periphery of the rear end side loosely wound portion 22. Further, a resin layer 40A (cured resin layer covering the coil wire) is formed by the cured resin 40, and a hydrophilic resin coating layer 50 is laminated on the surface of the resin layer 40A.
  • the core wire 10 and the coil spring 20 are integrated, and the torque transmission performance of the guide wire is greatly improved.
  • the rotational torque transmitted from the 10 proximal end large diameter portions 14 is reliably transmitted to the distal end of the coil spring 20 integrated with the distal end small diameter portion 11.
  • a resin layer 40A is formed on the outer periphery of the rear end side loosely wound portion 22 of the coil spring 20, and a hydrophilic resin coating layer 50 is laminated on the surface of the resin layer 40A (rear end side loosely wound portion). 2 2), the hydrophilic resin coating layer 50 is formed on the outer periphery of the coil spring 20 via the resin layer 40A. Therefore, the hydrophilic resin coating layer 50 is firmly fixed to the coil spring 20, thereby The suitable lubricity due to can be expressed stably.
  • the inside of the rear end side sparsely wound portion 22 is filled, and the cured resin 40 constituting the resin layer 40A has a good adhesiveness to both the coil spring 20 and the hydrophilic resin.
  • a photo-curing resin such as urethane acrylate resin, polyurethane resin, silicone resin, epoxy resin, acrylic resin, and nylon resin, or a cured product of thermosetting resin.
  • the film thickness of the resin layer 40A covering the outer periphery of the rear end side loosely wound portion 22 is, for example, 1 to 100 ⁇ m, preferably 3 to 10 ⁇ m.
  • hydrophilic resin that constitutes the hydrophilic resin coating layer 50 that is laminated on the surface of the resin layer 40A
  • all conventionally known hydrophilic polymers that are used for hydrophilic treatment of medical devices can be used.
  • polysaccharides such as polyethylene glycol, polyethylene oxide, polyol, polyacrylamide, polyvinyl pyrrolidone, polyvinyl alcohol, polyether, polyurethane, polycarboxylic acid and derivatives thereof, cellulose, protein, hyaluronic acid can be exemplified.
  • these hydrophilic polymers may have a crosslinked structure.
  • the thickness of the hydrophilic resin layer 50 is, for example, 1 to 30 ⁇ m, preferably 3 to 19 ⁇ m.
  • the method of filling the cured resin 40 and forming the resin layer 40A and the method of forming the laminated layer of the hydrophilic resin 50 are not particularly limited.
  • the rear end side loosely wound portion attached to the core wire 10 is used. 22 is immersed in a curable resin to fill the inside of the rear end side loosely wound portion 22 with a curable resin, and a resin layer is formed on the surface of the rear end side loosely wound portion 22, which is thermoset.
  • a method may be mentioned in which a cured resin 40 (resin layer 40A) is obtained by photocuring, and then a hydrophilic resin is applied to the surface of the resin layer 40A by an appropriate means.
  • the outer periphery of the tip side densely wound part 21 is masked, etc. It is preferable to prevent inflow and adhesion of the curable resin to the inside or the outer periphery.
  • the outer periphery of the tip side densely wound portion 21 of the coil spring 20 is not covered with resin, and the constituent material of the coil spring 20 (X-ray opaque substance) Etc.) are exposed.
  • information in the blood vessel into which the guide wire 1 of the present embodiment is inserted for example, the state of a lesion site such as a stenosis part or an obstruction part
  • resistance (change) on the hand side for example, the state of a lesion site such as a stenosis part or an obstruction part
  • the guide wire 1 of the present embodiment can be reliably pushed toward the site.
  • the inside of the front end side tightly wound portion 21 is not filled with resin.
  • the flexibility and softness in the front end side densely wound portion 21 can be sufficiently secured, and the shaping operation can be easily performed in the front end side closely wound portion 21.
  • the torque transmission property of the guide wire 1 is improved by filling the inside of the rear end side loosely wound portion 22 with the cured resin 40. Sufficiently secured.
  • the length (L 2 ) of the coil spring 20 shown in FIG. 2 is preferably 51 to 800 mm, more preferably 85 to 310 mm, and 115 mm if a suitable example is shown.
  • the length (L 21 ) of the tip side densely wound portion 21 is preferably 1 to 50 mm, more preferably 20 to 40 mm, and 30 mm if a suitable example is shown.
  • the length (L 22 ) of the rear end side loosely wound portion 22 is preferably 50 to 750 mm, more preferably 65 to 270 mm, and 85 mm if a suitable example is shown.
  • the length (L 21 ) of the distal end side tightly wound portion 21 that is not coated with resin is too small, information in the blood vessel into which the guide wire is inserted cannot be sufficiently grasped, and the guide The distal end of the wire becomes slippery and it is difficult to push such a guidewire toward the target site.
  • the length (L 21 ) of the distal end side tightly wound portion 21 is excessive, the lubricity at the distal end portion of the guide wire is insufficient and, for example, it is difficult to pass through the stenosis site. For example, the insertion property of the guide wire is impaired.
  • the guide wire is Information in the inserted blood vessel cannot be fully grasped, and it is difficult to push the guide wire toward the target site.
  • the length (L 3 ) of the substantially hemispherical tip formed by the solder 31 is, for example, 0.1 to 5.0 mm, and 0.3 mm is a preferable example.
  • the distal end portion to which the coil spring 20 (rear end side loosely wound portion 22) is attached has good lubricity and enters the blood vessel. While the insertability of the coil spring 20 is good, the outer periphery of the distal end side densely wound portion 21 is not covered with resin, and the constituent material (metal) of the coil spring 20 is exposed, so that the information in the blood vessel is resisted (changed). ) Can be grasped sufficiently on the hand side, and can be reliably pushed toward the target site. Further, since the cured resin 40 is filled in the rear end side loosely wound portion 22, the torque transmission is excellent. In addition, since the inside of the distal end side tightly wound portion 21 is not filled with resin, the shaping operation can be easily performed.

Abstract

A medical guide wire has: a core wire (10) having a distal end small-diameter section (11) and a proximal end large-diameter section (14); and a coiled spring (20) mounted to the outer periphery of the distal end small-diameter section (11). The coiled spring (20) comprises: a front end closely wound section (21) having a pitch which is 1.0 to 1.8 times the diameter of the coil wire; and a rear end loosely wound section (22) having a pitch which is 1.8 to 2.5 times the diameter of the coil wire. The inside of the rear end loosely wound section (22) is filled with a resin (40), and a resin layer (40A) consisting of the resin is formed on the outer periphery of the rear end loosely wound section (22). A hydrophilic resin coating layer (50) is laminated and formed on the surface of the resin layer (40A). The outer periphery of the front end closely wound section (21) is not coated with a resin, and a material which forms the coiled spring (20) is exposed at the outer periphery. The guide wire has satisfactory lubricating properties at the distal end thereof, has satisfactory insertability, enables information within a blood vessel to be sufficiently sensed as resistance (change) by the operator's hand, and can be reliably advanced to a destination site.

Description

医療用ガイドワイヤMedical guidewire
 本発明は、コアワイヤの遠位端側小径部の外周に装着されたコイルスプリングを有する医療用ガイドワイヤに関する。 The present invention relates to a medical guide wire having a coil spring attached to the outer periphery of a small-diameter portion on the distal end side of a core wire.
 カテーテルなどの医療器具を血管などの体腔内の所定位置へと案内するためのガイドワイヤには、遠位端部における可撓性・柔軟性が要求される。
 このため、コアワイヤの遠位端部の外径を、近位端部の外径よりも小さくするとともに、コアワイヤの遠位端部(遠位端側小径部)の外周にコイルスプリングを装着して、遠位端部の可撓性の向上を企図したガイドワイヤが知られている(特許文献1参照)。
A guide wire for guiding a medical device such as a catheter to a predetermined position in a body cavity such as a blood vessel requires flexibility and flexibility at the distal end.
For this reason, the outer diameter of the distal end portion of the core wire is made smaller than the outer diameter of the proximal end portion, and a coil spring is attached to the outer periphery of the distal end portion (distal end side small diameter portion) of the core wire. A guide wire intended to improve the flexibility of the distal end is known (see Patent Document 1).
 また、コアワイヤの遠位端部に装着されたコイルスプリングの内部に樹脂が充填されているとともに、コイルスプリングの外周に前記樹脂による樹脂層が形成され、この樹脂層の表面に親水性樹脂層が積層形成されているガイドワイヤが紹介されている(特許文献2参照)。コイルスプリングの外周に親水性樹脂層を形成することにより、ガイドワイヤの遠位端部に潤滑性が付与されて、ガイドワイヤの挿入性を向上させることができる。 In addition, the inside of the coil spring attached to the distal end portion of the core wire is filled with resin, and a resin layer made of the resin is formed on the outer periphery of the coil spring, and a hydrophilic resin layer is formed on the surface of the resin layer. A laminated guide wire is introduced (see Patent Document 2). By forming the hydrophilic resin layer on the outer periphery of the coil spring, lubricity is imparted to the distal end portion of the guide wire, and the insertion property of the guide wire can be improved.
特開2003-299739号公報JP 2003-299739 A 特開2010-214054号公報JP 2010-214054 A
 ガイドワイヤが挿入されている血管内の情報(例えば、狭窄部や閉塞部などの病変部位の状況)について、オペレータは、ガイドワイヤの遠位端部が接触している血管部位の抵抗(変化)を手元で感じることによって把握している。 For information in the blood vessel in which the guide wire is inserted (for example, the status of a lesion site such as a stenosis or an occlusion), the operator can change the resistance (change) of the blood vessel site with which the distal end of the guide wire is in contact. Is grasped by feeling at hand.
 然るに、上記特許文献2に記載されたガイドワイヤのように、コイルスプリングの外周に親水性樹脂層が被覆形成されてなるガイドワイヤにおいては、そのような抵抗(変化)を殆ど感じることができないため、情報の把握が困難となる。
 また、このようなガイドワイヤは、良好な潤滑性が得られる反面、その遠位端部が滑りやすくなっているために、目的部位へ向けてこれを押し進めることが困難である。
 更に、抵抗(変化)を殆ど感じることができないことによって、必要以上に先端荷重を掛けてしまい、血管に損傷を与えるおそれもある。
However, in the guide wire in which the hydrophilic resin layer is formed on the outer periphery of the coil spring as in the guide wire described in Patent Document 2, such resistance (change) can hardly be felt. This makes it difficult to grasp information.
In addition, such a guide wire can obtain good lubricity, but its distal end portion is easy to slip, so that it is difficult to push it toward the target site.
Furthermore, since the resistance (change) can hardly be felt, a tip load is applied more than necessary, and the blood vessel may be damaged.
 一方、例えば、CTO病変におけるマイクロチャンエル内にガイドワイヤを挿通させる際には、その先端部分を折り曲げて癖づけること(シェイピング)がオペレータによって行われる。 On the other hand, for example, when a guide wire is inserted into a microchannel in a CTO lesion, an operator performs bending and shaping of the distal end portion (shaping).
 然るに、上記特許文献2に記載されたガイドワイヤのように、コイルスプリングの内部に樹脂が充填されてなるガイドワイヤにおいては、先端部分において充填されている樹脂によってシェイピング操作を行いにくい。 However, in the guide wire in which the resin is filled in the coil spring like the guide wire described in Patent Document 2, the shaping operation is difficult to be performed by the resin filled in the tip portion.
 本発明は以上のような事情に基いてなされたものである。
 本発明の目的は、遠位端部において良好な潤滑性を有し、ガイドワイヤの挿入性が良好でありながら、血管内の情報を抵抗(変化)として手元側で十分に把握することができ、
目的部位に向けて確実に押し進めることができる医療用ガイドワイヤを提供することにある。
 本発明の他の目的は、更に、シェイピング操作を容易に行うことができる医療用ガイドワイヤを提供することにある。
The present invention has been made based on the above situation.
The object of the present invention is to have a good lubricity at the distal end and a good guide wire insertion property, but it is possible to sufficiently grasp information in the blood vessel as resistance (change) on the hand side. ,
An object of the present invention is to provide a medical guide wire that can be reliably pushed toward a target site.
Another object of the present invention is to provide a medical guide wire that can easily perform a shaping operation.
(1)本発明の医療用ガイドワイヤは、遠位端側小径部と前記遠位端側小径部より外径の大きい近位端側大径部とを有するコアワイヤと、
 前記コアワイヤの遠位端側小径部の外周に軸方向に沿って装着され、少なくとも先端部および後端部において、前記コアワイヤに固着されているコイルスプリングとを有する医療用ガイドワイヤであって、
 前記コイルスプリングは、コイルピッチがコイル線径の1.0~1.8倍である先端側密巻部と、コイルピッチがコイル線径の1.8~2.5倍である後端側疎巻部とからなり、
 前記後端側疎巻部の内部に樹脂が充填されているとともに、前記後端側疎巻部の外周に前記樹脂による樹脂層が形成され、前記樹脂層の表面に親水性樹脂被覆層が積層形成され、
 前記先端側密巻部の外周は、樹脂により被覆されることなく、前記コイルスプリングの構成材料(金属)が露出していることを特徴とする。
(1) The medical guidewire of the present invention includes a core wire having a distal end side small diameter portion and a proximal end side large diameter portion having a larger outer diameter than the distal end side small diameter portion;
A medical guide wire having a coil spring attached to the outer periphery of the small-diameter portion on the distal end side of the core wire along the axial direction, and having a coil spring fixed to the core wire at least at the front end portion and the rear end portion;
The coil spring includes a close winding portion on the front end side having a coil pitch of 1.0 to 1.8 times the coil wire diameter, and a sparse winding on the rear end side having a coil pitch of 1.8 to 2.5 times the coil wire diameter. Consisting of winding parts,
The inside of the rear end side loosely wound portion is filled with resin, a resin layer made of the resin is formed on the outer periphery of the rear end side loosely wound portion, and a hydrophilic resin coating layer is laminated on the surface of the resin layer Formed,
The outer periphery of the tip side densely wound portion is not covered with resin, and the constituent material (metal) of the coil spring is exposed.
このような構成の医療用ガイドワイヤによれば、先端側密巻部の外周が樹脂により被覆されることなく、コイルスプリングの構成材料が露出していることにより、ガイドワイヤが挿入されている血管内の情報を抵抗(変化)として手元側で十分に把握することができる(情報伝達性に優れている)。
 また、先端側密巻部が接触している血管部位の情報を十分に把握することができるとともに、先端側密巻部が滑りにくいため、血管内の目的部位に向けて本発明の医療用ガイドワイヤを確実に押し進めることができる(ガイドワイヤの方向選択性に優れている)。
According to the medical guide wire having such a configuration, the outer periphery of the distal-side densely wound portion is not covered with the resin, and the constituent material of the coil spring is exposed, so that the blood vessel into which the guide wire is inserted The information inside can be fully grasped as resistance (change) on the hand side (excellent in information transmission).
In addition, it is possible to sufficiently grasp the information on the blood vessel part in contact with the distal side tightly wound part, and the distal side closely wound part is difficult to slip, so that the medical guide of the present invention is directed toward the target part in the blood vessel. The wire can be pushed forward reliably (excellent guide wire direction selectivity).
 また、後端側疎巻部の内部に樹脂が充填されていることにより、コアワイヤとコイルスプリング(後端側疎巻部)とを一体化させることができ、ガイドワイヤのトルク伝達性・操作性を向上させることができる(トルク伝達性に優れている)。
 また、後端側疎巻部の外周に樹脂層が形成され、この樹脂層の表面に親水性樹脂被覆層が積層形成されていることにより、後端側疎巻部の内部に充填されているものと同じ樹脂による樹脂層を介して、後端側疎巻部の外周に親水性樹脂被覆層が積層形成されているので、親水性樹脂被覆層が確実に固定され、親水性樹脂による好適な潤滑性を安定的に発現させることができる(後端側疎巻部の外周に対する親水性樹脂被覆層の密着性に優れている)。
In addition, since the inside of the rear end side loosely wound portion is filled with resin, the core wire and the coil spring (rear end side loosely wound portion) can be integrated, and the torque transmission and operability of the guide wire can be integrated. Can be improved (excellent torque transmission).
In addition, a resin layer is formed on the outer periphery of the rear end side loosely wound portion, and a hydrophilic resin coating layer is laminated on the surface of the resin layer, thereby filling the inside of the rear end side loosely wound portion. Since the hydrophilic resin coating layer is laminated on the outer periphery of the rear end side loosely wound portion through the resin layer made of the same resin as the one, the hydrophilic resin coating layer is securely fixed, and the hydrophilic resin is preferably used. Lubricity can be stably expressed (excellent adhesion of the hydrophilic resin coating layer to the outer periphery of the rear end side loosely wound portion).
(2)本発明の医療用ガイドワイヤにおいて、前記先端側密巻部の内部に樹脂が充填されていないことが好ましい。
 このような構成によれば、先端側密巻部における可撓性・柔軟性を十分に確保することができ、コイルスプリング(先端側密巻部)において、シェイピング操作を容易に行うことができる。
(2) In the medical guidewire of the present invention, it is preferable that the distal end side closely wound portion is not filled with resin.
According to such a configuration, it is possible to sufficiently ensure flexibility and flexibility in the front end side closely wound portion, and it is possible to easily perform a shaping operation in the coil spring (front end side closely wound portion).
(3)本発明の医療用ガイドワイヤにおいて、前記コアワイヤの近位端側大径部の外径(D)および前記コイルスプリングのコイル外径(D)が0.012インチ以下、
 前記コイルスプリングの長さ(L)が51~800mm、
 前記先端側密巻部の長さ(L21)が1~50mm、
 前記後端側疎巻部の長さ(L22)が50~750mmであることが好ましい。
(3) In the medical guidewire of the present invention, an outer diameter (D 1 ) of the proximal end side large diameter portion of the core wire and a coil outer diameter (D 2 ) of the coil spring are 0.012 inches or less,
The coil spring length (L 2 ) is 51 to 800 mm,
The length (L 21 ) of the tip side densely wound portion is 1 to 50 mm,
It is preferable that the length (L 22 ) of the rear end side loosely wound portion is 50 to 750 mm.
(4)本発明の医療用ガイドワイヤにおいて、前記コイルスプリングの先端側密巻部と後端側疎巻部とを含む中間部がはんだによって前記コアワイヤに固着されていることが好ましい。
(5)上記(4)の医療用ガイドワイヤにおいて、前記コイルスプリングの先端部および中間部が金含有はんだによって前記コアワイヤに固着されていることが好ましい。
(6)本発明の医療用ガイドワイヤにおいて、前記コアワイヤがステンレスからなることが好ましい。
(4) In the medical guide wire of the present invention, it is preferable that an intermediate portion including the front end side closely wound portion and the rear end side loosely wound portion of the coil spring is fixed to the core wire by solder.
(5) In the medical guidewire according to (4), it is preferable that a tip portion and an intermediate portion of the coil spring are fixed to the core wire with gold-containing solder.
(6) In the medical guidewire of the present invention, it is preferable that the core wire is made of stainless steel.
 本発明の医療用ガイドワイヤによれば、遠位端部において良好な潤滑性を有し、挿入性が良好でありながら、血管内の情報を抵抗(変化)として手元側で十分に把握することができ、目的部位に向けて確実に押し進めることができる。
 また、後端側疎巻部の内部に樹脂が充填されていることにより、トルク伝達性に優れている。
 また、内部に樹脂が充填されていない先端側密巻部を備えてなる本発明の医療用ガイドワイヤによれば、更に、シェイピング操作を容易に行うことができる。
According to the medical guidewire of the present invention, it has good lubricity at the distal end, and has good insertability, while sufficiently grasping information in the blood vessel as resistance (change) on the hand side. Can be pushed forward toward the target site.
Further, since the resin is filled in the rear end side loosely wound portion, the torque transmission is excellent.
In addition, according to the medical guide wire of the present invention including the distal end side tightly wound portion that is not filled with resin, the shaping operation can be further easily performed.
本発明のガイドワイヤの一実施形態を示す一部を破断した側面図である。It is the side view which fractured | ruptured one part which shows one Embodiment of the guide wire of this invention. 本発明のガイドワイヤの一実施形態を示す一部を破断した側面図(寸法を説明するための図)である。It is the side view (figure for demonstrating a dimension) which fractured | ruptured a part which shows one Embodiment of the guide wire of this invention.
 図1および図2に示すガイドワイヤ1は、遠位端側小径部11と遠位端側小径部11より外径の大きい近位端側大径部14とを有するコアワイヤ10と、コアワイヤ10の遠位端側小径部11の外周に軸方向に沿って装着され、先端部、中間部および後端部において、コアワイヤ10に固着されているコイルスプリング20とを有する医療用ガイドワイヤであって、コイルスプリング20は、コイルピッチがコイル線径の1.0~1.8倍である先端側密巻部21と、コイルピッチがコイル線径の1.8~2.5倍である後端側疎巻部22とからなり、後端側疎巻部22の内部に硬化樹脂40が充填されているとともに、後端側疎巻部22の外周に当該硬化樹脂による樹脂層40Aが形成され、樹脂層40Aの表面に親水性樹脂被覆層50が積層形成され、他方、先端側密巻部21の外周は、樹脂により被覆されることなく、コイルスプリング20の構成材料が露出しており、先端側密巻部21の内部にも樹脂が充填されていないガイドワイヤである。 A guide wire 1 shown in FIGS. 1 and 2 includes a core wire 10 having a distal end side small diameter portion 11 and a proximal end side large diameter portion 14 having a larger outer diameter than the distal end side small diameter portion 11, and the core wire 10. A medical guide wire having a coil spring 20 attached to the outer periphery of the distal end side small-diameter portion 11 along the axial direction and fixed to the core wire 10 at the front end portion, the intermediate portion, and the rear end portion, The coil spring 20 includes a front end side closely wound portion 21 having a coil pitch of 1.0 to 1.8 times the coil wire diameter, and a rear end side having a coil pitch of 1.8 to 2.5 times the coil wire diameter. The rear end side loosely wound portion 22 is filled with the cured resin 40, and a resin layer 40A made of the cured resin is formed on the outer periphery of the rear end side loosely wound portion 22 to form the resin. Hydrophilic resin coating layer 50 on the surface of layer 40A On the other hand, the outer periphery of the tip side densely wound portion 21 is not covered with resin, and the constituent material of the coil spring 20 is exposed, and the inside of the tip side closely wound portion 21 is also filled with resin. Not a guide wire.
 本実施形態のガイドワイヤ1は、コアワイヤ10と、コイルスプリング20とを有する。コアワイヤ10は、近位方向に拡径するようテーパ加工された遠位端側小径部11と、近位方向に拡径するテーパ部13と、近位端側大径部14とを有する。
 遠位端側小径部11、テーパ部13および近位端側大径部14は、同一の線材(例えば、丸棒部材)により一体的に構成されている。
The guide wire 1 of the present embodiment has a core wire 10 and a coil spring 20. The core wire 10 includes a distal end side small diameter portion 11 that is tapered so as to expand in the proximal direction, a tapered portion 13 that expands in the proximal direction, and a proximal end large diameter portion 14.
The distal end side small diameter portion 11, the taper portion 13, and the proximal end side large diameter portion 14 are integrally configured by the same wire (for example, a round bar member).
 テーパ部13および近位端側大径部14の横断面は、略円形である。
 遠位端側小径部11の近位端側における横断面は略円形であるが、遠位端側小径部11の遠位端側は、線材が圧縮されて板状となっていてもよく、その場合の横断面は略矩形となる。
The cross section of the taper part 13 and the proximal end side large diameter part 14 is substantially circular.
The cross section on the proximal end side of the distal end side small diameter portion 11 is substantially circular, but the distal end side of the distal end side small diameter portion 11 may be formed into a plate shape by compressing the wire. In that case, the cross section is substantially rectangular.
 コアワイヤ10の材質としては、特に限定されるものではないが、ステンレス(例えばSUS316、SUS304)、金、白金、アルミニウム、タングステン、タンタルまたはこれらの合金などの金属を挙げることができるが、本実施形態では、ステンレスで構成されている。
 また、コアワイヤ10の外周面には、撥水性樹脂層(図示省略)が形成されている。
 撥水性樹脂層を構成する樹脂としては、医療用として用いられる樹脂であって、撥水性を有するものをすべて用いることができ、好適な樹脂としてPTFEなどのフッ素系樹脂を挙げることができる。
The material of the core wire 10 is not particularly limited, and examples thereof include metals such as stainless steel (for example, SUS316, SUS304), gold, platinum, aluminum, tungsten, tantalum, and alloys thereof. Then, it is made of stainless steel.
A water repellent resin layer (not shown) is formed on the outer peripheral surface of the core wire 10.
As the resin constituting the water-repellent resin layer, any resin that is used for medical purposes and has water repellency can be used, and suitable resins include fluorine-based resins such as PTFE.
 図2に示すガイドワイヤ1の全長(L)は、例えば1500~3000mmとされ、好適な一例を示せば1780mmである。
 また、近位端側大径部14の外径(D)は、通常0.012インチ(0.305mm)以下とされ、好ましくは0.010インチ(0.254mm)以下、更に好ましくは0.006~0.010インチとされ、好適な一例を示せば0.010インチである。
The total length (L 1 ) of the guide wire 1 shown in FIG. 2 is, for example, 1500 to 3000 mm, and is 1780 mm if a suitable example is shown.
In addition, the outer diameter (D 1 ) of the proximal end side large-diameter portion 14 is usually 0.012 inches (0.305 mm) or less, preferably 0.010 inches (0.254 mm) or less, more preferably 0. 0.006 to 0.010 inch, and a preferred example is 0.010 inch.
 近位端側大径部14の外径(D)が0.012インチ以下であることにより、本発明のガイドワイヤとともに使用するカテーテルなどの医療器具の小型化、延いては、低侵襲化に寄与することができる。 Since the outer diameter (D 1 ) of the proximal-end-side large-diameter portion 14 is 0.012 inches or less, the medical instrument such as a catheter used with the guide wire of the present invention can be reduced in size and further reduced in invasiveness. Can contribute.
 遠位端側小径部11の最大外径としては、コイルスプリング20の内径より小さければ特に限定されるものではないが、近位端側大径部14の外径(D)の1/5~3/5程度とされる。 The maximum outer diameter of the distal end side small-diameter portion 11, is not particularly limited smaller than the inner diameter of the coil spring 20, the outer diameter of the proximal end side large-diameter portion 14 (D 1) 1/5 About 3/5.
 本実施形態のガイドワイヤ1を構成するコイルスプリング20は、コアワイヤ10の遠位端側小径部11の外周に軸方向に沿って装着されている。
 コイルスプリング20は、1本の線材から形成され、コイルピッチがコイル線径の1.0~1.8倍である先端側密巻部21と、コイルピッチがコイル線径の1.8~2.5倍である後端側疎巻部22とからなり、先端側密巻部21および後述する先端チップにより、X線不透過領域が構成されている。
The coil spring 20 constituting the guide wire 1 of the present embodiment is mounted on the outer periphery of the distal end side small diameter portion 11 of the core wire 10 along the axial direction.
The coil spring 20 is formed of a single wire, and has a closely wound end 21 with a coil pitch of 1.0 to 1.8 times the coil wire diameter, and a coil pitch of 1.8 to 2 of the coil wire diameter. The rear end side sparsely wound portion 22 which is .5 times larger, and the tip side densely wound portion 21 and a tip which will be described later constitute an X-ray opaque region.
 先端側密巻部21におけるコイルピッチは、コイル線径の1.0~1.8倍とされ、好適な一例を示せば1.0倍である。
 後端側疎巻部22におけるコイルピッチは、コイル線径の1.8~2.5倍とされ、好適な一例を示せば2.0倍である。
 このように、先端側と後端側とにおいてコイルピッチを変化させることにより、先端側密巻部21において良好な造影性(視認性)を発現させることができる。
 コイルスプリング20全域にわたり同一のピッチとする場合には、X線不透過領域が長くなるために視認性の低下を招く。
The coil pitch in the front end side densely wound portion 21 is 1.0 to 1.8 times the coil wire diameter, and is 1.0 times as a suitable example.
The coil pitch in the rear end side loosely wound portion 22 is 1.8 to 2.5 times the coil wire diameter, and is 2.0 times if a suitable example is shown.
As described above, by changing the coil pitch between the front end side and the rear end side, good contrast (visibility) can be expressed in the front end side closely wound portion 21.
When the pitch is the same throughout the coil spring 20, the X-ray non-transparent region becomes long, and the visibility is lowered.
 コイルスプリング20のコイル外径(D)は、通常0.012インチ(0.305mm)以下とされ、好ましくは0.010インチ(0.254mm)以下、更に好ましくは0.006~0.010インチとされ、好適な一例を示せば0.010インチである。 The coil outer diameter (D 2 ) of the coil spring 20 is usually 0.012 inch (0.305 mm) or less, preferably 0.010 inch (0.254 mm) or less, more preferably 0.006 to 0.010. Inches are 0.010 inches.
 コアワイヤ10の近位端側大径部14の外径(D)が0.012インチ以下であるとともに、コイルスプリング20のコイル外径(D)も0.012インチ以下であることにより、マイクロチャンネルにアクセスする際の操作性(例えば、マイクロチャンネルでの潤滑性)に優れたものとなる。
 コイルスプリング20を構成する線材の外径は、特に限定されないが、好ましくは30~90μm、好適な一例を示せば60μmである。
When the outer diameter (D 1 ) of the proximal end side large diameter portion 14 of the core wire 10 is 0.012 inch or less and the coil outer diameter (D 2 ) of the coil spring 20 is also 0.012 inch or less, The operability when accessing the microchannel (for example, lubricity in the microchannel) is excellent.
The outer diameter of the wire constituting the coil spring 20 is not particularly limited, but is preferably 30 to 90 μm, and 60 μm is a preferable example.
 コイルスプリング20の材質としては、白金、白金合金(たとえばPt/W=92/8)、金、金-銅合金、タングステン、タンタルなどのX線に対する造影性が良好な材質(X線不透過物質)を挙げることができる。 The material of the coil spring 20 is a material (X-ray opaque material) having good contrast properties with respect to X-rays such as platinum, platinum alloys (for example, Pt / W = 92/8), gold, gold-copper alloy, tungsten, tantalum and the like. ).
 本実施形態のガイドワイヤ1は、コイルスプリング20の先端部、後端部および中間部(先端側密巻部21と後端側疎巻部22の境界部分)のそれぞれが、はんだ31,32,33により、コアワイヤ10の遠位端側小径部11の外周に固着されている。 In the guide wire 1 of the present embodiment, the front end portion, the rear end portion, and the intermediate portion of the coil spring 20 (boundary portions of the front end side densely wound portion 21 and the rear end side loosely wound portion 22) are soldered 31 and 32, respectively. 33 is fixed to the outer periphery of the distal end side small diameter portion 11 of the core wire 10.
 図1に示すように、コイルスプリング20の先端部は、はんだ31により、コアワイヤ10に固着されている。すなわち、はんだ31がコイルスプリング20の内部に浸透し、このはんだ31がコアワイヤ10(遠位端側小径部11)の外周と接触することにより、コイルスプリング20の先端部がコアワイヤ10に固着されている。
 また、コイルスプリング20の先端部においてコイルスプリング20の内部に浸透しなかったはんだ31によって略半球状の先端チップが形成されている。これにより、ガイドワイヤの先端部には、はんだ31による先端硬直部分(コイル内部に浸透したはんだ31により自由に曲げることができなくなったコイルスプリング20の先端部分と、このはんだ31により形成された先端チップとによる硬直部分)が形成される。
As shown in FIG. 1, the tip of the coil spring 20 is fixed to the core wire 10 with solder 31. That is, the solder 31 penetrates into the coil spring 20, and the solder 31 comes into contact with the outer periphery of the core wire 10 (distal end side small diameter portion 11), whereby the tip of the coil spring 20 is fixed to the core wire 10. Yes.
In addition, a substantially hemispherical tip is formed by solder 31 that has not penetrated into the coil spring 20 at the tip of the coil spring 20. As a result, the distal end portion of the guide wire is provided with a rigid end portion by the solder 31 (the distal end portion of the coil spring 20 that can no longer be freely bent by the solder 31 that has penetrated into the coil, and the distal end formed by the solder 31. A rigid part) is formed.
 また、コイルスプリング20の先端側密巻部21と後端側疎巻部22との境界領域を含む中間部は、はんだ32により、コアワイヤ10に固着されている。すなわち、はんだ32がコイルスプリング20の内部に浸透し、このはんだ32がコアワイヤ10(遠位端側小径部11)の外周と接触することにより、コイルスプリング20の中間部がコアワイヤ10に固着されている。 Further, an intermediate portion including a boundary region between the front end side densely wound portion 21 and the rear end side loosely wound portion 22 of the coil spring 20 is fixed to the core wire 10 by the solder 32. That is, the solder 32 penetrates into the coil spring 20, and the solder 32 comes into contact with the outer periphery of the core wire 10 (distal end side small diameter portion 11), whereby the intermediate portion of the coil spring 20 is fixed to the core wire 10. Yes.
 さらに、コイルスプリング20の後端部は、はんだ33により、コアワイヤ10に固着されている。すなわち、はんだ33がコイルスプリング20の内部に浸透し、このはんだ33がコアワイヤ10(遠位端側小径部11)の外周と接触することにより、コイルスプリング20の後端部がコアワイヤ10に固着されている。 Furthermore, the rear end portion of the coil spring 20 is fixed to the core wire 10 with solder 33. That is, the solder 33 penetrates into the coil spring 20, and the solder 33 comes into contact with the outer periphery of the core wire 10 (distal end side small diameter portion 11), whereby the rear end portion of the coil spring 20 is fixed to the core wire 10. ing.
 コイルスプリング20の先端部および中間部を、それぞれコアワイヤ10に固着させるためのはんだ31,32としては、金含有はんだを用いることが好ましい。
 はんだ31.32として金含有はんだを使用することにより、コアワイヤ10に対するコイルスプリング20の固着強度を十分に高い(コアワイヤ10の遠位端側小径部11の破断強度より高い)ものとすることができ、コイルスプリング20に挿入されている状態のコアワイヤ10に引張力を作用させても、コアワイヤ10が引き抜かれるようなことはない。ここに、「金含有はんだ」には、Au-Sn系はんだ、Au-Ge系はんだ、Au-Si系はんだ、Au-In系はんだ、Au-Sb系はんだなどのAu合金はんだおよびAuはんだが含まれる。
 一方、コイルスプリング20の後端部をコアワイヤ10に固着させるためのはんだ33としては、Ag-Sn系など銀系はんだを例示することができる。
It is preferable to use gold-containing solder as the solders 31 and 32 for fixing the tip part and the intermediate part of the coil spring 20 to the core wire 10 respectively.
By using gold-containing solder as the solder 31.32, the fixing strength of the coil spring 20 to the core wire 10 can be made sufficiently high (higher than the breaking strength of the small diameter portion 11 on the distal end side of the core wire 10). Even when a tensile force is applied to the core wire 10 inserted in the coil spring 20, the core wire 10 is not pulled out. Here, “gold-containing solder” includes Au alloy solder such as Au—Sn solder, Au—Ge solder, Au—Si solder, Au—In solder, Au—Sb solder, and Au solder. It is.
On the other hand, examples of the solder 33 for fixing the rear end portion of the coil spring 20 to the core wire 10 include silver-based solder such as Ag—Sn.
 図1に示すように、本実施形態のガイドワイヤ1においては、コイルスプリング20の後端側疎巻部22の内部に硬化樹脂40が充填されているとともに、後端側疎巻部22の外周に、この硬化樹脂40による樹脂層40A(コイル線材を被覆する硬化樹脂の層)が形成され、この樹脂層40Aの表面に、親水性樹脂被覆層50が積層形成されている。 As shown in FIG. 1, in the guide wire 1 according to the present embodiment, the inside of the rear end side loosely wound portion 22 of the coil spring 20 is filled with the cured resin 40 and the outer periphery of the rear end side loosely wound portion 22. Further, a resin layer 40A (cured resin layer covering the coil wire) is formed by the cured resin 40, and a hydrophilic resin coating layer 50 is laminated on the surface of the resin layer 40A.
 コイルスプリング20の後端側疎巻部22の内部に硬化樹脂40が充填されていることにより、コアワイヤ10とコイルスプリング20とが一体化され、ガイドワイヤのトルク伝達性が格段に向上し、コアワイヤ10の近位端側大径部14から伝達される回転トルクが、遠位端側小径部11と一体化されたコイルスプリング20の遠位端まで確実に伝達される。 By filling the inside of the rear end side sparsely wound portion 22 of the coil spring 20 with the cured resin 40, the core wire 10 and the coil spring 20 are integrated, and the torque transmission performance of the guide wire is greatly improved. The rotational torque transmitted from the 10 proximal end large diameter portions 14 is reliably transmitted to the distal end of the coil spring 20 integrated with the distal end small diameter portion 11.
 また、コイルスプリング20の後端側疎巻部22の外周に樹脂層40Aが形成され、この樹脂層40Aの表面に、親水性樹脂被覆層50が積層形成されている(後端側疎巻部2
2の外周に、樹脂層40Aを介して、親水性樹脂被覆層50が形成されている)ので、親水性樹脂被覆層50はコイルスプリング20に対して強固に固定され、これにより、親水性樹脂による好適な潤滑性を安定的に発現させることができる。
Further, a resin layer 40A is formed on the outer periphery of the rear end side loosely wound portion 22 of the coil spring 20, and a hydrophilic resin coating layer 50 is laminated on the surface of the resin layer 40A (rear end side loosely wound portion). 2
2), the hydrophilic resin coating layer 50 is formed on the outer periphery of the coil spring 20 via the resin layer 40A. Therefore, the hydrophilic resin coating layer 50 is firmly fixed to the coil spring 20, thereby The suitable lubricity due to can be expressed stably.
 ここに、後端側疎巻部22の内部に充填されるとともに、樹脂層40Aを構成する硬化樹脂40としては、コイルスプリング20および親水性樹脂の両方に対して良好な接着性を有するものが好ましく、具体的には、ウレタンアクリレート樹脂、ポリウレタン樹脂、シリコーン樹脂、エポキシ樹脂、アクリル樹脂、ナイロン樹脂などの光硬化性樹脂または熱硬化性樹脂の硬化物などを例示することができる。
 後端側疎巻部22の外周を被覆する樹脂層40Aの膜厚としては、例えば1~100μmとされ、好ましくは3~10μmとされる。
Here, the inside of the rear end side sparsely wound portion 22 is filled, and the cured resin 40 constituting the resin layer 40A has a good adhesiveness to both the coil spring 20 and the hydrophilic resin. Specific examples thereof include a photo-curing resin such as urethane acrylate resin, polyurethane resin, silicone resin, epoxy resin, acrylic resin, and nylon resin, or a cured product of thermosetting resin.
The film thickness of the resin layer 40A covering the outer periphery of the rear end side loosely wound portion 22 is, for example, 1 to 100 μm, preferably 3 to 10 μm.
 樹脂層40Aの表面に積層形成される親水性樹脂被覆層50を構成する親水性樹脂としては、医療用具の親水性処理に供されている従来公知の親水性ポリマーをすべて使用することができる。具体的にはポリエチレングリコール、ポリエチレンオキサイド、ポリオール、ポリアクリルアミド、ポリビニルピロリドン、ポリビニルアルコール、ポリエーテル、ポリウレタン、ポリカルボン酸およびこれらの誘導体、セルロース、たんぱく質、ヒアルロン酸などの多糖類を例示することができる。また、これらの親水性ポリマーは架橋構造を有していてもよい。
 親水性樹脂層50の膜厚としては、例えば1~30μmとされ、好ましくは3~19μmとされる。
As the hydrophilic resin that constitutes the hydrophilic resin coating layer 50 that is laminated on the surface of the resin layer 40A, all conventionally known hydrophilic polymers that are used for hydrophilic treatment of medical devices can be used. Specifically, polysaccharides such as polyethylene glycol, polyethylene oxide, polyol, polyacrylamide, polyvinyl pyrrolidone, polyvinyl alcohol, polyether, polyurethane, polycarboxylic acid and derivatives thereof, cellulose, protein, hyaluronic acid can be exemplified. . Moreover, these hydrophilic polymers may have a crosslinked structure.
The thickness of the hydrophilic resin layer 50 is, for example, 1 to 30 μm, preferably 3 to 19 μm.
 硬化樹脂40の充填および樹脂層40Aの形成方法、並びに親水性樹脂50の積層形成方法としては特に限定されるものではないが、例えば、コアワイヤ10に装着したコイルスプリング20の後端側疎巻部22を、硬化性樹脂に浸漬することにより、後端側疎巻部22の内部に硬化性樹脂を充填するとともに、後端側疎巻部22の表面に樹脂層を形成し、これを熱硬化または光硬化させることにより硬化樹脂40(樹脂層40A)とし、次いで、樹脂層40Aの表面に、適宜の手段により親水性樹脂を塗布する方法を挙げることができる。
 ここに、後端側疎巻部22とともに先端側密巻部21を硬化性樹脂に浸漬する場合には、先端側密巻部21の外周をマスキングするなどして、先端側密巻部21の内部や外周への硬化性樹脂の流入・付着を防止することが好ましい。
The method of filling the cured resin 40 and forming the resin layer 40A and the method of forming the laminated layer of the hydrophilic resin 50 are not particularly limited. For example, the rear end side loosely wound portion attached to the core wire 10 is used. 22 is immersed in a curable resin to fill the inside of the rear end side loosely wound portion 22 with a curable resin, and a resin layer is formed on the surface of the rear end side loosely wound portion 22, which is thermoset. Alternatively, a method may be mentioned in which a cured resin 40 (resin layer 40A) is obtained by photocuring, and then a hydrophilic resin is applied to the surface of the resin layer 40A by an appropriate means.
Here, in the case where the tip side densely wound part 21 is immersed in the curable resin together with the rear end side loosely wound part 22, the outer periphery of the tip side densely wound part 21 is masked, etc. It is preferable to prevent inflow and adhesion of the curable resin to the inside or the outer periphery.
 図1に示すように、本実施形態のガイドワイヤ1においては、コイルスプリング20の先端側密巻部21の外周は樹脂により被覆されることなく、コイルスプリング20の構成材料(X線不透過物質などの金属)が露出している。
 これにより、本実施形態のガイドワイヤ1が挿入されている血管内の情報(例えば、狭窄部や閉塞部などの病変部位の状況)を抵抗(変化)として手元側で十分に把握することができる。
 また、先端側密巻部21が接触している血管部位の情報を十分に把握することができるとともに、親水性樹脂により被覆されていない先端側密巻部21は滑りにくいため、血管内の目的部位に向けて本実施形態のガイドワイヤ1を確実に押し進めることができる。
As shown in FIG. 1, in the guide wire 1 of the present embodiment, the outer periphery of the tip side densely wound portion 21 of the coil spring 20 is not covered with resin, and the constituent material of the coil spring 20 (X-ray opaque substance) Etc.) are exposed.
Thereby, information in the blood vessel into which the guide wire 1 of the present embodiment is inserted (for example, the state of a lesion site such as a stenosis part or an obstruction part) can be sufficiently grasped as resistance (change) on the hand side. .
In addition, it is possible to sufficiently grasp the information on the blood vessel part that is in contact with the distal side densely wound portion 21, and the distal side closely wound portion 21 that is not covered with the hydrophilic resin is difficult to slip. The guide wire 1 of the present embodiment can be reliably pushed toward the site.
 また、本実施形態のガイドワイヤ1において、先端側密巻部21の内部には樹脂が充填されていない。これにより、先端側密巻部21における可撓性・柔軟性を十分に確保することができ、先端側密巻部21において、シェイピング操作を容易に行うことができる。
 なお、先端側密巻部21の内部には樹脂が充填されていなくても、後端側疎巻部22の内部に硬化樹脂40が充填されていることにより、ガイドワイヤ1のトルク伝達性は十分に確保される。
Moreover, in the guide wire 1 of this embodiment, the inside of the front end side tightly wound portion 21 is not filled with resin. Thereby, the flexibility and softness in the front end side densely wound portion 21 can be sufficiently secured, and the shaping operation can be easily performed in the front end side closely wound portion 21.
In addition, even if the inside of the front end side densely wound portion 21 is not filled with resin, the torque transmission property of the guide wire 1 is improved by filling the inside of the rear end side loosely wound portion 22 with the cured resin 40. Sufficiently secured.
 図2に示すコイルスプリング20の長さ(L)は51~800mmであることが好ましく、更に好ましくは85~310mm、好適な一例を示せば115mmである。
 先端側密巻部21の長さ(L21)は1~50mmであることが好ましく、更に好ましくは20~40mm、好適な一例を示せば30mmである。
 後端側疎巻部22の長さ(L22)は50~750mmであることが好ましく、更に好ましくは65~270mm好適な一例を示せば85mmである。
The length (L 2 ) of the coil spring 20 shown in FIG. 2 is preferably 51 to 800 mm, more preferably 85 to 310 mm, and 115 mm if a suitable example is shown.
The length (L 21 ) of the tip side densely wound portion 21 is preferably 1 to 50 mm, more preferably 20 to 40 mm, and 30 mm if a suitable example is shown.
The length (L 22 ) of the rear end side loosely wound portion 22 is preferably 50 to 750 mm, more preferably 65 to 270 mm, and 85 mm if a suitable example is shown.
 樹脂被覆されていない先端側密巻部21の長さ(L21)が過小である場合には、ガイドワイヤが挿入されている血管内の情報を十分に把握することができず、また、ガイドワイヤの遠位端部が滑りやすくなり、そのようなガイドワイヤを目的部位へ向けてこれを押し進めることは困難となる。
 一方、先端側密巻部21の長さ(L21)が過大である場合には、ガイドワイヤの遠位端部における潤滑性が不足して、例えば、狭窄部位を通過させることが困難となるなど、ガイドワイヤの挿入性が損なわれる。
If the length (L 21 ) of the distal end side tightly wound portion 21 that is not coated with resin is too small, information in the blood vessel into which the guide wire is inserted cannot be sufficiently grasped, and the guide The distal end of the wire becomes slippery and it is difficult to push such a guidewire toward the target site.
On the other hand, when the length (L 21 ) of the distal end side tightly wound portion 21 is excessive, the lubricity at the distal end portion of the guide wire is insufficient and, for example, it is difficult to pass through the stenosis site. For example, the insertion property of the guide wire is impaired.
 また、後端側疎巻部22の長さ(L22)が過小である場合には、ガイドワイヤの遠位端部の潤滑性が不足してガイドワイヤの挿入性が損なわれる。また、ガイドワイヤのトルク伝達性が損なわれることがある。
 一方、後端側疎巻部22の長さ(L22)が過大であることにより、先端側密巻部21の長さ(L21)が相対的に過小になる場合には、ガイドワイヤが挿入されている血管内の情報を十分に把握することができず、また、ガイドワイヤを目的部位へ向けてこれを押し進めることは困難となる。
Further, when the length (L 22 ) of the rear end side loosely wound portion 22 is too small, the lubricity of the distal end portion of the guide wire is insufficient and the guide wire insertion property is impaired. Further, the torque transmission performance of the guide wire may be impaired.
On the other hand, when the length (L 21 ) of the leading end side densely wound portion 21 becomes relatively small due to the excessive length (L 22 ) of the rear end side loosely wound portion 22, the guide wire is Information in the inserted blood vessel cannot be fully grasped, and it is difficult to push the guide wire toward the target site.
 はんだ31により形成される略半球状の先端チップの長さ(L)は、例えば0.1~5.0mmとされ、好適な一例を示せば0.3mmである。 The length (L 3 ) of the substantially hemispherical tip formed by the solder 31 is, for example, 0.1 to 5.0 mm, and 0.3 mm is a preferable example.
 以上説明したように、本実施形態のガイドワイヤ1によれば、コイルスプリング20(後端側疎巻部22)が装着されている遠位端部において良好な潤滑性を有し、血管内への挿入性が良好でありながら、先端側密巻部21の外周が樹脂で被覆されることなくコイルスプリング20の構成材料(金属)が露出していることにより、血管内の情報を抵抗(変化)として手元側で十分に把握することができ、しかも、目的部位に向けて確実に押し進めることができる。
 また、後端側疎巻部22の内部に硬化樹脂40が充填されていることにより、トルク伝達性に優れている。
 また、先端側密巻部21の内部には樹脂が充填されていないので、シェイピング操作を容易に行うことができる。
As described above, according to the guide wire 1 of the present embodiment, the distal end portion to which the coil spring 20 (rear end side loosely wound portion 22) is attached has good lubricity and enters the blood vessel. While the insertability of the coil spring 20 is good, the outer periphery of the distal end side densely wound portion 21 is not covered with resin, and the constituent material (metal) of the coil spring 20 is exposed, so that the information in the blood vessel is resisted (changed). ) Can be grasped sufficiently on the hand side, and can be reliably pushed toward the target site.
Further, since the cured resin 40 is filled in the rear end side loosely wound portion 22, the torque transmission is excellent.
In addition, since the inside of the distal end side tightly wound portion 21 is not filled with resin, the shaping operation can be easily performed.
 10 コアワイヤ
 11 遠位端側小径部
 13 テーパ部
 14 近位端側大径部
 20 コイルスプリング
 21 先端側密巻部
  22 後端側疎巻部
 31 はんだ
 32 はんだ
 33 はんだ
 40 硬化樹脂
 40A 樹脂層
 50 親水性樹脂層
DESCRIPTION OF SYMBOLS 10 Core wire 11 Distal end side small diameter part 13 Tapered part 14 Proximal end side large diameter part 20 Coil spring 21 Front end side close winding part 22 Back end side loose winding part 31 Solder 32 Solder 33 Solder 40 Curing resin 40A Resin layer 50 Hydrophilic Resin layer

Claims (6)

  1.  遠位端側小径部と前記遠位端側小径部より外径の大きい近位端側大径部とを有するコアワイヤと、
     前記コアワイヤの遠位端側小径部の外周に軸方向に沿って装着され、少なくとも先端部および後端部において、前記コアワイヤに固着されているコイルスプリングとを有する医療用ガイドワイヤであって、
     前記コイルスプリングは、コイルピッチがコイル線径の1.0~1.8倍である先端側密巻部と、コイルピッチがコイル線径の1.8~2.5倍である後端側疎巻部とからなり、
     前記後端側疎巻部の内部に樹脂が充填されているとともに、前記後端側疎巻部の外周に前記樹脂による樹脂層が形成され、前記樹脂層の表面に親水性樹脂被覆層が積層形成され、
     前記先端側密巻部の外周は、樹脂により被覆されることなく、前記コイルスプリングの構成材料が露出していることを特徴とする医療用ガイドワイヤ。
    A core wire having a distal end side small diameter portion and a proximal end side large diameter portion having an outer diameter larger than that of the distal end side small diameter portion;
    A medical guide wire having a coil spring attached to the outer periphery of the small-diameter portion on the distal end side of the core wire along the axial direction, and having a coil spring fixed to the core wire at least at the front end portion and the rear end portion;
    The coil spring includes a close winding portion on the front end side having a coil pitch of 1.0 to 1.8 times the coil wire diameter, and a sparse winding on the rear end side having a coil pitch of 1.8 to 2.5 times the coil wire diameter. Consisting of winding parts,
    The inside of the rear end side loosely wound portion is filled with resin, a resin layer made of the resin is formed on the outer periphery of the rear end side loosely wound portion, and a hydrophilic resin coating layer is laminated on the surface of the resin layer Formed,
    The medical guide wire according to claim 1, wherein the outer peripheral portion of the distal-end side densely wound portion is not covered with resin, and the constituent material of the coil spring is exposed.
  2.  前記先端側密巻部の内部に樹脂が充填されていないことを特徴とする請求項1に記載の医療用ガイドワイヤ。 2. The medical guide wire according to claim 1, wherein the distal end side tightly wound portion is not filled with resin.
  3.  前記コアワイヤの近位端側大径部の外径(D)および前記コイルスプリングのコイル外径(D)が0.012インチ以下、
     前記コイルスプリングの長さ(L)が51~800mm、
     前記先端側密巻部の長さ(L21)が1~50mm、
     前記後端側疎巻部の長さ(L22)が50~750mmであることを特徴とする請求項1または請求項2に記載の医療用ガイドワイヤ。
    The outer diameter (D 1 ) of the large diameter portion on the proximal end side of the core wire and the coil outer diameter (D 2 ) of the coil spring are 0.012 inches or less,
    The coil spring length (L 2 ) is 51 to 800 mm,
    The length (L 21 ) of the tip side densely wound portion is 1 to 50 mm,
    3. The medical guide wire according to claim 1, wherein a length (L 22 ) of the rear end side loosely wound portion is 50 to 750 mm.
  4.  前記コイルスプリングの先端側密巻部と後端側疎巻部とを含む中間部がはんだによって前記コアワイヤに固着されていることを特徴とする請求項1乃至請求項3の何れかに記載の医療用ガイドワイヤ。 The medical device according to any one of claims 1 to 3, wherein an intermediate portion including a front end side closely wound portion and a rear end side loosely wound portion of the coil spring is fixed to the core wire by solder. Guide wire.
  5.  前記コイルスプリングの先端部および中間部が金含有はんだによって前記コアワイヤに固着されていることを特徴とする請求項4に記載の医療用ガイドワイヤ。 The medical guide wire according to claim 4, wherein a tip portion and an intermediate portion of the coil spring are fixed to the core wire by a gold-containing solder.
  6.  前記コアワイヤがステンレスからなることを特徴とする請求項1乃至請求項5の何れかに記載の医療用ガイドワイヤ。 The medical guide wire according to any one of claims 1 to 5, wherein the core wire is made of stainless steel.
PCT/JP2013/053077 2012-03-29 2013-02-08 Medical guide wire WO2013145893A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CN201380004444.6A CN104023783B (en) 2012-03-29 2013-02-08 Medical guide wire
KR1020147026779A KR101844630B1 (en) 2012-03-29 2013-02-08 Medical guide wire
HK15101141.9A HK1200746A1 (en) 2012-03-29 2015-02-03 Medical guide wire

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2012-077045 2012-03-29
JP2012077045A JP5404840B2 (en) 2012-03-29 2012-03-29 Medical guidewire

Publications (1)

Publication Number Publication Date
WO2013145893A1 true WO2013145893A1 (en) 2013-10-03

Family

ID=49259177

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2013/053077 WO2013145893A1 (en) 2012-03-29 2013-02-08 Medical guide wire

Country Status (6)

Country Link
JP (1) JP5404840B2 (en)
KR (1) KR101844630B1 (en)
CN (1) CN104023783B (en)
HK (1) HK1200746A1 (en)
TW (1) TWI517869B (en)
WO (1) WO2013145893A1 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6793303B2 (en) * 2015-11-17 2020-12-02 グンゼ株式会社 Medical guide wire
DE102016009871A1 (en) * 2016-08-12 2018-02-15 Häberle Laser- und Feinwerktechnik GmbH & Co. KG Guidewire for use in tubular medical probes, in particular for nutritional therapy
EP3508246B1 (en) * 2016-09-05 2021-08-11 Asahi Intecc Co., Ltd. Guide wire
EP4279006A3 (en) * 2017-06-29 2024-02-21 Asahi Intecc Co., Ltd. Plasma guide wire
KR20200112807A (en) * 2018-02-01 2020-10-05 아사히 인텍크 가부시키가이샤 Guide wire
KR20230144761A (en) 2022-04-08 2023-10-17 성원메디칼 주식회사 Medical Micro Guide Wire

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5409470A (en) * 1993-05-07 1995-04-25 C. R. Bard, Inc. Dilatation catheter and guidewire with threaded tip connection
WO2009119386A1 (en) * 2008-03-27 2009-10-01 テルモ株式会社 Guide wire
EP2402051A1 (en) * 2010-06-30 2012-01-04 PatentStra Co. Ltd. Medical guide wire
WO2012009518A1 (en) * 2010-07-16 2012-01-19 Neurointerventional Therapeutics, Inc. Guidewire and catheter system and method for treating a blood clot

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8777873B2 (en) 2008-06-13 2014-07-15 Cook Medical Technologies Llc Wire guide having a rib for coil attachment
CN102341142B (en) * 2009-05-20 2016-08-03 日本来富恩株式会社 Medical guiding wire
JP5004256B2 (en) * 2009-12-25 2012-08-22 朝日インテック株式会社 Medical guidewire

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5409470A (en) * 1993-05-07 1995-04-25 C. R. Bard, Inc. Dilatation catheter and guidewire with threaded tip connection
WO2009119386A1 (en) * 2008-03-27 2009-10-01 テルモ株式会社 Guide wire
EP2402051A1 (en) * 2010-06-30 2012-01-04 PatentStra Co. Ltd. Medical guide wire
WO2012009518A1 (en) * 2010-07-16 2012-01-19 Neurointerventional Therapeutics, Inc. Guidewire and catheter system and method for treating a blood clot

Also Published As

Publication number Publication date
CN104023783B (en) 2016-01-20
HK1200746A1 (en) 2015-08-14
TWI517869B (en) 2016-01-21
TW201350154A (en) 2013-12-16
CN104023783A (en) 2014-09-03
KR20140141605A (en) 2014-12-10
JP2013202308A (en) 2013-10-07
JP5404840B2 (en) 2014-02-05
KR101844630B1 (en) 2018-04-02

Similar Documents

Publication Publication Date Title
WO2010106848A1 (en) Medical guide wire
JP4354523B1 (en) Medical guidewire
AU2010250563B2 (en) Medical guide wire
JP4354525B1 (en) Medical guidewire
JP5404840B2 (en) Medical guidewire
JP5605949B2 (en) Medical guidewire
JP6066477B2 (en) Medical guidewire
JP2011010900A5 (en)
JP2006271901A (en) Coiled contrast marker, its manufacturing method and catheter
JP5408727B2 (en) Medical guidewire
JP2012210292A (en) Guidewire
JP2018192058A (en) Medical guide wire
JP5424248B2 (en) Medical guidewire
JP5424247B2 (en) Medical guidewire
JP5505902B2 (en) Guide wire
JP2013208351A (en) Guide wire

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 13770076

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 20147026779

Country of ref document: KR

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 13770076

Country of ref document: EP

Kind code of ref document: A1