Balloon for balloon catheter

Abstract

A balloon for a balloon catheter is provided, which allows for easy folding of the balloon and facilitates insertion into and perforation within a body cavity, while preventing elongation of the balloon along its long axis. The balloon for the balloon catheter satisfies at least one of the following (1) and (2): (1) The distal conical portion (24) comprises: a first portion (610) having a medial protrusion (61); and a second portion (620) not having a medial protrusion (61), wherein the distal conical portion (24) has a lateral protrusion (62) throughout the entire section of the second portion (620). (2) The proximal conical portion (22) comprises: a first portion (610) having a medial protrusion (61); and a second portion (620) not having a medial protrusion (61), wherein the proximal conical portion (22) has a lateral protrusion (62) throughout the entire section of the second portion (620).

Description

Technical Field

[0001] This invention relates to balloons for balloon catheters. Background Technology

[0002] Because narrowing of the blood vessel walls due to calcification and other hardening processes can cause conditions such as angina and myocardial infarction, angioplasty, a procedure that uses a balloon catheter to dilate the narrowed area, is one treatment option. Angioplasty is a minimally invasive procedure that does not require open-chest surgery like bypass surgery and is widely performed.

[0003] In angioplasty, conventional balloon catheters sometimes fail to dilate stenosis that has hardened due to calcification or other factors. Alternatively, methods are used to dilate the stenosis by placing an indwelling dilator called a stent within the stenosis. However, this method can lead to conditions such as in-stent restenosis (ISR), where excessive proliferation of the neointimal layer after treatment causes re-stenosis. In ISR lesions, the neointimal layer is soft and smooth, so during balloon dilation with a conventional balloon catheter, the balloon may deviate from the lesion, potentially causing damage to the vessel.

[0004] As a balloon catheter capable of dilating the stenosis even in the aforementioned calcified lesions and ISR lesions, a balloon catheter is provided with a protrusion for entering the stenosis, a blade, and a scribing element in the balloon. For example, Patent Document 1 discloses a balloon catheter with a scribing element made of a polymer material with a higher rigidity than the polymer material forming the balloon body, and the scribing element is flattened at one end and the other end of the balloon. Patent Document 2 discloses a scribing balloon structure in which the height of the scribing element decreases along the tapered shape of the balloon's front end. Patent Document 3 discloses a balloon catheter with a high protrusion where the protrusion of the protrusion disposed on the tapered part of the front end is greater than the protrusion of the protrusion disposed on the straight part of the balloon. In addition, Patent Document 4 discloses a balloon catheter with an outer protrusion in the straight part of the balloon and an inner protrusion in the tapered part.

[0005] Patent Document 1: U.S. Patent Application Publication No. 2016 / 0128718

[0006] Patent Document 2: Japanese Patent Publication No. 2014-506140

[0007] Patent Document 3: International Publication No. 2020 / 012850

[0008] Patent Document 4: International Publication No. 2020 / 012851

[0009] A balloon catheter is inserted into a body cavity in a retracted and folded state and delivered to the treatment site. For safe and appropriate treatment, the balloon catheter must be easily foldable, easily inserted into the body cavity, and easily delivered to the treatment site within the body cavity. However, existing balloon catheters, as described above, still have room for improvement in terms of the ease of balloon folding, the ease of insertion into the insertion site, and the ease of penetration into the body cavity. Furthermore, to prevent damage caused by balloon expansion into normal blood vessels that are not part of the treatment target, and to ensure sufficient radial expansion of the balloon to improve treatment efficiency, there is room for improvement in suppressing balloon elongation along its long axis. Therefore, the object of the present invention is to provide a balloon for a balloon catheter that allows for easy folding of the balloon, easier insertion into the body cavity, and easier penetration into the body cavity, while preventing balloon elongation along its long axis. Summary of the Invention

[0010] An embodiment of the balloon catheter of the present invention, which is able to solve the above-mentioned problems, has the following features: it has a balloon body having an outer surface and an inner surface, the balloon body having a straight tube portion, a distal conical portion located on the distal side of the straight tube portion, and a proximal conical portion located on the proximal side of the straight tube portion, and the balloon catheter satisfies at least one of the following (1) and (2).

[0011] (1) In the long axis direction of the balloon body, the distal conical portion comprises: a first portion having an inner protrusion that protrudes radially inward beyond the inner surface of the balloon body and extends along the long axis direction of the balloon body; and a second portion, which is the entire interval excluding the first portion and does not have an inner protrusion, wherein the distal conical portion has an outer protrusion that protrudes radially outward beyond the outer surface of the balloon body and extends along the long axis direction of the balloon body.

[0012] (2) In the long axis direction of the balloon body, the proximal conical portion includes: a first portion having an inner protrusion that protrudes radially inward beyond the inner surface of the balloon body and extends along the long axis direction of the balloon body; and a second portion that is the entire interval excluding the first portion and does not have an inner protrusion, the proximal conical portion having an outer protrusion that protrudes radially outward beyond the outer surface of the balloon body and extends along the long axis direction of the balloon body.

[0013] In the aforementioned balloon catheter, it is preferable that the outer protrusion and the inner protrusion are positioned at the same location circumferentially on the balloon body.

[0014] In the above-mentioned balloon catheter, it is preferable that the first part is not provided on the side closer to the straight tube section than the second part.

[0015] In the balloon catheter described above, it is preferable that, in the long axis direction of the balloon body, when one end of the distal conical portion and the straight tube portion of the proximal conical portion are set to a 0% position and the other end is set to a 100% position, the second portion is provided throughout the range from at least 0% to 10% of at least one of the distal conical portion and the proximal conical portion.

[0016] The balloon used in the above-mentioned balloon catheter preferably has an lateral protrusion throughout the entire first section.

[0017] In the balloon catheter described above, the straight portion preferably has an outer protrusion. In this case, it is preferable to satisfy at least one of (1) and (2) below.

[0018] (1) The lateral protrusion of the distal conical part and the lateral protrusion of the straight tube part extend continuously in the long axis direction of the balloon body.

[0019] (2) The lateral protrusion of the proximal conical part and the lateral protrusion of the straight tube part extend continuously in the long axis direction of the balloon body.

[0020] In the balloon catheter described above, preferably, in the long axis direction of the balloon body, when one end of the distal conical portion and the proximal conical portion is set to the straight tube side at 0%, and the other end is set to the 100% position, an outer protrusion is provided in at least one of the distal conical portion and the proximal conical portion in the interval from at least 20% to 80%. In the radial direction of the balloon body, when the difference between the radius of the outer circle with the outer diameter of the balloon body as the radius and the radius of the circumscribed circle of the outer protrusion sharing the center with the outer circle is set as the height of the outer protrusion, at least one of the following (1) and (2) is satisfied.

[0021] (1) The height of the lateral protrusion at 80% of the distal conical part is the same as or lower than the height of the lateral protrusion at 20% of the distal conical part.

[0022] (2) The height of the lateral protrusion at 80% of the position of the proximal conical part is the same as or lower than the height of the lateral protrusion at 20% of the position of the proximal conical part.

[0023] In the balloon catheter described above, preferably, in the long axis direction of the balloon body, when one end of the distal conical portion and the proximal conical portion on the straight tube side is set to a 0% position and the other end is set to a 100% position, an outer protrusion is provided at a 60% position of at least one of the distal conical portion and the proximal conical portion. In the radial direction of the balloon body, when the difference between the radius of the outer circle with the outer diameter of the balloon body as its radius and the radius of the circumscribed circle of the outer protrusion sharing the center with the outer circle is defined as the height of the outer protrusion, the height of the outer protrusion at the 60% position is the same as or lower than the height of the outer protrusion in the straight tube portion.

[0024] In the balloon catheter described above, preferably, in the long axis direction of the balloon body, when one end of the distal conical portion and the proximal conical portion on the straight tube side is set to a 0% position and the other end is set to a 100% position, an outer protrusion is provided at a 40% position of at least one of the distal conical portion and the proximal conical portion. In the radial direction of the balloon body, when the difference between the radius of the outer circle with the outer diameter of the balloon body as its radius and the radius of the circumscribed circle of the outer protrusion sharing the center with the outer circle is defined as the height of the outer protrusion, the height of the outer protrusion at the 40% position is the same as or lower than the height of the outer protrusion in the straight tube portion.

[0025] In the balloon catheter described above, preferably, in the long axis direction of the balloon body, when one end of the distal conical portion and the proximal conical portion is set to a 0% position and the other end is set to a 100% position, a first part is arranged in at least the interval from 80% to 100% of at least one of the distal conical portion and the proximal conical portion. In the radial direction of the balloon body, when the difference between the radius of the inner circle with the inner diameter of the balloon body as its radius and the radius of the inscribed circle of the inner protrusion sharing the center with the inner circle is set as the height of the inner protrusion, at least one of the following (1) and (2) is satisfied.

[0026] (1) The height of the medial protrusion at 90% of the distal conical part is the same as or higher than the height of the medial protrusion at 80% of the distal conical part.

[0027] (2) The height of the medial protrusion at 90% of the position of the proximal conical part is the same as or higher than the height of the medial protrusion at 80% of the position of the proximal conical part.

[0028] In the aforementioned balloon catheter, the distal conical portion preferably has a first part and a second part, while the proximal conical portion does not have a medial protrusion. In this case, the balloon body preferably has a proximal sleeve portion closer to the proximal conical portion, and both the proximal sleeve portion and the proximal conical portion have lateral protrusions but no medial protrusions. Furthermore, in this case, the lateral protrusions of the proximal sleeve portion and the proximal conical portion preferably extend continuously along the long axis of the balloon body. Additionally, in this case, the straight tube portion preferably has a lateral protrusion, and the lateral protrusions of the proximal conical portion and the straight tube portion preferably extend continuously along the long axis of the balloon body.

[0029] In the above-mentioned balloon catheter, the proximal conical portion preferably has a first part and a second part, while the distal conical portion does not have an inner protrusion.

[0030] In the above-mentioned balloon catheter balloon, it is preferable that the outer protrusion and the inner protrusion are made of the same material as the balloon body.

[0031] The balloon used in the aforementioned balloon catheter can be easily folded when inflated and its outer diameter can be kept small, thus facilitating insertion into body cavities and improving follow-up during intracavitary access. Therefore, the treatment time using balloon catheters can be shortened, reducing the burden on patients. Furthermore, the balloon used in the aforementioned balloon catheter prevents elongation of the balloon's long axis when inflated by introducing pressurized fluids or other fluids. This prevention of long-axis elongation prevents the balloon from dilating into normal blood vessels that are not intended for treatment, thus avoiding damage and allowing for the dilation of stenotic areas. Attached Figure Description

[0032] Figure 1 A side view of a balloon catheter according to one embodiment of the present invention is shown.

[0033] Figure 2 Show Figure 1 A cross-sectional view along the long axis of the distal portion of the balloon catheter shown.

[0034] Figure 3 Show Figure 1 Sectional view III-III.

[0035] Figure 4 Showing the representation Figure 3 A cross-sectional view of a modified example.

[0036] Figure 5 Show Figure 1 VV sectional view.

[0037] Figure 6 Showing the representation Figure 5A cross-sectional view of a modified example.

[0038] Figure 7 A cross-sectional view along the long axis of the distal portion of a balloon catheter according to another embodiment of the present invention is shown.

[0039] Figure 8 This is a partially enlarged view of a cross-section along the long axis of a balloon according to one embodiment of the present invention.

[0040] Figure 9 A partially enlarged view of a cross-section along the long axis of a balloon according to another embodiment of the present invention is shown.

[0041] Figure 10 A partially enlarged view of a cross-section along the long axis of a balloon according to another embodiment of the present invention is shown.

[0042] Figure 11 A partially enlarged view of a cross-section along the long axis of a balloon according to another embodiment of the present invention is shown.

[0043] Figure 12 A cross-sectional view along the long axis of the distal portion of a balloon catheter according to another embodiment of the present invention is shown.

[0044] Figure 13 A cross-sectional view along the long axis of the distal portion of a balloon catheter according to another embodiment of the present invention is shown.

[0045] Figure 14 A cross-sectional view along the long axis of the distal portion of a balloon catheter according to another embodiment of the present invention is shown.

[0046] Figure 15 A perspective view of the preform before expansion according to one embodiment of the present invention is shown. Detailed Implementation

[0047] The present invention will now be specifically described based on embodiments, but the present invention is of course not limited to the embodiments described below, and may be implemented by appropriate modifications within the scope of the foregoing and following spirit, all of which are included within the technical scope of the present invention. Furthermore, in the various drawings, for convenience, shaded lines, component reference numerals, etc., are sometimes omitted; in such cases, refer to the specification and other drawings. Additionally, the dimensions of various components in the drawings are primarily helpful in understanding the features of the present invention, and therefore sometimes differ from the actual dimensions.

[0048] One embodiment of the balloon catheter of the present invention has the following features: having a balloon body having an outer surface and an inner surface, the balloon body having a straight tube portion, a distal conical portion located on the distal side of the straight tube portion, and a proximal conical portion located on the proximal side of the straight tube portion, and the balloon catheter has at least one of the following (1) and (2).

[0049] (1) In the long axis direction of the balloon body, the distal conical portion comprises: a first portion having an inner protrusion that protrudes radially inward beyond the inner surface of the balloon body and extends along the long axis direction of the balloon body; and a second portion, which is the entire interval excluding the first portion and does not have an inner protrusion, wherein the distal conical portion has an outer protrusion that protrudes radially outward beyond the outer surface of the balloon body and extends along the long axis direction of the balloon body.

[0050] (2) In the long axis direction of the balloon body, the proximal conical portion includes: a first portion having an inner protrusion that protrudes radially inward beyond the inner surface of the balloon body and extends along the long axis direction of the balloon body; and a second portion that is the entire interval excluding the first portion and does not have an inner protrusion, wherein the proximal conical portion has an outer protrusion in the entire interval of the second portion that protrudes radially outward beyond the outer surface of the balloon body and extends along the long axis direction of the balloon body.

[0051] In this manner, at least one of the distal conical portion and the proximal conical portion comprises: a first portion having a medial protrusion; and a second portion, which is the entire section excluding the first portion, without a medial protrusion. Therefore, it can be easily folded when the balloon is contracted, and the outer diameter of the balloon can be kept small. This results in a balloon catheter balloon that is easier to insert into the body cavity and has high followability during insertion into the body cavity. Furthermore, by having a medial protrusion in the first portion and a lateral protrusion throughout the entire section of the second portion without a medial protrusion, the balloon body is reinforced by both the medial and lateral protrusions. This prevents elongation of the balloon along its long axis, such as when a pressurized fluid or other fluid is introduced into the balloon to cause balloon expansion. Hereinafter, the balloon catheter balloon will sometimes be simply referred to as a "balloon".

[0052] Reference Figures 1 to 11 The balloon catheter is explained. Figure 1 A side view of a balloon catheter according to one embodiment of the present invention is shown. Figure 2 Show Figure 1 A cross-sectional view along the long axis of the distal portion of the balloon catheter shown. Figure 3 Show Figure 1 Sectional view III-III, Figure 4 Show Figure 3 A cross-sectional view of a modified example. Figure 5 Show Figure 1 VV sectional view, Figure 6 Showing the representation Figure 5 A cross-sectional view of a modified example. In Figures 3-6 The axis is omitted in the text. Figure 7 A cross-sectional view along the long axis of the distal portion of a balloon for a balloon catheter according to another embodiment of the present invention is shown. Figures 8-11 Partially enlarged cross-sectional views along the long axis of the distal or proximal portion of the balloon according to different embodiments of the present invention are shown. Figures 8-11 The axis is omitted in the text.

[0053] In this invention, relative to the extension direction of the balloon catheter 1 or the long axis direction of the axis 3, the proximal side refers to the direction near the user or surgeon, and the distal side refers to the opposite direction of the proximal side, that is, the direction of the treatment object side.

[0054] like Figures 1-2 As shown, the balloon catheter 1 has a shaft 3 and a balloon 2 disposed outside the shaft 3. The balloon catheter 1 has a proximal side and a distal side, with the balloon 2 disposed distal to the shaft 3. The balloon catheter 1 is configured to supply fluid to the interior of the balloon 2 through the shaft 3, and the expansion and contraction of the balloon 2 can be controlled using a pressurizer (balloon pressurizer). The fluid can also be a pressurized fluid pressurized by a pump or the like.

[0055] The shaft 3 has an internal fluid flow path, and more preferably, a guidewire insertion path. To form a structure in which the shaft 3 has both a fluid flow path and a guidewire insertion path, for example, the following structure can be described: the shaft 3 has an outer tube 31 and an inner tube 32, the inner tube 32 functions as the guidewire insertion path, and the space between the inner tube 32 and the outer tube 31 functions as a fluid flow path. When the shaft 3 has an outer tube 31 and an inner tube 32, it is preferable that the inner tube 32 extends and protrudes from the distal end of the outer tube 31 and penetrates to a position distal to the balloon 2, the distal side of the balloon 2 is joined to the inner tube 32, and the proximal side of the balloon 2 is joined to the outer tube 31.

[0056] like Figures 1-8 As shown, the balloon 2 of the balloon catheter 1 has a balloon body 20, the balloon body 20 has an outer surface and an inner surface, the balloon body 20 has a straight tube 23, a distal conical part 24 located on the distal side of the straight tube 23, and a proximal conical part 22 located on the proximal side of the straight tube 23, and the balloon 2 of the balloon catheter 1 satisfies at least one of the following (1) and (2).

[0057] (1) In the long axis direction of the balloon body 20, the distal conical portion 24 includes: a first portion 610, the first portion 610 having an inner protrusion 61, the inner protrusion 61 protruding radially inward from the inner surface of the balloon body 20 and extending along the long axis direction of the balloon body 20; and a second portion 620, the second portion 620 being the entire interval excluding the first portion 610, without having an inner protrusion 61, the distal conical portion 24 having an outer protrusion 62 in the entire interval of the second portion 620, the outer protrusion 62 protruding radially outward from the outer surface of the balloon body 20 and extending along the long axis direction of the balloon body 20.

[0058] (2) In the long axis direction of the balloon body 20, the proximal conical portion 22 includes: a first portion 610, the first portion 610 having an inner protrusion 61, the inner protrusion 61 protruding radially inward from the inner surface of the balloon body 20 and extending along the long axis direction of the balloon body 20; and a second portion 620, the second portion 620 being the entire area excluding the first portion 610, without having an inner protrusion 61, the proximal conical portion 22 having an outer protrusion 62 in the entire area of ​​the second portion 620, the outer protrusion 62 protruding radially outward from the outer surface of the balloon body 20 and extending along the long axis direction of the balloon body 20.

[0059] By having a second portion 620, in which at least one of the distal conical portion 24 and the proximal conical portion 22 has a medial protrusion 61 that does not obstruct the folding of the balloon 2, the balloon 2 can be easily folded when it is contracted, and the outer diameter of the balloon 2 can be kept small. Furthermore, since at least one of the distal conical portion 24 and the proximal conical portion 22 has a lateral protrusion 62 throughout the entire section of the second portion 620 without the medial protrusion 61, the rigidity of the balloon 2 is ensured, preventing elongation of the balloon 2 along its long axis, such as when a pressurized fluid or other fluid is introduced into the balloon 2 to inflate it. Therefore, the stenotic portion can be easily dilated, and the risk of injury caused by dilating the balloon 2 into a normal blood vessel that is not the target of treatment is reduced.

[0060] exist Figure 2 The illustration shows an example where both the distal conical portion 24 and the proximal conical portion 22 have a first portion 610 (the portion with the inner protrusion 61) and a second portion 620 (the portion without the inner protrusion 61 but with the outer protrusion 62 throughout the entire interval). However, it is also possible for only the distal conical portion 24 or only the proximal conical portion 22 to have the first portion 610 and the second portion 620. In this case, the conical portion that does not have the first portion 610 and the second portion 620 may have either the outer protrusion 62 or the inner protrusion 61 throughout the entire interval.

[0061] The distal conical portion 24 and the proximal conical portion 22 are preferably formed such that their diameters decrease as they move away from the straight tube portion 23. Because the balloon 2 has a straight tube portion 23 with its maximum diameter in the inflated state, the straight tube portion 23 can make sufficient contact with the narrowed portion, facilitating the expansion of the narrowed portion. Furthermore, the balloon 2 has a distal conical portion 24 and a proximal conical portion 22 whose outer diameters decrease as they move away from the straight tube portion 23. Therefore, when the balloon 2 is contracted and wound around the shaft 3, the outer diameters of the distal and proximal sides of the balloon 2 can be reduced, thus reducing the step difference between the shaft 3 and the balloon 2. This allows the balloon 2 to be easily inserted into the body cavity.

[0062] like Figure 3 As shown, at least one of the distal conical portion 24 and the proximal conical portion 22 can have an inner protrusion 61 in the circumferential direction of the first portion 610, or it can be as follows: Figure 4 The balloon 2 has a plurality of inner protrusions 61 along the circumferential direction. In the case of a plurality of inner protrusions 61 along the circumferential direction, it is preferable that the inner protrusions 61 are spaced apart along the circumferential direction, and more preferably that they are arranged at equal intervals along the circumferential direction. By having inner protrusions 61 as described above on at least one of the distal conical portion 24 and the proximal conical portion 22, elongation along the long axis of the balloon 2 can be prevented evenly along the circumferential direction.

[0063] like Figure 5 As shown, at least one of the distal conical portion 24 and the proximal conical portion 22 may have an outer protrusion 62 in the circumferential direction of the second portion 620, or may be as follows: Figure 6 The balloon 2 has multiple lateral protrusions 62 along its circumferential direction. When multiple lateral protrusions 62 are present, it is preferable that the lateral protrusions 62 are spaced apart circumferentially, and more preferably arranged at equal intervals circumferentially. By having lateral protrusions 62 as described above on at least one of the distal conical portion 24 and the proximal conical portion 22, elongation of the balloon 2 along its long axis can be prevented evenly along its circumferential direction. Furthermore, the balloon 2 can be fixed to the narrow portion or cut open through the lateral protrusions 62; therefore, by circumferentially separating the lateral protrusions 62 and preferably arranging them at equal intervals, it is easier to fix the balloon 2 and cut open the narrow portion.

[0064] The shape of the cross-section perpendicular to the long axis direction of the inner protrusion 61 and the outer protrusion 62 can be any shape, or it can be... Figures 3-6The shape is roughly triangular as shown, but it can also be polygonal, fan-shaped, wedge-shaped, convex, spindle-shaped, etc. The maximum height of the inner protrusion 61 and the outer protrusion 62 in the first part 610 and the second part 620, respectively, is preferably more than 1 times the membrane thickness of the balloon body 20, more preferably more than 1.5 times, and even more preferably more than 2 times. However, it is also permissible to have a maximum height of less than 50 times, less than 30 times, or less than 10 times. By ensuring that the maximum height of the inner protrusion 61 and the outer protrusion 62 in the first part 610 and the second part 620, respectively, falls within the above range, elongation along the long axis of the balloon 2 can be prevented. The definition of the height of the inner protrusion 61 and the outer protrusion 62 will be described later.

[0065] like Figure 2 As shown, the outer protrusion 62 and the inner protrusion 61 are preferably positioned at the same location in the circumferential direction of the balloon body 20. Thus, the balloon 2 has the outer protrusion 62, which can reinforce the balloon body 20 from the outside, and the inner protrusion 61, which can reinforce the balloon body 20 from the inside, at the same location in the circumferential direction, thereby making it easier to prevent elongation of the balloon 2 in the long axis direction.

[0066] Along the long axis of the balloon body 20, one end of the balloon body 20 is set to position D0 (0%) on the side of the straight tube 23 of the distal cone 24 and the proximal cone 22, and the other end is set to position D0 (100%). 100 When the first part 610 is provided, the interval can be, for example, from 90% to 100%. As long as the first part 610 is provided in at least the above-mentioned interval, elongation of the balloon 2 in the long axis direction can be prevented. The interval where the first part 610 is provided can be, for example, from 80% to 100%, from 70% to 100%, from 60% to 100%, from 50% to 100%, from 40% to 100%, from 30% to 100%, from 20% to 100%, or from 10% to 100%. As long as the interval where the first part 610 is provided is within the above-mentioned range, elongation in the long axis direction can be prevented. In addition, the entire interval except for the first part 610 does not have the second part 620 with the inner protrusion 61, so an easily foldable balloon 2 can be formed.

[0067] like Figure 2As shown, it is preferable that the first part 610 is not provided on the side closer to the straight tube 23 than the second part 620. That is, it is preferable that the second part 620 without the inner protrusion 61 is provided on at least one of the distal conical part 24 and the proximal conical part 22 adjacent to the side of the straight tube 23. By not providing the inner protrusion 61 on the inner side of the conical part adjacent to the side of the straight tube 23 where the folding amount increases, the balloon 2 can be folded more easily.

[0068] Along the long axis of the balloon body 20, one end of the balloon body 20 is set to position D0 (0%) on the side of the straight tube 23 of the distal cone 24 and the proximal cone 22, and the other end is set to position D0 (100%). 100 In this configuration, the second portion 620 is preferably provided over at least one of the distal conical portion 24 and the proximal conical portion 22, covering a range from at least 0% to 10%. Specifically, it is preferable that the inner protrusion 61 is not provided in the range from 0% to 10% of the distal conical portion 24 and the proximal conical portion 22. More preferably, the second portion 620 is provided over a range from 0% to 15%, and even more preferably, it is provided over a range from 0% to 20%. Alternatively, the second portion 620 may also be provided over a range from 0% to 90%, or from 0% to 80%. Because the second portion 620 is provided over a range from at least 0% to 10%, i.e., the inner protrusion 61 is not provided over a range from at least 0% to 10%, the balloon 2 can be easily folded.

[0069] The balloon 2 preferably has a lateral protrusion 62 throughout the entire area of ​​the first portion 610. The balloon 2 also has a lateral protrusion 62 throughout the entire area of ​​the second portion 620, excluding the first portion 610. Therefore, if the balloon 2 has a lateral protrusion 62 throughout the entire area of ​​the first portion 610, it can be configured to have a lateral protrusion 62 throughout the entire area of ​​at least one of the distal conical portion 24 and the proximal conical portion 22 of both the first portion 610 and the second portion 620. With this structure, elongation of the balloon 2 along its long axis can be further suppressed.

[0070] At this time, the height of the outer protrusion 62 provided on the first part 610 is preferably lower on the end side of the other side compared to the end side on the straight tube portion 23 side of the first part 610. With such a structure, the height of the outer protrusion 62 is lower on the side of the balloon 2 that is more constricted, thus suppressing the outer diameter of the balloon 2, thereby facilitating insertion into the body cavity and improving followability during insertion into the body cavity. Even though the height of the outer protrusion 62 is lower in the portion of the first part 610 that includes the end on the side opposite to the straight tube portion 23, the rigidity of the tapered portion can be ensured because the first part 610 has an inner protrusion 61, preventing elongation of the balloon 2 in the long axis direction.

[0071] Alternatively, the balloon 2 may have an outer protrusion 62 in a portion of the first part 610. In this case, the balloon 2 preferably has an outer protrusion 62 in the portion of the first part 610 containing the straight tube portion 23 along the long axis direction of the balloon body 20, and does not have an outer protrusion 62 in the portion containing the other end. With such a structure, since the outer protrusion 62 is not provided on the side of the balloon 2 that is more constricted, the outer diameter of the balloon 2 can be suppressed, insertion into the body cavity can be easily performed, and the followability during insertion into the body cavity can be improved. Even if the outer protrusion 62 is not provided in the portion of the first part 610 containing the end opposite to the straight tube portion 23, since the balloon 2 has an inner protrusion 61 in the first part 610, the rigidity of the tapered portion can be ensured, and elongation in the long axis direction of the balloon 2 can be prevented.

[0072] Furthermore, at this time, the height of the outer protrusion 62 provided on the first part 610 is preferably higher towards the straight tube part 23 of the first part 610. As a result, the height of the outer protrusion 62 becomes lower on the side of the balloon 2 that is further constricted, thereby suppressing the outer diameter of the balloon 2, making it easier to insert into the body cavity and improving the followability when inserting into the body cavity.

[0073] like Figure 7 As shown, the straight tube portion 23 preferably has an outer protrusion 62. By having the outer protrusion 62 on the straight tube portion 23, which has the largest diameter when the balloon 2 is in the expanded state, it is easy to fix the balloon 2 and cut the narrow part through the outer protrusion 62 on the straight tube portion 23.

[0074] like Figure 7 As shown, the balloon 2 preferably satisfies at least one of (1) and (2) below.

[0075] (1) The outer protrusion 62 of the distal conical portion 24 and the outer protrusion 62 of the straight tube portion 23 extend continuously in the long axis direction of the balloon body 20.

[0076] (2) The outer protrusion 62 of the proximal conical portion 22 and the outer protrusion 62 of the straight tube portion 23 extend continuously in the long axis direction of the balloon body 20.

[0077] exist Figure 7The diagram shows an example where the lateral protrusion 62 of the distal conical portion 24, the lateral protrusion 62 of the straight tube portion 23, and the lateral protrusion 62 of the proximal conical portion 22 extend along the long axis, thus simultaneously satisfying conditions (1) and (2) above. However, satisfying at least one of conditions (1) and (2) above is sufficient. By having a lateral protrusion 62 in at least one of the distal conical portion 24 and the proximal conical portion 22, and having the lateral protrusion 62 continuously extending along the long axis of the balloon body 20 with the lateral protrusion 62 of the straight tube portion 23, the elongation of the balloon 2 along the long axis can be further suppressed.

[0078] like Figure 8 As shown, along the long axis of the balloon body 20, one end of the balloon body 20 is set to position D0 (0%) on the side of the straight tube 23 of the distal cone 24 and the proximal cone 22, and the other end is set to position D0 (100%). 100 At least from position D of at least one of the distal conical portion 24 and the proximal conical portion 22. 20 To 80% of position D 80 The section is provided with an outer protrusion 62, which is located radially on the outer circle C with the outer diameter of the balloon body 20 as the radius. o radius r o , and outer circle C o The radius r of the circumcircle CC of the outer protrusion 62 of the shared center P cc The difference is set as the height t of the outer protrusion 62. o In this case, it is preferable to satisfy at least one of (1) and (2) below.

[0079] (1) The height of the outer protrusion 62 at 80% of the position of the distal conical portion 24 is the same as or lower than the height of the outer protrusion 62 at 20% of the position of the distal conical portion 24.

[0080] (2) The height of the outer protrusion 62 at 80% of the position of the proximal conical portion 22 is the same as or lower than the height of the outer protrusion 62 at 20% of the position of the proximal conical portion 22.

[0081] When at least one of the distal conical portion 24 and the proximal conical portion 22 has a plurality of lateral protrusions 62 in the circumferential direction, it is preferable that 80% of the positions D of all the lateral protrusions 62 are located. 80 The height at the location and the 20% position D 20 The height of the balloon 2 is the same as or lower than that of the other side. By satisfying the above conditions through the lateral protrusion 62, the height of the lateral protrusion 62 on the side of the balloon 2 that is further constricted can be reduced to suppress the outer diameter of the balloon 2, making insertion into the body cavity easier and improving followability during insertion into the body cavity. In addition, even at 80% of the position D 80The height of the outer protrusion 62 is reduced. Since the balloon 2 of the embodiment of the present invention has an inner protrusion 61 in the first part 610, the rigidity of the tapered part can be ensured and the elongation of the balloon 2 in the long axis direction can be prevented.

[0082] Here, refer to Figure 5 and Figure 6 The method for measuring the height of the outer protrusion 62 is explained. After introducing UV-curable resin at 5 atmospheres into the balloon 2 to expand it, UV irradiation is used to cure the UV-curable resin. The height is measured at a desired position along the long axis of the balloon body 20, for example, at position D at 20% if the above is true. 20 and 80% of the positions D 80 The balloon body 20 is cut radially perpendicular to its major axis. The cut surface is observed using a microscope such as an optical microscope, and the outer circle C of the balloon body 20 with its outer diameter as the radius is determined. o radius r o , and outer circle C o The radius r of the circumcircle CC of the outer protrusion 62 of the shared center P cc The radius r of the circumcircle CC cc Subtract the outer circle C with the outer diameter of the balloon body 20 as the radius. o radius r o The obtained value is taken as the height t of the outer protrusion 62. o As a UV-curable resin, any resin can be used as long as it can be introduced into the balloon 2 to cause it to expand.

[0083] like Figure 9 As shown, along the long axis of the balloon body 20, one end of the balloon body 20 is set to position D0 (0%) on the side of the straight tube 23 of the distal cone 24 and the proximal cone 22, and the other end is set to position D0 (100%). 100 At the time, at a position D of at least one of the distal conical portion 24 and the proximal conical portion 22 at 60% of its length. 60 An outer protrusion 62 is provided, which is located radially on the outer circle C with the outer diameter of the balloon body 20 as the radius. o radius r o , and outer circle C o The radius r of the circumcircle CC of the outer protrusion 62 of the shared center P CC The difference is set as the height t of the outer protrusion 62. o At that time, 60% of the position D 60The height of the outer protrusion 62 is preferably the same as or lower than the height of the outer protrusion 62 in the straight tube portion 23. When at least one of the distal tapered portion 24 and the proximal tapered portion 22 has a plurality of outer protrusions 62 circumferentially, it is preferable that 60% of the position D of all the outer protrusions 62 is located at... 60 The height of the outer protrusion 62 in the straight tube 23 is the same as or lower than that of the outer protrusion 62. By satisfying the above conditions with the outer protrusion 62, the height of the outer protrusion 62 on the side that is further constricted than the midpoint of the long axis of the conical section can be reduced to suppress the outer diameter of the balloon 2, making insertion into the body cavity easier and improving followability during insertion into the body cavity. The outer protrusion 62 in the portion near the straight tube 23 of the conical section can also be formed to the same height as or higher than the outer protrusion 62 in the straight tube 23, so the outer protrusion 62 in the conical section can also be used for fixation of the lesion and incision of the stenosis. In addition, even at 60% of the position D 60 The height of the outer protrusion 62 is reduced. Since the balloon 2 of the embodiment of the present invention has an inner protrusion 61 in the first part 610, the rigidity of the tapered part can also be ensured, and the elongation of the balloon 2 in the long axis direction can be prevented.

[0084] like Figure 10 As shown, along the long axis of the balloon body 20, one end of the balloon body 20 is set to position D0 (0%) on the side of the straight tube 23 of the distal cone 24 and the proximal cone 22, and the other end is set to position D0 (100%). 100 At the time, at a position D of at least one of the distal conical portion 24 and the proximal conical portion 22 at 40% of its length. 40 An outer protrusion 62 is provided, which is located radially on the outer circle C with the outer diameter of the balloon body 20 as the radius. o radius r o , and outer circle C o The radius r of the circumcircle CC of the outer protrusion 62 of the shared center P CC The difference is set as the height t of the outer protrusion 62. o At that time, 40% of the position D 40 The height of the outer protrusion 62 is preferably the same as or lower than the height of the outer protrusion 62 in the straight tube portion 23. When at least one of the distal tapered portion 24 and the proximal tapered portion 22 has a plurality of outer protrusions 62 circumferentially, it is preferable that 40% of all the outer protrusions 62 are located at position D. 40The height of the outer protrusion 62 in the straight tube section 23 is the same as or lower than its height. By satisfying the above conditions through the outer protrusion 62, the height of the outer protrusion 62 can be reduced in the portion near the straight tube section 23 of the conical section to suppress the outer diameter of the balloon 2, making insertion into the body cavity easier and improving followability during insertion into the body cavity. Furthermore, even at 40% of the position D... 40 The height of the outer protrusion 62 is reduced. Since the balloon 2 of the embodiment of the present invention has an inner protrusion 61 in the first part 610, the rigidity of the tapered part can also be ensured, and the elongation of the balloon 2 in the long axis direction can be prevented.

[0085] like Figure 11 As shown, along the long axis of the balloon body 20, one end of the balloon body 20 is set to position D0 (0%) on the side of the straight tube 23 of the distal cone 24 and the proximal cone 22, and the other end is set to position D0 (100%). 100 At the same time, at least one of the distal conical portion 24 and the proximal conical portion 22 is at least from position D of 80%. 80 To 100% position D 100 The interval is configured with the first part 610, which is located radially on the balloon body 20, within an inner circle C with a radius equal to the inner diameter of the balloon body 20. i radius r i 、 and inner circle C i The radius r of the inscribed circle IC of the inner protrusion 61 of the shared center P IC The difference is set as the height t of the inner protrusion 61. i In this case, it is preferable to satisfy at least one of (1) and (2) below.

[0086] (1) The height of the inner protrusion 61 at 90% of the position of the distal conical portion 24 is the same as or higher than the height of the inner protrusion 61 at 80% of the position of the distal conical portion 24.

[0087] (2) The height of the inner protrusion 61 at 90% of the position of the proximal conical portion 22 is the same as or higher than the height of the inner protrusion 61 at 80% of the position of the proximal conical portion 22.

[0088] When at least one of the distal conical portion 24 and the proximal conical portion 22 has a plurality of inner protrusions 61 in the circumferential direction, it is preferable that 90% of the positions D of all the inner protrusions 61 are located. 90 The height at the location and the 80% position D 80The height of the inner protrusion 61 is the same as or higher than that of the straight tube 23. By satisfying the above conditions through the inner protrusion 61, the height of the inner protrusion 61 of the tapered portion on the side of the straight tube 23, where the folding amount increases, can be reduced, making it easier to fold the balloon 2. In addition, since the height of the inner protrusion 61 can be increased at the end opposite to the straight tube 23 where the diameter is further reduced in the tapered portion, the rigidity of the tapered portion in this part can be ensured, and elongation in the long axis direction of the balloon 2 can be prevented.

[0089] Here, refer to Figure 3 and Figure 4 The method for measuring the height of the inner protrusion 61 will be described. Similar to the method for measuring the height of the outer protrusion 62, after introducing UV-curable resin at 5 atmospheres into the balloon 2 to expand it, UV irradiation is used to cure the UV-curable resin. The height is measured at a desired position along the long axis of the balloon body 20, for example, at position D (80% of the length, as described above). 80 and 90% of the positions D 90 The balloon body 20 is cut radially perpendicular to its major axis. The cut surface is observed using a microscope such as an optical microscope, and the inner circle C of the balloon body 20 with its inner diameter as the radius is determined radially. i radius r i 、 and inner circle C i The radius r of the inscribed circle IC of the inner protrusion 61 of the shared center P IC The radius r of the inscribed circle IC IC Subtract the inner circle C with the inner diameter of the balloon body 20 as the radius. i radius r i The obtained value is used as the height t of the inner protrusion 61. i As a UV-curable resin, any resin can be used as long as it can be introduced into the balloon 2 to cause it to expand.

[0090] Reference Figure 12 and Figure 13 The balloon 2 for the balloon catheter of other embodiments of the present invention will be described. Figure 12 and Figure 13 Cross-sectional views along the long axis of the distal portion of the balloon catheter 1 in different embodiments.

[0091] like Figure 12As shown, the distal conical portion 24 preferably has a first portion 610 and a second portion 620, while the proximal conical portion 22 does not have a medial protrusion 61. By having a second portion 620 in the distal conical portion 24 that does not have a medial protrusion 61 that obstructs the folding of the balloon 2, the balloon 2 can be easily folded when contracted, and the outer diameter of the balloon 2 can be kept small. By keeping the distal outer diameter of the balloon 2 small, the balloon catheter 1 can be easily advanced within the body cavity. Furthermore, since the distal conical portion 24 has a lateral protrusion 62 throughout the entire section of the second portion 620 without the medial protrusion 61, the rigidity of the balloon 2 can be ensured, preventing elongation of the balloon 2 along its long axis when pressure fluid or other fluids are introduced into the balloon 2 to inflate it. This allows for easy dilation of stenotic portions, reducing the risk of injury caused by dilating the balloon 2 into normal blood vessels that are not intended for treatment. Additionally, as... Figure 12 As shown, the proximal conical portion 22 may also have an outer protrusion 62. By having an outer protrusion 62 in the proximal conical portion 22, the rigidity of the balloon 2 in the proximal conical portion 22 can be ensured, and elongation of the balloon 2 in the long axis direction can be prevented.

[0092] like Figure 13 As shown, the balloon body 20 has a proximal sleeve portion 21 closer to the proximal conical portion 22. As described above, when the distal conical portion 24 has a first portion 610 and a second portion 620, and the proximal conical portion 22 does not have an inner protrusion 61, it is preferable that the proximal sleeve portion 21 and the proximal conical portion 22 have outer protrusions 62 but not inner protrusions 61. The outer protrusions 62 in the proximal conical portion 22 and the proximal sleeve portion 21 ensure the rigidity of the proximal side of the balloon 2, preventing not only axial elongation of the balloon 2 but also compression of the balloon 2 during fluid drainage. Furthermore, the absence of an inner protrusion 61 in the proximal sleeve portion 21 allows for faster fluid introduction or drainage during balloon 2 expansion or contraction, reducing the burden on the patient.

[0093] In the above situations, such as Figure 13 As shown, preferably, the outer protrusion 62 of the proximal sleeve portion 21 and the outer protrusion 62 of the proximal conical portion 22 extend continuously in the long axis direction of the balloon body 20. By having the outer protrusion 62 of the proximal sleeve portion 21 and the outer protrusion 62 of the proximal conical portion 22 extend continuously in the long axis direction of the balloon body 20, the elongation of the proximal side of the balloon 2 in the long axis direction can be further suppressed.

[0094] In addition, such as Figure 13As shown, the straight tube portion 23 may also have an outer protrusion 62. In this case, it is preferable that the outer protrusion 62 of the proximal conical portion 22 and the outer protrusion 62 of the straight tube portion 23 extend continuously in the long axis direction of the balloon body 20. If the outer protrusion 62 extends continuously from the proximal sleeve portion 21 through the proximal conical portion 22 to the straight tube portion 23, the elongation in the long axis direction from the straight tube portion 23 of the balloon 2 to the proximal side can be further suppressed.

[0095] like Figure 14 As shown, the balloon 2 for the balloon catheter can also be configured such that the proximal conical portion 22 has a first portion 610 and a second portion 620, while the distal conical portion 24 does not have an inner protrusion 61. By having a second portion 620 in the proximal conical portion 22 that does not have an inner protrusion 61 that obstructs the folding of the balloon 2, the balloon 2 can be easily folded when contracted, and the outer diameter of the balloon 2 can be kept small. By keeping the outer diameter of the balloon 2 proximally small, the balloon catheter 1 can be easily withdrawn from the body cavity. Furthermore, the proximal conical portion 22 has an outer protrusion 62 throughout the entire section of the second portion 620 without the inner protrusion 61, thus ensuring the rigidity of the balloon 2 and preventing elongation of the balloon 2 along its long axis when a pressurized fluid or other fluid is introduced into the balloon 2 to inflate it. Additionally, the distal conical portion 24 does not have an inner protrusion 61, so the balloon 2 can also be easily folded distally. like Figure 14 As shown, the distal conical portion 24 may also have a lateral protrusion 62. By having a lateral protrusion 62 in the distal conical portion 24, the rigidity of the balloon 2 within the distal conical portion 24 can be ensured, preventing elongation of the balloon 2 along its long axis. Furthermore, if the distal conical portion 24 has a lateral protrusion 62, it is effective for treatments such as those involving the balloon catheter 1 serpentinely advancing while simultaneously incising and dilating the lesion.

[0096] Materials constituting the balloon body 20 include, for example, polyolefin resins such as polyethylene, polypropylene, and ethylene-propylene copolymer; polyester resins such as polyethylene terephthalate and polyester elastomers; polyurethane resins such as polyurethane and polyurethane elastomers; polyphenylene sulfide resins; polyamide resins such as polyamide elastomers; fluorinated resins; silicone resins; and natural rubber such as latex rubber. Only one type may be used, or two or more types may be used in combination. Polyamide resins, polyester resins, and polyurethane resins are preferred. In particular, from the perspective of the balloon body 20's thin-film properties and flexibility, elastomer resins are preferred. For example, among polyamide resins, nylon 12 and nylon 11 are preferred as the resin constituting the balloon body 20, and nylon 12 is more preferred from the perspective of easier molding during blow molding. Furthermore, from the perspective of the balloon body 20's thin-film properties and flexibility, polyamide elastomers such as polyether ester amide elastomers and polyamide ether elastomers are preferred. Among these considerations, polyether amide elastomer is preferred because it offers high yield strength and good dimensional stability of the balloon body 20.

[0097] The outer protrusion 62 and the inner protrusion 61 are preferably made of the same material as the balloon body 20. If the outer protrusion 62 and the inner protrusion 61 are made of the same material as the balloon body 20, the flexibility of the balloon 2 can be maintained, and the outer protrusion 62 and the inner protrusion 61 are less likely to scratch the outer surface of the balloon body 20. The balloon body 20 and the outer protrusion 62 and the inner protrusion 61 are preferably integrally formed. This prevents the outer protrusion 62 and the inner protrusion 61 from detaching from the balloon body 20.

[0098] For example, balloon 2 can pass through Figure 15 A cylindrical preform 200 made of resin, as shown, is disposed in a mold having a groove in its inner cavity and manufactured by biaxial stretching blow molding. The outer protrusion 62 is formed, for example, by inserting the preform 200 into the inner cavity of the mold, causing the thick-walled portion 220 of the preform to enter the groove of the mold, and introducing fluid into the inner cavity 210 of the preform 200 to expand it. Similarly, the inner protrusion 61 is formed, for example, by pressing the thick-walled portion 220 of the preform 200 against a non-grooved portion of the mold, and introducing fluid into the inner cavity 210 of the preform 200 to expand it. For the materials constituting the preform 200, please refer to the description of the materials constituting the aforementioned balloon body 20.

[0099] Examples of materials constituting the shaft 3 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorinated resins, vinyl chloride resins, silicone resins, and natural rubber. Only one type may be used, or two or more may be used in combination. Preferably, the material constituting the shaft 3 is at least one of a polyamide resin, a polyolefin resin, or a fluorinated resin, thereby improving the slippage of the shaft 3 surface and enhancing the insertion portability of the balloon catheter 1 within the body cavity.

[0100] Examples of joining balloon 2 and shaft 3 include bonding with adhesive, fusion bonding, and installing a ring-shaped component at the overlapping portion of balloon 2 and shaft 3 and then pressing them together. Preferably, balloon 2 and shaft 3 are joined by fusion bonding. By fusion bonding balloon 2 and shaft 3, the joint between balloon 2 and shaft 3 is less likely to disintegrate even with repeated expansion and contraction of balloon 2, thus easily improving the joint strength between balloon 2 and shaft 3.

[0101] like Figure 1 As shown, a hub 4 can also be provided on the proximal side of the shaft 3, and a fluid injection section 7 can be provided on the hub 4, which is connected to the flow path of fluid supplied to the interior of the balloon 2. Furthermore, the hub 4 preferably has a guidewire insertion section 5 that communicates with the guidewire insertion path. By having a hub 4 with a fluid injection section 7 and a guidewire insertion section 5 in the balloon catheter 1, it is easy to supply fluid to the interior of the balloon 2 to inflate and deflate the balloon 2, and to deliver the balloon catheter 1 along the guidewire to the treatment site. This is not only applicable to so-called over-the-wire type balloon catheters where the guidewire is inserted from the distal side of the shaft to the proximal side, but also to so-called quick-exchange type balloon catheters where the guidewire is inserted midway from the distal side of the shaft to the proximal side.

[0102] The connection between the shaft 3 and the hub 4 can be achieved, for example, by bonding with an adhesive or by fusion. Preferably, the shaft 3 and the hub 4 are joined by adhesive. By bonding the shaft 3 and the hub 4, for example, when the materials constituting the shaft 3 are different from those constituting the hub 4 (e.g., the shaft 3 is made of a highly flexible material and the hub 4 is made of a highly rigid material), the connection strength between the shaft 3 and the hub 4 can be increased, thereby improving the durability of the balloon catheter 1.

[0103] This application claims priority based on Japanese Patent Application No. 2020-190296, filed on November 16, 2020. The entire contents of the description of Japanese Patent Application No. 2020-190296, filed on November 16, 2020, are incorporated herein by reference.

[0104] Explanation of reference numerals in the attached figures

[0105] 1…Balloon catheter; 2…Balloon; 3…Shaft; 4…Gathering device; 5…Guidewire insertion section; 7…Fluid injection section; 20…Balloon body; 21…Proximal sleeve section; 22…Proximal conical section; 23…Straight tube section; 24…Distal conical section; 31…Outer tube; 32…Inner tube; 61…Inner protrusion; 62…Outer protrusion; 200…Preform; 210…Inner cavity of preform; 220…Thick-walled section of preform; 610…First section; 620…Second section; C i …the inner circle with radius equal to the inner diameter of the balloon body; C o …the outer circle with radius r, defined by the outer diameter of the balloon body; i …the radius of the inner circle, with the inner diameter of the balloon body as its radius; r o …the radius of the outer circle with the outer diameter of the balloon body as its radius; IC…the inscribed circle of the inner protrusion; CC…the circumscribed circle of the outer protrusion; r IC …the radius of the inscribed circle of the inner protrusion; r CC …the radius of the circumcircle of the outer protrusion; the position of D0…0%; D 100 …100% position.

Claims

1. A balloon for a balloon catheter, characterized in that, It has a balloon body, which has an outer surface and an inner surface. The balloon body has a straight tube portion, a distal conical portion located distal to the straight tube portion, and a proximal conical portion located closer to the straight tube portion. The balloon catheter balloon satisfies at least one of the following (1) and (2): (1) In the long axis direction of the balloon body, the distal conical portion comprises: a first portion having an inner protrusion that protrudes radially inward beyond the inner surface of the balloon body and extends along the long axis direction of the balloon body; and a second portion, which is the entire interval excluding the first portion and does not have the inner protrusion. The second part is disposed adjacent to the straight pipe part, so that the first part is not disposed on the side of the straight pipe part that is closer to the second part than the second part. The distal conical portion has a lateral protrusion throughout the entire range of the second portion. This lateral protrusion projects radially outward from the outer surface of the balloon body and extends along the long axis of the balloon body. (2) In the long axis direction of the balloon body, the proximal conical portion comprises: a first portion having an inner protrusion that protrudes radially inward beyond the inner surface of the balloon body and extends along the long axis direction of the balloon body; and a second portion, which is the entire section excluding the first portion and does not have the inner protrusion. The second part is disposed adjacent to the straight pipe part, so that the first part is not disposed on the side of the straight pipe part that is closer to the second part than the second part. The proximal conical portion has an outer protrusion throughout the entire range of the second portion, the outer protrusion protruding radially outward from the outer surface of the balloon body and extending along the long axis of the balloon body.

2. The balloon for balloon catheters according to claim 1, characterized in that, The outer protrusion and the inner protrusion are positioned at the same circumferential position on the balloon body.

3. The balloon for balloon catheters according to claim 1 or 2, characterized in that, In the long axis direction of the balloon body, when one end of the straight tube side of the distal conical portion and the proximal conical portion is set to the 0% position and the other end is set to the 100% position, the second portion is provided throughout the interval from at least the 0% position to the 10% position of at least one of the distal conical portion and the proximal conical portion.

4. The balloon for balloon catheters according to claim 1 or 2, characterized in that, The outer protrusion is present throughout the entire range of the first part.

5. The balloon for balloon catheters according to claim 1 or 2, characterized in that, The straight tube section has the outer protrusion.

6. The balloon for balloon catheters according to claim 5, characterized in that, Satisfying at least one of (1) and (2) below, (1) The outer protrusion of the distal conical portion and the outer protrusion of the straight tube portion extend continuously along the long axis of the balloon body. (2) The outer protrusion of the proximal conical portion and the outer protrusion of the straight tube portion extend continuously along the long axis of the balloon body.

7. The balloon for balloon catheters according to claim 1 or 2, characterized in that, Along the long axis of the balloon body, with one end of the straight tube side of the distal conical portion and the proximal conical portion set at 0% and the other end set at 100%, the lateral protrusion is provided in at least one of the distal conical portion and the proximal conical portion within a range from at least 20% to 80%. In the radial direction of the balloon body, when the difference between the radius of the outer circle (with the outer diameter of the balloon body as its radius) and the radius of the circumscribed circle of the outer protrusion sharing a center with the outer circle is defined as the height of the outer protrusion, Satisfying at least one of (1) and (2) below, (1) The height of the outer protrusion at 80% of the distal conical portion is the same as or lower than the height of the outer protrusion at 20% of the distal conical portion. (2) The height of the outer protrusion at 80% of the position of the proximal conical portion is the same as or lower than the height of the outer protrusion at 20% of the position of the proximal conical portion.

8. The balloon for balloon catheters according to claim 5, characterized in that, Along the long axis of the balloon body, with one end of the straight tube side of the distal conical portion and the proximal conical portion set to 0% and the other end set to 100%, the lateral protrusion is provided at a position of 60% of at least one of the distal conical portion and the proximal conical portion. In the radial direction of the balloon body, when the difference between the radius of the outer circle (with the outer diameter of the balloon body as its radius) and the radius of the circumscribed circle of the outer protrusion sharing a center with the outer circle is defined as the height of the outer protrusion, The height of the outer protrusion at 60% position is the same as or lower than the height of the outer protrusion in the straight tube section.

9. The balloon for balloon catheters according to claim 5, characterized in that, Along the long axis of the balloon body, with one end of the straight tube side of the distal conical portion and the proximal conical portion set at 0% and the other end set at 100%, the lateral protrusion is provided at a position of 40% of at least one of the distal conical portion and the proximal conical portion. In the radial direction of the balloon body, when the difference between the radius of the outer circle (with the outer diameter of the balloon body as its radius) and the radius of the circumscribed circle of the outer protrusion sharing a center with the outer circle is defined as the height of the outer protrusion, The height of the outer protrusion at the 40% position is the same as or lower than the height of the outer protrusion in the straight tube section.

10. The balloon for balloon catheters according to claim 1 or 2, characterized in that, In the long axis direction of the balloon body, with one end of the straight tube side of the distal conical portion and the proximal conical portion set to 0% and the other end set to 100%, the first portion is disposed in at least one of the distal conical portion and the proximal conical portion within a range from at least 80% to 100%. In the radial direction of the balloon body, when the difference between the radius of the inner circle (with the inner diameter of the balloon body as its radius) and the radius of the inscribed circle of the inner protrusion sharing a center with the inner circle is set as the height of the inner protrusion, Satisfying at least one of (1) and (2) below, (1) The height of the inner protrusion at 90% of the distal conical portion is the same as or higher than the height of the inner protrusion at 80% of the distal conical portion. (2) The height of the inner protrusion at 90% of the position of the proximal conical portion is the same as or higher than the height of the inner protrusion at 80% of the position of the proximal conical portion.

11. The balloon for balloon catheters according to claim 1 or 2, characterized in that, The distal conical portion has the first portion and the second portion, while the proximal conical portion does not have the inner protrusion.

12. The balloon for balloon catheters according to claim 11, characterized in that, The balloon body has a proximal sleeve portion closer to the proximal side than the proximal conical portion, and the proximal sleeve portion and the proximal conical portion have the outer protrusion but not the inner protrusion.

13. The balloon for balloon catheters according to claim 12, characterized in that, The outer protrusion of the proximal sleeve portion and the outer protrusion of the proximal conical portion extend continuously along the long axis of the balloon body.

14. The balloon for balloon catheters according to claim 12, characterized in that, The straight tube portion has the outer protrusion, and the outer protrusion of the proximal conical portion and the outer protrusion of the straight tube portion extend continuously along the long axis of the balloon body.

15. The balloon for balloon catheters according to claim 1 or 2, characterized in that, The proximal conical portion has the first portion and the second portion, while the distal conical portion does not have the inner protrusion.

16. The balloon for balloon catheters according to claim 1 or 2, characterized in that, The outer protrusion and the inner protrusion are made of the same material as the balloon body.

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