Balloon for balloon catheter

Abstract

A balloon catheter is provided that improves the strength of the balloon to prevent it from elongating or rupturing in an undesirable direction, and provides smooth insertion into the body cavity with improved tracking and delivery. The first balloon has a protrusion (60) that protrudes outward from the outer surface of the balloon body (20). The protrusion (60) has a base (61) and a front end (62). The protrusion (60) located in the proximal sleeve portion and / or the distal sleeve portion tilts in a first direction (d1) or a second direction (d2). A straight line (L) connecting the midpoint of the base (61) in the width direction and the front end (62) is drawn. p The perpendicular line (L) to the base (61) v The angle (θ) formed by the two is 45° or more.

Description

Technical Field

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

[0002] Angina pectoris, myocardial infarction, and other diseases can occur due to the formation of narrowed sections in the inner wall of blood vessels caused by calcification and other hardening. As one treatment for these conditions, angiogenesis surgery, which uses a balloon catheter to dilate the narrowed sections, is performed. Angiogenesis surgery is a low-invasive treatment that does not require open-chest surgery like bypass surgery and is widely used.

[0003] A balloon catheter, with the balloon in a contracted state, is inserted into a body cavity and delivered to the treatment site. During delivery, balloon delivery is controlled by transmitting manipulation from the hand side to the front end where the balloon is located. At this time, easy insertion into the body cavity and easy transmission of manipulation from the hand side to the front end (high pushability) are required. However, when fluid is introduced into the balloon's lumen to inflate it, there is a problem that the balloon may elongate in an undesirable direction due to fluid pressure or rupture. To address such problems, for example, Patent Document 1 discloses a balloon catheter that improves the fixation strength between the balloon and the outer shaft without increasing the outer diameter of the fixation portion.

[0004] Patent Document 1: International Publication No. 2017 / 158735 Summary of the Invention

[0005] Balloon catheters require not only high delivery speed and balloon strength, but also the ability to smoothly insert into body cavities and maneuver flexibly within winding body cavities (trackability). However, existing balloon catheters do not adequately balance improved strength with improved smooth insertion and trackability. Therefore, the object of this invention is to provide a balloon for a balloon catheter that improves balloon strength to prevent undesirable elongation and rupture, and provides smooth insertion into body cavities while also improving trackability and delivery speed.

[0006] The first balloon catheter balloon according to the embodiments of the present invention that can solve the above-mentioned problems is as follows.

[0007] [1] A balloon for a balloon catheter has: a straight tube portion; a proximal conical portion located closer to the position than the straight tube portion; a proximal sleeve portion located closer to the position than the proximal conical portion; a distal conical portion located distal to the position than the straight tube portion; and a distal sleeve portion located distal to the position than the distal conical portion, wherein it has: a balloon body having an outer surface and an inner surface; and a protrusion that protrudes radially outward from the outer surface of the balloon body and extends along the long axis of the balloon body. In the radial cross-section, the protrusion provided in the straight tube portion has: a base end connected to the outer surface of the balloon body; and a front end located radially outward from the base end, which is the radially outer end of the protrusion. The balloon for the balloon catheter satisfies at least one of (1) and (2) below.

[0008] (1) In the radial section described above, the protrusion provided on the proximal sleeve portion is tilted toward the first or second direction of the circumferential direction of the balloon body, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more.

[0009] (2) In the radial section, the protrusion provided on the distal sleeve portion tilts toward the first or second direction of the circumferential direction of the balloon body, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more.

[0010] According to the aforementioned first balloon catheter balloon, the balloon's strength is increased by having a protrusion, preventing the balloon from elongating or rupturing in an undesirable direction. Furthermore, by having the protrusions located in the distal and / or proximal sleeve portions, which become the leading edge when the balloon is advanced or retracted, tilting in a first or second direction circumferentially toward the balloon body, the tilted protrusions act as a buffer, thus forming a balloon catheter balloon that allows for smooth insertion into the body cavity and improves tracking accuracy. Additionally, by having the protrusions located in the distal and / or proximal sleeve portions tilt in the first or second direction circumferentially toward the balloon body, the outer diameter of the balloon can be suppressed without reducing the size of the protrusions themselves, thereby balancing balloon strength and ease of insertion into the body cavity.

[0011] The preferred embodiment of the balloon for the first balloon catheter involved in the present invention is as follows.

[0012] [2] According to the balloon catheter described in [1], among which,

[0013] The balloon for the above-mentioned balloon catheter satisfies at least one of (3) and (4) below.

[0014] (3) In the radial cross-section described above, the protrusion of the proximal sleeve portion is tilted toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more.

[0015] The aforementioned proximal sleeve portion has an inner protrusion that protrudes radially inward from the inner surface of the aforementioned balloon body and extends along the aforementioned long axis direction.

[0016] (4) In the radial cross-section described above, the protrusion of the distal sleeve portion is tilted toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more.

[0017] The distal sleeve portion has an inner protrusion that protrudes radially inward from the inner surface of the balloon body and extends along the long axis.

[0018] [3] According to the balloon catheter described in [1], among which,

[0019] The balloon for the above-mentioned balloon catheter satisfies at least one of (5) and (6) below.

[0020] (5) In the radial cross-section described above, the protrusion of the proximal sleeve portion tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more.

[0021] In the aforementioned radial cross-section, the aforementioned protrusion of the aforementioned proximal side cone tilts toward the aforementioned first direction or the aforementioned second direction, and the angle formed by the straight line connecting the midpoint of the width direction of the aforementioned base end and the aforementioned front end with the perpendicular line of the aforementioned base end is 30° or more.

[0022] (6) In the radial cross-section described above, the protrusion of the distal sleeve portion is tilted toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more.

[0023] In the aforementioned radial cross-section, the aforementioned protrusion of the aforementioned distal side cone tilts toward the aforementioned first direction or the aforementioned second direction, and the angle formed by the straight line connecting the midpoint of the width direction of the aforementioned base end and the aforementioned front end with the perpendicular line of the aforementioned base end is 30° or more.

[0024] [4] According to the balloon catheter described in [1], among which,

[0025] The balloon for the above-mentioned balloon catheter satisfies at least one of (7) and (8) below.

[0026] (7) In the radial cross-section described above, the protrusion of the proximal sleeve portion tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more.

[0027] In the aforementioned radial cross-section, the protrusion of the proximal side cone tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line to the base end is 30° or more.

[0028] The proximal sleeve portion and the proximal cone portion have an inner protrusion that protrudes radially inward from the inner surface of the balloon body and extends along the long axis.

[0029] (8) In the radial cross-section described above, the protrusion of the distal sleeve portion is tilted toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more.

[0030] In the aforementioned radial cross-section, the aforementioned protrusion of the aforementioned distal side cone tilts toward the aforementioned first direction or the aforementioned second direction, and the angle formed by the straight line connecting the midpoint of the width direction of the aforementioned base end and the aforementioned front end with the perpendicular line of the aforementioned base end is 30° or more.

[0031] The distal sleeve portion and the distal cone portion have an inner protrusion that protrudes radially inward from the inner surface of the balloon body and extends along the long axis.

[0032] The second balloon catheter balloon according to the embodiments of the present invention that can solve the above-mentioned problems is as follows.

[0033] [5] A balloon for a balloon catheter, comprising: a straight tube portion; a proximal conical portion located closer to the position than the straight tube portion; a proximal sleeve portion located closer to the position than the proximal conical portion; a distal conical portion located distal to the position than the straight tube portion; and a distal sleeve portion located distal to the position than the distal conical portion, wherein it comprises: a balloon body having an outer surface and an inner surface; and a protrusion extending radially outward beyond the outer surface of the balloon body and extending along the long axis of the balloon body, wherein in the radial cross-section, the protrusion provided in the straight tube portion has: a base end connected to the outer surface of the balloon body; and a front end located radially outward beyond the base end, being the radially outer end of the protrusion.

[0034] The balloon for the above-mentioned balloon catheter satisfies at least one of (9) and (10) below.

[0035] (9) In the radial section described above, the protrusion of the proximal side cone tilts toward the first or second direction of the circumferential direction of the balloon body, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 30° or more.

[0036] (10) In the radial section described above, the protrusion of the distal side cone tilts toward the first or second direction of the circumferential direction of the balloon body, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 30° or more.

[0037] According to the above-described second balloon catheter, the balloon's strength is increased by having a protrusion, preventing the balloon from elongating or rupturing in an undesirable direction. Furthermore, by having the protrusion located at the distal and / or proximal cones, which become the leading edge when the balloon is advanced or retracted, tilting in a first or second direction circumferentially toward the balloon body, the tilted protrusion acts as a buffer. This results in a balloon catheter that allows for smooth insertion into the body cavity and improves tracking accuracy. Additionally, by tilting the protrusion at the distal and / or proximal cones in the first or second direction circumferentially toward the balloon body, the outer diameter of the balloon can be suppressed without reducing the size of the protrusion itself, thus balancing balloon strength and ease of insertion into the body cavity.

[0038] The preferred embodiment of the second balloon catheter balloon involved in the present invention is as follows.

[0039] [6] According to the balloon catheter described in [5], among which,

[0040] The balloon for the above-mentioned balloon catheter satisfies at least one of (11) and (12) below.

[0041] (11) In the radial cross-section described above, the protrusion of the proximal side cone tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 30° or more.

[0042] The aforementioned proximal lateral cone has an inner protrusion that protrudes radially inward from the inner surface of the balloon body and extends along the aforementioned long axis.

[0043] (12) In the radial section described above, the protrusion of the distal side cone tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 30° or more.

[0044] The distal conical portion has an inner protrusion that protrudes radially inward from the inner surface of the balloon body and extends along the long axis.

[0045] [7] A balloon catheter according to [5] or [6], wherein,

[0046] The balloon for the above-mentioned balloon catheter satisfies at least one of (13) and (14) below.

[0047] (13) In the radial cross-section described above, the protrusion of the proximal side cone tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 30° or more.

[0048] The entire region of the aforementioned protrusion along the long axis of the aforementioned proximal lateral cone tilts toward the aforementioned first direction or the aforementioned second direction.

[0049] (14) In the radial section described above, the protrusion of the distal side cone tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 30° or more.

[0050] The entire region of the aforementioned protrusion along the long axis of the aforementioned distal conical portion tilts toward the aforementioned first or second direction.

[0051] [8] A balloon catheter as described in [5] or [6], wherein,

[0052] The balloon for the above-mentioned balloon catheter satisfies at least one of (15) and (16) below.

[0053] (15) In the radial section described above, the protrusion of the proximal side cone tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 30° or more.

[0054] At least a portion of the aforementioned protrusion in the long axis direction of the aforementioned proximal lateral cone tilts toward the aforementioned first direction or second direction.

[0055] (16) In the radial section described above, the protrusion of the distal side cone tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 30° or more.

[0056] At least a portion of the aforementioned protrusion in the long axis direction of the aforementioned distal side cone tilts toward the aforementioned first direction or second direction.

[0057] According to the above-described balloon catheter, the balloon's strength is increased by having a protrusion, preventing the balloon from elongating or rupturing in an undesirable direction. Furthermore, by having the protrusion, which forms the leading part when the balloon is advanced or retracted, tilt towards the balloon body in a first or second circumferential direction, the tilted protrusion acts as a buffer. This allows for smooth insertion into the body cavity and improves tracking accuracy. Additionally, by tilting the protrusion towards the balloon body in the first or second circumferential direction, the outer diameter of the balloon can be suppressed without reducing the size of the protrusion itself, thus balancing balloon strength and ease of insertion into the body cavity. Attached Figure Description

[0058] Figure 1 This is a side view of a balloon catheter according to one embodiment of the present invention.

[0059] Figure 2 Indicates along Figure 1 A sectional view along line II-II.

[0060] Figure 3 express Figure 2 The cross-sectional view shown is of the balloon in its contracted state.

[0061] Figure 4 Indicates along Figure 1 A cross-sectional view along line IV-IV.

[0062] Figure 5 express Figure 4 The cross-sectional view shown is of the balloon in its contracted state.

[0063] Figure 6 Indicates along Figure 1 A sectional view along line VI-VI.

[0064] Figure 7 express Figure 6 A variation of the above.

[0065] Figure 8 This is a cross-sectional view of a balloon according to another embodiment of the present invention.

[0066] Figure 9This is a cross-sectional view showing a balloon according to yet another embodiment of the present invention.

[0067] Figure 10 This is a cross-sectional view showing a balloon according to yet another embodiment of the present invention.

[0068] Figure 11 This is a perspective view of the preform before expansion according to one embodiment of the present invention. Detailed Implementation

[0069] The present invention will now be specifically described based on embodiments. However, the present invention is not limited to these embodiments, and it is undoubtedly possible to implement it by appropriate modifications within the scope of the preceding / following descriptions, all of which are included within the technical scope of the present invention. Furthermore, in the various drawings, for convenience, there are instances where shaded lines, component reference numerals, etc., are omitted. In such cases, please refer to the specification and other drawings. Additionally, the dimensions of various components in the drawings are primarily advantageous for understanding the features of the present invention, and therefore may differ from the actual dimensions.

[0070] The first balloon catheter of the present invention comprises: a straight tube portion; a proximal conical portion located closer to the position than the straight tube portion; a proximal sleeve portion located closer to the position than the proximal conical portion; a distal conical portion located distal to the position than the straight tube portion; and a distal sleeve portion located distal to the position than the distal conical portion. It further comprises: a balloon body having an outer surface and an inner surface; and a protrusion extending radially outward from the outer surface of the balloon body and along the long axis of the balloon body. In a radial cross-section, the protrusion provided in the straight tube portion has: a base end connected to the outer surface of the balloon body; and a front end located radially outward from the base end and being the radially outer end of the protrusion. The balloon catheter of the present invention satisfies at least one of (1) and (2) below.

[0071] (1) In a radial section, the protrusion provided on the proximal sleeve is tilted toward the first or second direction of the circumference of the balloon body, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more.

[0072] (2) In the radial section, the protrusion provided on the distal sleeve is tilted toward the first or second direction of the circumference of the balloon body, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more.

[0073] In this way, the balloon for the first balloon catheter according to the embodiments of the present invention improves the strength of the balloon by having a protrusion, preventing the balloon from elongating or rupturing in an undesirable direction. Furthermore, by having the protrusions located in the distal sleeve portion and / or proximal sleeve portion, which become the front when the balloon is advanced or retracted, tilting in a first or second direction circumferentially toward the balloon body, the tilted protrusions act as a buffer. This allows for a balloon catheter balloon that can be smoothly inserted into the body cavity and has improved tracking ability. In addition, by having the protrusions located in the distal sleeve portion and / or proximal sleeve portion tilt in the first or second direction circumferentially toward the balloon body, the outer diameter of the balloon can be suppressed without reducing the size of the protrusions themselves, thus balancing balloon strength and ease of insertion into the body cavity.

[0074] Reference Figures 1-10 The balloon catheter according to the first embodiment of the present invention will be described. Figure 1 This is a side view of a balloon catheter according to one embodiment of the present invention. Figure 2 Indicates along Figure 1 A sectional view of line II-II, showing Figure 1 The diagram shows a cross-sectional view of the balloon in its expanded state, representing the straight section of the balloon catheter. Figure 3 express Figure 2 A cross-sectional view of the expanded portion in its contracted state. Figure 4 Indicates along Figure 1 A cross-sectional view of line IV-IV, showing Figure 1 A cross-sectional view of the distal cone of the balloon catheter in its expanded state. Figure 5 express Figure 4 A cross-sectional view of the distal lateral cone in its contracted state. Figure 6 Indicates along Figure 1 A sectional view of the VI-VI line, representing Figure 1 A cross-sectional view of the distal sleeve portion of the balloon in the balloon catheter shown. Figure 7 express Figure 6 A variation of the above. Figures 8-10 The images show cross-sectional views of balloon catheters according to various embodiments of the present invention. Figure 8 A sectional view showing the distal sleeve portion. Figure 9 and Figure 10 A cross-sectional view showing the distal lateral cone in its contracted state. Figure 9 Indicates the distal cone on the more distal side. Figure 10 A cross-sectional view showing the distal cone on the more proximal side. In this specification, the balloon catheter is sometimes referred to simply as a "balloon".

[0075] In this invention, the proximal side, relative to the extension direction of the balloon catheter 1 or the long axis direction of the axis 3, refers to the direction on the user's hand side, and the distal side refers to the opposite direction of the proximal side, i.e., the direction on the side of the treatment recipient. Preferably, the long axis direction of the balloon catheter 1 is the same as the long axis direction x of the balloon body 20. Furthermore, in this specification, it is assumed that all components except for the elongated ones have the same long axis direction x. The radial direction y of the balloon body 20 is a direction perpendicular to the long axis direction x, and is the direction connecting the center of the balloon body 20 and a point on the outer edge of the balloon body 20 in a cross-section perpendicular to the long axis direction x. The circumferential direction z of the balloon body 20 is the direction along the outer edge of the balloon body 20 in its expanded state in a cross-section of the radial direction y.

[0076] like Figure 1 As shown, the balloon catheter 1 has: a shaft 3; and a balloon 2 disposed at the distal end of the shaft 3. The balloon catheter 1 is configured to supply fluid to the interior of the balloon 2 through the shaft 3, and the expansion and contraction of the balloon 2 can be controlled using an inflator (balloon pressurizer). The fluid may also be a pressurized fluid pressurized by a pump or the like.

[0077] Preferably, shaft 3 has an internal fluid flow path and a guide wire insertion path. To form a structure in which shaft 3 has both an internal fluid flow path and a guide wire insertion path, for example, as... Figure 1 As shown, an example can be formed as follows: the balloon catheter 1 is an OTW (Over-The-Wire) type with a guidewire insertion passage extending from the distal side to the proximal side of the axis 3; the axis 3 has an outer tube 31 and an inner tube 32, the inner tube 32 functions as the guidewire insertion passage, and the space between the inner tube 32 and the outer tube 31 functions as a fluid flow path. Thus, in the case where the axis 3 has an outer tube 31 and an inner tube 32, it is preferable that the inner tube 32 extends from the distal end of the outer tube 31 and protrudes to a position distal to the balloon 2, the distal side of the balloon 2 is joined to the inner tube 32, and the proximal side of the balloon 2 is joined to the outer tube 31.

[0078] Alternatively, although not illustrated, the balloon catheter according to embodiments of the present invention may also be an RX (Rapid Exchange) type, having a guidewire port midway from the distal side of the axis to the proximal side, and a guidewire insertion passage provided from the guidewire port to the distal side of the axis. In this case, it is preferable that the balloon catheter has an outer axis and an inner axis that functions as a guidewire insertion passage, and preferably the space inside the outer axis and outside the inner axis functions as a fluid flow path. Preferably, the inner axis extends from the distal end of the outer axis, protrudes through the balloon, the distal side of the balloon is connected to the inner axis, and the proximal side of the balloon is connected to the outer axis.

[0079] like Figure 1As shown, the balloon 2 for the balloon catheter has: a straight tube portion 23; a proximal conical portion 22 located closer to the position than the straight tube portion 23; a proximal sleeve portion 21 located closer to the position than the proximal conical portion 22; a distal conical portion 24 located distal to the position than the straight tube portion 23; and a distal sleeve portion 25 located distal to the position than the distal conical portion 24. The balloon 2 for the balloon catheter also has: a balloon body 20 having an outer surface and an inner surface. The protrusion 60 protrudes outward from the outer surface of the balloon body 20 in the radial direction y and extends along the long axis direction x of the balloon body 20. In the radial y section, the protrusion 60 provided in the straight tube section 23 has: a base end 61 connected to the outer surface of the balloon body 20; and a front end 62 located outward from the base end 61 in the radial direction y, which is the outer end of the protrusion 60 in the radial direction y. The balloon 2 for the balloon catheter satisfies at least one of the following (1) and (2).

[0080] (1) In the radial y-section, the protrusion 60 provided on the proximal sleeve portion 21 tilts toward the circumferential z-direction d1 or the second direction d2 of the balloon body 20, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62 is drawn. p perpendicular line L to base 61 v The angle θ formed is 45° or more.

[0081] (2) In the radial y-section, the protrusion 60 provided on the distal sleeve portion 25 tilts toward the first direction d1 or the second direction d2 of the circumferential z of the balloon body 20, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62 is drawn. p perpendicular line L to base 61 v The angle θ formed is 45° or more.

[0082] By having a protrusion 60, the strength of the balloon 2 can be improved to prevent it from elongating or rupturing in an undesirable direction. Furthermore, when the balloon 2 is inserted into the body cavity and delivered to the lesion, the protrusion 60, located at the distal sleeve portion 25 and / or the proximal sleeve portion 21 (which becomes the front during the forward or backward movement of the balloon 2), tilts towards the balloon body 20 in the first direction d1 or the second direction d2 of the circumferential z direction. This tilted protrusion 60 acts as a buffer, thereby creating a balloon catheter balloon 2 that allows for smooth insertion into the body cavity and improved tracking. Moreover, by tilting the protrusion 60 at the distal sleeve portion 25 and / or the proximal sleeve portion 21 towards the balloon body 20 in the first direction d1 or the second direction d2 of the circumferential z direction, the outer diameter of the balloon 2 can be suppressed without reducing the size of the protrusion 60 itself, thus balancing the strength of the balloon 2 with ease of insertion into the body cavity.

[0083] like Figure 1As shown, the balloon 2 has: a straight tube portion 23; a proximal conical portion 22 located closer to the position than the straight tube portion 23; a proximal sleeve portion 21 located closer to the position than the proximal conical portion 22; a distal conical portion 24 located distal to the position than the straight tube portion 23; and a distal sleeve portion 25 located distal to the position than the distal conical portion 24. It is possible to form a structure in which at least a portion of the proximal sleeve portion 21 and the distal sleeve portion 25 are fixed to the shaft 3. When the balloon catheter 1 is an OTW type and the shaft 3 has an outer tube 31 and an inner tube 32, it is possible to form a structure in which at least a portion of the proximal sleeve portion 21 is fixed to the outer tube 31 and at least a portion of the distal sleeve portion 25 is fixed to the inner tube 32. Alternatively, when the balloon catheter 1 is of the RX (Rapid Exchange) type and the shaft 3 has an outer shaft and an inner shaft, it can be configured such that at least a portion of the proximal sleeve portion 21 is fixed to the outer shaft and at least a portion of the distal sleeve portion 25 is fixed to the inner shaft.

[0084] Preferably, the proximal conical portion 22, the straight tube portion 23, and the distal conical portion 24 are the portions that expand by supplying fluid to the interior of the balloon 2 via the shaft 3, while the proximal sleeve portion 21 and the distal sleeve portion 25 do not expand even when fluid is supplied to the interior of the balloon 2. Thus, the balloon 2 and the shaft 3 can be stably fixed even when the balloon 2 is inflated.

[0085] Preferably, the straight tube portion 23 has the same diameter along its long axis x and is cylindrical in shape. Preferably, the proximal conical portion 22 and the distal conical portion 24 are formed with a tapered diameter as they move away from the straight tube portion 23, having a conical or frustum-shaped shape. The tapered diameter of the proximal conical portion 22 and the distal conical portion 24 allows the outer diameter of the proximal and distal ends of the balloon 2 to decrease when the balloon 2 is contracted, thereby reducing the step difference between the shaft 3 and the balloon 2 and facilitating the insertion of the balloon 2 into the body cavity.

[0086] like Figure 2 As shown, balloon 2 has: a balloon body 20 having an outer surface and an inner surface; and a protrusion 60 that protrudes radially outward from the outer surface of the balloon body 20 and extends along the long axis x of the balloon body 20. If balloon 2 is delivered to the lesion, then as... Figure 2 As shown, the balloon body 20 is expanded, enabling treatment such as cutting open the stenosis of the lesion through the protrusion 60.

[0087] The protrusion 60 located in the straight tube section 23 has: a base end 61, connected to the outer surface of the balloon body 20; and a front end 62, located radially y-laterally beyond the base end 61, which is the outer end of the protrusion 60 in the radial y direction. Regardless of the shape of the cross-section of the protrusion 60 in the radial y direction, the outer end in the radial y direction can be uniquely determined, defining the front end 62 of the protrusion 60. Preferably, the balloon 2 is fixed to the lesion by the front end 62, or an incision is made in the lesion, thereby allowing the protrusion 60 to bite into the lesion up to the base end 61 side to open the lesion and dilate the stenosis. The front end 62 of the protrusion 60 can be a sharp shape with an acute angle, or it can be a curved or planar shape, but from the above viewpoint, a sharp shape is preferred for the front end 62.

[0088] Preferably, the base end 61 has a predetermined width in the circumferential z direction of the balloon body 20. The width of the base end 61 in the circumferential z direction is preferably more than 1 / 100 of the circumference of the balloon body 20, more preferably more than 1 / 80, even more preferably more than 1 / 70, and preferably less than 1 / 4, more preferably less than 1 / 8, and even more preferably less than 1 / 10.

[0089] like Figure 2 As shown, multiple protrusions 60 may be provided along the circumferential direction z, or although not shown, a single protrusion 60 may be provided along the circumferential direction z. When multiple protrusions 60 are provided along the circumferential direction z, the number of protrusions 60 in the circumferential direction z is not particularly limited; for example, preferably two or more, more preferably three or more, and possibly four or more. Furthermore, preferably ten or fewer, preferably eight or fewer, and possibly six or fewer. In this case, it is preferable that the protrusions 60 are arranged separately along the circumferential direction z, and more preferably that they are arranged at equal intervals along the circumferential direction z. This facilitates the fixation of the balloon 2 and the cutting of the stenotic portion.

[0090] The protrusion 60 can be continuously provided from the proximal end to the distal end of the balloon body 20, or it can be provided intermittently, or it can be provided on the outer surface of the balloon body 20 in any pattern such as lines, dots, or mesh. Furthermore, the protrusion 60 can be configured parallel to the long axis direction x of the balloon body 20, or it can be configured in a spiral shape that surrounds the outer surface of the balloon body 20 in the circumferential direction z. If the protrusion 60 is configured parallel to the long axis direction x, the narrow portion can be cut straight through the protrusion 60. If the protrusion 60 is configured in a spiral shape, the narrow portion can be cut obliquely through the protrusion 60.

[0091] The shape of the cross-section of the protrusion 60 perpendicular to the major axis direction x can be any shape, and can be... Figure 2The approximate triangle shown can also be, for example, a triangle, quadrilateral, polygon, semicircle, part of a circle, approximately circular, sector, wedge, convex, spindle, and combinations thereof. Furthermore, triangles, quadrilaterals, and polygons, besides shapes with clearly defined vertices and straight sides, also include so-called rounded polygons with rounded corners and shapes where at least a portion of the sides is curved. Alternatively, the cross-sectional shape of the protrusion 60 can be an amorphous shape with concavity, convexity, notches, etc. Even in such cases, the outer end of the radial direction y of the protrusion 60 can be uniquely determined, defining the front end 62 of the protrusion 60.

[0092] Preferably, the protrusion 60 located on the straight tube portion 23 does not tilt in either the first direction d1 or the second direction d2 of the circumferential z. This allows for efficient fixation of the balloon 2 to the lesion and incision of the stenosis using the protrusion 60. When the protrusion 60 does not tilt in either the first direction d1 or the second direction d2 of the circumferential z, it is preferable to use the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62. p perpendicular line L to base 61 v Consistent, the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62 p perpendicular line L to base 61 v The angle formed is 0°. It is also permissible for the absolute value of this angle to be less than 3°, less than 5°, or less than 10°. In this case, the aforementioned straight line L... p perpendicular line L to base 61 v The angle formed is based on the midpoint of the width direction of the base end 61, and the straight line L p perpendicular line L relative to base 61 v The angle formed by the direction in which the protrusion tilts at 60 degrees. Here, the perpendicular line L... v Let be the perpendicular line of the line segment connecting one end of the base end 61 in the circumferential z direction to the other end in the radial y section.

[0093] The maximum height of the protrusion 60 at the straight tube 23 is preferably more than 1 times the membrane thickness of the balloon body 20, more preferably more than 1.5 times, and even more preferably more than 2 times. It is also permissible to have a height of less than 50 times, less than 30 times, or less than 10 times. By limiting the height of the protrusion 60 to the above range, it becomes easier to cut through the narrow portion, and it is also easier to prevent the balloon 2 from elongating in the long axis direction x, thus improving the pushing ability of the balloon 2. The height of the protrusion 60 can be obtained by subtracting the length from the centroid of the balloon body 20 to the point where this line segment intersects the outer edge of the balloon body 20 in a radial y-section from the length of the line segment connecting the centroid of the balloon body 20 and the front end 62.

[0094] like Figure 3As shown, in the contracted state of balloon 2, the balloon body 20 at the straight tube 23 preferably forms a blade 29, which is folded. At this time, a protrusion 60 is preferably formed on the portion other than the blade 29, and the blade 29 is folded to cover the protrusion 60. In the contracted state, balloon 2 is delivered to the lesion within the body cavity, but because the protrusion 60 is covered by the blade 29, unnecessary scratching of the body cavity wall or damage to the protrusion 60 during delivery can be prevented. In the contracted state, it is also preferable that the protrusion 60 located in the straight tube 23 does not tilt in either the first direction d1 or the second direction d2 of the circumferential z. Thus, the protrusion 60 can be kept from tilting when balloon 2 is inflated.

[0095] The number of blades 29 in the contracted state of the balloon 2 is not particularly limited. For example, it is preferable to have 2 or more blades, more preferably 3 or more blades, and possibly 4 or more blades. In addition, it is preferable to have 10 or fewer blades, more preferably 8 or fewer blades, and even more preferably 6 or fewer blades. If the number of blades 29 is within the above range, the balloon 2 can be easily contracted.

[0096] like Figure 4 As shown, the protrusion 60 located on the distal cone 24 may not tilt in either the first direction d1 or the second direction d2 of the circumferential z. Although not shown, the proximal cone 22, similarly to the distal cone 24, also has a protrusion 60 that does not tilt in either the first direction d1 or the second direction d2 of the circumferential z. By ensuring that the protrusion 60 of the cone does not tilt when the balloon 2 is inflated, the protrusion 60 located on the cone can be used to fix the balloon 2 to the lesion or to incise the stenosis. Figure 5 In the contracted state of the balloon 2 as shown, the cone portion can be easily folded so that its outer diameter is smaller than that of the straight tube portion 23. Therefore, even if the protrusion 60 does not tilt, the balloon 2 can be delivered to the lesion without significantly impairing its patency.

[0097] The balloon 2 satisfies at least one of (1) and (2) below.

[0098] (1) In the radial y-section, the protrusion 60 provided on the proximal sleeve portion 21 tilts toward the circumferential z-direction d1 or the second direction d2 of the balloon body 20, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62 is drawn. p perpendicular line L to base 61 v The angle θ formed is 45° or more.

[0099] (2) In the radial y-section, the protrusion 60 provided on the distal sleeve portion 25 tilts toward the first direction d1 or the second direction d2 of the circumferential z of the balloon body 20, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62 is drawn. pperpendicular line L to base 61 v The angle θ formed is 45° or more.

[0100] Here, the perpendicular line L v Let be the perpendicular line of the line segment connecting one end of the base end 61 in the circumferential z direction in the radial y section.

[0101] Figure 6 A cross-sectional view of the distal sleeve portion 25 is shown, but the proximal sleeve portion 21 can also be described in the same way, therefore, refer to... Figure 6 Please provide an explanation. For example... Figure 6 As shown, the protrusions 60 provided on the proximal sleeve portion 21 and / or the distal sleeve portion 25 tilt in the first direction d1 or the second direction d2 of the circumferential direction z, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62... p perpendicular line L to base 61 v The angle θ is 45° or more. With this structure, when the balloon 2 is delivered to the lesion within the body cavity, the tilted protrusion 60 acts as a buffer between the balloon body 20 and the body cavity wall, thereby enabling the balloon 2 to be smoothly inserted into the body cavity and improving tracking. Furthermore, only the protrusion 60 tilts circumferentially (z), without the protrusion 60 itself being reduced in size. Therefore, the outer diameter of the balloon 2 is suppressed to prevent elongation based on the protrusion 60 and to improve pushing ability, making insertion of the balloon 2 easier. The angle θ is preferably 50° or more, more preferably 60° or more, and even more preferably 65° or more. The base 61 is connected to the outer surface of the balloon body 20, and the front end 62 can only tilt to contact the outer surface of the balloon body 20. Therefore, the upper limit of the angle θ is naturally limited; for example, the angle θ can be less than 100°, less than 95°, or less than 90°. In this case, the straight line L... p perpendicular line L to base 61 v The angle θ formed is the line L starting from the midpoint of the width direction of the base end 61. p perpendicular line L relative to base 61 v The angle formed by the direction in which the protrusion tilts at 60 degrees.

[0102] Here, if the protrusion 60 tilts in the first direction d1 or the second direction d2 of the circumferential direction z, the outer end of the radial direction y of the protrusion 60 in this state is different from the outer end of the protrusion 60 when it is not tilted. However, in this specification, the front end 62 of the protrusion 60 when it is tilted refers to the same part as the front end 62 of the protrusion 60 when it is not tilted.

[0103] Preferably, on both the proximal sleeve portion 21 and the distal sleeve portion 25, the protrusions 60 tilt in either a first direction d1 or a second direction d2 in the circumferential direction z. Thus, the protrusions 60 on both the distal sleeve portion 25 and the proximal sleeve portion 21, which become the front when the balloon 2 advances and retracts within the body cavity, act as a buffer, enabling the balloon 2 to be smoothly inserted into the body cavity and with improved tracking in both advancing and retracting situations.

[0104] Alternatively, the protrusion 60 may tilt only in the distal sleeve portion 25 in the first direction d1 or the second direction d2 of the circumferential z, while the protrusion 60 does not tilt in the proximal sleeve portion 21. Thus, the protrusion 60, which forms the front of the balloon 2 as it advances within the body cavity, acts as a buffer, facilitating the advancement of the balloon 2. In this case, the protrusion 60 located in the proximal sleeve portion 21 can support the proximal portion of the balloon 2 relative to the body cavity wall during delivery, thereby improving the tracking performance of the balloon 2.

[0105] Alternatively, the protrusion 60 may tilt in either the first direction d1 or the second direction d2 of the circumferential z only in the proximal sleeve portion 21, while the protrusion 60 remains tilted in the distal sleeve portion 25. This allows for treatment involving simultaneous cutting of the body cavity wall and crawling advance using the protrusion 60 positioned on the anterior side of the balloon 2, i.e., the distal sleeve portion 25. Furthermore, when the balloon 2 retracts, the cushioning effect of the tilted protrusion 60 positioned in the proximal sleeve portion 21 facilitates easy retraction.

[0106] like Figure 7 As shown, when multiple protrusions 60 are provided along the circumferential direction z, one protrusion 60 may tilt in the first direction d1 of the circumferential direction z, while the other protrusions 60 tilt in the second direction d2 of the circumferential direction z.

[0107] like Figure 6 As shown, it is preferable that a space is formed between the front end 62 of the tilted protrusion 60 and the outer surface of the balloon body 20, and preferably the distance h from the outer surface of the balloon body 20 to the front end 62, which can serve as an indicator of the size of this space, is a predetermined value or more. The distance h can be defined as the distance between a tangent to the outer surface of the balloon body 20 perpendicular to the line segment connecting the centroid O of the balloon body 20 and the front end 62, and a straight line parallel to the tangent and passing through the front end 62. The distance h is preferably 1 / 5 or more of the membrane thickness of the balloon body 20, more preferably 1 / 4 or more, and even more than 1 / 2. It is also permissible to be less than 10 times, less than 5 times, or less than 3 times. If the distance h is within the above range, the size of the space formed between the front end 62 of the tilted protrusion 60 and the outer surface of the balloon body 20 can be a predetermined value or more, and the tracking performance of the balloon 2 can be improved by the buffering effect of the tilted protrusion 60.

[0108] In either case, the protrusion 60 disposed on the sleeve portion can tilt either over the entire range of the long axis direction x or over a portion of the long axis direction x. The range in which the protrusion 60 tilts can be determined according to the desired degree of cushioning.

[0109] The preferred balloon 2 satisfies at least one of (3) and (4) below.

[0110] (3) In the radial y-section, the protrusion 60 of the proximal sleeve portion 21 tilts toward the first direction d1 or the second direction d2, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62 p perpendicular line L to base 61 v The angle formed is 45° or more.

[0111] The proximal sleeve portion 21 has an inner protrusion 70 that protrudes radially inward from the inner surface of the balloon body 20 and extends along the long axis direction x.

[0112] (4) In the radial y-section, the protrusion 60 of the distal sleeve portion 25 tilts toward the first direction d1 or the second direction d2, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62 p perpendicular line L to base 61 v The angle formed is 45° or more.

[0113] The distal sleeve portion 25 has an inner protrusion 70 that protrudes radially inward from the inner surface of the balloon body 20 and extends along the long axis direction x.

[0114] like Figure 8 As shown, the proximal sleeve portion 21 and / or the distal sleeve portion 25 preferably have an inner protrusion 70 at the portion where the protrusion 60 is tilted. This inner protrusion 70 protrudes radially inward from the inner surface of the balloon 20 and extends along the long axis direction x. Therefore, even at the tilted portion of the protrusion 60, the strength of the proximal and / or distal ends of the balloon 2 can be improved by the inner protrusion 70. Preferably, the inner protrusion 70 is positioned at the same location as the protrusion 60 in the circumferential direction z. This further enhances the strength of the proximal and / or distal ends of the balloon 2.

[0115] The preferred balloon 2 satisfies at least one of (5) and (6) below.

[0116] (5) In the radial y-section, the protrusion 60 of the proximal sleeve portion 21 tilts toward the first direction d1 or the second direction d2, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62 p perpendicular line L to base 61v The angle θ formed is greater than 45°.

[0117] In the radial y-section, the protrusion 60 of the proximal side cone 22 tilts towards the first direction d1 or the second direction d2, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62... p perpendicular line L to base 61 v The angle formed is 30° or more.

[0118] (6) In the radial y-section, the protrusion 60 of the distal sleeve portion 25 tilts toward the first direction d1 or the second direction d2, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62 p perpendicular line L to base 61 v The angle θ formed is greater than 45°.

[0119] In the radial y-section, the protrusion 60 of the distal side cone 24 tilts towards the first direction d1 or the second direction d2, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62... p perpendicular line L to base 61 v The angle formed is 30° or more.

[0120] like Figure 9 and Figure 10 As shown, in the cone, the protrusion 60 can also tilt in the first direction d1 or the second direction d2. Figure 9 A cross-sectional view showing the distal cone 24 on the more distal side in the contracted state. Figure 10 This is a cross-sectional view showing the distal cone 24 on the proximal side in the contracted state. Preferably, on the distal side, i.e., the end side of the balloon 2, in the shorter portion of the blade 29 in the contracted state away from the straight tube 23, the protrusion 60 tilts deeply, while on the proximal side, i.e., the longer portion of the blade 29 in the contracted state on the straight tube 23 side of the balloon 2, the protrusion 60 tilts shallowly. Thus, the closer to the straight tube 23, the shallower the tilt of the protrusion 60, making it easier to fix the balloon 2 to the lesion or cut open the stenosis when it is delivered to the lesion via the protrusion 60 located on the distal cone 24. The same applies to the proximal cone 22. That is, it is also preferable that the protrusion 60 tilts deeply on the proximal side of the proximal cone 22, that is, in the shorter portion of the blade 29 in the contracted state, away from the straight tube 23 at the end of the balloon 2, and that the protrusion 60 tilts shallowly on the more distal side, that is, in the longer portion of the blade 29 in the contracted state, on the side of the straight tube 23 of the balloon 2. A deeper tilt of the protrusion 60 means a shorter distance h, and a shallower tilt of the protrusion 60 means a longer distance h. The amount of cushioning provided by tilting the protrusion 60 can be controlled by determining how the distance h is determined.

[0121] Alternatively, the protrusion 60 at the tapered portion may also tilt to the same degree in the long axis direction x. Furthermore, the protrusion 60 may have both tilted and undiluted portions in the long axis direction x.

[0122] By tilting the protrusion 60 at the cone, the protrusion 60 at the cone can also function as a buffer, thereby improving the tracking performance of the balloon 2. The effect of whether the protrusion 60 located in either the proximal cone 22 or the distal cone 24 tilts can be compared with the effect of whether the protrusion 60 located in either the proximal sleeve 21 or the distal sleeve 25 tilts.

[0123] The angle θ of the protrusion 60 at the cone is preferably 30° or more, more preferably 45° or more, and even more preferably 50° or more. In addition, it can be 95° or less, 90° or less, or 80° or less, for example.

[0124] The preferred balloon 2 satisfies at least one of (7) and (8).

[0125] (7) In the radial y-section, the protrusion 60 of the proximal sleeve portion 21 tilts toward the first direction d1 or the second direction d2, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62 p perpendicular line L to base 61 v The angle formed is 45° or more.

[0126] In the radial y-section, the protrusion 60 of the proximal side cone 22 tilts towards the first direction d1 or the second direction d2, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62... p perpendicular line L to base 61 v The angle formed is 30° or more.

[0127] The proximal sleeve portion 21 and the proximal cone portion 22 have an inner protrusion 70 that protrudes radially inward from the inner surface of the balloon body 20 and extends along the long axis direction x.

[0128] (8) In the radial y-section, the protrusion 60 of the distal sleeve portion 25 tilts toward the first direction d1 or the second direction d2, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62 p perpendicular line L to base 61 v The angle formed is 45° or more.

[0129] In the radial y-section, the protrusion 60 of the distal side cone 24 tilts towards the first direction d1 or the second direction d2, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62... pperpendicular line L to base 61 v The angle formed is 30° or more.

[0130] The distal sleeve portion 25 and the distal cone portion 24 have an inner protrusion 70 that protrudes radially inward from the inner surface of the balloon body 20 and extends along the long axis direction x.

[0131] Preferably, the portion of the protrusion 60 disposed in the cone and sleeve portions that is tilted has an inner protrusion 70. This inner protrusion 70 protrudes radially inward from the inner surface of the balloon 20 and extends along the long axis direction x. Therefore, even in the tilted portion of the protrusion 60, the strength of the proximal and / or distal ends of the balloon 2 can be improved by the inner protrusion 70. Preferably, the inner protrusion 70 is disposed at the same position as the protrusion 60 in the circumferential direction z. This further improves the strength of the proximal and / or distal ends of the balloon 2. Although the inner protrusion disposed in the cone portion is not shown, it can be referred to... Figure 8 The inner protrusion 70.

[0132] Next, the balloon for the second balloon catheter according to an embodiment of the present invention will be described. Since the components are the same as those of the balloon 2 for the first balloon catheter, the same reference numerals are used, and will be referred to accordingly. Figure 9 and Figure 10 The following explanation will be provided. Additionally, any explanations that overlap with those concerning the balloon 2 for the first balloon catheter will be omitted and can be found in the above explanation of the balloon 2 for the first balloon catheter.

[0133] like Figure 9 and Figure 10 As shown, the second balloon catheter balloon is a type of balloon catheter balloon, having: a straight tube portion 23; a proximal cone portion 22 located closer to the position than the straight tube portion 23; a proximal sleeve portion 21 located closer to the position than the proximal cone portion 22; a distal cone portion 24 located distal to the position than the straight tube portion 23; and a distal sleeve portion 25 located distal to the position than the distal cone portion 24. The second balloon catheter balloon also has: a balloon body 20 having an outer surface... and inner surface; and protrusion 60, which protrudes outward from the outer surface of the balloon body 20 in the radial y direction and extends along the long axis direction x of the balloon body 20. In the radial y section, the protrusion 60 provided in the straight tube section 23 has: a base end 61, which is connected to the outer surface of the balloon body 20; and a front end 62, which is located on the radial y side of the base end 61 and is the radial y outer end of the protrusion 60. The balloon for the second balloon catheter satisfies at least one of (9) and (10) below.

[0134] (9) In the radial y-section, the protrusion 60 of the proximal side cone 22 tilts toward the first direction d1 or the second direction d2 of the circumferential z of the balloon body 20, and the straight line L connecting the midpoint of the width direction of the base end 61 and the front end 62 p perpendicular line L to base 61 v The angle formed is 30° or more.

[0135] (10) In the radial y-section, the protrusion 60 of the distal cone 24 tilts toward the first direction d1 or the second direction d2 of the circumferential z of the balloon body 20, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62 p perpendicular line L to base 61 v The angle formed is 30° or more.

[0136] According to the above-described second balloon catheter, the balloon's strength is enhanced by the protrusion 60, preventing the balloon from elongating or rupturing in an undesirable direction. Furthermore, by having the protrusion 60 located at the distal cone 24 and / or proximal cone 22, which becomes the proximal portion when the balloon is advanced or retracted, tilting towards the balloon body 20 in the first direction d1 or the second direction d2 of the circumferential z direction, the tilted protrusion 60 acts as a buffer. This allows for smooth insertion into the body cavity and improved tracking of the balloon catheter. Additionally, by tilting the protrusion 60 located at the distal cone 24 and / or proximal cone 22 towards the balloon body 20 in the first direction d1 or the second direction d2 of the circumferential z direction, the outer diameter of the balloon can be suppressed without reducing the size of the protrusion 60 itself, thus balancing balloon strength and ease of insertion into the body cavity.

[0137] The angle θ of the protrusion 60 at the cone is 30° or more, more preferably 45° or more, and even more preferably 50° or more. In addition, for example, it can be 95° or less, 90° or less, or 80° or less.

[0138] Preferably, the second balloon catheter balloon involved in the embodiments of the present invention satisfies at least one of (11) and (12) below.

[0139] (11) In the radial y-section, the protrusion 60 of the proximal side cone 22 tilts toward the first direction d1 or the second direction d2, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62 p perpendicular line L to base 61 v The angle formed is 30° or more.

[0140] The proximal conical portion 22 has an inner protrusion 70 that protrudes radially inward from the inner surface of the balloon body 20 and extends along the long axis direction x.

[0141] (12) In the radial y-section, the protrusion 60 of the distal side cone 24 tilts toward either the first direction d1 or the second direction d2, and the straight line L connecting the midpoint of the base end 61 in the width direction and the front end 62 p perpendicular line L to base 61 v The angle formed is 30° or more.

[0142] The distal cone 24 has an inner protrusion 70 that protrudes radially inward from the inner surface of the balloon body 20 and extends along the long axis direction x.

[0143] Regarding the inner protrusion 70 of the cone portion, please refer to the above description regarding the inner protrusion 70 of the sleeve portion.

[0144] Figure 9 A cross-sectional view showing the distal cone 24 on the more distal side in the contracted state. Figure 10 This diagram shows a cross-sectional view of the distal cone 24 on the proximal side in the contracted state. However, it is preferable that the protrusion 60 tilts deeply in the shorter portion of the blade 29 in the contracted state, away from the straight tube 23 on the distal side (i.e., the end side of the balloon 2), and shallowly in the longer portion of the blade 29 in the contracted state on the proximal side (i.e., the side of the straight tube 23 of the balloon 2). Thus, the closer to the straight tube 23, the shallower the tilt of the protrusion 60, making it easier to fix the balloon 2 to the lesion or cut open the stenosis when it is delivered to the lesion. The same applies to the proximal cone 22. That is, it is also preferable that the protrusion 60 tilts deeply on the proximal side of the proximal cone 22, that is, in the shorter portion of the blade 29 in the contracted state, away from the straight tube 23 at the end of the balloon 2, and that the protrusion 60 tilts shallowly on the more distal side, that is, in the longer portion of the blade 29 in the contracted state, on the side of the straight tube 23 of the balloon 2. A deeper tilt of the protrusion 60 means a shorter distance h, and a shallower tilt of the protrusion 60 means a longer distance h. The amount of cushioning provided by tilting the protrusion 60 can be controlled by determining how the distance h is determined.

[0145] Alternatively, the protrusion 60 at the cone may also tilt to the same degree in the long axis direction x. Additionally, the protrusion 60 may have a tilted portion and an untilted portion in the long axis direction x. That is, in the second balloon catheter balloon according to the embodiments of the present invention, in the proximal cone 22 and / or the distal cone 24, the protrusion 60 may tilt in the entire region in the long axis direction x towards the first direction d1 or the second direction d2, or at least a portion of the protrusion 60 may tilt in the long axis direction x towards the first direction d1 or the second direction d2.

[0146] Materials constituting the balloon body 20 include, for example, polyolefin resins such as polyethylene, polypropylene, and ethylene-propylene copolymer; polyester resins such as polyethylene terephthalate and polyester elastomers; polyurethane resins such as polyurethane and polyurethane elastomers; polyphenylene sulfide resins; polyamide resins such as polyamide elastomers; fluorinated resins; silicone resins; and natural rubber such as latex rubber. Only one type of these can be used, or two or more types can be used in combination. Polyamide resins, polyester resins, and polyurethane resins are particularly suitable. Especially considering the thin-film properties and flexibility of the balloon body 20, elastomer resins are preferred. For example, among polyamide resins, nylon 12 and nylon 11 are suitable as resins constituting the balloon body 20; nylon 12 is more suitable because it is easier to form during blow molding. Furthermore, considering the thin-film properties and flexibility of the balloon body 20, polyamide elastomers such as polyether ester amide elastomers and polyamide ether elastomers are preferred. Among these considerations, considering the high yield strength and good dimensional stability of the balloon body 20, polyether ester amide elastomer is preferred.

[0147] Preferably, the protrusion 60 and the inner protrusion 70 are made of the same material as the balloon body 20. If the protrusion 60 and the inner protrusion 70 are made of the same material as the balloon body 20, the flexibility of the balloon 2 can be maintained, and the protrusion 60 and the inner protrusion 70 are less likely to damage the outer surface of the balloon body 20. Preferably, the balloon body 20 is integrally formed with the protrusion 60 and the inner protrusion 70. This prevents the protrusion 60 and the inner protrusion 70 from detaching from the balloon body 20. Alternatively, the materials forming the protrusion 60 and the inner protrusion 70 may be different from the materials forming the balloon body 20, provided they have some degree of compatibility with the material forming the balloon body 20.

[0148] balloon 2, for example, by... Figure 11 A cylindrical preform 200 made of resin, as shown, is disposed in a mold with a grooved inner cavity and formed by biaxial stretching blow molding. The protrusion 60 can be formed, for example, by inserting the preform 200 into the inner cavity of the mold, causing the thick-walled portion 220 of the preform to enter the groove of the mold, and introducing fluid into the inner cavity 210 of the preform 200 to cause the preform 200 to expand. Alternatively, when forming the inner protrusion 70, for example, the thick-walled portion 220 of the preform 200 is pressed against a grooveless portion of the mold, and fluid is introduced into the inner cavity 210 of the preform 200 to cause the preform 200 to expand, thereby forming the inner protrusion 70. The materials constituting the preform 200 can be found in the description of the materials constituting the aforementioned balloon body 20.

[0149] Preferably, the shaft 3 is made of resin, metal, or a combination of resin and metal. By using resin as the constituent material of the shaft 3, flexibility and elasticity can be easily imparted to the shaft 3. Furthermore, by using metal as the constituent material of the shaft 3, the delivery capability of the balloon catheter 1 can be improved. Examples of resins constituting the shaft 3 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorinated resins, vinyl chloride resins, silicone resins, and natural rubber. Only one type can be used, or two or more types can be used in combination. Preferably, the material constituting the shaft 3 is at least one of polyamide resins, polyolefin resins, and fluorinated resins, thereby improving the surface slippage of the shaft 3 and enhancing the insertion success of the balloon catheter 1 within the body cavity. Examples of metals constituting the shaft 3 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloys, Co-Cr alloys, or combinations thereof.

[0150] For shaft 3, it can extend from the distal side to the proximal side, or it can be a shaft 3 consisting of a distal shaft and a proximal shaft, which are connected by the proximal end of the distal shaft to the distal end of the proximal shaft. The distal shaft and the proximal shaft can also be composed of multiple tubular components. When shaft 3 is composed of a distal shaft and a proximal shaft, for example, both the distal shaft and the proximal shaft can be made of resin, or the distal shaft can be made of resin and the proximal shaft can be made of metal. Additionally, shaft 3 can also have a laminated structure made of different materials or the same material.

[0151] For the joining of balloon 2 and shaft 3, methods such as bonding with adhesive, fusion bonding, and installing an annular component at the overlapping portion of balloon 2 and shaft 3 and then suturing can be used. Among these methods, it is preferable that balloon 2 and shaft 3 are joined by fusion bonding. Because balloon 2 and shaft 3 are fused together, even if balloon 2 is repeatedly expanded and contracted, the joining of balloon 2 and shaft 3 is not easily dislodged, and the joining strength of balloon 2 and shaft 3 can be easily improved.

[0152] Although not shown in the figure, it is preferable to provide a front end component at the distal end of the balloon catheter 1. The front end component can be provided at the distal end of the balloon catheter 1 by being connected to the distal end of the balloon 2 as a component separate from the inner tube 32 or the inner shaft, or it can function as a front end component extending to the inner tube 32 or the inner shaft further distal to the distal end of the balloon 2.

[0153] X-ray-blocking marks may be provided on the inner tube 32 or inner axis inside the balloon 2, along the long axis x, at the portion where the balloon 2 is located, so that the position of the balloon 2 can be confirmed under X-ray fluoroscopy. Preferably, the X-ray-blocking marks are positioned at the two ends corresponding to the straight tube 23 of the balloon 2, or they may be positioned at the center corresponding to the long axis x of the straight tube 23.

[0154] like Figure 1 As shown, a hub 4 may also be provided on the proximal side of the axis 3, and a fluid injection section 7 communicating with the flow path of fluid supplied to the interior of the balloon 2 may also be provided on the hub 4. Furthermore, it is preferable that the hub 4 has a guidewire insertion section 5 communicating with the guidewire insertion path. By having a hub 4 with the fluid injection section 7 and the guidewire insertion section 5 in the balloon catheter 1, it is possible to easily perform operations such as supplying fluid to the interior of the balloon 2 to inflate and deflate the balloon 2, and to deliver the balloon catheter 1 to the treatment site along the guidewire. The balloon 2 according to the embodiments of the present invention can be applied not only to so-called OTW (Over-The-Wire) type balloon catheters in which a guidewire is inserted from the distal side to the proximal side of the axis, but also to so-called RX (Rapid Exchange) type balloon catheters in which a guidewire is inserted from the distal side of the axis to the midway point of reaching the proximal side. In the case of the RX (Rapid Exchange) type, the guidewire insertion part is located midway from the distal side of the shaft to the proximal side, so the pivot 4 may not have a bifurcated structure.

[0155] For the connection between the shaft 3 and the pivot 4, examples include bonding with an adhesive or fusion bonding. Preferably, the shaft 3 and the pivot 4 are joined by adhesive bonding. By bonding the shaft 3 and the pivot 4, for example, when the materials constituting the shaft 3 and the pivot 4 are different (e.g., the shaft 3 is made of a highly flexible material while the pivot 4 is made of a highly rigid material), the joint strength between the shaft 3 and the pivot 4 can be increased, thereby improving the durability of the balloon catheter 1.

[0156] When the balloon catheter 1 is an OTW (Over-The-Wire) type, it is preferable to apply an appropriate coating to the outer wall of the lateral axis 31. When it is an RX (Rapid Exchange) type, it is preferable to apply an appropriate coating to the outer wall of the distal lateral axis and / or the proximal lateral axis, and more preferably to apply a coating to both the distal and proximal lateral axes.

[0157] Depending on the purpose, the coating can be a hydrophilic coating or a hydrophobic coating, and can be carried out by immersing the shaft 3 in a hydrophilic or hydrophobic coating agent, applying a hydrophilic or hydrophobic coating agent to the outer wall of the shaft 3, or covering the outer wall of the shaft 3 with a hydrophilic or hydrophobic coating agent. The coating agent may also contain pharmaceuticals or additives.

[0158] Examples of hydrophilic coating agents include hydrophilic polymers such as polyvinyl alcohol, polyethylene glycol, polyacrylamide, polyvinylpyrrolidone, and methyl vinyl ether maleic anhydride copolymer, or hydrophilic coating agents made from any combination thereof.

[0159] Examples of hydrophobic coating agents include polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), silicone oil, hydrophobic polyurethane resin, carbon coating, diamond coating, diamond-like carbon (DLC) coating, ceramic coating, and substances with low surface free energy terminated by alkyl or perfluoroalkyl groups.

[0160] This application claims the benefit of priority based on Japanese Patent Application No. 2021-182149, filed November 8, 2021, and Japanese Patent Application No. 2022-104809, filed June 29, 2022. The entire contents of the descriptions of Japanese Patent Application No. 2021-182149, filed November 8, 2021, and Japanese Patent Application No. 2022-104809, filed June 29, 2022, are incorporated herein by reference.

[0161] Explanation of reference numerals in the attached figures

[0162] 1…Balloon catheter; 2…Balloon; 3…Axis; 4…Pivot; 5…Guidewire insertion section; 7…Fluid injection section; 20…Balloon body; 21…Proximal sleeve section; 22…Proximal cone section; 23…Straight tube section; 24…Distal cone section; 25…Distal sleeve section; 29…Blade; 31…Outer tube; 32…Inner tube; 60…Protrusion; 61…Base; 62…Anterior end; 70…Inner protrusion; 200…Preform; 210…Inner cavity of the preform; 220…Thick-walled portion of the preform; x…Long axis direction of the balloon body; y…Radial direction of the balloon body; z…Circumferential direction of the balloon body; d1…First direction; d2…Second direction; L v …the perpendicular line from the base; L p θ: The straight line connecting the midpoint of the base in the width direction to the front end; v With L p The angle formed; h: the distance from the outer surface of the balloon body to the front end in the space between the outer surface of the balloon body and the front end.

Claims

1. A balloon catheter, comprising: a straight tube portion; a proximal conical portion located closer to the position than the straight tube portion; a proximal sleeve portion located closer to the position than the proximal conical portion; a distal conical portion located distal to the position than the straight tube portion; and a distal sleeve portion located distal to the position than the distal conical portion, characterized in that... It comprises: a balloon body having an outer surface and an inner surface; and a protrusion that protrudes radially outward from the outer surface of the balloon body and extends along the long axis of the balloon body. In the radial cross-section, the protrusion disposed on the straight tube portion has: a base end, connected to the outer surface of the balloon body; and a front end, located radially outer than the base end, which is the radially outer end of the protrusion. In the radial cross-section, for the protrusion provided in the straight tube section, the angle formed by the straight line connecting the midpoint of the base end in the width direction and the front end with the perpendicular line to the base end is 10° or less. The balloon for the balloon catheter satisfies at least one of the following (1) and (2): (1) In the radial cross-section, the protrusion provided on the proximal sleeve portion is tilted toward the balloon body in a first or second circumferential direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more. (2) In the radial section, the protrusion provided on the distal sleeve portion tilts toward the first or second direction of the circumferential direction of the balloon body, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more.

2. The balloon for balloon catheters according to claim 1, characterized in that, The balloon for the balloon catheter satisfies at least one of the following (3) and (4): (3) In the radial cross-section, the protrusion of the proximal sleeve portion is tilted toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more. The proximal sleeve portion has an inner protrusion that protrudes radially inward beyond the inner surface of the balloon body and extends along the long axis. (4) In the radial cross-section, the protrusion of the distal sleeve portion is tilted toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more. The distal sleeve portion has an inner protrusion that protrudes radially inward beyond the inner surface of the balloon body and extends along the long axis.

3. The balloon for balloon catheters according to claim 1, characterized in that, The balloon for the balloon catheter satisfies at least one of the following (5) and (6): (5) In the radial cross-section, the protrusion of the proximal sleeve portion is tilted toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more. In the radial cross-section, the protrusion of the proximal side cone tilts towards the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line to the base end is 30° or more. (6) In the radial cross-section, the protrusion of the distal sleeve portion is tilted toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more. In the radial cross-section, the protrusion of the distal side cone tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 30° or more.

4. The balloon catheter according to claim 1, characterized in that, The balloon catheter balloon satisfies at least one of the following (7) and (8): (7) In the radial cross-section, the protrusion of the proximal sleeve portion is tilted toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more. In the radial cross-section, the protrusion of the proximal side cone tilts towards the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line to the base end is 30° or more. The proximal sleeve portion and the proximal cone portion have an inner protrusion that protrudes radially inward beyond the inner surface of the balloon body and extends along the long axis. (8) In the radial cross-section, the protrusion of the distal sleeve portion is tilted toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 45° or more. In the radial cross-section, the protrusion of the distal conical portion tilts towards the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line to the base end is 30° or more. The distal sleeve portion and the distal cone portion have an inner protrusion that protrudes radially inward from the inner surface of the balloon body and extends along the long axis.

5. A balloon catheter, comprising: a straight tube portion; a proximal conical portion located closer to the position than the straight tube portion; a proximal sleeve portion located closer to the position than the proximal conical portion; a distal conical portion located distal to the position than the straight tube portion; and a distal sleeve portion located distal to the position than the distal conical portion, characterized in that... It comprises: a balloon body having an outer surface and an inner surface; and a protrusion that protrudes radially outward from the outer surface of the balloon body and extends along the long axis of the balloon body. In the radial cross-section, the protrusion disposed on the straight tube portion has: a base end, connected to the outer surface of the balloon body; and a front end, located radially outer than the base end, which is the radially outer end of the protrusion. In the radial cross-section, for the protrusion provided in the straight tube section, the angle formed by the straight line connecting the midpoint of the base end in the width direction and the front end with the perpendicular line to the base end is 10° or less. The balloon for the balloon catheter satisfies at least one of the following (9) and (10): (9) In the radial section, the protrusion of the proximal lateral cone tilts toward the circumferential first or second direction of the balloon body, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 30° or more. (10) In the radial section, the protrusion of the distal side cone tilts toward the first or second direction of the circumferential direction of the balloon body, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 30° or more.

6. The balloon for balloon catheters according to claim 5, characterized in that, The balloon catheter balloon satisfies at least one of the following (11) and (12): (11) In the radial cross-section, the protrusion of the proximal side cone tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 30° or more. The proximal lateral cone has an inner protrusion that protrudes radially inward beyond the inner surface of the balloon body and extends along the long axis. (12) In the radial cross-section, the protrusion of the distal side cone tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 30° or more. The distal conical portion has an inner protrusion that protrudes radially inward from the inner surface of the balloon body and extends along the long axis.

7. The balloon for balloon catheters according to claim 5 or 6, characterized in that, The balloon catheter balloon satisfies at least one of the following (13) and (14): (13) In the radial cross-section, the protrusion of the proximal side cone tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line to the base end is 30° or more. The protrusion tilts in the first or second direction along the entire long axis of the proximal lateral cone. (14) In the radial cross-section, the protrusion of the distal side cone tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line to the base end is 30° or more. The protrusion tilts in the first or second direction along the entire region of the distal side cone in the long axis direction.

8. The balloon for balloon catheters according to claim 5 or 6, characterized in that, The balloon catheter balloon satisfies at least one of the following (15) and (16): (15) In the radial cross-section, the protrusion of the proximal side cone tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line of the base end is 30° or more. At least a portion of the protrusion in the long axis direction of the proximal lateral cone tilts toward the first direction or the second direction. (16) In the radial cross-section, the protrusion of the distal side cone tilts toward the first direction or the second direction, and the angle between the straight line connecting the midpoint of the width direction of the base end and the front end and the perpendicular line to the base end is 30° or more. At least a portion of the protrusion in the long axis direction of the distal side cone tilts toward the first direction or the second direction.

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