JP2001238955A - Balloon catheter - Google Patents

Abstract

(57) [Problem] To provide a balloon catheter excellent in responsiveness of expansion and contraction in a balloon portion. SOLUTION: A balloon portion 4 which can be expanded and contracted by introducing and discharging a fluid into the inside thereof, and a proximal end portion of the balloon portion 4 are joined, and a lumen communicating with the inside of the balloon portion 4 has an axis. A catheter tube 6 that is formed in the direction, and formed at the distal end of the catheter tube 6 so as to extend in the axial direction inside the balloon portion 4,
From the lumen 12 of the catheter tube 6 to the balloon portion 4
A part of the fluid introduced toward the inside of the
A fluid guide member 6c that guides the distal end of the balloon catheter.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical balloon catheter, and more particularly, to a balloon catheter having excellent responsiveness to expansion and contraction in a balloon portion.

[0002]

2. Description of the Related Art Intra-aortic balloon pumping (Intra Ao)
As represented by a balloon catheter for rtic balloon pumping (hereinafter also abbreviated as "IABP method"), a balloon catheter performs medical treatment by expanding and contracting a balloon portion. In order to expand and contract the balloon portion, a catheter tube having a lumen along the axial direction is connected to the balloon portion, through which a fluid such as helium gas is introduced and led out into the balloon portion through the lumen. You.

[0003] In recent years, as the number of opportunities for performing medical procedures using balloon catheters has increased, it has been required to improve the responsiveness of expansion and contraction in the balloon portion more than ever. If the responsiveness of the balloon portion is poor, it is difficult to expand and contract the balloon portion in a timely manner in accordance with the pulsation of the patient's heart, and there is a possibility that the assisting effect of the heart function cannot be sufficiently exerted. In order to improve the responsiveness of the balloon portion, at least the inflation time from when the balloon portion is deflated to the maximum inflation and the deflation time when the balloon portion is from the inflated state to the minimum when deflated. One of them needs to be shortened.

[0004]

SUMMARY OF THE INVENTION An object of the present invention is to provide a balloon catheter which has been made in view of such circumstances and has excellent responsiveness of expansion and contraction in a balloon portion.

[0005]

Means for Solving the Problems The present inventor has conducted intensive studies on a balloon catheter excellent in responsiveness of inflation and deflation in the balloon portion. Since it is easy to start from the proximal end side of the balloon portion close to the distal end opening of the catheter tube, which is the portion to be introduced into the portion, the present inventor suspects that this may reduce the responsiveness of the balloon portion. Thinking, inside the balloon part,
By arranging a fluid guide member for guiding a part of the fluid introduced from the lumen of the catheter tube toward the inside of the balloon portion toward the distal end in the balloon portion, the responsiveness of the balloon can be significantly improved. As a result, the present invention has been completed.

That is, the balloon catheter according to the present invention has a balloon portion which can be expanded and contracted by introducing and discharging a fluid into the inside thereof, and a proximal end portion of the balloon portion, which is joined to the balloon portion. A catheter tube in which a lumen communicating with the interior is formed in the axial direction; and a distal end portion of the catheter tube, which is formed so as to extend in the axial direction inside the balloon portion, and extends from the lumen of the catheter tube to the balloon. A fluid guide member for guiding a part of the fluid introduced toward the inside of the balloon portion toward a distal end in the balloon portion.

In the present invention, the fluid guide member is preferably formed integrally with the catheter tube at the distal end of the catheter tube. The fluid guide member has a radial direction such as a notch or a hole (including an opening and a slit) for guiding a part of the fluid guided in the axial direction by the guide member into the balloon portion. Preferably, a communication port is formed. These radial communication ports also function as fluid discharge ports when discharging the fluid in the balloon section into the catheter tube.

[0008] The distal end of the fluid guide member may be separated from the distal end tip to which the distal end of the balloon section is joined, or may be joined.

Further, it is preferable that an inner tube extending in the axial direction is disposed inside the catheter tube and inside the balloon portion. The fluid guide member may be separated from the inner tube, but it is preferable that the fluid guide member is bonded by means such as adhesion, heat fusion, or integral molding.

In the balloon catheter according to the present invention, a part of the fluid flowing into the inside of the balloon portion from the opening at the distal end of the catheter tube passes through the guide flow path of the fluid guide member toward the distal end of the balloon portion. And is discharged into the balloon portion on the distal end side through a radial communication port such as a notch or a hole (including an opening and a slit). As a result, it is considered that the balloon portion does not start expanding from the proximal end side, but starts expanding over the entire balloon portion. For this reason, it is considered that the responsiveness of the balloon portion particularly during expansion is improved. This idea is supported by examples described later.

Further, in the balloon catheter according to the present invention, since the fluid guide member is disposed inside the balloon portion, the balloon portion has appropriate flexibility and axial strength, and the insertion characteristics of the balloon catheter are improved. Can be expected to improve.

[0012]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below based on embodiments shown in the drawings. A balloon catheter 2 according to the embodiment shown in FIG. 1 is used for IABP, and has a balloon portion 4 that expands and contracts in accordance with the heartbeat. The balloon 4 is made of a cylindrical balloon membrane 22.
Preferably, a balloon space is formed inside. In the present embodiment, the balloon portion 4 in the expanded state
Is a cylindrical shape, but the present invention is not limited to this and may be a polygonal cylindrical shape.

The IABP balloon membrane 22 is preferably made of a material having excellent bending fatigue resistance, for example, formed of a material such as polyurethane, silicone, soft polyethylene, soft polyamide, or soft polyester, and particularly formed of polyurethane. Has a high ability to suppress the occurrence of thrombus,
It is suitable because it has high wear resistance.

The outer diameter and length of the balloon portion 22 are determined according to the inner volume of the balloon portion 22, which greatly affects the assisting effect of the heart function, the inner diameter of the arterial blood vessel, and the like. For example, the inner volume of the balloon portion 4 is 20 to 50 cc, the outer diameter D of the balloon portion 4 when expanded (see FIG. 2) is preferably 10 to 25 mm, and the length L of the balloon portion 4 (see FIG. 1).
), But preferably 110 to 300 mm. The length L of the balloon portion 4 is the length from the joint with the distal end of the catheter tube 6 to the joint with the distal end tip 7.

The minimum thickness of the balloon film 22 constituting the balloon portion 4 is preferably 30 μm or more, more preferably 50 μm or more, and the maximum thickness of the balloon film 22 is preferably 130 μm or less, more preferably 1 μm or less.
It is not more than 00 μm. If the thickness of the balloon membrane is too thin,
The strength of the balloon tends to decrease, and if it is too thick,
Inner tube 10 and fluid guide member 6c (described later)
Tend to be difficult to wind around and fold.

The method for forming the cylindrical balloon film is not particularly limited. For example, a mold for molding the cylindrical balloon film is immersed in a molding solution to form a resin film on the outer peripheral surface of the mold. Examples of the method include a method of drying and removing the mold (dipping molding method) and a method of forming a balloon film by blow molding a parison (blow molding method).

The balloon membrane 22 thus formed is
As shown in FIG. 1, a tapered distal end side tapered portion 24 is formed at the distal end of the distal end portion. It is attached by means such as wearing or bonding. The distal end of the inner tube 10 is attached to the inner peripheral surface of the tip 7 by means such as heat fusion or adhesion. However, in the present invention, the distal end of the balloon membrane 22 may be directly joined to the outer peripheral surface of the distal end of the inner tube 10.

Further, a tapered proximal end side taper portion 26 is formed at the proximal end of the balloon membrane 22, and the cylindrical end portion 5 at the most proximal end thereof is formed outside the catheter tube 6. The outer peripheral portion of the distal end opening 6b of the tube 6a is joined by heat fusion.

The catheter tube 6 includes an outer tube 6a
And the inner tube 10 has a double catheter tube structure, a first lumen 12 is formed in a gap between the outer tube 6a and the inner tube 10, and a balloon membrane 22 is formed inside the inner tube 10. And a second lumen 14 not communicating with the first lumen 12 is formed.

The distal end of the inner tube 10 is connected to the outer tube 6a.
Projecting farther from the distal end of the. The inner tube 10
The inside of the balloon membrane 22 and the double catheter tube 6 is inserted in the axial direction. The proximal end of the inner tube 10 communicates with a second port 18 of a branch portion 8 described below. As will be described later, the inner tube 10 constituting the catheter tube 6 sends 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 measures the blood pressure fluctuation from there. ing.

When the balloon catheter 2 is inserted into the artery, the second lumen 14 of the inner tube 10 located in the balloon membrane 22 serves as a guide wire insertion lumen for conveniently inserting the balloon membrane 22 into the artery. Is also used. When the balloon catheter 2 is inserted into a body cavity such as a blood vessel, the cylindrical balloon membrane 22 is folded and wound around the inner tube 10 and the outer circumference of the fluid guide member 6c (described later). The inner tube 10 shown in FIG. 1 may be made of, for example, the same material as the outer tube 6a, and may be a synthetic resin tube such as polyurethane, polyvinyl chloride, polyethylene, polyamide, or polyimide, or a metal spring reinforced tube, a stainless steel thin tube, or the like. Be composed. Note that a stainless wire, a nickel / titanium alloy wire, or the like may be used as a reinforcing material. The inner diameter of the inner tube 10 is not particularly limited as long as it is a diameter through which a guide wire can be inserted, and for example, 0.15 to 1.5 mm, preferably 0.5 to 1.5 mm.
1 mm. The inner tube 10 has a thickness of 0.1 to
0.4 mm is preferred. At less than 0.1 mm, the strength is poor,
If the thickness is 0.4 mm or more, the volume of the space for the shuttle gas formed between the outer tube and the inner tube becomes small, and the response characteristics of the balloon deteriorate. 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.

Outer tube 6 of double catheter tube 6
a is preferably composed of a material having a certain degree of flexibility, for example, polyethylene, polyethylene terephthalate, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, polyvinyl chloride (PVC), crosslinked Type ethylene-vinyl acetate copolymer,
Polyurethane, polyamide, polyamide elastomer,
Polyimide, polyimide elastomer, silicone rubber, natural rubber, or the like can be used, and is preferably made of polyurethane, polyethylene, polyamide, or polyimide. The outer diameter of the outer tube 6a of the catheter tube 6 is
Although it may be uniform in the axial direction, a step portion or a tapered portion may be formed in the middle so as to be small near the balloon film 22 side and large at other portions (proximal end side). By increasing the cross section of the flow passage of the first lumen 12, 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, and the thickness of the outer tube 6a is preferably 0.05 to 0.4 mm.
If the thickness is less than 0.05 mm, the strength is inferior. The length of the outer tube 6a is preferably about 300 to 800 mm.

The proximal end of the double catheter tube 6 is connected to a bifurcation 8 which is located outside the patient's body. The branch portion 8 is formed separately from the catheter tube 6, and is fixed by means such as heat fusion or adhesion. The branch 8 has a first lumen 12 and a balloon membrane 2 in the catheter tube 6.
A first port 16 for introducing or discharging a pressure fluid into the inside 2 and a second port 18 communicating with the second lumen 14 of the inner tube 10 are formed. The branch portion 8 is formed of a thermoplastic resin such as polycarbonate, polyamide, polysulfone, polyacrylate, methacrylate-butylene-styrene copolymer, and the like.

The first port 16 is connected to, for example, a pump device 28 shown in FIG. 3, and the shuttle device 28 introduces or discharges the shuttle gas into the balloon membrane 22. The shuttle gas to be introduced is not particularly limited, but helium gas or the like having a small viscosity and mass is used so that the balloon membrane 22 expands or contracts quickly according to the driving of the pump device 28. Further, as the pump device 28, for example, a device as shown 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 so that the fluctuation of the blood pressure in the artery taken from the open end 20 at the distal end of the balloon membrane 22 can be measured. Has become. Based on the fluctuation of the blood pressure measured by the blood pressure measuring device 29, the pump device 28 is controlled in accordance with the pulsation of the heart 1 shown in FIG. 3 to expand and contract the balloon unit 4 in a short cycle of 0.4 to 1 second. It is supposed to do.

In the balloon catheter 2 according to the present embodiment, as shown in FIGS. 1 and 2, a fluid guide member 6c is arranged on the outer circumference of an inner tube located inside the balloon portion 4. The fluid guide member 6c is formed integrally with the outer tube 6a by forming an axial cutout 6d at the distal end of the outer tube 6a constituting the catheter tube 6, as shown in FIG. 4A. Is done.

The notch angle θ of the axial notch 6d (see FIG. 4A) is not particularly limited, but is 10 to 240.
Degrees, preferably 90 to 200 degrees. This notch 6
If the angle θ of d is too small, the flow of the fluid becomes difficult, which is not preferable. If the angle θ is too large, the effect of disposing the fluid guide member 6c is reduced.

The axial length of the notch 6d corresponds to the axial length of the fluid guide member 6c, and is not particularly limited, but is preferably smaller than the length L of the balloon portion 4.
The axial length of the fluid guide member 6c is preferably 70 to 100% of the length L of the balloon portion 4. If the length is too short, the effect of arranging the fluid guide member 6c is reduced.

When the notch angle θ of the notch 6d formed in the fluid guide member 6c is small, the notch 6d has a slit shape, and the guide passage 30 formed inside the fluid guide member 6c has , Becomes a pipe shape. When the notch angle θ of the notch 6d is large, the notch 6d becomes an opening rather than a slit, and the guide passage 30 formed in the fluid guide member 6c has a gutter shape.

In the present embodiment, the notch 6d has a linear shape along the axial direction. However, in the present invention, the notch 6d may not necessarily have a linear shape but may have a curved shape. In the present embodiment, the notch angle θ of the notch 6d is constant along the axial direction. However, in the present invention, the notch angle is not necessarily constant, and may be changed continuously or stepwise. .
For example, the notch angle θ may be configured to increase toward the distal end side of the guide member 6c. In that case, a part of the fluid introduced into the balloon portion 6 from the distal end opening 6b of the catheter tube 6 easily flows to the distal end side of the balloon portion 6 through the guide channel 30. .

In the present embodiment, the distal end 6e of the fluid guide member 6c is not joined to the distal end tip 7 as shown in FIG. The distal end tip 7 may be bonded to the distal end tip 7 by means such as adhesion or heat fusion.

Further, as shown in FIG. 2A, the fluid guide member 6c may be free with respect to the inner tube 10, but as shown in FIG. To the part, by means such as adhesion, heat fusion or integral molding,
They may be joined. Similarly, not only inside the balloon section 4 but also inside the catheter tube 6, a part of the outer wall of the inner tube 10 is joined to a part of the inner wall of the outer tube 6a in a substantially straight line along the axial direction (heat). Fusion, bonding,
(Integral molding). Inside the catheter tube 6, the outer tube 6a and the inner tube 10
Is joined, it can be expected that the flow resistance of the first lumen 12 is reduced, and the responsiveness of expansion and contraction of the balloon portion 4 is further improved.

Next, a method of manufacturing the balloon catheter 2 will be described. To manufacture the outer tube 6a having the fluid guide member 6c, it is only necessary to form the notch 6d at the distal end of the outer tube 6a using a cutting tool such as a cutter. However, in the present invention, the fluid guide member 6c formed as a member separate from the outer tube 6a may be bonded to the distal end of the outer tube 6a by adhesion or heat fusion. Further, in the present invention, the rigidity of the fluid guide member 6c formed at the distal end of the outer tube 6a is configured to be lower than the rigidity of the outer tube 6a located at other portions. The flexibility of the part may be improved.

Next, the proximal end of the outer tube 6a is joined to the branch portion 8. Before and after that, the proximal end of the inner tube 10 is joined to the branch portion with the distal end of the inner tube 10 protruding from the distal end opening 6b of the outer tube 6a.
Next, the fluid guide member 6c is joined to the outer peripheral portion of the inner tube 10 protruding from the distal end opening of the outer tube 6a by heat fusion or adhesion. When the double-lumen catheter tube 6 in which the inner tube 10 and the outer tube 6a are integrated is integrally formed by extrusion or the like, the inner tube 10 and the fluid guide member 6 are formed.
Bonding with c is unnecessary.

Thereafter, the distal end opening 6 of the outer tube 6a is opened.
b, the outer periphery of the inner tube 10 and the fluid guide member 6c are covered with a cylindrical balloon membrane 22, and the proximal end of the balloon membrane 22 is connected to the distal end opening 6b of the outer tube 6a.
Is bonded to the outer periphery by heat fusion or the like. Then, the inner tube 1
0, the distal end tip is joined to the outer periphery, the distal end of the cylindrical balloon membrane 22 is joined to the outer periphery by heat fusion or the like, and the balloon portion in which the fluid guide member 6c is disposed. A balloon catheter 2 having a 4 is manufactured.

In order to perform treatment by IABP using the balloon catheter 2 according to the present embodiment, first, the air inside the balloon portion 4 is evacuated, and the balloon portion 4 is contracted so that the inner tube 10 and / or the fluid Guide member 6c
Wrap around. Next, as shown in FIG. 3, the balloon portion 4 is inserted into the blood vessel of the patient from the side of the balloon portion 4 having the reduced outer diameter by using a guide wire or the like. And
With the distal end of the balloon portion 4 positioned in a blood vessel near the heart 1 shown in FIG. 3, the balloon portion 4 expands and contracts in accordance with the pulsation of the heart 1. At that time, in this embodiment,
Through the distal end opening 6b, the guide channel 30, and the notch 6d of the catheter tube 6, into the balloon portion 4,
The pressurized fluid is smoothly introduced or led out, and the balloon section 4 expands and contracts quickly, thereby improving the responsiveness.

The present invention is not limited to the above-described embodiment, but can be variously modified within the scope of the present invention. For example, in the balloon catheter according to the present invention, the inner tube 10 is not necessarily required, and a single lumen type balloon catheter having no inner tube may be used.

In the present invention, as shown in FIG. 4B, an outer tube 46 constituting the catheter tube 46 is provided.
The fluid guide member 46c having the guide flow path 30 may be formed by forming the through-hole 46d without forming a notch at the distal end portion a. The distal end 46e of the fluid guide member 46c may be separated or joined to the distal end tip 7 shown in FIG.

The inner diameter of the through hole 46d is not particularly limited, and may be uniform or different along the axial direction. For example, the inner diameter of the through hole 46d may be increased toward the distal end 46e of the guide member 46d. Also,
The arrangement pitch of the through holes 46d may be uniform in the axial direction, but may be different. For example, the pitch of the through holes 46d may be narrowed toward the distal end 46e of the guide member 46d to increase the density of the through holes 46d.

Further, in the embodiment shown in FIG. 4B, the through holes 46d are arranged in a straight line along the axial direction. However, in the present invention, the through holes 46d are not particularly limited, and may be curved, spiral, zigzag. May be arranged. In the embodiment shown in FIG. 4B, a single through hole 46d is arranged at the same axial position of the guide member 46c. A through hole 46d may be formed.

By changing the inner diameter, pitch and / or number of the through-holes 46d along the axial direction of the guide member 46c as described above, helium gas is introduced at a predetermined axial position inside the balloon portion 4. Quantity and derived quantity,
It can be varied along the axial direction. As a result, the expansion operation is started from the distal end side of the balloon portion 4,
For example, the contraction operation can be started, and the responsiveness can be optimized.

Further, in the present invention, the thickness of the balloon film constituting the balloon portion 4 may be increased at the proximal end side as compared with the distal end side of the balloon portion 4. In this case, it is expected that the responsiveness at the time of deflation of the balloon portion is particularly improved. This is because, when the balloon portion is contracted, the balloon portion starts to contract from the distal end side of the thin balloon portion, and the helium gas in the balloon portion is compressed by the contraction operation of the distal end side of the balloon portion. It is considered that it is discharged efficiently.

[0043]

EXAMPLES Hereinafter, the present invention will be described based on more detailed examples, but the present invention is not limited to these examples.

Example 1 First, a cylindrical balloon membrane 22 made of polyurethane and having a uniform thickness of 90 μm was formed in the axial direction, and the balloon catheter 2 shown in FIG. 1 was manufactured by the method described in the above embodiment. The outer diameter D of the balloon portion 4 in the expanded state was 20 mm, and the axial length L was 240 mm. A fluid guide member 6c is provided at the distal end of the outer tube 6a constituting the catheter tube 6 by forming a linear notch 36d having a notch angle θ of 120 degrees and a length of 230 mm. Was. Also, as shown in FIG.
Inside the balloon section 4, a part of the outer wall of the inner tube 10 is joined to the inside of the fluid guide member 6c, and also inside the catheter tube 6, a part of the outer wall of the inner tube 10 is formed along the axial direction along the outer tube. 6a.

A responsiveness test was performed using this balloon catheter. The response test was performed as follows. Filling the inside of the chamber 40 shown in FIG. 5 with water;
The balloon portion 4 of the balloon catheter 2 was arranged inside the inside. A pressure (back pressure) of 60 mmHg was applied to the outer periphery of the balloon portion 4. The balloon unit 4 is driven by the driving device. An electrocardiographic waveform from the ECG simulator is input, and the balloon unit 4 is inflated to the end of the T wave.
Contracted by Q wave. The heart rate was set at 80 bpm.

The height of the water column is determined by the ultrasonic sensor 42.
It was measured as the volume excluded and its response speed was measured. From the obtained measurement chart (for example, FIG. 6), the time required for the balloon portion to expand and the displacement volume to change from 5% to 95% (expansion time T1), the balloon portion to wither and the displacement volume to change from 95% to 5% Time (shrink time T
2). Table 1 shows the results.

[0047]

[Table 1]

Embodiment 2 The inner tube 10 is not joined to the inside of the fluid guide member 6c inside the balloon section 4 and the catheter tube 6
A balloon catheter was manufactured in the same manner as in Example 1 except that the inner tube 10 was not joined to the inner wall of the outer tube 6a. Table 1 shows the results.

Comparative Example 1 Notch 6d was not formed at the distal end of outer tube 6a.
A balloon catheter was manufactured in the same manner as in Example 1, except that the proximal end of the balloon portion 4 was joined to the outer peripheral portion of the distal end opening 6b of the outer tube 6a having no fluid guide member. Was done. Table 1 shows the results.

As shown in Evaluation Table 1, it was confirmed that, according to Examples 1 and 2, in particular, the inflation time T1 was greatly shortened and the responsiveness of the balloon portion was improved as compared with Comparative Example 1. . The reason can be explained as follows. Part of the helium gas flowing into the inside of the balloon portion 4 from the distal end opening portion 6b of the catheter tube passes through the guide channel 30 of the fluid guide member 6c, and is guided toward the distal end direction of the balloon portion 4, The gas is discharged into the balloon portion 4 on the distal end side through the notch 6d. As a result, the balloon section does not start expanding from the proximal end side, but starts expanding over the entire balloon section. For this reason, it is considered that the responsiveness of the balloon portion particularly during expansion is improved.

The reason why the expansion time T1 and the expansion time T2 of the first embodiment are further reduced as compared with the second embodiment is that the inner tube 10 is joined to the inner wall of the outer tube 6a to thereby reduce the length of the catheter tube 6. This is considered to be a synergistic effect due to the reduction of the flow resistance in the first lumen.

[0052]

As described above, according to the present invention, it is possible to provide a balloon catheter excellent in responsiveness of expansion and contraction in the balloon portion.

[Brief description of the drawings]

FIG. 1 is a sectional view of a main part of a balloon catheter according to one embodiment of the present invention.

2 (A) and 2 (B) show II-II shown in FIG.
It is principal part sectional drawing along a line.

FIG. 3 is a schematic view showing a use state of a balloon catheter.

4 (A) and 4 (B) are perspective views of a fluid guide member.

FIG. 5 is a schematic diagram of a test apparatus used in the embodiment.

FIG. 6 is a graph showing an example of a balloon drive waveform in the embodiment.

[Explanation of symbols]

 2 Balloon catheter 4 Balloon part 6, 46 Catheter tube 6a, 46a Outer tube 6b, 46b Distal end opening 6c, 46c Fluid guide member 6d Notch 22 Balloon membrane 30 Guide flow channel 46d … Through hole

Claims (1)

[Claims] 1. A balloon portion expandable and contractable by introducing and discharging a fluid into the interior thereof, and a proximal end portion of the balloon portion is joined, and a lumen communicating with the interior of the balloon portion has an axial direction. And a catheter tube formed at the distal end of the catheter tube so as to extend in the axial direction inside the balloon portion, and introduced from the lumen of the catheter tube toward the inside of the balloon portion. A fluid guide member for guiding a part of the fluid to a distal end portion in the balloon portion.