Balloon catheter balloon

Abstract

The present invention provides a balloon for a balloon catheter that can cut open a stenotic portion in a contracted state. The balloon for the balloon catheter has a balloon body (20) and a protrusion (60) having a front end (61), satisfying the following (1) and / or (2). (1) The distal conical portion (24) from D 20 To D 50 The front end (61) relative to the front end (61) of D0 and D 100 The straight line L obtained by connecting the front end (61) d The imaginary surface C obtained by rotating about the central axis (20C) d It is positioned on the outer side of the radial y. (2) The proximal conical portion (22) from D 20 To D 50 The front end (61) relative to the front end (61) of D0 and D 100 The straight line L obtained by connecting the front end (61) p The imaginary surface C obtained by rotating about the central axis (20C) p It is positioned on the outer side of the radial direction y.

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 narrowing of the blood vessel walls caused by calcification and other factors. One treatment for these conditions is angioplasty, which uses a balloon catheter to dilate the narrowed area. Angioplasty is a minimally invasive procedure that does not require open-chest surgery like bypass surgery and is widely performed.

[0003] In angioplasty, conventional balloon catheters sometimes fail to dilate stenosis that has hardened due to calcification or other factors. Alternatively, methods are used to dilate the stenosis by placing an indwelling dilator called a stent in the stenosis. However, even with this treatment, there are cases of in-stent restenosis (ISR), where excessive proliferation of the neointimal layer leads to re-stenosis. In ISR lesions, the neointimal layer is soft and smooth, so with conventional balloon catheters, there is a risk of the balloon deviating from the lesion and scratching the vessel during dilation.

[0004] As a balloon catheter capable of dilating stenosis even in calcified lesions and ISR lesions, balloon catheters have been developed that include a protrusion for constricting the stenosis, a blade, and a scoring element within the balloon. For example, Patent Document 1 discloses a balloon catheter with a scoring element made of a polymer material with a higher rigidity than the polymer material forming the balloon body, and the scoring element is flattened at one and the other ends of the balloon. Patent Document 2 discloses a scoring balloon structure in which the height of the scoring element decreases along the tapered shape of the balloon's front end. Patent Document 3 discloses a balloon catheter with an outer protrusion in the straight portion of the balloon and an inner protrusion in the tapered portion. In Patent Documents 1 to 3, the height of the scoring element decreases at both ends of the balloon, or an inner protrusion is provided but no outer protrusion is provided. In contrast, there is also a balloon catheter with a high protrusion where the protrusion of the protrusion located on the distal conical portion is greater than the protrusion of the protrusion located on the straight portion of the balloon (Patent Document 4).

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

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

[0007] Patent Document 3: International Publication No. 2020 / 012851

[0008] Patent Document 4: International Publication No. 2020 / 012850

[0009] The balloon catheter is inserted into the body cavity in a contracted and folded state and delivered to the treatment site. Therefore, in the balloon catheters disclosed in Patent Documents 1-3, to facilitate insertion into the body cavity, the outer diameter is suppressed by inhibiting the height of the scoring element in the front end of the balloon, thereby attempting to improve balloon permeability. However, in such balloon catheters, because the height of the scoring element at the front end is suppressed, the balloon remains contracted at the lesion site during delivery, making it difficult to cut the stenosis. Furthermore, in the balloon catheter disclosed in Patent Document 4, the height of the protrusion disposed on the front-side cone is increased so that when only the front-side cone region is introduced into the lesion site and the balloon is expanded, the element disposed on the front-side cone region can be used to form an incision at the lesion site while expanding the balloon. However, this is not sufficient from the viewpoint of ensuring insertion patency while the balloon is contracted and cutting the stenosis while advancing or retracting the balloon. Summary of the Invention

[0010] In view of the above, the object of the present invention is to provide a balloon for a balloon catheter that, during balloon delivery and when the balloon is delivered to the lesion, can cut open the stenosis in a contracted state.

[0011] One embodiment of the balloon catheter of the present invention, which can solve the above-mentioned problems, is a balloon catheter balloon having a balloon body having an outer surface and an inner surface, wherein the balloon body has a straight tube portion, a distal conical portion located distal to the straight tube portion, and a proximal conical portion located closer to the straight tube portion, the distal conical portion, the straight tube portion, and the proximal conical portion having a protrusion that protrudes radially outward from the outer surface of the balloon body and extends along the long axis of the balloon body, the protrusion having a front end in the radial section of the balloon body, and in the contracted state of the balloon catheter balloon, when one end of the distal conical portion and the proximal conical portion on the straight tube side in the long axis direction of the balloon body is set to a 0% position and the other end is set to a 100% position, at least one of the following (1) and (2) is satisfied.

[0012] (1) The anterior end of the protrusion in the interval from the 20% position to the 50% position of the distal cone is relative to the straight line L obtained by connecting the anterior end of the distal cone at the 0% position to the anterior end of the distal cone at the 100% position. d An imaginary surface, obtained by rotating around the central axis of the balloon body, is positioned radially outward of the balloon body.

[0013] (2) The anterior end of the protrusion in the interval from the 20% position to the 50% position of the proximal conical part is relative to the straight line L obtained by connecting the anterior end of the proximal conical part at the 0% position to the anterior end of the proximal conical part at the 100% position. p An imaginary surface, obtained by rotating around the central axis of the balloon body, is positioned radially outward of the balloon body.

[0014] Preferably, the balloon of the balloon catheter is folded when the balloon is in the contracted state.

[0015] Preferably, when the balloon of the balloon catheter is in the contracted state, at least one of (1) and (2) below is satisfied.

[0016] (1) The anterior end of the protrusion in the interval from 90% to 100% of the distal conical portion relative to the straight line L d An imaginary surface obtained by rotating about the central axis of the balloon body is positioned radially inside the balloon body or at the same location.

[0017] (2) The anterior end of the protrusion in the range from 90% to 100% of the position of the proximal conical part relative to the straight line L p An imaginary surface obtained by rotating about the central axis of the balloon body is positioned radially inside the balloon body or at the same location.

[0018] Preferably, when the balloon of the balloon catheter is in the inflated state, the protrusions of the distal conical portion, the straight portion, and the proximal conical portion are positioned at the same location circumferentially on the balloon body.

[0019] Preferably, when the balloon of the balloon catheter is in the contracted state, the protrusions of the straight tube, the distal conical section, and the proximal conical section are positioned at the same location circumferentially on the balloon body.

[0020] Preferably, the balloon body has a blade-forming portion that forms a blade in the contracted state, and the protrusion is located in a part other than the blade-forming portion.

[0021] Preferably, the protrusions of the distal conical portion, the straight tube portion, and the proximal conical portion extend continuously along the long axis of the balloon body.

[0022] The preferred protrusion is made of the same material as the balloon body.

[0023] Furthermore, the present invention also provides a method for manufacturing the balloon for a balloon catheter described above. One embodiment of the manufacturing method includes: a step of preparing a first cylindrical object, a second cylindrical object, and a third cylindrical object, wherein the first and second cylindrical objects each have a space extending along their long axis internally and a pressing member protruding from the outside towards the inside on their inner surface; and the third cylindrical object has a space extending along its long axis internally; and a step of preparing a balloon for a balloon catheter, wherein the balloon for a balloon catheter has a balloon body having an outer surface and an inner surface, and the balloon body has a straight tube portion and a distal side located distal to the straight tube portion. The manufacturing method comprises a conical portion and a proximal conical portion located closer to the position side than the straight tube portion, a distal conical portion, a straight tube portion and a proximal conical portion having a protrusion that protrudes radially outward from the outer surface of the balloon body and extends along the long axis of the balloon body; a configuration step in which a distal conical portion is configured in a first cylindrical container, a proximal conical portion is configured in a second cylindrical container, and a straight tube portion is configured in a third cylindrical container; and a contraction step in which the balloon catheter is contracted. The manufacturing method comprises at least one of the steps of (1) and (2) below.

[0024] (1) In the shrinking process, the pressing component of the first cylindrical object presses the two sides of the protrusion in the cross section of the main body of the spherical bag perpendicular to the long axis towards the inside of the first cylindrical object.

[0025] (2) During the shrinking process, the pressing component of the second cylindrical object presses the two sides of the protrusion in the cross section of the main body of the spherical bag perpendicular to the long axis towards the inside of the second cylindrical object.

[0026] According to the balloon for the above-mentioned balloon catheter, in the balloon's contracted state, the anterior end of the protrusion of at least one of the distal conical portion and the proximal conical portion is arranged radially outside the balloon in a manner that satisfies specified conditions. Therefore, during balloon delivery, when the balloon is delivered to the lesion, the stenosis can be cut open while the balloon is advanced or retracted in the contracted state. Attached Figure Description

[0027] Figure 1 A side view of a balloon catheter according to one embodiment of the present invention.

[0028] Figure 2 express Figure 1 The balloon of the balloon catheter shown is in a cross-sectional view along its long axis in the inflated state.

[0029] Figure 3 express Figure 1 Sectional view III-III.

[0030] Figure 4 express Figure 2The diagram shows a radial cross-sectional view of the straight section of the balloon in its contracted state.

[0031] Figure 5 express Figure 2 The diagram shows a radial cross-sectional view of the conical portion of the balloon in its contracted state.

[0032] Figure 6 express Figure 2 The image shows a partial cross-sectional view of the balloon along its long axis in the contracted state.

[0033] Figure 7 A partial cross-sectional view along the long axis of a balloon in a contracted state, representing another embodiment of the present invention.

[0034] Figure 8 express Figure 2 The balloon shown is a side view in its folded state.

[0035] Figure 9 express Figure 8 IX-IX sectional view.

[0036] Figure 10 express Figure 8 XX sectional view.

[0037] Figure 11 express Figure 8 XI-XI sectional view.

[0038] Figure 12 A partial cross-sectional view along the long axis of a balloon in a contracted state, representing another embodiment of the present invention.

[0039] Figure 13 Indicates from Figure 2 A top view of the balloon from the side of its protrusion.

[0040] Figure 14 A perspective view of a preform before expansion, representing one embodiment of the present invention.

[0041] Figure 15 This is a cross-sectional view perpendicular to the long axis direction of the first cylindrical object in a manufacturing method according to an embodiment of the present invention.

[0042] Figure 16 A cross-sectional view perpendicular to the long axis direction of the second cylindrical object in a manufacturing method according to an embodiment of the present invention.

[0043] Figure 17 A cross-sectional view perpendicular to the long axis direction of a third cylindrical object in a manufacturing method according to an embodiment of the present invention.

[0044] Figure 18This is a cross-sectional view perpendicular to the long axis direction during the process of arranging a distal tapered portion inside a first cylindrical object in a manufacturing method according to one embodiment of the present invention.

[0045] Figure 19 This is a cross-sectional view perpendicular to the long axis direction during the process of pressing the two sides of the protrusion by the pressing member in a manufacturing method according to one embodiment of the present invention. Detailed Implementation

[0046] The present invention will now be specifically described based on embodiments, but the present invention is of course not limited to the embodiments described below, and may be implemented by appropriate modifications within the scope of the foregoing and following spirit, all of which are included within the technical scope of the present invention. Furthermore, in the various drawings, for convenience, shaded lines, component reference numerals, etc., are sometimes omitted; in such cases, please refer to the specification and other drawings. Additionally, the dimensions of various components in the drawings are primarily helpful in understanding the features of the present invention, and therefore sometimes differ from the actual dimensions.

[0047] The balloon catheter of the present invention has a balloon body having an outer surface and an inner surface. The balloon body has a straight tube portion, a distal conical portion located distal to the straight tube portion, and a proximal conical portion located closer to the straight tube portion. The distal conical portion, the straight tube portion, and the proximal conical portion have protrusions that protrude radially outward from the outer surface of the balloon body and extend along the long axis of the balloon body. The protrusions have a front end in the radial section of the balloon body. In the contracted state of the balloon catheter, when one end of the distal conical portion and the proximal conical portion on the straight tube side in the long axis direction of the balloon body is set to a 0% position and the other end is set to a 100% position, at least one of (1) and (2) below is satisfied.

[0048] (1) The anterior end of the protrusion in the interval from the 20% position to the 50% position of the distal cone is relative to the straight line L obtained by connecting the anterior end of the distal cone at the 0% position to the anterior end of the distal cone at the 100% position. d An imaginary surface, obtained by rotating around the central axis of the balloon body, is positioned radially outward of the balloon body.

[0049] (2) The anterior end of the protrusion in the interval from the 20% position to the 50% position of the proximal conical part is relative to the straight line L obtained by connecting the anterior end of the proximal conical part at the 0% position to the anterior end of the proximal conical part at the 100% position. p An imaginary surface, obtained by rotating around the central axis of the balloon body, is positioned radially outward of the balloon body.

[0050] In this manner, when the balloon is in its contracted state, the anterior ends of the protrusions of at least one of the distal and proximal conical portions are positioned radially lateral to the balloon body in a way that satisfies the aforementioned conditions. Therefore, during balloon delivery, when the balloon is delivered to the lesion, the stenosis can be cut open while the balloon is being advanced or retracted in its contracted state. In this specification, the balloon catheter is sometimes simply referred to as a "balloon".

[0051] Reference Figures 1 to 13 The balloon catheter is explained. Figure 1 A side view showing a balloon catheter according to one embodiment of the present invention. Figure 2 express Figure 1 The image shows a cross-sectional view of the balloon of the balloon catheter in its inflated state along its long axis. Figure 3 express Figure 1 Sectional view III-III. Figure 4 express Figure 2 The diagram shows a radial cross-sectional view of the straight section of the balloon in its contracted state. Figure 5 express Figure 2 The diagram shows a radial cross-sectional view of the conical portion of the balloon in its contracted state. Figure 6 express Figure 2 The diagram shows a partial sectional view of the balloon in its contracted state along its long axis, specifically a sectional view of the balloon membrane including the balloon body and the protrusions. Figure 7 It means Figure 6 A cross-sectional view of a modified example. Figure 8 express Figure 2 The image shows a side view of the balloon in its folded state. Figure 9 , Figure 10 and Figure 11 They represent Figure 8 The balloon is shown in IX-IX, XX and XI-XI cross-sectional views. Figure 12 A partial cross-sectional view along the long axis of a balloon in a contracted state, representing another embodiment of the present invention, that is, a cross-sectional view of the balloon membrane including the balloon body and the protrusion. Figure 13 Indicates from Figure 2 A top view of the balloon from the side of its protrusion.

[0052] In this invention, the proximal side refers to the direction proximal to the user or surgeon relative to the extension direction of the balloon catheter 1 or the long axis direction x of the axis 3, while the distal side refers to the opposite direction of the proximal side, i.e., the direction on the side of the patient being treated. Besides the elongated component like the axis 3, it also has the same long axis direction x as the axis 3. The radial direction y is perpendicular to the long axis direction x, and is the direction connecting the center of the balloon body 20 to a point on the circumference of the balloon body 20 in a section perpendicular to the long axis direction x. The circumferential direction z is the direction along the circumference of the circumference of the balloon body 20 in its expanded state in a section perpendicular to the long axis direction x.

[0053] like Figure 1 and Figure 2 As shown, the balloon catheter 1 has a shaft 3 and a balloon 2 disposed outside the shaft 3. The balloon catheter 1 has a distal side and a proximal side, with the balloon 2 disposed on the distal side 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 indeflator. The fluid can also be a pressurized fluid pressurized by a pump or the like.

[0054] Shaft 3 preferably has a fluid flow path internally, and further has a guidewire insertion path. For example, a structure in which shaft 3 has both a fluid flow path and a guidewire insertion path internally can be described, where shaft 3 has an outer tube 31 and an inner tube 32, with the inner tube 32 functioning as the guidewire insertion path and the space between the inner tube 32 and the outer tube 31 functioning as a fluid flow path. In this case, with shaft 3 having 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, with the distal side of the balloon 2 engaging with the inner tube 32 and the proximal side of the balloon 2 engaging with the outer tube 31.

[0055] like Figures 1 to 7 As shown, the balloon catheter 1 uses a balloon 2 with a balloon body 20, which has an outer surface and an inner surface. The balloon body 20 has a straight tube portion 23, a distal conical portion 24 located distal to the straight tube portion 23, and a proximal conical portion 22 located proximal to the straight tube portion 23. The distal conical portion 24, the straight tube portion 23, and the proximal conical portion 22 have a protrusion 60, which protrudes outward radially y from the outer surface of the balloon body 20 and extends along the long axis direction x of the balloon body 20. The protrusion 60 has a front end portion 61 in the radial y section of the balloon body 20. In the contracted state of the balloon 2, one end of the distal conical portion 24 and the proximal conical portion 22 on the straight tube portion 23 side in the long axis direction x of the balloon body 20 is set to a 0% position D0, and the other end is set to a 100% position D10. 100 When, at least one of (1) and (2) below is satisfied.

[0056] (1) The distal conical portion 24 from position D at 20% 20 To 50% of position D 50 The front end portion 61 of the protrusion 60 in the interval is relative to the position D0 of the distal tapered portion 24 at 0% and the position D0 of the distal tapered portion 24 at 100%. 100 The straight line L obtained by connecting the front end 61 d The imaginary surface C obtained by rotating around the central axis 20C of the balloon body 20 d It is positioned on the outer side of the balloon body 20 in the radial direction y.

[0057] (2) The position D of the proximal conical part 22 at 20% of its length 20 To 50% of position D 50 The front end portion 61 of the protrusion 60 in the interval is relative to the position D0 of the proximal side cone 22 at 0% and the position D0 of the proximal side cone 22 at 100%. 100 The straight line L obtained by connecting the front end 61 p The imaginary surface C obtained by rotating around the central axis 20C of the balloon body 20 p It is positioned on the outer side of the balloon body 20 in the radial direction y.

[0058] In the contracted state of the balloon 2, the anterior end portion 61 of the protrusion 60 of at least one of the distal conical portion 24 and the proximal conical portion 22 is arranged on the outer side of the balloon body 20 in a manner that satisfies the above-mentioned conditions. Therefore, during the delivery of the balloon 2, when the balloon 2 is delivered to the lesion, the stenosis can be cut open by the anterior end portion 61 while the balloon 2 is moved forward or backward in the contracted state.

[0059] like Figure 2 As shown, the balloon 2 may also have a non-expanding distal cannula portion 25 and a proximal cannula portion 21, respectively, on the distal side of the distal conical portion 24 and the proximal side of the proximal conical portion 22. At least a portion of the distal cannula portion 25 and the proximal cannula portion 21 can be configured to be fixed to the shaft 3. When the shaft 3 has an outer tube 31 and an inner tube 32, at least a portion of the proximal cannula portion 21 can be configured to be fixed to the outer tube 31, and at least a portion of the distal cannula portion 25 can be fixed to the inner tube 32.

[0060] Preferably, the distal conical portion 24 and the proximal conical portion 22 are formed with a decreasing diameter as they move away from the straight tube portion 23. Because the balloon body 20 has a straight tube portion 23 with its maximum diameter in the inflated state, when the balloon 2 is inflated in the narrow portion, the straight tube portion 23 can make sufficient contact with the narrow portion, facilitating the expansion and even cutting of the narrow portion. Furthermore, as described later, when the balloon 2 is contracted, a blade 29 is formed. However, because the balloon body 20 has a distal conical portion 24 and a proximal conical portion 22 with decreasing outer diameter as they move away from the straight tube portion 23, when the balloon 2 is contracted and the blade 29 is wound around the shaft 3, a protrusion 60 can be exposed from the blade 29 of the balloon 2 in the distal conical portion 24 and the proximal conical portion 22. Using this exposed protrusion 60, the narrow portion can be cut even when the balloon 2 is contracted.

[0061] like Figure 2 and Figure 3 As shown, the protrusion 60 of the balloon 2 is a portion that protrudes radially outward from the outer surface of the balloon body 20 in its expanded state. In the radially y-section, the maximum length of the protrusion 60 protruding radially outward from the outer surface of the balloon body 20 is preferably at least 1.2 times the membrane thickness of the balloon body 20, more preferably at least 1.5 times, and even more preferably at least 2 times. However, lengths of less than 100 times, less than 50 times, less than 30 times, or less than 10 times are also permissible. Thus, the protrusion 60 facilitates the formation of an incision of appropriate depth in the narrow portion, making incision easier. This protrusion 60 facilitates incision of the narrow portion and can improve the strength of the balloon 2 or suppress excessive expansion of the balloon 2 during pressurization.

[0062] The number of protrusions 60 on the circumferential z-direction of the balloon 2 can be one, or as follows: Figure 3 As shown, there are multiple protrusions 60. When the balloon 2 has multiple protrusions 60 along the circumferential direction z, it is preferable that the multiple protrusions 60 are separated in the circumferential direction z, and more preferably that they are arranged at equal intervals in the circumferential direction z. The separation distance is preferably greater than the maximum circumference of the protrusions 60. By separating the protrusions 60 in the circumferential direction z and preferably arranging them at equal intervals, it is easy to fix the balloon 2 and cut the narrow part.

[0063] like Figure 3 As shown, the protrusion 60 has a front end 61 in a radial y-section of the balloon body 20. The front end 61 facilitates the formation of an incision in the stenosis, thus preventing dissociation of the vascular intima and allowing for the incision of the stenosis. The front end 61 is the portion of the protrusion 60 that protrudes most outward from the outer surface of the balloon body 20 in the radial y direction, and can have… Figure 3The acute angle shape shown can also be an obtuse angle, a curved shape, or a flat shape. From the perspective of ease of forming the cut, an acute angle shape is preferred. The shape of the radial y-section of the protrusion 60 can be arbitrary, and can be... Figure 3 It can be a roughly triangular shape as shown, or it can be a polygon, sector, wedge, convex shape, spindle shape, etc.

[0064] like Figure 4 and Figure 5 As shown, the contracted state of balloon 2 is the state after fluid is discharged from the inside of balloon 2 or before fluid is supplied to the inside of balloon 2. In the contracted state of balloon 2, the inner surface of the balloon body 20 near the shaft 3 and the blades 29 are formed. In other words, as Figure 3 As shown, the balloon 2 in the expanded state can be said to have a blade-forming part 28 that forms a blade 29 in the contracted state. Figure 4 and Figure 5 The arrangement shown is such that shaft 3 has an outer tube 31 and an inner tube 32, and balloon 2, in its contracted state, has a portion of the inner surface of balloon body 20 near the inner tube 32. A cross-sectional view of the straight tube portion 23 in its contracted state, showing the radial y-axis, is shown below. Figure 4 A cross-sectional view showing the radial y-axis of the conical portion (distal conical portion 24 or proximal conical portion 22). Figure 5 As clearly demonstrated by comparison, the straight tube portion 23 is the part of the balloon 2 with the largest diameter in the expanded state, while the tapered portion is the portion with a reduced diameter. Therefore, in the radial y-section, the radial y-length of the blade 29 of the straight tube portion 23 is longer than the radial y-length of the blade 29 of the tapered portion. When the distal tapered portion 24 and the proximal tapered portion 22 gradually decrease in diameter towards the distal and proximal sides, respectively, the radial y-length of the blade 29 in the radial y-section also gradually shortens towards the distal and proximal sides, respectively. Consequently, blades 29 are not formed in the distal portion of the distal tapered portion 24 and the proximal portion of the proximal tapered portion 22. Preferably, blades 29 are not formed at the distal end of the distal tapered portion 24 and the proximal end of the proximal tapered portion 22. If the blade 29 is not formed on the distal end of the distal conical portion 24 and the proximal end of the proximal conical portion 22, then in that part, the protrusion 60 can abut against the body cavity wall without being obstructed by the blade 29, thereby enabling the cutting of the narrow portion.

[0065] like Figure 6 and Figure 7 As shown, in the contracted state of the balloon 2, one end of the distal conical portion 24 and the proximal conical portion 22 on the straight tube portion 23 side of the balloon body 20 in the long axis direction x is set to position D0 of 0%, and the other end is set to position D of 100%. 100At that time, the distal conical portion 24 from position D at 20% 20 To 50% of position D 50 The interval and the proximal lateral cone 22 from position D at 20% 20 To 50% of position D 50 The front end portion 61 of the protrusion 60 in at least one of the intervals is respectively relative to the straight line L d The imaginary surface C obtained by rotating around the central axis 20C of the balloon body 20 d And make the straight line L p The imaginary surface C obtained by rotating around the central axis 20C of the balloon body p The balloon body 20 is positioned radially y-laterally on the outer side. Specifically, during balloon 2 contraction, the anterior ends 61 of the protrusions 60 of both the distal conical portion 24 and the proximal conical portion 22 can be positioned radially y-laterally on the outer side of the balloon body 20 in a manner that satisfies the aforementioned conditions. Alternatively, the anterior ends 61 of the protrusions 60 in either conical portion can be positioned radially y-laterally on the outer side of the balloon body 20 in a manner that satisfies the aforementioned conditions. If the anterior ends 61 of the protrusions 60 in both conical portions are positioned radially y-laterally on the outer side of the balloon body 20 in a manner that satisfies the aforementioned conditions, then whether the balloon 2 advances or retracts within the body cavity in the contracted state, the anterior ends 61 can act on the narrowed portion and cut it open. Furthermore, for example, if the front end 61 of the protrusion 60 is positioned on the outer side of the balloon body 20 in a manner that satisfies the above-mentioned conditions only in the proximal cone 22, and the front end 61 of the protrusion 60 is not positioned on the outer side of the balloon 20 in the distal cone 24, the diameter of the distal cone 24 that passes through the body cavity first when the balloon 20 is advanced can be reduced. Therefore, the stenosis can be cut by the front end 61 of the protrusion 60 of the proximal cone 22 while the balloon 2 is contracted and easily passes through the body cavity. Conversely, if the anterior end portion 61 of the protrusion 60 is positioned on the outer side of the balloon body 20 radially y only in the distal cone portion 24 in a manner that satisfies the aforementioned conditions, and the anterior end portion 61 of the proximal cone portion 22 is not positioned on the outer side of the balloon 20 radially y, then the narrow portion can be cut by first passing through the distal cone portion 24 within the body cavity when the balloon 20 is advanced, thereby improving the subsequent insertion success of the balloon 2. Furthermore, it allows for easier passage within the body cavity when the balloon 20 is retracted.

[0066] Figure 5 This refers to the tapered portion on the outer side of the balloon body 20 in a manner that allows the front end 61 of the protrusion 60 to be positioned in a manner that satisfies specified conditions. For example... Figure 5As shown, in the tapered portion of the balloon body 20, the front end 61 of the protrusion 60 is positioned on the radially outer side of the balloon body 20 in a manner that satisfies predetermined conditions. The inner surface of the portion of the balloon body 20 in which the protrusion 60 is formed floats above the shaft 3 (inner tube 32), and this portion, except for the blade 29, can also approach the shaft 3 (inner tube 32). Thus, the front end 61 of the protrusion 60 can be positioned on the radially outer side of the balloon body 20 in the tapered portion, and the outer diameter of this portion and the portion other than the blade 29 can be suppressed. Even though the front end 61 of the protrusion 60 in the tapered portion is positioned on the radially outer side of the y-section, by suppressing the outer diameter of the balloon 2 after folding, it is possible to make the balloon 2 easy to insert into the body cavity.

[0067] In at least one of the distal conical portion 24 and the proximal conical portion 22, the front end portion 61 of the protrusion 60 is located at position D from 20%. 20 To 50% of position D 50 The protrusion 60 can be positioned on the outer side of the balloon body 20 in the radial direction y. In other areas, the front end portion 61 of the protrusion 60 can be positioned on the outer side of the balloon body 20 in the radial direction y, at the same position as the balloon body 20 in the radial direction y, or on the inner side of the balloon body 20 in the radial direction y. In at least one of the distal cone 24 and the proximal cone 22, the front end portion 61 of the protrusion 60 is more preferably positioned on the outer side of the balloon body 20 in the radial direction y between 15% and 60%, and more preferably between 10% and 70%. Alternatively, for example, the front end portion 61 of the protrusion 60 can also be positioned between 0% and 100%. 100 The interval (where the 0% position D0 and the 100% position D) 100 Except for the outer side of the balloon body 20 in the radial direction y.

[0068] The amount by which the front end 61 of the protrusion 60 protrudes radially y toward the balloon body 20 can be adjusted by the amount by which the inner surface of the balloon body 20, where the protrusion 60 is formed, floats above the shaft 3 (inner tube 32), and can also be adjusted by the radial y length of the protrusion 60 in the radial y cross-section. However, from the viewpoint of the balloon 2's permeability in its expanded state, the amount by which the front end 61 protrudes radially y is preferably adjusted by the amount by which the inner surface of the balloon body 20, where the protrusion 60 is formed, floats above the shaft 3. Thus, the front end 61 of the protrusion 60 can be positioned on the outer side of the radial y without increasing the radial y length of the protrusion 60 in the radial y cross-section of the conical portion. With such a structure, the balloon 2 can move forward or backward within the body cavity, cutting through the narrow portion by the front end 61 of the protrusion 60 positioned on the outer side of the radial y. At the same time, since the inner surface of the balloon body 20 with the protrusion 60 is raised from the shaft 3, there is room for the protrusion 60 to move inward in the radial direction y when the balloon 2 passes through the narrow part and the curved part, thereby reducing the outer diameter of the balloon 2, thereby preventing the balloon 2 from getting caught in the narrow part and the curved part, and improving the insertion performance.

[0069] By adjusting the distance in the long axis direction x where the front end 61 of the protrusion 60 is positioned on the outer side of the radial y direction, and the amount by which the front end 61 of the protrusion 60 protrudes radially y toward the balloon body 20, the balloon 2 can be applied to treatment sites in various states.

[0070] Regarding the radial y-length of the protrusion 60 in the radial y-section, it is preferable that the length of the protrusion 60 in the distal conical portion 24 or the proximal conical portion 22 is shorter than the length of the protrusion 60 in the straight tube portion 23. Even if the radial y-length of the protrusion 60 in the conical portion is shorter than the radial y-length of the protrusion 60 in the straight tube portion 23, by making the inner surface of the balloon body 20 in which the protrusion 60 is formed float from the shaft 3 (inner tube 32) as described above, the front end portion 61 of the protrusion 60 of the conical portion can be positioned on the outer side of the radial y-section.

[0071] Preferably, in the expanded state, the front end portion 61 of the protrusion 60 in the distal tapered portion 24 and the proximal tapered portion 22 is positioned relative to the straight line L. d and L p It is not positioned on the outside. Therefore, when the balloon 2 is in the inflated state, the risk of the anterior end 61 of the protrusion 60 in the conical portion other than the straight portion 23 acting on the lesion coming into contact with normal blood vessels or other sites that are not the target of treatment can be reduced.

[0072] like Figure 6 As shown, the front end portion 61 of the distal conical portion 24 at position D0 (0%) is compared with the 100% position D of the distal conical portion 24.100 The straight line L obtained by connecting the front end 61 d and the anterior end portion 61 at position D0 of the proximal conical portion 22 at 0% and position D0 of the proximal conical portion 22 at 100%. 100 The straight line L obtained by connecting the front end 61 p It can also be parallel to the central axis 20C of the balloon body 20. On the straight line L... d and line L p Imaginary surface C in a manner parallel to the central axis 20C of the balloon body 20 d and imaginary surface C p like Figure 6 The image shown represents the lateral surface of a cylinder. If line L... d and line L p Parallel to the central axis 20C of the balloon body 20, the diameter of the straight tube 23 can be suppressed when the balloon 2 contracts. Since the diameter of the straight tube 23 can also be suppressed when the blade 29 formed by the contraction of the balloon 2 is wound around the axis 3, insertion into the body cavity becomes easier.

[0073] like Figure 7 As shown, the front end portion 61 of the distal conical portion 24 at position D0 (0%) is compared with the 100% position D of the distal conical portion 24. 100 The straight line L obtained by connecting the front end 61 d and the anterior end portion 61 at position D0 of the proximal conical portion 22 at 0% and position D0 of the proximal conical portion 22 at 100%. 100 The straight line L obtained by connecting the front end 61 p It can also have an angle in the radial y direction relative to the central axis 20C of the balloon body 20. In this case, the imaginary surface C d and imaginary surface C p like Figure 7 The side of the cone is shown. In cases where the diameter of the balloon 2 is large, or where the radial y-length of the protrusion 60 at the straight tube portion 23 in the radial y-section is longer than the radial y-length of the protrusion 60 at the distal conical portion 24 and the proximal conical portion 22, etc., the straight line L... d Or straight line L p The balloon body 20 has an angle in the radial y direction relative to the central axis 20C of the balloon body 20, thus creating an imaginary curved surface C. d and imaginary surface C p The side of the truncated cone that forms the bottom surface of the straight tube 23. In this manner, the diameters of the distal and proximal portions of the distal cone 24 and the proximal cone 22 can be reduced to a smaller size during contraction, thereby reducing the diameter of the anterior portion when the balloon 2 is inserted into the body cavity and moved forward or backward, thus facilitating the insertion of the balloon 2 into the body cavity.

[0074] exist Figure 6 and Figure 7 The image shows the imaginary curved surfaces C at the distal conical portion 24 and the proximal conical portion 22. d and imaginary surface C p Both can be the side surface of a cylinder or a frustum of a cone, but it can also be the imaginary curved surface C at the distal conical portion 24. d The imaginary curved surface C at the proximal conical portion 22 of the cylinder's lateral side. p It can be the side of a truncated cone, or it can be the opposite.

[0075] exist Figure 6 and Figure 7 In the illustrated configuration, both the distal cannula portion 25 and the proximal cannula portion 21 have a protrusion 60. However, the distal cannula portion 25 and the proximal cannula portion 21 may also lack the protrusion 60. Alternatively, the distal cannula portion 25 and the proximal cannula portion 21 may have an inner protrusion that protrudes radially inward from the inner surface of the balloon body 20. If the distal cannula portion 25 and the proximal cannula portion 21 do not have the protrusion 60, then insertion of the balloon 2 into the body cavity, as well as its advancement and retraction within the body cavity, become easier.

[0076] As described above, for the balloon 2 of the embodiment of the present invention, preferably, the anterior end portion 61 of at least a portion of the protrusion 60 of the distal conical portion 24 and the proximal conical portion 22 is within a predetermined range relative to the imaginary curved surface C in the contracted state. d and imaginary surface C p It is positioned on the outer side of the balloon body 20 in the radial direction y, but in the expanded state, the anterior ends 61 of the protrusions 60 of the distal cone 24 and the proximal cone 22 are positioned relative to the imaginary curved surface C. d and imaginary surface C p It is not positioned on the radial y-side of the balloon body 20. As a result, not only can the risk of the anterior end 61 of the protrusion 60 in the conical portion other than the straight tube portion 23 acting on the lesion be reduced when the balloon 2 is inflated after delivery, but it is also possible to form a balloon that can cut through the stenosis while advancing or retracting in the constricted state.

[0077] like Figures 8-11 As shown, in the contracted state of balloon 2, balloon 2 is preferably folded. In the folded state of balloon 2, through... Figure 4 and Figure 5 The blade 29, formed by the contraction of the balloon 2 shown, is wound around the shaft 3. In the straight tube section 23 with the largest diameter, the radial length y of the blade 29 is relatively long, therefore... Figure 9As shown, the amount of winding of the blade 29 increases. On the other hand, in the distal tapered portion 24 and proximal tapered portion 22, which are reduced in diameter, the radial length y of the blade 29 is shortened by the reduction in diameter. In one embodiment of the invention, its length increases from the 0% position D0 on the straight tube side towards the 100% position D. 100 And it becomes shorter. At the 0% position D0 side of the distal conical portion 24 and the proximal conical portion 22, such as... Figure 10 As shown, the shorter blades 29 in the straight tube section 23 are wound around the shaft 3 (inner tube 32) at position D of 100%. 100 Side, such as Figure 11 As shown, the further shortened blades 29 are wound around the shaft 3 (inner tube 32). Alternatively, by adjusting the outer diameter of the balloon 2 and the number of blades 29, it is possible to achieve the same effect even at the 0% position D0 side of the distal cone 24 and the proximal cone 22. Figure 11 The amount of winding of blade 29 is reduced to 100% at position D. 100 On the side, it can also hardly form blades 29. By folding the balloon 2, the balloon 2 can be easily inserted into the body cavity.

[0078] like Figure 12 As shown, in the contracted state of balloon 2, it is preferable to satisfy at least one of (1) and (2) below.

[0079] (1) The distal conical portion 24 from the 90% position D 90 To 100% position D 100 The front end 61 of the protrusion 60 in the interval is relative to the straight line L d The imaginary surface C obtained by rotating around the central axis 20C of the balloon body 20 d It is positioned on the inner side of the balloon body 20 in the radial direction y or at the same location.

[0080] (2) The proximal conical portion 22 from the 90% position D 90 To 100% position D 100 The front end 61 of the protrusion 60 in the interval is relative to the straight line L p The imaginary surface C obtained by rotating around the central axis 20C of the balloon body 20 p It is positioned on the inner side of the balloon body 20 in the radial direction y or at the same location.

[0081] The distal conical portion 24 and the proximal conical portion 22 are located at positions 90% from the straight tube portion 23. 90 To 100% position D 100The section is the part that forms the anterior end when the balloon 2 moves forward or backward within the body cavity. Therefore, in the contracted state of the balloon 2, if the anterior end 61 of the protrusion 60 of at least one of the distal conical portion 24 and the proximal conical portion 22 in this section is relative to the imaginary curved surface C... d and imaginary surface C p By positioning the balloon 2 inside the radial direction y of the balloon body 20 or at the same location, the diameter of that portion can be reduced, thus allowing for easy insertion when the balloon 2 is moved forward or backward within the body cavity.

[0082] In at least one of the distal conical portion 24 and the proximal conical portion 22, a position from 80% to 100% is more preferred. 100 The front end 61 of the protrusion 60 of the interval is relative to the imaginary surface C d Or C p The balloon is positioned inside the radial direction y of the balloon body 20 or at the same location, more preferably from a 70% to a 100% position D. 100 The front end 61 of the protrusion 60 of the interval is relative to the imaginary surface C d Or C p It is positioned inside the radial direction y of the balloon body 20 or at the same location. If, within the aforementioned range, the front end 61 of the protrusion 60 is positioned relative to the imaginary curved surface C... d Or C p By positioning the balloon 2 inside the radial y direction of the balloon body 20 or at the same location, the diameter of the portion that forms the anterior end when the balloon 2 moves forward or backward within the body cavity can be reduced over a longer range in the long axis direction x. Therefore, the balloon 2 can be inserted more easily when it moves forward or backward within the body cavity.

[0083] exist Figure 12 The image shows the imaginary surface C. d and imaginary surface C p Both are methods of depicting the side of a frustum, but either or both can be... Figure 6 The side of the cylinder as shown. If at position D (90%)... 90 To 100% position D 100 The interval satisfies at least one of (1) and (2) above, and the hypothetical surface C d and imaginary surface C p The side of the cone is a truncated cone, so that when it contracts, the diameters of the distal and proximal portions of the distal cone 24 and the proximal cone 22 can be reduced to a smaller size, thereby making it easier to insert the balloon 2 into the body cavity and move it forward or backward.

[0084] exist Figure 12 The image shows the position D at 90% of the two conical sections. 90 To 100% position D100 The balloon 2 of the present invention satisfies the conditions of (1) and (2) above in a manner that satisfies the conditions of (1) or (2) above, but the balloon 2 of the present invention includes either the distal conical portion 24 or the proximal conical portion 22. From the viewpoint of improving the insertion patency when the balloon 2 is inserted into the body cavity and advanced to the lesion, it is preferable to place the distal conical portion 24 at a position of 90% D. 90 To 100% position D 100 Within the interval, the front end 61 of the protrusion 60 is relative to the imaginary curved surface C. d It is positioned inside the radial direction y of the balloon body 20 or at the same location. This reduces the diameter of the anterior portion of the balloon 2 when it is inserted into the body cavity and advanced, thus making insertion of the balloon 2 into the body cavity easier.

[0085] like Figure 13 As shown, in the inflated state of the balloon 2, the protrusions 60 of the distal conical portion 24, the straight tube portion 23, and the proximal conical portion 22 are preferably positioned at the same location in the circumferential z direction of the balloon body 20. With the balloon 2 in the inflated state, by arranging the protrusions 60 at the same location in the circumferential z direction throughout the long axis x of the balloon 2, when the balloon 2 is inflated in the narrow portion for treatment, the protrusions 60 can be cut vertically or fixed to the body cavity wall.

[0086] like Figure 13 As shown, preferably, the protrusions 60 of the distal conical portion 24, the straight tube portion 23, and the proximal conical portion 22 extend continuously in the long axis direction x of the balloon body 20. By having the protrusions 60 extend continuously in the long axis direction x of the balloon 20, the strength of the balloon 2 can be improved or excessive expansion of the balloon 2 during pressurization can be suppressed.

[0087] like Figure 4 , Figure 5 and Figures 9-11 As shown, preferably, in the contracted state of the balloon 2, the protrusions 60 of the straight tube 23, the distal conical portion 24, and the proximal conical portion 22 are positioned at the same location in the circumferential z direction of the balloon body 20. That is, the anterior ends 61 of the protrusions 60 of the distal conical portion 24 and the proximal conical portion 22 are positioned on the outer side of the balloon body 20 in the radial y direction during contraction in a manner that satisfies the aforementioned conditions, but preferably do not move in the circumferential z direction of the balloon body 20 due to contraction. Thus, by positioning the anterior ends 61 acting on the lesion at the same location in the circumferential z direction, it is possible to make a straight cut while advancing or retracting the balloon 2 in the contracted state.

[0088] like Figures 3-5 and Figures 9-11As shown, the preferred balloon body 20 has a blade-forming portion 28 that forms a blade 29 in the contracted state, and a protrusion 60 is disposed in a portion other than the blade-forming portion 28. If the protrusion 60 is disposed in a portion other than the blade-forming portion 28, the protrusion 60 will not obstruct the folding of the blade 29, thus allowing the balloon 2 to be easily folded and suppressing the outer diameter of the balloon 2 in the folded state. In a more preferred embodiment, such as... Figure 4 and Figure 5 As shown, preferably, multiple blades 29 are formed in the contracted state, and the protrusion 60 is disposed between the multiple blades 29. Thus, when the balloon 2 is folded, as... Figure 9 and Figure 10 As shown, the blades 29 can protect the protrusion 60, suppressing damage to the protrusion 60 or preventing it from acting on the body cavity wall at undesirable locations when the balloon 2 is folded and inserted into the body cavity. Furthermore, the radial length y of the blades 29 can be adjusted by adjusting the diameter of the balloon 2, the number of blades 29, etc., such as... Figure 10 and Figure 11 As shown, the extent to which the blade 29 covers the protrusion 60 can be adjusted in the distal conical portion 24 and the proximal conical portion 22. That is, if the blade 29 is short enough that the portion of the distal conical portion 24 and the proximal conical portion 22 near the 0% distance D0 from the straight tube portion 23 does not cover the protrusion 60, then the protrusion 60 can be exposed from the blade 29 for most of the distal conical portion 24 and the proximal conical portion 22, allowing the balloon 2 to advance or retract while cutting through the narrow portion through the exposed protrusion 60. Alternatively, the blade 29 can also be long enough to exceed the 50% distance D0 from the distal conical portion 24 and the proximal conical portion 22. 50 The extent to which the protrusion 60 is covered by the blade 29 is reduced, thereby minimizing the portion of the protrusion 60 exposed from the blade 29 and suppressing the effect of the protrusion 60 when the balloon 2 is advanced or retracted. In this way, by adjusting the extent to which the blade 29 covers the protrusion 60, applications to various lesions can be addressed.

[0089] exist Figure 4 , Figure 5 and Figures 9-11The diagram shows three blades 29, but the number of blades 29 is not particularly limited as long as the balloon 2 is foldable. For example, two or more blades are preferred, more preferably three or more, and four or five or more are also possible. If the lower limit of the number of blades 29 is within the above range, the protrusion 60 can be covered and the diameter of the balloon 2 can be reduced during folding to ensure good insertion into the body cavity. In addition, the number of blades 29 is preferably ten or less, more preferably eight or less, and even more preferably six or less. If the upper limit of the number of blades 29 is within the above range, even a balloon 2 with a large diameter can be easily folded. By setting the range of the number of blades 29 to the above range, the size of the portion of the protrusion 60 covered by the blades 29 in the distal conical portion 24 and the proximal conical portion 22 can be adjusted.

[0090] Examples of materials constituting the balloon body 20 include, for instance, 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 of these materials may be used, or two or more may be used in combination. Polyamide resins, polyester resins, and polyurethane resins are preferred. In particular, from the perspective of the thin-film properties and flexibility of the balloon body 20, elastomer resins are preferred. For example, among polyamide resins, resins constituting the balloon body 20 such as nylon 12 and nylon 11 are preferred, and nylon 12 is more preferred from the perspective of relatively easy molding during blow molding. Furthermore, from the perspective of 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, polyether ester amide elastomer is preferred due to its high yield strength and good dimensional stability of the balloon body 20.

[0091] Preferably, the protrusion 60 is made of the same material as the balloon body 20. If the protrusion 60 is made of the same material as the balloon body 20, the flexibility of the balloon 2 can be maintained, and the protrusion 60 is less likely to scratch the outer surface of the balloon body 20. Preferably, the balloon body 20 and the protrusion 60 are integrally formed. This prevents the protrusion 60 from detaching from the balloon body 20.

[0092] Examples of materials constituting the shaft 3 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorinated resins, vinyl chloride resins, silicone resins, and natural rubber. Only one of these materials may be used, or two or more may be used in combination. Preferably, the material constituting the shaft 3 is at least one of polyamide resins, polyolefin resins, and fluorinated resins. This improves the slipperiness of the shaft 3 surface, thereby enhancing the insertion portability of the balloon catheter 1 within the body cavity.

[0093] Examples of joining balloon 2 and shaft 3 include bonding with adhesive, fusion bonding, and installing a ring-shaped component at the overlapping portion of balloon 2 and shaft 3 followed by compression bonding. Preferably, balloon 2 and shaft 3 are joined by fusion bonding. By fusion bonding balloon 2 and shaft 3, even with repeated expansion and contraction of balloon 2, the joint between balloon 2 and shaft 3 is less likely to disintegrate, thus easily improving the joint strength between balloon 2 and shaft 3.

[0094] like Figure 1 As shown, in the balloon catheter 1, a hub 4 can be provided proximal to the shaft 3, and the hub 4 can also have a fluid injection section 7 communicating with the flow path of fluid supplied to the interior of the balloon 2. Furthermore, it is preferable that the hub 4 has a guidewire insertion section 5 communicating with the guidewire insertion path. The balloon catheter 1 has a hub 4, which includes a fluid injection section 7 and a guidewire insertion section 5, thereby facilitating the operation of supplying fluid to the interior of the balloon 2 to inflate and deflate the balloon 2, and the operation of delivering the balloon catheter 1 along the guidewire to the treatment site. Figure 1 As shown, not only is the balloon catheter of the so-called over-the-wire type that inserts the guidewire from the distal side to the proximal side of the shaft 3, but the balloon 2 of the embodiment of the present invention can also be applied to the so-called quick-exchange type balloon catheter that inserts the guidewire to the middle of the path from the distal side to the proximal side of the shaft.

[0095] The connection between the shaft 3 and the hub 4 can be achieved, for example, by bonding with an adhesive or by fusion. Preferably, the shaft 3 and the hub 4 are joined by adhesive. By bonding the shaft 3 and the hub 4, even when the materials constituting the shaft 3 and the hub 4 are different, such as when the shaft 3 is made of a highly flexible material and the hub 4 is made of a highly rigid material, the connection strength between the shaft 3 and the hub 4 can be increased, thereby improving the durability of the balloon catheter 1.

[0096] Furthermore, the present invention also provides a method for manufacturing a balloon 2 for a balloon catheter 1 according to an embodiment of the present invention. (See also...) Figures 14-19 The manufacturing method of the balloon 2 according to an embodiment of the present invention will be described. Figure 14 A perspective view of a preform before expansion, showing an embodiment of the present invention, illustrating its appearance with an inner cavity and a thick-walled portion. Figure 15This is a cross-sectional view perpendicular to the long axis direction of the first cylindrical object in a manufacturing method according to one embodiment of the present invention. Figure 16 This is a cross-sectional view perpendicular to the long axis direction of the second cylindrical object in a manufacturing method according to one embodiment of the present invention. Figure 17 A cross-sectional view perpendicular to the long axis direction of a third cylindrical object in a manufacturing method according to an embodiment of the present invention. Figure 18 This is a cross-sectional view perpendicular to the long axis direction during the process of arranging a distal tapered portion inside a first cylindrical object in a manufacturing method according to one embodiment of the present invention. Figure 19 This is a cross-sectional view perpendicular to the long axis direction during the process of pressing the two sides of the protrusion by the pressing member in a manufacturing method according to one embodiment of the present invention.

[0097] The method for manufacturing the balloon 2 according to an embodiment of the present invention includes the following steps: preparing a first cylindrical object 310, a second cylindrical object 320, and a third cylindrical object 330, wherein the first cylindrical object 310 and the second cylindrical object 320 have a space extending along the long axis direction x inside, and a pressing member 300 that can protrude and be inserted from the outside to the inside on the inner surface; the third cylindrical object 330 has a space extending along the long axis direction x inside; and preparing a balloon for a balloon catheter, wherein the balloon for a balloon catheter has a balloon body 20, the balloon body 20 having an outer surface and an inner surface, the balloon body 20 having a straight tube portion 23, a distal conical portion 24 located distal to the straight tube portion 23, and a distal conical portion 24 located distal to the straight tube portion 23. The balloon body 20 has a proximal conical portion 22 located closer to the position side than the straight tube portion 23, a distal conical portion 24, a straight tube portion 23 and a proximal conical portion 22 having a protrusion 60, the protrusion 60 protruding outward from the outer surface of the balloon body 20 in a radial direction y and extending along the long axis direction x of the balloon body 20; a configuration step in which the distal conical portion 24 is configured in the first cylindrical body 310, the proximal conical portion 22 is configured in the second cylindrical body 320 and the straight tube portion 23 is configured in the third cylindrical body 330; and a contraction step in which the balloon catheter 1 is contracted by the balloon 2, the manufacturing method of the balloon 2 having at least one of the steps of (1) and (2) below.

[0098] (1) In the shrinking process, the pressing component 300 of the first cylindrical object 310 presses the two sides of the protrusion 60 in the cross section of the main body 20 perpendicular to the long axis direction x towards the inside of the first cylindrical object 310.

[0099] (2) In the shrinking process, the pressing component 300 of the second cylindrical object 320 presses the two sides of the protrusion 60 in the cross section perpendicular to the long axis direction x of the balloon body 20 toward the inside of the second cylindrical object 320.

[0100] By pressing the two sides of the protrusion 60 of the distal conical portion 24 disposed within the first cylindrical part 310 with the pressing member 300, the protrusion 60 is guided by the pressing member 300 and can move outward in the radial direction y of the balloon body 20. As a result, the front end portion 61 of the protrusion 60 of the distal conical portion 24 can be positioned outward in the radial direction y of the balloon body 20.

[0101] Furthermore, by pressing the two sides of the protrusion 60 of the proximal conical portion 22 disposed within the second cylindrical part 320 by the pressing member 300, the protrusion 60 is guided by the pressing member 300 and can move outward in the radial direction y of the balloon body 20. As a result, the front end portion 61 of the protrusion 60 of the proximal conical portion 22 can be positioned outward in the radial direction y of the balloon body 20.

[0102] In order to place the front end 61 of the protrusion 60 of the distal cone 24 on the outer side of the balloon body 20 in the radial direction y, the above-described step (1) is performed. In order to place the front end 61 of the protrusion 60 of the proximal cone 22 on the outer side of the balloon body 20 in the radial direction y, the above-described step (2) is performed. In order to place the front end 61 of the protrusions 60 of both the distal cone 24 and the proximal cone 22 on the outer side of the balloon body 20 in the radial direction y, the above-described steps (1) and (2) are performed.

[0103] In the process of preparing a balloon with a protrusion 60, for example, Figure 14 A cylindrical preform 200 made of resin, as shown, is placed in a mold with a groove in its inner cavity, and a balloon can be prepared by biaxial stretch blow molding. For example, the preform 200 is inserted into the inner cavity of the mold, and the thick-walled portion 220 of the preform 200 is inserted into the groove of the mold. Fluid is introduced into the inner cavity 210 of the preform 200 to expand the preform 200, thereby forming the protrusion 60. Alternatively, when the protrusion 60 is not formed in the distal sleeve portion 25 and the proximal sleeve portion 21, but an inner protrusion is formed, for example, by pressing the thick-walled portion 220 of the preform 200 against the ungrooved portion of the mold, fluid is introduced into the inner cavity 210 of the preform 200 to expand the preform 200, thereby manufacturing the balloon 2. The material constituting the preform 200 can be referred to the description of the materials constituting the balloon body 20 described above.

[0104] like Figure 15 and Figure 16As shown, the first cylindrical member 310 and the second cylindrical member 320 have internal spaces extending along the long axis. Furthermore, when the distal tapered portion 24 is disposed internally, a pressing member 300 is provided at a position corresponding to the protrusion 60. Preferably, a pair of pressing members 300 are disposed for each protrusion 60 so that both sides of the protrusion 60 in a cross-section perpendicular to the long axis x-direction can be pressed. Figure 17 As shown, the third cylindrical object 330 has a space extending along its long axis inside.

[0105] Preferably, the lengths of the major axis x of the first cylindrical member 310, the second cylindrical member 320, and the third cylindrical member 330 are approximately the same as the lengths of the major axis x of the distal tapered portion 24, the proximal tapered portion 22, and the straight tube portion 23, respectively. Furthermore, it is preferable that the internal spaces of the first cylindrical member 310, the second cylindrical member 320, and the third cylindrical member 330 have a diameter slightly larger than the outer diameter of the straight tube portion 23.

[0106] In the above configuration process, it is preferable to arrange the first cylindrical object 310, the third cylindrical object 330, and the second cylindrical object 320 sequentially along the long axis x with their respective spatial portions aligned, and insert the balloon into the spatial portion from the side of the second cylindrical object 320. This allows for the placement of the distal conical portion 24 within the first cylindrical object 310, the straight tube portion 23 within the third cylindrical object 330, and the proximal conical portion 22 within the second cylindrical object 320.

[0107] like Figure 18 As shown, before the pressing process, the pressing component 300 does not abut against the protrusion 60; conversely, during the pressing process, as... Figure 19 As shown, the pressing member 300 protrudes radially y, pressing the two sides of the protrusion 60 in a cross-section perpendicular to the long axis x towards the inside of the first cylindrical portion and / or the second cylindrical portion. Thus, the protrusion 60 is guided by the pressing member 300 to move radially y outward from the balloon body 20. The radial y length of the pressing member 300 can be appropriately set according to the radial y length of the corresponding protrusion 60.

[0108] In cases where it is desired to suppress the movement of the anterior end 61 of the protrusion 60 of the distal cone 24 and / or proximal cone 22 toward the circumferential z of the balloon body 20, such as Figure 19As shown, for example, the spacing between the pair of pressing members 300 is preferably set such that a pair of pressing members 300 relative to one protrusion 60 can press near the base end of the protrusion 60. Alternatively, although not shown, by adjusting the position of the pressing members 300, it is also possible to allow the front end 61 of the protrusion 60 to move circumferentially z toward the balloon body 20, and to allow the front end 61 of the protrusion 60 to move radially y toward the outside of the balloon body 20.

[0109] When the pressing member 300 of the first cylindrical object 310 or the pressing member 300 of the second cylindrical object 320 does not perform the pressing process, the first cylindrical object 310 or the second cylindrical object 320 may be a cylindrical object without the pressing member 300, like the third cylindrical object 330, or it may be housed in the wall of the first cylindrical object 310 or the second cylindrical object 320 so that the pressing member 300 does not abut against the protrusion 60.

[0110] By performing the pressing steps (1) and / or (2) described above, the arrangement of the front end portion 61 of the protrusion 60 is determined, thereby creating creases in the arrangement of the front end portion 61 of the protrusion 60 in the distal cone portion 24 and / or the proximal cone portion 22. Then, the balloon 2 can be folded using a hand, various folding machines, or the like. When the protrusion 60 is positioned outside the blade forming portion 28, it is preferable to fold the balloon 2 such that the blade 29 covers the protrusion 60. During folding, the balloon is folded in a manner that does not damage the arrangement of the front end portion 61 of the protrusion 60, which has been creased, thereby obtaining a balloon 2 in which the front end portion 61 of the protrusion 60 is positioned radially y-outer of the balloon body 20 in the folded state.

[0111] Materials constituting the first cylindrical object 310, the second cylindrical object 320, and the third cylindrical object 330 may include, for example, synthetic resins such as polycarbonate resins, polyacetal resins, and fluorine resins, as well as metals such as iron, copper, and stainless steel.

[0112] This application claims the benefit of priority based on Japanese Patent Application No. 2020-215753, filed on December 24, 2020. The entire contents of the description of Japanese Patent Application No. 2020-215753, filed on December 24, 2020, are incorporated herein by reference.

[0113] Explanation of reference numerals in the attached figures

[0114] 1…Balloon catheter; 2…Balloon; 3…Axis; 4…Gathering device; 5…Guidewire insertion section; 7…Fluid injection section; 20…Balloon body; 20C…Central axis of balloon body; 21…Proximal cannula section; 22…Proximal conical section; 23…Straight tube section; 24…Distal conical section; 25…Distal cannula section; 28…Blade forming section; 29…Blade; 31…Outer tube; 32…Inner tube; 60…Protrusion; 61…Anterior end section; 200…Preform; 210…Inner cavity of preform; 220…Thick-walled section of preform; 300…Pressing component; 310…First tubular part; 320…Second tubular part; 330…Third tubular part; L d …connect the anterior end of the distal conical portion D0 with D… 100 The straight line obtained by connecting the front ends; L p …the anterior end of D0 of the near-side cone and D 100 The straight line obtained by connecting the front ends; C d …make L d An imaginary surface obtained by rotating about the central axis of the balloon body; C p …make L p An imaginary surface obtained by rotating around the central axis of the balloon body; the position of D0…0%; D 20 …20% of the position; D 50 …50% of the position; D 90 …90% of the position; D 100 …100% position; x…major axis direction; y…radial direction; z…circumferential direction.

Claims

1. A balloon for a balloon catheter, comprising a balloon body having an outer surface and an inner surface, The balloon used in the balloon catheter is characterized in that... The balloon body has a straight tube portion, a distal conical portion located distal to the straight tube portion, and a proximal conical portion located closer to the straight tube portion. The distal conical portion, the straight tube portion, and the proximal conical portion have protrusions that extend radially outward from the outer surface of the balloon body and along the long axis of the balloon body. The protrusion has a front end in the radial section of the balloon body. When the balloon of the balloon catheter is in the contracted state, with one end of the distal conical portion and the proximal conical portion of the balloon body set to 0% and the other end set to 100% in the long axis direction, at least one of the following (1) and (2) is satisfied. (1) The front end of the protrusion in the interval from 20% to 50% of the distal conical portion is relative to a straight line L obtained by connecting the front end of the distal conical portion at 0% of the position to the front end of the distal conical portion at 100% of the position. d An imaginary curved surface, obtained by rotating about the central axis of the balloon body, is positioned radially outward of the balloon body. (2) The anterior end of the protrusion in the interval from 20% to 50% of the proximal conical portion is relative to the straight line L obtained by connecting the anterior end of the proximal conical portion at 0% of the position to the anterior end of the proximal conical portion at 100% of the position. p An imaginary curved surface, obtained by rotating about the central axis of the balloon body, is positioned radially outward of the balloon body. In the contracted state of the balloon catheter, the balloon is folded.

2. The balloon for balloon catheters according to claim 1, characterized in that, In the contracted state of the balloon catheter balloon, at least one of the following (1) and (2) is satisfied: (1) The front end of the protrusion in the interval from 90% to 100% of the distal conical portion relative to the straight line L d An imaginary curved surface obtained by rotating about the central axis of the balloon body is positioned radially inside or at the same location as the balloon body. (2) The anterior end of the protrusion in the interval from 90% to 100% of the proximal conical portion relative to the straight line L p An imaginary surface obtained by rotating about the central axis of the balloon body is positioned radially inside the balloon body or at the same location.

3. The balloon for balloon catheters according to claim 1 or 2, characterized in that, In the inflated state of the balloon catheter, the protrusions of the distal conical portion, the straight portion, and the proximal conical portion are positioned at the same location circumferentially on the balloon body.

4. The balloon for balloon catheters according to claim 1 or 2, characterized in that, In the contracted state of the balloon catheter, the protrusions of the straight tube, the distal conical section, and the proximal conical section are positioned at the same location circumferentially on the balloon body.

5. The balloon for balloon catheters according to claim 1 or 2, characterized in that, The balloon body has a blade-forming portion that forms a blade in the contracted state, and the protrusion is disposed in a portion other than the blade-forming portion.

6. The balloon for balloon catheters according to claim 1 or 2, characterized in that, The protrusions of the distal conical portion, the straight tube portion, and the proximal conical portion extend continuously along the long axis of the balloon body.

7. The balloon for balloon catheters according to claim 1 or 2, characterized in that, The protrusion is made of the same material as the balloon body.

8. A method for manufacturing a balloon for a balloon catheter, comprising the method for manufacturing a balloon for a balloon catheter according to any one of claims 1 to 7. The method for manufacturing the balloon for the balloon catheter is characterized by having: The process of preparing a first cylindrical object, a second cylindrical object, and a third cylindrical object, wherein the first cylindrical object and the second cylindrical object each have a space extending along the long axis direction inside, and have a pressing member on the inner side that can protrude and be inserted from the outside to the inside; the third cylindrical object has a space extending along the long axis direction inside. The process of preparing a balloon for a balloon catheter, wherein the balloon for the balloon catheter has a balloon body, the balloon body has an outer surface and an inner surface, the balloon body has a straight tube portion, a distal conical portion located distal to the straight tube portion, and a proximal conical portion located closer to the straight tube portion, the distal conical portion, the straight tube portion and the proximal conical portion having protrusions, the protrusions protruding radially outward from the outer surface of the balloon body and extending along the long axis of the balloon body; The configuration process involves configuring the distal conical portion inside the first cylindrical object, configuring the proximal conical portion inside the second cylindrical object, and configuring the straight tube portion inside the third cylindrical object. as well as The shrinkage process involves shrinking the balloon catheter using a balloon. The method for manufacturing the balloon for the balloon catheter includes at least one of the steps of (1) and (2) below. (1) In the shrinkage process, the pressing member of the first cylindrical object presses the two sides of the protrusion in the cross section perpendicular to the long axis of the balloon body toward the inside of the first cylindrical object. (2) In the shrinkage process, the pressing component of the second cylindrical object presses the two sides of the protrusion in the cross section perpendicular to the long axis of the balloon body toward the inside of the second cylindrical object.

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