Balloon for balloon catheter and balloon catheter

Abstract

The balloon for a balloon catheter is provided with a protruding ridge (21) extending in the longitudinal axis direction on the linear tube part of the balloon. A specific notch (22X) is formed in the protruding ridge (21). The protruding ridge (21) is divided into a plurality of protruding ridge segments (24) by the specific notch (22X). On the distal surface (31) of a protruding ridge segment (24P) adjacent to the proximal side of the specific notch (22X), a normal vector A on a line of intersection with a virtual plane (H) formed from the longitudinal axis direction and the radial direction, passing through the apex (21A) of the protruding ridge (21), extends to one side of the virtual plane (H) toward the distal side. On the proximal surface (41) of a protruding ridge segment (24D) adjacent to the distal side of the specific notch (22X), a normal vector B on a line of intersection with the virtual plane (H) extends to the other side of the virtual plane (H) toward the proximal side.

Description

Balloon for balloon catheter and balloon catheter

[0001] The present invention relates to a balloon for a balloon catheter and a balloon catheter equipped with the balloon.

[0002] It is known that stenosis in blood vessels, which are the channels through which blood circulates in the body, can lead to various diseases due to stagnation of blood circulation. In particular, stenosis in the coronary arteries that supply blood to the heart can lead to serious diseases such as angina pectoris and myocardial infarction. One method for treating such vascular stenosis is angioplasty (PTA, PTCA, etc.), which dilates the stenotic area using a balloon catheter.

[0003] Balloon catheters with ridges on the surface of the balloon are known (see, for example, Patent Documents 1 to 3). When such a balloon catheter is used, the ridges of the balloon bite into the narrowed area when the balloon is inflated, effectively dilating the narrowed area. However, balloons with ridges tend to have higher rigidity in the areas where the ridges are provided, making them less flexible in the longitudinal direction. In contrast, balloon catheters with notches formed in the ridges on the balloon surface are known (see, for example, Patent Documents 4 and 5). By using such a balloon catheter, it is possible to ensure flexibility in the longitudinal direction even with a balloon that has ridges.

[0004] International Publication No. 2020 / 250611 Japanese Patent Application Laid-Open No. 2009-112361 Japanese Patent Application Laid-Open No. 2013-176507 International Publication No. 2012 / 099950 International Publication No. 2020 / 255923

[0005] A balloon having ridges on its surface and notches formed in the ridges can exhibit a scoring function due to the ridges, and the notches formed in the ridges can ensure the balloon's flexibility in the longitudinal direction. However, because blood vessels have large bends, it is desirable that a balloon with ridges can be smoothly inserted even through such bends. Therefore, it would be even more desirable if the balloon's flexibility could be further improved.

[0006] The present invention has been made in consideration of the above circumstances, and its object is to provide a balloon for a balloon catheter, which has a balloon with ridges on its surface that can enhance flexibility in the longitudinal axis direction, and a balloon catheter equipped with such a balloon.

[0007] The balloon for a balloon catheter of the present invention, which has been able to solve the above-mentioned problems, and the balloon catheter including said balloon, are as follows: [1] A balloon for a balloon catheter having a longitudinal axis direction extending from the proximal side to the distal side and a radial direction perpendicular to the longitudinal axis direction, wherein the balloon has a straight tube portion, a proximal tapered portion located proximal to the straight tube portion, and a distal tapered portion located distal to the straight tube portion, wherein the straight tube portion has a cylindrical balloon main body and a ridge on the outer surface of the balloon main body that protrudes radially outward and extends in the longitudinal axis direction, wherein notches are formed in the ridge and the ridge is divided into a plurality of ridge segments by the notches, and wherein the ridge includes a specific notch that satisfies the following requirement A: (Requirement A) The distal surface of the convex streak segment adjacent to the proximal side of the specific notch (hereinafter referred to as the "proximal convex streak segment") has a normal vector A on the line of intersection with an imaginary plane that passes through the apex of the convex streak and is formed by the longitudinal axis direction and the radial direction, extending distally to one side of the imaginary plane, and the proximal surface of the convex streak segment adjacent to the distal side of the specific notch (hereinafter referred to as the "distal convex streak segment") has a normal vector B on the line of intersection with the imaginary plane that extends proximally to the other side of the imaginary plane. [2] A balloon for a balloon catheter having a longitudinal axis direction extending from a proximal side to a distal side and a radial direction perpendicular to the longitudinal axis direction, wherein the balloon has a straight tube portion, a proximal tapered portion located proximal to the straight tube portion, and a distal tapered portion located distal to the straight tube portion, the straight tube portion having a cylindrical balloon main body and a ridge on the outer surface of the balloon main body that protrudes radially outward and extends in the longitudinal axis direction, wherein notches are formed in the ridge, and the ridge is divided into a plurality of ridge segments by the notches, and the ridge includes a specific notch that satisfies the following requirement B.(Requirement B) In a plan view seen from the apex side of the ridge, the distal end edge of the ridge segment adjacent to the proximal side of the specific notch (hereinafter referred to as the "proximal ridge segment") has a convex shape protruding distally, and the proximal end edge of the ridge segment adjacent to the distal side of the specific notch (hereinafter referred to as the "distal ridge segment") has a convex shape protruding proximally. [3] The ridge has a plurality of the specific notches arranged in the longitudinal axis direction, and when one side of the imaginary plane of the ridge is a first side and the other side of the imaginary plane is a second side, in all of the specific notches provided in the ridge, the normal vector A extends toward the first side toward the distal side, and the normal vector B extends toward the second side toward the proximal side. [4] The balloon according to [1], wherein the ridges have a plurality of the specific notches arranged in the longitudinal axis direction, and when one side of the imaginary plane in the ridges is defined as a first side and the other side of the imaginary plane is defined as a second side, the specific notches in the ridges have the normal vector A extending toward the first side toward the distal side and the normal vector B extending toward the second side toward the proximal side, and the specific notches in the ridges have the normal vector A extending toward the second side toward the distal side and the normal vector B extending toward the first side toward the proximal side, alternately arranged in the longitudinal axis direction. [5] The balloon according to [1], [3], or [4], wherein the distal surface of the proximal ridge segment and the proximal surface of the distal ridge segment are closest to each other in the longitudinal axis direction at least on an intersection line with the imaginary plane. [6] The balloon according to [5], wherein the distance between the distal surface of the proximal ridge segment and the proximal surface of the distal ridge segment in the longitudinal axis direction remains constant or increases with increasing distance from the imaginary plane. [7] The balloon according to [6], wherein the distance between the distal surface of the proximal ridge segment and the proximal surface of the distal ridge segment in the longitudinal axis direction increases at least partially with increasing distance from the imaginary plane.[8] The balloon according to any one of [1] and [3] to [7], wherein the distal surface of the proximal ridge segment is inclined radially outward toward the proximal side at an intersection with the imaginary plane, and the proximal surface of the distal ridge segment is inclined radially outward toward the distal side at an intersection with the imaginary plane. [9] The balloon according to any one of [1] and [3] to [8], wherein an angle formed between a projection vector AP of the normal vector A onto the outer surface of the balloon body and the longitudinal axis direction toward the distal side is 20° to 70°, and an angle formed between a projection vector BP of the normal vector B onto the outer surface of the balloon body and the longitudinal axis direction toward the proximal side is 20° to 70°.

[10] The balloon according to [2], wherein the most distal portion of the distal end edge of the proximal ridge segment is on an imaginary line passing through the apex of the ridge and extending in the longitudinal direction in a plan view seen from the apex side of the ridge, and / or the most proximal portion of the proximal end edge of the distal ridge segment is on an imaginary line passing through the apex of the ridge and extending in the longitudinal direction in a plan view seen from the apex side of the ridge.

[11] The balloon according to [2] or

[10] , wherein the convex shape of the distal end edge of the proximal ridge segment has a curved portion curved toward the distal side, and / or the convex shape of the proximal end edge of the distal ridge segment has a curved portion curved toward the proximal side.

[12] The balloon according to [2],

[10] , or

[11] , wherein the convex shape of the distal end edge of the proximal ridge segment has, in a plan view seen from the apex side of the ridge, a proximal first straight section located on one side of an imaginary line passing through the apex of the ridge and extending in the longitudinal axis direction, and a proximal second straight section located on the other side, and the proximal first straight section and the proximal second straight section extend so as to move away from the imaginary line as they extend proximally; and / or the convex shape of the proximal end edge of the distal ridge segment has, in a plan view seen from the apex side of the ridge, a distal first straight section located on one side of the imaginary line and a distal second straight section located on the other side, and the distal first straight section and the distal second straight section extend so as to move away from the imaginary line as they extend distally.

[13] The balloon according to

[12] , wherein the convex shape of the distal end edge of the proximal ridge segment further has a proximal third straight section between the proximal first straight section and the proximal second straight section in a plan view seen from the apex side of the ridge, the proximal first straight section and the proximal second straight section being located proximally relative to the proximal third straight section, and / or the convex shape of the proximal end edge of the distal ridge segment further has a distal third straight section between the distal first straight section and the distal second straight section in a plan view seen from the apex side of the ridge, the distal first straight section and the distal second straight section being located distal to the distal third straight section.

[14] The balloon according to

[13] , wherein the proximal third straight section and / or the distal third straight section extends perpendicular to the longitudinal axis direction.

[15] The balloon according to

[12] , wherein the distal end of the proximal first straight section is connected to the distal end of the proximal second straight section, and / or the proximal end of the distal first straight section is connected to the proximal end of the distal second straight section.

[16] The balloon according to any one of [2] and

[10] to

[15] , wherein, in a cross section along the longitudinal axis passing through the apex of the ridge, the distal outer edge of the proximal ridge segment extends at an inclination toward the proximal side toward the radially outward direction, and / or, in a cross section along the longitudinal axis passing through the apex of the ridge, the proximal outer edge of the distal ridge segment extends at an inclination toward the distal side toward the radially outward direction.

[17] The balloon according to any one of [1] to

[16] , wherein the ridge is made of resin, metal, or a combination thereof.

[18] A balloon catheter comprising the balloon according to any one of [1] to

[17] .

[0008] The balloon for a balloon catheter of the present invention has ridges on the outer surface of the straight tube portion of the balloon, so that when a balloon catheter equipped with the balloon is used to inflate the balloon at a stenosis or the like in a blood vessel, the ridges penetrate the stenosis or the like, allowing for effective inflation. In addition, the ridges of the balloon have notches, and the specific notches described above are formed as at least a portion of the notches, which improves the flexibility of the balloon.

[0009] 8( a ) and 8 ( b ) illustrate an example of the configuration of a balloon catheter according to an embodiment of the present invention, showing a side view of the balloon catheter. 1 A cross-sectional view of the balloon catheter shown in FIG. 1 taken along line II-II. 2 A cross-sectional view of the balloon catheter shown in FIG. 1 taken along line III-III. 3 An example of a perspective view of a balloon according to a first embodiment provided in a balloon catheter. 4 An example of a perspective view of a balloon according to a second embodiment provided in a balloon catheter. 5 A vertical cross-sectional view of the straight tube portion of the balloon shown in FIGS. 4 and 5 taken along the longitudinal axis. 6 A vertical cross-sectional view of the ridge of the balloon shown in FIG. 6. 7 An example of the configuration of a specific notch formed in the ridge of the balloon according to the first embodiment and the ridge segment adjacent thereto, where FIG. 8( a ) shows a perspective view of the end of the ridge segment, and FIG. 8( b ) shows a plan view of the end of the ridge segment as viewed from the top side of the ridge.

[0033] Figure 9(a) shows an example of the configuration of a specific notch formed in a ridge of a balloon according to the first embodiment and an adjacent ridge segment, with Figure 9(a) showing a perspective view of the end of the ridge segment and Figure 9(b) showing a plan view of the end of the ridge segment as viewed from the top side of the ridge.

[0034] Figure 10(a) shows an example of the configuration of a specific notch formed in a ridge of a balloon according to the first embodiment and an adjacent ridge segment, with Figure 10(b) showing a perspective view of the end of the ridge segment and Figure 10(b) showing a plan view of the end of the ridge segment as viewed from the top side of the ridge.

[0035] Figure 11(a) shows an example of the configuration of a specific notch formed in a ridge of a balloon according to the first embodiment and an adjacent ridge segment, with Figure 11(b) showing a perspective view of the end of the ridge segment and Figure 11(b) showing a plan view of the end of the ridge segment as viewed from the top side of the ridge. 12(a) shows a perspective view of the end of the ridge segment of the balloon according to the first embodiment, and Fig. 12(b) shows a plan view of the end of the ridge segment as viewed from the top side of the ridge. 13(a) shows a perspective view of the end of the ridge segment of the balloon according to the first embodiment, and Fig. 13(b) shows a plan view of the end of the ridge segment as viewed from the top side of the ridge.14(a) and 14(b) show examples of the configuration of a specific notch formed in a ridge of a balloon according to the first embodiment and adjacent ridge segments, with FIG. 14(a) showing a perspective view of the end of the ridge segment and FIG. 14(b) showing a plan view of the end of the ridge segment as viewed from the top side of the ridge. 15(a) and 15(b) show examples of the configuration of a specific notch formed in a ridge of a balloon according to the first embodiment and adjacent ridge segments, with FIG. 15(a) showing a perspective view of the end of the ridge segment and FIG. 15(b) showing a plan view of the end of the ridge segment as viewed from the top side of the ridge. 15(b) is a plan view of a balloon according to the first embodiment, as viewed from the top side of the ridge, showing an example of the configuration of a ridge in which multiple specific notches are provided in the longitudinal axis direction. 15(b) is a plan view of a balloon according to the first embodiment, as viewed from the top side of the ridge, showing another example of the configuration of a ridge in which multiple specific notches are provided in the longitudinal axis direction.

[0046] Figure 18(a) shows an example of the configuration of a specific notch formed in a ridge of a balloon according to a second embodiment and an adjacent ridge segment, with Figure 18(a) showing a perspective view of the end of the ridge segment and Figure 18(b) showing a plan view of the end of the ridge segment as viewed from the top side of the ridge.

[0047] Figure 19(a) shows an example of the configuration of a specific notch formed in a ridge of a balloon according to a second embodiment and an adjacent ridge segment, with Figure 19(b) showing a perspective view of the end of the ridge segment and Figure 19(b) showing a plan view of the end of the ridge segment as viewed from the top side of the ridge.

[0048] Figure 20(a) shows an example of the configuration of a specific notch formed in a ridge of a balloon according to a second embodiment and an adjacent ridge segment, with Figure 20(b) showing a perspective view of the end of the ridge segment and Figure 20(b) showing a plan view of the end of the ridge segment as viewed from the top side of the ridge. 21(a) shows a perspective view of the end of the ridge segment of a balloon according to the second embodiment, and Fig. 21(b) shows a plan view of the end of the ridge segment as viewed from the top side of the ridge. 22(a) shows a perspective view of the end of the ridge segment of a balloon according to the second embodiment, and Fig. 22(b) shows a plan view of the end of the ridge segment as viewed from the top side of the ridge.

[0046] Figure 23(a) shows an example of the configuration of a specific notch formed in a ridge of a balloon according to a second embodiment and an adjacent ridge segment, with Figure 23(a) showing a perspective view of the end of the ridge segment and Figure 23(b) showing a plan view of the end of the ridge segment as viewed from the top of the ridge.

[0047] Figure 24(a) shows an example of the configuration of a specific notch formed in a ridge of a balloon according to a second embodiment and an adjacent ridge segment, with Figure 24(a) showing a perspective view of the end of the ridge segment and Figure 24(b) showing a plan view of the end of the ridge segment as viewed from the top of the ridge.

[0048] Figure 25(a) shows an example of the configuration of a specific notch formed in a ridge of a balloon according to a second embodiment and an adjacent ridge segment, with Figure 25(b) showing a perspective view of the end of the ridge segment and Figure 25(b) showing a plan view of the end of the ridge segment as viewed from the top of the ridge.

[0049] Figure 23(b) shows an example of a cross-sectional view of a ridge and a specific notch provided on a balloon along the longitudinal axis. FIG. 1 shows another example of a cross-sectional view of the ridges and specific notches provided on the balloon, taken along the longitudinal axis direction. FIG. 2 shows another example of a cross-sectional view of the ridges and specific notches provided on the balloon, taken along the longitudinal axis direction. FIG. 3 shows another example of a cross-sectional view of the ridges and specific notches provided on the balloon, taken along the longitudinal axis direction. FIG. 4 shows another example of a perspective view of the balloon according to the first embodiment provided on the balloon catheter. FIG. 5 shows another example of a perspective view of the balloon according to the first embodiment provided on the balloon catheter. FIG. 6 shows another example of a perspective view of the balloon according to the second embodiment provided on the balloon catheter. FIG. 7 shows another example of a vertical cross-sectional view of the ridges of the balloon in the longitudinal axis direction.

[0010] The present invention will be described in detail below based on the following embodiments. However, the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. In addition, hatching and component symbols may be omitted in each drawing for convenience. In such cases, reference should be made to the specification or other drawings. Furthermore, the dimensions of various components in the drawings may differ from the actual dimensions, as priority is given to helping understand the features of the present invention.

[0011] A balloon for a balloon catheter according to an embodiment of the present invention and an example of a configuration of a balloon catheter equipped with the balloon will be described with reference to the drawings. FIGS. 1 to 5 show an example of a configuration of a balloon catheter. FIG. 1 shows a side view of the balloon catheter, FIG. 2 shows a cross-sectional view of the balloon catheter shown in FIG. 1 taken along II-II, FIG. 3 shows a cross-sectional view of the balloon catheter shown in FIG. 1 taken along III-III, and FIGS. 4 and 5 show perspective views of examples of balloons equipped in the balloon catheter. FIG. 1 shows an example of a configuration of a rapid exchange type balloon catheter. FIG. 4 shows a perspective view of a balloon according to a first embodiment, in which the ridges on the balloon surface have specific notches that satisfy requirement A, which will be described later. FIG. 5 shows a perspective view of a balloon according to a second embodiment, in which the ridges on the balloon surface have specific notches that satisfy requirement B, which will be described later.

[0012] The balloon catheter 1 has a shaft 2 and a balloon 10 provided on the outside of the shaft 2. The balloon catheter 1 has a proximal side and a distal side, and the balloon 10 is provided on the distal portion of the shaft 2. The proximal side of the balloon catheter 1 refers to the direction toward the user (operator) in the direction of extension of the balloon catheter 1, and the distal side refers to the opposite direction from the proximal side, i.e., the direction toward the treatment target. The direction from the proximal side to the distal side of the balloon catheter 1 is referred to as the longitudinal axis direction.

[0013] The balloon catheter 1 is configured so that fluid is supplied to the interior of the balloon 10 through the shaft 2, and the inflation and deflation of the balloon 10 can be controlled using an indeflator (a balloon pressurizer / depressurizer). The fluid may be pressurized fluid pressurized by a pump or the like. Hereinafter, the fluid supplied to the interior of the balloon 10 will be referred to as the "balloon inflation fluid."

[0014] The shaft 2 is composed of, for example, an inner shaft 3 and an outer shaft 4. The inner shaft 3 is disposed within the lumen of the outer shaft 4. The inner shaft 3 can function as a passage for a guide wire that guides the advancement of the shaft 2, and when the balloon catheter 1 is in use, the guide wire is inserted into the lumen of the inner shaft 3. The space between the inner shaft 3 and the outer shaft 4 can function as a flow path for the balloon inflation fluid.

[0015] In the rapid exchange type balloon catheter 1, a guidewire port 7 is provided midway from the distal side to the proximal side of the shaft 2, and the proximal end of the inner shaft 3 is connected to the guidewire port 7, and the distal end of the inner shaft 3 extends to the distal portion of the shaft 2, thereby forming a guidewire insertion passage extending from the guidewire port 7 to the distal portion of the shaft 2.

[0016] The outer shaft 4 may have a proximal outer shaft 4A and a distal outer shaft 4B. In this case, it is preferable that the inner shaft 3 is disposed in the lumen of the distal outer shaft 4B. The proximal outer shaft 4A and the distal outer shaft 4B may be made of the same material, or may be made of different materials. For example, it is preferable that the proximal outer shaft 4A is made of resin or metal, and the distal outer shaft 4B is made of resin. Note that the outer shaft 4 may not be divided into the proximal outer shaft 4A and the distal outer shaft 4B, but may be made of a single member, or the proximal outer shaft 4A and the distal outer shaft 4B may each be made of multiple tubular members.

[0017] A hub 5 is preferably provided on the proximal side of the shaft 2. The hub 5 preferably has a fluid injection section 6 that communicates with a flow path for balloon inflation fluid in the shaft 2. The balloon 10, shaft 2 (inner shaft 3, outer shaft 4), and hub 5 can be joined together using conventional joining means such as adhesives or thermal welding.

[0018] Although not shown in the drawings, the balloon catheter may be an over-the-wire type balloon catheter in which an inner shaft extends from the distal to the proximal end of the shaft and a guidewire insertion passage is formed from the distal to the proximal end of the shaft. In this case, a flow path for a balloon inflation fluid and a guidewire insertion passage provided in the shaft preferably extend to a hub, and the hub preferably has a fluid injection portion communicating with the balloon inflation fluid flow path and a treatment portion communicating with the guidewire insertion passage. Preferably, the hub has a bifurcated structure, with the fluid injection portion provided on one side and the treatment portion provided on the other side.

[0019] It is preferable that the outer surface of the shaft 2 is coated. In a rapid exchange type balloon catheter 1, it is preferable that the outer surface of one or both of the proximal outer shaft 4A and the distal outer shaft 4B is coated, and it is more preferable that the outer surfaces of both the proximal outer shaft 4A and the distal outer shaft 4B are coated. In an over-the-wire type balloon catheter, it is preferable that the outer surface of the outer shaft is appropriately coated.

[0020] The coating can be a hydrophilic coating or a hydrophobic coating depending on the purpose. The outer surface of the shaft 2 can be coated by immersing the shaft 2 in a hydrophilic or hydrophobic coating agent, applying a hydrophilic or hydrophobic coating agent to the outer surface of the shaft 2, or covering the outer surface of the shaft 2 with a hydrophilic or hydrophobic coating agent. The coating agent may contain drugs or additives.

[0021] Examples of hydrophilic coating agents include hydrophilic polymers such as polyvinyl alcohol, polyethylene glycol, polyacrylamide, polyvinylpyrrolidone, and methyl vinyl ether-maleic anhydride copolymers, as well as hydrophilic coating agents made from any combination of these.

[0022] Examples of hydrophobic coating agents include polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), silicone oil, hydrophobic urethane resin, carbon coat, diamond coat, diamond-like carbon (DLC) coat, ceramic coat, and substances terminated with alkyl groups or perfluoroalkyl groups and having low surface free energy.

[0023] A distal tip 8 is preferably provided at the distal end of the balloon catheter 1. The distal tip 8 may be provided as a separate member from the inner shaft 3, on a more distal side than the distal end of the inner shaft 3, or the inner shaft 3 may extend distally beyond the distal end of the balloon 10, so that the distal end of the inner shaft 3 functions as the distal tip 8.

[0024] To enable confirmation of the position of the balloon 10 under X-ray fluoroscopy, a radiopaque marker 9 may be placed on the shaft 2 at the portion where the balloon 10 is located in the longitudinal direction. The radiopaque marker 9 may be placed, for example, on the inner shaft 3 placed inside the balloon 10, and is preferably placed at positions corresponding to both ends of the straight tube portion of the balloon 10, or may be placed at a position corresponding to the center of the straight tube portion of the balloon 10.

[0025] The balloon 10 has a longitudinal axis direction and a radial direction, and is formed in a cylindrical shape with openings on the proximal and distal sides (see Figures 4 and 5). The radial direction of the balloon 10 refers to a direction perpendicular to the longitudinal axis direction, extending radially from the center of the balloon 10. The balloon 10 also has a circumferential direction, which is the direction along the outer periphery of the balloon 10 in an expanded state in a vertical cross section of the balloon 10 in the longitudinal axis direction.

[0026] The balloon 10 has a straight tube section 13, a proximal tapered section 12 located proximal to the straight tube section 13, and a distal tapered section 14 located distal to the straight tube section 13 in the longitudinal axis direction. The straight tube section 13 is formed into a substantially cylindrical shape extending in the longitudinal axis direction and is formed to have the largest radial length (outer diameter) in the balloon 10. The proximal tapered section 12 is located proximal to the straight tube section 13 and connects to the proximal end of the straight tube section 13. The proximal tapered section 12 is formed so that the outer diameter decreases with increasing distance from the straight tube section 13. The distal tapered section 14 is located distal to the straight tube section 13 and connects to the distal end of the straight tube section 13. The distal tapered section 14 is formed so that the outer diameter decreases with increasing distance from the straight tube section 13. The balloon 10 preferably further has a proximal sleeve portion 11 located proximal to the proximal tapered portion 12 and a distal sleeve portion 15 located distal to the distal tapered portion 14. The proximal sleeve portion 11 is located proximal to the proximal tapered portion 12 and connects to the proximal end of the proximal sleeve portion 11. The proximal sleeve portion 11 is formed in a substantially cylindrical shape. The distal sleeve portion 15 is located distal to the distal tapered portion 14 and connects to the distal end of the distal sleeve portion 15. The distal sleeve portion 15 is formed in a substantially cylindrical shape.

[0027] By configuring the balloon 10 as described above, when the balloon 10 is inflated at a stricture, the straight tube portion 13 comes into sufficient contact with the stricture, facilitating treatment such as dilating the stricture. Furthermore, because the balloon 10 has the proximal tapered portion 12 and the distal tapered portion 14, the outer diameters of the proximal and distal ends of the balloon 10 can be reduced when the balloon 10 is deflated, thereby reducing the difference in level between the shaft 2 and the balloon 10, making it easier to insert the balloon 10 into a body cavity, a forceps channel of an endoscope, or a delivery catheter such as a guiding catheter.

[0028] In the distal portion of the shaft 2, the inner shaft 3 preferably extends distally beyond the distal end of the outer shaft 4, and the inner shaft 3 preferably extends through the interior space of the balloon 10 from the proximal sleeve portion 11 to the distal sleeve portion 15. The outer surface of the inner shaft 3 preferably joins to the inner surface of the distal sleeve portion 15 of the balloon 10, and the outer surface of the outer shaft 4 preferably joins to the inner surface of the proximal sleeve portion 11 of the balloon 10. By configuring the distal portion of the shaft 2 in this manner, balloon inflation fluid can be supplied to the interior space of the balloon 10 through the space between the inner shaft 3 and the outer shaft 4.

[0029] There is no particular limitation on the size of the balloon 10. The size of the balloon 10 can be appropriately set, for example, such that the length of the straight pipe portion 13 in the longitudinal direction is 4 mm to 400 mm, and the outer diameter of the straight pipe portion 13 is 1 mm to 30 mm.

[0030] The balloon 10 (particularly the balloon body 16) is preferably made of a resin, more preferably a thermoplastic resin. This facilitates the manufacturing of the balloon 10 by molding. Examples of resins that can be used to form the balloon 10 include polyolefin resins such as polyethylene, polypropylene, and ethylene-propylene copolymer; polyester resins such as polyethylene terephthalate and polyester elastomer; polyurethane resins such as polyurethane and polyurethane elastomer; polyphenylene sulfide resins; polyamide resins such as polyamide and polyamide elastomer; fluorine-based resins; silicone resins; and natural rubbers such as latex rubber. These may be used alone or in combination. Among these, polyamide resins, polyester resins, and polyurethane resins are preferred. Elastomer resins are particularly preferred in terms of the thinness and flexibility of the balloon 10. For example, among polyamide resins, nylon 12 and nylon 11 are preferred materials for the balloon 10. Nylon 12 is preferred because it can be easily molded during blow molding. Furthermore, polyamide elastomers such as polyether ester amide elastomers and polyamide ether elastomers are preferably used from the viewpoints of thinning and flexibility of the balloon 10. Among these, polyether ester amide elastomers are preferably used from the viewpoints of high yield strength and good dimensional stability of the balloon 10.

[0031] The balloon 10 has ridges 21 on the outer surface of the straight tube portion 13. The provision of the ridges 21 on the outer surface of the straight tube portion 13 gives the balloon 10 a scoring function, which allows the balloon 10 to bite into the calcified stenotic portion and create cracks in the stenotic portion when expanded at a stenotic portion of a blood vessel. This allows the stenotic portion to be expanded while suppressing vascular dissection. It also allows the balloon 10 to withstand high pressures and to prevent overexpansion when pressurized. The balloon 10 can also be used to treat stenotic portions or lesions in body cavities other than blood vessels, but the following description focuses on the application of the balloon 10 to vascular treatment.

[0032] The ribs 21 of the balloon 10 will be described in detail with reference to Figures 6 and 7. Figure 6 shows a vertical cross-section of the straight tube portion 13 of the balloon 10 in the longitudinal axis direction, and Figure 7 shows an enlarged cross-section of the ribs 21 of the balloon 10. Figure 6 shows an example of the configuration of the straight tube portion 13 of the balloon 10 shown in Figures 4 and 5 in the vertical cross-section in the longitudinal axis direction, in which the ribs 21 are provided at three locations around the straight tube portion 13.

[0033] The straight tube section 13 of the balloon 10 has a cylindrical balloon body 16, and ridges 21 are provided on the outer surface of the balloon body 16. The ridges 21 are provided so as to protrude radially outward from the outer surface of the balloon body 16. By providing the ridges 21, the outer surface of the straight tube section 13 of the balloon 10 is formed with ridge-present regions 25 and ridge-free regions 26. Note that the ridge-present regions 25 also include portions of the ridges 21 where notches 22 are formed, as described below. The outer surface of the straight tube section 13 is preferably formed flat in the ridge-free regions 26; for example, it is preferable that the outer surface of the straight tube section 13 is not formed as recessed in part of the ridge-free regions 26. This facilitates uniform inflation of the balloon 10 and facilitates the desired scoring function of the ridges 21. The outer surface of the straight pipe section 13 being formed flat in the ridge-free region 26 means that the ridge-free region 26 has a shape in which a plane is bent in an arch shape, and no irregularities are formed on the arched plane. The irregularities do not include surface roughness that is unavoidably formed during manufacturing.

[0034] The ridges 21 have a peak 21A and a base 21B. The peak 21A is the tip of the ridge 21, i.e., the radially outermost part of the ridge 21, and the base 21B is the boundary with the balloon body 16, i.e., the radially innermost part of the ridge 21.

[0035] The ridges 21 can be made of, for example, a resin. If the ridges 21 are made of a resin, the balloon 10 having the ridges 21 can be manufactured by resin molding, facilitating manufacturing. In this case, the ridges 21 and the balloon main body 16 are preferably made of the same resin, and the ridges 21 and the balloon main body 16 are preferably integrally molded. The balloon main body 16 may have an inner layer and an outer layer. In this case, the ridges 21 are preferably made of the same resin as the outer layer of the balloon main body 16. This makes it less likely that the ridges 21 will unintentionally fall off the balloon main body 16. Alternatively, the ridges 21 and the balloon main body 16 may be made of different resins, as long as the resins making up the ridges 21 and the balloon main body 16 are compatible to a certain extent.

[0036] The ridges 21 may be made of metal, or a combination of metal and resin. In this case, it is preferable that the portions of the ridges 21 including the apexes 21A are made of metal. This makes it easier for the ridges 21 to create cracks in or incise the narrowed area when the balloon 10 is inflated. For example, the entire ridges 21 may be made of metal, or the portions of the ridges 21 including the bases 21B may be made of resin and the portions of the ridges 21 including the apexes 21A may be made of metal. Therefore, it is preferable that the ridges 21 be made of resin, metal, or a combination thereof.

[0037] In the straight pipe section 13, the balloon main body 16 is defined as a cylindrical portion. The portion of the straight pipe section 13 excluding the ridges 21 protruding radially outward constitutes the balloon main body 16. The balloon main body 16 can be considered to have a cylindrical outer surface. Therefore, in a vertical cross section of the straight pipe section 13 in the longitudinal axis direction, the outer shape of the balloon main body 16 is substantially circular, which allows the balloon main body 16 and the ridges 21 to be distinguished. The ridge-present region 25 is composed of the balloon main body 16 and the ridges 21, and the ridge-free region 26 is composed of the balloon main body 16.

[0038] The ribs 21 are provided so as to extend in a ridge-like manner on the outer surface of the straight tube portion 13. The ribs 21 extend approximately parallel to the longitudinal axis of the balloon 10. Therefore, the ribs 21 have an extension direction approximately parallel to the longitudinal axis of the balloon 10 and a width direction corresponding to the circumferential direction of the balloon 10.

[0039] Multiple ridges 21 are provided at different circumferential positions on the straight tube portion 13 of the balloon 10. That is, the ridges 21 are provided at multiple locations around the circumference of the balloon 10. In this case, the ridges 21 are preferably arranged at approximately equal intervals around the circumference of the straight tube portion 13 of the balloon 10. This makes it possible to create cracks at multiple locations in the narrowed portion when the balloon 10 is inflated. The ridges 21 are preferably provided at two or more locations around the circumference of the balloon 10, more preferably at three or more locations, and preferably at 12 or fewer locations, more preferably at 10 or fewer locations, and even more preferably at 8 or fewer locations. In this case, the circumferential spacing between the ridges 21 is preferably longer than the circumferential length of one ridge 21.

[0040] The plurality of ridges 21 are preferably provided at approximately the same position in the longitudinal axis direction. That is, the proximal ends of the plurality of ridges 21 are preferably located at approximately the same position in the longitudinal axis direction, and the distal ends of the plurality of ridges 21 are preferably located at approximately the same position in the longitudinal axis direction.

[0041] The cross-sectional shape of the ridges 21 is not particularly limited. For example, the shape of the ridges 21 in a vertical cross section in the longitudinal axis direction of the straight pipe section 13 can be polygonal, such as a triangle or a rectangle, a partial circular shape, such as a semicircle or a sector, a wedge shape, a convex shape, a spindle shape, or an irregular shape. Polygons include polygons with clear corner apexes and straight sides, as well as rounded polygons with rounded corners and polygons with at least some of the sides curved. Note that the ridges 21 are preferably formed so that their width gradually decreases toward the apex 21A.

[0042] In a vertical cross section of the straight tube portion 13 in the longitudinal axis direction, the height of the ribs 21 is preferably at least 0.2 times the width (maximum width) of the ribs 21. Forming the ribs 21 in this manner allows the ribs 21 to more easily penetrate into the narrowed portion when the balloon 10 is inflated at the narrowed portion, thereby enhancing the scoring function of the ribs 21. The ribs 21 are preferably formed so that their width is at its maximum at the base 21B, thereby ensuring stable placement of the ribs 21 on the outer surface of the balloon body 16. The height of the ribs 21 is more preferably at least 0.4 times the width of the ribs 21, and even more preferably at least 0.7 times. Meanwhile, the height of the ribs 21 is preferably at most 2.0 times the width of the ribs 21, more preferably at most 1.8 times, and even more preferably at most 1.5 times. This facilitates ensuring the flexibility of the balloon 10 in the areas where the ribs 21 are present.

[0043] In the straight pipe section 13, the thickness of the portion where the ridges 21 are provided, i.e., the thickness of the ridge-presence region 25, is preferably formed thicker than the thickness of the portion where the ridges 21 are not provided, i.e., the thickness of the ridge-free region 26. This enhances the scoring function of the ridges 21. The thickness (maximum thickness) of the ridge-presence region 25 is preferably 1.5 times or more, more preferably 2.0 times or more, and even more preferably 2.5 times or more, the thickness (maximum thickness) of the ridge-free region 26. There is no particular upper limit to the thickness of the ridge-presence region 25, and it may be, for example, 30 times or less, 20 times or less, or 10 times or less the thickness of the ridge-free region 26.

[0044] In the balloon 10, the ridges 21 are preferably provided over an area of ​​60% or more, more preferably 70% or more, and even more preferably 80% or more, of the straight tubular section 13 in the longitudinal direction. This allows cracks to be formed over a wide area of ​​the stenotic region when the balloon 10 is inflated. The ridges 21 may be provided over an area of ​​90% or more of the straight tubular section 13 in the longitudinal direction, or over almost the entire straight tubular section 13 in the longitudinal direction. The ridges 21 may also be provided on the outer surfaces of the proximal tapered section 12 and / or the distal tapered section 14. The ridges 21 may also be provided on the outer surfaces of the proximal sleeve section 11 and / or the distal sleeve section 15.

[0045] The balloon 10 may have an inner ridge (not shown) that protrudes radially inward on the inner surface of the balloon 10. The ridge 21 and the inner ridge may be located at the same position in the longitudinal or circumferential direction of the balloon 10, and are preferably integrally molded, which may allow a portion of the balloon 10 to be thick-walled.

[0046] A balloon 10 provided with ridges 21 tends to exhibit increased rigidity in the areas where the ridges 21 are provided. Therefore, compared to a balloon 10 without ridges 21, a balloon 10 with ridges 21 is more likely to have reduced flexibility in the longitudinal direction. For example, in a shunt formed during hemodialysis, blood vessels bend significantly at the arteriovenous anastomosis. Passing a balloon through such an area may be difficult if the balloon has ridges. Alternatively, a balloon for lower limbs may be inserted through the iliac artery during treatment, where the blood vessels bend significantly at the bifurcation point where the left and right iliac arteries branch from the abdominal aorta. Therefore, if a balloon for lower limbs has ridges, it may be difficult to pass the balloon from one iliac artery to the other. In particular, due to the long length of a balloon for lower limbs, there is a high risk that the balloon will be unable to pass through areas where the blood vessels bend significantly. Therefore, as shown in Figures 4 and 5 , the balloon 10 has notches 22 formed in the ridges 21. By forming the notches 22 in the ridges 21, the flexibility of the balloon 10 in the longitudinal axis direction can be improved.

[0047] It is preferable that the notches 22 are formed in each of the ridges 21. This allows the flexibility of the balloon 10 to be improved regardless of the direction in which the balloon 10 bends.

[0048] The number of notches 22 formed in each ridge 21 is not particularly limited as long as it is one or more, but from the viewpoint of improving the flexibility of the balloon 10, the number of notches 22 formed in each ridge 21 is preferably two or more, and more preferably three or more. On the other hand, from the viewpoint of ensuring the scoring function of the balloon 10, the number of notches 22 formed in each ridge 21 is preferably 20 or less, more preferably 16 or less, even more preferably 12 or less, and even more preferably 8 or less.

[0049] The notch 22 may be formed so as to remove a portion of the apex 21A of the ridge 21 extending in the longitudinal direction. Figures 26 to 29 show cross-sectional views along the longitudinal direction passing through the apex 21A of the ridge 21 of a specific notch 22X described below. However, as shown in Figures 26 and 28, the notch 22 may be formed to extend from the apex 21A to the base 21B of the ridge 21, or as shown in Figures 27 and 29, the notch 22 may be formed to extend partway from the apex 21A to the base 21B of the ridge 21. In the former case, the depth of the notch 22 is equal to the height of the ridge 21. In the latter case, the depth of the notch 22 is formed shorter than the height of the ridge 21. Figures 26 to 29 show cross-sectional views of the ridge 21, including the notch 22, taken along an imaginary plane that passes through the apex 21A of the ridge 21 and is formed by the longitudinal direction and the radial direction of the balloon 10.

[0050] The notch 22 has a bottom 22B and a top 22A, where the bottom 22B refers to the radially innermost portion of the notch 22 and the top 22A refers to the radially outermost portion of the notch 22. The top 22A of the notch 22 coincides with the top 21A of the ridge 21. The radial length from the top 22A to the bottom 22B of the notch 22 is the depth of the notch 22.

[0051] The ridge 21 is divided into a plurality of ridge segments 24 by the notches 22. Specifically, the ridge 21 is divided into a proximal ridge segment 24 and a distal ridge segment 24, with the bottom 22B of the notch 22 as the boundary. Hereinafter, the ridge segment 24 adjacent to the proximal side of the notch 22 will be referred to as the proximal ridge segment 24P, and the ridge segment 24 adjacent to the distal side of the notch 22 will be referred to as the distal ridge segment 24D.

[0052] 26 and 27 , when the bottom 22B of the notch 22 is formed to a predetermined length in the longitudinal axis direction, a proximal ridge segment 24P is formed proximally from the proximal end of the bottom 22B of the notch 22, and a distal ridge segment 24D is formed distally from the distal end of the bottom 22B of the notch 22. That is, the proximal end of the bottom 22B of the notch 22 is the distal boundary of the proximal ridge segment 24P, and the distal end of the bottom 22B of the notch 22 is the proximal boundary of the distal ridge segment 24D. 26 and 28 , when the notch 22 is formed to extend from the apex 21A to the base 21B of the ridge 21, the notch 22 forms an interruption 23 of the ridge 21, and the ridge segments 24 are arranged on the proximal and distal sides of the interruption 23. In this case, the ridge 21 is formed by alternately arranging the ridge segments 24 and the discontinuous portions 23 in the longitudinal direction. The proximal ridge segment 24P and the distal ridge segment 24D adjacent to the notch 22 may be spaced apart in the longitudinal direction as shown in Figures 26 and 27, or may be adjacent to each other in the longitudinal direction as shown in Figures 28 and 29.

[0053] The length of the notch 22 in the longitudinal direction is preferably shorter than the length of the ridge segment 24 in the longitudinal direction. Specifically, in each ridge 21, the length of the notch 22 in the longitudinal direction (if multiple notches 22 are provided, the length of each notch 22 in the longitudinal direction) is preferably shorter than the length of any of the ridge segments 24 in the longitudinal direction. Furthermore, in each ridge 21, the length of the notch 22 in the longitudinal direction (if multiple notches 22 are provided, the length of each notch 22 in the longitudinal direction) is preferably 0.5 times or less, more preferably 0.3 times or less, and even more preferably 0.2 times or less, the average length of the ridge segments 24 in the longitudinal direction. This makes it easier to ensure the scoring function of the ridge 21. The longitudinal length of the notch 22 means the distance between the apexes of the proximal and distal ridge segments 24 on either side of the notch 22 in a cross section along the longitudinal direction passing through the apex 21A of the ridge 21, i.e., the distance between the distal end of the apex of the proximal ridge segment 24P and the proximal end of the apex of the distal ridge segment 24D.

[0054] In each ridge 21, the total longitudinal length of the notches 22 is preferably 20% or less of the longitudinal length of the ridge 21, more preferably 15% or less, and even more preferably 10% or less. This makes it easier to ensure the scoring function of the ridge 21. The longitudinal length of the ridge 21 is determined as follows: of the multiple ridge segments 24 that make up each ridge 21, the proximal end of the proximal-most ridge segment 24 is the proximal end of the ridge 21, the distal end of the distal-most ridge segment 24 is the distal end of the ridge 21, and the longitudinal length from the proximal end to the distal end of the ridge 21 is the longitudinal length of the ridge 21.

[0055] The length of each notch 22 in the longitudinal direction is preferably at least 0.2 times, more preferably at least 0.3 times, and even more preferably at least 0.5 times the depth of the notch 22. This facilitates improving the longitudinal flexibility of the straight tube portion 13 of the balloon 10. The length of each notch 22 in the longitudinal direction is preferably no more than 5 times, more preferably no more than 3 times, and even more preferably no more than 2 times the depth of the notch 22. This facilitates ensuring the scoring function of the balloon 10.

[0056] The length of the portion of the bottom 22B of each notch 22 extending parallel to the longitudinal axis direction is preferably not significantly longer than the longitudinal length of the notch 22 (the distance between the apexes of the ridge segments 24 on the proximal and distal sides of the notch 22). In each notch 22, the length of the portion of the bottom 22B of each notch 22 extending parallel to the longitudinal axis direction is preferably 0.5 times or less, more preferably 0.3 times or less, and even more preferably 0.2 times or less, the longitudinal length of the notch 22. This allows the balloon 10 to bend smoothly at the notches 22 and facilitates the scoring function of the ridges 21. The bottom 22B of each notch 22 does not need to include a portion extending parallel to the longitudinal axis direction. As shown in Figures 26 and 28, when the notch 22 is formed to extend from the top 21A of the convex rib 21 to the base 21B, the longitudinal length of the interrupted portion 23 of the convex rib 21 (the longitudinal length of the interrupted portion 23 on the outer surface of the balloon main body 16) corresponds to the longitudinal length of the bottom 22B of the notch 22.

[0057] The notch 22 may be formed at any position in the longitudinal direction of the ridge 21 provided in the straight pipe portion 13. For example, as shown in Figures 4 and 5 , when the ridge 21 in the straight pipe portion 13 is divided into three equal parts in the longitudinal direction into a proximal section 17, an intermediate section 18, and a distal section 19, the notch 22 may be provided in any of the proximal section 17, the intermediate section 18, and the distal section 19.

[0058] In one embodiment, the notches 22 are preferably provided at least in the distal section 19. By forming the notches 22 in the ridges 21 in this manner, the flexibility of the distal portion of the balloon 10 (specifically, the portion of the balloon 10 that corresponds to the distal section 19 of the ridges 21 in the longitudinal axis direction) can be improved. In this case, it is preferable to provide the notches 22 in the distal section 19 of each ridge 21 provided in the straight tube portion 13.

[0059] It is also preferable that the notches 22 are provided in the proximal sections 17 of the ridges 21. This increases the flexibility of the proximal portion of the balloon 10 (specifically, the portion of the balloon 10 that corresponds to the proximal section 17 of the ridges 21 in the longitudinal direction), and improves the insertability of the balloon 10 through the bent section when the balloon 10 is pulled back after treatment with the balloon 10 to pass through the bent section. In this case, it is preferable that the notches 22 are provided in the proximal sections 17 of each ridge 21 provided in the straight tube section 13.

[0060] The proximal section 17, intermediate section 18, and distal section 19 of the ridge 21 are defined as follows: When the length of each ridge 21 in the longitudinal direction from the proximal end to the distal end of the ridge 21 is L, the ridge 21 is divided into three sections with a length of L / 3, with the proximal-most section being defined as the proximal section 17, the distal-most section being defined as the distal section 19, and the section between the proximal section 17 and the distal section 19 being defined as the intermediate section 18. The longitudinal position of the notch 22 in the ridge 21, i.e., whether the notch 22 is located in the proximal section 17, intermediate section 18, or distal section 19 of the ridge 21, is determined based on the position of the bottom 22B of the notch 22 in a cross section along the longitudinal direction that passes through the apex 21A of the ridge 21 (specifically, a cross section along the longitudinal direction and radially that passes through the apex 21A of the ridge 21). When the bottom 22B of the notch 22 is formed to a predetermined length in the longitudinal direction, the midpoint of the bottom 22B of the notch 22 in the longitudinal direction is taken as the longitudinal position of the notch 22 in the ridge 21. When the bottom 22B of the notch 22 is located exactly at the boundary between the proximal section 17 and the intermediate section 18 or the boundary between the intermediate section 18 and the distal section 19, it is determined that the notch 22 exists in both sections but does not belong to either section.

[0061] The notches 22 do not have to be provided in the intermediate section 18 of the ridges 21. Forming the ridges 21 in this manner makes it easier to impart a high scoring function to the balloon 10 while improving the flexibility of the balloon 10. On the other hand, to further improve the flexibility of the balloon 10, the notches 22 may also be provided in the intermediate section 18 of the ridges 21. For example, since a balloon 10 for use in the lower limbs has a long length in the longitudinal direction, providing the notches 22 in the intermediate section 18 also ensures flexibility throughout the entire longitudinal direction of the balloon 10, even for a balloon 10 with a long length in the longitudinal direction.

[0062] In the balloon 10, when the ridges 21 are further provided on at least one of the proximal sleeve section 11, the proximal tapered section 12, the distal tapered section 14, and the distal sleeve section 15, the notches 22 may also be provided on the ridges 21 of the proximal sleeve section 11, the proximal tapered section 12, the distal tapered section 14, or the distal sleeve section 15. By providing the notches 22 in this manner, the flexibility of the balloon 10 can be improved in portions other than the straight tube section 13 as well.

[0063] The ridges 21 are provided with specific notches 22X that satisfy the following requirement A or requirement B as part or all of the notches 22 described above. The balloon 10 according to the first embodiment shown in FIG. 4 has the ridges 21 with the specific notches 22X that satisfy the following requirement A, and the balloon 10 according to the second embodiment shown in FIG. 5 has the ridges 21 with the specific notches 22X that satisfy the following requirement B. (Requirement A) The distal surface of the proximal ridge segment 24P adjacent to the distal side of the specific notch 22X has a normal vector A on the line of intersection with an imaginary plane H that passes through the apex 21A of the ridge 21 and is formed by the longitudinal axis direction and the radial direction, extending distally to one side of the imaginary plane H, and the proximal surface of the distal ridge segment 24D adjacent to the distal side of the specific notch 22X has a normal vector B on the line of intersection with the imaginary plane H that extends proximally to the other side of the imaginary plane H. (Requirement B) In a planar view from the apex 21A side of the convex strip 21, the distal end edge of the proximal convex strip segment 24P adjacent to the proximal side of the specific notch 22X has a convex shape protruding toward the distal side, and the proximal end edge of the distal convex strip segment 24D adjacent to the distal side of the specific notch 22X has a convex shape protruding toward the proximal side.

[0064] The configuration of the ridge 21 provided on the balloon 10 of the first embodiment, specifically the configuration of the end of the ridge segment 24 adjacent to the specific notch 22X that satisfies requirement A, will be described with reference to Figures 8 to 15. Figures 8 to 15 show various configuration examples of the end of the ridge segment 24 adjacent to the specific notch 22X that satisfies requirement A. Figures 8(a) to 15(a) show perspective views of the distal end of the proximal ridge segment 24P as seen from the distal side or perspective views of the proximal end of the distal ridge segment 24D as seen from the proximal side, while Figures 8(b) to 15(b) show plan views of the distal end of the proximal ridge segment 24P and the proximal end of the distal ridge segment 24D as seen from the apex 21A side of the ridge 21. The end of the ridge segment 24 means the distal end of the proximal ridge segment 24P adjacent to a particular notch 22X and / or the proximal end of the distal ridge segment 24D.

[0065] In the rib projections 21 of the balloon 10 according to the first embodiment, the distal end of the proximal rib segment 24P and the proximal end of the distal rib segment 24D adjacent to a particular notch 22X are formed as follows: The distal surface 31 of the proximal rib segment 24P has a normal vector A on the line of intersection with an imaginary plane H formed by the longitudinal axis direction and the radial direction, which passes through the apex 21A of the rib projection 21, extending distally to one side of the imaginary plane H, and the proximal surface 41 of the distal rib segment 24D has a normal vector B on the line of intersection with the imaginary plane H, which extends proximally to the other side of the imaginary plane H. The extension direction of the normal vector A of the distal surface 31 of the proximal ridge segment 24P and the extension direction of the normal vector B of the proximal surface 41 of the distal ridge segment 24D are determined when the proximal ridge segment 24P and the distal ridge segment 24D are arranged with a specific notch 22X between them, as shown in Figures 8(b) to 15(b).

[0066] By forming the distal end of the proximal ridge segment 24P and the proximal end of the distal ridge segment 24D in this manner, in a plan view from the apex 21A of the ridge 21, at least a portion of the distal surface 31 of the proximal ridge segment 24P (specifically, at least a portion including the portion intersecting with imaginary plane H) and at least a portion of the proximal surface 41 of the distal ridge segment 24D (specifically, at least a portion including the portion intersecting with imaginary plane H) are formed to face each other and extend obliquely relative to the longitudinal axis. Therefore, when the balloon 10 is bent with the specific notch 22X facing inward, when the distal surface 31 of the proximal ridge segment 24P adjacent to the specific notch 22X comes into contact with the proximal surface 41 of the distal ridge segment 24D, the distal end of the proximal ridge segment 24P and the proximal end of the distal ridge segment 24D are likely to shift relative to each other in the width direction of the ridge 21. This makes it easier to bend the balloon 10 significantly.

[0067] The distal surface 31 of the proximal ridge segment 24P refers to the portion of the proximal ridge segment 24P facing the distal side. On the distal surface 31 of the proximal ridge segment 24P, a normal vector A on the line of intersection with an imaginary plane H formed by the longitudinal axis direction and the radial direction, passing through the apex 21A of the ridge 21, extends distally to one side (first side) of the imaginary plane H. The normal vector A extends distally from the other side (second side) of the circumferential direction of the balloon 10 to one side (first side). The normal vector A may extend parallel to the outer surface of the balloon body 16 (i.e., so that the radial position does not change), may extend radially outward toward the distal side, or may extend radially inward toward the distal side. The distal surface 31 of the proximal convex rib segment 24P may be formed so that such a normal vector A exists on at least a portion of the intersection with the imaginary plane H, but it is preferable that it be formed so that it has such a normal vector A at the apex 22A of the notch 22X on the intersection with the imaginary plane H, and it is even more preferable that it be formed so that it has such a normal vector A on the entire intersection with the imaginary plane H.

[0068] The proximal surface 41 of the distal ridge segment 24D refers to the portion of the distal ridge segment 24D facing the proximal side. On the proximal surface 41 of the distal ridge segment 24D, a normal vector B on the line of intersection with an imaginary plane H formed by the longitudinal axis direction and the radial direction and passing through the apex 21A of the ridge 21 extends proximally to the other side of the imaginary plane H (the opposite side of the imaginary plane H from the normal vector A; the second side). The normal vector B extends proximally from one side (first side) to the other side (second side) of the circumferential direction of the balloon 10. The normal vector B may extend parallel to the outer surface of the balloon body 16 (i.e., so that its radial position does not change), or may extend radially outward toward the proximal side, or may extend radially inward toward the proximal side. The proximal surface 41 of the distal convex rib segment 24D may be formed so that such a normal vector B exists on at least a portion of the intersection with the imaginary plane H, but it is preferable that it be formed so that it has such a normal vector B at the apex 22A of the notch 22X on the intersection with the imaginary plane H, and it is even more preferable that it be formed so that it has such a normal vector B on the entire intersection with the imaginary plane H.

[0069] The distal surface 31 of the proximal ridge segment 24P and the proximal surface 41 of the distal ridge segment 24D may be formed in a flat shape, a curved shape, or a combination thereof. The shape of the distal surface 31 of the proximal ridge segment 24P may be the same as or different from the shape of the proximal surface 41 of the distal ridge segment 24D. Furthermore, the shapes of the distal surfaces 31 of multiple proximal ridge segments 24P may be the same as or different from each other, and the shapes of the proximal surfaces 41 of multiple distal ridge segments 24D may be the same as or different from each other.

[0070] 8, 9, 14, and 15, the distal surface 31 of the proximal ridge segment 24P may be formed as a single plane, and the proximal surface 41 of the distal ridge segment 24D may be formed as a single plane. In this case, the overall normal vector of the distal surface 31 of the proximal ridge segment 24P coincides with the normal vector A, and the overall normal vector of the proximal surface 41 of the distal ridge segment 24D coincides with the normal vector B.

[0071] 10 to 13, the distal surface 31 of the proximal ridge segment 24P may be composed of two or more planes, and the proximal surface 41 of the distal ridge segment 24D may be composed of two or more planes. In this case, of the planes constituting the distal surface 31 of the proximal ridge segment 24P, at least one plane intersecting with the imaginary plane H has the normal vector A described above, and of the planes constituting the proximal surface 41 of the distal ridge segment 24D, at least one plane intersecting with the imaginary plane H has the normal vector B described above.

[0072] Of the planes constituting the distal surface 31 of the proximal ridge segment 24P, the planes that do not intersect with the imaginary plane H may be formed so that their normal vectors extend parallel to the imaginary plane H, as shown in Figures 10 and 11, or may be formed so that their normal vectors extend in the opposite circumferential direction to the normal vector A toward the distal side, as shown in Figure 12. Furthermore, although not shown in the drawings, the distal surface 31 of the proximal ridge segment 24P may have a plane having a normal vector that extends in a different direction from the normal vector A and in the same circumferential direction as the normal vector A toward the distal side.

[0073] Among the planes constituting the distal surface 31 of the proximal convex rib segment 24P, the planes that do not have the normal vector A may be formed to include the apex 22A of a specific notch 22X, as shown in Figures 10 and 12, or may be formed not to include the apex 22A of a specific notch 22X, as shown in Figure 11.

[0074] Of the planes constituting the proximal surface 41 of the distal-side ridge segment 24D, the planes that do not intersect with the imaginary plane H may be formed so that their normal vectors extend parallel to the imaginary plane H, as shown in Figures 10 and 11, or may be formed so that their normal vectors extend in the opposite circumferential direction to the normal vector B toward the proximal side, as shown in Figure 12. Furthermore, although not shown in the drawings, the proximal surface 41 of the distal-side ridge segment 24D may have a plane having a normal vector that extends in a different direction from the normal vector B and in the same circumferential direction as the normal vector B toward the proximal side.

[0075] Among the planes constituting the proximal surface 41 of the distal convex rib segment 24D, the planes that do not have the normal vector B may be formed to include the apex 22A of a specific notch 22X, as shown in Figures 10 and 12, or may be formed not to include the apex 22A of a specific notch 22X, as shown in Figure 11.

[0076] 13 , the distal surface 31 of the proximal ridge segment 24P is composed of two or more planes, each of which intersects with the imaginary plane H and has the normal vector A described above, and the proximal surface 41 of the distal ridge segment 24D is composed of two or more planes, each of which intersects with the imaginary plane H and has the normal vector B described above. In this way, the distal surface 31 of the proximal ridge segment 24P may be composed of two or more planes intersecting with the imaginary plane H, and may be formed so that the normal vectors of each of the planes on the intersection line with the imaginary plane H extend to one side of the imaginary plane H toward the distal side, and the proximal surface 41 of the distal ridge segment 24D may be composed of two or more planes intersecting with the imaginary plane H, and may be formed so that the normal vectors of each of the planes on the intersection line with the imaginary plane H extend to the other side of the imaginary plane H toward the proximal side.

[0077] Although not shown in Figures 8 to 15, the distal surface 31 of the proximal ridge segment 24P may be configured to include a curved surface, and the proximal surface 41 of the distal ridge segment 24D may be configured to include a curved surface. The distal surface 31 of the proximal ridge segment 24P is preferably configured so that the area of ​​the region formed so that the normal vector extends from one circumferential side to the other circumferential side toward the distal side is 50% or more of the entire area of ​​the distal surface 31, more preferably 60% or more, and even more preferably 70% or more. The proximal surface 41 of the distal ridge segment 24D is preferably configured so that the area of ​​the region formed so that the normal vector extends from one circumferential side to the other circumferential side toward the proximal side is 50% or more of the entire area of ​​the proximal surface 41, more preferably 60% or more, and even more preferably 70% or more.

[0078] In a plan view from the apex 21A side of the ridge 21, the angle between the normal vector A and the longitudinal axis direction toward the distal side, i.e., the angle between the projection vector AP of the normal vector A onto the outer surface of the balloon body 16 and the longitudinal axis direction toward the distal side, is preferably 20° or more, more preferably 30° or more, and preferably 70° or less, more preferably 60° or less. In a plan view from the apex 21A side of the ridge 21, the angle between the normal vector B and the longitudinal axis direction toward the proximal side, i.e., the angle between the projection vector BP of the normal vector B onto the outer surface of the balloon body 16 and the longitudinal axis direction toward the proximal side, is preferably 20° or more, more preferably 30° or more, and preferably 70° or less, more preferably 60° or less. If the distal surface 31 of the proximal ridge segment 24P and the proximal surface 41 of the distal ridge segment 24D are formed in this manner, when the balloon 10 bends with the specific notch 22X facing inward and the distal surface 31 of the proximal ridge segment 24P and the proximal surface 41 of the distal ridge segment 24D come into contact with each other, the distal end of the proximal ridge segment 24P and the proximal end of the distal ridge segment 24D are more likely to bend apart in the width direction of the ridge 21. This makes it easier to bend the balloon 10 significantly. Note that the angle between the projection vector AP and the longitudinal axis direction toward the distal side and the angle between the projection vector BP and the longitudinal axis direction toward the proximal side are in the range of greater than 0° and less than 90°.

[0079] It is preferable that the distal surface 31 of the proximal ridge segment 24P and the proximal surface 41 of the distal ridge segment 24D are closest in the longitudinal direction at least on the line of intersection with the imaginary plane H. That is, the longitudinal separation distance between the distal surface 31 of the proximal ridge segment 24P and the proximal surface 41 of the distal ridge segment 24D is preferably shortest at least on the line of intersection with the imaginary plane H. The distal end of the proximal ridge segment 24P and the proximal end of the distal ridge segment 24D shown in Figures 8 to 15 are formed in this manner. This makes it easier to greatly bend the balloon 10 with the specific notch 22X facing inward. It is preferable that the distal surface 31 of the proximal ridge segment 24P and the proximal surface 41 of the distal ridge segment 24D are closest in the longitudinal direction at least on the line of intersection with the imaginary plane H in any vertical cross section in the radial direction. In addition, the distal surface 31 of the proximal side convex strip segment 24P and the proximal surface 41 of the distal side convex strip segment 24D may be closest in the longitudinal axis direction not only on the intersection line with the imaginary plane H but also in other parts.

[0080] The longitudinal separation distance between the distal surface 31 of the proximal ridge segment 24P and the proximal surface 41 of the distal ridge segment 24D is preferably constant or increases with increasing distance from the imaginary plane H, and more preferably increases at least in part. The distal end of the proximal ridge segment 24P and the proximal end of the distal ridge segment 24D shown in Figures 8 to 15 are formed in this manner. If the distal surface 31 of the proximal ridge segment 24P and the proximal surface 41 of the distal ridge segment 24D are formed in this manner, the balloon 10 can bend more greatly when a specific notch 22X is located on the side of the bent portion of the balloon 10 when the balloon 10 is bent. The longitudinal separation distance between the distal surface 31 of the proximal ridge segment 24P and the proximal surface 41 of the distal ridge segment 24D is preferably formed in this manner in any vertical cross section in the radial direction.

[0081] The distal surface 31 of the proximal ridge segment 24P may extend radially outward at an inclination toward the proximal side on the line of intersection with the imaginary plane H as shown in Figures 8 to 12, may extend radially as shown in Figure 14, or may extend radially outward at an inclination toward the distal side as shown in Figure 15. Furthermore, as shown in Figure 13, the distal surface 31 of the proximal ridge segment 24P may have, on the line of intersection with the imaginary plane H, a portion extending radially outward at an inclination toward the proximal side. Although not shown in the drawings, the distal surface 31 of the proximal convex rib segment 24P may have, on the intersection line with the imaginary plane H, a portion that extends radially outward at an inclination toward the proximal side and a portion that extends radially outward at an inclination toward the distal side, or may have a portion that extends radially outward at an inclination toward the distal side and a portion that extends radially, or may have a portion that extends radially outward at an inclination toward the proximal side, a portion that extends radially outward at an inclination toward the distal side and a portion that extends radially.

[0082] The proximal surface 41 of the distal ridge segment 24D may extend radially outward at an inclination distally on the line of intersection with the imaginary plane H as shown in Figures 8 to 12, may extend radially as shown in Figure 14, or may extend radially outward at an inclination proximally as shown in Figure 15. Furthermore, as shown in Figure 13, the proximal surface 41 of the distal ridge segment 24D may have, on the line of intersection with the imaginary plane H, a portion extending radially outward at an inclination distally. Although not shown in the drawings, the proximal surface 41 of the distal convex rib segment 24D may have, on the intersection line with the imaginary plane H, a portion that extends radially outward at an inclination distally and a portion that extends radially outward at an inclination proximally, or may have a portion that extends radially outward at an inclination proximally and a portion that extends radially, or may have a portion that extends radially outward at an inclination distally, a portion that extends radially outward at an inclination proximally and a portion that extends radially.

[0083] The distal surface 31 of the proximal ridge segment 24P preferably extends radially or extends radially outward at a proximal incline at the intersection with the imaginary plane H, and more preferably extends radially outward at a proximal incline at least a portion of the intersection with the imaginary plane H. The proximal surface 41 of the distal ridge segment 24D preferably extends radially or extends radially outward at a distal incline at the intersection with the imaginary plane H, and more preferably extends radially outward at a distal incline at least a portion of the intersection with the imaginary plane H. If the end of the ridge segment 24 is formed in this manner, the balloon 10 can be easily bent significantly when the balloon 10 is bent with the specific notch 22X facing inward.

[0084] The distal surface 31 of the proximal ridge segment 24P preferably extends radially outward at an inclination toward the proximal side on the line of intersection with the imaginary plane H, and the proximal surface 41 of the distal ridge segment 24D preferably extends radially outward at an inclination toward the distal side on the line of intersection with the imaginary plane H. Figures 26 to 29 show configuration examples of cross-sectional views of the distal end portion of the proximal ridge segment 24P and the proximal end portion of the distal ridge segment 24D shown in Figures 8 to 12 taken along the line of intersection with the imaginary plane H, and the distal surface 31 of the proximal ridge segment 24P and the proximal surface 41 of the distal ridge segment 24D are formed in this manner. When the specific notch 22X is formed so as to extend from the top 21A to the base 21B of the ridge 21, the cross-sectional view of Figure 26 or 28 should be referred to, and when the specific notch 22X is formed so as to extend partway from the top 21A to the base 21B of the ridge 21, the cross-sectional view of Figure 27 or 29 should be referred to. If the end of the ridge segment 24 is formed in this manner, it becomes easier to bend the balloon 10 significantly when the balloon 10 is bent with the specific notch 22X facing inward.

[0085] When a plurality of specific notches 22X are provided in the ridge 21, the extension directions of the plurality of specific notches 22X arranged in the longitudinal direction of the ridge 21, i.e., the extension directions of the distal surface 31 of the proximal ridge segment 24P and the proximal surface 41 of the distal ridge segment 24D, may or may not be aligned when viewed from the apex 21A side of the ridge 21. Figures 16 and 17 are plan views of the ridge 21 viewed from the apex 21A side, showing examples of the configuration of the ridge 21 in which a plurality of specific notches 22X are provided in the longitudinal direction. For example, as shown in Fig. 16 , when one side of an imaginary plane H of the ridge 21 is defined as a first side H1 and the other side of the imaginary plane H is defined as a second side H2, in all of the specific notches 22X provided in the ridge 21, a normal vector A may extend distally toward the first side H1 and a normal vector B may extend proximally toward the second side H2. Alternatively, as shown in Fig. 17 , the ridge 21 may be provided with specific notches 22X whose normal vector A extends distally toward the first side H1 and whose normal vector B extends proximally toward the second side H2, and specific notches 22X whose normal vector A extends distally toward the second side H2 and whose normal vector B extends proximally toward the first side H1, alternately provided in the longitudinal axis direction. In this way, the extending direction of the specific notches 22X can be set in various ways.

[0086] Next, the configuration of the ridge 21 provided on the balloon 10 of the second embodiment, specifically the configuration of the end of the ridge segment 24 adjacent to the specific notch 22X that satisfies requirement B, will be described with reference to Figures 18 to 25. Figures 18 to 25 show various configuration examples of the end of the ridge segment 24 adjacent to the specific notch 22X that satisfies requirement B. Figures 18(a) to 25(a) show perspective views of the distal end of the proximal ridge segment 24P as seen from the distal side or perspective views of the proximal end of the distal ridge segment 24D as seen from the proximal side, while Figures 18(b) to 25(b) show plan views of the distal end of the proximal ridge segment 24P and the proximal end of the distal ridge segment 24D as seen from the apex 21A of the ridge 21.

[0087] In the ridge 21 of the balloon 10 according to the second embodiment, the distal end of the proximal ridge segment 24P adjacent to the specific notch 22X and the proximal end of the distal ridge segment 24D are configured as follows: In a plan view from the apex 21A of the ridge 21, the distal edge 32 of the proximal ridge segment 24P adjacent to the proximal side of the specific notch 22X has a convex shape that protrudes distally, and the proximal edge 42 of the distal ridge segment 24D adjacent to the distal side of the specific notch 22X has a convex shape that protrudes proximally. Even with the specific notch 22X formed in this manner, the flexibility of the balloon 10 can be improved. Specifically, when the balloon 10 is bent with the specific notch 22X facing inward, the distal end of the proximal ridge segment 24P adjacent to the specific notch 22X and the proximal end of the distal ridge segment 24D collide, and the tips of the convex shapes tend to slip relative to each other. This makes it easier to bend the balloon 10 more greatly. Alternatively, if the specific notch 22X is located on the side of the bent portion of the balloon 10 rather than on the inside of the bent balloon 10 when the balloon 10 is bent, the balloon 10 can be bent more greatly.

[0088] The distal end edge 32 of the proximal ridge segment 24P means the outer edge of the portion of the proximal ridge segment 24P facing the distal side in a plan view of the ridge 21 seen from the apex 21A side. The proximal end edge 42 of the distal ridge segment 24D means the outer edge of the portion of the distal ridge segment 24D facing the proximal side in a plan view of the ridge 21 seen from the apex 21A side. The plan view of the ridge 21 seen from the apex 21A side means the plan view of the ridge 21 seen from the radially outer side.

[0089] The distal edge 32 of the proximal ridge segment 24P may be straight, curved, or a combination thereof, as long as it is formed into a convex shape that protrudes distally. The proximal edge 42 of the distal ridge segment 24D may be straight, curved, or a combination thereof, as long as it is formed into a convex shape that protrudes proximally. Note that when the distal edge 32 of the proximal ridge segment 24P and the proximal edge 42 of the distal ridge segment 24D are straight, these edges are formed of two or more straight lines. The convex shape of the distal edge 32 of the proximal ridge segment 24P may be the same as or different from the convex shape of the proximal edge 42 of the distal ridge segment 24D. Furthermore, the convex shapes of the distal end edges 32 of the multiple proximal side convex strip segments 24P may be the same as or different from each other, and the convex shapes of the proximal end edges 42 of the multiple distal side convex strip segments 24D may be the same as or different from each other.

[0090] As shown in Figures 18, 19, and 21, the convex shape of the distal edge 32 of the proximal ridge segment 24P may be configured to have a curved portion 33 that curves distally, and the convex shape of the proximal edge 42 of the distal ridge segment 24D may be configured to have a curved portion 43 that curves proximally. If the ends of the ridge segments 24 are formed in this manner, even if the ends of the ridge segments 24 hit the inner wall of a blood vessel when the balloon 10 is bent, the inner wall of the blood vessel is less likely to be damaged. This results in a balloon 10 with excellent safety. If the convex shape of the distal edge 32 of the proximal ridge segment 24P has a curved portion 33, the curved portion 33 that curves distally may be located distal to the line segment connecting both ends of the curved portion 33. When the convex shape of the proximal end edge 42 of the distal convex strip segment 24D has a curved portion 43, the curved portion 43 curved toward the proximal side may be located proximal to the line segment connecting both ends of the curved portion 43.

[0091] When the convex shape of the distal end edge 32 of the proximal ridge segment 24P and / or the proximal end edge 42 of the distal ridge segment 24D has a curved portion, the entire convex shape may be curved, or only a portion of the convex shape may be curved. In the latter case, the convex shape is preferably composed of a curved portion and a straight portion, and the distal end edge 32 of the proximal ridge segment 24P and / or the proximal end edge 42 of the distal ridge segment 24D is preferably formed smoothly from the curved portion to the straight portion (i.e., in a plan view of the ridge 21 seen from the top side, the slope at the connection between the curved portion and the straight portion changes continuously). In Figure 18, the convex shape of the distal end edge 32 of the proximal ridge segment 24P is composed only of the curved portion 33, and the convex shape of the proximal end edge 42 of the distal ridge segment 24D is composed only of the curved portion 43. In Fig. 19, the convex shape of the distal end edge 32 of the proximal ridge segment 24P is composed of a curved portion 33 and a straight portion 34, and the convex shape of the proximal end edge 42 of the distal ridge segment 24D is composed of a curved portion 43 and a straight portion 44. In Fig. 21, the convex shape of the distal end edge 32 of the proximal ridge segment 24P is composed of a curved portion 33, a proximal first straight portion 35, and a proximal second straight portion 36, and the convex shape of the proximal end edge 42 of the distal ridge segment 24D is composed of a curved portion 43, a distal first straight portion 45, and a distal second straight portion 46.

[0092] 20 to 22 , the convex shape of the distal end edge 32 of the proximal ridge segment 24P may be configured to have, when viewed from the apex 21A side of the ridge 21, a proximal first straight portion 35 located on one side of an imaginary line F that passes through the apex 21A of the ridge 21 and extends in the longitudinal direction, and a proximal second straight portion 36 located on the other side, such that the proximal first straight portion 35 and the proximal second straight portion 36 extend so as to move away from the imaginary line F as they move proximally. Also, the convex shape of the proximal end edge 42 of the distal ridge segment 24D may be configured to have, when viewed from the apex 21A side of the ridge 21, a distal first straight portion 45 located on one side of the imaginary line F and a distal second straight portion 46 located on the other side, such that the distal first straight portion 45 and the distal second straight portion 46 extend so as to move away from the imaginary line F as they move distally. If the end of the convex strip segment 24 is formed in this manner, the balloon 10 can be bent more greatly when a specific notch 22X is located on the side of the bent portion of the balloon 10 when the balloon 10 is bent.

[0093] When the distal end edge 32 of the proximal ridge segment 24P and / or the proximal end edge 42 of the distal ridge segment 24D are formed as described above, the proximal first straight portion 35 may be directly connected to the proximal second straight portion 36, or the proximal first straight portion 35 and the proximal second straight portion 36 may be connected via another straight portion or a curved portion, or the distal first straight portion 45 may be directly connected to the distal second straight portion 46, or the distal first straight portion 45 and the distal second straight portion 46 may be connected via another straight portion or a curved portion. Figures 20 to 22 show configuration examples of the distal end edge 32 of the proximal ridge segment 24P and the proximal end edge 42 of the distal ridge segment 24D formed in this manner, each of which will be described below.

[0094] 20 , the convex shape of the distal edge 32 of the proximal ridge segment 24P is configured by connecting the distal end of the proximal first straight portion 35 to the distal end of the proximal second straight portion 36, and the convex shape of the proximal edge 42 of the distal ridge segment 24D is configured by connecting the proximal end of the distal first straight portion 45 to the proximal end of the distal second straight portion 46. If the ends of the ridge segment 24 are configured in this manner, when the balloon 10 is bent with the specific notch 22X facing inward, the distal end of the proximal ridge segment 24P and the proximal end of the distal ridge segment 24D are more likely to come into misalignment with each other, making it easier to bend the balloon 10 significantly.

[0095] 21 , the convex shape of the distal end edge 32 of the proximal ridge segment 24P is configured to have a curved portion 33 between the proximal first straight portion 35 and the proximal second straight portion 36, and the convex shape of the proximal end edge 42 of the distal ridge segment 24D is configured to have a curved portion 43 between the distal first straight portion 45 and the distal second straight portion 46. The curved portion 33 constituting the convex shape of the distal end edge 32 of the proximal ridge segment 24P curves toward the distal side, and the curved portion 43 constituting the proximal end edge 42 of the distal ridge segment 24D curves toward the proximal side. If the end of the ridge segment 24 is formed in this manner, the inner wall of the blood vessel is less likely to be damaged even if the end of the ridge segment 24 hits the inner wall of the blood vessel when the balloon 10 is bent.

[0096] 22 , the convex shape of the distal end edge 32 of the proximal ridge segment 24P has a proximal third straight portion 37 between the proximal first straight portion 35 and the proximal second straight portion 36, and is configured so that the proximal first straight portion 35 and the proximal second straight portion 36 are located proximally relative to the proximal third straight portion 37, while the convex shape of the proximal end edge 42 of the distal ridge segment 24D has a distal third straight portion 47 between the distal first straight portion 45 and the distal second straight portion 46, and is configured so that the distal first straight portion 45 and the distal second straight portion 46 are located distal to the distal third straight portion 47. Even when the ends of the ridge segments 24 are formed in this manner, the inner wall of the blood vessel is less likely to be damaged even if the ends of the ridge segments 24 come into contact with the inner wall of the blood vessel when the balloon 10 is bent. In this case, it is sufficient that at least a portion of the proximal first straight portion 35 and at least a portion of the proximal second straight portion 36 are located proximal to the proximal third straight portion 37, and it is sufficient that at least a portion of the distal first straight portion 45 and at least a portion of the distal second straight portion 46 are located distal to the distal third straight portion 47.

[0097] The proximal third straight portion 37 preferably extends so that the angle it forms with the longitudinal axis direction, in a plan view seen from the apex 21A side of the ridge 21, is larger than the angle formed between the proximal first straight portion 35 and the longitudinal axis direction and the angle formed between the proximal second straight portion 36 and the longitudinal axis direction. The distal third straight portion 47 preferably extends so that the angle it forms with the longitudinal axis direction, in a plan view seen from the apex 21A side of the ridge 21, is larger than the angle formed between the distal first straight portion 45 and the longitudinal axis direction and the angle formed between the distal second straight portion 46 and the longitudinal axis direction. The angles formed by the proximal first straight portion 35, the proximal second straight portion 36, the distal first straight portion 45, and the distal second straight portion 46 with the longitudinal axis direction are greater than 0° and less than 90°, and the angles formed by the proximal third straight portion 37 and the distal third straight portion 47 with the longitudinal axis direction are greater than 0° and less than 90°. When the angle formed by the proximal third straight portion 37 and the distal third straight portion 47 with the longitudinal axis direction is 90°, the proximal third straight portion 37 and the distal third straight portion 47 extend perpendicular to the longitudinal axis direction. The angle formed by the proximal third straight portion 37 and the distal third straight portion 47 with the longitudinal axis direction is preferably greater than 60° and less than 90°, and more preferably greater than 75° and less than 90°. This makes it less likely that the inner wall of the blood vessel will be damaged when the end of the ridge segment 24 hits the inner wall of the blood vessel. It is more preferable that the proximal third straight portion 37 and / or the distal third straight portion 47 extend perpendicular to the longitudinal axis direction, and it is particularly preferable that both the proximal third straight portion 37 and the distal third straight portion 47 extend perpendicular to the longitudinal axis direction. The angles formed by the proximal first straight portion 35, the proximal second straight portion 36, the distal first straight portion 45, and the distal second straight portion 46 with the longitudinal axis direction are preferably 20° or more, more preferably 30° or more, and preferably 70° or less, more preferably 60° or less.

[0098] The most distal portion of the distal edge 32 of the proximal ridge segment 24P is preferably on an imaginary line F that passes through the apex 21A of the ridge 21 and extends in the longitudinal direction when viewed in a plan view from the apex 21A side of the ridge 21. The most proximal portion of the proximal edge 42 of the distal ridge segment 24D is preferably on an imaginary line F that passes through the apex 21A of the ridge 21 and extends in the longitudinal direction when viewed in a plan view from the apex 21A side of the ridge 21. In Figures 18 to 22, 24, and 25, the distal edge 32 of the proximal ridge segment 24P and the proximal edge 42 of the distal ridge segment 24D are formed as shown. By forming the end of the ridge segment 24 in this manner, when the balloon 10 is bent, the balloon 10 can be easily bent significantly regardless of the bending direction of the balloon 10, regardless of whether the specific notch 22X is located inside or on the side of the bent portion of the balloon 10.

[0099] On the other hand, the convex shape of the distal end edge 32 of the proximal side ridge segment 24P and the convex shape of the proximal end edge 42 of the distal side ridge segment 24D may be configured as shown in Fig. 23. That is, in a plan view seen from the apex 21A side of the ridge 21, the distalmost portion of the distal end edge 32 of the proximal side ridge segment 24P may be located on one side of an imaginary line F that passes through the apex 21A of the ridge 21 and extends in the longitudinal direction, and the proximalmost portion of the proximal end edge 42 of the distal side ridge segment 24D may be located on the other side of an imaginary line F that passes through the apex 21A of the ridge 21 and extends in the longitudinal direction. In this case, the distalmost portion of the distal edge 32 of the proximal ridge segment 24P and the proximalmost portion of the proximal edge 42 of the distal ridge segment 24D are offset from each other in the width direction of the ridge 21, which makes it easier to bend the balloon 10 particularly significantly when bending the balloon 10 with the specific notch 22X facing inward. In Figure 23, the specific notch 22X is configured to also satisfy requirement A.

[0100] The outer edge shape at any radial position of the distal end of the proximal ridge segment 24P (i.e., the outer edge shape of the distal end of the proximal ridge segment 24P when the ridge 21 is cut along any plane parallel to the outer surface of the balloon body 16) may be similar or dissimilar to the distal edge 32. For example, the distal edge 32 of the proximal ridge segment 24P may be composed of a curved portion, and the outer edge shape at any radial position of the distal end of the proximal ridge segment 24P may be composed of a straight portion. Similarly, the outer edge shape at any radial position of the proximal end of the distal ridge segment 24D may be similar or dissimilar to the proximal edge 42.

[0101] In a cross section along the longitudinal axis direction passing through the apex 21A of the ridge 21 (specifically, a cross section of the ridge 21 taken by an imaginary plane passing through the apex 21A of the ridge 21 and formed by the longitudinal axis direction and the radial direction), the distal outer edge 38 of the proximal ridge segment 24P may extend radially outward at an inclination toward the proximal side as shown in FIGS. 18 to 23 , or may extend radially as shown in FIG. 24 . Also, as shown in FIG. 25 , the distal outer edge 38 of the proximal ridge segment 24P may have a portion extending radially outward at an inclination toward the proximal side. Although not shown in the drawings, the distal outer edge 38 of the proximal ridge segment 24P may have a portion extending radially outward at an inclination toward the distal side.

[0102] In a cross section along the longitudinal axis passing through the apex 21A of the ridge 21, the proximal outer edge 48 of the distal ridge segment 24D may extend radially outward at an inclination toward the distal side as shown in Figures 18 to 23, or may extend radially as shown in Figure 24. Furthermore, as shown in Figure 25, the proximal outer edge 48 of the distal ridge segment 24D may have a portion that extends radially and a portion that extends radially outward at an inclination toward the distal side. Although not shown in the drawings, the proximal outer edge 48 of the distal ridge segment 24D may have a portion that extends radially outward at an inclination toward the proximal side.

[0103] In a cross section along the longitudinal axis direction passing through the apex 21A of the ridge 21, the distal outer edge 38 of the proximal ridge segment 24P preferably extends at an inclination toward the proximal side toward the radially outward direction, and the proximal outer edge 48 of the distal ridge segment 24D preferably extends at an inclination toward the distal side toward the radially outward direction. Figures 26 to 29 show configuration examples of cross sections along the longitudinal axis direction passing through the apex 21A of the ridge 21 of the distal end portion of the proximal ridge segment 24P and the proximal end portion of the distal ridge segment 24D shown in Figures 18 to 23, and the distal outer edge 38 of the proximal ridge segment 24P and the proximal outer edge 48 of the distal ridge segment 24D are formed in this manner. When the specific notch 22X is formed so as to extend from the apex 21A to the base 21B of the ridge 21, the cross-sectional view of Figure 26 or 28 should be referred to. When the specific notch 22X is formed so as to extend partway from the apex 21A to the base 21B of the ridge 21, the cross-sectional view of Figure 27 or 29 should be referred to. If the end of the ridge segment 24 is formed in this manner, it becomes easier to bend the balloon 10 greatly when bending the balloon 10 with the specific notch 22X facing inward. In this case, the distal end edge 32 of the proximal ridge segment 24P and the proximal end edge 42 of the distal ridge segment 24D, as viewed from the apex 21A side of the ridge 21, are determined in shape by the bottom 22B of the specific notch 22X.

[0104] In the straight tube portion 13 of the balloon 10 according to the first and second embodiments, only some of the notches 22 provided in the ridges 21 may be formed as the specific notches 22X, or all of the notches 22 may be formed as the specific notches 22X. It is preferable that more of the notches 22 provided in the ridges 21 be formed as the specific notches 22X. For example, it is preferable that one-quarter or more of the notches 22 provided in the ridges 21 be formed as the specific notches 22X, more preferably one-third or more of the notches 22X, even more preferably one-half or more of the notches 22X, and even more preferably two-thirds or more of the notches 22X.

[0105] It is preferable that the specific notch 22X is provided in each ridge 21. This allows the balloon 10 to bend easily in any radial direction.

[0106] The specific notch 22X is preferably provided at least in the distal section 19 of the ridge 21. Providing the specific notch 22X in the distal section 19 of the ridge 21 makes it easier to push and insert the balloon 10 into a bent portion of a blood vessel. In this case, the specific notch 22X may be provided in the distal section 19 of at least one ridge 21, but preferably the specific notch 22X is provided in the distal section 19 of each ridge 21. Furthermore, all of the notches 22 provided in the distal section 19 of the ridge 21 may be formed as the specific notch 22X.

[0107] It is also preferable that the specific notch 22X be provided in the proximal section 17 of the ridge 21. By providing the specific notch 22X in the proximal section 17 of the ridge 21, it becomes easier to pull back the balloon 10 and insert it through the bent portion. In this case, the specific notch 22X may be provided in the proximal section 17 of at least one ridge 21, but preferably the specific notch 22X is provided in the proximal section 17 of each ridge 21. Furthermore, all of the notches 22 provided in the proximal section 17 of the ridge 21 may be formed as the specific notch 22X.

[0108] The specific notch 22X may be provided in both the distal section 19 and the proximal section 17 of the ridge 21, and may also be provided in the middle section 18 of the ridge 21. By providing the specific notch 22X in the middle section 18 of the ridge 21, the flexibility of the balloon 10 can be further improved.

[0109] In the balloon 10 according to the first and second embodiments, when the ridges 21 are further provided on at least one of the proximal sleeve section 11, the proximal tapered section 12, the distal tapered section 14, and the distal sleeve section 15, the specific notches 22X may also be provided on the ridges 21 of the proximal sleeve section 11, the proximal tapered section 12, the distal tapered section 14, or the distal sleeve section 15. This makes it easier to bend the balloon 10 significantly in sections other than the straight tube section 13.

[0110] In the configuration example of the balloon 10 shown in Figures 4 and 5, the notches 22 are provided at approximately equal intervals in the ribs 21, but the notches 22 may also be provided at unequal intervals in the longitudinal direction of the ribs 21. Figures 30 to 33 show other configuration examples of the ribs 21 provided on the balloon 10. Figures 30 and 31 show a modified example of the balloon 10 shown in Figure 4, i.e., a configuration example of a balloon 10 provided with ribs 21 having specific notches 22X that satisfy requirement A, and Figures 32 and 33 show a modified example of the balloon 10 shown in Figure 5, i.e., a configuration example of a balloon 10 provided with ribs 21 having specific notches 22X that satisfy requirement B.

[0111] 30 and 32, the ridges 21 may be provided with notches 22 such that the number of notches 22 in the distal section 19 is greater than the number of notches 22 in the intermediate section 18. This can increase the flexibility of the distal portion of the balloon 10, making it easier to push the balloon 10 through a bent section. Also, by providing fewer notches 22 or no notches 22 in the intermediate section 18 of the ridges 21, the scoring function of the intermediate section 18 of the ridges 21 can be improved.

[0112] 31 and 33, the ridges 21 may be provided with notches 22 such that the number of notches 22 in the distal section 19 and the number of notches 22 in the proximal section 17 are greater than the number of notches 22 in the intermediate section 18. This makes it easier to insert the balloon 10 into the bent section whether the balloon 10 is pushed through the bent section or pulled through the bent section. This also improves the scoring function of the intermediate section 18 of the ridges 21.

[0113] When multiple notches 22 are provided in the ridge 21, the depths of the multiple notches 22 may be the same or different. In one embodiment, the ridge 21 may have the following notches 22. That is, the ridge 21 may have the notches 22 formed such that the deepest notch 22 in the distal section 19 is deeper than the deepest notch 22 in the intermediate section 18. This can increase the flexibility of the distal portion of the balloon 10, making it easier to push the balloon 10 through a curved section.

[0114] The ridges 21 may have notches 22 formed such that the deepest depth of the notches 22 in the distal section 19 and the deepest depth of the notches 22 in the proximal section 17 are deeper than the deepest depth of the notches 22 in the intermediate section 18. This increases the flexibility of the distal and proximal sections of the balloon 10, making it easier to insert the balloon 10 into a bent section whether the balloon 10 is pushed through the bent section or pulled through the bent section.

[0115] Conversely, the notches 22 may be formed in the ridges 21 as follows. That is, the notches 22 may be formed in the ridges 21 so that the deepest depth of the notches 22 formed in the intermediate section 18 is deeper than the deepest depth of the notches 22 formed in the distal section 19. Alternatively, the notches 22 may be formed in the ridges 21 so that the deepest depth of the notches 22 formed in the intermediate section 18 is deeper than the deepest depth of the notches 22 formed in the distal section 19 and the deepest depth of the notches 22 formed in the proximal section 17. If the notches 22 are formed in the ridges 21 in this manner, the number of notches 22 formed in the intermediate section 18 can be reduced while improving the flexibility of the intermediate section 18. This makes it easier to ensure flexibility throughout the entire longitudinal axis direction of the balloon 10 while maintaining the scoring function of the ridges 21.

[0116] The longitudinal length of the straight tube portion 13 of the balloon 10 may be, for example, 4 mm or more, 10 mm or more, 20 mm or more, or 30 mm or more, but the longer the longitudinal length of the balloon 10 provided with the ridges 21, the more difficult it becomes to insert the balloon 10 through a bent section. Therefore, in order to maximize the effect of providing the notches 22 in the ridges 21, the longitudinal length of the straight tube portion 13 of the balloon 10 is preferably 50 mm or more, more preferably 60 mm or more, and even more preferably 80 mm or more.

[0117] As shown in Figure 34, the ridge 21 may be formed so that its width narrows stepwise toward the apex 21A in a vertical cross section taken along the longitudinal axis of the straight tube portion 13, and the notch 22 may be formed only in the portion of the stepped ridge 21 closer to the apex 21A. For example, the ridge 21 may have a first step portion 27 adjacent to the outer surface of the balloon body 16 and a second step portion 28 closer to the apex 21A, and the notch 22 may be formed in the second step portion 28 but not in the first step portion 27. Alternatively, the deep notch 22 may be formed from the second step portion 28 to the first step portion 27, and the shallow notch 22 may be formed in the second step portion 28 but not in the first step portion 27. The first step portion 27 and the second step portion 28 may be made of the same material or different materials. For example, both the first step portion 27 and the second step portion 28 may be made of resin, or the first step portion 27 may be made of resin and the second step portion 28 may be made of metal.

[0118] A drug may be retained on the outer surface of the straight tube portion 13 of the balloon 10. The drug is not particularly limited as long as it is a pharmacologically active substance, and examples include medicaments acceptable as medicaments such as gene therapy drugs, non-gene therapy drugs, small molecules, and cells. In particular, when the catheter is used for the purpose of suppressing restenosis of a blood vessel after angioplasty, anti-restenosis drugs such as antiproliferative agents and immunosuppressants are preferably used as the drug. Examples of such drugs include paclitaxel, sirolimus (rapamycin), everolimus, and zotarolimus.

[0119] This application claims the benefit of priority based on Japanese Patent Applications Nos. 2023-109026 and 2023-109027, filed on July 3, 2023. The entire contents of the specifications of Japanese Patent Applications Nos. 2023-109026 and 2023-109027, filed on July 3, 2023, are incorporated herein by reference.

[0120] 1: Balloon catheter 2: Shaft 3: Inner shaft 4: Outer shaft, 4A: Proximal outer shaft, 4B: Distal outer shaft 5: Hub 6: Fluid injection section 7: Guidewire port 8: Distal tip 9: Radiopaque marker 10: Balloon 11: Proximal sleeve section 12: Proximal tapered section 13: Straight tube section 14: Distal tapered section 15: Distal sleeve section 16: Balloon body section 17: Proximal section 18: Intermediate section 19: Distal section 21: Ridge, 21A: Apex, 21B: Base 22: Notch, 22A: Apex, 22B: Bottom, 22X: Specific notch 23: Discontinued section 24: Ridge segment, 24P: Proximal rib segment, 24D: Distal rib segment 25: Ridge-present region 26: Ridge-absent region 27: First step portion 28: Second step portion 31: Distal surface (of proximal ridge segment) 32: Distal edge (of proximal ridge segment) 33: Curved portion (of distal edge of proximal ridge segment) 34: Straight portion (of distal edge of proximal ridge segment) 35: First proximal straight portion 36: Second proximal straight portion 37: Third proximal straight portion 38: Distal outer edge (of cross section along the longitudinal axis direction of proximal ridge segment) 41: Proximal surface (of distal ridge segment) 42: Proximal edge (of distal ridge segment) 43: Curved portion (of proximal edge of distal ridge segment) 44: Straight portion (of proximal edge of distal ridge segment) 45: First distal straight portion 46: Second distal straight portion 47: Distal side third straight portion 48: Proximal outer edge (of a cross section along the longitudinal axis direction of the distal side convex rib segment) H: Imaginary plane H1: First side H2: Second side F: Imaginary straight line

Claims

1. A balloon for a balloon catheter having a longitudinal axis direction extending from a proximal side to a distal side and a radial direction perpendicular to the longitudinal axis direction, wherein the balloon has a straight tube portion, a proximal tapered portion located proximal to the straight tube portion, and a distal tapered portion located distal to the straight tube portion, the straight tube portion having a cylindrical balloon main body and a ridge on an outer surface of the balloon main body that protrudes radially outward and extends in the longitudinal axis direction, the ridge having a notch formed therein and being divided into a plurality of ridge segments by the notch, the ridge including a specific notch that satisfies the following requirement A. (Requirement A) The distal surface of the ridge segment adjacent to the proximal side of the specific notch (hereinafter referred to as the "proximal ridge segment") has a normal vector A on the line of intersection with an imaginary plane that passes through the apex of the ridge and is formed by the longitudinal axis direction and the radial direction, which extends to one side of the imaginary plane toward the distal side, and the proximal surface of the ridge segment adjacent to the distal side of the specific notch (hereinafter referred to as the "distal ridge segment") has a normal vector B on the line of intersection with the imaginary plane, which extends to the other side of the imaginary plane toward the proximal side.

2. A balloon for a balloon catheter having a longitudinal axis direction extending from a proximal side to a distal side and a radial direction perpendicular to the longitudinal axis direction, wherein the balloon has a straight tube portion, a proximal tapered portion located proximal to the straight tube portion, and a distal tapered portion located distal to the straight tube portion, the straight tube portion having a cylindrical balloon main body and a ridge on the outer surface of the balloon main body that protrudes radially outward and extends in the longitudinal axis direction, the ridge having a notch formed therein and being divided into a plurality of ridge segments by the notch, the ridge including a specific notch that satisfies requirement B below. (Requirement B) In a planar view from the top side of the convex stripe, the distal end edge of the convex stripe segment adjacent to the proximal side of the specific notch (hereinafter referred to as the "proximal convex stripe segment") has a convex shape protruding toward the distal side, and the proximal end edge of the convex stripe segment adjacent to the distal side of the specific notch (hereinafter referred to as the "distal convex stripe segment") has a convex shape protruding toward the proximal side.

3. The balloon according to claim 1, wherein the convex rib has a plurality of the specific notches arranged in the longitudinal axis direction, and when one side of the imaginary plane of the convex rib is defined as a first side and the other side of the imaginary plane is defined as a second side, in all of the specific notches provided in the convex rib, the normal vector A extends toward the first side toward the distal side, and the normal vector B extends toward the second side toward the proximal side.

4. The balloon according to claim 1, wherein the convex rib has a plurality of the specific notches arranged in the longitudinal axis direction, and when one side of the imaginary plane of the convex rib is defined as a first side and the other side of the imaginary plane is defined as a second side, the convex rib has the specific notches in which the normal vector A extends toward the first side toward the distal side and the normal vector B extends toward the second side toward the proximal side, and the specific notches in which the normal vector A extends toward the second side toward the distal side and the normal vector B extends toward the first side toward the proximal side, alternately arranged in the longitudinal axis direction.

5. The balloon according to claim 1, wherein the distal surface of the proximal ridge segment and the proximal surface of the distal ridge segment are closest to each other in the longitudinal axis direction at least on the line of intersection with the imaginary plane.

6. The balloon according to claim 5, wherein the distance between the distal surface of the proximal ridge segment and the proximal surface of the distal ridge segment in the longitudinal direction remains constant or increases as the distance from the imaginary plane increases.

7. The balloon according to claim 6, wherein the distance between the distal surface of the proximal ridge segment and the proximal surface of the distal ridge segment in the longitudinal direction is formed so as to increase at least in part as it moves away from the imaginary plane.

8. The balloon according to claim 1, wherein the distal surface of the proximal ridge segment is inclined radially outward toward the proximal side at the intersection with the imaginary plane, and the proximal surface of the distal ridge segment is inclined radially outward toward the distal side at the intersection with the imaginary plane.

9. The balloon described in claim 1, wherein an angle between a projection vector AP of the normal vector A onto the outer surface of the balloon body and the longitudinal axis direction toward the distal side is greater than or equal to 20° and less than or equal to 70°, and an angle between a projection vector BP of the normal vector B onto the outer surface of the balloon body and the longitudinal axis direction toward the proximal side is greater than or equal to 20° and less than or equal to 70°.

10. A balloon as described in claim 2, wherein the distalmost portion of the distal end edge of the proximal ridge segment is on an imaginary line that passes through the apex of the ridge and extends in the longitudinal axis direction when viewed in a plan view from the apex side of the ridge, and / or the proximalmost portion of the proximal end edge of the distal ridge segment is on an imaginary line that passes through the apex of the ridge and extends in the longitudinal axis direction when viewed in a plan view from the apex side of the ridge.

11. The balloon of claim 2, wherein the convex shape of the distal end edge of the proximal ridge segment has a curved portion curved toward the distal side, and / or the convex shape of the proximal end edge of the distal ridge segment has a curved portion curved toward the proximal side.

12. The balloon according to claim 2, wherein the convex shape of the distal end edge of the proximal ridge segment, in a plan view seen from the apex side of the ridge, has a proximal first straight portion located on one side of an imaginary line passing through the apex of the ridge and extending in the longitudinal axis direction, and a proximal second straight portion located on the other side, the proximal first straight portion and the proximal second straight portion extending so as to move away from the imaginary line as they move proximally; and / or the convex shape of the proximal end edge of the distal ridge segment, in a plan view seen from the apex side of the ridge, has a distal first straight portion located on one side of the imaginary line and a distal second straight portion located on the other side, the distal first straight portion and the distal second straight portion extending so as to move away from the imaginary line as they move distally.

13. The balloon described in claim 12, wherein the convex shape of the distal end edge of the proximal ridge segment further has a proximal third straight portion between the proximal first straight portion and the proximal second straight portion in a plan view seen from the apex side of the ridge, the proximal first straight portion and the proximal second straight portion being located proximal to the proximal third straight portion, and / or the convex shape of the proximal end edge of the distal ridge segment further has a distal third straight portion between the distal first straight portion and the distal second straight portion in a plan view seen from the apex side of the ridge, the distal first straight portion and the distal second straight portion being located distal to the distal third straight portion.

14. The balloon of claim 13, wherein the proximal third straight portion and / or the distal third straight portion extend perpendicular to the longitudinal axis direction.

15. The balloon of claim 12, wherein the distal end of the proximal first straight section is connected to the distal end of the proximal second straight section, and / or the proximal end of the distal first straight section is connected to the proximal end of the distal second straight section.

16. A balloon as described in claim 2, wherein, in a cross section along the longitudinal axis direction passing through the apex of the ridge, the distal outer edge of the proximal ridge segment extends at an inclination toward the proximal side in a radially outward direction, and / or, in a cross section along the longitudinal axis direction passing through the apex of the ridge, the proximal outer edge of the distal ridge segment extends at an inclination toward the distal side in a radially outward direction.

17. The balloon according to any one of claims 1 to 16, wherein the ridges are made of resin, metal, or a combination thereof.

18. A balloon catheter comprising a balloon according to any one of claims 1 to 16.

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