JPH09239034A - Balloon catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a balloon catheter having an excellent contrast medium radiographic characteristic without increasing an outside diameter by fixing the end of a cylindrical balloon film to the distal ends of an outer tube and inner tube to form a hollow part segmented by the inner tube, the outer tube and the balloon film and injecting the particles of a contrast medium radiographic element into the distal part of the inner tube. SOLUTION: The air within the balloon film 22 is first removed to shrink the balloon film 22 and the film is wound around the inner tube 10 in order to make an intra-aorta balloon pumping treatment by using a balloon catheter 2. Next, the catheter is inserted into the patient's blood vessel by using a guide wire, etc., from the side of the balloon 4 reduced in the outside diameter. At the time of this insertion, the particles of the contrast medium radiographic element are already injected into a marker region 40a and, therefore, when the marker region is irradiated with X-rays from the outside of the patient, its position is checkable from the outside. The expansion and contraction of the balloon 4 are executed in synchronization with the beat of the heart in the state that the marker region 40a at the front end of the balloon 4 is held positioned within the blood vessel near the heart.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to a balloon catheter capable of X-ray imaging.

[0002]

2. Description of the Related Art For example, in the treatment of IABP (intra-aortic balloon pumping), a balloon catheter is used, and a tubular balloon membrane provided at the distal end of the catheter tube repeats expansion and contraction alternately to form a heart. To assist the pulsation of. Further, in the treatment of PTCA (percutaneous coronary angioplasty), a balloon catheter having a material and a shape different from those of the IABP balloon catheter is used. The balloon catheter is inserted into a body cavity such as a blood vessel to expand a tubular balloon membrane. By doing so, the channel in the body cavity is expanded.

In such a balloon catheter, it is necessary to observe with an X-ray in order to confirm the position of the catheter after it has been inserted into the body. Therefore, an X-ray contrast marker is usually attached to the balloon catheter. This marker is an X-ray contrasting metal ring which is fitted or glued onto the catheter tube.

In the balloon catheter for IABP or PTCA, in order to confirm the position of the balloon,
The marker is attached to the inside of the closed space (specifically, the inner tube surrounded by the balloon membrane) formed by the tubular balloon membrane.

[0005]

However, these balloon catheters are processed to have a small diameter for insertion into a blood vessel. For this reason, when the marker is attached, the outer diameter of the portion increases, which may cause resistance during insertion.
In addition, the inner surface of the balloon film may collide with the marker and cause damage to the balloon film.

Attempts have also been made to attach a marker to the distal end of the balloon catheter in order to identify it. For example, in a balloon catheter for IABP, since the tip is attached to the distal end, it is possible to impart contrast property to the tip.

However, a balloon catheter for PTCA cannot be attached to the tip tip of the balloon catheter for IABP. Because PT
This is because the CA balloon catheter is inserted into a blood vessel (coronary blood vessel) thinner than the IABP balloon catheter, so that the outer diameter of the CA balloon catheter is prevented from increasing due to attachment of a marker or the like.

In the IABP balloon catheter or other catheters, if the distal end portion of the catheter can be made to have the contrast property without attaching the tip having the contrast property, it contributes to the reduction of the diameter of the catheter. . The present invention has been made in view of such circumstances, and an object of the present invention is to provide a balloon catheter having excellent X-ray contrast properties without increasing the outer diameter.

[0009]

In order to achieve the above object, the balloon catheter according to the present invention has particles of an X-ray contrasting element injected into a member constituting at least a distal end portion of the balloon catheter. It is characterized by being

In the present invention, the specific construction of the balloon catheter is not particularly limited as long as particles of the X-ray contrasting element are injected into the member constituting at least the distal end portion of the balloon catheter. It can also be configured as follows. That is, a balloon catheter according to another aspect of the present invention has a double catheter tube composed of an outer tube and an inner tube, a tubular balloon membrane and a connector, and in the double catheter tube, the inner tube is the outer tube. A connector is fixed to the proximal end of the double catheter tube so as to extend toward the distal end side from the distal end so that the lumen of the double catheter tube and the lumen of the connector communicate with each other. At the distal end of the outer tube and the distal end of the inner tube, the ends of the tubular balloon membrane are fixed, and a hollow portion partitioned by the inner tube, the outer tube and the balloon membrane is formed. X-ray contrast element particles are injected into at least the distal end of the inner tube.

Further, in the present invention, the site where the particles of the X-ray contrasting element are injected is not necessarily limited to the distal end portion of the balloon catheter, and the distal end portion of the catheter tube to which the proximal end of the balloon membrane is joined is not limited. It may be the end part. That is, a balloon catheter according to yet another aspect of the present invention is a balloon catheter in which a tubular balloon membrane is attached to the distal end portion of the catheter tube, and at least the distal end portion of the catheter tube is provided. It is characterized in that particles of an X-ray contrast element are injected.

The particles of the X-ray contrasting element are compounds, atoms, molecules, ions or clusters of X-ray opaque elements. As the particles of the X-ray contrast element, Au, P
Examples thereof include atoms such as t, Ir, Ta, W, and Pb, ions and molecules containing the same, compounds such as titanium oxide, barium sulfate, bismuth trioxide, and bismuth subcarbonate.

A so-called ion implantation method is preferably used as a method for injecting particles of an X-ray contrasting element into a member constituting a balloon catheter. For example, a particle accelerator is used to accelerate the particles and irradiate (collide with) a member constituting the balloon catheter. In this method, ions penetrate into the surface of the inner tube or the catheter tube to form an X-ray opaque site, so that the outer diameter of these tubes does not increase and the burden on the patient can be reduced. .

The acceleration of the particles can be controlled by the energy applied by the accelerator. The acceleration energy is 0.1 eV to 10 KeV, although it varies depending on the type of the element used as the ion implantation source and the material of the member to be ion implanted.
In the range of 1, the particles are laminated on the surface, and particularly 1 keV to 10 k
With eV, the adhesion of the laminate is high. Further, when it exceeds 10 KeV, the particles are injected from the solid surface to the inside in the range, so that the particles having X-ray contrast property are hardly separated.

In the present invention, in addition to the X-ray contrast-imparting particles, other particles can be injected. For example, when an element selected from boron, carbon, nitrogen, oxygen, fluorine, helium, neon, argon and silicon is injected at the same time, the adhesiveness at that portion is improved, and the adhesiveness and airtightness with the balloon film are improved. improves.

When an element selected from boron, carbon, nitrogen, oxygen, fluorine, helium, neon, argon, chlorine, bromine, silicon and the like is also injected at the same time,
It is also possible to reduce the rigidity of that portion. Since the balloon catheter is inserted into the living body lumen, it is preferably soft and low in rigidity so as not to damage the living body lumen wall. However, since a balloon catheter is inserted into the living body lumen percutaneously or orally or nasally, the catheter tube portion (proximal end) not inserted into the living body lumen is manipulated to The catheter tube portion (distal end portion) inserted in the catheter must reach the target site. If the rigidity of the entire catheter tube is lowered, the operating force at the proximal end of the catheter tube becomes difficult to be transmitted to the distal end.

In the present invention, in addition to the X-ray contrast-imparting particles, particles for reducing the rigidity are injected, so that the balloon catheter having the distal end having a low rigidity and the proximal end having a high rigidity can be easily manufactured. Can be realized. In the balloon catheter according to the present invention, since at least particles of an X-ray contrast element are injected into the distal end of the inner tube or the distal end of the catheter tube, the distal end of the balloon catheter was inserted into the patient's body. At times, the position of the distal end of the balloon catheter can be very easily identified by X-ray. Further, in the present invention, since the X-ray contrast enhancing member is not separately attached to the outer circumference of the catheter tube or the inner tube, the outer diameter of these tubes does not increase. Therefore, the burden on the patient can be reduced.

[0018]

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, a balloon catheter according to the present invention will be described in detail based on an embodiment shown in the drawings. First Embodiment FIG. 1 is a schematic cross-sectional view of a main part of a balloon catheter according to an embodiment of the present invention, and FIG. 2 is a schematic view of an apparatus for performing ion implantation into some of the constituent elements of the balloon catheter shown in FIG. FIG. 3 is a schematic view showing an example of use of the balloon catheter of the same embodiment.

The balloon catheter 2 according to the embodiment shown in FIG. 1 is used for IABP treatment, for example, and has a balloon 4 that expands and contracts in accordance with the pulsation of the heart. The balloon 4 is composed of a tubular balloon film 22 having a film thickness of about 50 to 150 μm. In the present embodiment, the shape of the balloon membrane 22 in the expanded state is a cylindrical shape, but the present invention is not limited to this and may be a polygonal tube shape.

The IABP balloon membrane 22 is preferably made of a material having excellent bending fatigue resistance, and is made of a material such as polyurethane, silicone, soft polyethylene, soft polyamide, or soft polyester, and particularly made of polyurethane. Has a high ability to suppress the generation of blood clots,
It is suitable because it has high abrasion resistance. The outer diameter and the length of the balloon membrane 22 are determined according to the inner volume of the balloon membrane 22 that greatly affects the assisting effect of the cardiac function, the inner diameter of the arterial blood vessel, and the like. The balloon membrane 22 usually has an internal volume of 20.
The outer diameter is 10 to 25 mm when expanded, and the length is 150 to 300 mm. The method for manufacturing the balloon membrane 22 according to the present embodiment is not particularly limited,
For example, a method for dipping a balloon film-forming mold in a molding solution to form a resin film on the outer peripheral surface of the mold, and drying the resin film for demolding (depitting molding method) can be exemplified. There is also a method (blow molding method) of forming a balloon film by blow molding a parison.

A tapered distal end side taper portion 24 is formed at the distal end of the balloon membrane 22, and the most distal end 7 thereof is attached to the outer circumference of the distal end of the inner tube 10 by heat fusion or adhesion. It is attached by means. At the proximal end of the balloon membrane 22, a tapered proximal end side taper portion 26 is formed.
Is joined to the distal end of the catheter tube 6. The catheter tube 6 has a double catheter tube structure including an outer tube 6a and an inner tube 10, and a first lumen 14 is formed in a gap between the outer tube 6a and the inner tube 10. A second lumen 12 that is not communicated with the inside of the balloon membrane 22 and the first lumen 14 formed in the catheter tube 6 is formed inside the tube 10.

Through the first lumen 14 formed inside the catheter tube 6, the pressure fluid is introduced or discharged into the balloon membrane 22 so that the balloon membrane 22 is expanded or contracted. The balloon film 22 and the catheter tube 6 are joined by heat fusion or adhesion with an adhesive such as an ultraviolet curable resin.

The distal end of the inner tube 10 projects further than the distal end of the catheter tube 6. The inner tube 10 is a balloon membrane 22.
Also, the catheter tube 6 is inserted through the inside in the axial direction. The proximal end of the inner tube 10 communicates with a second port 18 of a branch portion 8 described later. As will be described later, the inner tube 10 is adapted to send the blood pressure taken in at the open end 20 at the distal end to the second port 18 of the branch portion 8 and measure the blood pressure fluctuation from there.

When the balloon catheter 2 is inserted into an artery, the second lumen of the inner tube 10 located in the balloon membrane 22 is also used as a guide wire insertion lumen for inserting the balloon membrane 22 into the artery conveniently. To be When inserting the balloon catheter into a body cavity such as a blood vessel, the balloon membrane 22 is folded and wound around the outer circumference of the inner tube 10. The inner tube 10 shown in FIG. 1 may be made of the same material as the catheter tube 6, for example, a synthetic resin tube of polyurethane, polyvinyl chloride, polyethylene, polyamide, polyimide or the like, or a metal spring reinforcing tube, a stainless thin tube, or the like. Composed. A stainless wire, a nickel-titanium alloy wire, or the like may be used as the reinforcing material. The inner diameter of the inner tube 10 is not particularly limited as long as it can be inserted through the guide wire, and is, for example, 0.1
It is 5 to 1.5 mm, preferably 0.5 to 1 mm. The wall thickness of the inner tube 10 is preferably 0.1 to 0.4 mm. Inner tube 1
0 is the total length of the balloon catheter 2 inserted into the blood vessel.
The length is determined according to the axial length and the like, and is not particularly limited, but is, for example, 500 to 1200 mm, preferably 700 to 1200 mm.
It is about 1000 mm.

The outer tube 6a of the double catheter tube 6 is preferably made of a material having some flexibility.
For example, polyethylene, polyethylene terephthalate,
Polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, polyvinyl chloride (PV
C), a cross-linked ethylene-vinyl acetate copolymer, polyurethane, polyamide, polyamide elastomer, polyimide, polyimide elastomer, silicone rubber, natural rubber, and the like can be used, and are preferably formed of polyurethane, polyethylene, polyamide, or polyimide. The outer diameter of the outer tube 6a of the catheter tube 6 may be uniform in the axial direction. However, the outer diameter of the outer tube 6a is small in the vicinity of the balloon membrane 22 and large in other portions (proximal end side). May be formed. By increasing the cross section of the flow passage of the first lumen 14, the responsiveness of expanding and contracting the balloon membrane 22 can be improved. The inner diameter of the outer tube 6a of the catheter tube 6 is preferably 1.5 to 4.0 mm.
The thickness of the outer tube 6a is preferably 0.05 to 0.
4 mm. The length of the outer tube 6a is preferably 300 to 8
It is about 00 mm.

Connected to the proximal end of the dual catheter tube 6 is a bifurcation 8 which is located outside the body of the patient. The branch portion 8 is formed separately from the catheter tube 6 and fixed by means such as heat fusion or adhesion. The bifurcation 8 has a first lumen 14 in the catheter tube 6 and a first port 16 for introducing or extracting a pressure fluid into the balloon membrane 22, and a second port communicating with the second lumen 12 of the inner tube 10. 18 are formed. The branch portion 8 is formed of a thermoplastic resin such as polycarbonate, polyamide, polysulfone, polyacrylate, methacrylate-butylene-styrene copolymer.

The first port 16 is connected to, for example, a pump device 28 shown in FIG. 3, and a fluid pressure is introduced into or discharged from the balloon membrane 22 by the pump device 28. The fluid to be introduced is not particularly limited, but helium gas or the like having a low viscosity and a small mass is used so that the balloon membrane 22 expands or contracts quickly in response to the driving of the pump device 28. As the pump device 28, for example, a device disclosed in Japanese Patent Publication No. 2-39265 is used.

The second port 18 shown in FIG. 1 is connected to the blood pressure fluctuation measuring device 29 shown in FIG. 3, and it becomes possible to measure the fluctuation of blood pressure in the artery taken from the open end 20 at the distal end of the balloon membrane 22. ing. Based on the change in blood pressure measured by the blood pressure measuring device 29, the pump device 28 is controlled according to the pulsation of the heart 1 shown in FIG. 3, and the balloon membrane 22 is expanded and contracted in a short cycle of 0.4 to 1 second. It is designed to let you.

In the present embodiment, in such a balloon catheter 2, at the distal end portion of the inner tube 10 shown in FIG.
A marker region 40a in which particles of the X-ray contrasting element are ion-implanted is formed. The particles of the X-ray contrasting element are compounds, atoms, molecules, ions or clusters of X-ray opaque elements. Examples of the particles of the X-ray contrasting element include atoms such as Au, Pt, Ir, Ta, W, and Pb, ions and molecules containing the same, compounds such as titanium oxide, barium sulfate, bismuth trioxide, and bismuth subcarbonate. To be

In order to ion-implant the particles of the X-ray contrasting element into the distal end portion of the inner tube 10, for example, the ion-implanting device 50 shown in FIG. 2 is used. This ion implanter 5
Reference numeral 0 has an ion generation chamber 52 provided with an ion source gas introduction port 51, an accelerator 54, a mass separator 56, a beam scanning system 58, and a target chamber 60.

In the ion generating chamber 52, the element serving as the ion implantation source is ionized. The method for ionizing is not particularly limited, but a method such as an electron impact method in which thermoelectrons generated from a heated filament are applied to gas atoms for ionization, or a high-frequency discharge method in which gas atoms are ionized in a high-frequency magnetic field. Is adopted.

In the accelerator 54 arranged next to the ion generation chamber 52, the ions generated in the ion generation chamber are accelerated by the extraction voltage and taken out to form an ion beam. In the mass separator 56 arranged next to the accelerator 54, a magnetic force is applied to the ion beam generated in the accelerator 54 by the action of a magnet to remove the impurity ions contained in the ion beam, and only ions having a specific mass are removed. The ion beam is directed to the beam scanning system 58. Beam scanning system 58
In this method, a triangular wave electrostatic field or the like is applied to the ion beam to sweep the ion beam to uniformly irradiate the inner tube 10, which is a target placed in the target chamber 60, with the ion beam.

In the target chamber 60, the distal end portion of the inner tube 10 which is a target irradiated with the ion beam is arranged. As a device for injecting ions only into the distal end portion of the inner tube 10, only the distal end portion of the inner tube 10 is housed in the target chamber, and the portion that does not require ion implantation is arranged outside the target chamber 60. You can also Further, the beam scanning system 58 is controlled so that the entire inner tube 10 is housed in the target chamber 60 and ions are implanted only in the distal end portion of the inner tube 10. Alternatively, the members other than the distal end portion of the inner tube 10 may be mechanically masked with some member so that the ion implantation is performed only on the distal end portion of the inner tube 10. Since it is necessary to perform ion implantation over the entire outer circumference of the distal end portion of the inner tube 10, it is preferable to perform ion implantation while rotating the inner tube 10.

Although it depends on the kind of the element as the ion implantation source and the material of the inner tube 10 into which the ion implantation is performed,
When the acceleration energy is in the range of 0.1 eV to 10 KeV, the particles are laminated on the surface, and particularly in the case of 1 keV to 10 keV, the adhesion of the lamination is high. Further, if it exceeds 10 KeV, the particles are injected from the solid surface to the inside in the range, so X
Almost no exfoliation of line-contrast particles. Therefore, the acceleration energy is preferably 10 to 400.
keV, and more preferably about 30 to 200 keV. In addition, the dose amount is preferably 10 because it is necessary to inject the particles enough to be visualized by X-ray.
¹⁴ to 10 ¹⁸ / cm ² , more preferably 10 ¹⁶ to 10 ¹⁸
/ Cm ² . However, if the dose is too large, the damage to the inner tube 10 will be too large, which is not preferable.

As shown in FIG. 1, at the distal end portion of the inner tube 10, a region (marker region 40) where ion implantation is performed.
The axial length L of a is not particularly limited, but the inner tube 10
Is preferably 0 to 400 mm, more preferably 0 to 250 mm from the distal end of the. In order to perform IABP treatment using the balloon catheter 2 according to this embodiment, first, the air inside the balloon membrane 22 is evacuated, and then the balloon membrane 22 is removed.
Is contracted and wound around the inner tube 10. Next, from the side of the wound balloon 4 having a smaller outer diameter, a guide wire or the like is used to insert into the blood vessel of the patient as shown in FIG. At the time of insertion, X-rays are irradiated from outside the patient. When irradiated with X-rays, particles of the X-ray contrast element are injected into the marker region 40a shown in FIG. 1, so that the position of the marker region 40a can be confirmed from outside the patient. .

Then, with the marker region 40a, which is the tip of the balloon 4, positioned inside the blood vessel near the heart 1 shown in FIG. 3, the balloon 4 is expanded / contracted according to the pulsation of the heart 1. Balloon catheter 2 according to the present embodiment
Since particles of the X-ray contrasting element are injected into the distal end of the inner tube 10, the position of the distal end of the balloon catheter 2 when the distal end of the balloon catheter 2 is inserted into the patient's body. Can be confirmed very easily by X-ray. Further, in the present embodiment, since the X-ray contrast enhancement member is not separately attached to the outer circumference of the distal end of the inner tube 10,
The outer diameter of the inner pipe 10 does not increase. Therefore,
The burden on the patient can be reduced.

When ions of an element selected from boron, carbon, nitrogen, oxygen, fluorine, helium, neon, argon, chlorine, bromine, silicon, etc. are simultaneously implanted at the time of ion implantation in this embodiment, the distal end of the inner tube 10 It is also possible to reduce the rigidity of the edges. Since the balloon catheter 2 is inserted into a blood vessel, it is preferably soft and low in rigidity so as not to damage the blood vessel. However, since the balloon catheter 2 is inserted into the blood vessel percutaneously or orally or nasally, the portion (proximal end) of the catheter tube 6 not inserted into the blood vessel is manipulated to be inserted into the blood vessel. Part of the balloon catheter 2 (distal end)
Need to reach the target site. If the rigidity of the catheter tube 6 as a whole is lowered, the operating force at the proximal end portion of the catheter tube becomes difficult to be transmitted to the distal end portion.

In this embodiment, the rigidity of only the distal end portion of the inner tube 10 can be reduced, so that the operability is excellent and the inner wall of the blood vessel is not easily damaged. Further, other than X-ray contrast-imparting particles, other particles can be injected at the time of ion implantation in the present embodiment. For example, when an element selected from boron, carbon, nitrogen, oxygen, fluorine, helium, neon, argon, silicon, etc. is simultaneously injected, the adhesiveness of the outer periphery of the distal end portion of the inner tube 10 is improved, and the balloon film 22 The adhesion and airtightness with the distal end of the are improved.

Second Embodiment The balloon catheter of the present embodiment is used for methods such as percutaneous coronary angioplasty (PTCA), dilatation of blood vessels of limbs, dilatation of upper ureter, renal vasodilation, etc. A balloon catheter used to dilate a stenosis formed in a blood vessel or other body cavity. The overall configuration of this balloon catheter is similar to that shown in FIG. 1, but the following portions are slightly different. In the following description, only the parts different from the above-described embodiment will be described, and the other parts are the same, so the description thereof will be partially omitted.

In the present embodiment, the outer diameter of the outer tube 6a of the double catheter tube 6 may be uniformly 0.6 to 1.2 mm in the axial direction, but it is 0.6 in the vicinity of the connecting portion with the balloon membrane 22. ~
About 1.0 mm, 0.8 to 1.2 mm on the branch 8 side
The outer diameter may be changed intermittently or continuously in the axial direction. The wall thickness of the outer tube 6a is preferably about 0.05 to 0.15 mm evenly in the axial direction.

In the present embodiment, the material forming the balloon membrane 22 is preferably a material having a certain degree of flexibility, such as polyethylene, polyethylene terephthalate, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate. Copolymers, polyvinyl chloride (PVC), cross-linked ethylene-vinyl acetate copolymers, polyurethanes, polyamides, polyamide elastomers, polyimides, polyimide elastomers, silicone rubbers, natural rubbers and the like can be used, and preferably polyethylene, polyethylene terephthalate. , Polyamide.

The balloon membrane 22 has tapered portions 2 at both ends.
It is composed of a tubular thin film having 4, 26, and its film thickness is not particularly limited, but is 50 to 500 μm, preferably 70
It is about 200 μm. The outer diameter of the balloon membrane 22 when expanded is determined by factors such as the inner diameter of the blood vessel, and is 1.5 to
It is preferably about 4.0 mm. The axial length of the balloon membrane 22 is determined by factors such as the size of the intravascular stenosis and is usually 15 to 50 mm, preferably 20 to 40 mm. The balloon membrane 22 before being expanded is folded and wound around the inner tube 10 and has a diameter equal to or smaller than the outer diameter of the outer tube 6a.

In this embodiment, the first port 16 of the branch portion 8 is an expansion port, and the pressure fluid is introduced into the first lumen 14 through the expansion port. The pressure fluid to be introduced is not particularly limited, but for example, a 50/50 mixed aqueous solution of a radiopaque dye and salts is used. The reason why the radiopaque dye is included is to use radiation to image the positions of the balloon 4 and the catheter tube 6 when the balloon catheter 2 is used. The pressure of the pressure fluid for inflating the balloon 4 is not particularly limited, but is 5 to 20 atm in absolute pressure, preferably 6 to 15 atm.
It is about atmospheric pressure.

For PTCA, the second port 18 of the branching portion 8 is a guide port 18 for inserting a guide wire.
Becomes Also in the present embodiment, as in the case of the first embodiment, ion implantation is performed on the distal end portion of the inner tube 10 to form the marker region 40a.
This is the same as the first embodiment.

Next, using the balloon catheter 2 of the embodiment shown in FIG. 1 as a balloon catheter for expanding a body cavity,
A method of performing PTCA treatment will be described. First, the air inside the balloon catheter 2 is removed as much as possible. Therefore, a liquid such as physiological saline is put into the second lumen 12 in the inner tube 10 from the second port 18 of the branch portion 8 to replace the air in the second lumen 12. Further, a suction / injection means such as a syringe is attached to the first port 16 of the branch portion 8,
A liquid such as a blood contrast agent (containing iodine, for example) is placed in the syringe, and suction and injection are repeated to replace the air in the first lumen 14 and the balloon membrane 22 with the liquid.

In order to insert the balloon catheter 2 into the arterial blood vessel, first, a guide catheter guide wire (not shown) is inserted into the blood vessel by the Seldinger method or the like so that the tip of the guide wire reaches the vicinity of, for example, the heart. . Then, the guide catheter is inserted into the arterial blood vessel along the guide wire for the guide catheter, and the tip thereof is positioned at the coronary artery entrance of the heart having a stenosis. The stenosis is
For example, it is formed by thrombus or arteriosclerosis. Upon insertion into a blood vessel, the balloon membrane 22 is deflated and wrapped around the inner tube 10.

Next, only the guide wire for the guide catheter is pulled out, a guide wire for a balloon catheter, which is thinner than the guide wire, is inserted along the guide catheter, and its tip is inserted to a position where it passes through the stenosis. After that, the end of the guide wire is inserted into the open end 20 of the balloon catheter 2 shown in FIG. 1, passed through the second lumen 12 of the inner tube 10, and the balloon membrane 22 is folded. Pass through. Then, as shown in FIG. 4A, the balloon membrane 22 of the balloon catheter 2 is inserted up to the front of the stenotic portion 36. Alternatively, after pulling out the guide wire for the guide catheter from the guide catheter, the inner tube 10 is inserted through the second port 18 of the branch portion 8.
The balloon catheter having the guide wire inserted into the second lumen 12 is inserted from the proximal end of the guide catheter to guide the balloon membrane 22 into the coronary artery, and the guide wire 4
The tip of 2 may be inserted to a position where it passes through the narrowed portion 36.

Thereafter, as shown in FIG. 4 (A), the distal end of the balloon membrane 22 formed at the tip of the balloon catheter 2 is inserted along the guide wire 42 between the narrowed portions 36. Next, as shown in FIGS. 4B and 4C, while observing the position of the balloon film 22 with an X-ray fluoroscope,
The balloon membrane 22 is accurately positioned at the center of the narrowed portion 36. By inflating the balloon membrane 22 at that position, the narrowed portion 36 of the blood vessel 34 can be widened and good treatment can be performed. The balloon membrane 22 is inflated by injecting a liquid such as a contrast agent into the balloon membrane 22 from the first port 16 shown in FIG. 1 through the first lumen 14. The state where the balloon membrane 22 is expanded to the maximum is shown in FIG.
It shows in (B).

The extension time is not particularly limited, but is about 1 minute, for example. After that, the liquid is quickly drained from the balloon film 22 to contract the balloon film, and the blood flow on the peripheral side of the expanded stenosis 36 is secured. Balloon membrane 2
The expansion of 2 is usually performed once for the same constricted portion 36, but may be performed multiple times depending on the condition of the constricted portion 36.

In the balloon catheter 2 according to this embodiment, particles of the X-ray contrasting element are injected into the distal end of the inner tube 10. Therefore, when the distal end of the balloon catheter 2 is inserted into the patient's body. Moreover, the position of the distal end of the balloon catheter 2 can be confirmed very easily by X-ray. In addition, in the present embodiment, since the X-ray contrast enhancement member is not separately attached to the outer circumference of the distal end of the inner tube 10, the outer diameter of the inner tube 10 does not increase. Therefore, the burden on the patient can be reduced.

Other functions of the balloon catheter according to this embodiment are the same as those of the first embodiment. Third Embodiment In the balloon catheter according to the present embodiment, as shown in FIG. 1, the inner tube 1 corresponding to the axial intermediate position of the balloon membrane 22.
Particles of the X-ray contrasting element are ion-implanted at the position 0,
The second marker region 40b is formed. Ion implantation conditions and the like are the same as those in the first embodiment.

The balloon catheter according to this embodiment is
It can be used as a PTCA balloon catheter as in the second embodiment or as an IABP balloon catheter as in the first embodiment. In the present embodiment, not only the tip position of the balloon 4 but also the intermediate position of the balloon 4 can be confirmed by fluoroscopy.

Fourth Embodiment In the balloon catheter according to the present embodiment, as shown in FIG. 1, only the distal end portion of the outer tube 6a of the double catheter tube 6,
Particles of an X-ray contrasting element are ion-implanted to form the third marker region 40c. Ion implantation conditions
This is the same as the first embodiment.

The balloon catheter according to this embodiment is
It can be used as a PTCA balloon catheter as in the second embodiment or as an IABP balloon catheter as in the first embodiment. In the present embodiment, the position of the proximal end of the balloon 4 can be confirmed by fluoroscopy. The length of the balloon 4 can also be confirmed by forming the marker region 40a at the distal end of the inner tube 10.

The present invention is not limited to the above-mentioned embodiments, but can be variously modified within the scope of the present invention. For example, the basic structure of the balloon catheter is not limited to that shown in FIG. 1, and a balloon catheter in which a solid rod-shaped member is arranged instead of the inner tube 10 may be used. In that case, particles of the X-ray contrasting element are ion-implanted into the distal end of the rod-shaped member.

Further, a balloon catheter having another structure may be used as long as particles of an X-ray contrasting element are injected into a member constituting the balloon catheter.

[0057]

EXAMPLES Next, the present invention will be explained with reference to more concrete examples. Example 1 A balloon catheter 2 for IABP as shown in FIG. 1 was prepared. As a thin film forming the balloon film 22, a polyurethane film having a film thickness of 0.1 mm is used, the outer diameter of the expanded balloon part is 15 mm, and the inner volume of the balloon part is 30 mm.
cc, and the axial length was 230 mm.

As the inner tube 10, a polyamide thin tube having an outer diameter of 1.5 mm and a wall thickness of 0.3 mm was used. The total length of the inner tube 10 was 830 mm. A polyurethane tube having a length of 550 mm was used as the outer tube 6a of the catheter tube 6, and the outer diameter was 3.0 mm and the wall thickness was 0.25 mm. Ion implantation was performed on the distal end of the inner tube 10 using the device shown in FIG. Ir was used as the X-ray contrasting element serving as an ion implantation source. The implantation energy at the time of ion implantation was 200 keV. The dose amount was 10 ¹⁸ / cm ² . At the time of ion implantation, the scanning system 5 shown in FIG. 2 is used so that the ion implantation is performed within a range of L = 300 mm from the distal end of the inner tube 10.
8 was controlled, and the inner tube 10 was rotated around the axis.

On the outer periphery of the marker region 40a formed at the distal end of the inner tube 10 in this manner, an adhesive such as an epoxy adhesive, a urethane adhesive or an acrylate adhesive is used to form the distal end 7 of the balloon membrane 4. Glued. It was also confirmed that the adhesiveness was good. The proximal end 5 of the balloon membrane 4 has an outer tube 6
The outer periphery of the distal end of a was adhered using the above adhesive.

The branching portion 8 shown in FIG. 1 was used as the branching portion, and was bonded to the proximal end of the catheter tube 6. The balloon catheter thus constructed is placed behind an X-ray permeable shielding plate (a layer of water having a thickness of 200 mm) corresponding to the human body, and X-rays having an energy density of 10 mAs are irradiated from the shielding plate. As a result of observation, the marker region 40a formed at the distal end of the inner tube 10 was clearly observed.

Example 2 Pr was used as the ion implantation source, and the implantation energy was 20.
A balloon catheter was produced in the same manner as in Example 1 except that the dose was 0 keV and the dose was 10 ¹⁸ / cm ² .
When the same experiment as in Example 1 was performed, the marker region 40a formed at the distal end of the inner tube 10 was clearly observed.

[0062]

As described above, according to the balloon catheter of the present invention, at least X-ray contrast element particles are injected into the distal end of the inner tube or the distal end of the catheter tube. When the distal end of the balloon catheter is inserted into the patient's body, the position of the distal end of the balloon catheter can be confirmed very easily by X-ray. Further, in the present invention, since the X-ray contrast enhancing member is not separately attached to the outer circumference of the catheter tube or the inner tube, the outer diameter of these tubes does not increase. Therefore, the burden on the patient can be reduced.

[Brief description of drawings]

FIG. 1 is a schematic cross-sectional view of a balloon catheter according to an embodiment of the present invention.

FIG. 2 is a schematic diagram showing an example of an ion implantation apparatus.

FIG. 3 is a schematic sectional view showing an example of a method of using the balloon catheter shown in FIG.

4A to 4C are schematic cross-sectional views showing other usage examples of the balloon catheter shown in FIG.

[Explanation of symbols]

 2 ... Balloon catheter 4 ... Balloon 6 ... Double catheter tube 6a ... Outer tube 8 ... Branch part 10 ... Inner tube 12 ... Second lumen 14 ... First lumen 22 ... Balloon membrane 40a, 40b, 40c ... Marker area 50 ... Ion Injection device

Claims (3)

[Claims] 1. A double catheter tube having an outer tube and an inner tube, a tubular balloon membrane, and a connector, wherein the inner tube is closer to the distal end side than the distal end of the outer tube. A connector is fixed to the proximal end of the double catheter tube so that the lumen of the double catheter tube and the lumen of the connector communicate with each other, and the distal end of the outer tube. An end of the tubular balloon membrane is fixed to each of the end portion and the distal end portion of the inner tube to form a hollow portion partitioned by the inner tube, the outer tube and the balloon membrane, and at least the distal end of the inner tube. A balloon catheter characterized in that particles of an X-ray contrasting element are injected into an end portion. 2. A balloon catheter having a tubular balloon membrane attached to the distal end of the catheter tube, wherein particles of an X-ray contrast element are injected into at least the distal end of the catheter tube. A balloon catheter characterized in that 3. A balloon catheter in which a tubular balloon membrane is attached to the distal end of the catheter tube, wherein a member constituting at least the distal end of the balloon catheter is made of an X-ray contrast element. A balloon catheter characterized in that particles are infused.