WO2014122757A1

WO2014122757A1 - Balloon catheter

Info

Publication number: WO2014122757A1
Application number: PCT/JP2013/052922
Authority: WO
Inventors: 達也川瀬
Original assignee: テルモ・クリニカルサプライ株式会社
Priority date: 2013-02-07
Filing date: 2013-02-07
Publication date: 2014-08-14
Also published as: JPWO2014122757A1; JP6201123B2

Abstract

A balloon catheter (1) is provided with an inner tube (3), an outer tube (2), and a balloon (4) having the tip section (42) thereof fixed to the inner tube (3) and the rear edge section (44) thereof fixed to the outer tube (2). The balloon is provided with an expandable section (41) and a non-expandable cylindrical section (43) that is positioned between the expandable section and the rear edge section (44) and that extends to a predetermined length. In the balloon catheter (1), the three-point bending load value (A1) per unit flexure in the central part of the expandable section of the balloon and the three-point bending load value (A2) per unit flexure in the fixed section of the rear edge section of the cylindrical section of the balloon and the tip section of the outer tube satisfy A1 < A2. In addition, the difference between the three-point bending load value (A1) and the three-point bending load value (A2) is equal to or less than 50 mN/mm and the three-point bending load value (A1) is equal to or less than 50 mN/mm.

Description

Balloon catheter

The present invention relates to a balloon catheter, and more particularly to a balloon catheter that is inserted into a small body cavity such as a blood vessel or a bile duct.

The balloon catheter is used for angiography, injection of a chemical solution such as a chemotherapeutic agent, embolization, percutaneous coronary artery dilatation (PTCA), percutaneous arterial dilatation (PTA) and the like.
As a balloon catheter, there is JP-A-2005-103120 proposed by the applicant of the present application.
The balloon catheter 1 of Patent Document 1 includes a double-tube catheter main body 3 including an inner tube 9 and an outer tube 21. A balloon 7 is attached to the distal end portion of the catheter body, and an infusate passage 23 formed between the inner tube and the outer tube is communicated with the balloon 7 through the distal end opening 22 of the outer tube.

JP-A-2005-103120

Recently, balloon catheters such as the above-mentioned Patent Document 1 have been required to be inserted into thinner and curved blood vessels.
Accordingly, an object of the present invention is to provide an inner tube having a first lumen, a coaxial shaft provided with the inner tube, a tip at a position retracted by a predetermined length from the tip of the inner tube, and an outer surface of the inner tube. A balloon catheter having an outer tube that forms a second lumen and a balloon that communicates with the second lumen on the inside, and is good in that there is little kinking in the region from the tip of the catheter to the tip of the outer tube Provided is a balloon catheter which has excellent bending portion passage properties and excellent insertion operability into a body cavity.

What achieves the above object is as follows.
An inner tube having a first lumen and a second lumen provided coaxially with the inner tube, having a tip at a position retracted by a predetermined length from the tip of the inner tube, and the outer surface of the inner tube A balloon catheter having a distal end fixed to the inner tube, a rear end fixed to the distal end of the outer tube, and an inflatable balloon communicating with the second lumen. The balloon is inflatable formed on the rear end side of the tip, formed between the inflatable part and the rear end, and extends a predetermined length in the rear end direction, and The balloon catheter includes a three-point bending load value A1 per unit deflection in the central portion of the inflatable portion of the balloon and a rear portion of the tubular portion of the balloon. At the fixed part between the end and the tip of the outer tube The three-point bending load value A2 per unit deflection is A1 <A2, the difference between the three-point bending load value A1 and the three-point bending load value A2 is 50 mN / mm or less, and the three points A balloon catheter having a bending load value A1 of 50 mN / mm or less.

FIG. 1 is a partially omitted external view of an embodiment of a balloon catheter according to the present invention. FIG. 2 is an enlarged external view of the distal end portion of the balloon catheter shown in FIG. FIG. 3 is a longitudinal sectional view of FIG. 4 is an enlarged longitudinal sectional view of a proximal end portion of the balloon catheter shown in FIG. FIG. 5 is an explanatory view for explaining a fixing portion between the balloon rear end portion and the outer tube front end portion of the balloon catheter of the present invention. FIG. 6 is an explanatory view for explaining a fixing portion between the balloon rear end portion and the outer tube front end portion of the balloon catheter of the present invention. FIG. 7 is an explanatory view for explaining a fixing portion between the balloon rear end portion and the outer tube front end portion of the balloon catheter of the present invention. FIG. 8 is an enlarged external view of the vicinity of a fixing portion between a balloon rear end portion and an outer tube front end portion of a balloon catheter according to another embodiment of the present invention. FIG. 9 is a longitudinal sectional view of FIG. FIG. 10 is an enlarged external view of the vicinity of a fixing portion between a balloon rear end portion and an outer tube front end portion of a balloon catheter according to another embodiment of the present invention. FIG. 11 is a longitudinal sectional view of FIG. FIG. 12 is an enlarged cross-sectional view of the vicinity of a fixing portion between a balloon rear end portion and an outer tube front end portion of a balloon catheter according to another embodiment of the present invention. FIG. 13 is an enlarged cross-sectional view of the vicinity of a fixing portion between a balloon rear end portion and an outer tube front end portion of a balloon catheter according to another embodiment of the present invention. FIG. 14 is an enlarged cross-sectional view of the vicinity of a fixing portion between a balloon rear end portion and an outer tube front end portion of a balloon catheter according to another embodiment of the present invention. FIG. 15 is an explanatory diagram for explaining a method of measuring a three-point bending load per unit deflection in the present invention.

The balloon catheter of the present invention will be described with reference to the embodiments shown in the drawings.
The balloon catheter 1 of the present invention is provided with an inner tube 3 having a first lumen 11, and coaxially with the inner tube 3, and has a distal end at a position retracted by a predetermined length from the distal end of the inner tube 3. The outer tube 2 forming the second lumen 12 between the outer tube 2 and the outer tube 2, the front end 42 is fixed to the inner tube 3, the rear end 44 is fixed to the outer tube 2, and the inner portion is connected to the second lumen 12. And an inflatable balloon 4 in communication therewith.
The balloon 4 is formed between the inflatable part 41 formed on the rear end side from the front end part 42, the inflatable part 41 and the rear end part 44, and extends substantially in the rear end direction for a predetermined length. And a cylindrical portion (sleeve) 43 that cannot be expanded.

The balloon catheter 1 has a three-point bending load value A1 per unit deflection in the inflatable portion of the balloon and a unit deflection per unit deflection in the fixed portion between the rear end portion of the cylindrical portion of the balloon and the distal end portion of the outer tube. The three-point bending load value A2 is A1 <A2. Furthermore, the difference between the three-point bending load value A1 and the three-point bending load value A2 is 50 mN / mm or less, and the three-point bending load value A1 is 50 mN / mm or less.
In addition, the measurement site | part of the three-point bending load value A1 is a site | part which does not have the inflatable part 41 of the balloon 4, and the marker of the inner tube | pipe 3. FIG. In the case where no marker is provided at the central portion of the expandable portion 41, the central portion is preferably used as the measurement site.

Further, in the present invention, the three-point bending load value per unit deflection is a test sample between fulcrums XX having a fixed distance (L) on the abutment M as shown in FIG. This is a load value when Y is supported and a load is applied to the test sample Y by moving it vertically by a metal pressure bar Z (outer diameter 1.5 mm) in the center. In the present invention, the distance between the fulcrums is 10 mm, the tester: RTC-1210A (manufactured by Orientec Co., Ltd.), the pressure rod vertical movement distance 2.0 mm, the pressure rod test speed 5.0 mm / min. ), And the load when pushing 1.0 mm was recorded. In the present invention, the three-point bending load per unit deflection is used as an index that simply represents the rigidity of the catheter.

The balloon catheter 1 of this embodiment is formed by an outer tube 2, an inner tube 3, a balloon 4 and a branch hub 5.
The inner tube 3 is a tube body having a first lumen 11 whose tip is open. The first lumen 11 is used for insertion of a guide wire, injection of a chemical solution, and the like. In the balloon catheter 1 of this embodiment, the first lumen 11 of the inner tube 3 communicates with the first opening 54 provided in the branch hub 5.
The inner tube 3 preferably has an outer diameter of 0.6 to 1.7 mm, particularly preferably 0.6 to 0.7 mm, and an inner diameter of 0.4 to 1.4 mm. It is preferably 0.4 to 0.5 mm.
The inner tube 3 is inserted into the outer tube 2, and the tip of the inner tube 3 protrudes from the outer tube 2. A second lumen (balloon inflation lumen) 12 is formed between the outer surface of the inner tube 3 and the inner surface of the outer tube 2 and has a sufficient volume.

In the inner tube 3, a contrast marker 32 is fixed at the distal end (slightly proximal from the distal end 31, near the distal end 42 of the balloon 4). The contrast marker is preferably formed of a radiopaque material (for example, gold, platinum, tungsten, or an alloy thereof, or a silver-palladium alloy, a platinum-iridium alloy, or the like). By doing in this way, the front-end | tip part of the balloon catheter 1 can be confirmed by X-ray contrast. Further, the inner tube 3 may be provided with a rigidity imparting body 35. As the rigidity imparting body, a blade formed of a metal wire or a synthetic resin wire is preferable. And when providing a rigidity imparting body in the inner tube 3, it is desirable to provide it in the whole except a front-end | tip part, as shown in FIG. Specifically, it is preferable to provide from the contrast marker 32 to the base end.

Further, in this embodiment, as shown in FIG. 1, the inner tube 3 is continuous with the first flexible region 3a and the first region 3a from the distal end side, and is flexible, but the first flexible region. A second flexible region 3b having a hardness higher than 3a and a third region 3c that is continuous with the second flexible region 3b and has a hardness higher than that of the second flexible region 3b. In particular, in this embodiment, as shown in FIG. 1, the most flexible first flexible region 3a extends from the distal end of the inner tube 3 in the rear end direction, and the rear end of the first flexible region 3a is an outer portion to be described later. It passes over the belt-like inclined annular fixing portion 6 between the tube 2 and the cylindrical portion of the balloon 4 and is located on the rear end side of a predetermined length. The length of the first region 3a is preferably 100 to 350 mm, and particularly preferably 200 to 300 mm.

The three-point bending load per unit deflection in the first region 3a is preferably 20 to 75 mN / mm. The length of the second flexible region 3b that is continuous with the first flexible region 3a is preferably 100 to 350 mm, and particularly preferably 200 to 300 mm. The three-point bending load per unit deflection in the second region 3b is preferably 65 to 105 mN / mm, and preferably 10 to 85 mN / mm three-point bending load higher than that of the first flexible region. Further, the length of the third region 3c continuous with the second flexible region 3b is preferably 500 to 1500 mm, and particularly preferably 800 to 1200 mm. The three-point bending load per unit deflection in the third region 3c is preferably 95 to 320 mN / mm, and the three-point bending load is preferably 30 to 250 mN / mm higher than that of the second region 3b.
Further, the inner tube 2 may be such that a portion near the fixed portion of the outer tube is an easily deformable portion that can be easily deformed as compared with other portions of the inner tube. Such an easily deformable part, for example, shall not be provided with a rigidity-imparting body only in a portion near the fixed portion of the outer tube of the inner tube, and is thin only in a portion near the fixed portion of the outer tube of the inner tube. Can be formed.

The outer tube 2 is a tube body that is inserted in the inner tube 3 and located at a portion (predetermined length base end side) whose tip is retracted by a predetermined length from the tip of the inner tube 3. The distal end of the second lumen 12 communicates with the rear end portion of the balloon 4 to be described later, and the rear end of the second lumen 12 is provided on the branch hub 5 and is a fluid for inflating the balloon (for example, the balloon It communicates with the second opening 55 of the injection port 53 for injecting an inflating liquid, specifically an angiographic agent.
The outer tube 2 preferably has an outer diameter of 0.8 to 2.0 mm, particularly preferably 0.8 to 1.0 mm, and an inner diameter of 0.7 to 1.9 mm. And particularly preferably 0.7 to 0.8 mm.
The distal end portion of the outer tube is preferably an easily deformable distal end portion that is easier to deform than other portions of the outer tube. In this embodiment, the outer tube 2 is provided with an inclined distal end surface 21 that is inclined with respect to the central axis of the outer tube 2 at the distal end, and the distal end is flexible. Note that, as in the embodiment shown in FIGS. 13 and 14, the distal end of the outer tube 2 may be made thin, or the slit may be formed to make the distal end flexible.

The material for forming the outer tube 2 and the inner tube 3 is preferably a material having a certain degree of hardness and a certain degree of flexibility. For example, polyolefins such as polyethylene and polypropylene, polyamides such as polyamide and polyethylene terephthalate, PTFE, Fluorine polymers such as ETFE, PEEK (polyetheretherketone), polyimide, olefin elastomer (eg, polyethylene elastomer, polypropylene elastomer), polyamide elastomer, styrene elastomer (eg, styrene-butadiene-styrene copolymer, styrene) -Isoprene-styrene copolymer, styrene-ethylenebutylene-styrene copolymer), polyurethane, urethane elastomer, fluororesin elastomer, etc. Synthetic resin elastomer, polyurethane rubber, silicone rubbers, synthetic rubbers such as butadiene rubber, a rubber such as natural rubber, such as latex rubber is used.
Further, the outer tube 2 may be provided with a rigidity imparting body. As the rigidity imparting body, a blade formed of a metal wire or a synthetic resin wire is preferable.

The balloon 4 has an inflatable portion 41 formed by plastic deformation and a distal end side tube which is formed on the distal end side of the inflatable portion 41 and has a diameter smaller than that of the inflatable portion 41 and is substantially inflatable. And a rear end side tubular portion 43 that is formed on the rear end side of the inflatable portion 41, has a smaller diameter and a larger wall thickness than the inflatable portion 41, and is substantially inexpandable. The inflatable portion 41 can be expanded by elastic deformation by applying an internal pressure. And in the catheter of this Example, it is preferable that the balloon 4 is shaped in the reduced diameter form which has the wrinkle 71 extended in an axial direction. Note that the inflatable portion 41 does not have wrinkles extending in the circumferential direction.

Further, the inflatable portion 41 of the balloon 4 is inflated by the injected liquid and can be in close contact with the inner wall of the blood vessel. Specifically, the inflatable portion 41 can be restored to a molded form from the shaped reduced diameter form by injection of a balloon inflating liquid, and further expandable (expandable). For this reason, it adheres firmly to the inner wall of the blood vessel and does not damage the inner wall. In particular, in this embodiment, the expandable portion 41 is formed by stretching under a temperature condition that is higher than the glass transition point and lower than the softening point. Then, until the plastically deformed form (molded form), it expands without resistance, and then the expansion expands (extends) by elastic deformation according to the pressure of the inflated balloon inflating liquid, and becomes elastic by reducing the pressure. Restores the shape before expansion due to deformation.

Further, the inflatable portion 41 is thinner than the front end side cylindrical portion 42 and the rear end side cylindrical portion 43. And the front end side cylindrical part 42 and the rear end side cylindrical part 43 which were mentioned above are not substantially extended | stretched in the radial direction of each cylindrical part. And the front end side cylindrical part side edge part 73 and the rear end side cylindrical part side edge part 72 of the expandable part 41 are the thickness change parts which become thin gradually toward the expandable part 41. Furthermore, it is preferable that the front end side cylindrical portion side end portion 73 and the rear end side cylindrical portion side end portion 72 of the expandable portion 41 are shaped so as to fall inside the expandable portion 41. By doing so, the rising portion of the expandable portion 41 is prevented from becoming an obstacle during advancement in the blood vessel, insertion into the guiding catheter, and storage, and the catheter insertion operation is improved.

As will be described later, the inflatable portion 41 is preferably formed by plastic deformation due to internal pressure partially applied at a temperature not lower than the glass transition point and not higher than the softening point of the synthetic resin as the forming material. Furthermore, it is preferable that the inflatable portion 41 is shaped to have a diameter smaller than that formed by plastic deformation. The inflatable portion is preferably shaped by heat setting by compression and heating using a heat-shrinkable tube. By doing in this way, the expandable part 41 can be shaped into a reduced diameter form having the wrinkles 71 extending in the axial direction in a good and reliable manner.
Further, the heat setting is preferably performed by heating near the softening point of the synthetic resin or within 10 degrees or less from the softening point. By doing in this way, without reducing the plastic deformation of the expandable portion, it is surely shaped into a reduced diameter form having wrinkles extending in the axial direction.

The distal end side cylindrical portion 42 is a short cylindrical portion extending with substantially the same outer diameter, and is thicker than the expandable portion 41. The rear end side cylindrical part 43 extends with substantially the same outer diameter, has a longer length in the axial direction than the front end side cylindrical part 42, and is thicker than the inflatable part 41. It has become a thing. Further, the distal end side cylindrical portion 42 has an outer diameter smaller than that of the rear end side cylindrical portion 43 and is fixed to the distal end portion of the inner tube 3.
Yes. Moreover, it is preferable that the most distal end of the distal end side cylindrical portion 42 is located at the rear end of the contrast marker 32 or close without reaching the rear end. Moreover, it is preferable that the distal end side cylindrical portion 42 does not cover the contrast marker 32. The distal end side cylindrical portion 42 is preferably fixed to the inner tube 3 by heat sealing.
In addition, the rear end side tubular portion 43 does not substantially expand even when liquid is injected. Further, the rear end side cylindrical portion 43 forms a part of the balloon inflation lumen 12 by the inner surface thereof and the inner surface of the inner tube 3. By providing the rear end side tubular portion 43 extending in the predetermined long axis direction on the rear end side of the balloon 4, the portion is more flexible than the outer tube 4, and thus is easily deformed. Profiling (thinning at the time of insertion into the living body) is possible, and insertion into a smaller body cavity (for example, a blood vessel) is facilitated.

As the material for forming the balloon 4, a thermoplastic synthetic resin having elasticity is used. Specifically, for example, polyurethane and urethane elastomer, olefin elastomer (for example, polyethylene elastomer, polypropylene elastomer), polyester such as polyethylene terephthalate, soft polyvinyl chloride, polyamide and amide elastomer (for example, polyamide elastomer), fluorine Synthetic resin elastomers such as resin elastomers and ethylene-vinyl acetate copolymers are preferred. In particular, polyurethane-based thermoplastic elastomers (for example, aromatic polyurethane-based thermoplastic elastomers, aliphatic polyurethane-based thermoplastic elastomers, etc. are preferred. Examples of polyurethane-based thermoplastic elastomers include aromatic and aliphatic thermoplastic elastomer polyurethanes. It is done.

Further, the material for forming the balloon 4 preferably has a glass transition point of 0 ° C. or less, and particularly preferably −10 ° C. or less. The softening point (Vicat softening point) is preferably 70 ° C. or higher, and particularly preferably from 80 ° C. to 130 ° C. The balloon 4 has higher flexibility and flexibility than the outer tube 4. In particular, the balloon 4 is preferably more flexible and flexible than the inner tube 3 and the outer tube 4.
In the balloon 4 of this embodiment, the inflatable portion side end portion of the front end side tubular portion 42 and the inflatable portion side end portion 74 of the rear end side tubular portion 43 have a small diameter. Furthermore, it is preferable that the rear end side cylindrical part 43 is longer than the length in the axial direction of the front end side cylindrical part and extends in the rear end part direction. By doing in this way, the full length of a balloon becomes long and a long low profile part can be formed in the front end side part of a catheter.

In particular, in the balloon 4 of this embodiment, as shown in FIGS. 2 and 3, the rear end side cylindrical portion 43 has a non-inflatable cylindrical portion (in other words, a sleeve) extending a predetermined length in the rear end direction. It has become. The rear end side cylindrical portion 43 includes an inclined rear end surface 45 that is inclined with respect to the central axis of the cylindrical portion. The rear end side tubular portion 43 of the balloon 4 and the distal end portion of the outer tube 4 to be described later are fixed by a band-shaped inclined annular fixing portion 6 that is inclined with respect to the central axis of the outer tube 4 and is hermetically formed. ing.

As the balloon 4, the outer diameter of the inflatable portion 41 (outer diameter when the molded form is restored) is preferably 0.9 to 2.1 mm, and particularly preferably 0.9 to 1.0 mm. Further, the outer diameter during expansion (outer diameter that can be expanded) is preferably 3.0 to 15.0 mm, and more preferably 4.0 to 8.0 mm. Further, the length of the expandable portion 41 is preferably 3.5 to 14.5 mm, particularly preferably 4.0 to 5.5 mm. The degree of stretching in the radial direction of the expandable part is preferably 300 to 900%, and the degree of stretching in the axial direction is preferably 200 to 350%.

Further, the outer diameter of the distal end side cylindrical portion 42 is preferably 0.6 to 1.9 mm, particularly preferably 0.7 to 0.9 mm, and the length is 1.0 to 3.0 mm. The thickness is preferably 1.5 to 2.5 mm. Further, the outer diameter of the rear end side cylindrical portion 43 is preferably 0.9 to 2.1 mm, particularly preferably 0.9 to 1.0 mm, and the length is 10 to 60 mm. It is preferably 15 to 30 mm.

The inflatable part 41 of the balloon 4 is thinner than the front end side cylindrical part 42 and the rear end side cylindrical part 43. The wall thickness of the expandable portion 41 is preferably 0.03 to 0.18 mm thinner than the rear end side cylindrical portion 43 and the front end side cylindrical portion 42, and particularly 0.04 to 0.11 mm thinner. It is preferable. Further, the thickness of the rear end side cylindrical portion 43 and the front end side cylindrical portion 42 is preferably 0.07 to 0.20 mm, particularly preferably 0.08 to 0.15 mm.
And in the catheter 1 of this Example, the balloon 4 is being fixed to the shaft part in the state extended | stretched to the axial direction. For this reason, as shown in FIGS. 2 and 3, the balloon 4 is slightly extended in the axial direction, and the inflatable portion shaped into a reduced diameter form has a smaller diameter. .

In the balloon catheter 1 of the present invention, the three-point bending load value per unit deflection in the inflatable portion of the balloon (P1 in FIGS. 2 and 3, in this example, the central portion of the inflatable portion where the marker is not located). A three-point bending load value A2 per unit deflection at the fixed portion (P2 in FIGS. 2 and 3) between A1 and the rear end portion of the cylindrical portion of the balloon and the distal end portion of the outer tube is A1 <A2. Yes. Further, the difference between the three-point bending load value A1 (P1 in FIGS. 2 and 3) and the three-point bending load value A2 (P2 in FIGS. 2 and 3) is 50 mN / mm or less.

In the balloon catheter of the present invention, as described above, the three-point bending load value A2 is both A1 <A2 and the difference between A1 and A2 is 50 mN / mm or less. For this reason, in the distal end region including the entire balloon of the catheter and the fixing portion with the outer tube, the flexibility is gradually lowered from the distal end side toward the rear end side, in other words, it is stiffened in stages. It has become. For this reason, the occurrence of kinks at the tip portion (flexibility change region) is small, and further, the flexibility (hardness) difference at the tip portion (flexibility change region) where the flexibility changes is small. The passing property of the curved portion is high. Therefore, the balloon catheter of the present invention has excellent operability for insertion into a body cavity.

The three-point bending load value A1 (P1 in FIGS. 2 and 3) is preferably 50 mN / mm or less. In particular, A1 is preferably 50 mN / mm or less. The three-point bending load value A2 (P2 in FIGS. 2 and 3) is preferably 100 mN / mm or less. Moreover, it is preferable that the three-point bending load value in the rear end side tubular portion 43 of the balloon 4 located between P1 in FIGS. 2 and 3 and P2 in FIGS. 2 and 3 is larger than A1 and smaller than A3. In such a case, the occurrence of kinks is less and the permeability of the curved portion of the blood vessel is high.

Further, the three-point bending load value A3 (P3 in FIGS. 2 and 3) per unit deflection in the portion on the base end side from the fixed portion 6 of the outer tube 2 is the three-point bending load value A2 (in FIGS. 2 and 3). P2) is preferably larger. Furthermore, the difference between the three-point bending load value A3 (P3 in FIGS. 2 and 3) and the three-point bending load value A2 (P2 in FIGS. 2 and 3) is preferably 300 mN / mm or less. By adopting such a configuration, in the distal end region from the distal end of the catheter to the distal end portion of the outer tube, flexibility is gradually lowered from the distal end side toward the rear end side. It becomes hard. Thereby, the occurrence of kinks in the tip region including the tip of the outer tube is reduced. Further, since the portion of the outer tube 2 on the proximal end side with respect to the fixing portion 6 has a certain degree of hardness, the transmission performance of the pushing force applied at the base portion of the catheter is also good.

The three-point bending load value A3 (P3 in FIGS. 2 and 3) is preferably 350 mN / mm or less. The difference between A2 and A3 is preferably 300 mN / mm or less.
The balloon catheter of the present invention is preferably insertable into a guiding catheter having an inner diameter of 1.1 mm, and is particularly preferably insertable into a 0.95 mm guiding catheter. As described above, the balloon catheter of the present invention has both the three-point bending load value A2 of A1 <A2 and the difference between A1 and A2 of 50 mN / mm or less. For this reason, it is equipped with sufficient insertion operability as a small-diameter balloon catheter. In addition, by making the catheter of such a small diameter, it is possible to insert into a smaller body cavity (inside a blood vessel). Further, the balloon catheter of the present invention has an outer diameter in the inner tube. It is preferable that a 0.36 mm guide wire can be inserted, and it is particularly preferable that a 0.53 mm guide wire can be inserted. By doing so, it becomes possible to use a guide wire having a certain thickness and capable of exhibiting a sufficient guiding function, and can be easily inserted into a body cavity (blood vessel).

In the balloon catheter of this embodiment, the fixing portion 6 that joins the rear end portion 44 of the balloon 4 and the distal end portion of the outer tube 2 is an inclined annular fixing portion (in other words, an inclined annular joint portion). . The three-point bending load value A2 (P2 in FIGS. 2 and 3) is the hardness at the inclined annular fixing portion. In other words, it is a load value when a load is applied to the central portion of the annular fixing portion in the vertical direction by the pressure rod.
The inclined annular fixing portion 6 that joins the rear end portion 44 of the balloon 4 and the distal end portion of the outer tube 2 in the balloon catheter of this embodiment will be described with reference to FIGS.

As described above, the distal end portion of the outer tube 2 includes the inclined distal end surface 21 that is inclined with respect to the central axis of the outer tube 2, and the balloon 4 is disposed at the rear end portion 44 with respect to the central axis of the tubular portion 43. And an inclined rear end face 45 that is slanted. And the front-end | tip part of the outer tube | pipe 2 and the rear-end part 44 of the balloon 4 have a part which overlaps with the axial direction of a balloon catheter. Further, a belt-shaped inclined annular fixing portion 6 provided at an overlapping portion of the distal end portion of the outer tube 2 and the rear end portion 44 of the balloon 4 and inclined with respect to the central axis of the outer tube 2 and formed airtight. I have. The outer tube 2 and the balloon 4 are fixed by the inclined annular fixing portion 6. Since the cylindrical portion 43 and the rear end portion 44 of the balloon 4 are more flexible and flexible than the distal end portion of the outer tube 2, the inclined annular fixing portion 6 is formed from the rear end side to the distal end side. Flexibility toward the side increases. Therefore, a sharp property change point in the vicinity of the distal end portion of the outer tube 2 is not formed, and the occurrence of kinks is prevented and good deformability is provided.

In particular, in the balloon catheter 1 of this embodiment, the rear end portion 44 of the balloon 4 is an enlarged diameter portion (in other words, an inclined enlarged diameter portion, an inclined inflatable portion), and the rear end face 45 is a cylindrical portion. It is an inclined rear end face inclined by a predetermined angle with respect to the central axis of 43 (outer tube 2). In addition, the distal end portion of the outer tube 2 enters the rear end portion 44 whose diameter has been increased, and this entering portion forms a portion where the distal end portion of the outer tube 2 and the rear end portion 44 of the balloon 4 overlap. The outer tube 2 has substantially the same outer diameter as the cylindrical portion 43 of the balloon 4, and the rear end portion 44 of the balloon 4 is in a bulged state.

In the balloon catheter 1 of this embodiment, as shown in FIG. 6, the inclined rear end surface 45 of the balloon 4 and the inclined front end surface 21 of the outer tube 2 are substantially parallel or have different inclination angles with respect to the central axis of the outer tube. 44 degrees or less, preferably 20 degrees or less. As shown in FIG. 6, an inclination angle C with respect to the central axis of the cylindrical portion 43 (outer tube 2) of the inclined rear end surface 45 of the balloon 4 is relative to the central axis of the outer tube 2 of the inclined tip surface 21 of the outer tube 2. It is preferable that the inclination angle D is large. The inclination angle C of the inclined rear end face 45 of the balloon 4 with respect to the central axis of the cylindrical portion 43 (outer tube 2) is preferably 20 degrees to 30 degrees, and more preferably 22 degrees to 28 degrees. In addition, the inclination angle D of the inclined front end face 21 of the outer tube 2 with respect to the central axis of the outer tube 2 is preferably 30 to 45 degrees, and particularly preferably 35 to 43 degrees.

And the front-end | tip part of the outer tube | pipe 2 which entered into the rear-end part 44 which the diameter of the balloon 4 expanded is airtightly fixed to the balloon 4, and forms the strip | belt-shaped inclined annular fixing part 6. FIG. The inclined annular fixing part 6 has an annular fixing part 61. The annular fixing portion 61 is formed on the entire inner surface of the proximal end portion 44 of the balloon 4 that contacts the outer surface of the distal end portion of the outer tube 2 of the inclined annular fixing portion 6. In addition, as will be described later, a non-fixed portion that does not affect the airtightness between the two may be included.
It is preferable that the annular fixing portion 61 has substantially the same width or gradually becomes wider toward the rear end. In the balloon catheter 1 of this embodiment, as shown in FIG. 6, the annular fixing portion 61 is gradually widened toward the rear end.

Further, in the balloon catheter 1 shown in FIG. 6, the imaginary line connecting the tip 22 of the inclined distal end surface 21 of the outer tube 2 and the tip 46 of the inclined rear end surface 45 of the balloon 4 is substantially parallel to the central axis of the outer tube 2. It has become. In other words, the distal end 22 of the inclined distal end surface 21 of the outer tube 2 is positioned substantially in front of the distal end 46 of the inclined rear end surface 45 of the balloon 4. Similarly, an imaginary line connecting the rear end 23 of the inclined distal end surface 21 of the outer tube 2 and the rear end 47 of the inclined rear end surface 46 of the balloon 4 is substantially parallel to the central axis of the outer tube 2. That is, the rear end 23 of the inclined front end surface 21 of the outer tube 2 is positioned substantially in front of the rear end 47 of the rear end surface 45 of the balloon 4 in the front end direction. For this reason, a narrow portion is not formed in the annular fixing portion 61.

Furthermore, in this embodiment, the tip 46 of the inclined rear end surface 45 of the balloon 4 is located on the front end side from the rear end 23 of the inclined front end surface 21 of the outer tube 2. For this reason, the physical property of the inclined annular fixing portion 6 continuously changes. Since the cylindrical portion 43 and the rear end portion 44 of the balloon 4 are more flexible and flexible than the distal end portion of the outer tube 2, the inclined annular fixing portion 6 is formed from the rear end side to the distal end side. Flexibility and softness gradually increase toward the side. In particular, in the inclined annular fixing portion 6 of this embodiment, the portion where the rear end portion of the balloon 4 covers the front end portion of the outer tube 2 is increased from the rear end side, and the rear end of the inclined front end surface 21 of the outer tube 2 is increased. Beyond the end 23, the rear end portion 44 of the balloon 4 continues to increase in cross-sectional area perpendicular to the axial direction, but decreases in cross-sectional area perpendicular to the axial direction of the distal end portion of the outer tube 2. And in the front-end | tip 46 of the inclined surface 45 of the rear-end part 44 of the balloon 4, the cross section of the rear-end part 44 becomes cyclic | annular, Furthermore, the front-end | tip part of the outer tube 2 reduces the cross-sectional area in the front, Terminate at the tip 22. In other words, in the present embodiment, the inclined annular fixing portion 6 is entirely formed on the cutting surface orthogonal to the central axis of the outer tube 2 so that the rear end portion 44 of the balloon 4 and the distal end portion of the outer tube 2 are both annular. It is something that has no part.

The distance O between the distal end 22 of the outer tube 2 and the distal end 46 of the inclined rear end face 45 of the balloon 4 in FIG. 6 is preferably 0.5 to 2.0 mm, particularly 0.6 to 1.5 mm. It is preferable that Further, the distance N between the rear end 23 of the inclined front end surface 21 of the outer tube 2 and the rear end 47 of the inclined rear end surface 45 of the balloon 4 is preferably 0.5 to 4.0 mm, particularly 0.6. It is preferable that it is -1.0 mm. The axial length L of the inclined annular fixing portion 6 (in other words, the distance L between the distal end 22 of the outer tube 2 and the rear end 47 of the inclined rear end face 45 of the balloon 4) is 2.0 to 8.0 mm. In particular, the thickness is preferably 2.3 to 3.5 mm. The distance M between the rear end 23 of the inclined front end surface 21 of the outer tube 2 and the front end 46 of the inclined rear end surface 45 of the balloon 4 is preferably 0.6 to 2.5 mm, particularly 0.8 to It is preferable that it is 1.5 mm.
The distance M between the rear end 23 of the inclined distal end surface 21 of the outer tube 2 and the distal end 46 of the inclined rear end surface 45 of the balloon 4 is 0, that is, the inclined distal end of the outer tube 2 as in the embodiment shown in FIG. The rear end 23 of the surface 21 and the tip 46 of the inclined rear end surface 45 of the balloon 4 may be located at the same position in the axial direction of the outer tube 2. The rear end 23 of the inclined front end surface 21 of the outer tube 2 is preferably not located on the front end side of the front end 46 of the inclined rear end surface 45 of the balloon 4.

In addition, as shown in FIG. 7, for example, the inclined annular fixing portion 6 is heated to an overlapped portion and about 2 mm before and after the end portion of the outer tube 2 is inserted into the rear end portion 44 of the balloon 4. The shrinkable tube is fitted, and the heat shrinkable tube is heated from the outer surface by the heat mold 7 so as to be fused together. And the outer edge of the inclined front end surface of the outer tube 2 is rounded with no edges due to melting. Moreover, in this fusion | melting process, as shown in FIG. 7, you may carry out so that the front-end | tip part of the inclination front end surface 21 of the outer tube 2 may not be heated directly. By doing in this way, the non-fusion | fusion part 76 or weak fusion part with the rear-end part of the balloon 4 can be formed in the front-end | tip of the outer tube | pipe 2. By forming such a weakly fused portion, in other words, the rear end portion of the balloon 4 where the outer tube 2 does not exist (the portion that does not overlap) is not heated and compressed by the heat-shrinkable tube, The formation of a thin portion in the seal portion is prevented.

Further, the joining form of the rear end portion of the balloon 4 and the front end portion of the outer tube 2 is not limited to the above-described one, but the type provided in the balloon catheter 10 of the embodiment shown in FIGS. 8 and 9. It may be.
In the balloon catheter 10 of this embodiment, the distal end portion of the outer tube 2 is an inclined small diameter portion 25, and an inclined distal end surface 21 is formed at the distal end thereof. Further, the outer diameter of the rear end portion 44 of the balloon 4 is substantially the same as the outer diameter of the outer tube main body portion on the proximal end side from the inclined small diameter portion of the outer tube 2. The inclined small-diameter portion of the outer tube 2 is inserted and fixed in the inclined rear end portion 44 of the balloon 4 to form the inclined annular fixing portion 6a. In this balloon catheter 10, the rear end portion 44 of the balloon 4 is an inflatable portion, but the rear end side extends to the rear end portion of the outer tube 2 with substantially the same outer diameter. It has become. Further, the joining form of the rear end portion of the balloon 4 and the distal end portion of the outer tube 2 may be of the type provided in the balloon catheter 20 of the embodiment shown in FIGS. 10 and 11.

In the balloon catheter 20 of this embodiment, the rear end portion of the balloon 4 is not an inclined diameter-expanded portion, and is formed by extending the tubular portion 43 as it is and terminating obliquely. And the front-end | tip part of the outer tube | pipe 2 is equipped with the inclination small diameter part 25 and the thick part 24 following it. An inclined tip surface 21 is formed at the tip of the inclined small diameter portion 25. In addition, the outer diameter of the outer tube main body portion on the proximal end side from the inclined small diameter portion of the outer tube 2 is substantially the same as the outer diameter of the cylindrical portion 43 and the rear end portion of the balloon 4. The inclined small-diameter portion 25 of the outer tube 2 is inserted and fixed in the inclined rear end portion of the balloon 4 to form the inclined annular fixing portion 6b. In the balloon catheter 20, the rear end side of the inflatable portion 41 of the balloon 4 extends to the rear end portion of the outer tube 2 with substantially the same outer diameter. And also in this catheter 20, there is no level | step difference in the junction end of the balloon 4 exposed to the outer surface, and the outer tube | pipe 2. FIG.
In addition, like the balloon catheter 30 shown in FIG. 12, the outer tube 2 may have an entire inner diameter extending to the rear end portion with the inner diameter of the inclined small diameter portion 25. Also in the balloon catheter 30 of this embodiment, the inclined distal end portion of the outer tube 2 is inserted into the inclined rear end portion of the balloon 4 and fixed, thereby forming the inclined annular fixing portion 6c.

Further, the joining form of the rear end portion of the balloon 4 and the distal end portion of the outer tube 2 is not limited to the one described above, and is a type provided in the balloon catheter 60 of the embodiment shown in FIG. Also good.
In the balloon catheter 60 of this embodiment, the distal end portion of the outer tube 2 is a thin and small diameter portion 27 and is not an inclined portion as in the above-described embodiment. Also in this embodiment, the distal end portion of the outer tube is an easily deformable distal end portion that can be easily deformed as compared to other portions of the outer tube. 2 is almost the same as the outer diameter of the thin small-diameter portion 27. The thin and small diameter portion 27 of the outer tube 2 is inserted and fixed in the rear end portion 44 of the balloon 4 to form the annular fixing portion 6f. In the balloon catheter 60, the rear end portion 44 of the balloon 4 is an enlarged diameter portion and covers the thin and small diameter portion 27 of the outer tube 2. Further, the outer diameter of the rear end portion 44 of the balloon 4 is substantially the same as the outer diameter of the rear end side portion of the thin outer diameter portion 27 of the outer tube 2. Further, there is no step or gap between the rear end of the balloon 4 exposed on the outer surface of the catheter 60 and the joint end of the outer tube 2.

Further, the joining form of the rear end portion of the balloon 4 and the distal end portion of the outer tube 2 may be of the type provided in the balloon catheter 70 of the embodiment shown in FIG.
In the balloon catheter 70 of this embodiment, like the balloon catheter 60 described above, the distal end portion of the outer tube 2 is a thin and small diameter portion 27 and is an inclined portion as in the above-described embodiment. Absent. Also in this embodiment, the distal end portion of the outer tube is an easily deformable distal end portion that is easier to deform than other portions of the outer tube. Further, the rear end portion 44 of the balloon 4 is the balloon catheter described above. Unlike 60, it is not an enlarged diameter part. For this reason, the cylindrical part 43 of the balloon 4 extends with substantially the same inner diameter and outer diameter. The outer diameter of the thin small diameter portion 27 at the distal end of the outer tube 2 is substantially the same as the inner diameter of the cylindrical portion 43 of the balloon 4.
The thin and small diameter portion 27 of the outer tube 2 is inserted and fixed in the rear end portion 44 of the balloon 4 to form the annular fixing portion 6g. The joint end of the balloon 4 and the outer tube 2 exposed on the outer surface of the catheter 70 does not have a step.

As shown in FIG. 4, the branch hub 5 includes a first opening 54 that communicates with the first lumen 11, an inner tube hub 52 fixed to the rear end portion of the inner tube 3, and a second The outer tube hub 51 and the inner tube hub 52 are provided with an outer tube hub 51 that has a second opening 55 that communicates with the lumen 12 and forms an injection port 53 and is fixed to the rear end of the outer tube 2. , Has been fixed. The outer tube hub 51 and the inner tube hub 52 are fixed by inserting and joining the inner tube 3 from the rear end of the outer tube hub 51 attached to the base end portion of the outer tube 2. Further, the branch hub 5 is provided with a bending prevention tube 56 that encloses the proximal end portion of the outer tube 2 and the distal end portion of the branch hub 5. The injection port 53 is formed by a branch port 53a extending from the side wall of the outer pipe hub 51, an injection port hub 53b, and a connection tube 53c that connects the branch port 53a and the injection port hub 53b. As a material for forming the branch hub, thermoplastic resins such as polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer can be preferably used. As the connection tube, a flexible or soft synthetic resin tube is used.

The structure of the balloon catheter is not limited to the one described above, and has a guide wire insertion port that communicates with the guide wire lumen in the middle portion of the balloon catheter (the rear end side from the inclined annular fixing portion 6). It may be a thing.
The balloon catheter of the present invention is preferably applied to a catheter for drug administration with a vascular occlusion function, but is not limited thereto, and can be applied to a PTCA catheter, a balloon inflatable stent delivery system, and the like. it can.

A plurality of types of balloon catheters having a structure as shown in FIGS. 1 to 5 were prepared, and the three-point bending load values per unit deflection at P1, P2, and P3 in FIGS. 2 and 3 were measured. In the measurement, a test sample Y is supported between fulcrums XX having a certain distance (L) as shown in FIG. 15, and a metal pressure bar Z (outer diameter 1.5 mm) is vertically placed at the center. This is a load value when a load is applied to the test sample Y by moving a certain distance in the direction. The distance between the fulcrums was 10 mm, the tester was RTC-1210A (made by Orientec Co., Ltd.), the wedge vertical movement distance was 2.0 mm, and the wedge test speed was 5.0 mm / min. .
(Experimental example 1)
In the balloon catheter of Experimental Example 1, the three-point bending load value A1 was 37 mN / mm, A2 was 60 mN / mm, and A3 was 88 mN / mm. Further, A2-A1 was 23 mN / mm.
(Experimental example 2)
In the balloon catheter of Experimental Example 2, the three-point bending load value A1 was 35 mN / mm, A2 was 79 mN / mm, and A3 was 331 mN / mm. Further, A2-A1 was 44 mN / mm.

(Experimental example 3)
In the balloon catheter of Experimental Example 3, the three-point bending load value A1 was 89 mN / mm, A2 was 110 mN / mm, and A3 was 138 mN / mm. Further, A2-A1 was 21 mN / mm.
(Experimental example 4)
In the balloon catheter of Experimental Example 4, the three-point bending load value A1 was 72 mN / mm, A2 was 133 mN / mm, and A3 was 382 mN / mm. Further, A2-A1 was 61 mN / mm.
(Experimental example 5)
A balloon catheter having a structure as shown in FIGS. 1 to 4 and having a structure as shown in FIG. 13 at the proximal end portion of the balloon and the distal end portion of the outer tube was prepared. In the balloon catheter of Experimental Example 4, the three-point bending load value A1 was 46 mN / mm, A2 was 118 mN / mm, and A3 was 105 mN / mm. Further, A2-A1 was 72 mN / mm.

(Experiment)
A SUS wire having an outer diameter of 0.35 mm bent into a U shape (curve diameter of 4 mm) was prepared. Then, the balloon catheter of each of the above experimental examples was inserted from the distal end side, and a part separated from the tip of the sample by an arbitrary distance was held to check whether the P2 part completely passed through the U-shaped part. The holding portion was sequentially moved away from the tip until the P2 portion did not pass, and the distance was measured.
In Experimental Examples 1 and 2, the longest holding distance through which the P2 portion passes was 14 cm. On the other hand, in Experimental Example 3, the longest holding distance through which the P2 portion passes is 12 cm, and in Experimental Example 4, the longest holding distance through which the P2 portion passes is 12 cm. In this case, the longest holding distance through which the P2 portion passes was 8 cm.

The balloon catheter of the present invention is as follows.
(1) An inner pipe having a first lumen; a first pipe disposed coaxially with the inner pipe; having a tip at a position retracted by a predetermined length from the tip of the inner pipe; And an inflatable balloon having a distal end fixed to the inner tube, a rear end fixed to the distal end of the outer tube, and an interior communicating with the second lumen. The balloon catheter includes an inflatable portion formed on the rear end side of the tip portion, and formed between the inflatable portion and the rear end portion, and has a predetermined length in the rear end direction. The balloon catheter includes a three-point bending load value A1 per unit deflection in the inflatable part of the balloon, and a rear part of the cylindrical part of the balloon. A single unit at the fixed part between the end and the tip of the outer tube The three-point bending load value A2 per deflection is A1 <A2, the difference between the three-point bending load value A1 and the three-point bending load value A2 is 50 mN / mm or less, and the three-point bending A balloon catheter having a load value A1 of 50 mN / mm or less.
The balloon catheter of the present invention has the above-described configuration, so that there is little difference in flexibility in a region (tip region) from the tip of the catheter to the tip of the outer tube, and the step toward the rear side. Therefore, the flexibility is low, so that the occurrence of kinks in the tip side region is small, and the bent portion can be easily passed. Therefore, the balloon cartels of the present invention are excellent in operability for insertion into a body cavity.

And the following may be sufficient as the embodiment of this invention.
(2) The balloon catheter according to (1), wherein the three-point bending load value A2 is 100 mN / mm or less.
(3) The balloon catheter according to (1), wherein the three-point bending load value A1 is 40 mN / mm or less.
(4) The balloon catheter according to any one of (1) to (3), wherein the measurement site of the three-point bending load value A1 is a site where the inflatable portion of the balloon and the inner tube do not have a marker. .
(5) In the balloon catheter, a three-point bending load value A3 per unit deflection in a portion of the outer tube on the proximal end side from the fixed portion is larger than the three-point bending load value A2, and the three-point bending The balloon catheter according to any one of (1) to (4), wherein a difference between the load value A3 and the three-point bending load value A2 is 300 mN / mm or less.

(6) The rear end portion of the balloon includes an inclined rear end surface that is inclined with respect to the central axis of the cylindrical portion, and the distal end portion of the outer tube is in relation to the central axis of the outer tube. The distal end portion of the outer tube and the rear end portion of the balloon have a portion overlapping in the axial direction of the balloon catheter, and further, the distal end of the outer tube And the rear end portion of the balloon are fixed by a belt-shaped inclined annular fixing portion that is provided in the overlapping portion, is inclined with respect to the central axis of the outer tube, and is formed in an airtight manner. The point bending load value A2 is the balloon catheter according to any one of the above (1) to (5), which is a hardness in the inclined annular fixing portion.
(7) The balloon according to any one of (1) to (6), wherein the distal end portion of the outer tube is an easily deformable distal end portion that is easier to deform than other portions of the outer tube. catheter.
(8) The balloon catheter according to (7), wherein the easily deformable distal end portion of the outer tube is formed by thinning the outer tube distal end portion and a slit provided in the outer tube distal end portion.

(9) The balloon catheter can be inserted into a guiding catheter having an inner diameter of 1.1 mm, and a 0.53 mm guide wire can be inserted into the inner tube. The balloon catheter according to any one of the above.
(10) The balloon catheter includes a hub fixed to proximal ends of the inner tube and the outer tube, and the hub includes a first opening communicating with the first lumen and the second lumen. The balloon catheter according to any one of (1) to (9), further including a second opening that communicates.

Claims

An inner tube having a first lumen and a second lumen provided coaxially with the inner tube, having a tip at a position retracted by a predetermined length from the tip of the inner tube, and the outer surface of the inner tube A balloon catheter having a distal end fixed to the inner tube, a rear end fixed to the distal end of the outer tube, and an inflatable balloon communicating with the second lumen. Because
The balloon is inflatable formed on the rear end side from the tip, and formed between the inflatable and the rear end, extends a predetermined length in the rear end direction, and substantially inflates. An impossible rear end side cylindrical portion,
The balloon catheter is fixed to a three-point bending load value A1 per unit deflection in the inflatable portion of the balloon, and a rear end portion of the rear end side tubular portion of the balloon and the distal end portion of the outer tube. The three-point bending load value A2 per unit deflection in the part is A1 <A2, and the difference between the three-point bending load value A1 and the three-point bending load value A2 is 50 mN / mm or less, and The balloon catheter, wherein the three-point bending load value A1 is 50 mN / mm or less.
The balloon catheter according to claim 1, wherein the three-point bending load value A2 is 100 mN / mm or less.
The balloon catheter according to claim 1, wherein the three-point bending load value A1 is 40 mN / mm or less.
The balloon catheter according to any one of claims 1 to 3, wherein the measurement site of the three-point bending load value A1 is a site where the inflatable portion of the balloon and the inner tube do not have a marker.
In the balloon catheter, the three-point bending load value A3 per unit deflection in the proximal end portion of the outer tube relative to the fixed portion is larger than the three-point bending load value A2, and the three-point bending load value A3. The balloon catheter according to any one of claims 1 to 4, wherein a difference between the three-point bending load value A2 is 300 mN / mm or less.
The rear end portion of the balloon includes an inclined rear end surface that is inclined with respect to the central axis of the tubular portion, and the distal end portion of the outer tube is inclined with respect to the central axis of the outer tube. The tip of the outer tube and the rear end of the balloon have a portion that overlaps in the axial direction of the balloon catheter, and further, the tip of the outer tube and the tip The rear end portion of the balloon is fixed by a belt-shaped inclined annular fixing portion provided in the overlapping portion, inclined with respect to the central axis of the outer tube and formed airtight, and the three-point bending load The balloon catheter according to any one of claims 1 to 5, wherein the value A2 is a hardness in the inclined annular fixing portion.
The balloon catheter according to any one of claims 1 to 6, wherein the distal end portion of the outer tube is an easily deformable distal end portion that is easier to deform than other portions of the outer tube.
The balloon catheter according to claim 7, wherein the easily deformable distal end portion of the outer tube is formed by thinning the distal end portion of the outer tube and a slit provided in the distal end portion of the outer tube.
9. The balloon catheter according to claim 1, wherein the balloon catheter can be inserted into a guiding catheter having an inner diameter of 1.1 mm, and a 0.53 mm guide wire can be inserted into the inner tube. Balloon catheter.
The balloon catheter includes a hub fixed to proximal ends of the inner tube and the outer tube, and the hub communicates with a first opening communicating with the first lumen and a second lumen. The balloon catheter according to claim 1, comprising two openings.