JP2003275323A - Medical long length body - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical long-length body which is clear and excellent in visibility by having a marker (color development part) of a desired shape and size at a desired position and where separation, disappearing, fading, etc., are less likely to occur. <P>SOLUTION: A guide wire (medical long length body) 1 comprises: a linear core material 2; an inner layer 3 covering nearly the whole length of this core material 2; and an outer layer 4 covering nearly the whole length of the inner layer 3. A color developer capable of developing colors by the irradiation of laser beams is added to the inner layer 3. A spiral visible marker, e.g. is formed on the outer surface 30 of the inner layer 3. The outer layer 4 transmits the laser beams and has a transparency of a degree enough to see the visible marker through the outer layer 4. The visible marker is formed by the color development of the color developer by irradiating the outer surface 30 of the inner layer 3 with the laser beams through the outer layer 4. <P>COPYRIGHT: (C)2003,JPO

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical elongated body such as a guide wire or a catheter, and more particularly to a medical elongated body (transendoscope) inserted into a living body via an endoscope. Medical long body for mirror).

[0002]

2. Description of the Related Art In observing or treating a living body lumen using an endoscope, in order to guide an endoscope or a catheter inserted into a lumen of the endoscope to a predetermined position such as the living body lumen. , A guide wire is used.

When inserting the guide wire, if the guide wire is monochromatic, the movement cannot be recognized even if the guide wire is moving in the axial direction. Therefore, it is preferable to provide marks indicating the position and the like on the surface of the guide wire. Therefore, conventionally, a method of providing various marks on the guide wire has been proposed.

For example, in Japanese Patent Publication No. 9-501593, a hollow tube made of polytetrafluoroethylene (Teflon: Teflon is a registered trademark) or the like and having a plurality of colored striped patterns is formed on a core material of a guide wire. Describes a method of attaching by wrapping it with heat shrinking. 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 are uniform on the whole.

Japanese Utility Model Laid-Open No. 4-108556 discloses a method of forming a mark by printing. However, in the method by printing, since the ink does not have solvent resistance, it is difficult to apply a lubrication coat such as a hydrophilic polymer on the surface of the guide wire after the mark is formed,
In addition, there are drawbacks such as difficult marking on a curved surface, a time required for drying the ink, and a possibility that the ink may peel off during use and flow into the living body.

Japanese Utility Model Laid-Open No. 4-63054 discloses a method of eliminating the drawbacks of the above-mentioned printing method by providing a transparent fluororesin coating layer after printing the mark. However, the manufacturing process is complicated, for example, the drying process of the ink and the forming process of the coating layer are indispensable, and there is a design constraint that only a transparent resin can be used for the coating layer.

Furthermore, Japanese Patent Publication No. 3-25945 discloses a method of heating a portion of a steel catheter guide wire (guide wire) where color marks are formed at a temperature at which a temper color (tempering color) appears. Has been done. However, this method can only be used with steel catheter guide wires. Further, the superelastic alloy (Ni-Ti alloy) generally used as the core material of the guide wire is apt to change its physical properties by heat treatment such as heating, and therefore such a method is not suitable. Further, the above publication also describes a method of forming a mark by stamping or laser light irradiation. However, the former method has a drawback that the formed mark portion is raised, and the latter method has a drawback that the formed mark portion is dented.

By the way, when a guide wire or a catheter is inserted to a predetermined position such as a living body lumen through an endoscope,
It may be inserted into a distal lumen outside the range that can be observed with an endoscope. X to diagnose a peripheral lumen
A line contrast agent is injected, and X-rays are irradiated to observe the diameter and shape of the lumen. The guide wire inserted into the lumen uses a material that can be imaged by X-rays as a part of its constituent materials because it is necessary to grasp the position of the tip thereof.

Regarding the guide wire inserted through such an endoscope, it is possible to perform X-ray imaging while having a mark visible under the endoscope.
In addition to the one described in Japanese Patent Laid-Open No. 501593, JP-A-200200
The method described in the above-mentioned mark formation is also used in this publication, for example, as a method of forming a mark, the tube having a pattern is heat-shrinked or a coating material is applied to a core material. It cannot solve the problem in.

[0010]

An object of the present invention is to have a marker (coloring portion) having a desired shape and size at a desired position, which is clearer and has excellent visibility, and can be peeled off or disappeared.
(EN) It is intended to provide a medical elongated body capable of obtaining a marker that is less likely to cause discoloration or the like.

[0011]

Such an object is achieved by the present invention described in (1) to (22) below.

(1) A medical long body having an inner layer and an outer layer, wherein the inner layer is a resin in which a color-developing agent capable of developing a color upon irradiation with a laser beam is added. On the surface, a colored portion is formed by coloring of the coloring agent, and the outer layer has a transparency such that the colored portion is visible through the outer layer. .

(2) A medical long body having an inner layer and an outer layer, wherein the inner layer is a resin in which a color-developing agent capable of developing a color upon irradiation with laser light is added. On the surface, a coloring portion is formed by coloring the coloring agent, and the outer layer is transparent to laser light and has transparency such that the coloring portion is visible through the outer layer. A long body for medical use characterized by.

(3) The medical long body according to the above (1) or (2), which is a guide wire.

(4) The medical long body according to any one of the above (1) to (3), which has a linear core material inside the inner layer.

(5) The medical elongated body according to the above (4), wherein the tip portion of the core material has a tapered shape whose outer diameter gradually decreases toward the tip.

(6) The medical long body according to (4) or (5), wherein the inner layer is installed so as to cover at least a part of the core material.

(7) The medical long body according to the above (1) or (2), which is a catheter.

(8) The medical elongated body according to any one of (1) to (7), wherein the outer layer is installed so as to cover at least the color forming portion of the inner layer.

(9) The above-mentioned (1), which has a portion in which the enlarged-diameter portion of the inner layer is continuously joined to the end portion of the outer layer.
A medical elongated body according to any one of (1) to (8).

(10) The medical long body according to any one of (1) to (9), wherein the resin forming the inner layer and the resin forming the outer layer have different flexibility.

(11) The medical long body according to the above (9), wherein the resin forming the inner layer has higher flexibility than the resin forming the outer layer.

(12) The medical elongated body according to any one of (1) to (11) above, wherein the content of the color former in the inner layer is 0.01 to 10% by weight.

(13) The medical elongated body according to any one of (1) to (12), wherein the coloring portion is a visual marker having a portion formed in a spiral shape or a ring shape.

(14) The above-mentioned (1) to (1), which has an imaging part for confirming the position in the living body near the tip part.
The medical elongated body according to any one of 3).

(15) The medical elongated body according to the above (14), wherein the contrast section has a structure in which a contrast agent is added to a resin.

(16) The contrast agent is composed of at least one of a metal powder and a metal oxide powder.
The long body for medical treatment according to.

(17) The medical elongated body according to (16), wherein the metal powder is tungsten or a noble metal, and the metal oxide powder is at least one of barium sulfate, barium carbonate and bismuth oxide. .

(18) The average particle size of the contrast agent is 1 to
The medical elongated body according to (16) or (17), which has a size of 10 μm.

(19) The medical elongated body according to any one of (15) to (18), wherein the content of the contrast agent in the contrast section is 40 to 80% by weight.

(20) The thickness of the outer layer is 5 to 100 μm.
The medical elongated body according to any one of (1) to (19), wherein m is m.

(21) The medical long body according to any one of the above (1) to (20), which has a hydrophilic lubricating coating and / or a hydrophobic lubricating coating on the outer surface.

(22) A hydrophilic lubricating coating is provided on the distal end side, and a hydrophobic lubricating coating is provided on the proximal end side, and the boundary between them is at the position of 30 to 500 mm from the distal end of the medical long body. The medical long body described.

[0034]

BEST MODE FOR CARRYING OUT THE INVENTION The medical elongated body of the present invention will be described below in detail with reference to the preferred embodiments shown in the accompanying drawings.

1 and 2 are a longitudinal sectional view and a side view, respectively, schematically showing a first embodiment in which the medical elongated body of the present invention is applied to a guide wire. In addition,
For convenience of explanation, the right side in FIGS. 1 and 2 is referred to as a “base end”, and the left side is referred to as a “distal end”.

As shown in FIG. 1, a guide wire (medical elongate body) 1 of this embodiment has a linear core material 2, an inner layer 3 covering at least a part of the core material 2, and the inner layer. And an outer layer 4 that covers at least a part of the outer layer 3. The guide wire 1 is a guide wire for a endoscope, but is not limited to such an application.

The core material 2 extends over substantially the entire length of the guide wire 1. The core material 2 is composed of a main body portion 22 corresponding to the main body portion of the guide wire 1 and a taper portion 24 located on the distal end side thereof. The outer diameter of the main body portion 22 is substantially constant, and the outer diameter of the tapered portion 24 is gradually reduced (tapered) toward the tip end direction.

By providing such a tapered portion 24, the flexibility of the core material 2 gradually increases from the vicinity of the boundary portion between the main body portion 22 and the tapered portion 24 in the distal direction, and as a result, the guide wire 1 Since the flexibility of is increased, the operability and safety when inserting into a living body are improved.

The outer diameter of the main body 22 of the core material 2 is not particularly limited, but is preferably about 0.30 to 0.90 mm, more preferably about 0.40 to 0.60 mm.

The length of the taper portion 24 varies depending on the application and type of the guide wire 1 and is not particularly limited, but can be, for example, about 3 to 30 cm.

As the constituent material of the core material 2, for example, various metal materials such as stainless steel, Ni--Ti alloy, Ni--Al alloy, Cu--Zn alloy and other superelastic alloys, and comparative materials are used. A highly rigid resin material can be used.

The core material 2 extends over the entire length, and the outer circumference thereof is the inner layer 3
Is covered by. The resin constituting the inner layer 3 is not particularly limited, and examples thereof include polyolefin such as polyurethane, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, fluorine-based resin such as polytetrafluoroethylene, polyethylene. Polyester such as terephthalate, polyvinyl chloride, polyamide, polyimide, ethylene-vinyl acetate copolymer,
Ethylene-ethylene acrylate copolymer, ABS resin,
Various thermoplastic elastomers such as AS resin, butadiene-styrene copolymer, polyisoprene, polybutadiene, silicone rubber, polyester-based, polyamide-based, and polyolefin-based are listed, and one or more of them are used in combination. Can be used as, but especially because of its excellent flexibility and adhesion to the core material,
A relatively flexible material such as polyurethane is preferred.

In the constituent material of the inner layer 3, a color former capable of developing a color upon irradiation with laser light is added. This will be described in detail below.

<Coloring Agent> The coloring agent is not particularly limited as long as it produces a color when irradiated with a laser beam. For example, mica, titanium oxide, inorganic materials such as these compounds, and other various organic coloring agents. Is mentioned.

For example, when a coloring agent containing mica is used, it is possible to achieve sufficient coloring by adding a small amount to the resin material forming the inner layer 3 and to substantially avoid the formation of ridges or depressions in the coloring portion. There is. Therefore, since the addition amount is small, it is possible to suppress the change in the color tone of the non-coloring portion.

The term "coloring" in the present invention includes all perceptible color changes such as discoloration, bleaching and fading in addition to color development in a narrow sense.

The coloring agent containing mica is, for example,
Mica belonging to the kurounmo series, mica belonging to the shirounmo series, synthetic mica, and further a composition comprising mica, titanium oxide, silicon oxide and antimony oxide-doped tin oxide, or a composition comprising mica and antimony oxide-doped tin oxide, mica And a composition comprising titanium oxide, a composition comprising mica, titanium oxide and iron oxide, a composition comprising mica and iron oxide. The above color formers may be used alone or in combination (especially mixed) of two or more.

The content of the color-developing agent in the inner layer 3 depends on the type of the color-developing agent, the composition and characteristics of the resin material (particularly the color tone),
In order to produce good coloration without excess or deficiency, it is preferably about 0.01 to 10% by weight with respect to the entire inner layer 3.
It is more preferably about 0.2 to 2% by weight. 0.0
If it is less than 1% by weight, color development may be insufficient. In the present invention, the color tone and color intensity after irradiation with laser light can be adjusted by the content of such a color former.

The color former in the inner layer 3 is preferably uniformly dispersed, but may be unevenly distributed on the outer surface side of the inner layer 3, for example.

If necessary, a contrast agent may be added to the constituent material of the inner layer 3. As will be described later, the contrast agent is preferably composed of at least one of metal powder and metal oxide powder, and more preferably composed of metal oxide powder.

A metallic member (not shown) having a contrast property may be provided at the tip of the core material 2. This metal member is
For example, it has a coil shape or a ring shape, and is made of platinum, gold, tungsten, or the like.

<Coloring Part (Visual Marker)> A visual marker 5 is provided as a coloring part on a predetermined portion of the outer surface 30 of the inner layer 3. As shown in FIG. 2, the visible marker 5 is provided on the distal end side of the guide wire 1, that is, near the distal end portion of the inner layer 3, and can be visually recognized through the outer layer 4. The method of forming the visual marker 5 will be described in detail later.

The shape and size of the visual recognition marker 5 are not particularly limited, but they are spirally provided in the illustrated configuration.
In the case of the spiral (or annular) visual marker 5, for example,
The width is 1 to 10 mm and the pitch (spacing) is 1 to 10 mm, and the guide wire 1 is provided in the longitudinal direction in the range of 3 to 50 cm.

The shape of the visual recognition marker 5 is not limited to a spiral shape or a circular shape, and may be, for example, a straight line, a waveform, a polka dot pattern, a lattice pattern, a mesh pattern, etc., as well as numbers, characters, symbols, scales, etc. Anything will do. Further, the position may be confirmed by combining two or more different patterns (patterns) such as providing a circular visual marker following the spiral shape.

Furthermore, such a visual marker 5 is provided not only when it is provided in a part of the inner layer 3 in the longitudinal direction,
It may be provided over the entire length of the inner layer 3.

In order to recognize the movement of the guide wire 1 through the endoscope, the color of the visual marker 5 is also an important element, but this is combined with the color of the inner layer 3 (the color of the non-coloring part). Should be considered. As an example, when the visual marker 5 is white or yellow and the inner layer 3 is black, the difference in lightness of the two colors is large (high contrast), which makes the visual marker 5 highly visible, which is preferable. Similarly, when the two colors have a complementary color relationship, the visual marker 5
Is highly visible, which is preferable. The color of the visual recognition marker 5 is mainly the type and characteristics of the color former contained in the inner layer 3,
Depending on its content, for example, yellow, yellow-green, orange for black or dark colors (charcoal gray, dark brown, navy blue, purple, etc.), or red, orange, pink for blue, etc. It is particularly preferable to select a combination that exhibits a clear contrast. Further, similar colors having different shades may be used, for example, dark blue and light blue, adzuki bean and pink.

Next, a method of forming the visual recognition marker 5 will be described. The visual recognition marker 5 is formed by applying energy to a predetermined portion of the outer surface 30 of the inner layer 3 containing the color-developing agent, and the energy causes the color-developing agent to develop a color. As a means for giving energy, irradiation of laser light is particularly preferable, but other methods include, for example, a method in which ordinary light (visible light or the like) is condensed by a lens and then irradiated. Irradiation of laser light will be described below as an example of a means for giving energy.

The laser light to be applied is appropriately selected according to the color former, and for example, near infrared laser light such as Nd-YAG laser light, far infrared laser light such as CO ₂ laser light, and the like.
Excimer laser light may be used.

The wavelength of the Nd-YAG laser light is 1.06 μm.
It is a near infrared ray of m and can be obtained by irradiating a YAG (yttrium-aluminum-garnet) lot with light of an arc lamp.

The CO ₂ laser beam is far infrared rays having a wavelength of 10.6 μm, and can be obtained by applying a high frequency (RF) and a high voltage (TEA) to a tube containing a CO ₂ mixed gas to excite the tube.

The irradiation amount of laser light is, for example, Nd-YAG.
In the case of laser light, the energy output of the irradiation source is 1.8 to
It is preferably about 2.0 kW.

The laser irradiation device is not particularly limited, and any known device may be used, for example, a scanning type, a dot type, or a mask type may be used. The scanning type laser irradiation device
Laser light emitted from the transmitter is scanned in the XY directions by two rotating mirrors, and then collected by a lens.
It is a method of being emitted. Further, the dot type laser irradiation device is of a type in which laser light is emitted in synchronization with a polygon mirror that rotates at a high speed.
The mask type laser is of a type in which a laser beam is emitted through a mask and a condenser lens which are cut out in a predetermined pattern.

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 inner layer 3 containing the color former by means of applying energy (irradiation of laser light) as described above. . Then, due to the heat, the color-developing agent is colored to form the visual recognition marker 5.

The formation of such a visual marker 5 is carried out by the outer layer 4
It may be either before or after forming. When the visual marker 5 is formed after the outer layer 4 is formed, the laser light passes through the outer layer 4 and is applied to the outer surface 30 of the inner layer 3.

The inner layer 3 as described above is covered with the outer layer 4 at least at the portion including the color-developing portion (visual marker 5). In the present embodiment, the outer circumference of the inner layer 3 is covered with the outer layer 4 over the entire length thereof.

As described above, since the visual recognition marker 5 is formed by coloring the color-developing agent by the irradiation of laser light or the like, it is difficult for peeling, disappearance, discoloration, etc., to occur. In the invention, since the outer layer 4 covers the visual recognition marker 5, the outer layer 4 functions as a protective layer, and as a result,
The effect of preventing peeling, disappearance, discoloration, etc. of the visual marker 5 is high. Further, even if the visual confirmation marker 5 has some irregularities, since the outer layer 4 covers the irregularities, the irregularities are not exposed on the surface of the guide wire 1, and the slidability of the guide wire 1 can be kept good. it can.

The resin constituting the outer layer 4 is not particularly limited, and for example, polyurethane (particularly hard polyurethane),
Polyolefin such as polyethylene, polypropylene, ethylene-propylene copolymer, fluorine resin such as polytetrafluoroethylene, polyester such as polyethylene terephthalate, polyvinyl chloride, polyamide, polyimide, ethylene-vinyl acetate copolymer, ethylene-ethylene acrylate Copolymers, ABS resins, AS resins, butadiene-styrene copolymers, polyisoprene, polybutadiene, polycarbonates, polyacetals, polysulfones, polymethylmethacrylates, polyetheretherketones, and the like can be mentioned. One or two of these can be mentioned. Although more than one species can be used in combination, in particular,
Since the slidability with respect to the inner surface of the lumen of the catheter into which the guide wire 1 is inserted can be improved, for example, a relatively hard material (rigidity) such as a rigid polyurethane or a fluororesin such as polytetrafluoroethylene is used. Higher materials are preferred. A tube formed of the fluororesin,
Particularly, by forming the outer layer 4 with a heat-shrinkable tube and covering the surface of the inner layer 3, excellent slidability is exhibited.

In order to improve the safety of the guide wire 1,
The tip of the outer layer 4 has a rounded shape.

The outer layer 4 as described above has the following optical characteristics (characteristics). That is, the outer layer 4 has such transparency that the visual marker 5 can be visually recognized through the outer layer 4. This prevents the presence of the outer layer 4 from making it difficult to visually recognize the visual marker 5, and the visual marker 5
The purpose of can be fully demonstrated. Further, as described above, when the visual marker 5 is formed after the outer layer 4 is formed, the outer layer 4 needs to be able to transmit the laser beam used for forming the visual marker 5, in addition to the above-mentioned conditions. It is said that Thereby, the visual marker 5 can be formed through the outer layer 4 without any trouble.

The optical characteristics as described above are determined by the conditions such as the transparency and refractive index of the constituent material of the outer layer 4 and the thickness of the outer layer 4.

The thickness of the outer layer 4 is not particularly limited, but is usually preferably about 5 to 100 μm, and 10 to 10 μm.
More preferably, it is about 50 μm. If the outer layer 4 is too thick, the visibility of the visual marker 5 may decrease depending on the transparency and refractive index of the constituent material of the outer layer 4,
If the outer layer 4 is too thin, a part of the outer layer 4 may be peeled off (damaged) due to rubbing, impact, or the like, and the function of protecting the visual marker 5 is deteriorated.

The optical characteristics of the outer layer 4 are as follows.
Not only when it is exerted over the entire length of the above, it is sufficient that the above-mentioned optical characteristics are satisfied in at least a portion of the outer layer 4 which covers the visual recognition marker 5.

<Coating of outer surface> Guide wire 1
The outer surface of the is preferably provided with a hydrophilic lubricating coating and / or a hydrophobic lubricating coating.

For example, the outer surface of the taper portion 24 of the core member 2 on the more distal end side corresponding to the midpoint in the longitudinal direction is coated with a hydrophilic lubricant, and the outer surface from the position corresponding to the midpoint to the base end side. The outer surface of the is coated with a hydrophobic lubricious coating.

By applying the hydrophilic lubrication coating, the hydrophilic lubrication coating wets in the living body and improves sliding, so that the insertion can be performed more smoothly and safely.

Further, by applying the hydrophobic lubricating coating, the sliding resistance of the guide wire 1 becomes low with respect to the lumen through which the guide wire 1 is inserted, for example, the lumen of the catheter or the lumen of the endoscope, and the guide wire 1 is reduced. Insert one,
The operability of removal is improved.

Although the boundary between the hydrophilic lubricating coating and the hydrophobic lubricating coating is located at the position corresponding to the intermediate point of the tapered portion 24 in the present embodiment, the boundary is not limited to this, and for example, the base end of the tapered portion 24 is formed. It may be a position corresponding to any position between the tips, or may be another position.

The boundary between the hydrophilic lubricating coating (on the tip side) and the hydrophobic lubricating coating (on the proximal side) is preferably located 30 to 500 mm from the tip of the guide wire 1. When the boundary is within this range, the effect of the hydrophilic lubricating coating and the effect of the hydrophobic lubricating coating can be exhibited in a well-balanced manner.

In the present invention, either one of the hydrophilic lubricating coating and the hydrophobic lubricating coating may be applied. Further, their forming positions are not particularly limited.

Examples of coating materials for the hydrophilic coating include cellulose-based, polyethylene oxide-based, maleic anhydride-based, and acrylamide-based polymeric substances.

Examples of the coating material for the hydrophobic lubricating coating include silicone.

It is preferable that the hydrophilic lubricating coating and the hydrophobic lubricating coating have a thickness that substantially transmits laser light or a thickness that allows laser light to pass therethrough.

FIG. 3 is a vertical sectional view schematically showing a second embodiment in which the medical elongated body of the present invention is applied to a guide wire. Hereinafter, the second embodiment will be described, but the description of the same matters as the first embodiment will be omitted, and the differences will be mainly described.

The guide wire 1 of the second embodiment has a contrast part 5 near the tip part thereof for confirming the position of the part in the living body. That is, as shown in FIG. 3, the inner layer 3 is defective near the tip (tapered portion 24) of the core material 2, and the contrast portion 6 having a contrast enhancement function for X-rays and the like is formed in this defective portion. ing. The contrast section 6 has a configuration in which a contrast agent is added to resin. This will be described in detail below.

<Contrast Section> The resin forming the contrast section 6 covers the tip portion of the core material 2, and the outer surface 61 of the contrast section 6 and the outer surface 30 of the inner layer 3 form a continuous surface without steps. I am configuring.

The resin constituting the contrast portion 6 may be the same as the constituent material of the inner layer 3 described above. In this case, the resin forming the contrast section 6 may be the same as the resin forming the inner layer 3, but a resin having a higher flexibility than the resin forming the inner layer 3 (soft resin) is preferably used. preferable. As a result, the flexibility of the distal end portion of the guide wire 1 is increased, and the operability during the insertion operation into the living body,
Safety is improved.

The boundary between the inner layer 3 and the contrast part 6 has a two-layer structure. That is, the thickness of the inner layer 3 is gradually reduced toward the tip, and the thickness of the resin forming the contrast portion 6 is gradually increased toward the tip, and these portions are overlapped. With such a structure, when resins having different characteristics such as flexibility are used, the change in the characteristics in the longitudinal direction is slowed down, the adhesion between the resins is improved, and peeling is prevented. It

The contrast agent added to the contrast section 6 is X
It is not particularly limited as long as it has a contrast function for lines and the like, but it is preferable that it is composed of at least one of metal powder and metal oxide powder. This will be described in detail below.

1. Metal powder contrast agent Examples of the metal powder contrast agent include tungsten and
Noble metals such as gold, silver and platinum are mentioned, but tungsten is particularly preferable. This metal powder contrast agent has a higher contrast function than the metal oxide powder contrast agent described below.

2. Metal Oxide Powder Contrast Agent Examples of the contrast agent made of a metal oxide powder include those having a contrast function for X-rays. As such, for example, barium sulfate, barium carbonate,
X-ray opaque materials such as bismuth oxide can be mentioned, and of these, barium sulfate and bismuth oxide are preferable.

The above contrast agents may be used alone or in combination of two or more (in particular, mixed).

The average particle size of the contrast agent is not particularly limited, but in view of dispersibility in the resin, it is preferably about 1 to 10 μm, more preferably about 2 to 4 μm.

The content of the contrast agent in the contrast section 6 depends on its type, but in order to exert the contrast function without excess or deficiency, it is about 40 to 80% by weight with respect to the entire contrast section 6. Is preferable, and more preferably about 50 to 80% by weight. If it is less than 40% by weight, the contrast function may be insufficient, and if it exceeds 80% by weight, it is difficult to knead it into the resin. In the present invention, the contrast function (contrast property) can be adjusted by the type and content of such contrast agent.

The contrast agent in the contrast section 6 is preferably dispersed uniformly, but for example, at the tip side of the contrast section 6,
Alternatively, it may be unevenly distributed on the outer peripheral surface side or the like.

As described above, in the present embodiment, since the contrast agent and the color former are added to different parts, that is, the contrast section 6 and the inner layer 3, the contrast agent and the color former react with each other. It is possible to prevent alteration and deterioration.

When a contrast agent made of, for example, a metal powder is added to the inner layer 3 in order to obtain the contrast property, when the outer surface 30 of the inner layer 3 is irradiated with the laser beam, the irradiation condition and the kind of the contrast agent are used. Depending on the case, the contrast agent may be deteriorated (oxidized or the like) or spark may be generated. However, by providing the contrast part 6 at a position different from the inner layer 3 (the tip side of the inner layer 3),
Such a problem can be avoided.

From the above, in the present embodiment, the degree of freedom in selecting the type and amount of the contrast agent and the color developing agent, the type of laser light and the irradiation conditions (irradiation intensity, etc.) is wide, and excellent contrast is achieved. In addition to being obtained, the color of the color-forming agent can be made clearer, which contributes to the improvement of the visibility of the visual marker 5.

By providing such a contrast unit 6,
The following effects can be obtained. Although the inner layer 3 itself does not have a contrast property, it may be preferable to grasp the position of the distal end portion of the guide wire 1 particularly in a living body. In such a case, the contrast layer having a contrast property can be used. It is advantageous to provide 6.

That is, for example, when the guide wire 1 is inserted through the endoscope to a predetermined position (target site) such as a living body lumen, the guide wire 1 is out of the range observable by the endoscope and further peripheral. The position of the distal end portion (imaging part 6) of the guide wire 1 can be grasped under fluoroscopy even when it is inserted into the lumen. Therefore, the tip of the guide wire 1 can be reliably guided to the target site.

Further, in the guide wire 1 having the structure shown in FIG. 3, the inner layer 3 may also have a contrast function, and the contrast part 6 may have a higher contrast function than the inner layer 3.

As a method of providing the inner layer 3 with a contrast function, there is a structure in which the same contrast agent as described above is added to the inner layer 3. In this case, the contrast agent added to the inner layer 3 is preferably one mainly containing the above-mentioned metal oxide powder contrast agent or metal oxide powder contrast agent. The reason is that since the metal oxide powder contrast agent is an oxide, when the outer surface 30 of the inner layer 3 is irradiated with laser light to form the visual marker 5, the contrast agent may be altered (oxidized or the like). This is because it is possible to prevent sparks (and heat generated thereby) from occurring. For this reason, the degree of freedom in selecting the type of laser light and the irradiation intensity (energy) is wide, and the color development of the color-developing agent should be clearer (for example, color should be developed so that the color contrast is increased). ) Can be performed, which contributes to the improvement of the visibility of the visual recognition marker 5.

Further, the contrast agent added to the contrast section 6 is preferably the metal powder contrast agent or one mainly containing the metal powder contrast agent. Since the metal powder contrast agent has a higher contrast function than the metal oxide powder contrast agent, it contrasts the contrast portion 6 more clearly than elsewhere (inner layer 3 to which the metal oxide powder contrast agent is added). Because you can.

As described above, the inner layer 3 has a contrast property by the addition of a contrast agent, but it may be preferable to grasp the position of the distal end portion of the guide wire 1 separately from other positions. In such a case, it is advantageous to provide the contrast part 6 having a stronger contrast property.

Incidentally, the contrast part 6 and the inner layer 3 having the contrast function.
Is not limited to one that can be imaged under fluoroscopy, but may be one whose position can be confirmed by CT scan, MRI, or the like.

FIG. 4 is a vertical sectional view schematically showing a third embodiment in which the medical elongated body of the present invention is applied to a guide wire. 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 differences will be mainly described.

The guide wire 1 of the third embodiment has the outer layer 4
Covers the outer periphery of the inner layer 3 leaving a part (tip portion) of the inner layer 3. The tip portion 31 of the inner layer 3 is expanded to an outer diameter that is approximately the same as the outer diameter of the outer layer 4, and the tip portion 31 is attached to the tip of the outer layer 4.
Are continuously joined. All or part of the tapered portion 24 of the core material 2 is included in the tip portion 31.

The outer surface 41 of the outer layer 4 and the outer surface (exposed surface) 32 of the tip 31 form a continuous surface having no step.

A contrast agent is added to the inner layer 3 in addition to the color former. This contrast agent is preferably a metal oxide powder contrast agent or one mainly containing a metal oxide powder contrast agent for the same reason as above.

As described above, the contrast agent is added to the inner layer 3, but the thickness of the layer at the distal end portion (diameter-increased portion) 31 of the inner layer 3 becomes thicker than that at the base end side. Therefore, when the contrast agent is uniformly dispersed in the resin, more contrast agent is present. More precisely, the distal end portion 31 has a large content of the contrast agent per unit length of the guide wire 1. Therefore, the tip portion 31 constitutes an imaging portion having a high contrast function (contrast property) such as X-ray. Then, the tip portion 31 exhibits the same function as that of the above-mentioned contrast enhancement portion 6.

As described above, the fact that the distal end portion 31 constitutes the contrast enhancement portion, that is, the contrast enhancement function of the distal end portion 31 is higher than that at other places, the following effects can be obtained.

As described above, the inner layer 3 has a contrast property by the addition of a contrast agent, but it may be preferable to grasp the position of the distal end portion of the guide wire 1 separately from other positions. In such a case, it is advantageous to provide a contrast enhancement section having stronger contrast.

That is, for example, when the guide wire 1 is inserted to a predetermined position (target site) such as a living body lumen via the endoscope, the guide wire 1 is out of the range observable by the endoscope and further peripheral. Even when the guide wire 1 is inserted into the lumen, the position of the distal end portion (imaging portion) 31 of the guide wire 1 can be more surely grasped under fluoroscopy. Therefore, the distal end portion 31 of the guide wire 1 can be reliably guided to the target site.

The resin forming the inner layer 3 and the resin forming the outer layer 4 may be the same (same kind), but it is preferable that they have different physical properties, particularly flexibility.

More preferably, the resin forming the inner layer 3 is more flexible than the resin forming the outer layer 4.

By doing so, the flexibility of the distal end portion (the distal end portion 31) of the guide wire 1 can be ensured, and the operability and safety when inserting into the living body are improved, while the outer layer 4 is formed. By using a resin material having a relatively high hardness (rigidity), it is possible to reduce the sliding resistance with respect to the inner surface of the catheter lumen into which the guide wire 1 is inserted or the lumen of the endoscope. It is possible to improve the operability during insertion and removal operations and positioning.

It is possible to embed a coil-shaped or ring-shaped metal member made of the above-mentioned metallic material having a contrast property in the contrast portion 6, the tip end portion 31 or other places. Even in the case, the same action and effect can be obtained.

FIG. 5 is a longitudinal sectional view schematically showing a fourth embodiment in which the medical elongated body of the present invention is applied to a catheter. Hereinafter, the fourth embodiment will be described, but the description of the same matters as those in the above-described first to third embodiments will be omitted, and the differences will be mainly described.

The catheter 7 has an inner layer 3 and an outer layer 4 covering at least a part of the inner layer 3. Catheter 7
At least one lumen 8 is formed inside. For the resin material forming the inner layer 3 and the outer layer 4, the color former added to the inner layer 3, the optical characteristics of the outer layer 4, and the like,
The same as above.

The catheter 7 may be formed with various lumens having different uses and functions as described below.

For example, as a catheter to be inserted into an endoscope (fiberscope) for observing the inside of a living body lumen such as a blood vessel or a digestive tract, the catheter is opened to the distal end portion of the catheter 7, and a fluid is introduced into the living body lumen through the opening. Lumens that can be infused or aspirated from within a body cavity or the like can be mentioned.

A lumen for accommodating a wire for pulling the tip of the catheter main body to bend the tip of the catheter 7 can be used.

In the vicinity of the distal end of the catheter 7, one or more expanders such as balloons that can be expanded by injecting a working fluid may be installed. in this case,
The catheter 7 is formed with a lumen for supplying a working fluid to the expansion body. This lumen communicates with the inside of the expansion body.

Further, the catheter 7 may be provided with one or more side holes communicating with a predetermined lumen.

The shape, structure, etc. of the catheter 7 are not particularly limited and may be appropriately changed depending on the purpose of use, the case, etc. of the catheter 7.

For example, in the case of an epidural catheter, the outer diameter of the catheter is preferably 0.6 to 1.5 mm, more preferably 0.8 to 1.2 mm, and the inner diameter of the catheter is 0. It is preferably 3 to 0.9 mm, and more preferably 0.4 to 0.6 mm. In the case of a blood vessel catheter, the outer diameter of the catheter is 0.
It is preferably 8 to 2.5 mm, and the inner diameter of the catheter is preferably 0.3 to 2.0 mm. Further, in the case of an imaging catheter, the outer diameter of the catheter is preferably 2.7 mm or less, more preferably 2.0 mm or less, and the inner diameter of the catheter is preferably 0.9 to 1.8 mm, More preferably, it is 1.0 to 1.5 mm. By setting the inner diameter and the outer diameter in such ranges, various characteristics of the catheter such as flexibility, followability with respect to bending, torque transmission, and pushability can be sufficiently exhibited.

The outer diameter and the inner diameter of the catheter 7 may be the same or may be different over the entire length of the catheter 7. When the distal end portion of the catheter 7 is made flexible, the outer diameter of the catheter 7 at the distal end portion of the catheter 7 may be gradually reduced toward the distal end.

The thicknesses of the inner layer 3 and the outer layer 4 constituting the catheter 7 may be the same or different over the entire length of the catheter 7.

On the outer surface 41 of the outer layer 4 of the catheter 7,
Visual markers similar to those described above are formed. The visual recognition marker (coloring portion) may be used as a scale indicating the length (insertion depth) of the catheter 7, for example.

In the catheter 7 of the present invention,
Inside the inner layer 3, between the inner layer 3 and the outer layer 4, and outside the outer layer 4,
There may be any layers. For example, a reinforcing material layer (stiffness imparting body) made of a wire or a mesh may be provided inside the inner layer 3 or between the inner layer 3 and the outer layer 4. In this case, the reinforcing material layer may be provided over the entire length of the catheter 7 or may be provided at a portion except a part (for example, the tip end portion).

When the catheter 7 is used by being directly inserted into a living body lumen (tubular organ) such as a blood vessel, a digestive tract, a bile duct, a pancreatic duct, a urethra or the like, the outer surface of the catheter 7 over substantially the entire length is used. It is preferable that the above-mentioned hydrophilic lubricating coating is applied.

In the present invention, the method of forming the inner layer 3 and the outer layer 4 is not particularly limited. For example, a method of integrally forming both layers by multicolor molding, injection molding (including inner molding or outer molding) Examples of the method include a method by press molding. Alternatively, the inner layer 3 may be formed and then the outer layer 4 may be formed on the outer surface thereof, or conversely, the outer layer 4 may be formed and then the inner layer 3 may be formed on the inner surface thereof. Examples of the method of forming the outer layer 4 on the inner layer 3 or the method of forming the inner layer 3 on the outer layer 4 include a coating method, a method of attaching a heat-shrinkable film, and heating to shrink the film.

After forming the inner layer 3 and the outer layer 4 in this way, the visible marker 5 is formed by irradiating the desired position of the inner layer 3 with laser light through the outer layer 4. After forming the visual marker 5 at a desired position on the inner layer 3, the visual marker 5 is formed.
You may form the outer layer 4 so that it may be covered.

The medical elongated body of the present invention has been described above with reference to the illustrated embodiments, but the present invention is not limited to these, and the configuration of each part is arbitrary as long as it can exhibit the same function. It can be replaced with the one having the configuration described above, and an arbitrary configuration can be added.

When the medical elongated body of the present invention is applied to a guide wire, the guide wire is not limited to one used by inserting it into the lumen of an endoscope. When the medical elongated body of the present invention is applied to a catheter, its use is not particularly limited.

Furthermore, the medical elongated body of the present invention is not limited to the guide wire and the catheter, and other medical elongated bodies such as medical tubes and
Examples thereof include a stent insertion device.

[0136]

As described above, according to the medical long body of the present invention, by having the coloring portion constituting a marker or the like, the medical long body can be observed in the living body by, for example, observation with an endoscope. The position of the body can be visually confirmed.

In particular, the coloring portion can be a visual marker formed in a desired position and in a desired shape and size, and the visibility can be improved.

Further, the color-developing portion can give a clear color difference and brightness (contrast) from the base material of the resin layer, and is less likely to disappear or fade due to peeling, dissolution, etc., and therefore has excellent visibility. A marker can be obtained. And, it is possible to make a marker without ridges or depressions.

Further, by providing the outer layer, the function of protecting the color-developed portion is exerted, and peeling, disappearance, discoloration, etc. can be prevented more reliably. Further, the optical characteristics of the outer layer do not impair the visibility of the color-developing portion or make it difficult to form the color-developing portion.

Further, when the contrast portion is provided, the position of, for example, the tip portion of the medical elongated body inserted into the living body can be grasped outside the body. In this case, it is possible to avoid affecting the formation of the color-developed portion by selecting the type of contrast agent and the addition site. As a result, the degree of freedom in selecting the type and amount of contrast agent, color developer, type of laser light, irradiation conditions (irradiation intensity, etc.) is wide, and as a result, excellent contrast can be obtained and The color of the agent can be made clearer, which contributes to the improvement of the visibility of the visual marker.

Further, by appropriately selecting the constituent materials in consideration of the physical characteristics of the inner layer and the outer layer, especially the flexibility, the tip portion can be made more flexible and the slidability can be improved. As a result, it is possible to improve safety and operability when inserting the body into a living body.

[Brief description of drawings]

FIG. 1 is a vertical cross-sectional view schematically showing a first embodiment in which a medical elongated body of the present invention is applied to a guide wire.

FIG. 2 is a side view schematically showing the first embodiment when the medical elongated body of the present invention is applied to a guide wire.

FIG. 3 is a vertical cross-sectional view schematically showing a second embodiment when the medical elongated body of the present invention is applied to a guide wire.

FIG. 4 is a vertical cross-sectional view schematically showing a third embodiment when the medical elongated body of the present invention is applied to a guide wire.

FIG. 5 is a vertical cross-sectional view schematically showing a fourth embodiment in which the medical elongated body of the present invention is applied to a catheter.

[Explanation of symbols]

1 guide wire 2 core material 22 Body 24 Tapered part 3 inner layer 30 outer surface 31 Tip 32 outer surface (exposed surface) 4 outer layer 41 outer surface 5 Visual marker (coloring part) 6 Contrast section 61 outer surface 7 catheter 8 lumens

Continued front page    F-term (reference) 4C061 AA06 AA07 AA15 AA22 AA26                       GG22 HH51 JJ01 JJ06 JJ11                       JJ17                 4C167 AA01 AA28 AA77 BB03 BB06                       BB13 BB47 BB48 BB61

Claims (3)

[Claims] 1. A medical long body having an inner layer and an outer layer, wherein the inner layer comprises a resin containing a color-developing agent capable of developing a color upon irradiation with a laser beam, and the outer surface of the inner layer. And a colored portion formed by coloring of the coloring agent, wherein the outer layer has transparency such that the colored portion is visible through the outer layer. 2. A medical long body having an inner layer and an outer layer, wherein the inner layer is a resin to which a color former capable of developing a color by irradiation of laser light is added, and the outer surface of the inner layer. In, a color-developing portion is formed by coloring the color-developing agent, and the outer layer is transparent to a laser beam, and the color-developing portion has transparency such that the color-developing portion is visible through the outer layer. A long body for medical use. 3. The medical elongated body according to claim 1, which has a hydrophilic lubricating coating and / or a hydrophobic lubricating coating on its outer surface.