WO2014162389A1 - Fil guide - Google Patents

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Publication number
WO2014162389A1
WO2014162389A1 PCT/JP2013/059830 JP2013059830W WO2014162389A1 WO 2014162389 A1 WO2014162389 A1 WO 2014162389A1 JP 2013059830 W JP2013059830 W JP 2013059830W WO 2014162389 A1 WO2014162389 A1 WO 2014162389A1
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WO
WIPO (PCT)
Prior art keywords
rigidity
guide wire
wire
portions
low
Prior art date
Application number
PCT/JP2013/059830
Other languages
English (en)
Japanese (ja)
Inventor
豊 松原
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Priority to PCT/JP2013/059830 priority Critical patent/WO2014162389A1/fr
Publication of WO2014162389A1 publication Critical patent/WO2014162389A1/fr

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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
    • 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
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • 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
    • A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • 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
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip

Definitions

  • the present invention relates to a guide wire.
  • the guide wire introduces and guides catheters used for treatment of difficult surgical sites or treatment for the purpose of minimally invasive to the human body, angiographic examination and treatment in heart disease, etc. Is used.
  • the tip of the guide wire is projected from the tip of the balloon catheter under fluoroscopy, and the target site is the target site together with the balloon catheter.
  • Insert the coronary artery (coronary artery) just before the stenosis then pass the tip of the guide wire through the stenosis, then guide the balloon catheter balloon along the guide wire to the stenosis, and expand the balloon to stenosis A treatment that spreads the part and secures blood flow is performed.
  • the guide wire in order to insert a guide wire from the femoral artery by the Seldinger method and advance to the coronary artery through the aorta, aortic arch, and coronary ostium, the guide wire has flexibility to follow the blood vessel (followability, safety) (Avoidance of blood vessel perforation, etc.) and the pushability and the torque transmission property are preferably excellent because the pushing force of the proximal portion is effectively transmitted to the tip portion.
  • followability, safety Avoidance of blood vessel perforation, etc.
  • the guide wire may be shaped into a shape that matches the shape of the branch portion. This shaping is usually performed by a doctor or the like with a finger at the time of treatment, and is called reshaping.
  • the desired branch cannot be selected with the conventional pre-shaped angle-shaped or J-shaped distal shape, and the distal end of the guide wire is desired.
  • the shape is changed and reinserted. If the tip shape of the guide wire still does not match, the guide wire must be removed from the catheter, reshaped, and inserted. Therefore, the distal end portion (reshape portion) of the guide wire needs to have flexibility.
  • a guide wire in which a reshape part provided at the tip part has a plate shape (see, for example, Patent Document 1).
  • the reshapable portion has a plate shape and can be easily bent in the thickness direction. That is, this reshapable part is rich in flexibility. However, since the reshapable portion has sufficient flexibility, there is a risk that torque transmission will be impaired. As described above, in the conventional guide wire, the tip portion has a plate-like structure to improve flexibility and reshapability, but at the same time, it is difficult to improve torque transmission.
  • An object of the present invention is to provide a guide wire capable of obtaining an excellent torque transmission property while ensuring sufficient flexibility at the distal end portion.
  • Such an object is achieved by the present inventions (1) to (13) below.
  • Each of the first part and the second part has a plate shape
  • the bending stiffness of the first portion is set higher than the bending stiffness of the second portion by setting the thickness of the first portion larger than the thickness of the second portion.
  • Guide wire as described.
  • the cross-sectional area of the first part located on the distal end side of the wire body is located on the proximal end side
  • the cross-sectional area of the second part located on the distal end side of the wire body is located on the proximal end side.
  • a first coil provided at a tip of the wire body and covering the reshapable part;
  • the guide wire according to any one of (1) to (12), further including a second coil provided on a proximal end side of the first coil.
  • the present invention it is possible to easily and surely shape the tip of the guide wire into a desired shape while ensuring sufficient flexibility at the tip of the guide wire, and to provide a guide wire with excellent torque transmission. Can be provided.
  • the second portion can be easily formed by alternately providing the first portion and the second portion having a lower bending rigidity than the first portion in the reshape portion along the longitudinal direction. While being able to make it easy to deform
  • FIG. 1 is a partial longitudinal sectional view (schematic side view) showing a first embodiment of the guide wire of the present invention.
  • FIG. 2 is a view seen from the direction of arrow A in FIG. 3 is a cross-sectional view taken along line BB in FIG.
  • FIG. 4 is a diagram (a) is a plan view of the reshapable portion, and (b) is a side view of the reshapable portion) showing the configuration of the reshapable portion in the guide wire (second embodiment) of the present invention.
  • FIG. 1 is a partial longitudinal sectional view (schematic side view) showing a first embodiment of the guide wire of the present invention.
  • FIG. 2 is a view seen from the direction of arrow A in FIG. 3 is a cross-sectional view taken along line BB in FIG.
  • FIG. 4 is a diagram (a) is a plan view of the reshapable portion, and (b) is a side view of the reshapable portion) showing the configuration of
  • FIG. 5 is a diagram (a) is a plan view of the reshapable portion and (b) is a side view of the reshapable portion) showing the configuration of the reshapable portion in the guide wire (third embodiment) of the present invention.
  • 6A and 6B are diagrams (a) a plan view of the reshapable part and (b) a side view of the reshapable part) showing the configuration of the reshapable part in the guide wire (fourth embodiment) of the present invention.
  • liquid administration device of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
  • FIG. 1 is a partial longitudinal sectional view (schematic side view) showing a first embodiment of the guide wire of the present invention
  • FIG. 2 is a view seen from the direction of arrow A in FIG. 1
  • FIG. 3 is shown in FIG. It is a BB sectional view.
  • the right side in FIGS. 1 to 3 is referred to as “base end”
  • the left side is referred to as “tip”
  • the upper side is referred to as “upper”
  • the lower side is referred to as “lower”.
  • 1 to 3 for the sake of easy understanding, the length direction of the guide wire is shortened and the radial direction (thickness direction) of the guide wire is exaggerated and schematically illustrated.
  • the ratio between the direction and the radial direction is different from the actual ratio (the same applies to FIG. 4 and thereafter).
  • the bending direction is described as the thickness direction of the reshaped portion.
  • the “rigidity” of the reshapable part refers to the rigidity of the reshapable part in the thickness direction.
  • a guide wire 1 shown in FIG. 1 is a guide wire for a catheter that is used by being inserted into the lumen of a catheter (including an endoscope), and includes a first wire 2 disposed on the distal end side, and a first wire 2.
  • a wire body 10 formed by joining the second wires 4 arranged on the proximal end side of the wire body, and a spiral coil 5 installed at the distal end portion (portion on the distal end side) of the wire body 10. .
  • the total length of the guide wire 1 is not particularly limited, but is preferably about 200 to 5000 mm.
  • the first wire 2 is composed of a flexible or elastic wire.
  • the first wire 2 has an outer diameter constant portion 21 whose outer diameter is substantially constant, and a first taper that is located on the distal side of the outer diameter constant portion 21 and whose outer diameter gradually decreases in the distal direction.
  • a portion 22 a tip-side outer diameter constant portion 26 located on the tip side of the first taper portion 22, and a plate-like transition located further on the tip side, with a thickness decreasing toward the tip direction and a wider width
  • a portion 27 a reshapable portion 3 positioned on the distal end side thereof, a large-diameter portion 24 located on the proximal end side of the outer diameter constant portion 21 and having a larger outer diameter than the constant outer diameter portion 21, and a constant outer diameter portion 21 And a large diameter portion 24, and a second taper portion 23 whose outer diameter gradually decreases toward the tip.
  • the reshapable part 3 the transition part 27, the distal end side outer diameter constant part 26, the first taper part 22, the outer diameter constant part 21, the second taper part 23, and the large diameter part 24. are arranged in the order.
  • the first taper portion 22 is formed between the reshape portion 3 and the constant outer diameter portion 21, and in particular, the reshape portion 3 is formed in the vicinity of the distal end side of the first taper portion 22, so that the first
  • the bending rigidity and torsional rigidity (hereinafter, simply referred to as “stiffness”) of the wire 2 can be gradually decreased toward the distal end, and as a result, the guide wire 1 passes through a good constriction at the distal end.
  • stiffness torsional rigidity
  • the constant outer diameter portion 21 and the large diameter portion 24 are formed via the second taper portion 23, so that the rigidity of the first wire 2 is increased in the distal direction. Can be gradually reduced.
  • the taper angle (the reduction rate of the outer diameter) of the first taper portion 22 (the same applies to the second taper portion 23) is constant along the longitudinal direction of the wire body 10, but may vary along the longitudinal direction. May be. For example, a portion in which a taper angle (an outer diameter reduction rate) and a relatively small portion are alternately formed a plurality of times may be used.
  • first taper portion 22 and the second taper portion 23 may have different taper shapes and taper angles.
  • a reshapable portion 3 configured as described below is preferably formed integrally with the first tapered portion 22 via a distal end side outer diameter constant portion 26 and a transition portion 27. ing.
  • the entire first wire 2 including the reshape portion 3 is integrally formed of the same material.
  • a preferable constituent material of the first wire 2 is typically a Ni—Ti alloy.
  • Superelastic alloy alloy (alloy exhibiting pseudoelasticity). Therefore, a preferable constituent material of the reshapable part 3 is also a superelastic alloy, and this case will be described below.
  • the reshape part 3 has a plate shape, and can be used after being deformed (reshaped: shaped) into a desired shape.
  • a doctor or the like previously sets the distal end of the guide wire to a desired shape. In this way, bending the tip of the guide wire into a desired shape is called reshaping.
  • reshape can be performed easily and reliably, and the operativity at the time of inserting the guide wire 1 in a biological body improves markedly.
  • the reshape part 3 includes a plurality (four in this embodiment) of high-rigidity parts (first parts) 31a, 31b, 31c, 31d, and high-rigidity parts 31a to 31d. It has a plurality of (in this embodiment, four) low-rigidity parts (second parts) 32a, 32b, 32c, and 32d that have lower rigidity.
  • These high-rigidity parts 31 a to 31 d and low-rigidity parts 32 a to 32 d are alternately arranged along the longitudinal direction of the wire body 10.
  • a low-rigidity portion 32a, a high-rigidity portion 31a, a low-rigidity portion 32b, a high-rigidity portion 31b, a low-rigidity portion 32c, a high-rigidity portion 31c, a low-rigidity portion 32d, and a high-rigidity portion 31d are provided in this order from the tip side. It has been.
  • the high-rigidity portions 31a to 31d have the same shape, the high-rigidity portion 31a will be representatively described below. Further, since the low-rigidity portions 32a to 32d have the same shape, the low-rigidity portion 32a will be representatively described below.
  • the high-rigidity portion 31a has a plate shape, and its thickness H1 is set larger than the thickness H2 of the low-rigidity portion 32a (see FIG. 3). Thereby, the rigidity of the high rigidity part 31a becomes higher than the rigidity of the low rigidity part 32a. Thus, the high rigidity portion 31a has higher torque transmission than the low rigidity portion 32a. As described above, the high-rigidity portion 31 a is responsible for increasing the rigidity of the reshape portion 3.
  • the low-rigidity portion 32a has a plate shape, and its length L2 is equal to the length L1 of the high-rigidity portion 31a. Further, the width W2 of the low-rigidity portion 32a is larger than the width W1 of the high-rigidity portion 31a, and the thickness H2 of the low-rigidity portion 32a is set smaller than the thickness H1 of the high-rigidity portion 31a. Thereby, the low rigidity part 32a becomes a thing whose rigidity is lower than the high rigidity part 31a.
  • the low-rigidity portion 32a is a portion having higher flexibility than the high-rigidity portion 31a.
  • the low-rigidity part 32a bears the flexibility in the reshapable part 3.
  • the reshape portion 3 Since the high-rigidity portions 31a to 31d and the low-rigidity portions 32a to 32d having the contradictory characteristics are alternately arranged, the reshape portion 3 has sufficient torque transmission performance that decreases as the flexibility increases. Can be secured.
  • the reshapable part 3 is also excellent in kink resistance.
  • a low-rigidity portion 32a is located at the forefront of the reshapable portion 3. Thereby, the front-end
  • the formation method of the reshapable part 3 is not particularly limited, and examples thereof include a press working method.
  • a press working method For example, when forming the reshape portion 3 by a press working method, first, a wire body 10 having a plate shape and having a reshape member that becomes the reshape portion 3 by pressing is prepared. Next, pressure is applied to the reshape member at regular intervals (intermittently) along the longitudinal direction of the wire body 10. Thereby, the thickness of the portion to which the pressure of the reshape portion 3 is applied becomes thin and the width becomes wide. The portions to which this pressure is applied become the low rigidity portions 32a to 32d.
  • a portion where no pressure is applied becomes a portion having a thickness larger than that of the low rigidity portions 32a to 32d.
  • the portions having a thickness larger than those of the low rigidity portions 32a to 32d become high rigidity portions 31a to 31d.
  • the length (length in the longitudinal direction of the wire body 10) L1 of the highly rigid portions 31a to 31d is not particularly limited, and is preferably 0.5 to 4 mm, more preferably 1 to 3 mm.
  • the thickness H1 of the high-rigidity portions 31a to 31d is not particularly limited, but is preferably 0.03 to 0.25 mm, and more preferably 0.05 to 0.1 mm.
  • the width W1 of the high-rigidity portions 31a to 31d is, for example, preferably 0.03 to 0.25 mm, and more preferably 0.05 to 0.15 mm.
  • the length (length in the longitudinal direction of the wire body 10) L2 of the low-rigidity portions 32a to 32d is not particularly limited, and is preferably 0.5 to 4 mm, more preferably 1 to 3 mm.
  • the thickness H2 of the low rigidity portions 32a to 32d is not particularly limited, but is preferably 0.01 to 0.1 mm, and more preferably 0.02 to 0.05 mm.
  • the width W2 of the low rigidity portions 32a to 32d is not particularly limited, but is preferably 0.05 to 0.3 mm, more preferably 0.1 to 0.2 mm.
  • the thickness H2 of the low rigidity portions 32a to 32d is preferably 10 to 70%, more preferably 30 to 50% of the thickness H1 of the high rigidity portions 31a to 31d.
  • the width W1 of the high-rigidity portions 31a to 31d is preferably 10 to 70%, more preferably 30 to 50%, of the width W2 of the low-rigidity portions 32a to 32d.
  • high-rigidity parts and four low-rigidity parts are provided, but two, three, or five or more high-rigidity parts and low-rigidity parts are provided. May be.
  • the outer diameter constant part 26, the constant outer diameter part 21, and the large diameter part 24 have constant outer diameters along the wire longitudinal direction.
  • the outer diameter of the tip side outer diameter constant portion 26 is substantially equal to the minimum outer diameter of the first taper portion 22, and the outer diameter of the outer diameter constant portion 21 is substantially equal to the maximum outer diameter of the first taper portion 22. In addition, it is substantially equal to the minimum outer diameter of the second taper portion 23.
  • the outer diameter of the large diameter portion 24 is substantially the same as the maximum outer diameter of the second tapered portion 23.
  • the distal end of the second wire 4 is joined to the proximal end of the first wire 2 (the proximal end of the large diameter portion 24).
  • the second wire 4 is made of a flexible or elastic wire.
  • the method for joining the first wire 2 and the second wire 4 is not particularly limited.
  • the joining is performed by welding such as friction welding, spot welding using a laser, butting resistance welding such as upset welding, or a tubular joining member.
  • butt resistance welding is particularly preferable because it is relatively simple and high joint strength can be obtained.
  • the outer diameter of the second wire 4 is substantially constant.
  • the outer diameter of the second wire 4 is substantially equal to the outer diameter of the large diameter portion 24 of the first wire 2.
  • the average outer diameter of the first wire 2 is smaller than the average outer diameter of the second wire 4.
  • the guide wire 1 is highly flexible on the first wire 2 on the distal end side and relatively high on the second wire 4 on the proximal end side. And excellent operability (pushability, torque transmission, etc.).
  • the constituent materials of the first wire 2 and the second wire 4 are not particularly limited, and for example, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, Various metal materials such as SUS430F, all types of SUS such as SUS302), piano wires, cobalt-based alloys, alloys showing pseudoelasticity (including superelastic alloys) can be used.
  • stainless steel for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429
  • Various metal materials such as SUS430F, all types of SUS such as SUS302), piano wires, cobalt-based alloys, alloys showing pseudoelasticity (including superelastic alloys) can be used.
  • the constituent material of the first wire 2 is preferably an alloy (including a superelastic alloy) exhibiting pseudoelasticity, more preferably a superelastic alloy.
  • the guide wire 1 is sufficiently flexible at the tip side by configuring the first wire 2 with the superelastic alloy. Performance and bendability, improved followability to complicatedly curved / bent blood vessels, etc., improved operability, and even if the first wire 2 repeatedly bends / bends, Since the bend crease is not attached due to the resilience of the 1 wire 2, it is possible to prevent the operability from being lowered due to the bend crease on the first wire 2 during use of the guide wire 1.
  • Pseudoelastic alloys include any shape of stress-strain curve due to tension, including those where the transformation point of As, Af, Ms, Mf, etc. can be remarkably measured, and those that cannot be measured. However, everything that returns to its original shape by removing stress is included.
  • the preferred composition of the superelastic alloy is a Ni—Ti alloy such as a Ni—Ti alloy of 49 to 52 atomic% Ni, a Cu—Zn alloy of 38.5 to 41.5 wt% Zn, 1 to 10 wt% X Cu—Zn—X alloy (X is at least one of Be, Si, Sn, Al, and Ga), Ni-Al alloy of 36 to 38 atomic% Al, and the like.
  • X is at least one of Be, Si, Sn, Al, and Ga
  • Ni-Al alloy of 36 to 38 atomic% Al, and the like.
  • the Ni—Ti alloy is particularly preferable.
  • a superelastic alloy typified by a Ni—Ti alloy is also excellent in the adhesion of a resin coating layer 8 described later.
  • the cobalt-based alloy has a high elastic modulus when used as a wire and has an appropriate elastic limit. For this reason, the wire comprised by the cobalt type alloy is excellent in torque transferability, and problems, such as buckling, do not arise very much.
  • Any cobalt-based alloy may be used as long as it contains Co as a constituent element, but it contains Co as a main component (Co-based alloy: Co content in the elements constituting the alloy) Is preferable, and a Co—Ni—Cr alloy is more preferably used. By using an alloy having such a composition, the above-described effects become more remarkable.
  • an alloy having such a composition has a high elastic modulus and can be cold-formed even as a high elastic limit, and by reducing the diameter while sufficiently preventing buckling from occurring due to the high elastic limit. And can have sufficient flexibility and rigidity to be inserted into a predetermined portion.
  • the above-mentioned stainless steel is preferable.
  • Stainless steel has higher strength and rigidity than the superelastic alloy, and therefore can impart excellent pushability and torque transmission to the guide wire 1.
  • the first wire 2 and the second wire 4 may be made of different materials, but may be made of the same or the same kind of metal material (the main metal material in the alloy is the same). In the latter case, the joint strength of the joint portion (welded portion) 6 becomes higher, and even if the outer diameter of the joint portion 6 is small, excellent torque transmission properties and the like are exhibited without causing separation or the like.
  • the first wire 2 and the second wire 4 are made of different materials
  • the first wire 2 is preferably made of the above-described superelastic alloy, and particularly made of a Ni—Ti alloy.
  • the second wire 4 is preferably made of the above-described stainless steel.
  • first wire 2 and the second wire 4 are joined.
  • first wire 2 and the second wire 4 may be composed of a single continuous wire body without a joint.
  • examples of the constituent material of the wire body include the same materials as described above, and stainless steel, cobalt-based alloys, and pseudoelastic alloys are particularly preferable.
  • the coil 5 is arranged on the outer periphery of the tip of the wire body 10 so as to cover the tip.
  • the installation of the coil 5 reduces the contact area of the surface of the wire body 10 with the inner wall of the catheter and the surface of the living body, thereby reducing the sliding resistance.
  • the operability of the guide wire 1 is further improved. improves.
  • a wire main body 10 is inserted through the central portion inside the coil 5.
  • the reshape part 3, the transition part 27, the distal end side outer diameter constant part 26, the first taper part 22, and all or part of the outer diameter constant part 21 are covered with the coil 5.
  • the distal end portion of the wire body 10 (particularly, the region from the reshapable portion 3 to the first tapered portion 22) is inserted in a non-contact manner with the inner surface of the coil 5. As a result, a gap 50 is formed between the coil 5 and the tip of the wire body 10.
  • the coil 5 includes a first coil 5A disposed on the distal end side and a second coil 5B provided on the proximal end side of the first coil 5A.
  • the first coil 5A and the second coil 5B are formed by spirally forming a strand 54A and a strand 54B having a circular cross section.
  • one strand 54A and 54B may be spirally wound, or a plurality of strands 54A and 54B may be spirally wound.
  • first coil 5A and the second coil 5B are joined (fixed) by welding, an adhesive, or the like.
  • the boundary portion 52 that is the joined portion is located in the middle of the first taper portion 22 in the longitudinal direction. That is, the first coil 5 ⁇ / b> A covers the entire reshape part 3. In this covered state, the first coil 5 ⁇ / b> A can be deformed following the deformation of the reshapable portion 3.
  • the constituent material of the strand 54A and the strand 54B is not particularly limited, and may be either a metal material or a resin material.
  • the constituent material of the strands 54A and 54B is a metal material, they may be composed of different materials or the same material.
  • the strand 54A is made of, for example, a noble metal such as Au or Pt, or an alloy containing the noble metal (for example, a Pt—Ni alloy).
  • the wire 54B is made of an X-ray transparent material such as stainless steel.
  • the first coil 5 ⁇ / b> A having X-ray contrast properties covers the entire reshape part 3 and can be deformed following the deformation of the reshape part 3. Thereby, it can insert in in vivo, confirming the shape and position of the reshape part 3 clearly under X-ray fluoroscopy.
  • the shape is not limited to the case where the portion from the reshape portion 3 to the constant outer diameter portion 21 is covered with the coil 5, but the reshape portion 3, the transition portion 27, the distal end side outer diameter constant portion 26, the first taper portion. 22 and a part of the constant outer diameter portion 21 may be covered with the coil 5.
  • the wire diameters of the strands 54A and 54B may be the same over the entire length of the coil 5, but the wire diameters of the strands 54A and 54B may be different between the distal end side and the proximal end side. .
  • the wire diameter of the strand 54A may be smaller (or larger) on the distal end side of the coil 5 than on the proximal end side. Thereby, the softness
  • the outer diameter of the coil 5 may be the same over the entire length of the coil 5, but the outer diameter of the coil 5 may be different between the distal end side and the proximal end side of the coil 5.
  • the outer diameter of the coil 5 may be smaller on the distal end side of the coil 5 than on the proximal end side.
  • the adjacent strands 54A and the strands 54B of the coil 5 are in contact with each other and are in a so-called densely wound state.
  • the strands 54A and the strands 54B generate a force (compression force) that pushes against each other in the axial direction of the wire body 10 in a natural state.
  • the “natural state” refers to a state where no external force is applied.
  • the present invention is not limited to this, and the adjacent strands 54 ⁇ / b> A and the strands 54 ⁇ / b> B may be separated from each other, and the strands may be separated from each other throughout the coil 5.
  • the coil 5 is fixed to the wire body 10 at two places (a plurality of places). That is, the distal end portion of the coil 5 is fixed to the distal end of the first wire 2 (the distal end of the reshape portion 3) by a fixing material (fixing portion) 51, and the proximal end portion of the coil 5 is first fixed by the fixing material (fixing portion) 53. It is fixed in the middle of the wire 2 (near the boundary between the outer diameter constant portion 21 and the second taper portion 23). By fixing at such a location, the respective portions of the coil 5 can be reliably fixed to the wire body 10 without impairing the flexibility of the distal end portion (the portion where the coil 5 is present) of the guide wire 1. .
  • part in the middle of the coil 5 may be fixed to the 1st taper part 22 of the 1st wire 2 with the fixing material.
  • the reshapable portion 3 since the distal end side (the distal end portion) and the proximal end side of the reshapable portion 3 are fixed by the fixing materials 51 and 53, respectively, the reshapable portion 3 can be securely fixed to the coil 5 and shaped. The shape of the reshapable part 3 can be maintained appropriately.
  • the fixing materials 51 and 53 are preferably made of solder (brazing material).
  • the fixing materials 51 and 53 are not limited to solder and may be adhesives.
  • the method for fixing the coil 5 to the wire body 10 is not limited to the above-described fixing material, and for example, welding may be used.
  • the distal end surface of the fixing material 51 is preferably rounded (see FIG. 1).
  • the outer surface of the guide wire 1 is provided with a resin coating layer 8 covering the whole (or a part thereof).
  • the resin coating layer 8 can be formed for various purposes. As an example, the operability of the guide wire 1 is reduced by reducing the friction (sliding resistance) of the guide wire 1 and improving the slidability. May be improved.
  • the resin coating layer 8 is preferably made of a material that can reduce friction as described below.
  • the frictional resistance (sliding resistance) with the inner wall of the catheter used together with the guide wire 1 is reduced, the slidability is improved, and the operability of the guide wire 1 in the catheter becomes better.
  • the sliding resistance of the guide wire 1 is reduced, when the guide wire 1 is moved and / or rotated in the catheter, kinks (bending) or twisting of the guide wire 1, Twist can be prevented more reliably.
  • materials that can reduce such friction include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyesters (PET, PBT, etc.), polyamides, polyimides, polyurethanes, polystyrenes, polycarbonates, silicone resins, fluorine resins ( PTFE, ETFE, etc.) or a composite material thereof.
  • polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyesters (PET, PBT, etc.), polyamides, polyimides, polyurethanes, polystyrenes, polycarbonates, silicone resins, fluorine resins ( PTFE, ETFE, etc.) or a composite material thereof.
  • the resin coating layer 8 can be provided for the purpose of improving safety when the guide wire 1 is inserted into a blood vessel or the like.
  • the resin coating layer 8 is made of a flexible material (soft material, elastic material).
  • Examples of such flexible materials include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, silicone resin, polyurethane elastomer, polyester elastomer, polyamide
  • examples thereof include thermoplastic elastomers such as elastomers, various rubber materials such as latex rubber and silicone rubber, or composite materials in which two or more of these are combined.
  • the resin coating layer 8 is not limited to being entirely composed of the same material, and the constituent material may be different in the middle of the guide wire 1 in the longitudinal direction.
  • the material of the portion covering the first wire 2 and the coil 5 of the resin coating layer 8 is made of the flexible material, and the material of the portion covering the second wire 4 of the resin coating layer 8 is the friction. The material can be reduced.
  • the resin coating layer 8 may be a single layer or a laminate of two or more layers (for example, an inner layer made of a material that is more flexible than an outer layer).
  • the portion of the resin coating layer 8 that covers the first wire 2 and the coil 5 can be a single layer
  • the material of the portion of the resin coating layer 8 that covers the second wire 4 can be a laminate of two or more layers. .
  • the reverse may be sufficient.
  • a groove may be formed on the outer peripheral surface of the resin coating layer 8.
  • a groove having a pattern such as a linear shape, a curved shape, a ring shape, a spiral shape, a net shape, or the like is formed in a portion corresponding to at least the reshape portion 3 of the resin coating layer 8 (the outer peripheral portion of the reshape portion 3). Is preferred.
  • the flexibility of the distal end portion of the guide wire 1 is increased, the friction (sliding resistance) of the guide wire 1 is reduced, and the slidability can be further improved.
  • a hydrophilic material is coated on the outer surface of at least the tip of the guide wire 1.
  • the hydrophilic material is wetted to produce lubricity, the friction (sliding resistance) of the guide wire 1 is reduced, and the slidability is improved. Therefore, the operability of the guide wire 1 is improved.
  • hydrophilic materials include cellulose-based polymer materials, polyethylene oxide-based polymer materials, and maleic anhydride-based polymer materials (for example, maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymer).
  • Acrylamide polymer substances for example, polyacrylamide, block copolymer of polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA)), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone and the like.
  • Such a hydrophilic material often exhibits lubricity by wetting (water absorption) and reduces frictional resistance (sliding resistance) with the inner wall of the catheter used together with the guide wire 1. Thereby, the slidability of the guide wire 1 is improved, and the operability of the guide wire 1 in the catheter becomes better.
  • Second Embodiment 4A and 4B are diagrams (a) is a plan view of the reshapable portion and (b) is a side view of the reshapable portion) showing the configuration of the reshapable portion in the guide wire (second embodiment) of the present invention.
  • FIGS. 4A and 4B are referred to as “base end”, the left side is referred to as “tip”, the upper side is referred to as “upper”, and the lower side is referred to as “lower”.
  • This embodiment is the same as the first embodiment except that the shapes of the high rigidity portions 31a to 31d are different.
  • the highly rigid portions 31a to 31d have a columnar shape with the longitudinal direction of the wire body 10 as the axial direction, and the cross-sectional shape thereof is circular.
  • the rigidity of the high-rigidity portions 31a to 31d is the same regardless of the bending direction, and is isotropic. Therefore, the guide wire 1 can obtain better (more natural) operability.
  • FIG. 5 is a diagram (a) is a plan view of the reshapable portion and (b) is a side view of the reshapable portion) showing the configuration of the reshapable portion in the guide wire (third embodiment) of the present invention.
  • the third embodiment of the guide wire of the present invention will be described with reference to this figure, but the description will focus on the differences from the second embodiment described above, and the description of the same matters will be omitted.
  • the right side in FIGS. 5A and 5B is referred to as “base end”, the left side is referred to as “tip”, the upper side is referred to as “upper”, and the lower side is referred to as “lower”.
  • This embodiment is the same as the second embodiment except that the shapes of the high rigidity portions 31a to 31d and the low rigidity portions 32a to 32d are different.
  • the reshapable portion 3 includes high-rigidity portions 31a to 31d having different lengths and low-rigidity portions 32a to 32d having different lengths. As a result, the reshapable portion 3 has portions having different rigidity in the row of the high rigidity portions 31a to 31d and the row of the low rigidity portions 32a to 32d.
  • the length L1a of the high-rigidity portion 31a, the length L1b of the high-rigidity portion 31b, the length L1c of the high-rigidity portion 31c, and the length L1d of the high-rigidity portion 31d are in this order in the longitudinal direction of the wire body Is configured to be long. That is, the lengths L1a, L1b, L1c, and L1d satisfy the relationship of L1a> L1b> L1c> L1d (see FIG. 5A). Thereby, it is possible to suppress (relieve) that the torque transmission performance sharply decreases toward the tip side.
  • the length L2a of the low-rigidity portion 32a, the length L2b of the low-rigidity portion 32b, the length L2c of the low-rigidity portion 32c, and the length L2d of the low-rigidity portion 32d are the lengths in the longitudinal direction of the wire body 10 in this order. Is configured to be long. That is, the lengths L2a, L2b, L2c, and L2d satisfy the relationship L2a> L2b> L2c> L2d (see FIG. 5A). Thereby, the flexibility of the reshapable part 3 gradually increases toward the tip as a whole.
  • the reshape portion 3 as a whole can ensure sufficient flexibility and more reliably ensure torque transmission at the tip of the reshape portion 3.
  • the reshapable portion 3 can further increase the bending rigidity on the base end side.
  • the reshapable portion 3 can further increase the bending rigidity of the tip portion.
  • desired portions of the high-rigidity portions 31a to 31d and the low-rigidity portions 32a to 32d having different lengths are provided in the reshape portion 3 as required.
  • the characteristics of can be imparted.
  • FIG. 6 is a diagram (a) is a plan view of the reshapable portion and (b) is a side view of the reshapable portion) showing the configuration of the reshapable portion in the guide wire (fourth embodiment) of the present invention.
  • the fourth embodiment of the guide wire of the present invention will be described with reference to these drawings.
  • the difference from the third embodiment described above will be mainly described, and the description of the same matters will be omitted.
  • the right side in FIGS. 6A and 6B is referred to as “base end”, the left side is referred to as “tip”, the upper side is referred to as “upper”, and the lower side is referred to as “lower”.
  • This embodiment is the same as the third embodiment except that the configurations of the high rigidity portions 31a to 31d and the low rigidity portions 32a to 32d are different.
  • the reshapable portion 3 of this embodiment has high-rigidity portions 31a to 31d having different cross-sectional areas and low-rigidity portions 32a to 32d having different cross-sectional areas. is doing.
  • the cross-sectional areas of the high-rigidity portions 31a to 31d increase in the order of the high-rigidity portion 31a, the high-rigidity portion 31b, the high-rigidity portion 31c, and the high-rigidity portion 31d.
  • the high-rigidity portion 31a has a tapered portion 310a that gradually decreases toward the distal end side
  • the high-rigidity portion 31b has a tapered portion 310b that gradually decreases toward the distal-end side
  • the high-rigidity portion 31c is directed toward the distal-end side.
  • the tapered portion 310c gradually decreases, and the high-rigidity portion 31d has a tapered portion 310d that gradually decreases toward the distal end side.
  • the tapered portions 310a to 310d are inclined at the same angle with respect to the axis of the high-rigidity portions 31a to 31d, respectively, and the tapered portions 310a to 310d are located on continuous surfaces.
  • width of the low rigidity portion 32c (average width ((maximum width-minimum value) / 2)) W2c
  • width of the low rigidity portion 32d (average width ((width 2) W2d is configured to gradually decrease toward the tip side, that is, the widths W2a to W2d of the low-rigidity portions 32a to 32d are: W2a ⁇ W2b ⁇ W2c ⁇ W2d Meet the relationship.
  • Such a reshape unit 3 can obtain the same effects as those of the third embodiment described above. Further, the reshape portion 3 can easily form the high rigidity portions 31a to 31d and 32a to 32d by pressing the conical reshape portion member as described above.
  • the present invention is not limited to this, and the same applies even when an external force in the width direction of the reshaped portion is applied. An effect can be obtained.
  • the high rigidity part in each embodiment functions as a low rigidity part
  • the low rigidity part in each embodiment functions as a high rigidity part.
  • the high rigid part and the low rigid part demonstrated the case where it formed by pressing a plate-shaped reshape part intermittently, it is not limited to this in this invention,
  • plate shape Solder (brazing material) or the like may be added separately to the desired shape at a desired shape.
  • the part to which the solder (brazing material) is added functions as a highly rigid part.
  • the portion to which the solder (brazing material) is not added functions as a low rigidity portion.
  • the high-rigidity part and the low-rigidity part are set so that the rigidity of the high-rigidity part and the low-rigidity part is different by setting the shapes (length, width, thickness) different from each other.
  • the present invention is not limited to this, and the high-rigidity part and the low-rigidity part may be set to have different rigidity by being composed of materials having different rigidity. .
  • the guide wire of the present invention includes a wire main body having a reshape portion that can be reshaped at a tip portion, and the reshape portion includes a plurality of first portions and a plurality of second portions having lower bending rigidity than the first portions.
  • the first portion and the second portion are alternately provided along the longitudinal direction of the wire body.
  • the present invention it is possible to easily and surely shape the tip of the guide wire into a desired shape while ensuring sufficient flexibility at the tip of the guide wire, and to provide a guide wire with excellent torque transmission. Can be provided.
  • the second portion can be easily formed by alternately providing the first portion and the second portion having a lower bending rigidity than the first portion in the reshape portion along the longitudinal direction. While being able to make it easy to deform

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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

L'invention concerne un fil guide (1) qui présente un corps principal (10) de fil présentant, en une extrémité correspondante, une partie de refaçonnage (3) qui peut être refaçonnée. La partie de refaçonnage (3) présente : des parties de haute rigidité (premières sections) (31a-31d) ; et des parties de faible rigidité (deuxièmes sections) (32a-32d) qui présentent une rigidité à la flexion plus basse que les parties de haute rigidité (31a-31d). Les parties de haute rigidité (31a-31d) et les parties de basse rigidité (32a-32d) sont situées en alternance le long de la direction longitudinale du corps principal (10) de fil. Les parties de haute rigidité (31a-31d) et les parties de basse rigidité (32a-32d) forment respectivement des formes de plaques. Par conséquent, par le réglage de l'épaisseur des parties de haute rigidité (31a-31d) de sorte qu'elle soit supérieure à l'épaisseur des parties de basse rigidité (32a-32d), la rigidité en flexion des parties de haute rigidité (31a-31d) est réglée à un niveau supérieur à la rigidité en flexion des parties de basse rigidité (32a-32d).
PCT/JP2013/059830 2013-04-01 2013-04-01 Fil guide WO2014162389A1 (fr)

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WO2014162389A1 true WO2014162389A1 (fr) 2014-10-09

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4044896A4 (fr) * 2019-10-16 2024-02-28 Embrace Medical Ltd. Fil-guide avec pointe élastiquement articulable

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008245852A (ja) * 2007-03-29 2008-10-16 Terumo Corp ガイドワイヤ
JP2011062223A (ja) * 2009-09-15 2011-03-31 Japan Lifeline Co Ltd 医療用ガイドワイヤ

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008245852A (ja) * 2007-03-29 2008-10-16 Terumo Corp ガイドワイヤ
JP2011062223A (ja) * 2009-09-15 2011-03-31 Japan Lifeline Co Ltd 医療用ガイドワイヤ

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4044896A4 (fr) * 2019-10-16 2024-02-28 Embrace Medical Ltd. Fil-guide avec pointe élastiquement articulable

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