JP4994831B2 - Guide wire - Google Patents

Description

  The present invention relates to a guide wire used when a catheter or the like is inserted into a living body lumen.

  As a conventional guide wire, one described in Patent Document 1 below is known. In this guide wire, a first synthetic resin film containing a radiopaque material at a high concentration is formed at the tip of the core wire, and the entire core wire on which the first synthetic resin film is formed is radiopaque. A second synthetic resin film containing or not containing a functional material at a low concentration is formed. Specifically, in this guide wire, a polyurethane resin film in which tungsten is kneaded is formed as the first synthetic resin film, and a polyurethane resin film is formed as the second synthetic resin film.

JP-A-8-257136

  In such a guide wire, since the above-described resin is used as the resin related to the second synthetic resin film, straightness and low resistance are limited to this. In addition, when the second synthetic resin film includes a radiopaque material, the thickness of the second synthetic resin film is small, so that particles of the radiopaque material come out on the surface, resulting in low resistance. May not be obtained. In addition, when a radiopaque material is included in the second synthetic resin film, the adhesion portion to the first synthetic resin film is reduced and the adhesiveness is relatively deteriorated, and accordingly, low resistance is obtained. There is no possibility.

SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a guide wire that has low resistance, excellent linearity and torque transmission , and excellent operability.

In order to achieve the above object, the invention described in claim 1 includes a core wire extending from a proximal end portion to a distal end portion, and a sleeve surrounding the distal end portion of the core wire, and the sleeve includes a radiopaque material and a polyimide resin. a radiation opaque layer containing, made of polyimide resin for covering the outer surface of the radiation opaque layer, and possess an outer layer forming the outer surface of the sleeve, and characterized in that it is rotatable about the core wire To do.

In order to achieve the above object, the invention described in claim 2 includes a core wire extending from the proximal end portion to the distal end portion, and a sleeve surrounding the distal end portion of the core wire, and the sleeve comprises a radiopaque material and a polyimide resin. And a radiopaque layer containing an outer layer which covers the outer surface of the radiopaque layer and is made of a polyimide resin containing a radiopaque material having a lower concentration than the radiopaque layer and forms the outer surface of the sleeve. And is rotatable around the core wire .

In order to achieve the object of further improving the smoothness in addition to the above object, the invention described in claims 3 and 4 is the above invention, wherein the outer surface of the sleeve is coated with a lubricating coating layer. The coating layer is made of polyethylene oxide or the like.

In addition to the above-mentioned object, the invention according to claim 5 is the above-mentioned invention, in order to achieve the object of achieving both advancing performance and flexibility, and is arranged on the tip side from the sleeve and attached so as to surround the core wire. A coil is provided, and the coil includes a proximal end portion wound densely and a distal end portion wound more coarsely than the proximal end portion.

According to the present invention, the sleeve provided at the tip of the core wire is coated with a radiopaque layer made of polyimide resin containing a radiopaque material and the outer surface thereof (containing a radiopaque material having a lower concentration). E) Since it has an outer layer made of polyimide resin and is rotatable around the core wire, it is possible to provide a guide wire with low resistance and excellent straightness and torque transmission and excellent operability. Play.

  Hereinafter, examples of embodiments of the present invention will be described with reference to the drawings as appropriate. The embodiments of the present invention are not limited to the following embodiments.

[First Embodiment]
FIG. 1 is an explanatory diagram of a guide wire 1 according to the first embodiment. The guide wire 1 includes a core wire 2 extending from the distal end of the guide wire 1 to the proximal end, and a sleeve provided outside the distal end edge of the core wire 2. 4, a small coil 5 which is fixed to the proximal end side of the sleeve 4 on the core wire 2, a coil 6 which is provided on the distal end side of the sleeve 4 and surrounds the outside of the distal end portion of the core wire 2, and the core wire 2 includes a chip 8 connected to the tip of the two.

  Here, the total length of the guide wire 1 is 1750 millimeters (mm), the outer diameter of the base end portion of the core wire 2 is 0.36 mm, the length of the sleeve 4 is 200 mm, and the total length of the coil 6 and the chip 8 is about 40 mm. Preferably, the total length of the guide wire 1 is 1500 to 3000 mm, the outer diameter of the core wire 2 base end is 0.25 to 0.45 mm, the length of the sleeve 4 is 150 to 300 mm, and the sleeve 4 with respect to the total length of the guide wire 1 The ratio of the length is [total length]: [sleeve length] = 10: 1 to 20: 1, the total length of the coil 6 and the tip 8 is 30 to 50 mm, and the sleeve 4 with respect to the total length of the coil 6 and the tip 8 The ratio of the lengths is [total length]: [sleeve length] = 1: 3 to 1: 6.

  FIG. 2 is a partially omitted cross-sectional view of the distal end side of the guide wire 1, and the core wire 2 is reduced in diameter from the inside of the sleeve 4 to the distal end, and has a tapered shape. In addition, an inner coil 10 is provided inside the both sides of the boundary between the sleeve 4 and the coil 6 to connect them in the front-rear direction.

  The sleeve 4 is a cylindrical member having an outer diameter or inner diameter that is the same as that of the small coil 5 and the coil 6. The sleeve 4 is sandwiched between them and does not move further forward or backward. Can be rotated. Further, the inner diameter of the sleeve 4, the outer diameter on the proximal end side of the core wire 2, and the outer diameter of the inner coil 10 are the same. On the other hand, the tip 8 is a round hemispherical member on the distal end side, and the outer diameter of the base end thereof is the same as the outer diameter of the sleeve 4 and the coil 6.

  The sleeve 4 has a two-layer structure including a radiopaque layer (inner layer) 4a and an outer layer 4b. The radiopaque layer 4a is formed by molding a polyimide resin mixed with tungsten powder, which is a radiopaque material, into a cylindrical shape. As the radiopaque material, any of tungsten, bismuth, barium sulfate, gold, platinum, or a combination thereof can be used. Further, the radiopaque material such as tungsten is preferably mixed in an amount of 50 to 90 weight percent (wt%) with respect to the polyimide resin. The term “radiopaque” is not limited to the meaning that the radiation is not completely transmitted, and includes a case where the radiation is not partially transmitted but partially transmitted.

  On the other hand, the outer layer 4b is formed by coating polyimide resin on the outer surface of the radiopaque layer 4a. The outer layer 4b may be a polyimide resin in which a powder of a radiopaque material is mixed at a lower concentration than the radiopaque layer 4a, and preferably 0 to 40 wt% is mixed with the polyimide resin.

  The thickness of the radiopaque layer 4a and the outer layer 4b (one piece, the same applies hereinafter) is preferably 10 to 25 micrometers (μm) and 25 to 40 μm in order, and the ratio of these thicknesses is preferably [ Radiopaque layer]: [Outer layer] = 1: 1 to 1: 4.

  FIG. 3 is a diagram illustrating a method for investigating smoothness (low resistance) between a sleeve 4 having a two-layer structure and a comparison target. In this investigation, the sleeve 4 has an outer diameter of 0.34 mm, an inner diameter of 0.24 mm, an outer layer thickness of 30 μm, a radiopaque layer thickness of 20 μm, and a length of 200 mm (Polyimide + W Double Layer, survey target). As a comparison object, a single layer structure tube made of polyimide resin (Polyimide Single Layer, comparison object 1) having an outer diameter of 0.34 mm, an inner diameter of 0.24 mm, and a length of 200 mm, and an outer diameter of 0.34 mm containing 50 wt% tungsten. A single-layer tube made of polyimide resin having an inner diameter of 0.24 mm and a length of 200 mm (Polyimide + W Single Layer, Comparative Object 2) is used.

  In the investigation, a pedestal 106 having a pulley 104 having a winding part diameter of 20 mm is rotatably placed in a water tank 102 filled with water 100 maintained at 37 degrees Celsius, and a 20-gram weight 108 is placed on the underwater side end. The fixed investigation object or comparison object is wound around the pulley 104 once, the force gauge 110 is attached to the water-side end of the investigation object or comparison object, and the value of the force gauge 110 when the force gauge 110 is raised is observed. As the value of the force gauge 110 is lower, resistance force is not generated in the pulley 104 in the investigation target or the comparison target, and the smoothness is higher.

  FIG. 4 is a graph showing the results of this investigation. [Swipes] on the horizontal axis is the value of how many times before and after reciprocating the force gauge 110, and the force [N] on the vertical axis indicates the force gauge 110 Value (unit Newton). According to this graph, it can be said that the investigation object consistently exhibits better smoothness than the comparison object 2 regardless of the number of round trips, and has the same smoothness as the comparison object 1. In more detail, although the initial survey target is slightly smoother than the comparison target 1, the survey target exhibits smoothness that exceeds the comparison target 1 as the round trip is repeated.

  The guide wire 1 according to the first embodiment includes a core wire 2 extending from the proximal end portion to the distal end portion and a sleeve 4 surrounding the distal end portion of the core wire 2, and the sleeve 4 includes a radiopaque layer 4a containing tungsten and polyimide resin. And an outer layer 4b made of a polyimide resin (including tungsten having a lower concentration than the radiopaque layer 4a) covering the outer surface of the radiopaque layer 4a and forming the outer surface of the sleeve 4. About the front-end | tip part of 1, the polyimide resin can be exposed and, therefore, straightness and low resistance can be improved. Further, since the radiopaque layer 4a (and the outer layer 4b) of the sleeve 4 contains tungsten, the distal end portion of the guide wire 1 can be made sufficiently visible via radiation.

  In the guide wire 1, the sleeve 4 can be rotated around the core wire 2, so that the core wire 2 can be rotated even in a lumen where most of the sleeve 4 is in contact with the core wire 2. The operability can be improved by dramatically improving the performance.

[Second Embodiment]
The guide wire of the second embodiment is the same as the guide wire 1 of the first embodiment except for the sleeve. The sleeve according to the second embodiment has a radiopaque layer and an outer layer in the same manner as the sleeve 4 according to the first embodiment. Further, the outer surface of the outer layer is coated with a lubricating coating layer.

  The coating layer is preferably polyethylene oxide (PEO), and preferably has a thickness of 3 to 10 μm, or the ratio of the thickness to the radiopaque layer is [radiation opaque layer]: [coating layer] = 1: 0.12 to 1: 1, and the thickness ratio with the outer layer is [outer layer]: [coating layer] = 1: 0.07 to 1: 0.4.

  In the guide wire of the second embodiment, the outer surface of the sleeve is coated with a lubricious coating layer (PEO), so that the low resistance of the sleeve is further enhanced while maintaining the influence of the properties of the inner polyimide resin. Can do. In particular, the combination of PEO and polyimide resin can improve the adhesiveness of the coating layer to the outer surface of the outer layer and make it favorable.

[Third Embodiment]
The guide wire of the third embodiment is the same as the guide wire of the first embodiment and the second embodiment except for the coil. As shown in FIG. 5, the coil 36 of the third embodiment has the same inner and outer diameters and lengths as the coil 6 of the first embodiment, but the winding method is different from the coil 6 and the proximal end portion 37 is dense. The distal end portion 38 is wound more roughly than the proximal end portion 37.

  In the guide wire according to the third embodiment, the coil 36 disposed on the distal end side of the sleeve and attached so as to surround the core wire includes a proximal end portion 37 wound tightly and a distal end portion 38 wound more coarsely than the proximal end portion 37. Therefore, while making the distal end edge of the guide wire flexible, the elastic force on the immediate proximal side can be made relatively high, and both flexibility and good progress can be achieved.

[Fourth Embodiment]
The guide wire of the fourth embodiment is the same as the guide wire of the first to third embodiments except for the sleeve. As shown in FIG. 6A, a spiral slit 45 is provided on the distal end side of the sleeve 44 of the fourth embodiment. The slit 45 becomes wider as it goes to the proximal end side.

  In the guide wire of the fourth embodiment, since the spiral slit 45 is inserted in the distal end portion of the sleeve 44, both end edges of the slit 45 are allowed to approach and close, and the distal end portion of the sleeve 44 is disposed at the base portion thereof. It can be made flexible compared to the end portion, and can exhibit both the flexibility on the distal end side and the elasticity on the proximal end side supporting the same, so that both flexibility and good progress can be achieved. .

  In addition, since the interval between the slits 45 is increased as it approaches the proximal end side, the flexibility of the slit 45 is increased stepwise as it goes to the distal end, and the elasticity of the slit 45 is increased stepwise as it approaches the proximal end side. It is possible to achieve a high degree of compatibility between flexibility and good progress.

[Fifth Embodiment]
The guide wire of the fifth embodiment is the same as the guide wire of the first to third embodiments except for the sleeve. As shown in FIG. 6B, the sleeve 54 of the fifth embodiment is formed by cutting the sleeve of the first embodiment to the third embodiment a plurality of times along the long axis vertical surface, and a plurality of cylinders. It is an assembly of bodies (enclosures of core wires) 55a, 55b. The axial length of the proximal end side cylindrical body 55b is longer than the axial length of the distal end side cylindrical body 55a. Hereinafter, the axial length of the proximal end side cylindrical body is further appropriately determined. This is repeated and this is repeated as appropriate.

  In the guide wire of the fifth embodiment, the sleeve 54 includes long and short cylindrical bodies 55a, 55b,..., The short cylindrical body is disposed on the distal end side, and the long cylindrical body is disposed on the proximal end side. By allowing the end surfaces between the cylinders to be close to each other, the distal end portion of the sleeve 54 can be made more flexible than the proximal end portion thereof, and the flexibility on the distal end side and the proximal end side supporting the same can be made. Both elasticity can be exhibited and both flexibility and good progress can be achieved.

  Further, since the lengths of the cylindrical bodies 55a, 55b,... Are made longer toward the proximal end side, the flexibility of the slit 55 is increased stepwise as it goes to the distal end, and the elasticity of the slit 55 is increased stepwise as it approaches the proximal end side. It is possible to achieve a high degree of compatibility between flexibility and good progress.

[Sixth Embodiment]
The guide wire of the sixth embodiment is the same as the guide wire of the first to third embodiments except for the sleeve. As shown in FIG. 6C, the sleeve 64 of the sixth embodiment is also an assembly of cylindrical bodies (enclosures) 65a, 65b, 65c, 65d, 65e, and the lengths of the cylindrical bodies 65a to 65d. Are equivalent, and only the cylindrical body 65e at the base end is longer than the cylindrical bodies 65a to 65d.

  Also in the guide wire of the sixth embodiment, the sleeve 54 includes long and short cylindrical bodies 65a to 65e, the cylindrical bodies 65a to 65d shorter than the cylindrical body 65e are arranged on the distal end side, and the cylindrical body 65e is proximal to the proximal side. Therefore, it is possible to allow the end face between the cylindrical bodies to be closer and closer, and to make the distal end portion of the sleeve 54 more flexible than the base end portion thereof. The elasticity of the base end side which supports can be exhibited together, and both flexibility and good progress can be achieved.

[Example of change]
In addition, other embodiment of this invention which mainly changes the said embodiment and illustrates is illustrated. The small coil is not arranged on the base end side of the sleeve, and the diameter of the core wire is continuously increased by the same amount as that of the small coil so that the sleeve is stopped in the front-rear direction at the large diameter portion on the sleeve base end side. At this time, the outer diameter of the core wire base end after the end of the diameter expansion is made the same as the outer diameter of the sleeve or the coil. Increase or decrease the wire thickness, line cross-sectional shape, number of turns, and interval of various coils. The diameter of the core wire (taper gradient) is made steeper or gentler.

  In the fourth embodiment, the slits are spirals at equal intervals, or the place where the slits enter is made shorter or longer. In the fifth embodiment, the length is increased by a predetermined number from the tip. In the fifth embodiment and the sixth embodiment, the number of cylindrical bodies is increased or decreased. Moreover, a slit and a cylindrical body are combined.

It is explanatory drawing of the guide wire which concerns on 1st Embodiment of this invention. FIG. 2 is a partially omitted cross-sectional view of the front end side of FIG. 1. It is explanatory drawing of an investigation method. It is a graph which shows a survey result. It is explanatory drawing of the coil which concerns on 3rd Embodiment of this invention. It is explanatory drawing of the sleeve which concerns on (a) 4th Embodiment, (b) 5th Embodiment, (c) 6th Embodiment of this invention.

Explanation of symbols

1 Guide wire 2 Core wire 4, 44, 54, 64 Sleeve
4a radiopaque layer 4b outer layer 6,36 coil 37 (coil) proximal end 38 (coil) tip

Claims (5)

A core wire extending from the proximal end to the distal end;
A sleeve surrounding the tip of the core wire,
Sleeve, radiopaque material, and a radiation opaque layer comprising a polyimide resin, made of polyimide resin for covering the outer surface of the radiation opaque layer, and possess an outer layer forming the outer surface of the sleeve, the core wire Guide wire characterized in that it can be rotated around . A core wire extending from the proximal end to the distal end;
A sleeve surrounding the tip of the core wire,
The sleeve is made of a radiopaque material, a radiopaque layer containing a polyimide resin, and a polyimide resin that covers the outer surface of the radiopaque layer and contains a radiopaque material having a lower concentration than the radiopaque layer. of which possess an outer layer forming the outer surface, the guide wire, characterized in that it is rotatable about the core wire. The guidewire of claim 1 or claim 2 on the outer surface of the sleeve, characterized in that coated with lubricious coating layer. The guide wire according to claim 3 , wherein the coating layer is made of polyethylene oxide. It is arranged on the tip side from the sleeve and has a coil attached so as to surround the core wire,
The guide wire according to any one of claims 1 to 4 , wherein the coil includes a proximal end portion wound densely and a distal end portion wound more coarsely than the proximal end portion.

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