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WO2024236759A1 - Fil de guidage de vaisseau sanguin - Google Patents

Fil de guidage de vaisseau sanguin Download PDF

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Publication number
WO2024236759A1
WO2024236759A1 PCT/JP2023/018408 JP2023018408W WO2024236759A1 WO 2024236759 A1 WO2024236759 A1 WO 2024236759A1 JP 2023018408 W JP2023018408 W JP 2023018408W WO 2024236759 A1 WO2024236759 A1 WO 2024236759A1
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WO
WIPO (PCT)
Prior art keywords
tip
blood vessel
section
guidewire
core wire
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/JP2023/018408
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English (en)
Japanese (ja)
Inventor
大作 池田
孝則 長谷川
俊介 渡辺
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mizuho Corp
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Mizuho Corp
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Filing date
Publication date
Application filed by Mizuho Corp filed Critical Mizuho Corp
Priority to PCT/JP2023/018408 priority Critical patent/WO2024236759A1/fr
Publication of WO2024236759A1 publication Critical patent/WO2024236759A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires

Definitions

  • This disclosure relates to a vascular guidewire.
  • Guidewires are used to deliver catheters and other devices into the cerebral blood vessels. It is necessary to deliver the guidewire to the desired vascular location appropriately within the cerebral blood vessels, which are bent and branched in complex ways.
  • shaping is performed by bending the tip of the guidewire into the desired shape in advance. Since shaping is performed manually, it is desirable for the tip of the guidewire to have good properties (hereinafter also referred to as shapeability) that allow it to be easily formed into the desired shape.
  • the tip is made thinner than the proximal side in order to increase flexibility near the tip (see, for example, Patent Document 1).
  • the diameter of the core wire becomes thinner from the rear end to the tip end over a sufficiently long range in the axial direction. Therefore, the highly flexible tapered range is long, and when the guidewire is pushed toward the tip end, this tapered range may bend, and the pushing force may not be fully transmitted to the tip. It is desirable for the guidewire to also have good pushing force transmission to the tip end (hereinafter also referred to as pushability).
  • the objective of this disclosure is to provide a vascular guidewire that has good shapeability and pushability.
  • the first disclosure is a vascular guidewire (1) comprising a tip portion (111) formed in a flat plate shape, and a first tapered portion (112) connected to the tip portion (111) at the rear end side of the tip portion (111) and having an outer diameter increasing from the tip side to the rear end side, and the axial length of the tip portion (111) is 5 mm or more and 25 mm or less.
  • the second disclosure is the vascular guidewire (1) described in the first disclosure, wherein the tip portion (111) includes a portion whose width in a direction perpendicular to the axial direction of the tip portion (111) as viewed from the normal direction of the flat surface of the tip portion (111) is wider than the width of the tip side of the first tapered portion (112).
  • the third disclosure is the vascular guidewire (1) described in the first or second disclosure, in which the taper angle of the first taper section (112) is 0.05° or more and 0.25° or less.
  • the fourth disclosure is a vascular guidewire (1) according to any one of the first to third disclosures, in which the side portion (111b) surrounding the flat surface of the tip portion (111) has a rounded shape.
  • the fifth disclosure is a vascular guidewire (1) according to any one of the first to fourth disclosures, in which the axial length of the first taper portion (112) is 25 mm or less.
  • the sixth disclosure is a vascular guidewire (1) according to any one of the first to fifth disclosures, which is provided with a coil that is inserted around at least the tip portion (111) and the first tapered portion (112).
  • the seventh disclosure is a vascular guidewire (1) according to any one of the first to sixth disclosures, in which the rear end side of the first tapered section (112) is provided with a plurality of tapered sections whose outer diameter increases from the tip side toward the rear end side.
  • the eighth disclosure is a vascular guidewire (1) according to any one of the first to seventh disclosures, which is used in the carotid artery or cerebral blood vessels.
  • the ninth disclosure is a shaping method for bending a vascular guidewire (1) described in any one of the first to eighth disclosures, in which a cylindrical mandrel is advanced while at least the tip portion (111) is bent and fixed, and at least the tip portion (111) is bent in a direction in which the flat surface of the tip portion (111) is bent.
  • the tenth disclosure is a method for delivering a vascular guidewire (1) whose tip portion (111) has been bent by the shaping method for bending the vascular guidewire (1) described in the ninth disclosure, in which the guidewire has an X-ray visible coil extrapolated to the tip portion (111), and the guidewire is rotated around its axis under observation using X-rays to align the tip of the tip portion (111) bent by the shaping method with the direction of the blood vessel to be delivered, and the guidewire is pushed toward the tip side while the tip of the tip portion (111) is oriented in the direction of the blood vessel to be delivered.
  • the present disclosure makes it possible to provide a vascular guidewire with good shapeability and pushability.
  • FIG. 1 is a side view showing an embodiment of a vascular guidewire according to the present disclosure as viewed from the -Y side.
  • FIG. FIG. 2 is a side view showing the configuration of the core wire 10 as viewed from the same direction as FIG. 1 .
  • FIG. 3 is a side view showing the configuration of the core wire 10 as viewed from the +Z side in FIGS. 1 and 2 .
  • FIG. 3 is an enlarged view of a range A1 in FIG. 2 .
  • FIG. 4 is an enlarged view of a range A2 in FIG. 3.
  • FIG. 4 is a view of the core wire 10 in the state of FIG. 3 as viewed from the tip side (+X side).
  • 1A to 1C are diagrams illustrating an example of a method for shaping the distal end side of the guide wire 1 of this embodiment.
  • 1A to 1C are diagrams illustrating a method for advancing a guidewire 1 within a cerebral blood vessel.
  • FIG. 1 is a side view showing an embodiment of a vascular guidewire according to the present disclosure as viewed from the -Y side.
  • FIG. 2 is a side view showing the configuration of the core wire 10 as viewed from the same direction as FIG. 1.
  • FIG. 3 is a side view showing the configuration of the core wire 10 as viewed from the +Z side in FIGS. 1 and 2.
  • the X-ray visible coil 20, the non-X-ray visible coil 30, the solder used for joining, etc. are omitted, and only the core wire 10 inside them is shown.
  • the guidewire 1 has a core wire 10, an X-ray visible coil 20 and a non-X-ray visible coil 30 that are extrapolated to the tip side of the core wire 10, and a tip fixing portion 40. It is a vascular guidewire that is inserted into blood vessels and can be suitably used for the carotid artery and cerebral blood vessels.
  • the X-ray visible coil 20 is a coil-shaped member formed by winding a linear body into a spiral and cylindrical shape.
  • the X-ray visible coil 20 is extrapolated onto the tip side (+X side) of the first core wire 110.
  • the X-ray visible coil 20 serves as a marker (sign) for confirming the position of the tip of the guide wire 1 in an X-ray transmission image.
  • the X-ray visible coil 20 is made of a material that is opaque (including poorly permeable) to radiation such as X-rays and that can be formed into a coil shape. Examples of materials that form the X-ray visible coil 20 include platinum tungsten (Pt-W) alloy, platinum-iridium (Pt-Ir) alloy, gold, tantalum, etc.
  • the provision of the X-ray visible coil 20 at the tip of the guidewire 1 is important for performing the procedure of delivering the guidewire 1.
  • the practitioner can grasp the direction of the tip of the guidewire 1 after it has been shaped within the blood vessel, and can advance the guidewire 1 in the appropriate direction.
  • the X-ray visible coil 20 is formed by a single linear body, with the first coarsely wound section 21, the densely wound section 22, and the second coarsely wound section 23, in order from the tip side in the axial direction.
  • the first coarsely wound section 21 and the second coarsely wound section 23 are provided at the tip side and the rear end side of the densely wound section 22, respectively, and the linear body is wound more coarsely than the densely wound section 22. That is, the densely wound section 22 has a densely wound linear body, and the first coarsely wound section 21 and the second coarsely wound section 23 have a coarsely wound linear body.
  • the densely wound section 22 is tightly wound, and there is almost no gap between adjacent linear bodies in the axial direction, but a gap may be provided.
  • the reason why it is said that there is “almost no gap” is that there may be gaps due to variations in the thickness of the linear body itself or manufacturing errors in the winding process.
  • a gap is intentionally provided between adjacent linear bodies in the axial direction.
  • the first coarsely wound portion 21 and the second coarsely wound portion 23 are illustrated as being provided with about two turns, but the first coarsely wound portion 21 and the second coarsely wound portion 23 can be provided with a larger number of turns.
  • the X-ray visible coil 20 it is desirable for the X-ray visible coil 20 to have an axial length of 30 mm or more so that the shape of the tip portion 111 can be accurately grasped during treatment. It is even more desirable for the axial length of the X-ray visible coil 20 to be 40 mm or more. It is also desirable for the axial length of the X-ray visible coil 20 to be 60 mm or less.
  • the non-X-ray visible coil 30 is a coil-shaped member formed by winding a linear body into a spiral and cylindrical shape, similar to the X-ray visible coil 20.
  • the non-X-ray visible coil 30 is inserted onto the core wire 10 at the tip side (+X side) of the first core wire 110 and the rear end side of the X-ray visible coil 20.
  • a reinforcing effect is obtained that makes the first core wire 110 less likely to break, while allowing it to bend moderately without losing flexibility.
  • Examples of materials for forming the non-X-ray visible coil 30 include stainless steel, tungsten, nickel-titanium alloy, etc.
  • the non-X-ray visible coil 30 is formed by a single linear body, with the first coarsely wound section 31, the densely wound section 32, and the second coarsely wound section 33, in that order from the tip side in the axial direction.
  • the first coarsely wound section 31 and the second coarsely wound section 33 are provided at the tip side and rear end side of the densely wound section 32, respectively, and the linear body is wound more coarsely than the densely wound section 32. That is, the linear body is densely wound in the densely wound section 32, and the linear body is wound coarsely in the first coarsely wound section 31 and the second coarsely wound section 33.
  • the densely wound section 32 is tightly wound, and there is almost no gap between adjacent linear bodies in the axial direction, but a gap may be provided.
  • first coarsely wound section 31 and the second coarsely wound section 33 a gap is intentionally provided between adjacent linear bodies in the axial direction.
  • first coarsely wound portion 31 and the second coarsely wound portion 33 are shown as having about 2 to 4 turns, but the first coarsely wound portion 31 and the second coarsely wound portion 33 can be provided with a larger number of turns.
  • the length of the non-X-ray visible coil 30 is preferably 150 mm or more and 350 mm or less.
  • a roughly hemispherical tip fixing portion 40 is provided further toward the tip side (+X side) than the X-ray visible coil 20.
  • the tip fixing portion 40 may be in the form of a roughly hemispherical component attached, or the tip fixing portion 40 may be formed of the solder itself by dropping an appropriate amount of solder onto the tip side of the X-ray visible coil 20.
  • the shape of the tip fixing portion 40 is not limited to a roughly hemispherical shape, and may be other shapes, such as a part of an ellipsoid. Solder is just one example and is not limiting.
  • the tip side of the X-ray visible coil 20 (part of the first coarsely wound portion 21) is soldered to the tip portion 111 (described below) of the first core wire 110 together with the tip fixing portion 40, or by the tip fixing portion 40 if the tip fixing portion 40 is formed by solder itself.
  • the solder in this portion fills the gaps in the first coarsely wound portion 21. Furthermore, the solder in this portion is attached only to a very small portion of the very tip of the tip portion 111, and is configured so as not to hinder bending of the tip portion 111.
  • the rear end side of the X-ray visible coil 20 (part of the second coarsely wound portion 23) and the tip side of the non-X-ray visible coil 30 (part of the first coarsely wound portion 31) are both soldered to the third taper portion 114 (described later) of the first core wire 110.
  • the rear end side of the X-ray visible coil 20 and the tip side of the non-X-ray visible coil 30 are connected and integrated by the solder in this portion. Also, in this portion, the respective gaps of the second coarsely wound portion 23 and the first coarsely wound portion 31 are filled with solder.
  • the bonding force between the solder and the X-ray visible coil 20 and the non-X-ray visible coil 30 is strengthened, and the X-ray visible coil 20 and the non-X-ray visible coil 30 can be prevented from falling off, thereby improving safety and reliability.
  • the rear end side of the non-X-ray visible coil 30 (part of the second coarsely wound portion 33) is soldered to the first cylindrical portion 116.
  • the gaps in the second coarsely wound portion 33 are filled with solder.
  • the bonding force between the solder and the non-X-ray visible coil 30 is stronger, preventing the non-X-ray visible coil 30 from falling off and improving safety and reliability.
  • the axial length of the first cylindrical portion 116 is preferably 10 mm or more and 90 mm or less, and more preferably 30 mm or more and 70 mm or less.
  • the difference between the outer diameter of the first cylindrical portion 116 and the inner diameter of the non-X-ray visible coil 30 is preferably 0.002 mm or more and 0.018 mm or less, and more preferably 0.006 mm or more and 0.014 mm or less. Note that the above-mentioned positions for soldering the X-ray visible coil 20 and the non-X-ray visible coil 30 are merely examples and are not limited to the examples in this embodiment.
  • the core wire 10 has a first core wire 110 and a second core wire 120.
  • the total length of the core wire 10 is, for example, about 1,800 to 3,500 mm.
  • the outer diameter of the core wire 10 is, for example, about 0.36 mm at the second cylindrical portion 118 where the outer diameter is maximum.
  • the first core wire 110 is a linear member that constitutes the tip side (+X side) of the core wire 10.
  • the first core wire 110 is preferably made of a material with excellent flexibility and shape recovery, such as a nickel-titanium (Ni-Ti) alloy, and a nickel-titanium alloy is used in this embodiment.
  • the second core wire 120 is a linear member that constitutes the rear end side (-X side) of the core wire 10.
  • the second core wire 120 is preferably made of a material with high rigidity, such as stainless steel, and stainless steel is used in this embodiment. That is, the core wire 10 is composed of a combination of the first core wire 110 made of a material with a low elastic modulus and the second core wire 120 made of a material with a higher elastic modulus than the material of the first core wire 110.
  • the elastic modulus of the material forming the first core wire 110 is preferably 30 GPa or more and 100 GPa or less, and the elastic modulus of the material forming the second core wire 120 is preferably 150 GPa or more and 300 GPa or less.
  • the tip side of the guide wire 1 is required to have flexibility to bend along the shape of the thin and complexly curved cerebral blood vessels, so a material with a low elastic modulus as described above is desirable.
  • the core wire 10 needs to be highly flexible. One of the reasons for this is that this region is delivered into the thin and complexly curved cerebral blood vessels.
  • the second core wire 120 provided at the rear end is made of a material with a higher elasticity than the material used for the first core wire 110.
  • the rear end (-X side) of the first core wire 110 and the tip end (+X side) of the second core wire 120 are joined at the core joint 50.
  • the first core wire 110 and the second core wire 120 can be joined by, for example, welding.
  • the outer surface of the range including the extrapolated X-ray visible coil 20 and non-X-ray visible coil 30 is coated with a hydrophilic resin.
  • the range to which this hydrophilic resin coating is applied includes the X-ray visible coil 20 and non-X-ray visible coil 30 as well as parts of the first core wire 110 and second core wire 120 of the core wire 10.
  • hydrophilic resin coating By applying a hydrophilic resin coating to the outer surface of the member included in such a range, it is possible to improve the lubricity in the blood vessel.
  • the hydrophilic resin coating is also applied to the outer surface of the core joint 50, so that it is possible to improve the lubricity of the core joint 50 in the blood vessel.
  • the outer surface in the area not coated with hydrophilic resin is coated with a fluororesin.
  • a fluororesin By coating almost the entire outer surface of the rear end side of the core wire 10 with a fluororesin, it is possible to reduce frictional resistance when a catheter (not shown) is inserted onto the guide wire 1.
  • the first core wire 110 has a tip portion 111, a first tapered portion 112, a second tapered portion 113, a third tapered portion 114, a fourth tapered portion 115, a first cylindrical portion 116, a fifth tapered portion 117, and a second cylindrical portion 118 arranged in this order from the tip side (+X side) to the rear end side (-X side).
  • tapered portion is also used in the following description as a general term for the first tapered portion 112, the second tapered portion 113, the third tapered portion 114, the fourth tapered portion 115, and the fifth tapered portion 117.
  • FIG. 4 is an enlarged view of range A1 in FIG. 2.
  • FIG. 5 is an enlarged view of range A2 in FIG. 3.
  • FIG. 6 is a view of the core wire 10 in the state of FIG. 3, viewed from the tip side (+X side).
  • the tip portion 111 is provided at the most tip side (+X side) of the first core wire 110, and is formed in a flat plate shape. More specifically, the outer shape of the tip portion 111 as viewed from the direction shown in FIG. 2 and FIG. 4 (direction along the Y axis) and the outer shape as viewed from the direction shown in FIG. 3 and FIG. 5 (direction along the Z axis) are both substantially rectangular and flat.
  • the tip fixing portion 40 is formed by soldering at the end on the most distal end side of the tip portion 111 (see FIG. 1).
  • the flat shape refers to a flat plate shape, but it is preferable that the tip portion 111 has a shape as viewed from the direction shown in FIG. 6 (or a cross-sectional shape in a cross section perpendicular to the X axis) such that w111/t ⁇ 2.
  • w111 is the width in the direction (Z-axis direction) perpendicular to the axial direction (X-axis direction) of the tip 111 as viewed from the normal direction of the flat surface 111a of the tip 111
  • t is the plate thickness (thickness in the Y direction) of the tip 111.
  • the width w111 of the tip portion 111 includes a portion wider than the width w112 of the tip side of the first tapered portion 112 described later.
  • the phrase "includes a wide portion” is used because it is assumed that the width w111 of the tip portion 111 is not constant and the width w111 may change depending on the position in the axial direction (X-axis direction). Since the width w111 of the tip portion 111 includes a portion wider than the width w112 of the tip side of the first tapered portion 112, the tip portion 111 becomes a shape that is sufficiently easier to deform than the first tapered portion 112, making shaping easier. Furthermore, the direction in which the tip portion 111 bends during shaping described later is unified, making it possible to prevent the tip portion 111 from twisting or bending in multiple directions.
  • the shape of the tip 111 viewed from the axial direction (+X direction) is a pair of opposing flat surfaces, and the ends of these flat surfaces are approximately circular, forming an approximately oval shape. That is, the side 111b around the flat surface 111a of the tip 111 is rounded.
  • the most distal end of the tip 111 is not rounded, but this part may also be rounded.
  • the tip 111 can be formed by pressing, making it easy to manufacture.
  • the length L111 of the tip 111 in the axial direction (X-axis direction) is preferably 5 mm or more and 25 mm or less.
  • the reason why the length L111 of the tip 111 is preferably 5 mm or more is that if the length L111 of the tip 111 is less than 5 mm, the region that is easy to bend (highly shapable) is too short and shaping is not possible.
  • the reason why the length L111 of the tip 111 is preferably 25 mm or less is that if the length L111 of the tip 111 exceeds 25 mm, the shapeability is good, but the region with low rigidity is too long, and the forward movement of the guidewire 1 (the property of advancing through a tortuous cerebral blood vessel) is impaired.
  • the length L111 of the tip 111 in the axial direction (X-axis direction) is more preferably 13 mm or more and 19 mm or less.
  • the width w111 of the tip portion 111 is 0.07 mm or more and 0.18 mm or less. If it is pressed to be thinner than this width (0.18 mm), the thickness will be too thin and the rigidity will be excessively small. On the other hand, if the width is smaller than this width (0.07 mm), the area of the flat plate will be small and it will be difficult to shape. Furthermore, it is desirable that the thickness t of the tip portion 111 is 0.025 mm or more and 0.045 mm or less. If it is pressed to be thinner than this thickness (0.025 mm), the thickness will be too thin and the rigidity will be excessively small. On the other hand, if the thickness is thicker than this thickness (0.045 mm), it will be difficult to shape. Furthermore, it is even more desirable that the width w111 of the tip portion 111 is 0.10 mm or more and 0.15 mm or less.
  • the first taper section 112, the second taper section 113, the third taper section 114, and the fourth taper section 115 are tapered sections provided to appropriately adjust the rigidity of the tip side (+X side) of the first core wire 110.
  • the configurations of the first taper section 112 to the fourth taper section 115 will be described later.
  • the first cylindrical section 116 is a cylindrical section provided on the rear end side (-X side) of the fourth tapered section 115.
  • the fifth tapered section 117 is a tapered section provided on the rear end side (-X side) of the first cylindrical section 116.
  • the second cylindrical section 118 is a cylindrical section provided on the rear end side of the fifth tapered section 117. As described above, the rear end side end of the second cylindrical section 118 and the tip end side (+X side) of the second core wire 120 are joined at the core joint section 50.
  • the first taper section 112 to the fourth taper section 115 are arranged so that the outer diameter increases in order from the tip side (+X side) in the axial direction of the first core wire 110. It is desirable that the axial length from the most axial end (end of tip section 111) of the first core wire 110 to the rear end of the fourth taper section 115 (the axial length of the range in which the first taper section 112 to the fourth taper section 115 are provided) is 400 mm or less.
  • the axial length from the most axial end (end of tip section 111) of the first core wire 110 to the rear end of the fourth taper section 115 is 200 mm or more and 300 mm or less.
  • the first tapered portion 112 is connected to the tip portion 111 at the rear end side (-X side) of the tip portion 111, and has an approximately conical surface with an outer diameter that increases from the tip side (+X side) to the rear end side (-X side).
  • the first tapered portion 112 has a shape that has a part of an "approximately conical surface" and does not have to be a complete conical surface.
  • the first tapered portion 112 is formed by cutting processing, etc., but when the tip portion 111 is formed by pressing processing, etc. after the first tapered portion 112 is formed, the first tapered portion 112 may be slightly deformed. In such a case, the cross section perpendicular to the axial direction of the tip side (+X side) of the first tapered portion 112 becomes an ellipse shape, a crushed circle shape, etc.
  • the length L112 of the first taper portion 112 in the axial direction (X-axis direction) is 25 mm or less. It is even more desirable that the length L112 is 7 mm or more and 23 mm or less. If the length L112 is less than 7 mm, the highly flexible region is too short, and the rigidity of the guidewire 1 is high, which may result in poor shaping or an increased risk of damaging blood vessels. If the length L112 exceeds 25 mm, the taper angle described below becomes small, so that the highly flexible region is not effectively formed, the rigidity of the guidewire 1 increases, and the length L111 of the tip portion 111 cannot be set to an appropriate length, making shaping difficult.
  • the reason why the length L111 of the tip portion 111 cannot be set to an appropriate length is that there is a desirable length in the range between the tip portion 111 and the first taper portion 112 as a region that is particularly flexible on the tip side of the guidewire 1.
  • the length in this range i.e., the combined length of lengths L111 and L112, is preferably 15 mm or more and 35 mm or less, and more preferably 20 mm or more and 30 mm or less.
  • the ratio of lengths L111 to L112, i.e., L112/L111 is preferably 0.2 or more and 1.0 or less. Furthermore, it is even more preferable that L112/L111 is 0.4 or more and 0.8 or less.
  • the width w112 is 0.06mm or more and 1.00mm or less
  • the width w113 is 0.11mm or more and 0.15mm or less.
  • the preferable ranges of the width w112 and the width w113 are also for providing appropriate flexibility for the first taper portion 112.
  • the outer diameters of the first taper section 112 to the fourth taper section 115 are configured to increase in order from the tip side (+X side) to the rear end side (-X side) of the first core wire 110.
  • the taper angles of the first taper section 112 to the fourth taper section 115 are set to an angle that inclines so that the outer diameter increases from the tip side to the rear end side of the first core wire 110.
  • the taper angles ⁇ 112 to ⁇ 115 are set to decrease in order from the tip side (+X side) to the rear end side (-X side) of the first core wire 110. That is, the taper angles ⁇ 112 to ⁇ 115 have a relationship (order) of ⁇ 112> ⁇ 113> ⁇ 114> ⁇ 115.
  • the taper angle ⁇ 1 of the first taper section 112, which is the most distal end side is set to 0.05° or more and 0.25° or less, as described above.
  • the taper angles ⁇ 113 to ⁇ 115 of the second taper section 113 to the fourth taper section 115 are set to be 0.1 to 0.2° or 60 to 98% smaller than the taper angle ⁇ 112 of the first taper section 112.
  • the boundaries between the first taper section 112 to the fourth taper section 115 have a mountain shape when viewed from a direction perpendicular to the X-axis direction.
  • the taper angle ⁇ 112 is particularly large compared to ⁇ 113 to ⁇ 115. This results in greater stress concentration in the first taper section 112 compared to the second taper section 113 to the fourth taper section 115, making it more likely to deform.
  • the axial lengths L112 to L115 of the first taper section 112 to the fourth taper section 115 are set to increase in order from the tip side (+X side) to the rear end side (-X side) of the first core wire 110. That is, the tapered section lengths L112 to L115 have a relationship of L112 ⁇ L113 ⁇ L114 ⁇ L115.
  • the axial length L112 of the tip-most first taper section 112 is desirably set to 25 mm or less as described above, and more desirably set to 7 mm or more and 23 mm or less.
  • the X-ray visible coil 20 is disposed so as to completely cover the first taper section 112 and the second taper section 113, and further cover a portion of the third taper section 114.
  • the first tapered section 112 to the fourth tapered section 115, including the tip portion 111 are all extrapolated with the X-ray visible coil 20 or the non-X-ray visible coil 30.
  • the first taper section 112 to the fourth taper section 115 are formed from the tip of the first core wire 110 in the axial direction (X-axis direction) as shown in Figures 2 and 3.
  • the rigidity of each taper section changes gradually from the rear end side (-X side) of the first core wire 110 to the tip side (+X side). Therefore, the stress acting on the first core wire 110 can be more evenly distributed in the axial direction. Therefore, when the guidewire 1 is rotated or pushed in the axial direction, it is possible to suppress the concentration of stress at a specific point of the first core wire 110.
  • FIG. 7 is a diagram illustrating an example of a method of shaping the tip side of the guidewire 1 of this embodiment.
  • the tip side of the guidewire 1 can be shaped using a mandrel M.
  • the mandrel M is a cylindrical tool with a rigidity sufficiently higher than that of the guidewire 1.
  • the guidewire 1 is pressed against the pad of a finger by the mandrel M, and the tip portion 111 is bent and fixed.
  • the tip portion 111 and the first tapered portion 112 can be primarily bent by performing the operation of advancing the cylindrical mandrel multiple times.
  • the strength of the force with which the mandrel M presses the guidewire 1 and the number of times the mandrel M is advanced can be adjusted to bend (shape) the tip side of the guidewire 1 into a desired shape.
  • the guidewire 1 has a tip 111 formed in a flat plate shape.
  • the width w111 in the direction perpendicular to the axial direction of the tip 111 as viewed from the normal direction of the flat surface 111a of the tip 111 includes a portion that is wider than the width w112 at the tip side of the first tapered portion 112.
  • the bending direction of the tip 111 will be the bending direction of the flat surface 111a of the tip 111 without any special operation.
  • the guidewire 1 will always be bent in the same direction unless the guidewire 1 is intentionally rotated 180°, which prevents the bending direction from becoming twisted and makes it easier to shape into the desired shape.
  • the axial length of the first taper portion 112 is 25 mm or less, and the taper angle is 0.05° or more and 0.25° or less, so that the flexibility from the first taper portion 112 to the tip side, including the first taper portion 112, is higher than the flexibility from the first taper portion 112 to the rear end side. Therefore, flexibility that can follow the bending of the blood vessel is exhibited.
  • the side portion 111b around the flat surface 111a of the tip portion 111 has a rounded shape, the side portion 111b is prevented from being caught by the X-ray visible coil 20 during shaping, and it is possible to prevent it from becoming an obstacle to shaping.
  • the axial length of the tip portion 111 is 5 mm or more and 25 mm or less, shaping can be easily performed by manual work.
  • FIG. 8 is a diagram explaining a method of advancing the guidewire 1 in a cerebral blood vessel.
  • the example shown in FIG. 8 shows a case where the guidewire 1, which has advanced through blood vessel B1, is to be advanced into blood vessel B2, which branches in the opposite direction.
  • the tip of the guidewire 1 can be directed toward blood vessel B2 by appropriately bending (shaping) the tip as shown in FIG. 8.
  • the direction of the tip of the tip portion 111 bent by shaping can be changed by rotating the guidewire 1 around its axis. Then, with the tip of the tip portion 111 oriented in the manner shown in FIG. 8, the guidewire 1 can be delivered into blood vessel B2 by pushing the guidewire 1 further toward the tip side.
  • a certain range of the tip (5 mm to 25 mm) of tip portion 111 is configured as a flat plate, so that it can be easily shaped into a bend with a small radius of curvature and can also exhibit forward movement.
  • the adjacent part at the rear end side of the tip 111 often abuts against the blood vessel. If the rigidity of the part abutting against the blood vessel is high, the blood vessel is burdened and may be damaged.
  • the first taper part 112 is provided in a predetermined range on the rear end side of the tip 111, and the rigidity is reduced by suddenly reducing the diameter, so that the part that contacts the blood vessel can be made flexible and safe.
  • the guide wire 1 of this embodiment can achieve both good shapeability and pushability.
  • the guide wire 1 of this embodiment has the characteristic of having good shapeability as described above, shaping is not essential.
  • tapered sections are provided continuously from the tip side (+X side) to the rear end side (-X side) of the first core wire 110, and these are extrapolated with a coil-shaped member.
  • the number of tapered sections to be extrapolated with a coil-shaped member is not limited to four, and may be five or more. Also, a cylindrical portion may be provided between the tapered sections.
  • the first core wire 110 is made of a nickel-titanium alloy and the second core wire 120 is made of stainless steel.
  • the entire core wire 10 may be made of a nickel-titanium alloy or stainless steel. That is, the core wire 10 may be made of both the nickel-titanium alloy and stainless steel as in the embodiment, or may be made of either the nickel-titanium alloy or stainless steel.
  • the shapes, structures, arrangements, etc. of the exemplified X-ray visible coil 20, non-X-ray visible coil 30, and tip fixing portion 40 can be selected as appropriate and are not limited to the example embodiments.
  • a fluororesin coating is applied to a predetermined area of the outer surface of the core wire 10.
  • This is not limiting, and for example, a configuration may be adopted in which no fluororesin coating is applied, or in the embodiment, a hydrophilic resin coating may be applied to the area where the fluororesin coating is applied.
  • the hydrophilic resin coating and fluororesin coating exemplified in the embodiment both have the effect of reducing frictional resistance, and therefore may be applied to any part of the core wire 10.
  • the embodiment illustrates a preferred use form of the hydrophilic resin coating and the fluororesin coating. In this way, the guide wire 1 of the embodiment may be applied with only one of the hydrophilic resin coating and the fluororesin coating.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Un fil de guidage de vaisseau sanguin (1) comprend une partie d'extrémité de pointe (111) formée dans une forme de plaque plate, et une première partie effilée (112) reliée à la partie d'extrémité de pointe (111) au niveau du côté d'extrémité arrière de la partie d'extrémité de pointe (111) et ayant un diamètre externe qui augmente du côté d'extrémité de pointe vers le côté d'extrémité arrière, et la longueur de la partie d'extrémité de pointe (111) dans la direction axiale est de 5 mm à 25 mm.
PCT/JP2023/018408 2023-05-17 2023-05-17 Fil de guidage de vaisseau sanguin Pending WO2024236759A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/JP2023/018408 WO2024236759A1 (fr) 2023-05-17 2023-05-17 Fil de guidage de vaisseau sanguin

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2023/018408 WO2024236759A1 (fr) 2023-05-17 2023-05-17 Fil de guidage de vaisseau sanguin

Publications (1)

Publication Number Publication Date
WO2024236759A1 true WO2024236759A1 (fr) 2024-11-21

Family

ID=93519538

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2023/018408 Pending WO2024236759A1 (fr) 2023-05-17 2023-05-17 Fil de guidage de vaisseau sanguin

Country Status (1)

Country Link
WO (1) WO2024236759A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05168717A (ja) * 1991-06-18 1993-07-02 Scimed Life Syst Inc 血管内ガイドワイヤ及びその製造方法
WO2009119387A1 (fr) * 2008-03-28 2009-10-01 テルモ株式会社 Fil-guide et procédé de fabrication correspondant
JP2016221198A (ja) * 2015-05-29 2016-12-28 株式会社エフエムディ 医療用ガイドワイヤ
WO2022074960A1 (fr) * 2020-10-06 2022-04-14 ミズホ株式会社 Fil-guide

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05168717A (ja) * 1991-06-18 1993-07-02 Scimed Life Syst Inc 血管内ガイドワイヤ及びその製造方法
WO2009119387A1 (fr) * 2008-03-28 2009-10-01 テルモ株式会社 Fil-guide et procédé de fabrication correspondant
JP2016221198A (ja) * 2015-05-29 2016-12-28 株式会社エフエムディ 医療用ガイドワイヤ
WO2022074960A1 (fr) * 2020-10-06 2022-04-14 ミズホ株式会社 Fil-guide

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