Balloon for balloon catheter

Abstract

The present invention provides a balloon for a balloon catheter, which can obliquely cut a stenotic portion or cut a stenotic portion more widely in the 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) In the contracted state, the front end (61) of the distal conical portion (24) relative to the straight line L d It is positioned on the first direction C1 side of the circumferential direction of the balloon body (20) but not on the second direction C2 side. (2) In the contracted state, the anterior end (61) of the proximal cone (22) is positioned relative to the straight line L. p It is positioned on the first direction C1 side of the circumferential direction of the balloon body (20) and not on the second direction C2 side.

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 anterior end of the balloon, thereby attempting to improve balloon permeability. Furthermore, in the balloon catheter disclosed in Patent Document 4, the height of the protrusion disposed on the anterior conical portion is increased so that when only the anterior conical region is introduced into the lesion and the balloon is inflated, the element disposed on the anterior conical region can be used to form an incision in the lesion while inflating the balloon. However, regardless of the balloon, it cannot be assumed that the narrow portion can be obliquely cut while the balloon is advanced or retracted in its contracted state, or that a wider area can be cut in a single action. 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 obliquely cut the stenosis or cut the stenosis more widely 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 cross section of the balloon body, and the balloon catheter balloon satisfies at least one of the following (1) and (2).

[0012] (1) In the contracted state of the balloon of the balloon catheter, the anterior end of the protrusion of the distal cone is relative to the straight line L obtained by connecting the anterior end of the proximal end of the distal cone and the anterior end of the distal end of the distal cone. d It is positioned on the first direction side of the circumference of the balloon body and not on the second direction side, or it is positioned on the second direction side and not on the first direction side.

[0013] (2) In the contracted state of the balloon catheter, the straight line L obtained by connecting the anterior end of the proximal conical portion of the proximal conical portion with the anterior end of the distal end of the proximal conical portion and the anterior end of the proximal end of the proximal conical portion. pIt is positioned on the first direction side of the circumference of the balloon body and not on the second direction side, or it is positioned on the second direction side and not on the first direction side.

[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, one end of the distal conical portion and the proximal conical portion of the balloon body is set to 0% and the other end is set to 100%, at least one of (1) and (2) below is satisfied.

[0016] (1) The anterior end of the protrusion of the distal conical portion in the entire range from the 20% position to the 70% position relative to the straight line L d The front end of the protrusion in the range of 90% to 100% position of the distal tapered portion, disposed on the first or second direction side, is relative to the straight line L. d It is not configured on the first direction side or the second direction side.

[0017] (2) The anterior end of the protrusion in the entire range from the 20% position to the 70% position of the proximal conical part relative to the straight line L p The anterior end of the protrusion in the range of 90% to 100% position of the proximal tapered portion, disposed on the first or second direction side, is relative to the straight line L. p It is not configured on the first direction side or the second direction side.

[0018] In this case, it is even more preferable to satisfy at least one of (1) and (2) below.

[0019] (1) The anterior end of the protrusion at the 40% position of the distal conical part and the straight line L d The distance is 60% of the distance of the protrusion at the front end of the distal conical part and the straight line L. d More than 1.2 times the distance.

[0020] (2) The anterior end of the protrusion at the 40% position of the proximal conical part and the straight line L p The distance is 60% of the distance of the protrusion at the front end of the protrusion and the straight line L. p More than 1.2 times the distance.

[0021] Preferably, when the balloon of the balloon catheter is in the contracted state, at least one of (1) and (2) below is satisfied.

[0022] (1) The anterior end of the protrusion in the entire range from the 20% position to the 70% position of the distal conical portion relative to the straight line L dAn 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.

[0023] (2) The anterior end of the protrusion in the entire range from the 20% position to the 70% 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.

[0024] Preferably, when the balloon of the balloon catheter is in the inflated state, the anterior ends of the protrusions of the distal conical portion, the protrusions of the straight portion, and the protrusions of the proximal conical portion are positioned at the same position circumferentially on the balloon body.

[0025] 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.

[0026] 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.

[0027] The preferred protrusion is made of the same material as the balloon body.

[0028] In addition, the present invention also provides a method for manufacturing the balloon for the balloon catheter described above. A manufacturing method according to one embodiment of the present invention includes: a step of preparing a first cylindrical object, a second cylindrical object, and a third cylindrical object, each of the first cylindrical object, the second cylindrical object, and the third cylindrical object having a space extending along the long axis direction inside; a step of preparing a balloon for a balloon catheter, the balloon for a balloon catheter having a balloon body having an outer surface and an inner surface, the balloon body having a straight tube portion, a distal conical portion located 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 that protrude radially outward from the outer surface of the balloon body and extend along the long axis direction of the balloon body; and a placement step, in which, in the contracted state of the balloon for a balloon catheter, the distal conical portion is placed in the first cylindrical object, the proximal conical portion is placed in the second cylindrical object, and the straight tube portion is placed in the third cylindrical object, the manufacturing method satisfying at least one of (1) and (2) below.

[0029] (1) In the configuration process, the inner surface of the first cylindrical object abuts against at least a portion of the protrusion of the distal conical portion.

[0030] (2) In the configuration process, the inner surface of the second cylindrical object abuts against at least a portion of the protrusion of the proximal conical portion.

[0031] According to the balloon for the above-mentioned balloon catheter, in the constricted state of the balloon, the anterior end of the protrusion of at least one of the distal conical portion and the proximal conical portion is positioned on the first circumferential direction side of the balloon and not on the second circumferential direction side, or positioned on the second circumferential direction side and not on the first circumferential direction side. Therefore, during balloon delivery, when the balloon is delivered to the lesion, it is possible to obliquely cut the stenosis or a wider area while advancing or retracting the balloon in the constricted state. Attached Figure Description

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

[0033] 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.

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

[0035] Figure 4 express Figure 2 The diagram shows a radial cross-sectional view of the straight section of the balloon in its contracted state.

[0036] Figure 5 express Figure 2 The diagram shows a radial cross-sectional view of the conical portion of the balloon in its contracted state.

[0037] Figure 6 express Figure 2 The balloon shown is a top view from the protruding side in its contracted state.

[0038] Figure 7 A top view of a balloon in a contracted state, as seen from the protrusion side, illustrating another embodiment of the present invention.

[0039] Figure 8 This is a top view of a balloon in a contracted state, as seen from the protrusion side, representing yet another embodiment of the present invention.

[0040] Figure 9 This is a top view of a balloon in a contracted state, as seen from the protrusion side, representing another embodiment of the present invention.

[0041] Figure 10 This is a top view of a balloon in a contracted state, as seen from the protrusion side, representing another embodiment of the present invention.

[0042] Figure 11 This is a top view of a balloon in a contracted state, as seen from the protrusion side, representing another embodiment of the present invention.

[0043] Figure 12 This is a top view of a balloon in a contracted state, as seen from the protrusion side, representing another embodiment of the present invention.

[0044] Figure 13 This is a top view of a balloon in a contracted state, as seen from the protrusion side, representing another embodiment of the present invention.

[0045] Figure 14 express Figure 2 The balloon shown is a side view in its folded state.

[0046] Figure 15 express Figure 14 XV-XV sectional view.

[0047] Figure 16 express Figure 14 XVI-XVI sectional view.

[0048] Figure 17 express Figure 14 Sectional view of XVII-XVII.

[0049] Figure 18 A top view of a balloon in a contracted state, as seen from the protrusion side, illustrating another embodiment of the present invention.

[0050] Figure 19 This is a top view of a balloon in a contracted state, as seen from the protrusion side, representing another embodiment of the present invention.

[0051] Figure 20 express Figure 2 The image shows a partial side view of the balloon in its contracted state.

[0052] Figure 21 express Figure 2 The balloon shown is viewed from the protruding side as a top view.

[0053] Figure 22 A perspective view of a preform before expansion, representing one embodiment of the present invention.

[0054] Figure 23 A cross-sectional view perpendicular to the long axis direction of a first or second cylindrical object in a manufacturing method according to an embodiment of the present invention.

[0055] Figure 24 This is a radial cross-sectional view showing a step in which a distal tapered portion is disposed within a first cylindrical object, or a proximal tapered portion is disposed within a second cylindrical object, in a manufacturing method according to one embodiment of the present invention.

[0056] Figure 25 express Figure 24Radial sectional views of different portions of the first or second cylindrical object along its long axis.

[0057] Figure 26 express Figure 24 A radial cross-sectional view of another different portion of the first or second cylindrical object along its major axis.

[0058] Figure 27 This is a radial cross-sectional view showing a third cylindrical object in a manufacturing method according to one embodiment of the present invention. Detailed Implementation

[0059] 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.

[0060] A balloon catheter of one embodiment 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 cross section of the balloon body. The balloon catheter of the present invention satisfies at least one of (1) and (2) below.

[0061] (1) In the contracted state of the balloon of the balloon catheter, the anterior end of the protrusion of the distal cone is relative to the straight line L obtained by connecting the anterior end of the proximal end of the distal cone and the anterior end of the distal end of the distal cone. d It is positioned on the first direction side of the circumference of the balloon body and not on the second direction side, or it is positioned on the second direction side and not on the first direction side.

[0062] (2) In the contracted state of the balloon catheter, the straight line L obtained by connecting the anterior end of the proximal conical portion of the proximal conical portion with the anterior end of the distal end of the proximal conical portion and the anterior end of the proximal end of the proximal conical portion. p It is positioned on the first direction side of the circumference of the balloon body and not on the second direction side, or it is positioned on the second direction side and not on the first direction side.

[0063] In this manner, when the balloon is in its contracted state, the anterior end of the protrusion of at least one of the distal and proximal conical portions is positioned on the first or second circumferential side of the balloon body. Therefore, during balloon delivery, when the balloon is delivered to the lesion, the stenosis can be obliquely cut while the balloon is advanced or retracted in its contracted state, or a wider area can be cut in a single action. In this specification, the balloon catheter is sometimes simply referred to as a "balloon".

[0064] Reference Figures 1 to 21 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 image shows a top view of the balloon in its contracted state, viewed from the protruding side. Figures 7-13 These are top views of balloons in their contracted state, as viewed from the protrusion side, representing different implementations. Figure 14 express Figure 2 The image shows a side view of the balloon in its folded state. Figure 15 , Figure 16 and Figure 17 They represent Figure 14 The XV-XV, XVI-XVI, and XVII-XVII sections of the balloon are shown. Figure 18 and Figure 19 These are top views of balloons in their contracted state, as viewed from the protrusion side, representing different implementations. Figure 20 express Figure 2 The diagram shows a partial side view of the balloon in its contracted state, representing a portion with a protrusion formed along the main body of the balloon when viewed from the front side. Figure 21 express Figure 2 The balloon shown is viewed from the protruding side as a top view.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] like Figures 1 to 13 As shown, the balloon 2 of the balloon catheter 1 has 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 radially outward 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. The balloon 2 of the balloon catheter 1 satisfies at least one of the following (1) and (2).

[0069] (1) When the balloon 2 of the balloon catheter 1 is in a contracted state, the anterior end 61 of the protrusion 60 of the distal conical portion 24 is relative to the straight line L obtained by connecting the anterior end 61 of the proximal end of the distal conical portion 24 and the anterior end 61 of the distal end of the distal conical portion 24. d It is configured on the first direction C1 side of the circumferential z of the balloon body 20 and not configured on the second direction C2 side, or configured on the second direction C2 side and not configured on the first direction C1 side.

[0070] (2) In the contracted state of the balloon 2 in the balloon catheter 1, the anterior end 61 of the proximal conical portion 22 is connected to the anterior end 61 of the distal end of the proximal conical portion 22 and the anterior end 61 of the proximal end of the proximal conical portion 22 to form a straight line L. p It is configured on the first direction C1 side of the circumferential z of the balloon body 20 and not configured on the second direction C2 side, or configured on the second direction C2 side and not configured on the first direction C1 side.

[0071] In the contracted state of the balloon 2, the anterior end 61 of the protrusion 60 of at least one of the distal cone portion 24 and the proximal cone portion 22 is disposed on the first direction C1 side or the second direction C2 side of the circumferential z of the balloon body 20. Therefore, during the delivery of the balloon 2, when the balloon 2 is delivered to the lesion, the stenosis can be cut obliquely while the balloon 2 is moved forward or backward in the contracted state, or a wider area can be cut in one action.

[0072] 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.

[0073] 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.

[0074] like Figure 2 and Figure 3 As shown, the protrusion 60 of the balloon 2 is a portion that protrudes outward from the outer surface of the balloon body 20 in a radially y-directed manner when the balloon 2 is in its expanded state. In the radially y-directed section, the maximum length of the protrusion 60 protruding 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. Therefore, the protrusion 60 facilitates the formation of an incision of appropriate depth in the narrow portion, making incision easier. Furthermore, this protrusion 60 can improve the strength of the balloon 2 or suppress excessive expansion of the balloon 2 during pressurization.

[0075] 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.

[0076] 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.

[0077] 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 radial y-sectional view of the straight tube portion 23 in its contracted state 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.

[0078] like Figures 6 to 13 As shown, 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 respectively relative to the straight line L d and line L pThey are independently disposed on the first direction C1 side of the circumferential z of the balloon body 20 and not disposed on the second direction C2 side, or disposed on the second direction C2 side and not disposed on the first direction C1 side. That is, the anterior end portion 61 of the protrusion 60 of at least one of the distal cone portion 24 and the proximal cone portion 22 does not cross the straight line L. d and line L p And it's positioned on both sides. Additionally, in Figures 6 to 13 The diagram shows that the front end portion 61 of the protrusion 60 of at least one of the distal conical portion 24 and the proximal conical portion 22, spanning the entire distance from the distal end to the proximal end, is disposed on the first direction C1 side or the second direction C2 side. However, the front end portion 61 of the protrusion 60 of at least one of the distal conical portion 24 and the proximal conical portion 22 may be disposed on the first direction C1 side or the second direction C2 side, and other portions may also be disposed on the straight line L. d Or straight line L p superior.

[0079] like Figure 6 and Figure 7 As shown, the front ends 61 of the protrusions 60 on both the distal conical portion 24 and the proximal conical portion 22 can also be relative to the straight line L. d and line L p It is configured on the first direction C1 side or the second direction C2 side. With such a structure, the anterior ends 61 of the protrusions 60 in the distal cone 24 and the proximal cone 22 can be configured on the same side in the circumferential direction z. Therefore, the anterior ends 61 of the balloon 2 in the case of advancement and retraction in the body cavity can be configured on the same side in the circumferential direction z. The anterior ends 61 of the protrusions 60 in the distal cone 24 and the proximal cone 22 can be used to obliquely cut the same side of the body cavity wall in the circumferential direction z or to cut a wider area in one action.

[0080] like Figure 8 and Figure 9 As shown, it is also possible that the front end portion 61 of the protrusion 60 of the distal tapered portion 24 is relative to the straight line L. d The front end portion 61 of the protrusion 60 of the proximal tapered portion 22, disposed on the first direction C1 side or the second direction C2 side, is relative to the straight line L. p The distal conical portion 24 is disposed on the second direction C2 side or the first direction C1 side, opposite to the distal conical portion 24. With such a structure, the anterior ends 61 of the protrusions 60 in the distal conical portion 24 and the proximal conical portion 22 can be disposed on different sides in the circumferential direction z. Therefore, the anterior ends 61 that allow the balloon 2 to advance and retract within the body cavity can be disposed on different sides in the circumferential direction z. This allows different parts to be cut obliquely by the advance and retraction of the balloon 2, or a wider area to be cut in one action.

[0081] like Figure 10 and Figure 11 As shown, it is also possible that the front end 61 of the protrusion 60 of the proximal side tapered portion 22 is relative to the straight line L. p The front end portion 61 of the protrusion 60 of the distal tapered portion 24, disposed on the first direction C1 side or the second direction C2 side, is relative to the straight line L. d It is not configured on either the first direction C1 side or the second direction C2 side. With such a structure, only the front end 61 of the protrusion 60 of the proximal cone 22 can be configured on the first direction C1 side or the second direction C2 side in the circumferential z direction. Since the front end 61 of the protrusion 60 of the distal cone 24 does not bend in the circumferential z direction, it is possible to cut straight on the front end 61 of the distal cone 24, and to cut obliquely, for example, while retracting the balloon 2, using the front end 61 of the proximal cone 22, or to cut a wider area in one action.

[0082] like Figure 12 and Figure 13 As shown, it is also possible that the front end portion 61 of the protrusion 60 of the distal tapered portion 24 is relative to the straight line L. d The front end portion 61 of the protrusion 60 of the proximal tapered portion 22, disposed on the first direction C1 side or the second direction C2 side, is relative to the straight line L. p It is not configured on either the first direction C1 side or the second direction C2 side. With such a structure, the front end 61 of the protrusion 60 of the distal cone 24 can be configured only on the first direction C1 side or the second direction C2 side in the circumferential z direction. Since the front end 61 of the protrusion 60 of the proximal cone 22 does not bend in the circumferential z direction, it is possible to cut straight on the front end 61 of the proximal cone 22, and to cut obliquely, for example, while advancing the balloon 2, using the front end 61 of the distal cone 24, or to cut a wider area in one action.

[0083] As mentioned above, for example, through appropriate selection Figures 6 to 13 The various methods shown allow for the use of balloon 2, which can be optimally suited for treating lesions at the target site. Figures 6 to 13 The figure shows the straight line L. d and line L p The way it extends along the major axis x, but the straight line L d and line L p It can also be extended in a manner that has an angle relative to the major axis direction x in the circumferential direction z.

[0084] In addition, Figures 6 to 13The diagram shows a configuration where both the distal cannula 25 and the proximal cannula 21 have protrusions 60. However, the distal cannula 25 and the proximal cannula 21 may also lack protrusions 60. Alternatively, the distal cannula 25 and the proximal cannula 21 may have inner protrusions that protrude radially inward from the inner surface of the balloon body 20. If the distal cannula 25 and the proximal cannula 21 do not have protrusions 60, insertion of the balloon 2 into the body cavity, its advancement within the body cavity, and its retraction become easier.

[0085] 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 tapered portion 24 or the proximal tapered portion 22 is shorter than the length of the protrusion 60 in the straight tube portion 23. Furthermore, it is preferable that, 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.

[0086] like Figures 14-17 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 15 As shown, the amount of winding of the blade 29 increases. On the other hand, in the distal conical portion 24 and the proximal conical 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 shortens further toward the distal side and further toward the proximal side. In one embodiment of the invention, in the portion near the straight tube portion 23 of the distal conical portion 24 and the proximal conical portion 22, such as Figure 16 As shown, the shorter blades 29 in the straight tube section 23 are wound around the shaft 3 (inner tube 32), and in the more distal and more proximal portions, as... Figure 17 As shown, the further shortened blades 29 are wound around the shaft 3 (inner tube 32). Alternatively, by adjusting the diameter of the balloon 2 and the number of blades 29, even in the portion near the straight tube portion 23 of the distal conical portion 24 and the proximal conical portion 22, it is possible to achieve the same effect. Figure 17 The amount of winding of the blade 29 is reduced, and the blade 29 is almost not formed. By folding the balloon 2, the balloon 2 can be easily inserted into the body cavity.

[0087] like Figure 18 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%. 100 In this case, it is preferable to satisfy at least one of (1) and (2) below.

[0088] (1) The distal conical portion 24 from position D at 20% 20 To 70% of position D 70 The front end 61 of the protrusion 60 in the entire interval is relative to the straight line L d The distal tapered portion 24 is positioned at 90% of its length on either the first direction C1 side or the second direction C2 side. 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 It is not configured on the first direction C1 side and the second direction C2 side.

[0089] (2) The position D of the proximal conical part 22 at 20% of its length 20 To 70% of position D 70 The front end 61 of the protrusion 60 in the entire interval is relative to the straight line L p The proximal conical portion 22 is positioned at 90% of its length on either the first direction C1 side or the second direction C2 side. 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 It is not configured on the first direction C1 side and the second direction C2 side.

[0090] The distal conical portion 24 and the proximal conical portion 22 are furthest from the straight tube portion 23 at position D (90%). 90 To 100% position D 100 The section is the portion 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, the anterior end 61 of the protrusion 60 of at least one of the distal cone portion 24 and the proximal cone portion 22 in this section is relative to the straight line L. d Or straight line L p Not positioned on the first direction C1 side and the second direction C2 side, thereby allowing a straight incision to be formed in the body cavity wall through the anterior end of the balloon 2. Based on this structure, at least one of the distal conical portion 24 and the proximal conical portion 22 is positioned at 20% of its length. 20 To 70% of position D 70 The front end 61 of the protrusion 60 in the entire interval is relative to the straight line L d Or straight line L pPositioned on the first direction C1 side or the second direction C2 side, the balloon 2 can be moved forward or backward, thereby making an oblique cut through the front end of the balloon 2, forming a straight incision, or cutting a wider area in one action.

[0091] exist Figure 18 The diagram shows a configuration where both conditions (1) and (2) above are met, but it is also possible for either the distal conical portion 24 or the proximal conical portion 22 to meet either condition (1) or (2). From the viewpoint of forming a straight incision through the frontal sides of both ends of the balloon 2, it is preferable that both the distal conical portion 24 and the proximal conical portion 22 meet the conditions (1) and (2) above. Thus, whether the balloon 2 is moved forward or backward, a straight incision can be formed through the frontal side of the balloon 2.

[0092] like Figure 19 As shown, the balloon 2 of the embodiment of the present invention, based on the manner described above, further preferably satisfies at least one of (1) and (2) below.

[0093] (1) The position D at 40% of the distal conical portion 24 40 The front end 61 of the protrusion 60 at the point and the straight line L d The distance is 60% of the position D of the distal conical portion 24. 60 The front end 61 of the protrusion 60 at the point and the straight line L d More than 1.2 times the distance.

[0094] (2) Position D at 40% of the proximal conical portion 22 40 The front end 61 of the protrusion 60 at the point and the straight line L p The distance is 60% of the position of the proximal conical portion 22, D. 60 The front end 61 of the protrusion 60 at the point and the straight line L p More than 1.2 times the distance.

[0095] 40% of the position D 40 The front end 61 of the protrusion 60 at the point and the straight line L d Or straight line L p The preferred distance is 60% of position D. 60 The front end 61 of the protrusion 60 at the point and the straight line L d Or straight line L p The distance is more than 1.5 times, and more preferably more than 2 times. Additionally, 40% of the position D... 40 The front end 61 of the protrusion 60 at the point and the straight line L d Or straight line L p The preferred distance is 60% of position D. 60The front end 61 of the protrusion 60 at the point and the straight line L d Or straight line L p The distance is less than 10 times, more preferably less than 8 times, and even more preferably less than 5 times. With the above structure, the front end portion 61 of the protrusion 60 of at least one of the distal conical portion 24 and the proximal conical portion 22 can be positioned relative to the straight line L. d Or straight line L p Position D, configured on the first direction C1 side or the second direction C2 side, from 20% position 20 To 70% of position D 70 The entire section forms a more curved section, which can cut at an angle while the balloon 2 moves forward or backward, or cut a wider area in one motion.

[0096] like Figure 20 As shown, in the contracted state of balloon 2, it is preferable to satisfy at least one of (1) and (2) below.

[0097] (1) The distal conical portion 24 from position D at 20% 20 To 70% of position D 70 The front end 61 of the protrusion 60 in the entire 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.

[0098] (2) The position D of the proximal conical part 22 at 20% of its length 20 To 70% of position D 70 The front end 61 of the protrusion 60 in the entire 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.

[0099] In the contracted state of 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 relative to the imaginary curved surface C. d Or imaginary surface C p It is positioned inside the radial y-axis of the balloon body 20 or at the same location, thus suppressing the diameter of that portion and allowing the balloon 2 to be easily inserted as it moves forward or backward within the body cavity.

[0100] like Figure 20 As shown, the straight line L d Or straight line L p It can also have an angle in the radial y direction relative to the central axis 20C (i.e., the major axis direction x) of the balloon body 20. In the straight line L...d Or straight line L p The imaginary surface C has an angle in the radial y direction relative to the central axis 20C of the balloon body 20. d and imaginary surface C p like Figure 20 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.

[0101] Although not illustrated, the straight line L... d Or straight line L p It can also be parallel to the central axis 20C (i.e., the long axis direction x) of the balloon body 20. In the straight line L d Or straight line L p Imaginary surface C parallel to the central axis 20C of the balloon body 20 d and imaginary surface C p It becomes the lateral surface of the cylinder. If the straight 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 wrapped around the axis 3, insertion into the body cavity becomes easier.

[0102] exist Figure 20 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 used as the side surface of a frustum, but it can also be the imaginary curved surface C at the distal conical part 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.

[0103] exist Figure 20The image shows the cone-shaped portion on both sides at position D, which is 20% of its length. 20 To 70% of position D 70 The balloon 2 of the present invention satisfies the conditions (1) and (2) above throughout the entire interval, but the balloon 2 of the present invention includes either the distal conical portion 24 or the proximal conical portion 22 in a manner that satisfies the conditions (1) or (2) above. From the viewpoint of improved insertion patency when the balloon 2 is inserted into the body cavity and advanced to the lesion, the distal conical portion 24 at position D of 20% is particularly effective. 20 To 70% of position D 70 Throughout the entire range, the front end portion 61 of the preferred 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.

[0104] As described above, in the inflated state of the balloon 2 of the embodiment of the present invention, the anterior end portion 61 of at least one of the protrusions 60 of the distal conical portion 24 and the proximal conical portion 22 is respectively positioned relative to the straight line L. d and line L p Each is independently configured to bend toward the first direction C1 or the second direction C2 of the circumferential z of the balloon body 20, but in the inflated state, as... Figure 21 As shown, the anterior end 61 of the protrusion 60 of the distal conical portion 24, the anterior end 61 of the protrusion 60 of the straight tube portion 23, and the anterior end 61 of the protrusion 60 of the proximal conical portion 22 are preferably positioned at the same location in the circumferential z direction of the balloon body 20. Thus, not only can the balloon 2 be cut straight when inflated in the lesion area after delivery, but it can also be formed into a balloon that, in the contracted state, can obliquely cut narrow sections while advancing or retracting, or cut a wider area in a single action.

[0105] like Figure 21 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 body 20, the strength of the balloon 2 can be further improved or the over-expansion of the balloon 2 during pressurization can be further suppressed.

[0106] like Figures 3-5 and Figures 15-17As 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 15 and Figure 16 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 16 and Figure 17 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 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 be advanced or retracted while the exposed protrusion 60 is used to cut through the stenosis. Alternatively, the blade 29 can also be long enough to cover the protrusion 60 beyond 50% of the distal conical portion 24 and the proximal conical portion 22. In this case, the portion of the protrusion 60 exposed from the blade 29 can be reduced, thus 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.

[0107] exist Figure 4 , Figure 5 and Figures 15-17The 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.

[0108] 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.

[0109] 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.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] 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.

[0114] 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 22-27 The manufacturing method of the balloon 2 according to an embodiment of the present invention will be described. Figure 22 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 23A radial cross-sectional view of a first or second cylindrical object in a manufacturing method according to an embodiment of the present invention. Figure 24 This is a radial cross-sectional view showing the process of arranging a distal conical portion in a first cylindrical object or a proximal conical portion in a second cylindrical object in a manufacturing method according to one embodiment of the present invention. It is also a radial cross-sectional view showing the portion in the first or second cylindrical object where the proximal end of the distal conical portion or the distal end of the proximal conical portion is respectively arranged. Figure 25 express Figure 24 A radial cross-sectional view of another portion along the major axis of the first or second cylindrical object, showing the front end of the protrusion with the distal tapered portion relative to the straight line L. d The portion disposed on the circumferential first direction side of the balloon body, or the anterior end of the protrusion having the proximal conical portion, relative to the straight line L. p A radial cross-sectional view of a portion of the balloon body located on the circumferential first direction side. Figure 26 express Figure 24 A radial sectional view of another portion of the first or second cylindrical object along its major axis, showing the front end of the protrusion with the distal tapered portion relative to the straight line L. d The portion disposed on the circumferential side of the balloon body, closer to the first direction, or the anterior end of the protrusion with the proximal conical portion, relative to the straight line L. p A radial cross-sectional view of a portion of the balloon body located circumferentially towards the first direction side. Figures 24-26 The dashed lines in the diagram represent the circumferential position of the anterior end of the proximal end of the distal conical portion or the circumferential position of the anterior end of the proximal end of the distal conical portion; these correspond to the straight line L. d or L p The basis. Figure 27 This is a radial cross-sectional view showing a third cylindrical object in a manufacturing method according to one embodiment of the present invention.

[0115] The method for manufacturing the balloon 2 according to an embodiment of the present invention includes: a step of preparing a first cylindrical object 310, a second cylindrical object 320, and a third cylindrical object 330, wherein the first cylindrical object 310, the second cylindrical object 320, and the third cylindrical object 330 each have a space extending along the long axis direction inside; and a step of 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 portion located closer to the straight tube portion 23. The proximal conical portion 22, the distal conical portion 24, the straight tube portion 23 and the proximal conical portion 22 have a protrusion 60, which protrudes outward from the outer surface of the balloon body 20 in a radial direction y and extends along the long axis direction x of the balloon body 20; and the arrangement process, in which, in the balloon in a contracted state, the distal conical portion 24 is arranged in the first cylindrical body 310, the proximal conical portion 22 is arranged in the second cylindrical body 320 and the straight tube portion 23 is arranged in the third cylindrical body 330, and the manufacturing method of the balloon 2 satisfies at least one of (1) and (2) below.

[0116] (1) In the configuration process, the inner surface of the first cylindrical object 310 abuts against at least a portion of the protrusion 60 of the distal conical portion 24.

[0117] (2) In the configuration process, the inner surface of the second cylindrical object 320 abuts against at least a portion of the protrusion 60 of the proximal conical portion 22.

[0118] By having at least a portion of the protrusion 60, configured as the distal conical portion 24, abut against the inner surface of the first cylindrical member 310, the protrusion 60 can be moved toward the circumferential z direction 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 configured to bend toward either the first direction C1 or the second direction C2 direction of the circumferential z direction of the balloon body 20 in the contracted state.

[0119] Furthermore, by having at least a portion of the protrusion 60 of the proximal conical portion 22 abut against the inner surface of the second cylindrical member 320, the protrusion 60 can be moved toward the circumferential z direction 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 configured to bend toward either the first direction C1 or the second direction C2 direction of the circumferential z direction of the balloon body 20 in the contracted state.

[0120] To move the front end 61 of the protrusion 60 of the distal cone 24 toward the circumferential z of the balloon body 20 in the contracted state, only the above-described step (1) needs to be performed. To move the front end 61 of the protrusion 60 of the proximal cone 22 toward the circumferential z of the balloon body 20 in the contracted state, only the above-described step (2) needs to be performed. To move the front end 61 of the protrusions 60 of both the distal cone 24 and the proximal cone 22 toward the circumferential z of the balloon body 20 in the contracted state, only the above-described steps (1) and (2) need to be performed.

[0121] In the process of preparing the balloon, for example, Figure 22 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.

[0122] like Figure 23 As shown, in the case of implementing the manufacturing method of one embodiment of the present invention, the first cylindrical object 310 preferably has a space extending along the long axis direction x inside, and the shape of the radial y cross section of this space is different in the long axis direction x. That is, preferably, the shape of the space is different according to the distance the front end portion 61 of the distal conical portion 24 moves in the circumferential z direction towards the balloon body 20 in the contracted state. As a result, the position where the inner surface of the first cylindrical object 310 abuts against at least a portion of the protrusion 60 of the distal conical portion 24 can be changed, the front end portion 61 of the protrusion 60 of the distal conical portion 24 can be prevented from moving radially y towards the balloon body 20 in the contracted state, and the distance of movement in the circumferential z direction towards the balloon body 20 can be adjusted.

[0123] An example of the shape in the radial y-section of the spatial portion of the first cylindrical member 310 will be described. The distal and proximal ends of the distal tapered portion 24 are provided, i.e., the straight line L... dThe space portion of the first cylindrical member 310 disposed at the front end 61 of the protrusion 60 of the distal conical portion 24 at the base and front end preferably has a shape that does not abut against the protrusion 60. For example, the space portion of the first cylindrical member 310 disposed at the proximal end of the distal conical portion 24 may also be a space portion. Figure 24 The shape shown. When it is desired to suppress the radial y-direction movement of the distal conical portion 24's protrusion 60 towards the balloon body 20, the distal conical portion 24's protrusion 60's protrusion 61 is positioned relative to the straight line L. d The space portion of the first cylindrical member 310 disposed in a portion disposed on the first direction C1 side of the circumferential z of the balloon body 20 preferably has Figure 25 A spatial portion, as shown, at least partially abutting against the protrusion 60. The front end portion 61 of the protrusion 60 of the distal tapered portion 24 is positioned relative to the straight line L. d The space portion of the first cylindrical member 310, which is further configured in the portion configured on the first circumferential direction C1 side, preferably has Figure 26 A spatial portion, as shown, at least partially abutting against the protrusion 60. Like this, as... Figures 24-26 As shown in the example, by changing the shape of the spatial portion, it is possible to prevent the front end 61 of the protrusion 60 of the distal conical portion 24 from moving radially y toward the balloon body 20 in the contracted state, and to adjust the distance of movement toward the circumferential z of the balloon body 20. Alternatively, although not shown, by adjusting the cross-sectional shape of the radially y-shaped portion of the spatial portion of the first cylindrical member 310, it is also possible to allow the front end 61 of the protrusion 60 to move radially y toward the balloon body 20 while simultaneously allowing at least a portion of the protrusion 60 to abut against the inner surface of the first cylindrical member 310, and to allow the front end 61 of the protrusion 60 to move radially y toward the balloon body 20 while simultaneously allowing it to move circumferentially z toward the balloon body 20, thereby allowing adjustment of the distance of movement toward the circumferential z along the long axis direction x. The shape of the spatial portion of the first cylindrical member 310 is not limited to Figures 24-26 The shape shown can be any shape, as long as it can suppress or allow the front end 61 of the protrusion 60 of the distal conical portion 24 to move radially y toward the balloon body 20 in the contracted state, and can adjust the distance of circumferential z movement toward the balloon body 20.

[0124] Preferably, the shapes of the first cylindrical member 310 and the second cylindrical member 320 in the radial y section change continuously in the long axis direction x. As a result, the front end portion 61 of the protrusion 60 of the distal conical portion 24 and the front end portion 61 of the protrusion 60 of the proximal conical portion 22 can move continuously in the long axis direction x toward the circumferential direction z of the balloon body 20 in the contracted state.

[0125] The third cylindrical member 330 has an internal space extending along its long axis x. The shape of the radial y-section of the space of the third cylindrical member 330 can be as follows: Figure 27 The shape shown is the same as that of the space portion of the first cylindrical member 310 in the portion where the distal conical portion 24 is disposed near its proximal end, or it may be different, but preferably the area of ​​the space portion of the third cylindrical member 330 in the radial y section is larger than the area of ​​the space portion of the first cylindrical member 310. This prevents the protrusion 60 of the straight tube portion 23 disposed in the space portion of the third cylindrical member 330 from abutting against the inner surface of the third cylindrical member 330, and avoids interference between the inner surface of the third cylindrical member 330 and the protrusion 60 of the straight tube portion 23.

[0126] In cases where step (2) is performed in addition to step (1) described above, it is preferable that the second cylindrical member 320 also has the same structure as the first cylindrical member 310 described above. That is, the shape of the space in the radial y-section of the second cylindrical member 320 in the portion where the distal end of the proximal conical portion 22 is disposed can also be Figure 24 As shown, the front end 61 of the protrusion 60 of the proximal tapered portion 22 is positioned relative to the straight line L. d The shape of the space portion of the second cylindrical member 320 disposed on the portion disposed on the first circumferential direction C1 side can also be... Figure 25 As shown, the front end 61 of the protrusion 60 of the proximal tapered portion 22 is positioned relative to the straight line L. d The shape of the space portion of the second cylindrical member 320, which is further configured on the portion configured on the first circumferential direction C1 side, can also be... Figure 26 The shape is as shown. Furthermore, similar to the first cylindrical member 310, the shape of the spatial portion in the radial y-section of the second cylindrical member 320 is not limited to these. As long as the second cylindrical member 320 has the above-described structure, the position where the inner surface of the second cylindrical member 320 abuts against at least a portion of the protrusion 60 of the proximal conical portion 22 can be changed, thereby suppressing or allowing the front end portion 61 of the protrusion 60 of the proximal conical portion 22 to move radially y-wise toward the balloon body 20 in the contracted state, and adjusting the distance of circumferential z-wise movement toward the balloon body 20.

[0127] When only step (1) is performed without step (2), it is preferable that the second cylindrical object 320 has the same structure as the third cylindrical object 330. This prevents the protrusion 60 of the proximal conical portion 22 disposed in the space of the second cylindrical object 320 from contacting the inner surface of the second cylindrical object 320, and avoids interference between the inner surface of the second cylindrical object 320 and the protrusion 60 of the proximal conical portion 22.

[0128] When only step (2) is performed without step (1), it is preferable that the first cylindrical object 310 has the same structure as the third cylindrical object 330. This prevents the protrusion 60 of the distal conical portion 24 disposed in the space of the first cylindrical object 310 from contacting the inner surface of the first cylindrical object 310, and avoids interference between the inner surface of the first cylindrical object 310 and the protrusion 60 of the distal conical portion 24.

[0129] Preferably, the lengths of the major axis x of the first cylindrical section 310, the second cylindrical section 320, and the third cylindrical section 330 are approximately the same as the lengths of the major axis x of the distal conical section 24, the proximal conical section 22, and the straight tube section 23.

[0130] 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 direction x, with the centers of their respective radial y-sections aligned, and insert the spherical bag 2 into the space 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.

[0131] By performing the above-described configuration process, the configuration of the front end portion 61 of the protrusion 60 is determined, thereby creating creases in the configuration 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 configuration of the front end portion 61 of the protrusion 60 with the creases, thereby obtaining a balloon 2 in which the front end portion 61 of the protrusion 60 bends circumferentially towards the balloon body 20 in the folded state.

[0132] 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.

[0133] This application claims the benefit of priority based on Japanese Patent Application No. 2020-215754, filed on December 24, 2020. The entire contents of the description of Japanese Patent Application No. 2020-215754, filed on December 24, 2020, are incorporated herein by reference.

[0134] Explanation of reference numerals in the attached figures

[0135] 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; 310…First cylindrical section; 320…Second cylindrical section; 330…Third cylindrical section; 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 formed by connecting the front ends; C1…first direction; C2…second direction; D0…0% position; D 20 …20% of the position; D 40 …40% of the position; D 60 …60% of the position; D 70 …70% of the position; D 90 …90% of the position; D 100 …100% position; 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; 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. In the inflated state of the balloon catheter, the anterior end portion of the protrusion of the distal conical portion is relative to the straight line L obtained by connecting the anterior end portion of the proximal end of the distal conical portion and the anterior end portion of the distal end of the distal conical portion. d Not positioned on the first and second circumferential directions of the balloon body, and the anterior end portion of the protrusion of the proximal conical portion relative to the straight line L obtained by connecting the anterior end portion of the distal end of the proximal conical portion to the anterior end portion of the proximal end of the proximal conical portion. p It is not configured on the first and second circumferential sides of the balloon body. The balloon catheter balloon satisfies at least one of the following (1) and (2): (1) In the contracted state of the balloon catheter, the anterior end of the protrusion of the distal conical portion is relative to the straight line L d It can be configured on the first direction side but not on the second direction side, or configured on the second direction side but not on the first direction side. (2) In the contracted state of the balloon catheter, the anterior end of the protrusion of the proximal conical portion is relative to the straight line L p It can be configured on the first direction side but not on the second direction side, or configured on the second direction side but not on the first direction side.

2. The balloon for balloon catheters according to claim 1, characterized in that, In the contracted state of the balloon catheter, the balloon is folded.

3. The balloon for balloon catheters according to claim 1 or 2, characterized in that, 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 of the distal conical portion in the entire range from 20% to 70% of its position relative to the straight line L d The front end of the protrusion disposed on the first direction side or the second direction side, in the interval from 90% to 100% of the distal tapered portion, is relative to the straight line L. d Not configured on the first direction side and the second direction side. (2) The anterior end portion of the protrusion in the entire range from 20% to 70% of the proximal conical portion relative to the straight line L p The front end of the protrusion disposed on the first direction side or the second direction side, in the interval from 90% to 100% of the position of the proximal tapered portion, is relative to the straight line L. p It is not configured on the first direction side or the second direction side.

4. The balloon catheter according to claim 3, characterized in that, Satisfying at least one of (1) and (2) below, (1) The front end of the protrusion at 40% of the distal conical portion and the straight line L d The front end of the protrusion located at a distance of 60% of the distance of the distal conical portion and the straight line L d More than 1.2 times the distance, (2) The anterior end of the protrusion at 40% of the position of the proximal conical portion and the straight line L p The anterior end of the protrusion located at a distance of 60% of the proximal conical portion and the straight line L p More than 1.2 times the distance.

5. The balloon for balloon catheters according to claim 1 or 2, 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 entire range from 20% to 70% 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 the balloon body or at the same location. (2) The anterior end portion of the protrusion in the entire range from 20% to 70% of the position 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.

6. The balloon for balloon catheters according to claim 1 or 2, characterized in that, In the inflated state of the balloon catheter, the anterior end of the protrusion of the distal conical portion, the anterior end of the protrusion of the straight portion, and the anterior end of the protrusion of the proximal conical portion are positioned at the same circumferential position of the balloon body.

7. 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.

8. 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.

9. 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.

10. A method for manufacturing a balloon for a balloon catheter, wherein the method for manufacturing a balloon for a balloon catheter is as described in any one of claims 1 to 9. 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, the second cylindrical object, and the third cylindrical object each have 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; as well as In the configuration process, while the balloon of the balloon catheter is in the contracted state, the distal conical portion is configured within the first cylindrical section, the proximal conical portion is configured within the second cylindrical section, and the straight tube portion is configured within the third cylindrical section. The method for manufacturing the balloon for the balloon catheter satisfies at least one of the following (1) and (2): (1) In the configuration process, the inner surface of the first cylindrical object abuts against at least a portion of the protrusion of the distal conical portion. (2) In the configuration process, the inner surface of the second cylindrical object abuts against at least a portion of the protrusion of the proximal conical portion.

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