JP4761671B2 - Shape memory balloon, manufacturing method thereof, and balloon catheter - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to medical balloons such as balloons for dilatation catheters such as vasodilator catheters, gastrointestinal dilatation catheters, ureters with balloons, balloons for intra-aortic balloon pumping catheters used for assisting cardiac functions, and the like. , Its manufacturing method and balloon catheter.
[0002]
[Prior art]
A catheter with a balloon is usually used in a guiding catheter introduced to the vicinity of the target site in the living body into which the balloon is inserted, or to a target site in the body through a narrow biological lumen such as a blood vessel, digestive organ, or ureter. Reach, where the balloon is inflated. For example, the catheter is fixed by inflating the balloon in the body and the balloon is brought into close contact with the inner surface of the living body lumen, or the stenotic part is expanded by inflating the balloon in a part constricted due to various diseases.
The method of using the dilatation balloon catheter will be schematically described with reference to FIG. 1 (details will be described later). A balloon 3 attached to the distal end of a hollow shaft 10 connected to the hub 2 so as to be in fluid communication is attached to a narrow guide. A balloon is inflated by applying pressure (pressurization) from an inflator or the like connected to the hub 2 through a body catheter such as a vascular catheter or blood vessel to reach a target location in the body.
[0003]
For this reason, the balloon is formed of an inflatable material, and is usually shaped and reduced in diameter so that it can be transferred through a guiding catheter having a thin lumen to a target location or a body cavity such as a blood vessel. Further, when the balloon once inflated is taken out of the body, it is necessary to deflate the balloon and automatically fold it around the catheter shaft again to reduce the diameter. For this purpose, various balloon shaping methods have been proposed.
[0004]
For example, in U.S. Pat. No. 4,261,339, the catheter tube and the balloon end attached to the catheter tube are gripped by separate hands and rotated around the long axis of the catheter, whereby the balloon is wound around the catheter and twisted to reduce the diameter. A method is disclosed.
Japanese Patent Application Laid-Open No. Sho 62-114565 discloses a method in which a flatly folded balloon is further folded in the longitudinal (long) axial direction of the catheter and wound in the axial direction with a quadruple thickness.
Japanese Patent Application Laid-Open No. 3-92173 discloses a method of providing a wall thickness distribution in a balloon cross section and attaching a folding fold by a difference in rigidity between the thin wall portion and the thick wall portion.
Japanese Patent No. 2671196 discloses a balloon shaped into a shape defined by at least three flutes and alternating wings.
Furthermore, Japanese National Publication No. 9-512190 discloses a method for shaping a balloon in which a cylindrical balloon is placed in a die having a square cross section and heated while being stretched.
[0005]
[Problems to be solved by the invention]
However, a balloon shaped by the conventional methods as described above once loses its original shape when it is pressurized and inflated and then depressurized, and it becomes flat as a whole in the longitudinal direction of the catheter, making it difficult to reduce the diameter. The cross-sectional length in the planar state is larger than the diameter when the balloon is inflated, which not only provides great resistance when the balloon is taken out of the body, but also may damage normal blood vessels or digestive organs.
In order to avoid flattening during decompression, a method to increase the shape retention by increasing the heat holding temperature while the tube is in close contact with the outside of the shaped balloon can be considered, but this makes the balloon thicker. This causes a harmful effect that it becomes difficult to obtain the characteristics of the balloon itself.
[0006]
Further, in the above-mentioned Japanese Patent No. 26711961, although it is possible to keep the folded shape to some extent, the longitudinal grooves and the wings are formed by heating the balloon while applying a longitudinal tension to control the tension. It is difficult to obtain a stable shape. Specifically, if the tension is excessively applied, the balloon is broken, while if it is weak, the longitudinal grooves are not sufficiently formed and the shape restoring property cannot be obtained. In Japanese National Standard Hei 9-512190, the balloon is shaped so as to be folded in a valley shape between the apexes of a regular square. However, in the regular square cross section, it is difficult to attach a valley-shaped folding rod and it is difficult to fold compactly. is there.
[0007]
In view of the circumstances as described above, the present invention can be contracted automatically around the catheter shaft to reduce the diameter by automatically contracting and returning to the original shape before the inflation when the inflated balloon is decompressed. It is an object of the present invention to provide a balloon having excellent shape memory, a method for producing a balloon that imparts such a shape, and a balloon catheter.
[0008]
[Means for Solving the Problems]
The present inventor uses a mold to shape a balloon at a high temperature, and at that time, preferably by giving a special cross-sectional shape to the balloon, once it is pressurized and expanded, It has been found that a balloon that contracts in the original folded shape is obtained, and that such a balloon can be obtained stably and easily, and that the above-described problems can be solved, thereby completing the present invention.
That is, said subject is solved by the following this invention (1)-(7).
[0009]
(1) In a mold having a cavity for shaping the balloon inside, a plurality of concave grooves over at least a part of the cavity in the longitudinal direction, and the same number of corresponding ridges,
By placing a balloon tube and heating and pressurizing it so that the tube is in close contact with the inner wall surface of the mold, a plurality of longitudinal grooves continuous in the longitudinal direction at least in a part of the longitudinal direction and the same number of wings corresponding thereto A method for manufacturing a balloon for a catheter to obtain a balloon in which the shape is shaped.
(2) By previously blow-molding the balloon tube, it has a distal end side connection portion and a proximal end side connection portion for joining the shaft of the catheter to both ends, and has a trunk portion larger in diameter than these connection portions. The method for producing a balloon for catheter according to (1) above, wherein a preformed balloon is used, and the preformed balloon is disposed in the mold.
[0010]
(3) The catheter according to (1) or (2), wherein the mold has a scroll-shaped cross section formed by the concave groove and the ridge, and a balloon having a wing portion and a vertical groove corresponding to the scroll cross section is obtained. Manufacturing method for a balloon.
(4) The catheter according to any one of (1) to (3), wherein the inner peripheral surface of the mold has a peripheral length equal to or longer than an outer periphery of the body of the balloon tube or preformed balloon. Manufacturing method for a balloon.
(5) The method for producing a balloon for a catheter according to any one of (1) to (4), wherein the balloon tube or the preformed balloon is stretched in the longitudinal direction while being heated and pressurized in a mold.
[0011]
(6) A shape memory balloon for a catheter obtained by the production method of any one of (1) to (4) above.
(7) A balloon catheter provided with the balloon of (6) above.
[0012]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, embodiments of the present invention will be described with reference to the drawings. The drawings shown below are for explaining the present invention more specifically, and the present invention is not limited to the description of these drawings. Moreover, in each figure, the same code | symbol shows the same or an equivalent part, and duplication description may be abbreviate | omitted.
In the present invention, a balloon for a dilatation catheter is manufactured by a method described later. First, a dilatation catheter provided with this balloon will be described.
FIG. 1 is an external view showing an embodiment of a dilatation catheter having a balloon of the present invention.
[0013]
The hub 2 of the dilatation catheter 1 is connected to a hollow outer tube shaft 10 so as to be in fluid communication, and is formed with a luer taper (not shown) that can be connected to a pressure application device (not shown) such as an inflator. Has been. The outer tube shaft 10 is generally composed of a base portion 11, an intermediate portion 12 and a distal end portion 13 in order from the hub 2 side, and when the dilatation catheter 1 is inserted into a guiding catheter (not shown) in the base portion 11. A depth marker 111 for confirming the insertion depth is provided. An opening 121 for introducing the guide wire 5 is formed from the shaft intermediate portion 12 to the tip portion 13.
[0014]
The base portion 11 of the outer tube shaft 10 can be formed of, for example, a metal such as Ni—Ti, brass, SUS, or aluminum, or a relatively rigid resin such as polyimide, vinyl chloride, polycarbonate, polypropylene, or polyamide.
The intermediate portion 12 and the tip portion 13 are polystyrene, polypropylene, polybutene, ethylene-propylene copolymer, styrene-vinyl acetate copolymer, polyolefin such as ionomer, polyester such as polyethylene terephthalate, polyester elastomer, polyvinyl chloride, polyurethane. It can be formed from a polymer material such as polyurethane elastomer, polyphenylene sulfide, polyamide, polyamide elastomer, fluororesin, a mixture of two or more thereof, and a tube in which these are appropriately laminated.
[0015]
Hereinafter, the hub 2 side of the dilatation catheter 1 is referred to as a base side, and the shaft distal end portion 13 side is referred to as a distal end side.
On the distal end side of the outer tube shaft 10, the balloon 3 is connected in fluid communication with the shaft distal end portion 13. The dilatation catheter 1 further has an inner tube 14 that coaxially penetrates the inside of the balloon 3 and the shaft tip portion 13, and one end of the inner tube 14 is provided in the opening 121 for introducing the guide wire 5 and the other. The ends are joined to the tip 4 connected to the tip of the balloon 3 in a state in which the connection part is kept airtight.
When pressure is applied by the hub 2 to the outer tube shaft 10 having an internal structure in which the connection portion is airtight and in fluid communication, the pressure medium is passed from the internal flow paths of the base 11 and the intermediate portion 12 of the outer tube shaft 10 The balloon 3 is reached through a flow path formed by a gap between the distal end portion 13 and the inner tube 14, and as a result, the balloon 3 can be expanded.
[0016]
On the inner tube shaft 14 inside the balloon 3, a contrast marker 141 may be provided, or a plurality of contrast markers 141 may be provided. The contrast marker 141 is preferably formed by a coil spring or a ring. As a material for forming the contrast marker 141, a material having high X-ray contrast properties, for example, Pt, Pt alloy, W, W alloy, Au, Au alloy, Ir, Ir alloy, Ag, Ag alloy, or the like is preferably used.
FIG. 1 shows an embodiment in which the shaft is constituted by the outer tube shaft 10, the inner tube 14 and the tip end 4 described above. However, in the present invention, the structure of the shaft is not limited to this embodiment, and any shaft can be used. Good.
[0017]
<Balloon>
A schematic front view of the balloon 3 during pressure expansion is shown in FIG. The balloon 3 at the time of pressurization and expansion has a substantially cylindrical body (maximum outer diameter portion) 30 having at least part of the same diameter in cross section so that a stenosis portion of a blood vessel can be easily expanded. In addition, this trunk | drum 30 may not be a perfect cylinder, but polygonal prism shape may be sufficient as it. The balloon 3 has a distal end side joint portion 33 for joining with the catheter distal tip 4 and a proximal side joint portion 32 for joining with the distal end portion 13 of the outer tube shaft 10 at both ends thereof. The joining portion 33 is usually formed with a smaller diameter than the proximal end joining portion 32. Tapered portions 31 and 31 are formed on the distal end side and proximal end portions of the body portion 30 that continues to the joint portions 32 and 33, respectively.
[0018]
The balloon 3 of the present invention is compactly reduced in diameter in a state where the balloon 3 is folded on the outer periphery of the inner tube shaft 14 in a state where the balloon 3 is not inflated under pressure (a contracted state). The collapsed folded shape is shaped using a mold by a balloon manufacturing method as described later. The balloon 3 of the present invention has shape memory, and can be automatically deflated when the pressure is released from the pressurized state, and can return to a folded shape before pressurization or a shape close thereto.
[0019]
In the present invention, a balloon 3 having a characteristic cross-sectional shape is provided as such a shape memory balloon. FIG. 3 is a cross-sectional view taken along line AA of the balloon 3 of FIG. 1 (when not inflated), and shows an example of the balloon according to the present invention. That is, the balloon 3 of the present invention is the substantially hollow cylindrical balloon described above with reference to FIG. 2 when inflated. When the pressure in the balloon 3 is released, a plurality of longitudinal grooves 302 and the same number of blades corresponding thereto are provided as shown in FIG. It has a scroll-like cross-sectional structure with respect to the longitudinal axis formed by the part 301. Although not illustrated in the longitudinal direction, the longitudinal groove 302 or the wing portion 301 is continuous in the longitudinal direction in at least a part of the longitudinal direction of the balloon 3. If it is scroll-shaped, it is shaped so that the wings 301 rotate in a certain direction, in other words, each wing 301 is curved in a certain direction from the center side of the balloon 3 to the outside. There is an effect that it is wound around the periphery in a compact manner. In the above-mentioned Japanese Patent No. 26711961 and Japanese Patent Application Laid-Open No. 9-512190, the wing portion is not shaped to rotate around the center of the balloon 3 in a certain direction. It is also impossible to shape. The present invention is excellent in that it can be shaped in this manner by a relatively simple method without requiring extensive equipment.
[0020]
In addition, although the example of an aspect which has three hollow wing | blade parts 301 is shown in FIG. 3, it cannot be overemphasized that it may be comprised by the number beyond this.
In the above, an example in which the body portion 30 of the balloon 3 is provided with the shape including the wing portion 301 and the longitudinal groove 302 is described. However, in the present invention, as long as the folding shape can be provided to the balloon, the shape is longitudinal. It does not have to be continuous throughout, and it is sufficient that it is formed at least in part of the balloon. Moreover, the shape may be given only on the taper part 31 of the trunk | drum 30, the shape may be given only to the trunk | drum (maximum diameter part) 30, and the shape may be given to both of these.
[0021]
The size of the balloon 3 is such that the maximum outer diameter of the body portion 30 when inflated (FIG. 2) is usually about 1 to 10 mm, preferably about 1 to 5 mm, and the length is usually about 5 to 5 mm. The length of the entire balloon 3 is usually about 10 to 70 mm, preferably about 15 to 60 mm.
The thickness of the balloon 3 is preferably about 10 to 50 μm. It may have a substantially uniform wall thickness or a non-uniform wall thickness.
[0022]
As the balloon material, those capable of expanding the stenosis of the blood vessel and having a certain degree of plasticity are preferable, for example, polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, Furthermore, these cross-linked or partially cross-linked products, polyesters such as polyethylene terephthalate, polyester elastomers, polyvinyl chloride, polyurethane, polyurethane elastomers, polyphenylene sulfide, polyamides, polyamide elastomers, fluororesins, etc., silicone rubber, latex rubber, etc. Is mentioned. Moreover, these 2 or more mixtures may be sufficient and the film (or sheet | seat) which laminated | stacked these suitably is also mentioned.
[0023]
<Production method of balloon>
In the present invention, the balloon 3 as described above is manufactured by shaping the balloon tube using a mold.
In the present invention, the balloon tube to be placed in the shaping mold can be formed in advance using a preforming mold. The preformed balloon can be formed in substantially the same shape as the inflated balloon shown in FIG. 2, for example, and has a hollow cylindrical body 30 and the same proximal end side joint portion 32 and distal end side joint portion 33 as the final balloon. It is preferable that
FIG. 4A is a cross-sectional view of a mold for obtaining such a preformed balloon, and FIG. 4B is an end view of the cross section taken along the line BB.
In the mold 300, the balloon 3 is provided with the hollow cylindrical body 30, and each of the lumen (cavity) 310 having the tapered portions 311 and 311 formed at both ends, the joining portion 32, and the joining portion 33 is provided. Voids 312 and 313 are formed. The mold 300 can be divided into a plurality of parts, and the preformed balloon after molding can be taken out by dividing the mold into divided parts. The figure shows an example of three divisions.
The preforming may be performed in accordance with a general blow molding method. The mold 300 is heated while pressurizing the inside of the tube placed in the mold 300, and stretched in the tube major axis direction. It can be shaped along the in-mold shape.
[0024]
FIG. 5 shows an example of a mold used for shaping the balloon tube or the preformed balloon as described above (main molding). 5A is a transparent front view of the inside of the mold 400, and FIG. 5B is an end view of the CC section thereof. The shaping mold 400 has a molding space (cavity) 410 for shaping the wing portion 301 and the longitudinal groove 302 of the balloon 3 inside. Here, the cavity 410 includes tapered portions 411 and 411 corresponding to the tapered portions 31 and 31 of the balloon 3. The cavity 410 has a plurality of concave grooves 401 continuous in the longitudinal direction over at least a part of the cavity 410 in the longitudinal direction, and the same number of ridges 402 corresponding thereto.
[0025]
In the mold 400, together with the cavity 410 for shaping the balloon, gaps 412 and 413 for the joint portions 32 and 33 of the balloon are formed. The mold 400 can be divided into a plurality of parts, and the molded balloon can be taken out by dividing the mold into divided parts. The figure shows an example in which the mold is divided into three parts.
The number of the concave grooves 401 and the convex ridges 402 may be plural, and is not limited to three shown in FIG. If the mold 400 having the sectional shape shown in FIG. 5B is used, the balloon 3 having the sectional shape shown in FIG. 2 can be obtained. FIG. 6 to FIG. 8 show diagrams corresponding to FIG. 5B in the case where the numbers are 4, 5, and 6 respectively. It is clear from the relationship between FIG. 2 and FIG. 5 (b) that the balloon 3 corresponding to these FIGS. 6 to 8 has the in-mold void shape of FIGS. A cross-sectional shape diagram is omitted.
In the present invention, in each of FIGS. 5 to 8, it is desirable that the cavity 410 in the mold has a scroll-like cross section formed by the concave groove 401 and the convex stripe 402.
[0026]
In the above, the balloon tube used for shaping, or the hollow cylindrical body of the preformed balloon has an outer peripheral length (l) that is equal to the peripheral length (L) of the inner peripheral surface of the molding die 400. It is preferable that the length is equal to or shorter than that, and specifically, it is preferable that l ≦ L ≦ 1.5 l. If the outer peripheral length of the balloon tube or preformed balloon is as described above, the balloon tube or preformed balloon will not be contracted in the circumferential direction when the shape is imparted using the molding die 400, and the balloon tube or preformed balloon will be improperly deformed. Folded balloons can be obtained without fear. Thereby, the blow-drawing orientation of the preformed balloon is not broken, and shaping can be performed without reducing the breaking strength of the balloon.
[0027]
A balloon tube or a pre-formed balloon, which is a molding material, is placed in the mold 400, and heated and pressurized to bring the tube into close contact with the inner wall surface 403 of the mold 3 so that at least one in the longitudinal direction of the balloon 3 can be obtained. A balloon 3 in which a plurality of longitudinal grooves continuous in the longitudinal direction over the portion and the same number of wings corresponding thereto can be obtained.
It is preferable that the heating temperature is basically higher than the glass transition temperature and lower than the melting point temperature of the balloon material, but usually about 60 to 160 ° C, further about 90 to 130 ° C is selected.
For pressurization in the mold, one end of the preformed balloon (or tube) is sealed with liquid nectar with a chuck or the like, and a liquid or gas such as nitrogen is introduced from the other end for pressurization. The pressurization is usually at least 1 to 5 MPa, preferably about 3 to 4 MPa.
[0028]
In the present invention, when the final shape balloon is formed using the mold 400, the balloon tube may be directly formed by the mold 400, or a preformed balloon may be formed. When manufacturing a balloon product with a small shape such as a large number, it is easier to use a pre-formed balloon than blow molding in one step in view of the burst strength of the balloon product. When a preformed balloon is used, the taper portion 411 may be eliminated in FIG. 5A and the portion may have the same cross section as the cavity (maximum diameter portion) 410.
As described above, a preformed balloon or balloon tube having a peripheral length (l) close to the peripheral length (L) of the main mold 400 is pre-molded, and then shaped using the mold 400. By performing the above, the balloon 3 having substantially no distribution in the tube thickness, that is, a substantially uniform wall thickness is obtained. In general, when a balloon is produced by blow molding, in order to enhance the stretch orientation of the balloon, a balloon tube having a relatively small outer diameter is expanded to several times the outer diameter (for example, 3 to 6 times) by blow molding. Is molded. For this reason, when blow molding is performed from the balloon tube using the mold 4 in one step, when the outer diameter of the balloon tube is greatly expanded by blow molding (the circumferential length is significantly increased), the concave groove of the mold 400 is used. The thickness of the balloon 3 located near the top (end) of 401 is significantly thinner than that of many parts, and there is a possibility that a considerable distribution occurs in the tube thickness.
[0029]
In the above, an example in which the mold 400 in which the concave groove 401 is continuous over the entire longitudinal direction of the cavity 410 excluding the gaps 412 and 413 as shown in FIG. 5 is used. It does not have to be continuous in the entire longitudinal direction of the cavity 410 in the mold, and may be formed in at least a part in the longitudinal direction of the cavity 410 as long as a suitable folding shape can be imparted to the balloon 3. For example, as shown in FIG. 9, only the tapered portion 411 of the cavity 410 has the concave groove 401, and the concave groove 401 is not formed in the portion corresponding to the general cylindrical body portion (maximum outer diameter portion) 30 of the balloon 3. It may be a mold. FIG. 9A is a perspective view in the longitudinal direction of such a mold 400, and FIG. 9B is an end view of the taper portion 411 (DD line or FF line). 9 (c) is an end view of a cavity (maximum outer diameter portion) 410 (EE line) cross section.
When such a mold 400 is used, a balloon 3 is obtained in which a plurality of longitudinal grooves 302 and wings 301 continuous in the longitudinal direction of the balloon 3 are formed only in the tapered portion 31 of the balloon 3.
The mold 400 can be divided into a plurality of parts, and the molded balloon can be taken out by dividing the mold into divided parts. The figure shows an example in which the mold is divided into three parts.
[0030]
Further, when the molding material is heated and pressurized in the mold, it can be stretched in the longitudinal direction. For example, the connecting portion having a small outer diameter of the preformed balloon is stretched if necessary in order to align the small diameter portions at both longitudinal ends (not shown) of the mold 400. Stretching varies depending on the molding material, but is usually 20 mm or less, preferably 7 mm or less.
[0031]
【The invention's effect】
In the present invention, a die is used to apply heating and pressurization as necessary to give the balloon a folded shape, and the heating and pressurization at the time of molding and further selecting the stretching conditions should be appropriately selected. Thus, a balloon having the intended folded shape and storing the shape is provided.
In addition, the balloon is not only easily wrapped around the inner tube shaft, but the scroll-shaped folded shape provided by the present invention has little resistance when moving the balloon in the body, and further the present invention. This balloon has little resistance when moved after being pressurized and inflated. In particular, since the scroll shape is such that a part or the whole of the wing part is oriented in a certain rotational direction, the balloon wing part is quickly and reliably applied according to the shape that has been quickly and reliably applied after contraction (shape memory). It is excellent in that it can be wound around the shaft and can be folded compactly.
[Brief description of the drawings]
FIG. 1 is an external view of a dilatation catheter according to an embodiment of the present invention.
FIG. 2 is a schematic front view showing a shape example of an inflation balloon according to the present invention.
3 is a cross-sectional view taken along the line AA of the balloon 3 of FIG. 1 showing one embodiment of the balloon according to the present invention.
4 (a) is a cross-sectional view of a mold for obtaining the preformed balloon shown in FIG. 3, and FIG. 4 (b) is an end view of the cross section taken along the line BB.
FIG. 5 (a) is a cross-sectional view showing an example of a mold shape (having three wings) used in the present invention, and FIG. 5 (b) is an end surface of the CC line cross section. FIG.
FIG. 6 is an end view of a cross section showing an example of a mold shape (having four wings) used in the present invention.
FIG. 7 is an end view of a cross section showing an example of a mold shape (having five wing parts) used in the present invention.
FIG. 8 is an end view of a cross section showing an example of a mold shape (having six wing parts) used in the present invention.
FIG. 9 (a) is a perspective view showing an example of a mold used in the present invention, and FIG. 9 (b) is an end view of a section taken along the line DD or FF. FIG. 9C is an end view of the cross section taken along the line EE.
[Explanation of symbols]
1: Dilatation catheter 2: Hub 3: Balloon 30: Cylindrical body 301: Hollow wing 302: Longitudinal groove 31: Tapered portion 32: Proximal end connection 33: Distal end connection 4: Distal tip 5: Guide wire 10 : Outer tube shaft 14: Shaft inner tube 300: Preliminary mold 400: Mold (Shaping mold)
401: Concave groove 402: Convex line 410: Cavity

Claims (7)

A plurality of concave grooves having a cavity for shaping the balloon inside and curved in a certain direction from the mold center side to the outside over at least a part in the longitudinal direction of the cavity, and the corresponding number of the projections possess, the concave grooves and ridges and a scroll-shaped cross section of the cavity in the mold which is formed by,
By placing a balloon tube and heating and pressurizing it so that the tube is in close contact with the inner wall surface of the mold, at least part of the longitudinal direction is continuous in the longitudinal direction from the center corresponding to the scroll-shaped cross section. A method for manufacturing a balloon for a catheter, which obtains a balloon having hollow wings curved in a certain direction toward the outside and the same number of longitudinal grooves corresponding thereto.   A preformed balloon having a distal end side connection portion and a proximal end side connection portion for joining a catheter shaft to both ends by previously blow-molding the balloon tube, and having a body portion larger in diameter than these connection portions. The method for manufacturing a catheter balloon according to claim 1, wherein the preformed balloon is disposed in the mold. The method for producing a catheter balloon according to claim 1, wherein the mold has three or more of the concave grooves .   The peripheral length of the inner peripheral surface of the mold is equal to or longer than the outer periphery of the body of the balloon tube or preformed balloon, or the catheter balloon according to any one of claims 1 to 3. Method.   The manufacturing method of the balloon for catheters in any one of Claims 1-4 extended | stretched in a longitudinal direction, heating and pressurizing the said tube for balloons or a preforming balloon within a metal mold | die. A shape obtained by the hollow wing portion curved in a certain direction from the center side of the balloon toward the outside and the same number of longitudinal grooves, which is obtained by the manufacturing method according to any one of claims 1 to 5, during decompression in the balloon. A shape memory balloon for a catheter having a scrolled cross section attached thereto.   A balloon catheter comprising the balloon according to claim 6.

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