JPH11128350A - Catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a catheter provided with a balloon which does not require the provision of a lumen to be exclusively used for medicinal liquid administration and is capable of administering a medicinal liquid in extreme proximity to the balloon and a catheter for vasodilation. SOLUTION: This catheter is the catheter for vasodilation having a catheter body, the vasodilative balloon 3 which is mounted at this catheter body and has the max. dilation form and a lumen 16 for the balloon which communicates whit the vasodilative balloon 3. When liquid is injected into the lumen 16 for the vasodilative balloon, the vasodilative balloon 3 is dilatable up to the max. dilation form and is capable of allowing the liquid flow out of the front end 3a or base end of the vasodilative balloon in this state.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a catheter having a liquid administration function. In particular, PTCA in stenotic lesions in the field of endovascular treatment, mainly in stenotic sites such as cardiovascular
The present invention relates to a catheter that can administer a drug solution at a treatment site during and after treatment.

[0002]

2. Description of the Related Art Conventionally, there is a catheter for administering a drug solution provided with a balloon. As such a catheter, for example, a type in which a micropore is formed in a balloon and a drug solution is exuded therefrom, a drug solution administration lumen and a drug solution administration port communicating with this lumen are provided on a side wall of the catheter body, and the catheter is provided therefrom. There is a type that discharges a chemical solution.

[0003]

However, in the above-mentioned type in which the drug solution is exuded from the micropores of the balloon, it is difficult to regularly and regularly open the micropores in the balloon. The balloon may be damaged. Further, in the case of having a lumen for drug solution administration, it is difficult to provide a drug solution administration port at a position close to the inflated portion of the balloon which is a treatment site due to the fusion portion of the balloon, and because only the drug solution is administered. It is also necessary to form a lumen, and there is a problem that the diameter of the catheter body becomes large due to the lumen for administering the drug solution.

SUMMARY OF THE INVENTION An object of the present invention is to provide a catheter and a vascular dilatation catheter having a balloon which does not require a dedicated lumen for administering a drug solution and which can administer a drug solution at an extremely expanded portion of the balloon. is there.

[0005]

The above object is achieved by a catheter having a catheter body, a balloon mounted on the catheter body, and a balloon lumen communicating with the balloon. The balloon is formed of a material incompatible with the catheter body forming material in the vicinity of the balloon mounting portion, and the distal end or the rear end of the balloon is formed of a material incompatible with the balloon forming material. The fixing tube is fitted, furthermore, the fixing tube is adhered or fused to the catheter body at a portion beyond the front end or the rear end of the balloon, and further, the balloon catheter is When a liquid is injected into the balloon lumen, the balloon is inflated and the distal end or base of the balloon is inflated. A catheter which is capable flow out from the liquid part.

In order to achieve the above object, there is provided a catheter including a catheter body, a balloon mounted on the catheter body, and a balloon lumen communicating with the balloon, wherein the balloon is mounted on the balloon. A portion of the balloon is formed of a material that is incompatible with the material for forming the catheter body, and a distal end portion and a rear end portion of the balloon are formed of a material that is incompatible with the balloon forming material. A tube is fitted, and the fixing tube is adhered or fused to a catheter body at a portion beyond a front end portion and a rear end portion of the balloon, and further, the balloon catheter is used for the balloon. When liquid is injected into the lumen, the liquid flows from the distal and proximal ends of the balloon as the balloon expands. Possible to be in that catheter that is.

[0007] Further, what achieves the above object is a catheter having a catheter main body, a balloon mounted on the catheter main body, and a balloon lumen communicating with the balloon, wherein the balloon has a distal end or a rear end. At the end, a fixing tube is fitted, the fixing tube is adhered or fused to the catheter body at a portion beyond the front end or the rear end of the balloon, and the balloon is The catheter body and the fixing tube are not adhered or fused to each other.When the liquid is injected into the lumen for the balloon, the balloon catheter inflates the liquid from the distal end or the proximal end of the balloon as the balloon expands. This is a catheter that can flow out.

It is preferable that the balloon is not bonded or fused to the catheter body and the fixing tube. In addition, it is preferable that the fixing tube is formed of a material that is compatible with the catheter body forming material near the balloon mounting portion. Further, the fixing tube is preferably a heat-shrinkable tube.

Another object of the present invention is to provide a vasodilator having a catheter body, a vascular dilatation balloon mounted on the catheter body and having a maximum expansion configuration, and a balloon lumen communicating with the vasodilator balloon. A catheter, wherein when the liquid is injected into the lumen for the vasodilatation balloon, the vasodilation balloon is expandable to a maximum inflation configuration, and in this state, liquid is supplied from the distal end or the proximal end of the vasodilation balloon. This is a vascular dilatation catheter capable of flowing out.

[0010] The catheter includes a sub-balloon provided at a position of the catheter body on the distal side or the proximal side of the vascular dilatation balloon, and a sub-balloon lumen communicating with the sub-balloon. There may be. Further, a fixing tube is fitted to the distal end or the rear end of the vasodilator balloon,
The fixing tube is adhered or fused to the catheter main body at a portion beyond the front end or the rear end of the vascular dilatation balloon, and the vascular dilatation balloon is adhered to the catheter main body and the fixing tube. Alternatively, it is preferable not to be fused. Also,
A fixing tube is fitted over the distal end and the rear end of the vasodilator balloon, and the fixing tube is adhered to the catheter body at a portion beyond the distal end and the rear end of the vascular dilatation balloon. It is preferable that the vascular dilatation balloon is fused and not adhered or fused to the catheter body and the fixing tube.

The vascular dilatation balloon is formed of a material that is incompatible with the catheter body forming material in the vicinity of the vascular dilatation balloon mounting portion, and the fixing tube is formed in the vicinity of the vascular dilation balloon mounting portion. The fixing tube is made of a material that is compatible with the material for forming the catheter main body and is incompatible with the material for forming the vasodilatation balloon. Preferably, they are fused.

The catheter further includes a first sub-balloon provided at a position of the catheter main body on the distal end side with respect to the vascular dilatation balloon; a first sub-balloon lumen communicating with the first sub-balloon; A second sub-balloon provided at a position of the catheter main body on the rear end side of the vascular dilatation balloon, and a second sub-balloon lumen communicating with the second sub-balloon may be provided. Further, the catheter may be configured so that liquid can flow out from the distal end portion and the proximal end portion of the vasodilator balloon. Further, the fixing tube,
Preferably, it is a heat-shrinkable tube.

[0013]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The catheter of the present invention will be described with reference to an embodiment in which a catheter for vascular dilatation is applied. FIG.
BRIEF DESCRIPTION OF THE DRAWINGS It is a front view of one Example of the vascular dilatation catheter of this invention. FIG. 2 is an enlarged cross-sectional view near the distal end of the vascular dilatation catheter shown in FIG. FIG. 3 is an enlarged cross-sectional view of a central junction portion of the vascular dilatation catheter shown in FIG.
FIG. 4 is a sectional view taken along line AA of FIG. FIG. 5 is a sectional view taken along line BB of FIG.

The catheter 1 of the present invention has a catheter body 2, a vascular dilatation balloon 3 mounted on the catheter body 2 and having a maximum expansion configuration, and a balloon lumen 16 communicating with the vasodilation balloon 3. It is a catheter. And lumen 1 for vascular dilatation balloon
6, when the liquid is injected into the vascular dilatation balloon 3, the vascular dilatation balloon 3 can be expanded to the maximum dilatation form, and in this state, the liquid can flow out from the distal end 3a or the base end of the vascular dilatation balloon 3. is there.

The catheter 1 further comprises a catheter body 2 and a balloon 3 mounted on the catheter body 2.
And a balloon lumen 16 that communicates with the balloon 3. The balloon 3 is formed of a material that is incompatible with the catheter body forming material in the vicinity of the balloon mounting portion, and the distal end 3 a or the rear end 3 b (or the distal end 3 a and the rear end 3) of the balloon 3.
In b), fixing tubes 4 and 5 formed of a material incompatible with the balloon forming material are fitted, and the fixing tubes 4 and 5 are further attached to the distal end 3 of the balloon 3.
a or a portion beyond the rear end 3b (or the front end 3a and the rear end 3b) is adhered or fused (fixed) to the catheter main body 2, and the balloon catheter 1 is filled with liquid in the balloon lumen 16. Is injected, the liquid can flow out from the distal end portion 3a or the proximal end portion 3b (or the distal end portion 3a and the rear end portion 3b) of the balloon 3 as the balloon 3 is inflated.

The catheter 1 of the present invention comprises a catheter body 2 and a balloon 3 attached to the catheter body 2.
And a balloon lumen 16 communicating with the balloon 3. The distal end 3 a or the rear end 3 b (or the distal end 3 a and the rear end 3 b) of the balloon 3.
The fixing tubes 4, 5 are fitted on the distal end portion 3 a of the balloon 3.
Alternatively, the rear end 3b (or the front end 3a and the rear end 3
The balloon 3 is bonded or fused (fixed) to the catheter body 2 at a portion exceeding b), and the balloon 3 is not bonded or fused (fixed) to the catheter body 2 and the fixing tubes 4 and 5. When the liquid is injected into the lumen 16, the distal end 3 a or the proximal end 3 b (or the distal end 3
a and the liquid can flow out from the rear end 3b).

The catheter 1 includes a tubular catheter body 2 and a collapsible and expandable balloon 3 attached to the distal end of the catheter body 2. The catheter body 2 has a vasodilation balloon lumen 16 having one end communicating with the inside of the balloon 3. The balloon 3 has a maximum expansion configuration, and is injected into the vasodilation balloon lumen 16 at the center. The expandable portion 31 is provided with an expandable portion having substantially the same diameter by a fluid.

Therefore, the vascular dilatation catheter 1 of the present invention
Is referred to as a rapid exchange type, in which a guide wire inlet 36 is provided at an intermediate portion of the catheter main body 2, and the catheter main body 2 is provided with a guide wire lumen 15 which communicates with the inlet and opens at the distal end. This will be described using

In this vascular dilatation catheter 1, the catheter body 2 has one end opened at the tip of the catheter body 2 and the other end opened at an intermediate portion of the catheter body (a joint connector 7 described later). Lumen 1
5 is provided.

The vascular dilatation catheter 1 includes a catheter body 2, a vascular dilatation balloon 3 fixed to the distal end of the catheter body 2, and a distal-side fixing tube 4 that covers the distal-side mounting portion of the balloon 3. And a rear end side fixing tube 5 for fitting the rear end side mounting portion of the balloon 3.

The catheter body 2 is provided with a joint connector 7 at an intermediate portion, and is divided into a distal shaft portion 10 and a rear shaft portion 20 with the joint connector 7 as a boundary. I have.

The distal shaft section 10 includes an inner tube 12 forming a guide wire lumen 15 as shown in FIG.
An outer tube 13 is provided which encloses the inner tube 12, has a distal end slightly behind the distal end of the inner tube 12, and forms a vascular dilatation balloon lumen 16 with the outer surface of the inner tube 12. .

The balloon 3 has a front end (front end mounting portion) 3a and a rear end (rear end mounting portion) 3b.
The distal mounting portion 3a is mounted and fixed at a position slightly rearward from the distal end of the inner tube 12 by a distal fixing tube 4, and the rear mounting portion 3b is fixed to the outer tube 1 by a rear fixing tube 5.
3 is attached and fixed. The balloon 3 is fixed to the inner tube 12 or the outer tube 13 but is not bonded or fused. The balloon 3 communicates with the vascular dilatation balloon lumen 16 near the base end.

The inner tube 12 has an outer diameter of 0.35-1.
0 mm, preferably 0.45 to 0.8 mm, and an inner diameter of 0.2 to 0.9 mm, preferably 0.35 to 0.7 m
m. The outer diameter of the outer tube 13 is 0.6 to 1.5 m.
m, preferably 0.8 to 1.1 mm and an inner diameter of 0.1 mm.
It is 5 to 1.4 mm, preferably 0.7 to 1.0 mm.

The material for forming the inner tube 12, the outer tube 13, and the fixing tubes 4 and 5 is preferably a material having a certain degree of flexibility.
Polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, etc., and also includes crosslinked or partially crosslinked products), thermoplastic resins such as polyvinyl chloride, polyamide elastomer, polyurethane, silicone rubber, latex rubber And the like can be used, preferably the above-mentioned thermoplastic resin, and more preferably a crosslinked or partially crosslinked polyolefin.

The balloon 3 has a maximum expandable form and is foldable. When the balloon 3 is not expanded, it can be folded around the inner tube 12. The balloon 3 has an expandable portion 31 which is a cylindrical portion (preferably, a cylindrical portion) having substantially the same diameter so as to expand a blood vessel stenosis. The above-mentioned substantially cylindrical portion does not have to be a perfect cylinder, and may be a polygonal column. The balloon 3 has a distal end (front end mounting portion) 3a on the inner tube 12 and a rear end (rear end mounting portion) 3b.
Are attached to the distal end of the outer tube 13 by the respective fixing tubes 4, 5
Therefore, it is mounted in a non-liquid-tight state. Specifically, when a liquid is injected into the lumen 16 for a vasodilatation balloon, the vasodilation balloon 3 can be expanded to the maximum dilatation form, and in this state, the vasodilation balloon 3 can be expanded from the distal end 3a and the proximal end. It is mounted so that liquid can flow out.

The balloon 3 forms an expansion space 30 between the inner surface of the balloon 3 and the outer surface of the inner tube 12, as shown in FIG. This expansion space communicates with the expansion lumen 16 at the rear end 3b on the entire circumference. in this way,
Since the rear end of the balloon 3 communicates with the expansion lumen having a relatively large volume, it is ensured that the expansion fluid is injected into the balloon from the expansion lumen 16.

The material for forming the balloon 3 is preferably a material having a certain degree of flexibility. For example, polyolefins (eg, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, cross-linked ethylene) -Vinyl acetate copolymer), polyvinyl chloride, polyamide elastomer, polyurethane,
Thermoplastic resins such as polyester (eg, polyethylene terephthalate) and polyarylene sulfide (eg, polyphenylene sulfide), silicone rubber, latex rubber, and the like can be used. In particular, it is preferably a stretchable material, and the balloon 3 is preferably biaxially stretched having high strength and expansion force. In the catheter 1, a combination of the catheter body 2 (the inner tube 12 and the outer tube 13) and the balloon 3 having no compatibility (heat fusion property) is selected.

As for the size of the balloon 3, the outer diameter of the cylindrical portion (expandable portion 31) when expanded is 2 to 4 m.
m, preferably 2.5-3.5 mm and a length of 10
５０50 mm, preferably 20-40 mm. Also,
The outer diameter of the distal end side mounting portion 3a is 0.9 to 1.5 mm, preferably 1 to 1.3 mm, and the length is 1 to 5 mm, preferably 1 to 1.3 mm. Also, the rear end mounting portion 3b
Has an outer diameter of 1 to 1.6 mm, preferably 1.1 to 1.5 mm.
mm and a length of 1 to 5 mm, preferably 2 to 4 mm
It is.

A contrast marker 38 is attached to the outer surface of the inner tube 12 at a position substantially at the center of the balloon 3. The marker 38 is preferably a ring-shaped member having a predetermined length, or a linear member wound in a coil shape. Further, the marker 38 is formed of an X-ray opaque material (for example, gold, platinum, tungsten or an alloy thereof, or a silver-palladium alloy or the like). By providing such a marker 38, the position of the expandable portion 31 of the balloon 3 can be confirmed by X-ray contrast. Note that two markers may be provided at both ends of the balloon, that is, at positions that extend over the expandable portion 31, the front end 3a, and the rear end 3b.

The material for forming the balloon 3 is the inner tube 1
2. A material having no compatibility (in other words, adhesiveness) with the material for forming the outer tube 13 and the fixing tubes 4 and 5 is used. Specifically, the balloon 3 is formed of a material that is incompatible with the catheter body 2 (the inner tube 12 and the outer tube 13) in the vicinity of the balloon mounting portion. The fixing tubes 4 and 5 formed of a material that is compatible with the material for forming the catheter body near the portion and that is incompatible with the material for forming the balloon are fitted. The fixing tubes 4 and 5 are fixed to the catheter main body 2 at portions beyond the distal end 3a and the rear end 3b of the balloon 3, and the balloons 3 are separated from the catheter main body 2 by the fixing tubes 4 and 5. It is held (mounted) so that it does not come off.

Specifically, the distal end side fixing tube 4 and the rear end side fixing tube 5 are connected to the distal end portion 3 a of the balloon 3.
And the proximal end portion is covered by about 1 to 3 mm,
It has a fixed portion (adhered or fused portion). The distal end side fixing tube 4 has a tapered shape whose diameter gradually decreases toward the distal end. With such a configuration, the fixing tube 4 can have a function of guiding to a stenosis portion. Furthermore, it is preferable that the rear end side fixing tube 5 also has a tapered shape whose diameter gradually decreases toward the rear end.

The rear end of the distal end side fixing tube 4 is
The liquid medicine is located near the distal end of the balloon expansion portion 31 and flows out from the proximal end of the fixing tube 4 to the outside.
Therefore, the drug solution flows out from a position extremely close to the balloon expansion portion 31. For this reason, a medical solution can be reliably brought into contact with a stenotic portion of a blood vessel. Similarly, the distal end of the rear end side fixing tube 5 is located near the rear end of the balloon expansion portion 31, and the chemical solution flows out from the front end of the fixing tube 5. Therefore, the drug solution flows out from a position extremely close to the balloon expansion portion 31. For this reason, a medical solution can be reliably brought into contact with a stenotic portion of a blood vessel.

As a material for forming the front end side fixing tube 4 and the rear end side fixing tube 5, a material having no compatibility (in other words, adhesiveness, heat fusion property) with the material forming the balloon 3 is used. Is preferred. Also, it is preferable to use a material that does not have compatibility (in other words, adhesiveness and heat-fusing property) with the material for forming the balloon 3 as the material for forming the fixing tube 5.

The fixing tubes 4 and 5 are connected to the inner tube 1.
2. A material compatible with the outer tube 13 or not. A compatible material is preferable because both can be easily fixed by heat fusion (so-called heating). When the materials are incompatible, both may be fixed with an adhesive. As adhesive, low molecular weight polyethylene, EVA
(Ethylene vinyl acetate) based hot melt adhesives are suitable.

The balloon 3, the catheter body 2 (the inner tube 1)
As a combination of materials of the outer tube 13) and the fixing tubes 4 and 5 (when the fixing tube is fused to the catheter body by heating), the balloon 3 is formed of polyester (for example, polyethylene terephthalate) or polyamide. The inner tube 12, the outer tube 13, and the fixing tubes 4 and 5 are made of polyolefin or cross-linked or partially cross-linked polyolefin (for example, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer or cross-linked or partially thereof). (Crosslinked product).

When the material of the balloon 3, the catheter body 2 (the inner tube 12, the outer tube 13) and the fixing tubes 4 and 5 are combined (when the fixing tube is fixed to the catheter body by an adhesive), Although any combination of materials may be used, when a heat-shrinkable tube is used as the fixing tube, the inner tube 12 and the outer tube 13 are formed of polyester, polyester elastomer, polyamide, or polyamide elastomer. Is formed of polyolefin or cross-linked polyolefin, the balloon 3 is formed of polyester, polyester elastomer, polyamide, polyamide elastomer, or silicone rubber. The fixing tube is made of silicone, and the balloon is made of polyester (for example, PET), polyamide, or polio. The catheter body (the inner tube 12 and the outer tube 13) is made of polyester (for example, PET), polyamide, or polyolefin, and is not a material for forming a balloon. , The inner tube 12 and the outer tube 13 are desirably different from each other.

It is preferable to use heat-shrinkable tubes as the fixing tubes 4 and 5. By using such a heat-shrinkable tube, the holding of the balloon 3 is ensured, and the operation of mounting the balloon is also facilitated.

As described above, the balloon 3 is attached (attached and fixed) to the catheter body 2, but is not liquid-tightly adhered or fused. However, the tip 3a of the balloon 3
Since the rear end portion 3b is firmly attached to the catheter body 2 (the inner tube 12 and the outer tube 13) by the fixing tubes 4 and 5, the liquid injected into the balloon 3 can easily flow out. Instead, the balloon 3 expands to its maximum expanded configuration, and when liquid is injected at a pressure higher than the pressure required for the maximum expanded configuration, the balloon 3 and the fixing tubes 4 and 5 have some flexibility. To have
The space between the distal end portion 3a of the balloon 3 and the inner tube 12 and the rear end portion 3b of the balloon 3 and the outer tube 13 spread, and the liquid passes therethrough.
Further, the liquid that has passed through the tip 3 of the balloon 3
a and the distal end side fixing tube 4, and between the rear end 3 b of the balloon 3 and the rear end side fixing tube 5, and flows out of the catheter 1. Examples of the liquid used for expanding the balloon 3 include thrombolytic agents (eg, urokinase, pro-urokinase, streptokinase, plasminogen activator), a mixture of an X-ray contrast agent and a thrombolytic agent, heparin, warfarin, Aspirin, a smooth muscle cell proliferation inhibitor and the like are used, and an anticancer agent and the like can be used for malignant tumors.

In the catheter 1 of the above-described embodiment, the liquid can flow out from both the front end and the rear end of the balloon 3. However, the present invention is not limited to this. The liquid may be allowed to flow out only from the rear end. In this case, the balloon 3 and the catheter body 2 (the inner tube 1)
The outer tube 2 or the outer tube 13) may be a combination having compatibility (heat fusibility), or may be liquid-tightly fixed using an adhesive, and a fixing tube on that side is unnecessary. is there.

In the case where only one outflow of the chemical is performed, it is preferable that the liquid can be outflowable from the distal end side of the balloon. When the liquid can flow out from both the front end and the rear end of the balloon 3, it is desirable that the strength of the balloon attached be higher on the rear end side. Even if the liquid is injected suddenly and under high pressure and the balloon is partially detached from the catheter, the distal end of the balloon will be detached, and the partially detached balloon will not hinder the removal of the catheter. .

As shown in FIG. 6, the distal end and the rear end of the balloon 3 have bulging portions 3c and 3d (parts larger than the other portions) in order to prevent the balloon 3 from coming off the fixing tubes 4 and 5. ). The bulging portion can be formed by heating the front and rear ends of the balloon 3.

Next, the rear end side shaft portion 20 of the catheter body 2 will be described with reference to FIGS. The rear end side shaft portion 20 includes a shaft tube 32 and the hub 8 fixed to the rear end. A rigidity imparting body 33 is inserted into the shaft tube 32,
The rigidity imparting body 33 is fixed to the shaft tube 32 at the rear end, and the distal end projects from the distal end of the shaft tube 32, penetrates the joint connector 7, and extends into the distal end side shaft. In this embodiment, the tip 3 of the rigidity imparting body 33
“a” has reached between the inner tube 12 and the outer tube 13 of the distal shaft, in other words, into the lumen 16 for the vasodilator balloon.

The rigidity imparting member 33 is formed of the shaft tube 32.
Extends from the base end toward the front end side. Further, the rigidity imparting body 33 is fixed to the shaft tube 32 or the hub 8 only at the base end so as not to obstruct the bending of the catheter body 2, and the other parts, specifically, the base of the shaft tube 32 Inner excluding the end, joint connector 7 portion, distal shaft portion (inner tube 12 and outer tube 1
It is not fixed to any of 3).

The rigidity imparting member 33 is formed of the shaft tube 32
The extreme bending of the shaft tube 32 at the bending portion without significantly reducing the flexibility of the shaft tube prevents the meandering of the shaft tube 32 in the blood vessel. Stiffness imparting body 33
Is preferably formed of a linear body. The linear body is preferably a metal wire and has a wire diameter of 0.0
An elastic metal such as stainless steel having a thickness of 5 to 1.5 mm, preferably 0.1 to 1.0 mm, a superelastic alloy, or the like is particularly preferable, and a high tensile strength stainless steel for a spring or a superelastic alloy wire is particularly preferable.

The superelastic alloy referred to here is generally called a shape memory alloy, and exhibits superelasticity at least at a biological temperature (around 37 ° C.). Particularly preferably, a Ti-Ni alloy of 49-53 atomic% Ni, 38.5-41.5% by weight
Cu-Zn alloy of Zn, Cu-Zn of 1-10 wt% X
-X alloy (X = Be, Si, Sn, Al, Ga), 36
A superelastic alloy such as a Ni-Al alloy of -38 atomic% Al is preferably used. In particular, the above-mentioned Ti-Ni alloy is desirable. Further, a part of the Ti—Ni alloy is reduced to 0.01 to 10.0.
Ti-Ni-X alloy substituted with atomic% X (X = Co, F
e, Mn, Cr, V, Al, Nb, W, B, etc.) or a part of the Ti—Ni alloy
Ti-Ni-X alloy substituted with atomic% X (X = Cu, P
b, Zr), and by selecting the cold working rate and / or the conditions of the final heat treatment, the mechanical properties can be changed as appropriate. In addition, the above Ti-Ni-
By selecting the cold working ratio and / or the conditions of the final heat treatment using the X alloy, the mechanical properties can be changed as appropriate.

The shaft tube 32 has a rigidity-imparting body 33 fixed at its proximal end. A kink preventing tube 35 is attached to the outer surface of the boundary between the hub 8 and the shaft tube 32 so as to cover them. The rear end of the hub 8 serves as a connection portion for a balloon inflation fluid injection device (for example, a syringe).

The shaft tube 32 has an outer diameter of 0.6 to 1.5 mm, preferably 0.8 to 1.3 mm, and an inner diameter of 0.5 to 1.4 mm, preferably 0.7 to 1.5 mm.
1.2 mm.

The material for forming the shaft tube 32 is preferably a material having a certain degree of flexibility, for example, polyolefin (eg, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, etc.), Thermoplastic resins such as polyvinyl chloride, polyamide elastomer, polyimide, polyurethane, silicone rubber, latex rubber, etc. can be used,
Preferably, the above-mentioned thermoplastic resin is used. The material for forming the fixing tube 4 preferably has an adhesive property (compatibility) with the material for forming the inner tube 12. Further, it is preferable that the material for forming the fixing tube 5 has adhesiveness (compatibility) with the material for forming the outer tube 13.

The front shaft portion and the rear shaft portion are
It is joined by the joining connector 7. As shown in FIGS. 3, 4, and 5, the joining connector 7 has an inner tube insertion passage that extends in the axial direction from the center of the distal end to the central portion, curves from the central portion, and reaches the outer surface on the rear end side. The inner tube 1
The rear end of the inner tube 12 penetrates the rear end of the inner tube 12 and projects from the side surface of the joint connector 7 to form a guide wire inlet 36. In addition, the connecting connector 7 has balloon expansion fluid flow passages 37a and 37b extending from the distal end to the proximal end.
Are formed.

In this embodiment, as shown in FIG. 5, two fluid flow paths for balloon expansion are formed. Through this flow passage, the vasodilator balloon lumen 16 formed between the inner tube 12 and the outer tube 13 communicates with the vasodilator balloon lumen 16 formed in the shaft tube 32. Further, as described above, the joining connector 7 is formed with the stiffening body conduction path penetrating from the distal end to the base end, and the stiffening body 33 penetrates this.

Next, a method for manufacturing the catheter of the present invention will be described. First, the inner tube 12 and the outer tube 13 are prepared. Then, a balloon 3 made of a material having no compatibility with the inner tube 12 and the outer tube 13 is prepared. Furthermore, it has compatibility with the inner tube 12 and the outer tube 13,
Two types of EVA heat-shrinkable tubes (about 3 mm) formed of a material having no compatibility with the balloon 3 are prepared. As the heat-shrinkable tube used for the distal end side fixing tube 4, the inner diameter before heat shrinkage is larger than the outer diameter of the inner tube 12, and the inner diameter after heat shrinkage (after heat treatment) is smaller than the outer diameter of the inner tube 12. Are more commonly used. As the heat-shrinkable tube used for the rear end side fixing tube 5, the inner diameter before heat shrinkage is larger than the outer diameter of the outer tube 13, and the inner diameter after heat shrinkage (after heat treatment) is larger than the outer diameter of the outer tube 13. Those that become smaller are more often used.

Then, the front end of the outer tube 13 (formed of, for example, a polyolefin material) is inserted into the rear end of the balloon 3 (formed of, for example, polyethylene terephthalate or polyamide), and the outer tube 13 and the rear end of the balloon 3 are inserted. A heat-shrinkable tube serving as the rear-end side fixing tube 5 is coated so as to cover the contact portion of the portion 3b by about 1 to 2 mm, and further extends to the rear end side and comes into direct contact with the outer surface of the outer tube 13 by about 1 to 2 mm. set. In addition, the tube has an end portion whose diameter is reduced in a tapered shape, and the tube is set so that the tapered end portion is on the rear end side.

Then, at 120 to 130 ° C. for about 5 seconds, EV
A heat-shrinkable tube made of A is shrunk by heating, further covered with a heat-shrinkable tube made of silicon, heated for about 20 seconds, and cooled,
Remove the silicone heat shrink tubing. This allows
The heat-shrinkable tube is heat-fused to the distal end of the outer tube 13, and the rear end 3 b of the balloon 3 is attached to the distal end of the outer tube 13 in close contact.

Next, a cut is made in the vicinity of the rear end of the outer tube 13 (at a position of about 10 mm) for about a half circumference. An X-ray contrast marker 38 (platinum,
An inner tube 12 to which gold or the like is adhered is prepared. A core (for example, an outer diameter of 0.40 mm) is inserted into the inner tube 12, inserted into the outer tube through a cut in the outer tube 13, and the distal end of the inner tube 12 is projected about 2 mm from the distal end of the balloon 3. Then, a core metal for securing the inflation lumen for the balloon (with an outer diameter of 0.1 mm).
(About 20 mm, 3 pieces) are inserted into a lumen formed between the inner tube 12 and the outer tube 13.

Then, a heat-shrinkable tube made of silicon is put on the cut formed at the rear end of the outer tube 13 and
Heat at 45 ° C. for 30 seconds to fuse the proximal end of the inner tube 12 and the proximal end of the outer tube 13 to form a guide wire port and a balloon inflation lumen.

Then, the inner tube 12 and the distal end portion 3 of the balloon 3
A heat-shrinkable tube serving as the distal end side fixing tube 4 is set so as to cover the contact portion a of about 1 to 2 mm and further extend to the distal end side and make direct contact with the outer surface of the inner tube 12 by about 1 to 2 mm. In addition, the tube has an end portion whose diameter is reduced in a tapered shape, and the tube is set so that the tapered end portion is on the distal end side.

Then, at 120 to 130 ° C. for about 5 seconds, EV
A heat-shrinkable tube made of A is shrunk by heating, further covered with a heat-shrinkable tube made of silicon, heated for about 20 seconds, and cooled,
Remove the silicone heat shrink tubing. This allows
The heat-shrinkable tube is heat-fused to the distal end of the inner tube 12, and the distal end 3 a of the balloon 3 is attached to the distal end of the inner tube 12 in close contact.

Then, a base shaft (polyamide, polyimide, polyester, polyolefin or the like) to which a drug solution injection port (also serving as a balloon expansion port) is attached is adhered or fused to the end of the outer tube 13 so that the catheter 1 of the present invention can be used. Is manufactured.

The catheter 1 of the above embodiment is of a so-called rapid exchange type and has a guide wire port in the middle of the catheter body 2.
However, the present invention is not limited to this type, and may be a so-called coaxial type in which the double pipe structure of the inner pipe 12 and the outer pipe 13 is continued to the rear end. Further, instead of the double tube structure, a type having a balloon inflation lumen in the wall of one catheter tube may be used. Further, the catheter of the present invention is not limited to a catheter for vasodilation, but can also be used for a urethral catheter, a cerebral vascular catheter, and the like.

Next, the catheter 50 of the embodiment shown in FIGS. 7 and 8 will be described. The catheter 50 of this embodiment includes a catheter main body 52 and a vascular dilatation balloon 3 attached to the catheter main body 52 and having a maximum expansion configuration.
And a lumen 16 for a vascular dilatation balloon that communicates with the vascular dilatation balloon 3, a sub-balloon 54 provided at a position of the catheter body 52 that is on the distal side or the proximal end side of the vascular dilation balloon 3, and communicates with the sub-balloon 54. This is a vascular dilatation catheter including a sub-balloon lumen 55. Then, when the liquid is injected into the lumen 16 for the vasodilatation balloon, the vasodilation balloon 3 can be expanded to the maximum dilatation form, and in this state, the distal end portion 3a or the proximal end portion (or the distal end portion) of the vasodilation balloon 3 3a and the base end).

The basic structure is the same as that of the above-mentioned catheter 1, and the difference is that this catheter is provided with a sub-balloon 54 provided on the distal side of the dilatation balloon 3, and a sub-balloon lumen 55 communicating with the sub-balloon 54. It is a point which has. Further, the catheter 50 is not a rapid exchange type but a coaxial type in which a double tube structure is continuous from the front end to the rear end. A hub 58 is attached to the proximal end of the catheter 50. The hub 58 includes a guide wire port 59,
A lumen port 60 for an expansion balloon and a lumen port 61 for a sub-balloon are provided. Further, the sub-balloon lumen 55 is formed in the inner wall of the inner tube 12, and an opening for communicating the sub-balloon lumen 55 with the inside of the sub-balloon 54 is formed on the side surface of the distal end portion of the inner tube 12. ing.

The sub-balloon 54 is preferably made of an extensible material (for example, silicone rubber or latex rubber). The front and rear ends of the sub-balloon 54 are attached to the front end of the inner tube 12. Liquid tightly fixed. The sub-balloon 54 can be used for pre-expansion by being inflated before expansion by the dilatation balloon 3. Further, the sub-balloon 54 is inflated at the same time as the dilatation of the dilation balloon 3, and is placed between the dilation balloon 3 and the sub-balloon 54. Liquid (medical solution), for example, a mixed solution of a thrombolytic agent, an X-ray contrast agent and a thrombolytic agent, which has flowed out from the tip side of the stenosis, and the liquid (chemical solution) can be reliably brought into contact with the stenosis part. .

As the vascular dilatation balloon 3, the inner tube 12, the outer tube 13, and the distal end fixing tube 4 and the rear end fixing tube 5, those described for the catheter 1 can be suitably used. Also, the method described above can be used.

In the catheter of this embodiment, the sub-balloon 54 is provided on the distal end side of the vascular dilatation balloon 3, but may be provided on the base end side of the vascular dilation balloon 3. In this case, the lumen for the sub-balloon is
3 is formed inside the inner wall of the sub-balloon.
An opening communicating with the inside will be formed. And
In such a catheter, the sub-balloon 54 is simultaneously inflated when the dilatation balloon is inflated, and a liquid flowing out of the distal end side of the dilatation balloon 3 between the dilation balloon 3 and the sub-balloon 54, for example, a thrombolytic agent, X-ray The mixed solution of the contrast agent and the thrombolytic agent can be stored, and the liquid can surely contact the stenosis.

Next, the catheter 60 of the embodiment shown in FIGS. 9 and 10 will be described. The catheter 60 of this embodiment includes a catheter body 62 and a catheter body 62.
Vascular dilatation balloon 3 attached to the diaper and having a maximum dilation configuration
And a lumen 16 for a vasodilator balloon communicating with the vascular dilator balloon 3, a first sub-balloon 54 provided at a position of the catheter body 62 on the distal end side of the vascular dilator balloon 3, and communicating with the first sub-balloon 54. A first sub-balloon lumen 55, a second sub-balloon 64 provided at a position of the catheter body 62 on the rear end side of the vascular dilatation balloon 3, and a second sub-balloon lumen 65 communicating with the second sub-balloon 64 And When a liquid is injected into the lumen 16 for the vasodilatation balloon, the vasodilation balloon 3 can be expanded to the maximum dilatation form, and in this state, the liquid flows out from the distal end portion 3a and the proximal end portion of the vasodilation balloon 3. It is possible.

The basic structure is the same as that of the catheter 50 described above, except that this catheter communicates with the second sub-balloon 64 provided on the proximal end side of the vascular dilatation balloon 3 and the second sub-balloon 64. The only difference is that a second sub-balloon lumen 65 formed in the inner wall of the outer tube 13 is provided. In addition, an opening that communicates the second sub-balloon lumen 65 and the inside of the second sub-balloon 64 is formed on the side surface of the distal end portion of the outer tube 13. In such a catheter, the first and second sub-balloons 54, 64
Are simultaneously inflated when the dilatation balloon 3 is inflated, and a liquid, for example, a thrombolytic agent, X-ray contrast, flowing between the dilatation balloon 3 and the two sub-balloons 54 and 64 from the front end side and the rear end side of the dilatation balloon 3 The liquid mixture of the agent and the thrombolytic agent can be stored, and the liquid can reliably contact the stenosis.

A hub 6 is fixed to the proximal end of the catheter 60. The hub 68 includes a guide wire port 59, a lumen port 60 for an expansion balloon, a lumen port 61 for a first sub-balloon, and a second sub-balloon. A balloon lumen port 63 is provided.

As the first and second sub-balloons 54 and 64, those formed of a stretchable material (for example, silicone rubber or latex rubber) are preferable. Part is inner tube 12
Is fixed in a liquid-tight manner to the front end of the head. First sub-balloon 5
4 can be used when inflating and pre-expanding before expansion by the dilatation balloon 3. As the vascular dilatation balloon 3, the inner tube 12, the outer tube 13, and the distal end fixing tube 4 and the rear end fixing tube 5, those described in the catheter 1 can be suitably used. The method described above can be used.

[0070]

According to the present invention, there is provided a catheter comprising a catheter body, a balloon mounted on the catheter body, and a balloon lumen communicating with the balloon, wherein the balloon is provided near the balloon mounting portion. The balloon is formed of a material that is incompatible with the material for forming the catheter body, and a fixing tube formed of a material that is incompatible with the balloon-forming material is provided at the front end or the rear end of the balloon. The balloon is fitted, and the fixing tube is fixed to the catheter body at a portion beyond the front end or the rear end of the balloon.Furthermore, the balloon catheter allows the liquid to flow into the balloon lumen. When infused, the liquid can flow out from the distal or proximal end of the balloon as the balloon expands. That.

Therefore, the medicinal solution can be discharged from the front end portion or the rear end portion of the balloon as the balloon is inflated, and the medicinal solution can be easily administered. Also, there is no need to provide a lumen for administering the drug solution.

The catheter of the present invention is a catheter comprising a catheter body, a balloon mounted on the catheter body, and a balloon lumen communicating with the balloon, wherein the balloon has a distal end or a rear end. In, a fixing tube is fitted, the fixing tube is fixed to the catheter body at a portion beyond the distal end or the rear end of the balloon, and,
The balloon is not fixed to the catheter body and the fixing tube, the balloon catheter, when injecting a liquid into the balloon lumen,
As the balloon is inflated, liquid can flow out from the distal end or the proximal end of the balloon.

Therefore, the medicinal solution can be discharged from the front end or the rear end of the balloon when the balloon is inflated, and the medicinal solution can be easily administered. Also, there is no need to provide a lumen for administering the drug solution.

Then, a fixing tube made of a material incompatible with the balloon-forming material is fitted to the front and rear ends of the balloon, and the fixing tube is passed over the front and rear ends of the balloon. By adhering to the catheter body in the part, when liquid is injected into the lumen for the balloon, by allowing the liquid to flow out from the distal end and the proximal end of the balloon as the balloon expands,
The drug solution can be easily administered from before and after the balloon.

Further, the vascular dilatation catheter of the present invention
A catheter body, a vascular dilatation balloon attached to the catheter body and having a maximum dilatation form, and a vascular dilatation catheter including a balloon lumen communicating with the vasodilation balloon, wherein the vascular dilatation balloon has a lumen. When a liquid is injected, the vascular dilatation balloon can be expanded to a maximum dilation configuration, and in this state, the liquid can flow out from the distal end or the proximal end of the vasodilation balloon.

For this reason, the balloon does not impede the maximum expansion configuration, which is the operation of expanding the stenosis in the stenosis portion, and in this state, the distal end or the rear end of the balloon is located very close to the expanded portion of the balloon. The liquid medicine can be more easily discharged. For this reason, the expansion of the stenosis portion and the ejection of the chemical solution can be performed simultaneously. Also, there is no need to provide a dedicated lumen for administering the drug solution.

Then, the vascular dilatation balloon is formed of a material that is incompatible with the material for forming the catheter body in the vicinity of the vascular dilatation balloon mounting portion. By fitting a fixation tube formed of an insoluble material to the catheter body at a portion beyond the distal end or the rear end of the vasodilator balloon, the distal end or the proximal end of the balloon is fixed. The liquid medicine can be more reliably discharged, and the balloon can be prevented from peeling from the catheter body.

[Brief description of the drawings]

FIG. 1 is a front view of an embodiment of the catheter of the present invention.

FIG. 2 is an enlarged cross-sectional view near the distal end of the catheter shown in FIG.

FIG. 3 is an enlarged cross-sectional view of a central junction portion of the catheter shown in FIG. 1;

FIG. 4 is a sectional view taken along line AA of FIG. 3;

FIG. 5 is a sectional view taken along line BB of FIG. 3;

FIG. 6 is an enlarged cross-sectional view near the distal end of another embodiment of the catheter of the present invention.

FIG. 7 is a front view of another embodiment of the catheter of the present invention.

FIG. 8 is an enlarged sectional view of the vicinity of the distal end of the catheter shown in FIG. 7;

FIG. 9 is a front view of another embodiment of the catheter of the present invention.

FIG. 10 is an enlarged sectional view of the vicinity of the distal end of the catheter shown in FIG. 9;

[Explanation of symbols]

 Reference Signs List 1 catheter 2 catheter body 3 balloon 4 distal end fixing tube 5 rear end fixing tube

Claims (14)

[Claims] 1. A catheter comprising a catheter body, a balloon mounted on the catheter body, and a balloon lumen communicating with the balloon, wherein the balloon is a material for forming the catheter body near the balloon mounting portion. Is formed of a material that is incompatible with
A fixing tube formed of a material that is incompatible with the balloon-forming material is fitted to the front end or the rear end of the balloon, and the fixing tube is further connected to the front end or the balloon. The balloon catheter is fixed to the catheter body at a portion beyond the rear end, and when the liquid is injected into the balloon lumen, the balloon flows out from the distal end or the proximal end of the balloon as the balloon expands. A catheter characterized in that it is possible. 2. A catheter comprising a catheter body, a balloon mounted on the catheter body, and a balloon lumen communicating with the balloon, wherein the balloon is formed of the catheter body forming material near the balloon mounting portion. Is formed of a material that is incompatible with
A fixing tube formed of a material that is incompatible with the balloon-forming material is fitted to the distal end and the rear end of the balloon, and further, the fixing tube is
The balloon catheter is fixed to the catheter body at a portion beyond the front end and the rear end of the balloon. Further, when a liquid is injected into the balloon lumen, the balloon is inflated and the front end and the base of the balloon are inflated. A catheter characterized in that liquid can flow out from an end. 3. The catheter according to claim 1, wherein the balloon is not bonded or fused to the catheter body and the fixing tube. 4. A catheter comprising a catheter body, a balloon mounted on the catheter body, and a balloon lumen communicating with the balloon, wherein a fixing tube is provided at a distal end or a rear end of the balloon. The fixing tube is adhered or fused to the catheter body at a portion beyond the front end or the rear end of the balloon, and the balloon is connected to the catheter main body and the fixing It is not bonded or fused with the tube, and the balloon catheter, when injecting liquid into the balloon lumen,
A catheter characterized in that a liquid can flow out from a distal end portion or a proximal end portion of the balloon when the balloon is inflated. 5. The fixing tube is formed of a material that is compatible with the catheter body forming material near the balloon mounting portion, and the fixing tube is heat-sealed to the catheter body. Item 5. The catheter according to any one of Items 1 to 4. 6. The catheter according to claim 1, wherein the fixing tube is a heat-shrinkable tube. 7. A catheter body, a vascular dilatation balloon mounted on the catheter body and having a maximum inflation configuration,
A vascular dilatation catheter comprising a balloon lumen communicating with the vasodilator balloon, wherein when a liquid is injected into the vasodilator balloon lumen, the vasodilator balloon is expandable to a maximum expanded configuration, and In this state, a catheter for vasodilation is characterized in that a liquid can flow out from a distal end portion or a proximal end portion of the vascular dilatation balloon. 8. The sub-balloon provided at a position of the catheter body on the distal side or the proximal side of the vascular dilatation balloon, and a lumen for the sub-balloon communicating with the sub-balloon. 8. The vascular dilatation catheter according to 7. 9. A fixing tube is fitted to a front end or a rear end of the vasodilator balloon, and the fixing tube is provided at a portion beyond the front or rear end of the vasodilator balloon. 9. The vascular dilatation catheter according to claim 7, wherein the vascular dilatation balloon is fixed to the catheter main body, and the vascular dilatation balloon is not fixed to the catheter main body and the fixing tube. 10. A fixing tube is fitted to a distal end and a rear end of the vasodilator balloon, and the fixing tube is provided at a portion beyond the distal end and the rear end of the vasodilator balloon. 9. The vascular dilatation catheter according to claim 7, wherein the vascular dilatation balloon is adhered or fused to the catheter body, and the vascular dilatation balloon is not adhered or fused to the catheter body and the fixing tube. 11. The vascular dilatation balloon is formed of a material that is incompatible with the catheter body forming material near the vascular dilatation balloon mounting part, and the fixing tube is formed near the vascular dilation balloon mounting part. Is compatible with the catheter body forming material, is formed of a material that is incompatible with the vascular dilatation balloon forming material,
The vascular dilatation catheter according to claim 9, wherein the fixing tube is heat-sealed to the catheter body at a portion beyond an end of the vasodilation balloon. 12. The catheter according to claim 12, wherein the catheter includes a first sub-balloon provided at a position of the catheter main body on the distal end side with respect to the vascular dilatation balloon; a first sub-balloon lumen communicating with the first sub-balloon; 12. The apparatus according to claim 7, further comprising a second sub-balloon provided at a position of the catheter body on the rear end side of the vascular dilatation balloon, and a second sub-balloon lumen communicating with the second sub-balloon. 13. The catheter for vascular dilatation according to claim. 13. The vascular dilatation catheter according to claim 7, wherein the catheter is configured to allow liquid to flow out from a distal end portion and a proximal end portion of the vasodilator balloon. 14. The vascular dilatation catheter according to claim 7, wherein the fixing tube is a heat-shrinkable tube.