JP2004229947A - Guidewire - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a guidewire having a marker, which is scarcely faded, with desired shape and dimension at a desired position and providing the further clear marker. <P>SOLUTION: This guide wire comprises a linear core material 2, a first resin layer 31 containing carbon fine particles and a second resin layer 32 positioned in its tip side. The position of the guide wire 1 can be endoscopically observed by the spiral visual recognition marker 5 provided on the surface 30 of the first resin layer 31. Hydrophilic coating covering the surface of the first resin layer 31 and the second resin layer 32 is applied thereon. <P>COPYRIGHT: (C)2004,JPO&NCIPI

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a guide wire, for example, to a guide wire (transendoscopic guide wire) inserted into a living body via an endoscope.
[0002]
[Prior art]
When observing or treating a body lumen using an endoscope, a guide wire is used to guide the endoscope or a catheter inserted into the lumen of the endoscope to a predetermined position in the body lumen or the like. Can be
[0003]
When the guide wire is inserted, if the guide wire is monochromatic, the movement cannot be recognized even if the guide wire moves in the axial direction. Therefore, it is preferable that a mark indicating a position or the like is provided on the surface of the guide wire. For this reason, conventionally, a method of providing various marks on a guide wire has been proposed.
[0004]
For example, a method is known in which a hollow tube made of polytetrafluoroethylene or the like and having a plurality of colored striped patterns is thermally shrunk and wrapped over a core material of a guide wire to attach the hollow tube. 1).
[0005]
However, in this method, since the mark is provided at the same time as the formation of the guide wire, it is difficult to provide the mark at a desired position. In addition, there is a restriction that the shape and width of the mark become uniform throughout.
[0006]
Further, a method of forming a mark by printing is known (for example, see Patent Document 2).
[0007]
However, in the printing method, since the ink does not have solvent resistance, it is difficult to apply a lubricating coat such as a hydrophilic polymer on the surface of the guide wire after forming the mark, and it is difficult to mark on a curved surface. There are drawbacks such as the need for time to dry the ink and the possibility that the ink may peel off during use and flow into the living body.
[0008]
As a method for solving the drawbacks of the above printing method, there is a method of providing a transparent fluororesin coating layer after printing a mark. (For example, see Patent Document 3)
[0009]
However, the manufacturing process is complicated, for example, an ink drying step and a coating layer forming step are required, and there are design restrictions that only a transparent resin can be used for the coating layer.
[0010]
Further, a method is known in which a portion of a steel catheter guide wire (guide wire) where a color mark is formed is heated at a temperature at which a temper color (tempered color) appears (for example, see Patent Document 4).
[0011]
However, this method can only be used with steel catheter guide wires. Further, a superelastic alloy (Ni-Ti alloy) generally used as a core material of a guide wire is apt to change its physical properties by heat treatment such as heating, and thus such a method is not suitable. Further, Patent Document 4 discloses a method of forming a mark by stamping or laser beam irradiation. However, the former method has a disadvantage that the formed mark portion is raised, and the latter method has a disadvantage that the formed mark portion is depressed.
[0012]
Furthermore, a guide wire covered with a polymer material containing a laser colorant containing mica as a component has been proposed (see Patent Document 5).
[0013]
Since such a guidewire has, for example, a white marker on a black surface, the movement of the guidewire can be sufficiently recognized even when used under an endoscope. However, there is a case where the light of the endoscope is reflected on the wet surface of the guide wire, so that a clearer marker is required.
[0014]
[Patent Document 1]
Japanese Patent Publication No. 9-501593
[Patent Document 2]
Japanese Utility Model Laid-Open No. 4-108556
[Patent Document 3]
Japanese Utility Model Publication No. 4-63054
[Patent Document 4]
Japanese Patent Publication No. 3-25945
[Patent Document 5]
JP 2002-136600 A
[0015]
[Problems to be solved by the invention]
An object of the present invention is to provide a guide wire having a marker having a desired shape or size that is hardly lost at a desired position and capable of obtaining a clearer marker.
[0016]
[Means for Solving the Problems]
Such an object is to provide a linear core material, a coating layer covering at least a part of the core material and containing carbon-based fine particles, a visual marker provided on the surface of the coating layer, the coating layer and / or This is achieved by a guidewire comprising a lubricious coating covering at least a portion of the surface of the core.
Further, the carbon-based fine particles are preferably carbon black and / or graphite. Further, it is preferable that a contrast portion having a higher contrast function than the resin layer is provided at a tip portion of the core material. A tip-side resin layer located on the tip side of the resin layer, an overlap portion in which a tip portion of the resin layer overlaps a base end portion of the tip-side resin layer, and at least a part of the overlap portion is formed. Preferably, it is located on the tapered portion. Further, it is preferable that at least a part thereof has an inner resin layer located between the resin layer and the core material.
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, a guide wire of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.
[0017]
1 and 2 are a longitudinal sectional view and a side view schematically showing a first embodiment of the guide wire of the present invention. For convenience of description, the right side in FIGS. 1 and 2 is referred to as a “proximal end”, and the left side is referred to as a “distal end”.
[0018]
As shown in FIG. 1, the guide wire 1 of the present embodiment has a linear core material 2 and a coating layer 3 that covers the outer periphery of the core material 2.
[0019]
The core 2 extends over substantially the entire length of the guidewire 1. The core member 2 includes a main body 22 corresponding to the main body of the guidewire 1, a tapered portion 24 located on the distal end side, and a small diameter portion 26 located on the distal end side. The outer diameter of the main body portion 22 is substantially constant, the outer diameter of the tapered portion 24 is gradually reduced toward the distal end (tapered), and the outer diameter of the small diameter portion 26 is substantially constant. It is constant.
[0020]
By providing the tapered portion 24 in the core material 2, the flexibility of the core material 2 gradually (continuously) from the vicinity of the boundary (the tapered portion base end 241) between the main body portion 22 and the tapered portion 24 toward the distal direction. As a result, the flexibility of the guidewire 1 is increased, so that the operability and safety at the time of insertion into a living body are improved. In addition, the provision of the small-diameter portion 26 on the distal end side of the tapered portion 24 makes it possible to lengthen the most flexible portion at the forefront, thereby producing an effect that the foremost portion becomes more flexible. Outer diameter of main body 22 of core material 2 (= outer diameter of tapered portion base end 241) D ₁ Is not particularly limited, but is preferably about 0.3 to 1.0 mm, and more preferably about 0.4 to 0.7 mm.
Outer diameter of small diameter portion 26 of core material 2 (= outer diameter of tapered portion tip 242) D ₂ Is not particularly limited, but is preferably about 0.05 to 0.3 mm, and more preferably about 0.1 to 0.2 mm. Note that the outer diameter of the small diameter portion 26 is not limited to the case where the outer diameter is constant, and may be such that the outer diameter gradually decreases toward the tip.
The length of the tapered portion 24 varies depending on the use and type of the guidewire 1 and is not particularly limited, but can be preferably about 10 to 300 mm, more preferably about 30 to 250 mm.
The length of the small diameter portion 26 is not particularly limited, but is preferably about 0 to 100 mm, more preferably about 10 to 50 mm.
Note that the small diameter portion 26 may be replaced with a small piece portion such as a flat plate shape (a band shape) or a prism shape.
Further, an enlarged diameter portion may be provided at the tip of the small diameter portion 26. It is preferable that the diameter of the enlarged diameter portion is partially increased to partially round the core material 2 itself. Further, an X-ray opaque ring or coil may be inserted (attached) to the distal end of the small-diameter portion 26 to form an enlarged-diameter portion. In addition, by having the plate-shaped small piece portion, the leading end portion becomes more flexible.
[0021]
Examples of the constituent material of the core material 2 include superelastic alloys such as Ni-Ti alloys and Cu-Zn alloys, and stainless steels, and cobalt-based alloys such as Co-Ni-Cr-Fe alloys. (Cobalt-based alloys) and various kinds of metal materials, and resin materials having relatively high rigidity.
[0022]
In the present invention, two (or two or more) types of cores (wires) made of different materials can be connected to form the core 2. In this case, the connecting portion (joining end face) of the two cores may be on the tapered portion 24, on the distal side of the tapered portion 24 or on the proximal side of the tapered portion 24, but on the tapered portion 24 or on the tapered portion 24. It is preferably more proximal. Further, in order to further increase the coupling force of the connecting portion, a connecting portion having a configuration in which deformed sections are fitted to each other can be used. The connecting method (joining method) of the two core materials is not particularly limited, and examples thereof include a welding method such as butt resistance welding.
[0023]
When two kinds of cores (wires) are connected to form the core 2, it is preferable that the core on the base end side has higher rigidity than the core on the distal end side. Thereby, the guide wire 1 can obtain excellent flexibility particularly in the vicinity of the connecting portion between the two core materials, and the base end portion is rich in rigidity (bending rigidity, torsional rigidity). In addition, the guide wire 1 can obtain excellent pushability and torque transmission and secure good operability, and at the distal end side, can have good flexibility and restorability. An example of such a core material 2 is one in which the base material on the base end side is made of stainless steel or a cobalt-based alloy, and the core material on the tip end side is made of a superelastic alloy.
[0024]
Such a core material 2 is covered with a coating layer (resin layer) 3. The resin constituting the coating layer 3 is not particularly limited, and examples thereof include a polyolefin such as polyurethane, polyethylene, polypropylene, and ethylene-propylene copolymer, a fluororesin such as polytetrafluoroethylene, a polyester such as polyethylene terephthalate, and a polychlorinated resin. Vinyl, polyamide, polyimide, ethylene-vinyl acetate copolymer, ethylene-ethylene acrylate copolymer, ABS resin, AS resin, butadiene-styrene copolymer, polyisoprene, polybutadiene, and the like. Alternatively, two or more kinds can be used in combination.
[0025]
The coating layer 3 contains carbon-based fine particles. Examples of the carbon-based fine particles include carbon black and graphite. By mixing (dispersing) the carbon-based fine particles in the material constituting the coating layer 3 and causing the carbon-based fine particles to exist in the coating layer 3, for example, when the coating layer 3 is irradiated with laser light, the carbon of the carbon-based fine particles burns and CO ₂ And is released as a gas. Therefore, a portion where the carbon fine particles do not exist is generated on the surface irradiated with the laser beam. In general, carbon-based fine particles such as carbon black and graphite are themselves black, and the coating layer 3 in which the carbon-based fine particles are mixed also becomes black or dark. The color (black) of the carbon fine particles is bleached and becomes the original color of the material of the coating layer 3. Therefore, the visual marker 5 of a desired color can be formed by the resin material of the coating layer 3 or the pigment added thereto. In particular, a chromatic (chromatic) visual marker 5 such as red, yellow, blue, or green can be formed on a black ground. Note that the carbon fine particles include all carbon-based substances that can be applied to the material of the guide wire by changing the color of the surface by applying energy such as laser to the surface of the coating layer containing the carbon fine particles.
[0026]
For example, the core material 2 may be a guide wire coated with a resin containing carbon-based particles, and the surface of the resin may not have the carbon-based particles or may have a portion less than other portions. No. A portion smaller than this other portion becomes the visual recognition marker 5 and can be clearly distinguished from the color of the other portion.
[0027]
As described above, since the carbon-based fine particles are present on at least the surface of the resin layer 3 covering the outer periphery of the core material 2, a white color and a colored portion (the visible marker 5) are irradiated by energy irradiation such as laser beam irradiation. ) Can be formed.
[0028]
In addition, when a coloring agent is used together with the carbon-based fine particles, sufficient coloring is exhibited by adding a small amount to the resin material constituting the coating layer 3.
[0029]
The content of the carbon-based fine particles in the coating layer 3 depends on the type thereof, the composition and the properties of the coating material, but in order to obtain a satisfactory visual marker without excess or deficiency, the content of the carbon-based particles is 0.05 to 0 with respect to the coating layer 3. It is preferably about 9.9% by weight, more preferably about 0.08 to 0.5% by weight. If the content is less than 0.05% by weight, the response of the laser light is deteriorated, and the color development may be weak. If the content is more than 0.9% by weight, there is a possibility that an excessive reaction to the laser light may cause burns in the coloration portion. Get higher. In the present invention, the color tone and the color intensity after the irradiation of the laser beam can be adjusted by the content of the carbon-based fine particles.
[0030]
A visual marker 5 is provided at a predetermined portion of the outer surface 30 of the coating layer 3. As shown in FIG. 2, the visual recognition marker 5 is provided on the distal end side of the guide wire 1, that is, near the distal end of the coating layer 3. A method for forming the visual recognition marker 5 will be described later in detail.
[0031]
The shape and size of the visual recognition marker 5 are not particularly limited, but are spirally provided in the illustrated configuration. In the case of the spiral (or annular) visual recognition marker 5, for example, it is provided in a range of 3 to 50 cm in the longitudinal direction of the guide wire 1 with a width of 1 to 10 mm and a pitch (interval) of 1 to 10 mm.
[0032]
The shape of the visual recognition marker 5 is not limited to a spiral shape or an annular shape. May be. Furthermore, the position may be confirmed by combining two or more types of different patterns (patterns) such as providing an annular visual marker following the spiral.
[0033]
Further, such a visual marker 5 may be provided not only when it is provided on a part of the coating layer 3 in the longitudinal direction but also over the entire length of the coating layer 3.
[0034]
In order to recognize the movement of the guidewire 1 through the endoscope, the color of the visual marker 5 is also one of the important factors, and this should be considered in combination with the color of the coating layer 3. As an example, when the visual marker 5 is white or yellow and the resin layer 3 is black, the difference in lightness between the two colors is large (high contrast), whereby the visibility of the visual marker 5 is high, which is preferable.
[0035]
Next, a method of forming the visual recognition marker 5 will be described.
The visual recognition marker 5 applies energy to a predetermined portion of the outer surface 30 of the coating layer 3 containing the carbon-based fine particles, and the energy burns carbon to generate CO2. ₂ Are formed as gas is released as a gas and a portion where the carbon fine particles do not exist is formed on the surface irradiated with the laser beam. As a means for applying energy, laser light irradiation is particularly preferable, and other methods include, for example, a method in which ordinary light (such as visible light) is condensed by a lens and irradiated. Hereinafter, irradiation of laser light will be described as an example of a means for applying energy.
[0036]
The laser light to be irradiated is, for example, near-infrared laser light such as Nd-YAG laser light, CO2 ₂ Far-infrared laser light such as laser light, and excimer laser light.
[0037]
The Nd-YAG laser light is near-infrared light having a wavelength of 1.06 μm, and can be obtained by irradiating a YAG (yttrium aluminum garnet) lot with arc lamp light.
[0038]
CO ₂ The laser light is far-infrared light having a wavelength of 10.6 μm, ₂ It can be obtained by applying high frequency (RF) and high voltage (TEA) to the tube in which the mixed gas is sealed to excite the tube.
[0039]
For example, in the case of Nd-YAG laser light, the irradiation amount of the laser light is preferably about 1 to 4 kW as the energy output of the irradiation source.
[0040]
The laser irradiation apparatus is not particularly limited, and any known laser irradiation apparatus may be used. For example, a scanning type, a dot type, or a mask type may be used. The scanning type laser irradiating apparatus is of a type in which laser light emitted from a transmitter is scanned in two XY directions in XY directions, then condensed by a lens, and emitted. Further, the dot type laser irradiating apparatus is of a type in which laser light is tuned to a polygon mirror rotating at high speed and emitted. The mask type laser is of a type in which laser light is emitted through a mask having a predetermined pattern cut out and a condenser lens.
[0041]
In the guide wire 1 of the present invention, heat is generated by applying energy to a specific portion of the outer surface 30 of the coating layer 3 containing carbon-based fine particles by means for applying energy as described above (for example, irradiation of laser light). Let it. Then, the carbon-based fine particles on the surface are gasified by the heat and decolorized to form the visible marker 5.
[0042]
In the present embodiment, as shown in FIG. 1, the coating layer 3 includes a first resin layer 31 and a second resin layer 32 located on the tip side of the first resin layer 31.
The first resin layer 31 contains the above-mentioned carbon-based fine particles, and as shown in FIG. 2, the visual markers 5 are provided in a spiral shape. The second resin layer 32 does not contain carbon-based fine particles, and the visual marker 5 is not provided. However, the second resin layer 32 also contains carbon-based fine particles, and the visual marker 5 may be provided up to the tip of the guide wire 1 (or in the vicinity thereof).
[0043]
Further, it is preferable that a contrast agent is added to the first resin layer 31 and the second resin layer 32. For the second resin layer 32, it is preferable to use a contrast agent of a metal powder such as tungsten. Further, it is preferable to use a metal oxide powder for the first resin layer 31 as described later. In addition, the contrast of the second resin layer 32 is made higher than that of the first resin layer 31 by making the amount of the contrast agent added to the second resin layer 32 larger than that of the first resin layer 31 (that is, the contrast is increased). Part is formed).
[0044]
Examples of the contrast agent made of metal oxide powder include those having a contrast function for X-rays. Examples of such a material include X-ray opaque materials such as barium sulfate, barium carbonate, and bismuth oxide. Of these, barium sulfate and bismuth oxide are preferable. One of such contrast agents may be used alone, or two or more thereof may be used in combination (particularly, mixed).
[0045]
As described above, the visible marker 5 is formed by irradiating the surface of the coating layer 3 with a laser beam. At this time, the contrast agent made of the metal oxide powder has almost no deterioration because it is already an oxide. There is no spark or heat generation due to laser light irradiation. Therefore, the degree of freedom in selecting the type of laser light and the irradiation intensity (energy) is wide, and it is possible to make the coloring of the coloring agent sharper (for example, to make the coloring so as to increase the color contrast), This contributes to improving the visibility of the visual recognition marker 5.
[0046]
The average particle size of such a metal oxide powder contrast agent is not particularly limited, but is preferably about 1 to 10 μm, and preferably about 2 to 4 μm in consideration of dispersibility in the resin layer 3. More preferred.
[0047]
The content of the metal oxide powder contrast agent in the coating layer 3 (the first resin layer 31) depends on the type and the like. It is preferably about 30 to 80% by weight, and more preferably about 50 to 80% by weight. If the amount is less than 30% by weight, the contrast function may be insufficient. If the amount is more than 80% by weight, kneading to the resin becomes difficult. In the present invention, the contrast function (contrast property) can be adjusted by the type and content of such a contrast agent.
[0048]
It is preferable that the metal oxide powder contrast agent in the coating layer 3 (the first resin layer 31) is uniformly dispersed, but, for example, is unevenly distributed on the outer surface side or the inner side (the core material 2 side) of the coating layer 3. May be. Further, the content of the metal oxide powder contrast agent in the coating layer 3 may be substantially equal or different along the longitudinal direction of the guide wire 1.
[0049]
The first resin layer 31 covers the main body 22 of the core member 2 and partially covers the tapered portion 24, and the second resin layer 32 covers the tapered portion 24 and the small diameter portion 26. In this case, the leading end of the first resin layer 31 and the base end of the second resin layer 32 partially overlap each other, and the overlapping portion (from the base end of the second resin layer 32 to the leading end of the first resin layer 31). At least a part (preferably half or more) of the portion 33 is located on the tapered portion 24. With such a configuration, the first resin layer 31 having a different flexibility moves from the first resin layer 31 to the second resin layer 32 in the tapered portion 24 in which the outer diameter gradually decreases toward the distal end. The characteristic of gradually softening can be exhibited as it is.
[0050]
In the embodiment shown in FIG. 1, the proximal end of the overlapping portion 33 is located near the tapered portion proximal end 241 of the tapered portion 24, and the distal end of the overlapping portion 33 is located in the middle of the tapered portion 24. However, the present invention is not limited to this. For example, (1) a configuration in which the base end and the distal end of the overlapping portion 33 are respectively located in the middle of the tapered portion 24; A configuration in which the base end is located closer to the base end side than the base end 241 of the tapered portion, and the tip end of the overlapping portion 33 is located in the middle of the tapered portion 24 may be adopted. Further, the tip of the overlapping portion 33 may be located near the tapered portion tip 242 or on the tip side thereof.
[0051]
In the overlapping portion 33, the second resin layer 32 is laminated so as to cover the outside (outer periphery) of the first resin layer 31. The thickness of the first resin layer 31 in the overlapping portion 33 gradually decreases toward the tip, and the thickness of the second resin layer 32 in the overlapping portion 33 gradually increases toward the tip. With such a configuration, the following effects are exhibited.
[0052]
In the overlapping portion 33, the thickness of the first resin layer 31 made of a relatively hard material gradually decreases toward the tip, and a material that is more flexible than the material of the first resin layer 31 (a relatively soft material). The thickness of the second resin layer 32 made of the material) gradually increases toward the tip and overlaps with each other, so that the flexibility of the coating layer 3 itself (the layered portion of both layers) increases toward the tip. It is gradually increasing. Here, as described above, the flexibility of the core material 2 gradually increases from the vicinity of the tapered portion base end 241 toward the distal end due to the presence of the tapered portion 24. By gradually increasing the flexibility of the coating layer 3 itself in the overlapping portion 33, a synergistic effect of the two is exerted, and the flexibility of the guide wire 1 gradually changes particularly in the tapered portion 24 and before and after the tapered portion 24 ( (Increase toward the tip), and can bend more flexibly. As a result, operability and safety when the guidewire 1 is inserted into a living body via a catheter or the like are remarkably improved.
[0053]
In the outer surface 30 of the coating layer 3, the boundary between the first resin layer 31 and the second resin layer 32 preferably forms a continuous surface having substantially no step. Thereby, operability and safety when the guide wire 1 is inserted into a living body via a catheter or the like are remarkably improved.
[0054]
The first resin layer 31 and the second resin layer 32 in the overlapping portion 33 are joined by fusion, adhesion, or the like. In this case, the coupling surface between the first resin layer 31 and the second resin layer 32 is not limited to the case where the boundary surface is clear, but the coupling surface between the first resin layer 31 and the second resin layer 32 (boundary surface). In the vicinity, the constituent material of the first resin layer 31 and the constituent material of the second resin layer 32 may be mixed.
[0055]
In such an overlapping portion 33, the thickness of the first resin layer 31 gradually decreases toward the tip, and the thickness of the second resin layer 32 gradually increases toward the tip, and these portions are overlapped. Therefore, in addition to the effect that the characteristics such as the flexibility in the longitudinal direction of the guide wire change more slowly and can flexibly bend, the area of the coupling surface between the first resin layer 31 and the second resin layer 32 is increased to some extent. As a result, the adhesion between the two layers is improved, and even if bending or twisting is repeatedly applied, the first resin layer 31 and the second resin layer 32 are prevented from peeling off. This effect is not limited to the case where the first resin layer 31 and the second resin layer 32 are originally made of the same kind of resin material having good adhesion, but also the case where the first resin layer 31 and the second resin layer 32 are made of different kinds of resin materials. It is also exerted when there is a difference in the composition (quality), addition amount, etc. of the additives (including the carbon-based fine particles, the contrast agent, the plasticizer, etc.) therein.
[0056]
As described above, the first resin layer 31 and the second resin layer 32 made of a material that is more flexible than the constituent material of the first resin layer 31 (a relatively soft material) have been described. However, when there is no large difference in the flexibility of the resin material between the first resin layer 31 and the second resin layer 32, for example, the additives (including the color former and the contrast agent) mixed in the resin layer are used. Even when there is a quantitative and qualitative difference in (1), the area of the bonding surface between the first resin layer 31 and the second resin layer 32 can be secured to some extent, so that the adhesion between the two layers is improved, Even when bending and twisting are repeatedly applied, the first resin layer 31 and the second resin layer 32 are prevented from being separated from each other.
[0057]
In the present embodiment, the outer diameter of the guidewire 1, that is, the outer diameter of the coating layer 3 is substantially constant over the entire length of the guidewire 1, but changes in the middle (particularly, gradually decreases toward the distal end). There may be. For example, the outer diameter of the guidewire 1 gradually decreases from the middle of the main body portion 22 toward the distal end, the outer diameter of the guide wire 1 gradually decreases from the vicinity of the tapered portion base end 241 to the distal end, or the middle diameter of the tapered portion 24 toward the distal end. It may be configured to decrease gradually.
[0058]
As the resin constituting the first resin layer 31 and the second resin layer 32, the above-described resins can be used, and one or more of them can be used in combination.
[0059]
When the same resin material (for example, polyurethane) is used for both the first resin layer 31 and the second resin layer 32, for example, by changing the average molecular weight (degree of polymerization), changing the addition amount of the plasticizer, etc. Can have a difference in flexibility. For example, the average molecular weight of the material of the first resin layer 31 may be substantially larger than the average molecular weight of the material of the second resin layer 32.
[0060]
In this embodiment, the guide wire 1 is formed by using a combination of the first resin layer 31 made of a relatively hard material and the second resin layer 32 made of a relatively soft material as the coating layer 3. The flexibility of the distal end portion can be ensured, and the operability and safety at the time of insertion into a living body are improved, while the first resin layer 31 occupying most of the outer surface 30 of the guide wire 1 is relatively hard. By using a resin material having high (rigidity), it is possible to reduce the sliding resistance with respect to the inner surface of the catheter lumen for inserting the guide wire 1 or the lumen of the endoscope, and the insertion and removal of the guide wire 1. Operability at the time of operation and positioning can be improved.
[0061]
In order to improve the safety of the guidewire 1, the tip of the second resin layer 32 has a rounded shape. Similarly, the base end of the first resin layer 31 also has a rounded shape.
[0062]
The use of the guidewire 1 of the present invention is not particularly limited, but it is used through an endoscope, more specifically, guides a catheter inserted into a lumen of the endoscope to a target site such as a biological lumen. The present invention can be applied to a guide wire (transendoscopic guide wire) that is used to perform the operation.
[0063]
Further, as another method for providing contrast at the distal end of the guide wire 1 (or imparting higher contrast), a coil having contrast is provided in the second resin layer 32 (the distal end of the guide wire 1). Shaped or annular (including a thin film) metal material can be separately embedded, and in this case, the same effect can be obtained.
[0064]
At least a part of the surface of the coating layer 3 is covered with a lubricating coating. In the present embodiment, a hydrophilic lubricating coating is applied to the outer surface on the distal end side from the position corresponding to the longitudinal middle point of the tapered portion 24 of the core material 2, and the position corresponding to the middle point is provided. A hydrophobic lubricating coating is applied to the outer surface on the base end side.
[0065]
By applying the hydrophilic lubricating coating, the hydrophilic lubricating coating wets in a living body and improves slipping, so that insertion can be performed more smoothly and safely.
[0066]
Further, by applying the hydrophobic lubricous coating, the sliding resistance of the guidewire 1 is reduced with respect to the lumen through which the guidewire 1 is inserted, for example, the lumen of the catheter or the lumen of the endoscope. Operability such as insertion and withdrawal of the device is improved.
[0067]
In this embodiment, the boundary between the hydrophilic lubricating coating and the hydrophobic lubricating coating is a position corresponding to the middle point of the tapered portion 24. However, the present invention is not limited to this. The position may correspond to an arbitrary position between and the tip, or may be another position.
[0068]
The boundary between the hydrophilic lubricious coating (distal side) and the hydrophobic lubricious coating (proximal side) is preferably located at a position of 30 to 500 mm from the distal end of the guidewire 1. When the boundary is in this range, the effect of the hydrophilic lubricious coating and the effect of the hydrophobic lubricious coating can be exhibited in a well-balanced manner.
[0069]
In the present invention, only one of the hydrophilic lubricating coating and the hydrophobic lubricating coating may be applied. Moreover, their formation positions are not particularly limited.
[0070]
Examples of the coating material for the hydrophilic lubricating coating include cellulose-based, polyethylene oxide-based, maleic anhydride-based, and acrylamide-based polymer substances.
[0071]
Examples of the coating material for the hydrophobic lubricating coating include silicone and fluororesin.
[0072]
In the guidewire 1 of the present invention, the portion to be imaged (a contrast agent or a metal material added to the first resin layer 31 or the second resin layer 32) is not limited to a material that can be imaged under X-ray fluoroscopy. Instead, the position may be confirmed by MRI.
[0073]
FIG. 3 is a longitudinal sectional view schematically showing a second embodiment of the guidewire of the present invention. Hereinafter, the second embodiment will be described, but the description of the same items as in the first embodiment will be omitted, and the description will focus on the differences.
[0074]
In the guidewire 1 according to the second embodiment shown in FIG. 3, the coating layer 3 covers a part of the main body 22 beyond the small diameter portion 26, the tapered portion 24, and the tapered portion base end 241 of the core 2. . The coating layer 3 contains the carbon-based particles, and has a visual marker on the surface of the coating layer 3.
[0075]
At least a part of the surface of the coating layer 3 and / or the core material 2 is covered with a lubricating coating. In this embodiment, the surface of the coating layer 3 is provided with a lubricating coating. In this embodiment, it is covered with a hydrophilic lubricating coating.
[0076]
The core material 2 on the base end side from the base end portion of the coating layer 3 is covered with a lubricating coating. In the present embodiment, it is covered with a hydrophobic lubricating coating 4 such as a fluororesin. Since this coating is performed by coating a fluororesin by baking or the like, an extremely thin coating of about 0.01 mm can be realized.
[0077]
FIG. 4 is a longitudinal sectional view schematically showing a third embodiment of the guide wire of the present invention. Hereinafter, the third embodiment will be described, but the description of the same matters as those of the first and second embodiments will be omitted, and the description will be focused on the differences.
[0078]
In the guide wire 1 of the third embodiment, the coating layer 3 covers almost the entire core material 2. The coating layer 3 contains the carbon-based particles, and the surface of the coating layer 3 has the above-mentioned visual marker.
[0079]
The surface of the coating layer 3 is covered with a lubricating coating. In the present embodiment, a hydrophilic lubricating coating is applied to the outer surface on the more distal end side corresponding to the middle point in the longitudinal direction of the tapered portion 24 of the core material 2, and from the position corresponding to the middle point. The outer surface on the proximal side is provided with a hydrophobic lubricious coating. The entire surface of the coating layer 3 may be covered with a hydrophilic or hydrophobic lubricating coating. The small diameter portion 26 of the core 2 is provided with an X-ray contrast coil.
[0080]
FIG. 5 is a side view schematically showing a fourth embodiment of the guide wire of the present invention. Hereinafter, the fourth embodiment will be described, but the description of the same items as those of the above-described first to third embodiments will be omitted, and differences will be mainly described.
[0081]
In the guide wire 1 according to the fourth embodiment, the distal end is curved, and the surface 30 of the coating layer 3 has a visual marker 5 as shown in FIG. The coating layer 3 covers the entire core material. The coating layer 3 contains the carbon-based fine particles. At least one visual marker 5 is provided on the proximal end side, and it is possible to visually confirm that the guide wire 1 is securely fixed and does not move when the catheter is replaced. In the embodiment shown in FIG. 5, markers 5 are provided at positions 80 cm, 100 cm, 110 cm, and 120 cm from the distal end of a guide wire having a total length of 150 cm. The markers 5 are ring-shaped, and the thickness and the number of the markers 5 change according to the respective positions, so that the distance from the tip can be easily grasped. The surfaces of the coating layer 3 and the visual marker 5 are covered with the aforementioned hydrophilic lubricating coating.
[0082]
In the present embodiment, the coating layer contains carbon-based particles, but any material can be used as long as it can form a visual marker. Furthermore, when a guide wire is used while observing an affected part, such as inserting a rigid endoscope to treat ureteral stones, it is preferable that such a guide wire be provided with a visual marker 5 at the distal end.
[0083]
FIG. 6 is a sectional view schematically showing a fifth embodiment of the guide wire of the present invention. Hereinafter, the fifth embodiment will be described, but the description of the same items as those in the above-described first to fourth embodiments will be omitted, and differences will be mainly described.
[0084]
The guidewire 1 according to the fifth embodiment has a first end 11 and a second end 12. Both ends can be used as the tip. Furthermore, both ends are curved. The core material 2 includes the main body 22, a first taper 243, and a second taper 244. Further, a first small diameter portion 261 and a second small diameter portion 262 are provided at the ends of the first taper portion 243 and the second taper 244, respectively. The first small diameter portion 261 and the second small diameter portion 262 have curved portions. Since the curved portion of the first small-diameter portion 261 is formed of a material exhibiting pseudoelasticity, the first end 11 easily passes through meandering blood vessels, and has excellent selectivity of blood vessel bifurcation. Since the curved portion of the second small-diameter portion 262 is formed of a material that is more easily plastically deformed than the curved portion of the first small-diameter portion 261, the second end 12 is desired by the operator according to the bifurcation of the blood vessel. Can be shaped (reshaped). Furthermore, when inserting into another blood vessel, it can be inserted using the opposite first end.
[0085]
The core material 2 is made of a NiTi-based alloy. However, in various embodiments described later, the present invention is not limited thereto, and stainless steel, a cobalt-based alloy, or the like can be appropriately used according to the embodiment. The curved portion of the first small diameter portion 261, the first tapered portion 243, and the main body 22 exhibit pseudoelasticity. The curved portion of the second small-diameter portion 262, which is formed of a material that is more easily plastically deformed than the curved portion of the first small-diameter portion 261, heat-treats a NiTi-based alloy exhibiting pseudoelasticity to substantially eliminate pseudoelasticity. ing. As a means for eliminating pseudoelasticity, there is also a method of performing cold working. For example, compression of a small diameter portion into a flat plate shape corresponds to this.
[0086]
A visual marker 5 is provided on the surface 30 of the second end 12 as shown in FIG. Although the shape of the second end 12 and the first end 11 is substantially the same, the characteristics thereof are different as described above, and the second end 12 and the first end 11 are formed so that the end on which reshaping is possible can be easily distinguished. The visual recognition marker 5 is provided on the end 12 side. The visual marker 5 has a clear contrast depending on the presence or absence of the carbon-based fine particles contained in the coating layer 3. The coating layer 3 and the surface 30 of the visual marker 5 are covered with the above-mentioned hydrophilic lubricating coating.
[0087]
In addition, although this embodiment demonstrated based on FIG. 7 which provides the visual recognition marker 5 on the surface 30 of the 2nd end part 12, it is not restricted to this, and may be provided in the position away from the 2nd end part 12, Further, it may be provided on the surface 30 on the first end 11 side. Further, markers of different colors and shapes may be provided at both ends. In short, it suffices if at least one end of the guide wire is provided with a visible marker.
[0088]
Further, in addition to the above-described embodiments of both curved end portions, there may be mentioned an embodiment in which an end portion capable of reshaping is straight and the other end is curved. If the straight end is reshaped and inserted, and once withdrawn and on standby, it will be difficult to immediately identify when reinserting. Therefore, if a marker is provided at the end where reshaping is possible, the marker can be easily identified and unnecessary labor is eliminated.
In addition, there is also a mode of an end portion having a different shape from the ease of reshaping. For example, one end has a smaller curvature radius of curvature than the other end, and one of them is a guide wire capable of reshaping, and a visual marker for distinguishing that reshaping is performed is attached to at least one of the guide wires.
[0089]
In addition to the aspect in which the difference in ease of reshaping at both ends is distinguished by the visual marker, at least one end of the first end 11 and the second end 12 having different flexibility is visually recognized at one end side. There is also an embodiment of a guide wire having the marker 5. That is, the first end portion 11 and the second end portion are changed depending on a difference in length between the first tapered portion 243 and the second tapered portion 244, a diameter and a length of the first small diameter portion 261 and the second small diameter portion 262, or a combination thereof. The flexibility of the part 12 can be changed. Not only when the first end 11 and the second end 12 have the same shape (for example, curved shape), but also when they have different shapes, for example, one end has a visual marker that is more flexible than the other end. If so, it is very easy to tell.
Further, there is an embodiment of a guide wire having a visual recognition marker 5 on at least one end side of the first end portion 11 and the second end portion 12 having different contrast properties. To illustrate, as an aspect, an X-ray contrast member (for example, a coil) is provided on the first end portion 11, and when the X-ray contrast property is higher than that of the second end portion 12, the first end portion is provided. A visual recognition marker is provided on the side of the unit 11. Alternatively, visual markers capable of determining the level of X-ray contrast are provided at both ends. Since X-contrast fine powders such as tungsten are mixed in the coating layers of the first end 11 and the second end 12, both ends of the guide wire are connected to the monitor under X-ray projection. Although the movement can be determined in real time, the end provided with the above-mentioned X-ray contrast member can be identified very clearly at the tip. Therefore, both ends can be used properly depending on the treatment site and the process of diagnosis, and it is possible to easily determine the difference in the X-ray contrast at the separated ends that cannot be visually identified.
As another example having different contrast properties, there is a mode in which one end has X-ray contrast properties and the other end has MRI contrast properties, and a marker for distinguishing between X-ray contrast properties and MRI contrast properties is provided on the surface. .
[0090]
In the guide wire of the present embodiment, the visible marker 5 is formed by irradiating the coating layer 3 containing the carbon-based fine particles with laser light. In the present embodiment, the material and method for forming the visible marker are particularly Not limited to For example, a material that changes color with a laser may be kneaded with the material constituting the coating layer to form the coating layer, or by coating one curved portion with a material having a different color from the other. Alternatively, the marker may be used as a visible marker.
[0091]
As described above, the present embodiment is configured such that both ends can be used and one end is provided with a visible marker on one end and / or the other end of a guide wire having different characteristics from the other end. And With such a configuration, the difference between the characteristics at both ends can be determined at a glance, and unnecessary time is not spent on the operation.
[0092]
As described above, the guidewire of the present invention has been described with respect to each embodiment shown in the drawings. However, the present invention is not limited to these embodiments, and the configuration of each part may be replaced with any configuration that can exhibit the same function. And an arbitrary configuration may be added.
[0093]
In particular, a configuration in which any two or more of the first to fifth embodiments are combined may be employed.
[0094]
【The invention's effect】
As described above, according to the guidewire of the present invention, a marker having a desired shape or size that is not easily lost at a desired position can be obtained.
[Brief description of the drawings]
FIG. 1 is a longitudinal sectional view schematically showing a first embodiment of a guide wire according to the present invention.
FIG. 2 is a side view schematically showing a first embodiment of the guide wire of the present invention.
FIG. 3 is a longitudinal sectional view schematically showing a second embodiment of the guide wire of the present invention.
FIG. 4 is a longitudinal sectional view schematically showing a third embodiment of the guide wire of the present invention.
FIG. 5 is a side view schematically showing a fourth embodiment of the guide wire of the present invention.
FIG. 6 is a longitudinal sectional view schematically showing a fifth embodiment of the guide wire of the present invention.
FIG. 7 is a partial side view schematically showing a fifth embodiment of the guidewire of the present invention.
[Explanation of symbols]
1 Guide wire
2 core material
22 Body
24 Tapered part
241 Base end of taper
242 Tapered tip
26 Small diameter part
3 Coating layer
30 outer surface
31 First resin layer
32 Second resin layer
33 Overlap
5 Visual marker

Claims (1)

A linear core material, a coating layer covering at least a part of the core material and containing carbon-based fine particles, a visual marker provided on a surface of the coating layer, and a surface of the coating layer and / or the core material. A lubricious coating that covers at least a portion of the guidewire.

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