Balloon catheter

Description

1 / 20 Balloon catheter Cross-reference to related request.

[001] The present application is based on Japanese Patent Application No. 2023-082515, filed on May 18, 2023, the entire content of which is incorporated into the present invention by reference. Technical Field

[002] This disclosure relates to a balloon catheter. Technical Background

[003] A balloon catheter that includes an inflatable and a deflatable balloon on one end. The balloon catheter is used to dilate a section of a blood vessel that is narrowed or blocked by an injury by inserting the balloon in a deflated state into the section and then inflating the balloon.

[004] Another type of balloon catheter includes a linear element on the outer surface of a balloon. The element extends in the axial direction of the balloon catheter. The element projects from the outer surface of the balloon. In treating the lesion using the balloon catheter with the element, the balloon is inflated and the element is pressed against the lesion. For example, the balloon is inflated so that the element penetrates the lesion and creates an incision in the lesion. With the incision used as a trigger for dilation, the section containing the lesion can be easily dilated.

[005] When the balloon of the balloon catheter is deflated, portions of the balloon form flaps that project outward in a radial direction. Patent Literature 1 discloses an example of such a configuration in which flaps are formed on a balloon of a balloon catheter with elements when the balloon catheter is deflated. In the balloon catheter in Patent Literature 1, the flaps are arranged to completely cover the elements. List of Citations Petition 870250086013, dated 09 / 23 / 2025, pp. 77 / 107 2 / 20 Patent Literature PLT1: International Publication WO2020 / 012851 Summary of the Invention Technical Problem

[006] Because the tabs are arranged to completely cover the elements when the balloon catheter balloon in patent literature 1 is deflated, a contour of the balloon is located more externally than the vertices of the protrusions by the thickness of the tabs. This may reduce the balloon's insertion capacity during its insertion into a body.

[007] This disclosure was made in view of the above circumstances. A primary objective of this disclosure is to provide a balloon catheter that is less likely to cause a reduction in balloon insertion capacity during balloon insertion into a body. Solution to the Problem

[008] To solve the problem described above, a balloon catheter in a first aspect of the present disclosure includes a balloon and protrusions. The balloon is inflatable and deflatable. The protrusions project from the surface of the balloon and extend in the axial direction of the balloon along the surface. The protrusions are arranged at intervals in the circumferential direction of the balloon. The balloon includes a flap that is formed when the balloon is deflated. The flap projects outward in a radial direction from the balloon. The flap extends in the axial direction. The flap is arranged so that a whole of the flap is located between the protrusions that are adjacent to each other in the circumferential direction in a cross-section that is perpendicular to the axial direction.

[009] In the first aspect, the balloon includes the flap that is formed when the balloon is deflated. The flap extends in the axial direction of the balloon. In a cross-section perpendicular to the axial direction, the flap is arranged so that the Petition 870250086013, dated 09 / 23 / 2025, pp. 78 / 107 3 / 20 of the entire flap is located between adjacent protrusions. In this configuration, the flap is arranged without covering the vertices of the protrusions. According to this configuration, the outer diameter of the balloon is less likely to increase, in contrast to a configuration where the vertices of the protrusions are covered by the flap. Therefore, the balloon's insertion capacity through a body is less likely to decrease.

[010] In a balloon catheter of a second aspect of the present disclosure, the tab in the first aspect includes a folding portion that is bent to project in the circumferential direction. The folding portion allows elastic deformation of the tab in the radial direction.

[011] In the second aspect, the tab is elastically deformable in the radial direction of the balloon, with the folding portion being bent to project in the circumferential direction. According to the configuration, the tab deforms elastically inward in the radial direction of the balloon when the tab comes into contact with a tube wall, such as a blood vessel, during balloon insertion through the tube. Therefore, the balloon's ability to be inserted through a body is additionally less likely to decrease.

[012] In a balloon catheter of a third aspect of the present disclosure, the tab in the second aspect includes a portion located externally in the radial direction to the vertices of the protrusions that are adjacent to each other.

[013] In a third aspect, the tab includes the outermost portion located in the radial direction more than the vertices of the adjacent protrusions. In such a configuration, the tab is more likely to contact the tube wall in the body before the vertices of the protrusions contact the wall during balloon insertion through the tube. Therefore, the vertices of the protrusions are less likely to be captured by the tube wall. Although the Petition 870250086013, dated 09 / 23 / 2025, pp. 79 / 107 4 / 20 flap has the configuration described above, it elastically deforms inward in the radial direction of the balloon when the flap comes into contact with the wall and therefore the balloon's insertion capacity is less likely to decrease.

[014] In a balloon catheter of a fourth aspect of the present disclosure, the flap in any of the first to third aspects is folded such that a tip portion of the flap at one end in a direction of extension in which the flap extends is covered with a portion of the flap closer to a base portion of the flap than the tip portion in the direction of extension. The tip portion is covered on an outer side in the radial direction.

[015] In the fourth aspect, the tip portion of the tab is covered with the tab portion closest to the base portion of the tab than the tip portion in the extension direction. The tip portion is covered by the outer side in the radial direction of the balloon. According to the configuration, the tip portion of the tab is less likely to get caught on the tube wall during balloon insertion through the tube.

[016] In a balloon catheter of a fifth aspect of the present disclosure, the balloon catheter in any one of the first to third aspects additionally includes an inner tube that is inserted through the balloon. The balloon includes a portion opposite the tube that is formed when the balloon is deflated and opposite the outer periphery of the inner tube. One of the protrusions is defined as a first protrusion and another of the protrusions is defined as a second protrusion. The flap includes a first portion, a second portion, and a third portion. The first portion extends outward from the portion opposite the tube in a radial direction along a lateral surface of the first protrusion. The second portion extends from one end of the first portion on an outer side in a radial direction toward the second protrusion in a circumferential direction. A Petition 870250086013, dated 09 / 23 / 2025, pp. 80 / 107 5 / 20 The third portion extends inward from one end of the second portion onto one side of the second protrusion in a radial direction along a lateral surface of the second protrusion.

[017] In the fifth aspect, the balloon includes the portion opposite the tube that is formed when the balloon is deflated and opposite the outer periphery of the inner tube. The flap includes the first portion, the second portion, and the third portion. The first portion extends outward from the portion opposite the tube in the radial direction along the lateral surface of the first protrusion. The second portion extends from the end of the first portion on the outer side in the radial direction toward the second protrusion in the circumferential direction. The third portion extends inward from the end of the second portion on the side of the second protrusion in the radial direction along the lateral surface of the second protrusion. According to the configuration, the dimensions of the sections of the vertices of the adjacent protrusions (the first protrusion and the second protrusion) that are outermost than the flap in the radial direction of the balloon are less likely to be larger.Therefore, the vertices of the protrusions are less likely to be captured by the tube wall during balloon insertion through the tube.

[018] In a balloon catheter of a sixth aspect of the present disclosure, the protrusions in any of the first to third aspects are arranged to incline toward the flap when the balloon is deflated.

[019] In the sixth aspect, the dimensions of the cross-sections of the outermost protrusions that are more than the flange in the radial direction of the balloon are less likely to be larger because the protrusions are arranged to tilt towards the flange when the balloon is deflated. Therefore, the vertices of the protrusions are less likely to be captured by the tube wall during insertion of the balloon through the tube. Brief Description of the Drawings Petition 870250086013, dated 09 / 23 / 2025, pp. 81 / 107 6 / 20

[020] The object described above and any other objects, attributes and advantages of this disclosure will be further explained by the following detailed description made with reference to the accompanying drawings.

[021] [FIG. 1] A general schematic side view illustrating a balloon catheter configuration.

[022] [FIG. 2] (a) is a side view illustrating a balloon configuration and around it, and (b) is a cross-sectional view along line AA in (a).

[023] [FIG. 3] A side view illustrating a balloon configuration in an inflated state and around it with longitudinal cross-section of the balloon and an outer tube.

[024] [FIG. 4] A side view illustrating the balloon in its deflated state and around it.

[025] [FIG. 5] A cross-sectional view along line BB in FIG. 4.

[026] [FIG. 6] Cross-sectional views illustrating other types of flaps.

[027] [FIG. 7] A cross-sectional view illustrating a projection resting on a flange.

[028] [FIG. 8] A view illustrating a configuration that includes a notch in a projection. Description of the Modalities

[029] One embodiment of the present disclosure will be described with reference to the drawings. FIG. 1 is a general schematic side view illustrating a balloon catheter configuration.

[030] As illustrated in FIG. 1, a balloon catheter 10 includes a catheter tube 11, a hub 12 and a balloon 13. The hub 12 is mounted on a portion Petition 870250086013, dated 09 / 23 / 2025, pp. 82 / 107 7 / 20 of the base (a portion of the proximal end) of the catheter tube 11. The balloon 13 is mounted on a tip portion (a portion of the distal end) of the catheter tube 11.

[031] The catheter tube 11 includes an outer tube 15 and an inner tube 16 that is inserted through the outer tube 15. The outer tube 15 is made of a resin material and formed into a tubular shape. The outer tube 15 includes a lumen 15a inside (see FIG. 3). The lumen 15a extends the entire length of the outer tube 15 in an axial direction of the outer tube 15. A base portion of the outer tube 15 is attached to the hub 12, and the tip portion of the outer tube 15 is attached to the balloon 13. The lumen 15a of the outer tube 15 communicates with an internal space of the hub 12 and an internal space of the balloon 13. The lumen 15a of the outer tube 15 is a fluid lumen through which a compressed fluid is passed to inflate and deflate the balloon 13.

[032] The outer tube 15 may be composed of multiple tubes that are arranged in a row in the axial direction and joined together. One of the multiple tubes on the base side may be made of a metallic material and another of the multiple tubes on the tip end side may be made of a resin material.

[033] The inner tube 16 is made of a resin material and formed into a tubular shape. The inner tube 16 includes a lumen 16a inside (see FIG. 3). The lumen 16a extends the entire length of the inner tube 16 in an axial direction of the inner tube 16. A portion of the base of the inner tube 16 is joined to a portion of the outer tube 15 midway with respect to the axial direction of the outer tube 15. A portion of the inner tube 16 on the tip end side extends beyond the tip of the outer tube 15 and is inserted into the inner space of the balloon 13. A portion of the inner tube 16 adjacent to the tip portion of the inner tube 16 is joined to a tip portion of the balloon 13. Petition 870250086013, dated 09 / 23 / 2025, p. 83 / 107 8 / 20

[034] Lumen 16a of inner tube 16 is a guidewire lumen through which a guidewire G is inserted. A base opening of lumen 16a of the guidewire is located midway with respect to the axial direction of the balloon catheter 10. That is, the balloon catheter 10 is classified as an RX-type catheter. A base opening 18 of lumen 16a of the guidewire may be located in a portion of the base of the balloon catheter 10. The balloon catheter 10 may be classified as an over-the-wire type catheter.

[035] Next, a configuration of balloon 13 and its surroundings will be described with reference to FIGS. 2 and 3. FIG. 2(a) is a side view illustrating the configuration of balloon 13 in an inflated state and its surroundings. FIG. 2(b) is a cross-sectional view along line AA in FIG. 2(a). FIG. 3 is a side view illustrating the configuration of balloon 13 in the inflated state and its surroundings with longitudinal cross-sections of balloon 13 and outer tube 15.

[036] Balloon 13 is made of a thermoplastic resin material, such as polyamide elastomer. As illustrated in FIGS. 2(a) and 3, balloon 13 is formed in a cylindrical shape (a tubular shape) with a circular cross-section as a whole. Specifically, balloon 13 includes a base leg portion 13a, a conical base portion 13b, a straight tube portion 13c, a conical tip portion 13d, and a leg tip portion 13e in this sequence from the base side towards the tip side.

[037] The base portion of leg 13a is joined to the tip end portion of the outer tube 15. The tapered portion of the base 13b increases in diameter from the tip of the base portion of leg 13a towards the tip side. That is, the tapered portion of base 13b has a conical shape. The straight tube portion 13c extends from the tip of the tapered portion of base 13b towards the tip side with a constant diameter. That is, the straight tube portion 13c Petition 870250086013, dated 09 / 23 / 2025, page 84 / 107 9 / 20 has a round tubular shape (a cylindrical shape). The straight tube portion 13c has a diameter that should be at its maximum when the balloon 13 is inflated. The pointed taper portion 13d decreases in diameter from the front end of the straight tube portion towards the tip side. That is, the pointed taper portion 13d has a conical shape. The pointed leg portion 13e is joined to an inner tube portion 16 on the tip side.

[038] When compressed fluid is supplied to the internal space of balloon 13 through lumen 15a of outer tube 15, balloon 13 inflates. When negative pressure is applied to lumen 15a of outer tube 15 and compressed fluid is discharged from the internal space of balloon 13, balloon 13 deflates (see FIGS. 4 and 5).

[039] Two contrast rings 19 are attached to the inner tube 16 inside the balloon 13. The contrast rings 19 serve to improve the visibility of the balloon 13 in X-ray images to easily position the balloon 13 in a target section for treatment.

[040] The balloon catheter 10 includes linear protrusions 20 on a balloon surface 13. The protrusions 20 serve to create incisions in a lesion during dilation of a section with the lesion, inflating the balloon 13. By creating incisions in the lesion with the protrusions 20, the balloon catheter 10 enables easy dilation of the section with the lesion using the incisions as a trigger for dilation. That is, the balloon catheter 10 is classified as a marking balloon catheter.

[041] The protrusions 20 project from a surface of the balloon 13. The protrusions 20 extend in the axial direction of the balloon 13 along the surface of the balloon 13. Multiple protrusions 20 are arranged at predetermined intervals (specifically, equal intervals) in the circumferential direction of the balloon 13. This embodiment includes three protrusions 20. Each protrusion 20 is Petition 870250086013, dated 09 / 23 / 2025, page 85 / 107 10 / 20 arranged in the straight tube portion 13c to extend the entire length of the straight tube portion 13c in the axial direction. The protrusions 20 are integrally formed with the balloon 13 and the heights of the protrusions 20 from the surface of the balloon 13 are equal.

[042] The protrusions 20 may be arranged on the conical base portion 13b or on the pointed conical portion 13d instead of or in addition to the straight tube portion 13c. In such a configuration in which the protrusions 20 are arranged on the conical portions 13b, 13d, in addition to the straight tube portion 13c, the heights of the protrusions 20 on the conical portions 13b, 13d may be equal to the height of the protrusions 20 on the straight tube portion 13c. Alternatively, the heights of the protrusions 20 on the conical portions 13b, 13d may be greater or less than the height of the protrusions 20 on the straight tube portion 13c.

[043] Each protrusion 20 has a chevron-shaped cross-section (specifically, a cross-section perpendicular to the longitudinal direction of the protrusion 20) that projects outward in the radial direction of the balloon 13, specifically, a triangular shape. Each protrusion 20 includes a vertex 20a at one end of the protrusion. The protrusion 20 includes two lateral surfaces 20b that are adjacent to each other through vertex 20a.

[044] Next, a configuration of balloon 13 in the deflated state will be described with reference to FIGS. 4 and 5. FIG. 4 is a side view illustrating balloon 13 in the deflated state and its surroundings. FIG. 5 is a cross-sectional view along line BB in FIG. 4.

[045] As illustrated in FIGS. 4 and 5, balloon 13 includes portions opposite tube 21 and tabs 22 that are formed when balloon 13 is deflated. The portions opposite tube 21 are opposite the outer periphery of the inner tube 16 which is placed inside balloon 13. The portions opposite tube 21 extend in the circumferential direction of the inner tube 16 (or in the direction Petition 870250086013, dated 09 / 23 / 2025, pp. 86 / 107 11 / 20 circumferential of balloon 13) along the outer periphery of inner tube 16.

[046] Flanges 22 extend outward from the portions opposite the tube 21 in the radial direction of balloon 13 (hereinafter referred to as the radial direction of the balloon). Multiple flanges 22 are arranged at predetermined intervals (specifically, equal intervals) in the circumferential direction of balloon 13. This embodiment includes three flanges 22, i.e., the number of flanges 22 and the number of protrusions 20 are equal. Each flange 22 extends in the axial direction over the conical portion 13b, 13d and the straight tube portion 13c of balloon 13. The flanges 22 have the same shape and size.

[047] Portions of the balloon 13 are folded and formed into the tabs 22. The tabs 22 include tip portions 23 that are at the ends in extension directions in which the tabs 22 extend from the portions opposite the tube 21. The tip portions 23 include creases 24 that extend in the axial direction of the balloon 13. The tabs 22 are folded along the creases 24.

[048] Multiple portions opposite tube 21, specifically three, are arranged in the circumferential direction of balloon 13, as well as in tabs 22. That is, the number of portions opposite tube 21 and the number of tabs 22 are equal. The portions opposite tube 21 are provided for tabs 22, respectively. Each portion opposite tube 21 extends between adjacent tabs 22 to connect one of the adjacent tabs 22 to the other.

[049] The balloon catheter 10 has a distinctive feature in the configuration of the tabs 22. The distinctive feature will be described.

[050] As illustrated in FIG. 5, each tab 22 is arranged between adjacent protrusions 20 in the circumferential direction of balloon 13 (hereinafter referred to as the circumferential direction of the balloon). Specifically, each tab 22 is arranged so that the entire tab 22 is located between adjacent protrusions 20 in a cross-section perpendicular to the axial direction of balloon 13. Petition 870250086013, dated 09 / 23 / 2025, pp. 87 / 107 12 / 20 (that is, the cross-section). In such a configuration, each flap 22 does not cover the vertex 20a of the protrusion 20 on an external side in the radial direction of the balloon. As each flap 22 is arranged as described above, the flaps 22 and the protrusions 20 appear alternately in the circumferential direction of the balloon 13.

[051] Each flap 22 is arranged in such a way that the flap 22 is pressed between the protrusions 20 that are adjacent to each other in the circumferential direction of the balloon. One of the adjacent protrusions 20 and another of the adjacent protrusions 20 may be referred to as a first protrusion 20 and a second protrusion 20, respectively. Each flap 22 includes a first portion 22a, a second portion 22b, and a third portion 22c. The first portion 22a extends outward from the portion opposite the tube 21 in the radial direction of the balloon along a lateral surface 20b of the first protrusion 20 (corresponding to a first protrusion). The second portion 22b extends from one end of the first portion 22a on the outer side in the radial direction of the balloon towards the second protrusion 20 (corresponding to a second protrusion) in the circumferential direction of the balloon.The third portion 22c extends inward from one end of the second portion 22b on a second side of the protrusion 20 in the radial direction of the balloon along a lateral surface 20b of the second protrusion 20. The first portion 22a contacts the lateral surface 20b of the first protrusion 20 and the third portion 22c contacts the lateral surface 20b of the second protrusion 20. One end of the third portion 22c on an opposite side of the second portion 22b is defined as a tip portion 23 of the flap 22.

[052] The second portion 22b is located approximately in the same position as the vertex of each protrusion 20 with respect to the radial direction of the balloon. When an imaginary circle E that has the axis J of balloon 13 as its center (a central axis) and passes through the vertices 20a of the protrusions 20 is drawn (see a Petition 870250086013, dated 09 / 23 / 2025, pp. 88 / 107 13 / 20 two-point chain line in FIG. 5) in a cross-section perpendicular to the axial direction of balloon 13 (i.e., a cross-section), the second portion 22b extends in an arc along the imaginary circle E. Specifically, the second portion 22b includes a dispersed section 26 that is located outside the imaginary circle E in the radial direction of the balloon. The dispersed section 26 of the second portion 22b is located externally to the vertex 20a of the protrusion 20 in the radial direction of the balloon. One dimension of the dispersed section 26 (i.e., a length measured in the radial direction of the balloon) is less than the thickness of the flap 22. The dimension is approximately equal to the thickness of balloon 13 (i.e., half the thickness of flap 22) in this embodiment.

[053] The second portion 22b of flap 22 includes folding sections 27 and 28 at the ends relative to the circumferential direction of the balloon. Folding section 27 is on an edge between the second portion 22b and the first portion 22a. Folding section 28 is on an edge between the second portion 22b and the third portion 22c. Folding sections 27 and 28 are folded to project on opposite sides of each other in the circumferential direction of the balloon. Specifically, folding sections 27 and 28 are curved to project towards opposite sides of each other. With folding sections 27 and 28, flap 22 is elastically deformable in the radial direction of the balloon. Since the folding section 28 is provided in flap 22, the tip portion 23 of flap 22 is covered with the second portion 22b on the outside in the radial direction of the balloon.The second portion 22b corresponds to a portion of the flange 22 that is closer to a portion of the base of the flange 22 than to the tip portion 23 in an extension direction in which the flange 22 extends.

[054] As folding sections 27 and 28 are provided in tab 22, tab 22 forms a circular shape. A predefined space 25 is defined inside tab 22. Space 25 is surrounded by the first portion 22a, by Petition 870250086013, dated 09 / 23 / 2025, pp. 89 / 107 14 / 20 second portion 22b and by the third portion 22c of tab 22.

[055] Next, a method of using the balloon catheter 10 will be described. Specifically, a procedure for dilating a section of a blood vessel with an injury using the balloon catheter 10 will be described.

[056] First, a guide catheter is inserted through a sheath introducer into the blood vessel until a tip opening of the guide catheter reaches a coronary ostium. Then, a G-guidewire is inserted through the guide catheter until the G-guidewire reaches a distal point through the coronary ostium and the section with the lesion.

[057] Next, the balloon catheter 10 is inserted through the guide catheter along the guidewire G. After insertion, the balloon 13 is advanced to (or positioned in) the section with the lesion while being pushed back and forth. During insertion, the balloon 13 is kept in the deflated state. When the balloon 13 is deflated, the flaps 22 are formed on the balloon 13, as described above. Each flap 22 is positioned so that the entire flap 22 is located between the adjacent protrusions 20 in the cross-section (see FIG. 5). In this state, each tab 22 is arranged without covering the vertex 20a of the protrusion 20. According to the configuration, the outer diameter of the balloon 13 is less likely to increase in contrast to a configuration in which the vertices 20a of the protrusions 20 are covered with the tabs 22. Therefore, the insertion capacity of the balloon 13 through the blood vessel is less likely to decrease.

[058] When balloon 13 reaches the section with the lesion, balloon 13 is inflated. The protrusions 20 are pressed against the lesion and incisions (fissures) are created with the protrusions 20. With the incisions used as a trigger for dilation, the region with the lesion can be dilated.

[059] When the dilation of the section with the lesion using balloon 13 is complete, balloon 13 is deflated. With balloon 13 in the deflated state, the Petition 870250086013, dated 09 / 23 / 2025, pp. 90 / 107 The 15 / 20 balloon catheter is pulled out of the body. This concludes the steps of the procedure.

[060] As described above, the balloon catheter 10 is generally used for the treatment of blood vessels, for example, treatment of coronary arteries, femoral arteries, pulmonary arteries or other types of blood vessels; however, the balloon catheter 10 can be used in the treatment of any other types of tubes in living organisms, in addition to blood vessels, such as ureters and gastrointestinal tracts or body cavities.

[061] According to the configuration of the modality described above in detail, the following advantageous effects can be achieved.

[062] The tabs 22 include the folding sections 27, 28 which are folded to project in the circumferential direction of the balloon 13. With the folding sections 27, 28, the tabs 22 are elastically deformable in the radial direction of the balloon 13. According to the configuration, the tabs 22 (especially the second portions 22b) deform inwards in the radial direction of the balloon 13 when the tabs 22 come into contact with a blood vessel wall and the blood vessel wall pushes the tabs 22 backward during the insertion of the balloon 13 through the blood vessel. Therefore, the insertion capacity of the balloon 13 is additionally less likely to decrease.

[063] The tabs 22 include portions located more externally than the vertices 20a of the corresponding protrusions 20 in the radial direction of the balloon (specifically, the dispersed sections 26). The corresponding protrusions 20 are adjacent to the tabs 22 in the circumferential direction of the balloon. According to the configuration, the tabs 22 are more likely to come into contact with the blood vessel wall before the vertices 20a of the protrusions 20 come into contact with the blood vessel wall during balloon insertion 13 through Petition 870250086013, dated 09 / 23 / 2025, pp. 91 / 107 16 / 20 of the blood vessel. Therefore, the vertices 20a of the protrusions 20 are less likely to be captured by the blood vessel wall. Although the tabs 22 have the configuration described above, the insertion capacity of the balloon 13 is less likely to decrease because the tabs 22 deform elastically inward in the radial direction of the balloon 13 when the tabs 22 come into contact with the blood vessel wall.

[064] The tabs 22 include the tip portions 23 which are folded so that the tip portions 23 are covered with portions of the tabs 22 located closer to the base portions than the tip portions 23 (specifically, the second portions 22b) on the outside in the radial direction of the balloon 13. According to the configuration, the tip portions 23 of the tabs 22 are less likely to be captured by the blood vessel wall during insertion of the balloon 13 through the blood vessel.

[065] Balloon 13 includes the portions opposite tube 21 that are formed when balloon 13 is deflated and are opposite the outer periphery of inner tube 16. Here, one of the protrusions 20 adjacent to flap 22 is defined as the first protrusion 20 and the other is defined as the second protrusion 20. Flap 22 includes the first portion 22a, the second portion 22b, and the third portion 22c. The first portion 22a extends outward from the portion opposite tube 21 in the radial direction of the balloon along the lateral surface 20b of the first protrusion 20. The second portion 22b extends from the end of the first portion 22a on the outer side in the circumferential direction of the balloon towards the second protrusion 20 in the circumferential direction of the balloon. The third portion 22c extends inward from the end of the second portion 22b on the side of the second protrusion 20 in the radial direction of the balloon along the lateral surface 20b of the second protrusion 20.According to the configuration, the dimensions of the sections of the vertices of the 20 adjacent external protrusions to the flange 22 in the radial direction of the balloon are less. Petition 870250086013, dated 09 / 23 / 2025, pp. 92-107 17 / 20 probability of being larger. Therefore, vertices 20a of protrusions 20 are less likely to be captured by the blood vessel wall during insertion of balloon 13 through the blood vessel.

[066] This disclosure is not limited to the above method and can be implemented as follows, for example.

[067] (1) In the embodiment above, each tab 22 includes the portion located outside the vertices 20a of the adjacent protrusions 20 in the radial direction of the balloon (specifically, the dispersed portion 26). The adjacent protrusions 20 are adjacent to each other in the circumferential direction of the balloon. However, the tab 22 can be configured without the dispersed portion 26. For example, the outer edges of each tab 22 and the vertices 20a of the adjacent protrusions 20 can be in the same position relative to the radial direction of the balloon. Namely, the tabs 22 can come into contact with the imaginary circle E.

[068] (2) FIGS. 6(a) to 6(c) illustrate other embodiments of flaps. The flaps illustrated in FIG. 6(a) extend wavy in the circumferential direction of balloon 13. In this configuration, each flap 31 includes multiple folding portions 33 that project outward in the radial direction of balloon 13. According to the configuration, the folding portions 33 of the flaps 31 come into contact with the blood vessel wall during insertion of balloon 13 through the blood vessel. That is, the contact area of ​​the flaps 31 that come into contact with the blood vessel wall is reduced. Therefore, it improves the ease of insertion of balloon 13 through a narrow section of the blood vessel.

[069] (3) The tabs 41 illustrated in FIG. 6(b) extend wavy in the radial direction of balloon 13. In this configuration, the tabs 41 include folding portions 42 that are folded to project toward one side in the circumferential direction of balloon 13 and folding portions 43 that are Petition 870250086013, dated 09 / 23 / 2025, pp. 93 / 107 18 / 20 folded to project towards the other side in the circumferential direction of balloon 13. With the folding portions 42, 43, the tabs 41 are elastically deformable in the radial direction of balloon 13. When the tabs 41 come into contact with the blood vessel wall during insertion of balloon 13 through the blood vessel, the tabs 41 elastically deform inwards in the radial direction of balloon 13. Therefore, the ability to insert balloon 13 through the blood vessel is additionally less likely to decrease.

[070] (4) The tabs 51 illustrated in FIG. 6(c) are rolled so that spiral shapes are shown in a cross-section perpendicular to the axial direction of the balloon 13 (i.e., a cross-section). In this configuration, a tip portion 53 of each tab 51 is located in the center of the spiral shape. According to the configuration, the tip portions 53 of the tabs 51 are less likely to be captured by the blood vessel wall during insertion of the balloon 13 through the blood vessel.

[071] As the tabs 51 are rolled, they include curved portions 55 that are curved to project in the circumferential direction of the balloon 13. With the curved portions 55, the tabs 51 are elastically deformable in the radial direction of the balloon 13. When the tabs 51 come into contact with the blood vessel wall, the tabs 51 deform elastically inward in the radial direction. According to the configuration, the insertion capacity of the balloon 13 is additionally less likely to decrease during the insertion of the balloon 13 through the blood vessel.

[072] Because the tabs 51 are rolled up, the contact area of ​​the tabs 51 that come into contact with the blood vessel wall is reduced. This reduces the resistance to sliding of the tabs 51 that slide on the blood vessel wall during insertion of the balloon 13 through the narrowed section of the vessel. Petition 870250086013, dated 09 / 23 / 2025, pp. 94 / 107 19 / 20 blood. Therefore, it improves the ease of insertion of balloon 13 through a narrow section of the blood vessel.

[073] (5) In the embodiment above, the second portion 22b of the tabs 22 and the vertices 20a of the protrusions 20 are approximately in the same position relative to the radial direction of the balloon. However, the second portions 22b of the tabs 22 may be located more internally in the radial direction of the balloon than the vertices 20a of the protrusions 20. In this configuration, the vertices 20a of the protrusions 20 are located more externally in the radial direction of the balloon than the tabs 22. As illustrated in FIG. 7, the protrusions 20 may be arranged to incline towards the tabs 22 when the balloon 13 is in the deflated state. In FIG. 7, the protrusion 20 rests on the flange 22. In this configuration, it is less likely that a dimension of a section of vertex 20a of the outer protrusion 20 in the radial direction of balloon 13 will be larger than flange 22.Therefore, vertex 20a of protrusion 20 is less likely to be captured by the blood vessel wall during insertion of balloon 13 through the blood vessel.

[074] (6) As illustrated in FIG. 8, the balloon 13 protrusions 20 may include notches 58. Each notch 58 is formed in an intermediate portion of the protrusion 20 relative to the longitudinal direction, specifically, in the middle relative to the longitudinal direction. In this configuration, the protrusions 20 can easily bend with the notch 58 as the starting point of the bend. This allows the balloon 13 to easily follow the curve of a curved blood vessel during insertion of the balloon 13 through the curved blood vessel.

[075] In a known configuration in which the vertices 20a of the protrusions 20 are covered by the flaps 22 when the balloon 13 is deflated, the folding of the protrusions 20 with the notches 58 as starting points of the folding may be disturbed by the flaps 22. This may cause the balloon Petition 870250086013, dated 09 / 23 / 2025, pp. 95 / 107 20 / 20 has difficulty following the curve of the curved blood vessel during insertion of balloon 13 through the curved blood vessel. According to the configuration of this disclosure, in which each tab 22 is arranged between adjacent protrusions 20, the bending of protrusion 20 is not disturbed by tab 22. Therefore, balloon 13 can easily follow the curve of the curved blood vessel.

[076] (7) In the above embodiment, the protrusions 20 are used to create incisions in the lesion. However, the protrusions 20 can be used for other purposes. For example, the balloon 13 can be inflated in the blood vessel until the protrusions 20 are embedded in the wall of the blood vessel and the protrusions 20 can be used for anti-slip purposes to prevent the balloon 13 from slipping.

[077] The present disclosure has been described with reference to embodiments. However, the present disclosure is not limited to embodiments or structures. Various modifications and alterations within a scope of equivalents may fall within the technical scope of this disclosure. Additionally, various combinations, configurations and other combinations and configurations including unique elements, more or less, may fall within the technical scope of this disclosure. List of Reference Signs

[078] 10: Balloon catheter, 13: Balloon, 16: Inner tube, 20: Protrusion, 20a: Vertex, 21: Portion opposite the tube, 22: Flange, 27: Folding portion, 28: Folding portion. Petition 870250086013, dated 09 / 23 / 2025, pp. 96 / 107

Claims

1 / 2 CLAIMS 1. Balloon catheter, characterized in that it comprises: a balloon that is inflatable and deflatable; and projections that extend from a surface of the balloon and extend in an axial direction from the balloon along the surface, wherein the projections are arranged at intervals in a circumferential direction from the balloon, the balloon includes a flap that is formed when the balloon is deflated, the flap projects outward in a radial direction from the balloon, the flap extends in the axial direction, and the flap is arranged so that a whole of the flap is located between the projections that are adjacent to each other in the circumferential direction in a cross-section that is perpendicular to the axial direction.

2. Balloon catheter, according to claim 1, characterized in that the tab includes a folding portion that is bent to project in the circumferential direction and that allows elastic deformation of the tab in the radial direction.

3. Balloon catheter, according to claim 2, characterized in that the tab includes a portion that is located externally in the radial direction to the vertices of the protrusions that are adjacent to each other.

4. Balloon catheter, according to any one of claims 1 to 3, characterized in that the flap is folded so that a flap tip portion at one end in an extension direction in which the flap extends is covered with a flap portion closer to a flap base portion than the tip portion in the extension direction, wherein the tip portion is covered on an outer side in the radial direction.

5. Balloon catheter, according to any of the claims in Petition 870250086013, dated 09 / 23 / 2025, page 1.97 / 107 2 / 2 3, characterized in that it further comprises an inner tube that is inserted through the balloon, wherein the balloon includes a portion opposite the tube that is formed when the balloon is deflated and opposite an outer periphery of the inner tube, one of the protrusions is defined as a first protrusion and another of the protrusions is defined as a second protrusion, and the flap includes: a first portion that extends outward from the portion opposite the tube in the radial direction along a lateral surface of the first protrusion; a second portion that extends from an end of the first portion on an outer side in the radial direction towards the second protrusion in the circumferential direction; and a third portion that extends inward from an end of the second portion on a side of the second protrusion in the radial direction along a lateral surface of the second protrusion.

6. Balloon catheter, according to any one of claims 1 to 3, characterized in that the protrusions are arranged to incline towards the flap when the balloon is deflated. Petition 870250086013, dated 09 / 23 / 2025, pp. 98 / 107

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