JPH0792B2 - Device for treatment of ischemic disease - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial application] The present invention relates to an ischemic disease for dilating a stenosis and improving blood flow on the peripheral side of the stenosis in order to treat the stenosis in the blood vessel. It relates to a therapeutic instrument.

[Prior Art] Conventionally, as a catheter with an expander for expanding an intravascular stenosis, for example, a catheter called a Gruntig type as shown in Japanese Patent Publication No. 54-70683, or, for example, US Pat. No. 4,323,071. What is called the Simpson-Robert type as shown in the specification is used.

In the above-described dilatation procedure for a vascular stenosis with a dilatation catheter, a guide catheter is first inserted up to the vicinity of the intended vascular stenosis, and the dilatation catheter is inserted into the guide catheter. A guide wire for guiding the dilatation catheter is inserted through the lumen of the dilatation catheter. Then, after inserting this guide wire into the vascular stenosis, and then positioning the dilatation catheter inside the vascular stenosis, the dilatation fluid is injected to dilate the dilatation to dilate the vascular stenosis. It is opened and the vascular stenosis is treated.

[Problems to be Solved by the Invention] However, in order to treat a vascular stenosis using the above dilatation catheter, as described above, it is necessary to insert the guide catheter, the guide wire, and the dilatation catheter. However, there was a problem that the treatment work was complicated.

[Means for Solving the Problems] An object of the present invention is to provide an ischemic vascular treatment instrument that solves the above-mentioned problems of the prior art and can easily treat a vascular stenosis.

What achieves the above-mentioned object has a core material and a blood vessel expansion portion fixed to a distal end portion of the core material, and the blood vessel expansion portion is formed of a synthetic resin to be solid, and The expanded portion is a device for treating ischemic disease, which has a large diameter portion and a tapered portion whose diameter decreases from the large diameter portion toward the distal end side.

The device for treating ischemic disease has a lumen having one end open at the proximal end side of the vasodilator and the other end at the rear end of the device for treating ischemic disease. Good.

Further, what achieves the above-mentioned object has a core material and a blood vessel expansion portion fixed to a tip portion of the core material, and the blood vessel expansion portion has a large diameter portion and a tip side from the large diameter portion. It has a taper part that decreases in diameter toward the end, and also has a lumen that passes through the inside of the blood vessel dilation part and has one end open on the distal end side and the other end open on the rear end part of the device for treating ischemic disease. The vasodilator is a device for treating ischemic disease, which is solidly formed of synthetic resin except for the lumen portion.

The tip of the core material is preferably a small diameter portion. Furthermore, it is preferable that the tip portion of the core material has a taper portion whose diameter decreases toward the tip.
The core material includes a first linear body made of a flexible material and a second linear body made of a material that is connected to the tip of the first linear body and is easily plastically deformed. It is preferable that The first linear body is preferably made of a super elastic metal. Further, the second linear body is preferably made of stainless steel or piano wire. Further, it is preferable that the synthetic resin forming the blood vessel dilation is a soft synthetic resin. Further, it is preferable that the core material is covered with a synthetic resin. A groove extending in the longitudinal direction is preferably provided on the outer surface of the large diameter portion of the blood vessel expansion portion. Further, it is preferable that a guide portion of the device for treating ischemic disease is provided at the tip of the device for treating ischemic disease.

Therefore, the device for treating ischemic disease of the present invention will be described with reference to the embodiments shown in the drawings.

A device 1 for treating ischemic disease according to the present invention comprises a core material 2 and a core material 2.
And a blood vessel expansion portion 3 fixed to the tip of the blood vessel expansion portion 3, the blood vessel expansion portion 3 is made of synthetic resin and is solid, and
The blood vessel expansion part 3 has a large diameter part 3a and a taper part 3b whose diameter decreases from the large diameter part 3a toward the distal end side.

Therefore, the instrument for treating ischemic disease according to the present invention of the embodiment shown in FIG. 1 will be described.

FIG. 1 is a sectional view of an ischemic disease treatment instrument according to an embodiment of the present invention.

The device 1 for treating ischemic disease of this embodiment has a core material 2 and a vasodilator 3 fixed to the outer periphery of the tip portion thereof, and the entire core material 2 is covered with a synthetic resin layer 6. ing. The treatment instrument 1 is roughly divided into a tip portion 12,
It is divided into three parts, a main body part 14 and a base end part 16.

More specifically, the core material 2 has a function of reliably transmitting the operation at the base end portion (hand side during use) of the core material 2 to the distal end, and is further thinned in the meandering blood vessel. It has the function of easily advancing inside the blood vessel.

As the core material 2, stainless steel, piano wire, and super elastic metal are preferably used. Preferably, it is a super elastic metal, for example, Ni-Ti-based alloy, Cu-Al-Ni-based alloy, C
A super elastic material such as u-Zn-Al alloy is suitable. As the core material 2, specifically, a Ti-Ni alloy containing 49 to 58 atomic% Ni, 38.
5-41.5 wt% Zn Cu-Zn alloy, 1-10 wt% X Cu-Zn-
X alloy (X = Be, Si, Sn, Al, Ga), Ni-Al with 36-38 atomic% Al
A super elastic metal body such as an alloy is preferably used. The above Ti-Ni alloy is particularly preferable. Furthermore, it is preferable that the tip end side of the core material 2 is more flexible, and in particular, the flexibility is gradually increased toward the tip end. Therefore, in the embodiment shown in FIG. The diameter gradually becomes smaller toward, and the flexibility can be changed according to the adaptation by changing the diameter. The change in flexibility can also be made by changing the heat treatment conditions of the metal forming the core material. Further, it is preferable that the base end portion of the core material 2 has higher rigidity. Therefore, in the embodiment shown in FIG. 1, the outer diameter of the base end portion 16 is larger than that of the main body portion 14. . Further, as described above, the base end portion 16 may have high rigidity by changing the heat treatment conditions.

The outer diameter of the tip of the tip portion 12 of the core material 2 is 0.005 to 0.2.
00 mm, preferably 0.010 to 0.150 mm, the outer diameter of the distal end of the tip 12 is 0.10 to 0.40 mm, preferably 0.25 to 0.35 mm,
The length of the tip 12 part is 50-600 mm, preferably 100-450 m
m, the bending load of the tip is 0.1 to 10 g, preferably 0.3 to 6.
0 g, the restoration load is 0.1 to 10 g, preferably 0.3 to 6.0 g. The outer diameter of the main body of the core material 2 is 0.40 to 1.50 mm, preferably 0.60 to 0.90, and the length of the main body is 950 to 160.
0 mm, preferably 1100-1500 mm, bending load of the main body is 1
The recovery load is 0 to 50 g, preferably 20 to 40 g, and the restoration load is 10 to 50 g, preferably 20 to 40 g. The outer diameter of the base end portion of the core material 2 is 0.80 to 3.00 mm, preferably 0.80 to 2.00, and the length of the base end portion 16 is 50 to 500 mm, preferably 100 to 400 m.
m, the bending load of the base end portion 16 is 80 to 400 g, preferably 100 to 250 g, and the restoring load is 80 to 400 g, preferably 100 to
It is 250g. The outer surface of the core material 2 is covered with the first synthetic resin layer 6. The first synthetic resin layer 6 is
It has the function of reducing the frictional resistance with the blood vessel wall to some extent and improving the adherence of the blood vessel dilatation described later. The material of the first synthetic resin layer 6 includes polyethylene, polyvinyl chloride, polyester, polypropylene,
Polyamide, polyurethane, polystyrene, fluororesin (eg PTFE, ETFE), silicone rubber or their elastomers and composite materials are preferably used,
Polyurethane is particularly preferable. Then, in the case of forming a lubricating surface to be described later, it is preferable to use a synthetic resin having a high effect of fixing the lubricating substance, and as such a resin, polyvinyl chloride, polyurethane,
Polyester is preferable, and when a synthetic resin other than these synthetic resins is used, it is preferable to use a mixture of the synthetic resin with the above-mentioned synthetic resin having a high fixing effect. The synthetic resin layer 6 is preferably flexible enough not to hinder the bending of the core material 2, and the outer surface is preferably a smooth surface without irregularities. Further, it is preferable to mix a fine powdery X-ray contrast substance with a simple metal or a compound such as Ba, W, Bi, Pb, and Pt into the synthetic resin forming the synthetic resin layer 6. This facilitates the confirmation of the position of the tip of the treatment instrument 1 being introduced into the blood vessel. The wall thickness of the synthetic resin layer 6 is 0.20 to 0.40 mm, and preferably 0.30 to 0.35 mm at the leading edge.
The thickness of the main body is 0.20 to 1.50 mm, preferably 0.40
~ 1.30mm, wall thickness at the base end is 2.00 ~ 3.00mm, preferably
2.30 to 2.70 mm.

The blood vessel expanding portion 3 is for forcibly expanding the blood vessel narrowing portion, and is provided at the tip portion 12. It is preferable that the blood vessel expansion portion 3 be capable of expanding the narrowed portion of the blood vessel, have some plasticity, and do not damage the inner wall of the blood vessel during insertion. Therefore, the blood vessel dilating portion 3 used in the therapeutic device 1 of the present invention is formed solid as shown in FIG. 1, and is forcibly inserted into the blood vessel narrowing portion to dilate the blood vessel narrowing portion. It is configured to be able to. Specifically, it has a large diameter portion 3a for expanding a blood vessel and a taper portion 3b for introducing the large diameter portion 3a into a blood vessel stenosis portion.

Further, the large-diameter portion 3a is a second sectional view taken along line II of FIG.
As shown in the drawing, it is preferable to have a groove 40 extending in the longitudinal direction of the large diameter portion 3a, and in particular, as shown in FIG. 2, the cross section has a star shape or a gear shape, and further, as shown in FIG. However, a shape in which only the groove 40 is a recess is preferable. By doing so, the contact area of the vascular dilation portion 3 with the intravascular narrowing portion is reduced, so that it is possible to easily insert the blood vessel dilating portion 3 into the intravascular narrowing portion. After that, the stenosis-causing substance (thrombus, atheroma, etc.) can be easily removed by rotating or advancing or retracting the proximal end portion 16.

Further, although the insertion resistance to the narrowed portion is slightly increased, the blood vessel dilation portion 3 may be a cylindrical shape having a circular cross section as shown in FIG.

Further, it is preferable that the proximal end side of the large diameter portion 3a is also a taper portion, and by forming the taper portion, when the therapeutic instrument 1 is removed from the blood vessel stenosis portion and further into the blood vessel, the inner wall of the blood vessel is removed. It can prevent damage.

As a material of the blood vessel expansion part 3, a material which can expand a narrowed part of a blood vessel and has a certain degree of plasticity is preferable, and examples thereof include polyolefin such as polyethylene, polypropylene and ethylene-propylene copolymer, polyester such as polyethylene terephthalate and poly. Vinyl chloride, ethylene-vinyl acetate copolymer, cross-linking type ethylene-vinyl acetate copolymer, thermoplastic resin such as polyurethane, polyamide elastomer, silicone rubber, latex rubber and the like can be used.

Furthermore, in the synthetic resin forming the vasodilator 3, Ba,
It is preferable to mix a fine powdery X-ray contrast substance with a simple metal or a compound such as W, Bi, Pb, or Pt. By doing so, the position of the vasodilator 3 being introduced into the blood vessel can be confirmed. It will be easy.

Regarding the size of the vasodilator 3, the maximum diameter of the large diameter portion 3a is 0.5 to 8.0 mm, preferably 1.0 to 5.0 mm, and the large diameter portion has a length of 5 to 50 mm, preferably 15 mm. ~ 30 mm, the overall length of the vasodilator 3 is 15-55 mm, preferably 20-35
mm, and the diameter of the tip of the taper part on the tip side is 0.2 to 1.0.
mm, preferably 0.4 to 0.6 mm, and the diameter of the tapered portion on the proximal end side is 0.2 to 1.0 mm, preferably 0.4 to 0.6 mm. Further, the length of the taper portion on the tip side is 5 to 20 mm, preferably 7 to
The length of the taper portion on the base end side is 15 mm, and the length is 1 to 10 mm, preferably 3 to 8 mm.

Further, as shown in FIG. 1, the tip 5 of the therapeutic instrument 1 is preferably curved, and by doing so, the tip of the therapeutic instrument 1 is damaged on the inner wall of the blood vessel during insertion. Can be suppressed. further,
As shown in FIG. 1, when the tip 5 is slightly constricted, the force is not concentrated at the tip when contacting the blood vessel wall, the tip is easily bent, and the tip easily moves in another direction. 5 becomes easy. The tip 5 may be formed of the resin forming the first synthetic resin layer 6 described above, or may be formed of another member and fixed to the tip of the core material 2.

Furthermore, on the outer surface of the blood vessel expansion portion 3 on the tip side from the base end,
It is preferable to provide the second synthetic resin layer 7. This second
The synthetic resin layer 7 has a smooth outer surface on the distal side of the blood vessel dilation portion 3, and the synthetic resin forming the synthetic resin layer 7 has a substance having an extremely high X-ray contrast property, such as W. The position of the distal end portion 12 of the therapeutic instrument 1 can be more easily confirmed by mixing a fine powdery X-ray contrast substance made of a simple metal or a compound such as Bi, Pt, or Pt. As the synthetic resin layer 7, the materials described in the above synthetic resin layer 6 can be preferably used. The thickness of the synthetic resin layer 7 is 0.02 to 0.15 mm, preferably 0.05 to 0.10 mm.

The surfaces of the tip 12 and the body 14 of the therapeutic instrument 1 are preferably lubricious surfaces. The lubricious surface is
It is preferably formed by fixing a lubricating substance on the surface of the synthetic resin layer 6 (or the synthetic resin layer 7 and the synthetic resin layer 6). Lubricant refers to a substance that has lubricity when wet. Specifically, for example, hydrophilic polymers such as poly (2-hydroxyethyl methacrylate), polyhydroxyethyl acrylate, hydroxypropyl cellulose, methyl vinyl ether maleic anhydride copolymer, polyethylene glycol, polyacrylamide, and polyvinylpyrrolidone are suitable. used.

Further, instead of the lubricating substance, the tip 12 of the therapeutic device 1
The outer surface of the body 14 is coated with an anticoagulant such as heparin or urokinase, or a silicone rubber, a block copolymer of urethane and silicone (registered trademark Abucosan), or an antithrombogenic material such as hydroxyethyl methacrylate-styrene copolymer. You may.

Next, the therapeutic instrument 20 shown in FIG. 5 will be described.

The therapeutic device 20 of this embodiment includes a first linear body 31 made of a flexible material and a second linear body 31 made of a material which is connected to the tip end portion of the first linear body 31 and is easily plastically deformed. It has a core material constituted by the linear body 32 and a blood vessel expansion portion 3 fixed to the tip end portion of the core material, and the blood vessel expansion portion 3 is made of synthetic resin and is solid, and The expanded portion 3 has a large diameter portion and a taper portion that reduces its diameter toward the distal end side from the large diameter portion, and further has a guide portion 38 provided at the most distal end portion of the therapeutic device 20. is doing.

The basic configuration of the guiding instrument 20 is the same as that shown in FIG. 1, and the difference is that the core material is formed by the first linear body 31 and the second linear body 32. And a point having the guiding portion 38.

As the first linear body 31, a Ti-Ni alloy containing 49 to 58 atomic% Ni, a Cu-Zn alloy containing 38.5 to 41.5 wt% Zn, and 1 to 10 wt% X
Cu-Zn-X alloy (X = Be, Si, Sn, Al, Ga), 36-38 atomic% A
Ni-Al alloy of 1 is preferably used. Tip 12, body
The outer diameter and length of 14 and the base end portion are the same as those of the embodiment shown and described in FIG.

As the second linear body 32, it is preferable to use a material that is easily plastically deformed. By doing so, the distal end portion of the therapeutic device 20 can be deformed into an arbitrary shape for use. As the material of the second linear body 32, stainless steel, piano wire, etc. can be preferably used.

The connection between the first linear body 31 and the second linear body 32 is
A method of fitting the base end portion of the second linear body 3 to the distal end portion of the first linear body 2, a method of brazing the both, and the like,
Alternatively, a combination of both can be used.
Alternatively, an annular member may be fitted on the joint surface of the first linear body 31 and the second linear body 32 to fix the joint surface.

The guiding portion 38 is for guiding the therapeutic device 20 to a target blood vessel site, and in the embodiment shown in FIG.
It is formed by a coil spring 34 fixed to the tip of the linear body 32. The guide portion 38 has flexibility, and when the tip of the guide portion 38 abuts on the blood vessel wall, it suppresses the concentration of force to the forefront and easily bends. , Is designed to ensure a shift in the other direction. Further, since the guide portion 38 is also the tip of the device 20 for treating ischemic disease, it is preferable that the position can be easily confirmed under fluoroscopy. As the material of the guide portion 38, Pt, Pt alloy, W, W It is preferable to use an alloy, Ag, an Ag alloy, or the like. Further, it is preferable to make the guide portion 38 more flexible, and for this reason, a coil spring may be formed of a super elastic metal wire or an elastic metal wire. The guide portion 38 has an outer diameter of 0.25 to 1.60 mm and a length of
20-80 mm is preferable. In addition, when the super-elastic metal wire is used for the induction part, the buckling strength (falling stress under load) is
5-200kg / mm ² (22 ℃), more preferably 8-150kg / m
m ² , restoration stress (unloading stress when unloading) is 3 to 180 kg / mm ²
(22 ° C.), more preferably 5 to 150 kg / mm ² .

The tip 35 of the guiding portion 38 is preferably formed in the shape of a headpiece having a smooth convex curved surface by heating and melting an extremely fine metal wire. Further, in order to secure the fixing to the core member, the guiding portion 38 preferably removes the synthetic resin layer of the fixed portion and is directly bonded to the core member by the adhesive 37. A brazing material or an adhesive can be preferably used as the fixing agent. Further, in order to prevent the extension of the coil spring 34, it is preferable that the tip of the second linear body 32 reaches the tip 35 of the guiding portion 38, and that the tip is further fixed.

Next, the therapeutic device 30 shown in FIG. 6 will be described.

The therapeutic device 30 of this embodiment has a core material 2 and a blood vessel dilating portion 3 fixed to a tip portion of the core material 2, and the blood vessel dilating portion 3
Is made of a synthetic resin and is solid, and the blood vessel dilating portion 3 has a large diameter portion and a taper portion whose diameter decreases from the large diameter portion toward the distal end side. 30
Has a lumen 22 that opens near the blood vessel dilation 3 and at the proximal end of the therapeutic device 30.

The basic configuration of this guiding instrument 20 is the same as that shown in FIG. 1, except that a lumen 22 is provided that passes through the inside of the synthetic resin layer 6 and opens near the blood vessel dilation portion 3. And that the hub 24 is provided at the base end of the core material 2.

The lumen 22 is, as shown in FIG. 6 and FIG. 7 which is a sectional view taken along the line II-II of FIG. 6 and FIG. 8 and FIG. 9 which are modifications thereof, as shown in FIG. It extends toward the distal end side, penetrates through the blood vessel expansion portion 3, and communicates with the outside through an opening 23 provided on the distal end side. The lumen 22 has a passage formed inside the hub 24 at its proximal end. Is in communication with. As shown in FIGS. 6 to 9, the blood vessel expansion section 3 is solid except for the lumen 22. Also, the lumen 22 only needs to open near the blood vessel dilation 3,
The opening 23 may be provided on the proximal end side of the blood vessel expansion portion 3 without inserting the blood vessel expansion portion 3. The hub 24 has a chemical liquid injection port 25 that communicates with the lumen 22. The lumen 22 functions as a flow path for injecting a drug solution, for example, a thrombolytic agent such as urokinase, and in some cases, a cardiotonic agent, into the blood vessel. Then, the hub 24 and the port 25 function as a mounting port for a liquid medicine injection means such as a syringe. As the material of the hub 24, a thermoplastic resin such as polycarbonate, polyamide, polysulfone, polyarylate, or methacrylate-butylene-styrene copolymer is used, and is fixed to the base end of the core material 2 by a solvent or the like. By providing the lumen 22 in this way, when the distal end 5 of the therapeutic device 30 reaches the vascular stenosis, the thrombolytic agent is injected into the stenosis before the vasodilator 3 is inserted into the stenosis, and the stenosis is achieved. After softening the stenosis material of the vascular stenosis to some extent, the vasodilator 3 can be inserted into the stenosis, and the vascular stenosis can be treated reliably and easily. Further, by removing the stenosis-causing substance such as thrombus by contact with the vasodilator 3 and then injecting the thrombolytic agent, the fragmented thrombus can be easily removed.

The other points are similar to those of the embodiment shown in FIG.

Next, the therapeutic device 50 shown in FIG. 10 will be described.

The therapeutic device 50 of this embodiment includes a first linear body 31 made of a flexible material, and a second linear body 31 made of a material which is connected to the distal end portion of the first linear body 31 and is easily plastically deformed. It has a core material constituted by the linear body 32 and a blood vessel expansion portion 3 fixed to the tip end portion of the core material, and the blood vessel expansion portion 3 is made of synthetic resin and is solid, and The expansion part 3 has a large diameter part and a taper part that reduces its diameter toward the distal end side from the large diameter part. Furthermore, the treatment device 50 is open near the blood vessel expansion part 3 and the treatment is performed. It has a lumen 22 that opens at the rear end of the medical device 50 and a guide portion 38 provided at the most distal end of the therapeutic device 50.

The basic configuration of this therapeutic device 50 is the same as that shown in FIG. 6, and the difference is that the core material is formed by the first linear body 31 and the second linear body 32. And a point having the guiding portion 38.

As the first linear body 31, for the second linear body 32 and the guide portion 38, those described in the embodiment shown in FIG. 5 can be preferably used.

[Example] Next, an example of the therapeutic instrument of the present invention will be described.

(Example 1) Ni-Ti alloy (56 atomic% Ni) was used as the core material.
The outer diameter of the main body is 0.7 mm, the length is 1200 mm, and the base end
The outer diameter is 1.0 mm, the length is 300 mm, and the tip is the tip.
The diameter of the tip is reduced to 50 μmm,
With a length of 300 mm and a total length of 1800 mm, the core material is
Contains 45% by weight of Gustene fine powder (particle size: about 3-4 μm)
Polyurethane (Pandex T-5000, Dainippon Ink
First synthetic resin
Layers were formed.

As a vasodilator, platinum fine powder (particle size about 3-4μ
m) containing 30% by weight of polyurethane (Pandex
T-5070, made by Dainippon Ink Co., Ltd.) and shown in Fig. 2.
It has a cross-sectional shape and the maximum diameter of the large diameter part is 1.5 mm.
The length of the large diameter part is 20 mm and the diameter of the tip of the tapered part is
Is 0.46 mm, the length is 10 mm, and it is the most base of the taper part on the base end side.
The diameter of the end is 0.64mm, and the length is 5mm by injection molding.
Made with a solvent (THF) and fixed to the tip of the core material
did.

The thickness of the front end portion of the first synthetic resin layer was 0.30 mm, the thickness of the main body portion was 0.40 mm, and the thickness of the base end portion was 2.50 mm. Further, the same material as that used for molding the first synthetic resin layer was used, and a glass mold was formed into a curved shape having a constricted tip as shown in FIG.

Furthermore, from the base end of the blood vessel expansion part to the tip side, platinum fine powder
Polyureta containing 60% by weight of droplets (particle size of about 3-4 μm)
(Pandex (T-5000, made by Dainippon Ink Co., Ltd.)
Coat by dipping with 5% / THF solution,
The synthetic resin layer of was formed. The thickness of the second synthetic resin layer is
It was set to 0.10 mm.

Then, on the outer surface of the distal end portion and the proximal end portion, a solution prepared by dissolving maleic anhydride methyl vinyl ether copolymer in tetrahydrofuran so as to be 2.0% by weight is applied to the surface of the synthetic resin layer formed by the above polyurethane. , A maleic anhydride methyl vinyl ether copolymer was fixed to form a lubricious surface, and a therapeutic device of the present invention having a shape as shown in FIG. 1 was prepared.

The therapeutic instrument of this example had a total length of about 1800 mm, the outer diameter of the main body portion was 1.5 mm, the outer diameter of the base end portion was 6.0 mm, and the outermost diameter of the front end was 0.81 mm.

(Example 2) The same core material as in Example 1 was used, and the tongue
Poly containing 45% by weight of Ten fine powder (particle size 3 to 4 μm)
Urethane (Pandex T-5000, Dainippon Ink Stock Association
1% by dipping using 5% / THF solution)
A synthetic resin layer was formed. As a vasodilator, the tongue
Contains 45% by weight of fine stainless steel powder (particle size: about 3-4 μm)
Polyurethane (Pandex T-5000, Dainippon Ink Co., Ltd.
Manufactured by Shikisha Co., Ltd., and has a cross-sectional shape as shown in FIG.
However, the maximum diameter of the large diameter part is 1.5 mm, and the length of the large diameter part is
Is 20 mm, the diameter of the tip of the taper part on the tip side is 0.46 mm, long
The diameter is 10 mm, and the diameter of the base end of the taper part on the base end side is 0.64 m.
m with a length of 5 mm and an inner diameter of 0.9 mm in the longitudinal direction
The one with the through hole is made by injection molding,
A solvent (THF) is added to the tip of the core material on which the synthetic resin layer is formed.
It was fixed using. Tube for forming lumen
As an inner diameter made of polyimide, 0.8mm, outer
A tube having a diameter of 0.9 mm was used. This tube is a blood vessel
The tip of the tube is passed through the tube through hole of the expansion part.
The tube from the opening on the tip side of the through hole to the outside.
The tip opening of the was closed with a metal rod.

Furthermore, the tube portion extending from the opening at the base end of the through hole was partially fixed to the first synthetic resin layer using an adhesive, and then the entire polyurethane 5% / T
A second synthetic resin layer was formed by dipping in an HF solution to completely fix the tube. The total thickness of the first synthetic resin layer and the second synthetic resin layer was 0.3 mm at the leading edge, 1.3 mm at the main body, and 2.5 mm at the base end. Further, the above synthetic resin was processed in a glass mold to form a curved surface with a constricted tip as shown in FIG.

Furthermore, from the base end of the blood vessel expansion part to the tip side, platinum fine powder
Polyureta containing 60% by weight of powder (particle size about 3-4 μm)
(Pandex T-5000, made by Dainippon Ink and Co., Ltd.) 7
Coat by dipping with 5% / THF solution,
The synthetic resin layer of was formed. The thickness of the third synthetic resin layer is
It was set to 0.1 mm.

Then, a hub made of nylon was fitted to the base end of the core material, and the fitting surface was fixed using an adhesive.

Then, on the outer surface of the distal end portion and the proximal end portion, a solution prepared by dissolving maleic anhydride methyl vinyl ether copolymer in tetrahydrofuran so as to be 2.0% by weight is applied to the surface of the synthetic resin layer formed by the above polyurethane. , A maleic anhydride methyl vinyl ether copolymer was fixed to form a lubricious surface, and a therapeutic device of the present invention having a shape as shown in FIG. 6 was prepared.

The treatment instrument of this example had a total length of about 1800 mm, the outer diameter of the main body portion was 1.8 mm, the outer diameter of the base end portion was 6.0 mm, and the outermost diameter of the front end was 0.81 mm.

(Example 3) A Ni-Ti alloy (56 atomic% Ni) was used as the first linear body, and the outer diameter of the main body portion was 0.7 mm, the length was 1200 mm, and the outer diameter of the base end portion was The length used was 1.0 mm, the length was 300 mm, the tip was reduced in diameter toward the tip, the outermost diameter was 150 μm, the tip length was 250 mm, and the total length was 1750 mm.

Stainless steel (SUS304) is used as the second linear body
The outer diameter is 50 μm and the tip length is 50 mm.
Pd the tip of the first linear body and the base end of the second linear body.
After plating, soldering was performed to prepare a core material. This core
Fine tungsten powder (particle size about 3-4 μm) on the surface of the material
45% Polyurethane (Pandex T-5000, large
Extruded and molded from Nippon Ink Co., Ltd.
Then, the first synthetic resin layer was formed. Of the first synthetic resin layer
The thickness of the leading edge is 0.30 mm, the thickness of the main body is 0.40 mm,
The wall thickness at the base end was 2.50 mm.

As a vasodilator, platinum fine powder (particle size about 3-4μ
m) containing 30% by weight of polyurethane (Pandex
T-5070, made by Dainippon Ink Co., Ltd.) and shown in Fig. 2.
It has a cross-sectional shape and the maximum diameter of the large diameter part is 1.5 mm.
The diameter of the large diameter part is 20 mm, and the taper part on the tip side is straight.
Diameter is 0.46 mm, length is 10 mm, diameter of the taper part on the proximal side
Made by injection molding with a length of 0.64 mm and a length of 5 mm
In the vicinity of the tip of the core material coated with the first synthetic resin layer
Then, it was fixed by using a solvent (THF).

Furthermore, from the proximal end of the blood vessel dilation portion to the distal end side (the second linear body is
60 pieces of fine platinum powder (particle size about 3-4 μm)
Polyurethane containing% by weight (Pandex T-5000, large
Cass using 5% / THF solution of Nippon Ink Co., Ltd.
Coating to form a second synthetic resin layer.
The thickness of the second synthetic resin layer was 0.05 mm.

Then, the second linear body is covered with a coil spring made of platinum (wire diameter 120 μm, spring outer diameter 0.81 mm, length 50 mm), and the end of the second linear body is attached to the tip of the coil spring. It was fixed by a brazing material. In addition, the base end portion of the coil spring was fixed to the second linear body from which the synthetic resin layer was removed, with a brazing material.

Then, on the outer surface of the synthetic resin layer at the distal end and the proximal end, a solution prepared by dissolving maleic anhydride methyl vinyl ether copolymer in tetrahydrofuran so as to be 2.0% by weight, of the synthetic resin layer formed by the polyurethane described above. A therapeutic device of the present invention having a shape as shown in FIG. 5 was prepared by applying it on the surface and fixing a maleic anhydride methyl vinyl ether copolymer to form a lubricious surface.

The therapeutic instrument of this example had a total length of about 1800 mm, the outer diameter of the main body portion was 1.5 mm, the outer diameter of the base end portion was 6.0 mm, and the outermost diameter of the front end was 0.81 mm.

(Example 4) A Ni-Ti alloy (56 atomic% Ni) was used as the first linear body, and the outer diameter of the main body portion was 0.7 mm, the length was 1200 mm, and the outer diameter of the base end portion was The length used was 1.0 mm, the length was 300 mm, the tip was reduced in diameter toward the tip, the outermost diameter was 150 μm, the tip length was 250 mm, and the total length was 1750 mm.

Stainless steel (SUS304) is used as the second linear body
The outer diameter is 50 μm and the tip length is 50 mm.
Pd the tip of the first linear body and the base end of the second linear body.
After plating, soldering was performed to prepare a core material. This core
Fine tungsten powder (particle size about 3-4 μm) on the surface of the material
Polyurethane containing 30% by weight (Pandex T-500
0, made by Dainippon Ink and Co., Ltd.) by dipping
did.

As a vasodilator, tungsten fine powder (particle size of about 3 ~
Polyurethane (Pandex T-5000, manufactured by Dainippon Ink and Chemicals, Inc.) containing 30% by weight of 4 μm) has a cross-sectional shape as shown in FIG. 7, and the maximum diameter of the large diameter portion is 1.
The diameter of the large diameter portion is 20 mm, the diameter of the tapered portion on the distal side is 0.46 mm, the length is 10 mm, the diameter of the tapered portion on the proximal side is 0.64 mm, and the length is 5 mm. , Inner diameter in the longitudinal direction
A tube having a 0.9 mm tube through hole was formed by injection molding, and was fixed by using a solvent (THF) near the tip of the core material on which the first synthetic resin layer was formed.

A tube having an inner diameter of 0.8 mm, an outer diameter of 0.9 mm, and a tube formed of polyimide was used as the tube for forming the lumen.

This tube was inserted into the tube through hole of the blood vessel expansion part, the tip portion of the tube was extended outside from the tip side opening of the through hole, and the tip opening of the tube was closed with a metal rod. Further, the tube portion extending from the opening on the base end side of the through hole was partially fixed to the first synthetic resin layer using an adhesive. In addition, the same polyurethane 5 as above
% / THF solution to form a second synthetic resin layer and completely fix the tube. The total thickness of the first synthetic resin layer and the second synthetic resin layer was 0.3 mm at the leading edge, 1.3 mm at the main body, and 2.5 mm at the base.

Furthermore, polyurethane (Pandex T-5000, Dainippon Nippon, containing 60% by weight of platinum fine powder (particle size of about 3 to 4 μm) from the base end of the vasodilator to the distal side (excluding the second linear body) 5% / THF solution (manufactured by Ink Co., Ltd.) was used to form a third synthetic resin layer. The thickness of the third synthetic resin layer was 0.05 mm.

Then, the second linear body is covered with a coil spring formed of platinum (wire diameter 120 μm, spring outer diameter 0.81 mm, length 30 mm), and the tip of the second linear body is used as the tip of the coil spring. It was fixed by a brazing material. In addition, the base end portion of the coil spring was fixed to the second linear body from which the synthetic resin layer was removed by a brazing material.

Then, a hub made of nylon was fitted to the base end of the core material, and the fitting surface was fixed with an adhesive.

Then, on the outer surface of the synthetic resin layer of the tip portion and the main body portion, a solution of maleic anhydride methyl vinyl ether copolymer dissolved in tetrahydrofuran so as to be 2.0% by weight, the surface of the synthetic resin layer formed by the above polyurethane Then, a maleic anhydride methyl vinyl ether copolymer was fixed to form a lubricious surface, and a therapeutic device of the present invention having a shape as shown in FIG. 10 was prepared.

The treatment instrument of this example had a total length of about 1800 mm, the outer diameter of the main body portion was 1.8 mm, the outer diameter of the base end portion was 0.6 mm, and the outermost diameter at the front end was 0.81 mm.

[Effects of the Invention] An instrument for treating ischemic disease according to the present invention has a core material and a blood vessel expansion portion fixed to a tip portion of the core material, and the blood vessel expansion portion is formed of a synthetic resin to be solid. Since the blood vessel dilation portion has a large-diameter portion and a taper portion having a diameter reduced from the large-diameter portion toward the distal end side, a conventional dilatation catheter was used. There is no need to perform complicated work such as insertion of a guide catheter, a guide wire, and a dilatation catheter as in the treatment of a vascular stenosis,
The vascular stenosis can be easily treated.

Furthermore, if the device for treating ischemic disease has a lumen that opens on the distal side from the vasodilator and opens at the rear end of the device for treating ischemic disease, the device for treating ischemic disease. When the tip of the vascular stenosis reaches the stenosis, before inserting the vasodilation into the stenosis, a thrombolytic agent is injected into the stenosis to soften the stenosis substance in the stenosis to some extent, and then the stenosis is narrowed. Since it can be inserted into the region, the treatment of the vasodilator can be performed reliably and easily.

[Brief description of drawings]

FIG. 1 is a sectional view of an embodiment of the device for treating ischemic disease of the present invention, FIG. 2 is a sectional view taken along line II of FIG. 1, and FIGS. 3 and 4 are ischemic of the present invention. FIG. 5 is a cross-sectional view of a vasodilator of another embodiment of the disease treatment device, FIG. 5 is a cross-sectional view of another embodiment of the ischemic disease treatment device of the present invention, and FIG.
Sectional drawing of the other Example of the device for ischemic disease treatment of this invention,
FIG. 7 is a sectional view taken along line II-II of FIG. 6, FIG. 8 and FIG.
FIG. 10 is a cross-sectional view of a vasodilator of another embodiment of the ischemic disease treatment instrument of the present invention, and FIG. 10 is a cross-sectional view of another embodiment of the ischemic disease treatment instrument of the present invention. 1,20,30,50 …… Instrument for ischemic disease treatment 2 …… Core material, 3
...... Vascular expansion part, 5 ... tip, 6 ... first synthetic resin layer, 7 ... second synthetic resin layer, 8 ... lubricant, 22 ...
… Lumen, 23 …… Aperture, 24 …… Hub, 31 …… First linear body, 32 …… Second linear body, 38 …… Induction part,

Claims (5)

[Claims] 1. A core material and a blood vessel expansion portion fixed to a tip portion of the core material, wherein the blood vessel expansion portion is made of a synthetic resin and is solid. An instrument for treating ischemic disease, comprising: a large-diameter portion and a taper portion having a diameter reduced from the large-diameter portion toward the distal end side. 2. The ischemic disease treatment device has a lumen having one end open at the proximal end side of the vasodilator and the other end opened at the rear end of the ischemic disease treatment device. The device for treating ischemic disease according to claim 1, wherein 3. A core material and a blood vessel expanding portion fixed to a tip portion of the core material, the blood vessel expanding portion having a large diameter portion and a diameter reduced toward the tip side from the large diameter portion. It has a taper part,
The blood vessel dilating portion is provided with a lumen that is open at one end on the end side and is open at the other end at the rear end portion of the device for treating ischemic disease, and the blood vessel dilating portion is synthetic except for the lumen portion. A device for treating ischemic disease, which is formed of a solid resin. 4. The device for treating ischemic disease according to claim 1, wherein a groove extending in the longitudinal direction is provided on the outer surface of the large diameter portion of the vasodilator. 5. The guide portion of the device for treating ischemic disease is provided at the tip of the device for treating ischemic disease.
5. The device for treating ischemic disease according to any one of 4 to 4.