WO2024106176A1 - Balloon for balloon-catheter, balloon catheter equipped with same, and method for manufacturing balloon catheter - Google Patents

Balloon for balloon-catheter, balloon catheter equipped with same, and method for manufacturing balloon catheter Download PDF

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Publication number
WO2024106176A1
WO2024106176A1 PCT/JP2023/038878 JP2023038878W WO2024106176A1 WO 2024106176 A1 WO2024106176 A1 WO 2024106176A1 JP 2023038878 W JP2023038878 W JP 2023038878W WO 2024106176 A1 WO2024106176 A1 WO 2024106176A1
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WIPO (PCT)
Prior art keywords
balloon
inner layer
distal
proximal
exposed
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Application number
PCT/JP2023/038878
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French (fr)
Japanese (ja)
Inventor
真弘 小嶋
崇亘 ▲濱▼淵
良紀 中野
昌人 杖田
Original Assignee
株式会社カネカ
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Publication of WO2024106176A1 publication Critical patent/WO2024106176A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates to a balloon for a balloon catheter, a balloon catheter including the same, and a method for manufacturing a balloon catheter.
  • angioplasty which uses a balloon catheter to expand the narrowed area.
  • Angioplasty is a minimally invasive therapy that does not require open chest surgery like bypass surgery, and is widely performed.
  • ISR In-Stent-Restenosis
  • the neointima is soft and has a slippery surface, so with a typical balloon catheter, the position of the balloon can shift from the lesion when it is expanded, causing damage to the blood vessel.
  • Patent Document 1 discloses a balloon catheter that uses an amorphous polymer for the protrusions, making the rigidity of the protrusions greater than that of the balloon wall, thereby improving the efficiency of incision by the protrusions.
  • the present invention aims to provide a balloon for a balloon catheter that is less likely to damage the inner wall of a lumen when the balloon is inserted into a lumen such as a blood vessel, and that can improve the ease of insertion into the lumen and the efficiency of incising a stenotic part, as well as a balloon catheter including the same, and a method for manufacturing the balloon catheter.
  • a balloon for a balloon catheter having a longitudinal axis, a radial direction, and a circumferential direction, and having an outer layer and an inner layer made of a material having a Shore D hardness lower than that of the outer layer, the balloon having a straight tube portion, a proximal tapered portion located proximal to the straight tube portion, a proximal sleeve portion located proximal to the proximal tapered portion, a distal tapered portion located distal to the straight tube portion, and a distal sleeve portion located distal to the distal tapered portion, the balloon having a protruding portion protruding radially outward and extending in the longitudinal axis direction, and satisfying at least one of the following (1) and (2).
  • the protruding portion of the proximal sleeve portion has an exposed inner layer portion where the outer layer is not present, and when viewed from the radial outside, the exposed inner layer portion is sandwiched between the outer layer in the circumferential direction.
  • the protrusion portion of the distal sleeve portion has an exposed inner layer portion where the outer layer is not present, and when viewed from the radially outward side, the exposed inner layer portion is sandwiched between the outer layer in the circumferential direction.
  • the condition (1) is satisfied, and when, in the longitudinal axis direction, the proximal end of the proximal sleeve portion is the 0% position S P0 and the end of the proximal sleeve portion on the proximal taper portion side is the 100% position S P100 , the exposed inner layer portion of the proximal sleeve portion is arranged in at least a part of the section from position S P0 to 75% position S P75 .
  • the distal sleeve portion has a low protrusion region in which the protrusion has a height equal to or less than the height of the protrusion of the straight tube portion.
  • a balloon for a balloon catheter according to any one of [1] to [8], which satisfies at least one of the following (11) and (12):
  • the protruding portion of the proximal taper section has an exposed inner layer portion where the outer layer is not present, and when viewed from the radial outside, the exposed inner layer portion is sandwiched between the outer layer in the circumferential direction.
  • the protruding portion of the distal taper section has an inner layer exposed portion where the outer layer is not present, and when viewed from the radial outside, the inner layer exposed portion is sandwiched between the outer layer in the circumferential direction.
  • (13) The condition (11) is satisfied, and when, in the longitudinal axis direction, the end of the proximal taper portion on the proximal sleeve portion side is defined as the 0% position T P0 and the end of the proximal taper portion on the straight tube portion side is defined as the 100% position T P100 , the exposed inner layer portion of the proximal taper portion is located in at least a part of the section from position T P0 to 75% position T P75 .
  • the condition (12) is satisfied, and when, in the longitudinal axis direction, the end of the distal taper portion on the distal sleeve portion side is defined as a 0% position T D0 and the end of the distal taper portion on the straight tube portion side is defined as a 100% position T D100 , the exposed inner layer portion of the distal taper portion is located in at least a part of the section from position T D0 to 75% position T D75 .
  • the balloon for a balloon catheter according to [10] which satisfies at least one of the following (15) and (16): (15) The above (13) is satisfied, and the inner layer exposed portion of the proximal taper portion is disposed in a section including the position T P0 .
  • the present invention also provides the following: [14] A balloon catheter comprising the balloon for a balloon catheter according to any one of [1] to [13] above.
  • the present invention further provides a method for producing the balloon catheter according to the present invention.
  • a method for producing a balloon catheter as described in [14] above comprising the steps of: preparing a parison having a longitudinal axis, a radial direction, and a circumferential direction, and an inner lumen extending in the longitudinal axis direction; stretching the parison to produce a balloon having the proximal sleeve portion, the proximal tapered portion, the straight tube portion, the distal tapered portion, and the distal sleeve portion, and having the protruding portion; and cutting off an apex side of the protruding portion of the proximal sleeve portion and/or the distal sleeve portion along the longitudinal axis direction to form the exposed inner lumen, wherein the parison has an outer layer and an inner layer made of a material having a Shore D hardness lower than that of the outer layer, and has a protruding region including the protru
  • the above-mentioned balloon for balloon catheter, balloon catheter including the same, and method for manufacturing a balloon catheter can provide a balloon for balloon catheter, which is less likely to damage the inner wall of a lumen when the balloon is inserted into a lumen such as a blood vessel, and which can improve the ease of insertion into the lumen and the efficiency of incising the stenosis, as well as a balloon catheter including the same, and a method for manufacturing a balloon catheter. This makes it possible to efficiently incise the stenosis while improving the safety of treatments and procedures using the balloon catheter.
  • FIG. 1 illustrates a side view of a balloon catheter according to one embodiment of the present invention.
  • 2 shows a cross-sectional view of the balloon catheter shown in FIG. 1 along line II-II.
  • 3 shows a cross-sectional view of the balloon catheter shown in FIG. 1 taken along line III-III.
  • 4 shows an enlarged view of a portion P of FIG. 3.
  • 5 shows a view of FIG. 4 seen from the radial outside.
  • FIG. 2 is a plan view of the balloon of the balloon catheter shown in FIG. 1 as viewed from the protruding portion side. 2 illustrates a longitudinal cross-sectional view of the distal end of the balloon catheter shown in FIG. 1 .
  • FIG. 7 illustrates a plan view showing a modified example of FIG. 6 .
  • FIG. 13A shows a longitudinal cross-sectional view of the distal end of a balloon catheter according to another embodiment of the present invention.
  • FIG. FIG. 2 illustrates a perspective view of a parison prior to stretching according to one embodiment of the present invention.
  • 11 illustrates a cross-sectional view of the parison shown in FIG. 10 taken along the line XI-XI.
  • 11 shows a cross-sectional view perpendicular to the longitudinal axis direction of a parison mold used to manufacture the parison shown in FIG. 10.
  • 12 illustrates a modified example of the cross-sectional view taken along the line XI-XI of FIG.
  • FIG. 14 shows a cross-sectional view perpendicular to the longitudinal axis direction of a parison mold used to manufacture the parison shown in FIG. 13.
  • 1 is a cross-sectional view of a longitudinal axis of a mold according to one embodiment of the present invention.
  • 16 is a cross-sectional view of the mold shown in FIG. 15 taken along the line XVI-XVI.
  • 17 shows a cross-sectional view of the mold shown in FIG. 15 along the line XVII-XVII.
  • 18 illustrates a modified example of the cross-sectional view taken along the line XVII-XVII of FIG. 17.
  • a balloon for balloon catheter is a balloon for balloon catheter having a longitudinal axial direction, a radial direction, and a circumferential direction, an outer layer, and an inner layer made of a material having a lower Shore D hardness than the outer layer, the balloon having a straight tube portion, a proximal tapered portion located proximal to the straight tube portion, a proximal sleeve portion located proximal to the proximal tapered portion, a distal tapered portion located distal to the straight tube portion, and a distal sleeve portion located distal to the distal tapered portion, the balloon having a protruding portion protruding radially outward and extending in the longitudinal axial direction, and satisfying at least one of the following (1) and (2).
  • the protruding portion of the proximal sleeve portion has an exposed inner layer portion where no outer layer is present, and when viewed from the radially outward side, the exposed inner layer portion is sandwiched between the outer layers in the circumferential direction.
  • the protruding portion of the distal sleeve portion has an exposed inner layer portion where no outer layer is present, and when viewed from the radially outward side, the exposed inner layer portion is sandwiched between the outer layers in the circumferential direction.
  • the dilation of the stenosis using a balloon catheter is performed by inserting a balloon provided at the distal end of the balloon catheter into the blood vessel lumen, delivering it to the stenosis, and then expanding the balloon, causing the protrusions provided on the radially outward side of the balloon to bite into the stenosis and cut the stenosis.
  • the protrusions provided at both ends in the longitudinal direction of the balloon come into contact with the blood vessel lumen, which may damage the blood vessel lumen wall.
  • the proximal sleeve portion and/or the distal sleeve portion have an inner layer exposed portion made of a material with a low Shore D hardness, so that damage to the blood vessel lumen wall can be prevented.
  • the surface of the protrusions other than the inner layer exposed portion is formed of an outer layer with a high Shore D hardness, so that the insertion of the blood vessel lumen and the efficiency of cutting the stenosis can be improved. This makes it possible to efficiently cut the stenosis while improving the safety of treatment and procedures using a balloon catheter.
  • the balloon when the balloon is inserted into the stenosis or removed from the body, the balloon is deflated by discharging fluid from the inner cavity, and the wing-shaped portion of the balloon is wrapped around the shaft to reduce the outer diameter of the balloon.
  • the balloon diameter is large at the expansion portion of the balloon, the protrusions provided at the expansion portion of the balloon are covered by the wing-shaped portion, but since the balloon diameter is small at both ends of the balloon and it is difficult to form wing-shaped portions, the protrusions provided at both ends of the balloon may be exposed from the wing-shaped portion.
  • a balloon for a balloon catheter according to an embodiment of the present invention, damage to the blood vessel lumen wall can be prevented because the proximal sleeve portion and/or the distal sleeve portion have an inner layer exposed portion made of a material with a low Shore D hardness.
  • a balloon for a balloon catheter may be simply referred to as a "balloon.”
  • Fig. 1 is a side view of a balloon catheter according to an embodiment of the present invention.
  • Fig. 2 shows a cross-sectional view of the balloon catheter shown in Fig. 1 taken along line II-II, which is a cross-sectional view perpendicular to the longitudinal axis of the straight tube portion.
  • Fig. 3 shows a cross-sectional view of the balloon catheter shown in Fig. 1 taken along line III-III, which is a cross-sectional view perpendicular to the longitudinal axis of the distal sleeve portion.
  • Fig. 4 shows an enlarged view of part P in Fig.
  • FIG. 3 which is an enlarged cross-sectional view perpendicular to the longitudinal axis of a portion including the protruding portion of the distal sleeve portion.
  • Fig. 5 shows a view of the portion shown in Fig. 4 as seen from the radially outer side.
  • Fig. 6 shows a plan view of the balloon of the balloon catheter shown in Fig. 1 as seen from the protruding portion side, and
  • Fig. 7 shows a cross-sectional view of the distal end portion of the balloon catheter shown in Fig. 1 in the longitudinal direction.
  • Fig. 8 shows a plan view showing a modified example of Fig. 6, and Fig.
  • FIG. 9 shows a cross-sectional view of the distal end portion of a balloon catheter according to another embodiment of the present invention in the longitudinal direction. Note that the hatching in Figures 5, 6, and 8 does not represent a cross section, but instead shows the exposed inner layer portion 20A for ease of understanding.
  • the balloon 2 is used in the balloon catheter 1.
  • the balloon 2 is connected to the distal end of the shaft 30, and the balloon 2 can be expanded by introducing fluid through the inner cavity of the shaft 30, and can be deflated by discharging the fluid.
  • the fluid can be introduced or discharged using an indeflator (balloon pressurizer).
  • the fluid may be a pressurized fluid pressurized by a pump or the like.
  • the balloon catheter 1 will be described in detail in the section "2. Balloon Catheter.”
  • the balloon 2 has a longitudinal axis direction x1, a radial direction y1 connecting the centroid of the outer edge of the balloon 2 to a point on the outer edge in a cross section perpendicular to the longitudinal axis direction x1, and a circumferential direction z1 along the outer edge of the balloon 2 in a cross section perpendicular to the longitudinal axis direction x1.
  • the direction toward the user's hand in the longitudinal axis direction x1 is referred to as the proximal side
  • the side opposite the proximal side i.e., the direction toward the subject of treatment
  • the members and parts other than the balloon 2 each have a longitudinal axis direction, a radial direction, and a circumferential direction, which may or may not be the same as the longitudinal axis direction x1, radial direction y1, and circumferential direction z1 of the balloon 2.
  • this specification describes all members and parts as having the same longitudinal axis direction, radial direction, and circumferential direction as the longitudinal axis direction x1, radial direction y1, and circumferential direction z1 of the balloon 2.
  • the balloon 2 has a protrusion 28 that protrudes outward in the radial direction y1 and extends in the longitudinal axis direction x1.
  • the protrusion 28 is a portion that is formed to be thicker than the thickness of the portion of the balloon 2 where the protrusion 28 is not provided.
  • the protrusion 28 can be said to be a portion that protrudes outward in the radial direction y1 from the outer surface of the balloon body 20, which has the thickness of the portion of the balloon 2 where the protrusion 28 is not provided.
  • the thickness of the protruding portion 28 of the balloon 2 is, for example, preferably 1.2 times or more, more preferably 1.5 times or more, even more preferably 1.8 times or more, 2.0 times or more, or 2.5 times or more, the thickness of the portion of the balloon 2 where the protruding portion 28 is not provided.
  • the balloon body 20 defines the basic shape of the balloon 2, and the protrusions 28 are preferably provided on the outer surface of the balloon body 20 in any pattern, such as lines, dots, a mesh, or a spiral.
  • the protrusions 28 provide the balloon 2 with a scoring function, making it possible to expand the balloon 2 by creating cracks in calcified stenotic areas during angioplasty.
  • the protrusions 28 can also contribute to improving the strength of the balloon 2 and preventing overexpansion when pressurized.
  • multiple protrusions 28 may be provided in the circumferential direction z1, or only one protrusion may be provided.
  • the number of protrusions 28 in the circumferential direction z1 may be 1 or more, 2 or more, 3 or more, 4 or more, 6 or more, and may be 20 or less, 15 or less, or 10 or less.
  • the multiple protrusions 28 are provided in the circumferential direction z1, it is preferable that the multiple protrusions 28 are spaced apart in the circumferential direction z1, and it is more preferable that the multiple protrusions 28 are arranged at equal intervals in the circumferential direction z1.
  • the separation distance is preferably longer than the maximum circumferential length of the protrusions 28.
  • the cross-sectional shape of the protrusion 28 in a cross section perpendicular to the longitudinal axis direction x1 may be any shape, such as a triangle, a rectangle, a polygon, a semicircle, a part of a circle, an approximate circle, a sector, a wedge, a convex shape, a spindle shape, or a combination thereof.
  • triangles, rectangles, and polygons include shapes with clearly defined corners and straight sides, as well as so-called rounded polygons with rounded corners and shapes with at least some of the sides curved.
  • the cross-sectional shape of the protrusion 28 may be an irregular shape with irregularities, chips, etc.
  • the protrusion 28 other than the portion where the inner layer exposed portion 20A described below is provided may have an apex 28t, which is the outer end in the radial direction y1. If the protrusion 28 has an apex 28t, the cutting efficiency by the protrusion 28 can be improved.
  • the protrusions 28 are formed in a line or dot shape, it is preferable that the protrusions 28 are arranged so as to extend along the longitudinal axis direction x1. Alternatively, the protrusions 28 may be arranged so as to extend in a spiral shape around the longitudinal axis.
  • the balloon 2 may have an inner protrusion that protrudes inward in the radial direction y1.
  • the inner protrusion preferably extends in the longitudinal axis direction x1.
  • the protrusion 28 and the inner protrusion are preferably located at the same position in the longitudinal direction x1 or the circumferential direction z1 of the balloon 2, and are preferably formed integrally.
  • the protrusion 28, the balloon body 20, and the inner protrusion are formed integrally and thickly, so that the balloon 2 may have the protrusion 28 and the inner protrusion.
  • the balloon 2 has an outer layer 20b and an inner layer 20a made of a material having a lower Shore D hardness than the outer layer 20b.
  • the balloon 2 preferably has a two-layer structure consisting of the inner layer 20a and the outer layer 20b in all parts other than the inner layer exposed part 20A described in detail later.
  • the inner layer 20a and the outer layer 20b are continuously present over the entire 360° of the circumferential direction z1 at any position in the longitudinal axis direction x1 except for the part where the inner layer exposed part 20A is formed.
  • all parts other than the inner layer exposed part 20A in the longitudinal axis direction x1 include the inner layer 20a and the outer layer 20b.
  • the outer surface of the balloon 2 is formed of the outer layer 20b with a high Shore D hardness except for the inner layer exposed part 20A, so that the outer surface of the balloon 2 is less likely to be damaged and its strength can be improved.
  • the outer surface of the protrusion 28 is also formed of the outer layer 20b, which has a high Shore D hardness, which enhances the scoring function of the protrusion 28.
  • the Shore D hardness of the inner layer 20a is preferably 20 or more, 25 or more, 30 or more, 35 or more, or 40 or more, and is preferably 70 or less, 65 or less, 60 or less, or 55 or less.
  • the Shore D hardness of the outer layer 20b is preferably more than 70, 72 or more, 74 or more, or 75 or more, and is preferably 90 or less, 85 or less, or 80 or less. If the Shore D hardness of the inner layer 20a is within the above range, it can contribute to improving the flexibility of the balloon 2. If the Shore D hardness of the outer layer 20b is within the above range, it can contribute to improving the strength of the balloon 2 and the scoring function of the protrusion 28.
  • the Shore D hardness can be measured, for example, using a Type D durometer based on the description of JIS K6253-2:2012.
  • the Shore D hardness of each of the inner layer 20a and the outer layer 20b may be the Shore D hardness of the material before it is molded into the balloon 2.
  • the material of the outer layer 20b is preferably a polyamide resin such as nylon 11 or nylon 12; a polyester resin such as polyethylene terephthalate or polybutylene terephthalate; or a polyurethane resin.
  • the material of the inner layer 20a is preferably a thermoplastic elastomer, which has a low Shore D hardness.
  • a polyamide elastomer such as a polyether block amide copolymer is preferably used.
  • the balloon 2 has a proximal end and a distal end in the longitudinal axis direction x1, and has a straight tube section 23, a proximal taper section 22 located proximal to the straight tube section 23, a proximal sleeve section 21 located proximal to the proximal taper section 22, a distal taper section 24 located distal to the straight tube section 23, and a distal sleeve section 25 located distal to the distal taper section 24.
  • the straight tube section 23 is preferably substantially cylindrical with approximately the same diameter in the longitudinal axis direction x1, but may have different diameters in the longitudinal axis direction x1.
  • the proximal taper section 22 and the distal taper section 24 are preferably formed into a substantially conical or truncated conical shape with a reduced diameter as they move away from the straight tube section 23.
  • the straight tube section 23 has the maximum diameter, so that when the balloon 2 is expanded at a lesion such as a stenosis, the straight tube section 23 can be in sufficient contact with the lesion, making it easier to perform treatment such as expansion of the lesion.
  • proximal taper section 22 and the distal taper section 24 are reduced in diameter, when the balloon 2 is deflated, the outer diameter of the proximal and distal ends of the balloon 2 is reduced, thereby reducing the step between the shaft 30 and the balloon 2, making it easier to insert the balloon 2 into the body cavity.
  • proximal tapered section 22, the straight tube section 23, and the distal tapered section 24 are sections that expand when fluid is introduced into the balloon 2, it is preferable that the proximal sleeve section 21 and the distal sleeve section 25 do not expand. This allows for a configuration in which at least a portion of the proximal sleeve section 21 is fixed to the distal end of the shaft 30, and at least a portion of the distal sleeve section 25 is fixed to the inner shaft 60 described below.
  • the balloon 2 preferably has protrusions 28 in each of the regions of the proximal sleeve section 21, the proximal tapered section 22, the straight tube section 23, the distal tapered section 24, and the distal sleeve section 25.
  • the protrusions 28 provided in the straight tube section 23 can contribute to improving the scoring function
  • the protrusions 28 provided in other sections than the straight tube section 23 can contribute to improving the strength of the balloon 2 and preventing overexpansion when pressurized.
  • the balloon 2 satisfies at least one of the following (1) and (2).
  • the protrusion 28 of the proximal sleeve portion 21 has an inner layer exposed portion 28A where the outer layer 20b is not present, and when viewed from the outside in the radial direction y1, the inner layer exposed portion 28A is sandwiched between the outer layer 20b in the circumferential direction z1.
  • the protrusion 28 of the distal sleeve portion 25 has an inner layer exposed portion 28A where the outer layer 20b is not present, and when viewed from the outside in the radial direction y1, the inner layer exposed portion 28A is sandwiched between the outer layer 20b in the circumferential direction z1.
  • the protrusion 28 provided with the inner layer exposed portion 20A has a portion where the outer layer 20b is not present and the inner layer 20a forms the surface of the protrusion 28.
  • the inner layer exposed portion 20A is sandwiched between the outer layers 20b in the circumferential direction z1. This allows the inner layer 20a to be present at the outer end in the radial direction y1 of the protrusion 28 provided with the inner layer exposed portion 20A.
  • the exposed inner layer portion 20A arranged on the proximal sleeve portion 21 and/or the distal sleeve portion 25 may be arranged continuously in the entire longitudinal axis direction x1, may be arranged in a part of the longitudinal axis direction x1, or multiple exposed inner layer portions 20A may be arranged discontinuously in the longitudinal axis direction x1.
  • 3 to 5 show the exposed inner layer portion 28A of the distal sleeve portion 25, but the exposed inner layer portion 28A may be provided on both the proximal sleeve portion 21 and the distal sleeve portion 25, or on either the proximal sleeve portion 21 or the distal sleeve portion 25.
  • the proximal sleeve portion 21 and the distal sleeve portion 25 form the leading portion.
  • the protrusions 28 provided on the proximal sleeve portion 21 and the distal sleeve portion 25 may come into contact with the blood vessel lumen and damage the blood vessel lumen wall, but the balloon 2 has the exposed inner layer portion 20A with a low Shore D hardness on the proximal sleeve portion 21 and/or the distal sleeve portion 25, and therefore damage to the blood vessel lumen wall can be prevented.
  • the surface of the protrusion 28 other than the inner layer exposed portion 20A and the surface of the balloon 2 in the portion where the protrusion 28 is not provided are formed of the outer layer 20b with a high Shore D hardness, so that the insertion property of the balloon 2 in the blood vessel lumen and the efficiency of cutting the stenosis part can be improved, and the strength of the balloon 2 can be improved and overexpansion can be suppressed.
  • the protrusion 28 when the protrusion 28 is viewed from the outside in the radial direction y1, the inner layer exposed portion 20A is sandwiched between the outer layer 20b, so that even in the proximal sleeve portion 21 and/or the distal sleeve portion 25 where the inner layer exposed portion 20A is provided and the inner layer 20a with a low Shore D hardness is exposed, the protrusion 28 can ensure the rigidity in the longitudinal axis direction x1, which can contribute to improving the insertion property of the balloon 2.
  • the fluid when the balloon 2 is inserted into the stenotic area or removed from the body, the fluid is discharged from the inner cavity of the balloon 2 to cause it to shrink, and the wing-shaped portion of the balloon 2 is wrapped around the shaft 30 to reduce the outer diameter of the balloon 2.
  • the sleeve portion is a portion that does not expand, it is difficult for the wing-shaped portion to form, and therefore the protrusion 28 provided on the sleeve portion may be exposed and not covered by the wing-shaped portion. Even in such a case, damage to the blood vessel lumen wall can be prevented because the balloon 2 has an inner layer exposed portion 20A on the sleeve portion.
  • the exposed inner layer portion 20A can be formed by cutting the apex 28t side of the protrusion 28 along the longitudinal axis direction x1 as shown in FIG. 2.
  • the method for forming the exposed inner layer portion 20A will be described in detail in the section "3. Method for manufacturing a balloon catheter.”
  • the balloon 2 when the inner layer exposed portion 20A is not formed, the balloon 2 includes the inner layer 20a and the outer layer 20b throughout.
  • the balloon 2 preferably has a two-layer structure consisting of the inner layer 20a and the outer layer 20b, and the outer surface of the balloon 2 is preferably formed by the outer layer 20b.
  • the inner layer 20a can be continuously present over the entire 360° of the circumferential direction z1 in a vertical cross section taken at any position in the longitudinal axis direction x1. Therefore, the flexibility of the balloon 2 can be improved by the inner layer 20a, which has a lower Shore D hardness than the outer layer 20b.
  • the outer layer 20b between the inner layer exposed portions 20A in the circumferential direction z1 (parts other than the inner layer exposed portion 20A when there is one inner layer exposed portion 20A in the circumferential direction z1) is continuous in the circumferential direction z1.
  • the balloon 2 can be formed with a two-layer structure by integrally molding the protruding portion 28 and the balloon body portion 20, and it is possible to prevent the protruding portion 28 from falling off the balloon body portion 20.
  • the inner layer 20a and the outer layer 20b in the portion of the balloon 2 where the inner protrusion is not provided and the portion where the inner protrusion is provided are continuous in the circumferential direction z1. This allows the inner protrusion and the balloon main body 20 to be integrally formed, and prevents the inner protrusion from falling off the balloon main body 20.
  • the protruding portion 28 of the straight pipe section 23 does not have an exposed inner layer portion 20A where the outer layer 20b is not present. Since the protruding portion 28 of the straight pipe section 23 is the portion that contributes most to the incision of the narrowed portion, by not having the exposed inner layer portion 20A, the surface of the protruding portion 28 of the straight pipe section 23 can be formed of the outer layer 20b with a high Shore D hardness, thereby improving the efficiency of incising the narrowed portion.
  • the balloon 2 satisfies at least one of the following (3) and (4).
  • (3) The above (1) is satisfied, and when, in the longitudinal axis direction x1, the proximal end of the proximal sleeve portion 21 is the 0% position S P0 and the end of the proximal sleeve portion 21 on the proximal taper portion 22 side is the 100% position S P100 , the exposed inner layer portion 20A of the proximal sleeve portion 21 is arranged in at least a part of the section from position S P0 to 75% position S P75 .
  • FIG. 6 shows an embodiment in which both the proximal sleeve portion 21 and the distal sleeve portion 25 satisfy the above (3) and (4), but it is sufficient for the balloon 2 to satisfy at least one of the above (3) and (4).
  • the inner layer 20a with a low Shore D hardness can be exposed at the protrusion 28 at the leading portion when the balloon 2 advances or retreats within the blood vessel lumen, making it easier to prevent damage to the blood vessel lumen wall.
  • the exposed inner layer portion 20A arranged on the proximal sleeve portion 21 and/or the distal sleeve portion 25 may be arranged continuously in the entire longitudinal axis direction x1 in the above section, may be arranged in a part of the longitudinal axis direction x1, or multiple exposed inner layer portions 20A may be arranged discontinuously in the longitudinal axis direction x1.
  • the exposed inner layer portion 20A of the proximal sleeve portion 21 is disposed in at least a portion of the section from the position S P0 to the 50% position. It is also more preferable that the exposed inner layer portion 20A of the distal sleeve portion 25 is disposed in at least a portion of the section from the position S D0 to the 50% position.
  • the balloon 2 satisfies at least one of the following (5) and (6).
  • (5) The above condition (3) is satisfied, and the exposed inner layer portion 20A of the proximal sleeve portion 21 is disposed in a section including the position S P0 .
  • (6) The above (4) is satisfied, and the exposed inner layer portion 20A of the distal sleeve portion 25 is disposed in a section including the position S- D0 .
  • FIG. 6 shows an embodiment in which both the proximal sleeve portion 21 and the distal sleeve portion 25 satisfy the above (5) and (6), but it is sufficient for the balloon 2 to satisfy at least one of the above (5) and (6).
  • the exposed inner layer portion 20A being disposed in a section including position S P0 of the proximal sleeve portion 21 means that the exposed inner layer portion 20A is disposed at the proximal end (position S P0 ) of the proximal sleeve portion 21.
  • the exposed inner layer portion 20A being disposed in a section including position S D0 of the distal sleeve portion 25 means that the exposed inner layer portion 20A is disposed at the distal end (position S D0 ) of the distal sleeve portion 25. This makes it easier to prevent damage to the blood vessel lumen wall because the inner layer 20a with low Shore D hardness is exposed at the protruding portion 28, which is the foremost portion when the balloon 2 advances or retreats in the blood vessel lumen.
  • the length La of the exposed inner layer portion 20A in the circumferential direction z1 is longer than the length Lb of each of the outer layers 20b on both sides of the exposed inner layer portion 20A in the circumferential direction z1.
  • the length La in the circumferential direction z1 of the exposed inner layer portion 20A may be shorter than the length Lb in the circumferential direction z1 of each of the outer layers 20b on both sides of the exposed inner layer portion 20A.
  • the rigidity can be improved, and the insertability in the longitudinal axis direction x1 can be further improved.
  • the balloon 2 satisfies at least one of the following (7) and (8).
  • (7) The above (1) is satisfied, and the proximal sleeve portion 21 has a low protrusion region 28L in which the protrusion 28 has a height equal to or less than the height of the protrusion 28 of the straight pipe portion 23.
  • (8) The above (2) is satisfied, and the distal sleeve portion 25 has a low protrusion region 28L in which the protrusion 28 has a height equal to or less than the height of the protrusion 28 of the straight pipe portion 23.
  • the height of the protrusion 28 can be defined as the distance from the line segment connecting the base ends of both sides of the protrusion 28 to the outer end of the protrusion 28 in the vertical direction in a cross section perpendicular to the longitudinal axis direction x1.
  • FIG. 7 shows an embodiment in which both the proximal sleeve portion 21 and the distal sleeve portion 25 satisfy the above (7) and (8), but it is sufficient for the balloon 2 to satisfy at least one of the above (7) and (8).
  • the protruding portion 28 of the proximal sleeve portion and/or the distal sleeve portion 25, which is the leading portion when the balloon 2 advances or retreats through the blood vessel lumen, has a low protruding portion region 28L that has a height lower than the height of the protruding portion 28 of the straight tube portion 23, which makes it easier to improve the insertability of the balloon 2.
  • the low protrusion region 28L may be provided continuously in the longitudinal axis direction x1 in the proximal sleeve portion 21 and/or the distal sleeve portion 25, or may be provided discontinuously.
  • the balloon 2 satisfies at least one of the following (9) and (10).
  • FIG. 7 shows an embodiment in which both the proximal sleeve portion 21 and the distal sleeve portion 25 satisfy the above (9) and (10), but it is sufficient for the balloon 2 to satisfy at least one of the above (9) and (10).
  • the protrusion 28 of the proximal sleeve portion and/or the distal sleeve portion 25, which is the leading portion when the balloon 2 advances or retreats through the blood vessel lumen, can be made low in height and soft, making it easier to improve the insertion ability of the balloon 2 while also improving the effect of preventing damage to the blood vessel lumen wall.
  • the balloon 2 satisfies at least one of the following (11) and (12).
  • the protrusion 28 of the proximal taper section 22 has an inner layer exposed portion 20A where the outer layer 20b is not present, and when viewed from the outside in the radial direction y1, the inner layer exposed portion 20A is sandwiched between the outer layer 20b in the circumferential direction z1.
  • the protrusion 28 of the distal taper portion 24 has an inner layer exposed portion 20A where no outer layer 20b is present, and when viewed from the outside in the radial direction y1, the inner layer exposed portion 20A is sandwiched between the outer layer 20b in the circumferential direction z1.
  • the protrusion 28 provided with the inner layer exposed portion 20A has a portion where the outer layer 20b is not present and the inner layer 20a forms the surface of the protrusion 28.
  • the inner layer exposed portion 20A is sandwiched between the outer layers 20b in the circumferential direction z1. This allows the inner layer 20a to be present at the outer end in the radial direction y1 of the tapered protrusion 28 provided with the inner layer exposed portion 20A.
  • the inner layer exposed portion 20A arranged in the tapered portion may be arranged continuously in the entire longitudinal axis direction x1, may be arranged in a part of the longitudinal axis direction x1, or multiple inner layer exposed portions 20A may be arranged discontinuously in the longitudinal axis direction x1.
  • the inner layer exposed portion 20A is provided on both the proximal taper portion 22 and the distal taper portion 24, but the inner layer exposed portion 20A may be provided on both the proximal taper portion 22 and the distal taper portion 24, or on either the proximal taper portion 22 or the distal taper portion 24.
  • the tapered portion has a smaller diameter than the straight tube portion 23 when the balloon 2 is inserted into the stenosis portion or removed from the body, fluid is discharged from the inner cavity of the balloon 2 to contract the balloon 2 and the wing-shaped portion of the balloon 2 is wrapped around the shaft 2.
  • the wing-shaped portion formed is short, and the protruding portion 28 may be exposed from the wing-shaped portion.
  • the protruding portion 28 of the tapered portion since the protruding portion 28 of the tapered portion has the inner layer exposed portion 20A, it is easier to prevent damage to the blood vessel lumen wall.
  • the protruding portion 28 of the tapered portion when the protruding portion 28 of the tapered portion is viewed from the outside in the radial direction y1, the exposed inner layer portion 20A is sandwiched between the outer layer 20b, so that the protruding portion 28 can ensure rigidity in the longitudinal axis direction x1 even in the portion where the exposed inner layer portion 20A is formed, improving the insertability of the balloon 2.
  • the configuration of the protrusion 28, including the exposed inner layer portion 20A in the tapered portion, can be understood by replacing the “sleeve portion” in the description of the sleeve portion above with “tapered portion.”
  • the exposed inner layer portion 20A may be formed in the tapered portion continuously from the sleeve portion, or the exposed inner layer portion 20A of the sleeve portion and the exposed inner layer portion 20A of the tapered portion may be formed discontinuously.
  • the exposed inner layer portion 20A may be formed in the distal tapered portion 24, and in an embodiment where the exposed inner layer portion 20A is formed in the distal sleeve portion 25 and the exposed inner layer portion 20A is not formed in the proximal sleeve portion 21 (an embodiment that satisfies only (2) above), the exposed inner layer portion 20A may be formed in the proximal tapered portion 22.
  • the length in the circumferential direction z1 of the exposed inner layer portion 20A (inner layer 20a) in a cross section perpendicular to the longitudinal axis direction x1 may be constant or may vary depending on the position in the longitudinal axis direction x1.
  • the length in the circumferential direction z1 of the exposed inner layer portion 20A (inner layer 20a) can be constant along the longitudinal axis direction x1.
  • FIG. 6 the length in the circumferential direction z1 of the exposed inner layer portion 20A (inner layer 20a) in a cross section perpendicular to the longitudinal axis direction x1 may be constant or may vary depending on the position in the longitudinal axis direction x1.
  • the length in the circumferential direction z1 of the exposed inner layer portion 20A (inner layer 20a) can be constant along the longitudinal axis direction x1.
  • the length in the circumferential direction z1 of the exposed inner layer portion 20A may vary along the longitudinal axis direction x1, and for example, the length in the circumferential direction z1 of the exposed inner layer portion 20A (inner layer 20a) may gradually decrease from the end of the balloon 2 to the side closer to the straight tube portion 23.
  • the balloon 2 satisfies at least one of the following (13) and (14).
  • (13) The above (11) is satisfied, and in the longitudinal axis direction x1, when the end of the proximal taper portion 22 on the proximal sleeve portion 21 side is defined as the 0% position T P0 and the end of the proximal taper portion 22 on the straight tube portion 23 side is defined as the 100% position T P100 , the exposed inner layer portion 20A of the proximal taper portion 22 is arranged in at least a part of the section from position T P0 to 75% position T P75 .
  • FIG. 8 shows an embodiment in which both the proximal taper portion 22 and the distal taper portion 24 satisfy the above (13) and (14), but it is sufficient for the balloon 2 to satisfy at least one of the above (13) and (14).
  • proximal section from position T P0 to position T P75 of proximal taper section 22 and/or the section from position T D0 to position T D75 of distal taper section 24 are portions that are formed with a smaller diameter than the other portions of the taper section, and are portions where protrusions 28 are more likely to be exposed from the wing-shaped portions when balloon 2 is deflated.
  • the exposed inner layer portion 20A arranged in the proximal taper portion 22 and/or the distal taper portion 24 may be arranged continuously in the entire longitudinal axis direction x1 in the above section, may be arranged in a part of the longitudinal axis direction x1, or multiple exposed inner layer portions 20A may be arranged discontinuously in the longitudinal axis direction x1.
  • the exposed inner layer portion 20A of the proximal tapered portion 22 is disposed in at least a portion of the section from the position S P0 to the 50% position. It is also more preferable that the exposed inner layer portion 20A of the distal tapered portion 24 is disposed in at least a portion of the section from the position S D0 to the 50% position.
  • the balloon 2 satisfies at least one of the following (15) and (16).
  • (15) The above (13) is satisfied, and the exposed inner layer portion 20A of the proximal taper portion 22 is disposed in a section including the position T P0 .
  • (16) The above (14) is satisfied, and the inner layer exposed portion 20A of the distal taper portion 24 is disposed in a section including the position T- D0 .
  • FIG. 8 shows an embodiment in which both the proximal taper portion 22 and the distal taper portion 24 satisfy the above (15) and (16), but it is sufficient for the balloon 2 to satisfy at least one of the above (15) and (16).
  • That the exposed inner layer portion 20A is disposed in a section including position T P0 of the proximal taper portion 22 means that the exposed inner layer portion 20A is disposed at the end (position T P0 ) of the proximal sleeve portion 21 side of the proximal taper portion 22. That the exposed inner layer portion 20A is disposed in a section including position T D0 of the distal taper portion 24 means that the exposed inner layer portion 20A is disposed at the end (position T D0 ) of the distal sleeve portion 25 side of the distal taper portion 22.
  • the inner layer 20a which has a low Shore D hardness, to be exposed in the portion of the taper portion where the protruding portion 28 is most likely to be exposed from the wing-shaped portion, making it easier to improve the effect of preventing damage to the blood vessel lumen wall.
  • the balloon 2 satisfies at least one of the following (17) and (18).
  • (17) The above (11) is satisfied, and the proximal taper section 22 has a low protrusion region 28L in which the protrusion 28 has a height equal to or less than the height of the protrusion 28 of the straight pipe section 23.
  • (18) The above (12) is satisfied, and the distal tapered section 24 has a low protrusion region 28L in which the protrusion 28 has a height equal to or less than the height of the protrusion 28 of the straight pipe section 23.
  • FIG. 9 shows an embodiment in which both the proximal taper portion 22 and the distal taper portion 24 satisfy the above (17) and (18), but it is sufficient for the balloon 2 to satisfy at least one of the above (17) and (18).
  • the protruding portion 28 of the tapered portion which is the next leading portion after the sleeve portion and has a larger outer diameter than the sleeve portion, has a low protruding portion region 28L that has a height lower than the height of the protruding portion 28 of the straight tube portion 23, making it easier to improve the insertability of the balloon 2.
  • the low protrusion region 28L may be provided continuously in the longitudinal axis direction x1 in the proximal taper section 22 and/or the distal taper section 24, or may be provided discontinuously.
  • the balloon 2 satisfies at least one of the following (19) and (20).
  • (19) The above (17) is satisfied, and the inner layer exposed portion 20A is arranged in the low protrusion region 28L of the proximal taper portion 22.
  • (20) The above (18) is satisfied, and the inner layer exposed portion 20A is arranged in the low protrusion region 28L of the distal taper portion 24.
  • FIG. 9 shows an embodiment in which both the proximal taper portion 22 and the distal taper portion 24 satisfy the above (19) and (20), but it is sufficient for the balloon 2 to satisfy at least one of the above (19) and (20).
  • the protrusion 28 of the taper portion which is the next leading portion after the sleeve portion and has a larger outer diameter than the sleeve portion, can be made low in height and soft, making it easier to improve the insertion ability of the balloon 2 while also improving the effect of preventing damage to the blood vessel lumen wall.
  • the balloon catheter 1 according to the embodiment of the present invention includes the above-mentioned balloon for balloon catheter 2. As described in the above section "1. Balloon for balloon catheter", the balloon 2 is connected to the distal end of the shaft 30 as shown in FIG.
  • the balloon catheter 1 shows a so-called rapid exchange type balloon catheter 1 having a guidewire port 50 on the way from the distal side to the proximal side of the shaft 30, and an inner shaft 60 that functions as a guidewire insertion passage from the guidewire port 50 to the distal side of the shaft 30.
  • the balloon catheter 1 preferably has a distal shaft 31 and a proximal shaft 32, and the distal shaft 31 and the proximal shaft 32 may be separate members, and the proximal end of the distal shaft 31 may be connected to the distal end of the proximal shaft 32 to form the shaft 30 that extends from the balloon 2 to the proximal end of the balloon catheter 1.
  • one shaft 30 may extend from the balloon 2 to the proximal end of the balloon catheter 1, and the distal shaft 31 and the proximal shaft 32 may be further composed of multiple tube members.
  • the shaft 30 has a fluid flow path and a guidewire insertion path inside.
  • the shaft 30 can be configured to have a fluid flow path and a guidewire insertion path inside by configuring the inner shaft 60 disposed inside the shaft 30 to function as a guidewire insertion path, and the space between the shaft 30 and the inner shaft 60 to function as a fluid flow path.
  • the inner shaft 60 extends from the distal end of the shaft 30 and penetrates the balloon 2, the distal side of the balloon 2 is connected to the inner shaft 60, and the proximal side of the balloon 2 is connected to the shaft 30.
  • the shaft 30 is preferably made of a resin, a metal, or a combination of a resin and a metal.
  • a resin as the material for the shaft, it becomes easier to impart flexibility and elasticity to the shaft 30.
  • a metal as the material for the shaft 30, the deliverability of the balloon catheter 1 can be improved.
  • resins that make up the shaft 30 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorine resins, vinyl chloride resins, silicone resins, natural rubber, synthetic rubber, etc. These may be used alone or in combination of two or more.
  • Examples of metals that make up the shaft 30 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloys, Co-Cr alloys, or combinations thereof.
  • the shaft 30 is made up of a distal shaft 31 and a proximal shaft 32 that are separate members, the distal shaft 31 may be made of a resin, and the proximal shaft 32 may be made of a metal, for example.
  • the shaft 30 may also have a laminated structure made of different materials or the same materials.
  • the balloon 2 and the shaft 30 can be joined by bonding with an adhesive, welding, or by attaching a ring-shaped member to the overlapping portion of the end of the balloon 2 and the shaft 30 and crimping the end. Of these, it is preferable that the balloon 2 and the shaft 30 are joined by welding. By welding the balloon 2 and the shaft 30 together, the bond between the balloon 2 and the shaft 30 is less likely to come apart even if the balloon 2 is repeatedly expanded or contracted, and the strength of the bond can be improved.
  • a tip member 70 is provided at the distal end of the balloon catheter 1.
  • the tip member 70 may be provided at the distal end of the balloon catheter 1 by being connected to the distal end of the balloon 2 as a separate member from the inner shaft 60, or the inner shaft 60 that extends distally beyond the distal end of the balloon 2 may function as the tip member 70.
  • an X-ray opaque marker 80 may be placed at the portion where the balloon 2 is located in the longitudinal axis direction x1 so that the position of the balloon 2 can be confirmed by X-ray fluoroscopy.
  • the X-ray opaque marker 80 is preferably placed at positions corresponding to both ends of the straight tube section 23 of the balloon 2, and may be placed at a position corresponding to the center of the straight tube section 23 in the longitudinal axis direction x1.
  • a hub 5 may be provided on the proximal side of the shaft 30, and the hub 5 is preferably provided with a fluid injection section 6 that is connected to a flow path for fluid to be supplied to the inside of the balloon 2.
  • the shaft 30 and the hub 5 can be joined by, for example, bonding with an adhesive, welding, etc. Among these, it is preferable that the shaft 30 and the hub 5 are joined by adhesion. By bonding the shaft 30 and the hub 5 together, the bond strength between the shaft 30 and the hub 5 can be increased and the durability of the balloon catheter 1 can be improved when the shaft 30 and the hub 5 are made of different materials, for example, when the shaft 30 is made of a highly flexible material and the hub 5 is made of a highly rigid material.
  • the present invention can also be applied to so-called over-the-wire type balloon catheters that have a guidewire passage from the distal side to the proximal side of the shaft.
  • over-the-wire type it is preferable that the inflation lumen and guidewire lumen extend to a hub located on the proximal side, and that the proximal opening of each lumen is provided in a bifurcated hub.
  • the outer wall of the distal shaft 31 and/or the proximal shaft 32 is appropriately coated, and it is more preferable that both the distal shaft 31 and the proximal shaft 32 are coated.
  • the outer wall of the outer shaft is appropriately coated.
  • the coating can be a hydrophilic coating or a hydrophobic coating depending on the purpose, and can be applied by immersing the shaft 30 in a hydrophilic coating agent or a hydrophobic coating agent, applying a hydrophilic coating agent or a hydrophobic coating agent to the outer wall of the shaft 30, or covering the outer wall of the shaft 30 with a hydrophilic coating agent or a hydrophobic coating agent.
  • the coating agent may contain a drug or an additive.
  • Hydrophilic coating agents include hydrophilic polymers such as polyvinyl alcohol, polyethylene glycol, polyacrylamide, polyvinylpyrrolidone, methyl vinyl ether maleic anhydride copolymer, or hydrophilic coating agents made from any combination thereof.
  • Hydrophobic coating agents include polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), silicone oil, hydrophobic urethane resin, carbon coat, diamond coat, diamond-like carbon (DLC) coat, ceramic coat, and substances with low surface free energy terminated with alkyl groups or perfluoroalkyl groups.
  • PTFE polytetrafluoroethylene
  • FEP fluorinated ethylene propylene
  • PFA perfluoroalkoxyalkane
  • silicone oil silicone oil
  • hydrophobic urethane resin carbon coat
  • diamond coat diamond coat
  • DLC diamond-like carbon
  • ceramic coat and substances with low surface free energy terminated with alkyl groups or perfluoroalkyl groups.
  • a method for manufacturing a balloon catheter according to an embodiment of the present invention is a method for manufacturing the balloon catheter, comprising the steps of: preparing a parison having a radial direction, a circumferential direction, and a longitudinal direction, and an inner lumen extending in the longitudinal direction; stretching the parison to manufacture a balloon having a proximal sleeve portion, a proximal tapered portion, a straight tube portion, a distal tapered portion, and a distal sleeve portion, and having a protruding portion; and cutting the top side of the protruding portion of the proximal sleeve portion and/or the distal sleeve portion along the longitudinal direction to form an exposed inner layer portion, wherein the parison has an outer layer and an inner layer made of a material having a Shore D hardness lower than that of the outer layer, and has a protruding region including the protruding portion protruding radially outward and extending in the
  • the parison has an outer layer and an inner layer made of a material having a lower Shore D hardness than the outer layer, and has a protruding region and a non-protruding region, and in a cross section perpendicular to the longitudinal axis, the inner layer has a thin portion in the non-protruding region and a thick portion in the protruding region.
  • the top side of the protruding region of the part corresponding to the proximal sleeve portion and/or the distal sleeve portion of the parison is cut along the longitudinal axis, or the top side of the protruding portion of the proximal sleeve portion and/or the distal sleeve portion after molding into a balloon is cut along the longitudinal axis, thereby forming an exposed inner layer portion in the proximal sleeve portion and/or the distal sleeve portion, and a "2.
  • Balloon catheter can be produced that includes a "1. Balloon for balloon catheter” in which the exposed inner layer portion is sandwiched between the outer layers in the circumferential direction when viewed from the outside in the radial direction.
  • Figure 10 shows a perspective view of a parison before stretching according to an embodiment of the present invention.
  • Figure 11 shows a XI-XI cross-sectional view (without a middle thickness portion) of the parison shown in Figure 10
  • Figure 12 shows a cross-sectional view perpendicular to the longitudinal axis of a parison mold used to manufacture the parison shown in Figure 11.
  • Figure 13 shows a modified example of the XI-XI cross-sectional view (with a middle thickness portion)
  • Figure 14 shows a cross-sectional view perpendicular to the longitudinal axis of a parison mold used to manufacture the parison shown in Figure 13.
  • Figure 15 shows a cross-sectional view in the longitudinal axis direction of a mold used to stretch a parison in a manufacturing method according to an embodiment of the present invention.
  • Figure 16 shows a XVI-XVI cross-sectional view of the mold shown in Figure 15, i.e., a cross-sectional view of the straight tube portion of the mold
  • Figure 17 shows a XVII-XVII cross-sectional view of the mold shown in Figure 15, i.e., a cross-sectional view of the mold sleeve portion.
  • Figure 18 shows a modified example of the XVII-XVII cross section.
  • the parison 200 is made of resin and is a tubular member having an inner cavity 205.
  • the parison 200 has a first end 201 and a second end 202, and extends in a longitudinal axis direction x2 from the first end 201 to the second end 202.
  • the parison 200 has a radial direction y2 and a circumferential direction z2, similar to the balloon 2.
  • the parison 200 has an outer layer 200b and an inner layer 200a made of a material having a lower Shore D hardness than the outer layer 200b.
  • materials constituting the inner layer 200a and the outer layer 200b and their Shore D hardness please refer to the description of the resins constituting the inner layer 20a and the outer layer 20b in the section "1. Balloon for balloon catheter" and the description of their Shore D hardness.
  • the parison 200 has a protruding region R1 including a protruding portion 208 that protrudes outward in the radial direction y2 and extends in the longitudinal direction x2, and a non-protruding region R2 other than the protruding region R1.
  • the protruding portion 208 can be molded into the protruding portion 28 of the balloon 2
  • the non-protruding region R2 can be molded into the balloon body portion 20 other than the protruding portion 28.
  • the parison 200 can be stretched by blow molding the parison 200 or by biaxially stretching it.
  • multiple protrusions 208 may be provided in the circumferential direction z2, or, although not shown, one protrusion 208 may be provided in the circumferential direction z2.
  • the multiple protrusions 208 are spaced apart in the circumferential direction z2, and it is more preferable that they are arranged at equal intervals in the circumferential direction z2.
  • the inner layer 200a has a thin portion 220 in the non-protruding region R2 and a thick portion 210 that is thicker than the thin portion 220 in the protruding region R1. Because the inner layer 200a has a thick portion 210 in the protruding region R1, the top side of the protruding portion 208 can be cut along the longitudinal axis direction x2 in the cutting process described below to form an exposed inner layer portion.
  • Such a parison 200 can be manufactured, for example, by extrusion molding a resin using a parison mold 250 as shown in Fig. 12.
  • the parison mold 250 has a first tubular member 251, a second tubular member 252, and a third tubular member 253, and it is preferable that the first tubular member 251 has a cylindrical shape so as to form the inner cavity 205 of the parison 200, the second tubular member 252 has a tubular shape with a protrusion so as to form the large thickness portion 210 and the small thickness portion 220 of the inner layer 200a, and the third tubular member 253 has a tubular shape with a protrusion so as to form the protrusion 208.
  • the material constituting the parison mold 250 is preferably a metal, and more preferably iron, copper, aluminum, or an alloy of these.
  • an iron alloy may be stainless steel
  • an copper alloy may be brass
  • an aluminum alloy may be duralumin.
  • the parison mold 250 is preferably made of stainless steel.
  • the parison 200 may have a configuration as shown in FIG. 13. That is, in a cross section perpendicular to the longitudinal axis direction x2, the inner layer 200a may have a medium thickness portion 230 in the non-protruding region R2 that is thicker than the small thickness portion 220 and thinner than the large thickness portion 210, and the small thickness portion 220 may be located between the large thickness portion 210 and the medium thickness portion 230 in the circumferential direction z2.
  • the parison 200 as shown in FIG. 13 can be manufactured by extruding resin using a parison mold 250 as shown in FIG. 14.
  • the parison mold 250 shown in FIG. 14 preferably has a cylindrical shape with a protruding portion in the portion forming the protruding region R1 and a low protruding portion having a lower height than the protruding portion in the portion forming the non-protruding region R2 so that the second cylindrical member 252 can form the large thickness portion 210, the small thickness portion 220, and the medium thickness portion 230 of the inner layer 200a.
  • a balloon 2 having a proximal sleeve portion 21, a proximal tapered portion 22, a straight tube portion 23, a distal tapered portion 24, and a distal sleeve portion 25, and a protruding portion 28 is manufactured.
  • a mold 300 as shown in FIG. 15 can be used.
  • the mold 300 has a longitudinal axis direction x3, a radial direction y3, and a circumferential direction z3, and has an inner cavity 305 extending in the longitudinal axis direction x3 and into which the parison 200 is inserted. It is preferable that a portion of the parison 200 in the longitudinal axis direction x2 is placed in the inner cavity 305 of the mold 300.
  • the mold 300 preferably has, in the longitudinal axis direction x3, a mold straight pipe section 300C that forms the straight pipe section of the balloon 2, two mold taper sections 300T arranged on both sides of the mold straight pipe section 300C that form the tapered section of the balloon 2, and two mold sleeve sections 300S arranged on the side farther from the mold straight pipe section 300C than the mold taper sections 300T that form the sleeve section of the balloon 2.
  • the mold straight pipe section 300C forms the straight pipe section 23 of the balloon 2
  • the mold taper sections 300T form the proximal side taper section 22 and the distal side taper section 24
  • the mold sleeve sections 300S form the proximal side sleeve section 21 and the distal side sleeve section 25.
  • the mold 300 may be made of one member or may be made of multiple members. As shown in FIG. 15, multiple mold members may be connected to each other in the longitudinal axis direction x3. For example, the mold straight tube section 300C, the mold taper section 300T, and the mold sleeve section 300S may each be different mold members, and these may be connected to each other in the longitudinal axis direction x3.
  • the mold 300 may also be separable in the radial direction y. This makes it easier to insert the parison 200 into the inner cavity 305 of the mold 300. As shown in FIG. 15, each mold member may be joined by engaging adjacent mold members with each other, or, although not shown, adjacent mold members may be attached with magnets and joined by the attractive force of the magnets.
  • the inner cavity 305 of the mold 300 is preferably formed of a groove portion 310 recessed outward in the radial direction y3 and extending in the longitudinal axis direction x3, and a cylindrical wall portion 320 other than the groove portion 310.
  • a plurality of groove portions 310 may be provided in the circumferential direction z3, or, although not shown, one groove portion 310 may be provided in the circumferential direction z3.
  • the groove portions 310 are preferably spaced apart in the circumferential direction z3, and more preferably arranged at equal intervals in the circumferential direction z3.
  • the groove 310 is preferably provided in the mold straight pipe section 300C, and may be provided in the mold taper section 300T or mold sleeve section 300S.
  • a protrusion 28 can be formed in the straight pipe section 23 of the balloon 2, and the efficiency of cutting the narrowed part by the balloon 2 can be improved.
  • the depth of the groove 310 provided in the mold taper section 300T or mold sleeve section 300S may be shallower than or equal to the depth of the groove 310 provided in the mold straight pipe section 300C, and can be appropriately selected depending on the order of performing the cutting process described below.
  • the material constituting the mold 300 is preferably a metal, and more preferably iron, copper, aluminum, or an alloy of these.
  • an iron alloy may be stainless steel
  • an copper alloy may be brass
  • an aluminum alloy may be duralumin.
  • the parison mold 300 is preferably made of stainless steel.
  • the top side of the protruding portion 28 of the proximal sleeve portion 21 and/or the distal sleeve portion 25 is cut along the longitudinal axis direction x1 to form the exposed inner layer portion 20A.
  • the cutting step may be performed after the parison 200 is stretched to form the balloon 2. At this time, only the outer layer 20b of the protruding portion 28 may be cut, or a part of the inner layer 20a may be cut together with the outer layer 20b of the protruding portion 28.
  • the top side of the protruding portion 208 of the parison 200 corresponding to the proximal sleeve portion 21 and/or the distal sleeve portion 25 may be cut along the longitudinal axis direction x2, and the parison 200 in this state may be stretched to form a balloon 2 in which the top side of the protruding portion 28 of the proximal sleeve portion 21 and/or the distal sleeve portion 25 has been cut off.
  • only the outer layer 200b of the protruding portion 208 may be removed, or a part of the inner layer 200a may be removed together with the outer layer 200b of the protruding portion 208.
  • proximal sleeve portion 21 and/or the distal sleeve portion 25 to have an inner layer exposed portion 20A where the outer layer 20b is not present, and the balloon 2 can be manufactured so that the inner layer exposed portion 20A is sandwiched between the outer layers 20b in the circumferential direction z1 when viewed from the outside in the radial direction y1.
  • the height of the protruding portion 28 of the proximal sleeve portion 21 and/or the distal sleeve portion 25 can be reduced by the cutting process, so that the depth of the groove portion 310 in the mold sleeve portion 300S of the mold 300 when molding the balloon 2 may be equal to the depth of the groove portion of the mold straight tube portion 300C, as shown in FIG. 17.
  • the portion of the protrusion 208 whose height has been reduced by the cutting process is formed in the proximal sleeve portion 21 and/or the distal sleeve portion 25, so that, as shown in FIG. 18, the depth of the groove portion 310 in the mold sleeve portion 300S of the mold 300 when molding the balloon 2 may be shallower than the depth of the groove portion in the mold straight tube portion 300C.
  • the manufacturing method according to an embodiment of the present invention may further include a step of cutting the top side of the protruding portion 28 of the proximal taper portion 22 and/or the distal taper portion 24 along the longitudinal axis direction x1 to form the exposed inner layer portion 20A.
  • this cutting step of the taper portion may be performed after the parison 200 is stretched and formed into the balloon 2, or may be performed at the parison 200 stage.
  • the height of the protruding portion 28 of the proximal tapered portion 22 and/or the distal tapered portion 24 can be reduced by the cutting process, so the depth of the groove portion 310 in the mold taper portion 300T of the mold 300 when molding the balloon 2 may be equal to the depth of the groove portion in the mold straight tube portion 300C.
  • the portion of the protrusion 208 whose height has been reduced by the cutting process is formed in the proximal tapered portion 22 and/or the distal tapered portion 24, so the depth of the groove portion 310 in the mold taper portion 300T of the mold 300 when molding the balloon 2 may be shallower than the depth of the groove portion in the mold straight tube portion 300C.
  • Balloon catheter 2 Balloon for balloon catheter 5: Hub 6: Fluid injection section 20: Balloon body section 20A: Inner layer exposed section 20a: Inner layer 20b: Outer layer 21: Proximal sleeve section 22: Proximal taper section 23: Straight tube section 24: Distal taper section 25: Distal sleeve section 28: Protruding section 28L: Low protruding section region 28t: Apex section 30: Shaft 31: Distal shaft 32: Proximal shaft 50: Guidewire port 60: Inner shaft 70: Tip member 80: Marker 200: Parison 200a: Inner layer of parison 200b: outer layer of parison 201: first end of parison 202: second end of parison 205: inner cavity of parison 208: protruding portion of parison 210: large thickness portion 220: small thickness portion 230: medium thickness portion 250: mold for parison 251: first cylindrical member 252: second cylindrical member 253: third cylindrical member 300: mold 300: mold

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Abstract

Provided is a balloon for a balloon-catheter, which is less likely to damage lumenal walls when the balloon is inserted into the lumen of a blood vessel or other vessel and achieves improvements in lumenal insertability and stenosis incision efficiency.　This balloon for a balloon-catheter includes outer layers 20b and an inner layer 20a having a lower Shore D hardness than that of the outer layers 20b, and additionally includes a protruding part 28 protruding outward in the radial direction y1 and extending in the longitudinal axial direction x1. The protruding part 28 in a proximal sleeve section and/or distal sleeve section 25 has an inner layer exposing portion 20A where the outer layer 20b is not present. When viewed from the outside in the radial direction y1, the inner layer exposing portion 20A is located between the outer layers 20b in the circumferential direction z1.

Description

バルーンカテーテル用バルーン及びそれを備えるバルーンカテーテル、並びにバルーンカテーテルの製造方法Balloon for balloon catheter, balloon catheter including same, and method for manufacturing balloon catheter
　本発明は、バルーンカテーテル用バルーン及びそれを備えるバルーンカテーテル、並びにバルーンカテーテルの製造方法に関する。 The present invention relates to a balloon for a balloon catheter, a balloon catheter including the same, and a method for manufacturing a balloon catheter.
　血管内壁に石灰化等により硬化した狭窄部が形成されることにより、狭心症や心筋梗塞等の疾病が引き起こされる。これらの治療の一つとして、バルーンカテーテルを用いて狭窄部を拡張させる血管形成術がある。血管形成術は、バイパス手術のような開胸術を必要としない低侵襲療法であり、広く行われている。 Diseases such as angina and myocardial infarction can occur when narrowed areas harden due to calcification on the inner walls of blood vessels. One treatment for this is angioplasty, which uses a balloon catheter to expand the narrowed area. Angioplasty is a minimally invasive therapy that does not require open chest surgery like bypass surgery, and is widely performed.
　血管形成術において、一般的なバルーンカテーテルでは石灰化等により硬化した狭窄部を拡張させにくいことがある。また、ステントと称される留置拡張器具を狭窄部に留置することによって狭窄部を拡張する方法も用いられているが、例えば、この治療後に血管に新生内膜が過剰に増殖して再び血管の狭窄が発生してしまうＩＳＲ（Ｉｎ－Ｓｔｅｎｔ－Ｒｅｓｔｅｎｏｓｉｓ）病変等が起こる場合もある。ＩＳＲ病変では新生内膜が柔らかく、また表面が滑りやすいため、一般的なバルーンカテーテルではバルーンの拡張時にバルーンの位置が病変部からずれてしまい血管を傷つけてしまうことがある。 In angioplasty, it can be difficult to use a typical balloon catheter to expand a narrowed area that has hardened due to calcification, etc. One method used is to expand the narrowed area by placing an indwelling expansion device called a stent in the narrowed area, but this can lead to, for example, ISR (In-Stent-Restenosis) lesions, in which excessive neointima grows in the blood vessel after treatment, causing the blood vessel to narrow again. In ISR lesions, the neointima is soft and has a slippery surface, so with a typical balloon catheter, the position of the balloon can shift from the lesion when it is expanded, causing damage to the blood vessel.
　このような石灰化病変やＩＳＲ病変等の病変であっても狭窄部を拡張できるバルーンカテーテルとして、狭窄部に食い込ませるための突出部やブレード、スコアリングエレメントがバルーンに設けられているバルーンカテーテルが開発されている。例えば、特許文献１には、突出部にアモルファスポリマーを用いることにより、突出部の剛性をバルーン壁よりも大きくして、突出部による切開効率を向上したバルーンカテーテルが開示されている。 Balloon catheters that have protrusions, blades, and scoring elements on the balloon to penetrate the narrowed area have been developed as balloon catheters that can expand the narrowed area even in lesions such as calcified lesions and ISR lesions. For example, Patent Document 1 discloses a balloon catheter that uses an amorphous polymer for the protrusions, making the rigidity of the protrusions greater than that of the balloon wall, thereby improving the efficiency of incision by the protrusions.
米国特許出願公開第２０１６／０１２８７１８号明細書US Patent Application Publication No. 2016/0128718
　しかし、上記従来のバルーンでは、収縮状態のバルーンを血管等の管腔内に挿通させて病変部まで送達したり病変部から抜去させたりする際に、バルーンの前進又は後退において先頭となる部分に設けられた突出部により血管等の管腔内壁を損傷する不具合があった。 However, with the above-mentioned conventional balloons, when the deflated balloon is inserted into the lumen of a blood vessel or the like to be delivered to the affected area or removed from the affected area, a protrusion provided at the leading part of the balloon when it is advanced or retracted can damage the inner wall of the lumen of the blood vessel or the like.
　上記の事情に鑑み本発明は、血管等の管腔内にバルーンを挿通した際に管腔内壁を損傷しにくく、また、管腔内の挿通性や狭窄部の切開効率を向上できるバルーンカテーテル用バルーン及びそれを備えるバルーンカテーテル、並びにバルーンカテーテルの製造方法を提供することを目的とする。 In consideration of the above circumstances, the present invention aims to provide a balloon for a balloon catheter that is less likely to damage the inner wall of a lumen when the balloon is inserted into a lumen such as a blood vessel, and that can improve the ease of insertion into the lumen and the efficiency of incising a stenotic part, as well as a balloon catheter including the same, and a method for manufacturing the balloon catheter.
　上記課題を解決し得た本発明の実施形態に係るバルーンカテーテル用バルーンは、以下の通りである。
　［１］長手軸方向、径方向、及び周方向を有し、外層と、前記外層よりもショアＤ硬度が低い材料から構成されている内層とを有しているバルーンカテーテル用バルーンであって、直管部と、前記直管部よりも近位側に位置している近位側テーパー部と、前記近位側テーパー部よりも近位側に位置している近位側スリーブ部と、前記直管部よりも遠位側に位置している遠位側テーパー部と、前記遠位側テーパー部よりも遠位側に位置している遠位側スリーブ部と、を有しており、前記径方向の外方に突出し前記長手軸方向に延在している突出部を有しており、下記（１）及び（２）の少なくとも一方を満たしているバルーンカテーテル用バルーン。
　（１）前記近位側スリーブ部の前記突出部は、前記外層が存在していない内層露出部を有しており、前記径方向の外方から見たとき前記周方向において前記内層露出部は前記外層に挟まれている。
　（２）前記遠位側スリーブ部の前記突出部は、前記外層が存在していない内層露出部を有しており、前記径方向の外方から見たとき前記周方向において前記内層露出部は前記外層に挟まれている。
　［２］前記直管部の前記突出部は、前記外層が存在していない内層露出部を有していない［１］に記載のバルーンカテーテル用バルーン。
　［３］下記（３）及び（４）の少なくとも一方を満たしている［１］又は［２］に記載のバルーンカテーテル用バルーン。
　（３）前記（１）を満たしており、前記長手軸方向において、前記近位側スリーブ部の近位端を０％の位置ＳＰ０、前記近位側スリーブ部の前記近位側テーパー部側の端を１００％の位置ＳＰ１００としたとき、前記近位側スリーブ部の前記内層露出部は位置ＳＰ０から７５％の位置ＳＰ７５までの区間の少なくとも一部に配されている。
　（４）前記（２）を満たしており、前記長手軸方向において、前記遠位側スリーブ部の遠位端を０％の位置ＳＤ０、前記遠位側スリーブ部の前記遠位側テーパー部側の端を１００％の位置ＳＤ１００としたとき、前記遠位側スリーブ部の前記内層露出部は位置ＳＤ０から７５％の位置ＳＤ７５までの区間の少なくとも一部に配されている。
　［４］下記（５）及び（６）の少なくとも一方を満たしている［３］に記載のバルーンカテーテル用バルーン。
　（５）前記（３）を満たしており、前記近位側スリーブ部の前記内層露出部は前記位置ＳＰ０を含む区間に配されている。
　（６）前記（４）を満たしており、前記遠位側スリーブ部の前記内層露出部は前記位置ＳＤ０を含む区間に配されている。
　［５］前記長手軸方向に垂直な断面において、前記内層露出部の前記周方向の長さは、前記内層露出部の両側のそれぞれの前記外層の前記周方向の長さよりも長い［１］～［４］のいずれかに記載のバルーンカテーテル用バルーン。
　［６］前記長手軸方向に垂直な断面において、前記内層露出部の前記周方向の長さは、前記内層露出部の両側のそれぞれの前記外層の前記周方向の長さよりも短い［１］～［４］のいずれかに記載のバルーンカテーテル用バルーン。
　［７］下記（７）及び（８）の少なくとも一方を満たしている［１］～［６］のいずれかに記載のバルーンカテーテル用バルーン。
　（７）前記（１）を満たしており、前記近位側スリーブ部は、前記突出部が前記直管部の前記突出部の高さ以下の高さを有する低突出部領域を有している。
　（８）前記（２）を満たしており、前記遠位側スリーブ部は、前記突出部が前記直管部の前記突出部の高さ以下の高さを有する低突出部領域を有している。
　［８］下記（９）及び（１０）の少なくとも一方を満たしている［７］に記載のバルーンカテーテル用バルーン。
　（９）前記（７）を満たしており、前記内層露出部は前記近位側スリーブ部の前記低突出部領域に配されている。
　（１０）前記（８）を満たしており、前記内層露出部は前記遠位側スリーブ部の前記低突出部領域に配されている。
　［９］下記（１１）及び（１２）の少なくとも一方を満たしている［１］～［８］のいずれかに記載のバルーンカテーテル用バルーン。
　（１１）前記近位側テーパー部の前記突出部は、前記外層が存在していない内層露出部を有しており、前記径方向の外方から見たとき前記周方向において前記内層露出部は前記外層に挾まれている。
　（１２）前記遠位側テーパー部の前記突出部は、前記外層が存在していない内層露出部を有しており、前記径方向の外方から見たとき前記周方向において前記内層露出部は前記外層に挟まれている。
　［１０］下記（１３）及び（１４）の少なくとも一方を満たしている［９］に記載のバルーンカテーテル用バルーン。
　（１３）前記（１１）を満たしており、前記長手軸方向において、前記近位側テーパー部の近位側スリーブ部側の端を０％の位置ＴＰ０、前記近位側テーパー部の前記直管部側の端を１００％の位置ＴＰ１００としたとき、前記近位側テーパー部の前記内層露出部は位置ＴＰ０から７５％の位置ＴＰ７５までの区間の少なくとも一部に配されている。
　（１４）前記（１２）を満たしており、前記長手軸方向において、前記遠位側テーパー部の遠位側スリーブ部側の端を０％の位置ＴＤ０、前記遠位側テーパー部の前記直管部側の端を１００％の位置ＴＤ１００としたとき、前記遠位側テーパー部の前記内層露出部は位置ＴＤ０から７５％の位置ＴＤ７５までの区間の少なくとも一部に配されている。
　［１１］下記（１５）及び（１６）の少なくとも一方を満たしている［１０］に記載のバルーンカテーテル用バルーン。
　（１５）前記（１３）を満たしており、前記近位側テーパー部の前記内層露出部は前記位置ＴＰ０を含む区間に配されている。
　（１６）前記（１４）を満たしており、前記遠位側テーパー部の前記内層露出部は前記位置ＴＤ０を含む区間に配されている。
　［１２］下記（１７）及び（１８）の少なくとも一方を満たしている［９］～［１１］のいずれかに記載のバルーンカテーテル用バルーン。
　（１７）前記（１１）を満たしており、前記近位側テーパー部は、前記突出部が前記直管部の前記突出部の高さ以下の高さを有する低突出部領域を有している。
　（１８）前記（１２）を満たしており、前記遠位側テーパー部は、前記突出部が前記直管部の前記突出部の高さ以下の高さを有する低突出部領域を有している。
　［１３］下記（１９）及び（２０）の少なくとも一方を満たしている［１２］に記載のバルーンカテーテル用バルーン。
　（１９）前記（１７）を満たしており、前記内層露出部は前記近位側テーパー部の前記低突出部領域に配されている。
　（２０）前記（１８）を満たしており、前記内層露出部は前記遠位側テーパー部の前記低突出部領域に配されている。 A balloon for a balloon catheter according to an embodiment of the present invention that can solve the above problems is as follows.
[1] A balloon for a balloon catheter having a longitudinal axis, a radial direction, and a circumferential direction, and having an outer layer and an inner layer made of a material having a Shore D hardness lower than that of the outer layer, the balloon having a straight tube portion, a proximal tapered portion located proximal to the straight tube portion, a proximal sleeve portion located proximal to the proximal tapered portion, a distal tapered portion located distal to the straight tube portion, and a distal sleeve portion located distal to the distal tapered portion, the balloon having a protruding portion protruding radially outward and extending in the longitudinal axis direction, and satisfying at least one of the following (1) and (2).
(1) The protruding portion of the proximal sleeve portion has an exposed inner layer portion where the outer layer is not present, and when viewed from the radial outside, the exposed inner layer portion is sandwiched between the outer layer in the circumferential direction.
(2) The protrusion portion of the distal sleeve portion has an exposed inner layer portion where the outer layer is not present, and when viewed from the radially outward side, the exposed inner layer portion is sandwiched between the outer layer in the circumferential direction.
[2] The balloon for a balloon catheter according to [1], wherein the protruding portion of the straight tube portion does not have an exposed portion of the inner layer where the outer layer is not present.
[3] A balloon for a balloon catheter according to [1] or [2], which satisfies at least one of the following (3) and (4):
(3) The condition (1) is satisfied, and when, in the longitudinal axis direction, the proximal end of the proximal sleeve portion is the 0% position S P0 and the end of the proximal sleeve portion on the proximal taper portion side is the 100% position S P100 , the exposed inner layer portion of the proximal sleeve portion is arranged in at least a part of the section from position S P0 to 75% position S P75 .
(4) The condition (2) is satisfied, and when, in the longitudinal axis direction, the distal end of the distal sleeve portion is defined as the 0% position S D0 and the end of the distal sleeve portion on the distal taper portion side is defined as the 100% position S D100 , the exposed inner layer portion of the distal sleeve portion is arranged in at least a part of the section from position S D0 to 75% position S D75 .
[4] The balloon for a balloon catheter according to [3], which satisfies at least one of the following (5) and (6):
(5) The above (3) is satisfied, and the exposed portion of the inner layer of the proximal sleeve portion is disposed in a section including the position S P0 .
(6) The above (4) is satisfied, and the exposed portion of the inner layer of the distal sleeve portion is disposed in a section including the position S- D0 .
[5] A balloon for a balloon catheter according to any one of [1] to [4], wherein, in a cross section perpendicular to the longitudinal axis direction, the circumferential length of the exposed inner layer portion is longer than the circumferential length of each of the outer layers on either side of the exposed inner layer portion.
[6] A balloon for a balloon catheter described in any one of [1] to [4], wherein, in a cross section perpendicular to the longitudinal axis direction, the circumferential length of the exposed inner layer portion is shorter than the circumferential length of each of the outer layers on both sides of the exposed inner layer portion.
[7] A balloon for a balloon catheter according to any one of [1] to [6], which satisfies at least one of the following (7) and (8):
(7) The above (1) is satisfied, and the proximal sleeve portion has a low protrusion region in which the protrusion has a height equal to or less than the height of the protrusion of the straight pipe portion.
(8) The above (2) is satisfied, and the distal sleeve portion has a low protrusion region in which the protrusion has a height equal to or less than the height of the protrusion of the straight tube portion.
[8] The balloon for a balloon catheter according to [7], which satisfies at least one of the following (9) and (10):
(9) The above (7) is satisfied, and the exposed inner layer portion is disposed in the low protrusion region of the proximal sleeve portion.
(10) The above (8) is satisfied, and the exposed inner layer portion is disposed in the low protrusion region of the distal sleeve portion.
[9] A balloon for a balloon catheter according to any one of [1] to [8], which satisfies at least one of the following (11) and (12):
(11) The protruding portion of the proximal taper section has an exposed inner layer portion where the outer layer is not present, and when viewed from the radial outside, the exposed inner layer portion is sandwiched between the outer layer in the circumferential direction.
(12) The protruding portion of the distal taper section has an inner layer exposed portion where the outer layer is not present, and when viewed from the radial outside, the inner layer exposed portion is sandwiched between the outer layer in the circumferential direction.
[10] The balloon for a balloon catheter according to [9], which satisfies at least one of the following (13) and (14).
(13) The condition (11) is satisfied, and when, in the longitudinal axis direction, the end of the proximal taper portion on the proximal sleeve portion side is defined as the 0% position T P0 and the end of the proximal taper portion on the straight tube portion side is defined as the 100% position T P100 , the exposed inner layer portion of the proximal taper portion is located in at least a part of the section from position T P0 to 75% position T P75 .
(14) The condition (12) is satisfied, and when, in the longitudinal axis direction, the end of the distal taper portion on the distal sleeve portion side is defined as a 0% position T D0 and the end of the distal taper portion on the straight tube portion side is defined as a 100% position T D100 , the exposed inner layer portion of the distal taper portion is located in at least a part of the section from position T D0 to 75% position T D75 .
[11] The balloon for a balloon catheter according to [10], which satisfies at least one of the following (15) and (16):
(15) The above (13) is satisfied, and the inner layer exposed portion of the proximal taper portion is disposed in a section including the position T P0 .
(16) The above (14) is satisfied, and the exposed inner layer portion of the distal taper portion is disposed in a section including the position T- D0 .
[12] A balloon for a balloon catheter according to any one of [9] to [11], which satisfies at least one of the following (17) and (18):
(17) The above (11) is satisfied, and the proximal taper portion has a low protrusion region in which the protrusion has a height equal to or less than the height of the protrusion of the straight pipe portion.
(18) The above (12) is satisfied, and the distal tapered portion has a low protrusion region in which the protrusion has a height equal to or less than the height of the protrusion of the straight tube portion.
[13] The balloon for a balloon catheter according to [12], which satisfies at least one of the following (19) and (20):
(19) The above (17) is satisfied, and the exposed inner layer portion is disposed in the low protrusion region of the proximal taper portion.
(20) The above (18) is satisfied, and the exposed inner layer portion is disposed in the low protrusion region of the distal taper portion.
　本発明はまた、以下を提供する。
　［１４］上記［１］～［１３］のいずれかに記載のバルーンカテーテル用バルーンを備えるバルーンカテーテル。 The present invention also provides the following:
[14] A balloon catheter comprising the balloon for a balloon catheter according to any one of [1] to [13] above.
　本発明はさらに、［１４］に記載のバルーンカテーテルの製造方法を提供する。本発明の実施形態に係る製造方法は、以下の通りである。
　［１５］上記［１４］に記載のバルーンカテーテルの製造方法であって、長手軸方向、径方向、及び周方向を有し、前記長手軸方向に延在する内腔を有しているパリソンを準備するステップと、前記パリソンを延伸して、前記近位側スリーブ部、前記近位側テーパー部、前記直管部、前記遠位側テーパー部、前記遠位側スリーブ部を有し、前記突出部を有するバルーンを製造するステップと、前記近位側スリーブ部及び／又は前記遠位側スリーブ部の前記突出部の頂部側を前記長手軸方向に沿って切除して前記内腔露出部を形成するステップと、を有しており、前記パリソンは、外層と、前記外層よりもショアＤ硬度が低い材料から構成されている内層と、を有しており、前記径方向の外方に突出し前記長手軸方向に延在している突出部を含む突出領域と、前記突出領域以外の非突出領域と、を有しており、前記長手軸方向に垂直な断面において、前記内層は、前記非突出領域において小厚部を有しており前記突出領域において前記小厚部よりも厚い厚みを有している大厚部を有しているバルーンカテーテルの製造方法。
　［１６］前記近位側テーパー部及び／又は前記遠位側テーパー部の前記突出部の頂部側を前記長手軸方向に沿って切除して前記内層露出部を形成するステップをさらに有する［１５］に記載のバルーンカテーテルの製造方法。
　［１７］前記長手軸方向に垂直な断面において、前記内層は、前記小厚部よりも厚い厚みを有し前記大厚部よりも薄い厚みを有する中厚部を前記非突出領域において有しており、前記周方向において前記小厚部は前記大厚部と前記中厚部の間に位置している［１５］又は［１６］に記載のバルーンカテーテルの製造方法。 The present invention further provides a method for producing the balloon catheter according to the present invention.
[15] A method for producing a balloon catheter as described in [14] above, comprising the steps of: preparing a parison having a longitudinal axis, a radial direction, and a circumferential direction, and an inner lumen extending in the longitudinal axis direction; stretching the parison to produce a balloon having the proximal sleeve portion, the proximal tapered portion, the straight tube portion, the distal tapered portion, and the distal sleeve portion, and having the protruding portion; and cutting off an apex side of the protruding portion of the proximal sleeve portion and/or the distal sleeve portion along the longitudinal axis direction to form the exposed inner lumen, wherein the parison has an outer layer and an inner layer made of a material having a Shore D hardness lower than that of the outer layer, and has a protruding region including the protruding portion protruding radially outward and extending in the longitudinal axis direction, and a non-protruding region other than the protruding region, and in a cross section perpendicular to the longitudinal axis direction, the inner layer has a thin portion in the non-protruding region and a thick portion in the protruding region that is thicker than the thin portion.
[16] The method for manufacturing a balloon catheter described in [15], further comprising a step of cutting off the apex side of the proximal taper portion and/or the distal taper portion along the longitudinal axis direction to form the exposed inner layer portion.
[17] The method for manufacturing a balloon catheter described in [15] or [16], wherein, in a cross section perpendicular to the longitudinal axis direction, the inner layer has a medium thickness portion in the non-protruding region that is thicker than the small thickness portion and thinner than the large thickness portion, and the small thickness portion is located between the large thickness portion and the medium thickness portion in the circumferential direction.
　上記バルーンカテーテル用バルーン及びそれを備えるバルーンカテーテル、並びにバルーンカテーテルの製造方法によれば、血管等の管腔内にバルーンを挿通した際に管腔内壁を損傷しにくく、また、管腔内の挿通性や狭窄部の切開効率を向上できるバルーンカテーテル用バルーン及びそれを備えるバルーンカテーテル、並びにバルーンカテーテルの製造方法を提供することができる。これにより、バルーンカテーテルによる治療や処置の安全性を向上しつつ効率的な狭窄部の切開を行うことが可能になる。 The above-mentioned balloon for balloon catheter, balloon catheter including the same, and method for manufacturing a balloon catheter can provide a balloon for balloon catheter, which is less likely to damage the inner wall of a lumen when the balloon is inserted into a lumen such as a blood vessel, and which can improve the ease of insertion into the lumen and the efficiency of incising the stenosis, as well as a balloon catheter including the same, and a method for manufacturing a balloon catheter. This makes it possible to efficiently incise the stenosis while improving the safety of treatments and procedures using the balloon catheter.
本発明の一実施形態に係るバルーンカテーテルの側面図を表す。1 illustrates a side view of a balloon catheter according to one embodiment of the present invention. 図１に示したバルーンカテーテルのＩＩ－ＩＩ断面図を表す。2 shows a cross-sectional view of the balloon catheter shown in FIG. 1 along line II-II. 図１に示したバルーンカテーテルのＩＩＩ－ＩＩＩ断面図を表す。3 shows a cross-sectional view of the balloon catheter shown in FIG. 1 taken along line III-III. 図３の部分Ｐの拡大図を表す。4 shows an enlarged view of a portion P of FIG. 3. 図４を径方向の外方から見た図を表す。5 shows a view of FIG. 4 seen from the radial outside. 図１に示したバルーンカテーテルのバルーンを突出部側から見た平面図を表す。FIG. 2 is a plan view of the balloon of the balloon catheter shown in FIG. 1 as viewed from the protruding portion side. 図１に示したバルーンカテーテルの遠位端部の長手軸方向の断面図を表す。2 illustrates a longitudinal cross-sectional view of the distal end of the balloon catheter shown in FIG. 1 . 図６の変形例を示す平面図を表す。FIG. 7 illustrates a plan view showing a modified example of FIG. 6 . 本発明の他の実施形態に係るバルーンカテーテルの遠位端部の長手軸方向の断面図を表す。13A shows a longitudinal cross-sectional view of the distal end of a balloon catheter according to another embodiment of the present invention. FIG. 本発明の一実施形態に係る延伸前のパリソンの斜視図を表す。FIG. 2 illustrates a perspective view of a parison prior to stretching according to one embodiment of the present invention. 図１０に示したパリソンのＸＩ－ＸＩ断面図を表す。11 illustrates a cross-sectional view of the parison shown in FIG. 10 taken along the line XI-XI. 図１０に示したパリソンの製造に用いられるパリソン用金型の長手軸方向に垂直な断面図を表す。11 shows a cross-sectional view perpendicular to the longitudinal axis direction of a parison mold used to manufacture the parison shown in FIG. 10. 図１１に示したＸＩ－ＸＩ断面図の変形例を表す。12 illustrates a modified example of the cross-sectional view taken along the line XI-XI of FIG. 図１３に示したパリソンの製造に用いられるパリソン用金型の長手軸方向に垂直な断面図を表す。14 shows a cross-sectional view perpendicular to the longitudinal axis direction of a parison mold used to manufacture the parison shown in FIG. 13. 本発明の一実施形態に係る金型の長手軸方向の断面図を表す。1 is a cross-sectional view of a longitudinal axis of a mold according to one embodiment of the present invention. 図１５に示した金型のＸＶＩ－ＸＶＩ断面図を表す。16 is a cross-sectional view of the mold shown in FIG. 15 taken along the line XVI-XVI. 図１５に示した金型のＸＶＩＩ－ＸＶＩＩ断面図を表す。17 shows a cross-sectional view of the mold shown in FIG. 15 along the line XVII-XVII. 図１７に示したＸＶＩＩ－ＸＶＩＩ断面図の変形例を表す。18 illustrates a modified example of the cross-sectional view taken along the line XVII-XVII of FIG. 17.
　以下、実施の形態に基づき本発明を説明するが、本発明はもとより下記実施の形態によって制限を受けるものではなく、前・後記の趣旨に適合し得る範囲で適当に変更を加えて実施することも勿論可能であり、それらはいずれも本発明の技術的範囲に包含される。なお、各図面において、便宜上、ハッチングや部材符号等を省略する場合もあるが、かかる場合、明細書や他の図面を参照するものとする。また、図面における種々部材の寸法は、本発明の特徴の理解に資することを優先しているため、実際の寸法とは異なる場合がある。 The present invention will be described below based on the embodiments, but the present invention is of course not limited to the embodiments below, and can of course be implemented with appropriate modifications within the scope of the intent described above and below, all of which are included in the technical scope of the present invention. In addition, hatching and component symbols may be omitted in each drawing for convenience, but in such cases, reference should be made to the specification or other drawings. Furthermore, the dimensions of various components in the drawings may differ from the actual dimensions, as priority is given to contributing to an understanding of the features of the present invention.
　１．バルーンカテーテル用バルーン
　本発明の実施形態に係るバルーンカテーテル用バルーンは、長手軸方向、径方向、及び周方向を有し、外層と、外層よりもショアＤ硬度が低い材料から構成されている内層とを有しているバルーンカテーテル用バルーンであって、直管部と、直管部よりも近位側に位置している近位側テーパー部と、近位側テーパー部よりも近位側に位置している近位側スリーブ部と、直管部よりも遠位側に位置している遠位側テーパー部と、遠位側テーパー部よりも遠位側に位置している遠位側スリーブ部と、を有しており、径方向の外方に突出し長手軸方向に延在している突出部を有しており、下記（１）及び（２）の少なくとも一方を満たしている。
　（１）近位側スリーブ部の突出部は、外層が存在していない内層露出部を有しており、径方向の外方から見たとき周方向において内層露出部は外層に挟まれている。
　（２）遠位側スリーブ部の突出部は、外層が存在していない内層露出部を有しており、径方向の外方から見たとき周方向において内層露出部は外層に挟まれている。 1. Balloon for Balloon Catheter A balloon for balloon catheter according to an embodiment of the present invention is a balloon for balloon catheter having a longitudinal axial direction, a radial direction, and a circumferential direction, an outer layer, and an inner layer made of a material having a lower Shore D hardness than the outer layer, the balloon having a straight tube portion, a proximal tapered portion located proximal to the straight tube portion, a proximal sleeve portion located proximal to the proximal tapered portion, a distal tapered portion located distal to the straight tube portion, and a distal sleeve portion located distal to the distal tapered portion, the balloon having a protruding portion protruding radially outward and extending in the longitudinal axial direction, and satisfying at least one of the following (1) and (2).
(1) The protruding portion of the proximal sleeve portion has an exposed inner layer portion where no outer layer is present, and when viewed from the radially outward side, the exposed inner layer portion is sandwiched between the outer layers in the circumferential direction.
(2) The protruding portion of the distal sleeve portion has an exposed inner layer portion where no outer layer is present, and when viewed from the radially outward side, the exposed inner layer portion is sandwiched between the outer layers in the circumferential direction.
　バルーンカテーテルによる狭窄部の拡張は、バルーンカテーテルの遠位端部に設けられたバルーンを血管内腔に挿入して狭窄部まで送達した後バルーンを拡張させ、バルーンの径方向の外方に設けられた突出部を狭窄部に食い込ませることにより狭窄部を切開することで行われる。バルーンが血管内腔を前進又は後退すると、バルーンの長手軸方向の両端に設けられた突出部が血管内腔に接触することにより血管内腔壁が損傷する虞があるところ、上記バルーンカテーテル用バルーンによれば、近位側スリーブ部及び／又は遠位側スリーブ部がショアＤ硬度の低い材料から構成されている内層露出部を有しているため、血管内腔壁の損傷を防止することができる。また、内層露出部以外の突出部の表面は、ショアＤ硬度が高い外層で形成されているため、血管内腔の挿通性や狭窄部の切開効率を向上することができる。これにより、バルーンカテーテルによる治療や処置の安全性を向上しつつ効率的な狭窄部の切開を行うことが可能になる。 　The dilation of the stenosis using a balloon catheter is performed by inserting a balloon provided at the distal end of the balloon catheter into the blood vessel lumen, delivering it to the stenosis, and then expanding the balloon, causing the protrusions provided on the radially outward side of the balloon to bite into the stenosis and cut the stenosis. When the balloon advances or retreats through the blood vessel lumen, the protrusions provided at both ends in the longitudinal direction of the balloon come into contact with the blood vessel lumen, which may damage the blood vessel lumen wall. However, according to the balloon for balloon catheter, the proximal sleeve portion and/or the distal sleeve portion have an inner layer exposed portion made of a material with a low Shore D hardness, so that damage to the blood vessel lumen wall can be prevented. In addition, the surface of the protrusions other than the inner layer exposed portion is formed of an outer layer with a high Shore D hardness, so that the insertion of the blood vessel lumen and the efficiency of cutting the stenosis can be improved. This makes it possible to efficiently cut the stenosis while improving the safety of treatment and procedures using a balloon catheter.
　本発明の一実施形態において、狭窄部へのバルーンの挿入時や体内からの抜去時には、バルーンの内腔から流体を排出して収縮させ、シャフトにバルーンの羽根形状部を巻き付けることによりバルーンの外径を小さくする。このとき、バルーンの拡張部はバルーン径が大きいため、バルーンの拡張部に設けられた突出部は羽根形状部に覆われるところ、バルーンの両端部はバルーン径が小さく羽根形状部が形成されにくいため、バルーンの両端部に設けられた突出部は羽根形状部から露出する状態になることがある。このような場合であっても、本発明の実施形態に係るバルーンカテーテル用バルーンであれば、近位側スリーブ部及び／又は遠位側スリーブ部がショアＤ硬度の低い材料から構成されている内層露出部を有しているため、血管内腔壁の損傷を防止することができる。 In one embodiment of the present invention, when the balloon is inserted into the stenosis or removed from the body, the balloon is deflated by discharging fluid from the inner cavity, and the wing-shaped portion of the balloon is wrapped around the shaft to reduce the outer diameter of the balloon. At this time, since the balloon diameter is large at the expansion portion of the balloon, the protrusions provided at the expansion portion of the balloon are covered by the wing-shaped portion, but since the balloon diameter is small at both ends of the balloon and it is difficult to form wing-shaped portions, the protrusions provided at both ends of the balloon may be exposed from the wing-shaped portion. Even in such a case, with a balloon for a balloon catheter according to an embodiment of the present invention, damage to the blood vessel lumen wall can be prevented because the proximal sleeve portion and/or the distal sleeve portion have an inner layer exposed portion made of a material with a low Shore D hardness.
　本明細書において、バルーンカテーテル用バルーンを単に「バルーン」と称することがある。 In this specification, a balloon for a balloon catheter may be simply referred to as a "balloon."
　以下、図１～図９を参照しつつ、本発明の実施形態に係るバルーンカテーテル用バルーンについて説明する。図１は、本発明の一実施形態に係るバルーンカテーテルの側面図である。図２は図１に示したバルーンカテーテルのＩＩ－ＩＩ断面図を表し、直管部の長手軸方向に垂直な断面図を表している。図３は図１に示したバルーンカテーテルのＩＩＩ－ＩＩＩ断面図を表し、遠位側スリーブ部の長手軸方向に垂直な断面図を表している。図４は、図３の部分Ｐの拡大図を表し、遠位側スリーブ部の突出部を含む部分の長手軸方向に垂直な拡大断面図を表している。図５は、図４に示した部分を径方向の外方側から見た図を表す。図６は図１に示したバルーンカテーテルのバルーンを突出部側から見た平面図を表し、図７は図１に示したバルーンカテーテルの遠位端部の長手軸方向の断面図を表す。図８は図６の変形例を示す平面図を表し、図９は本発明の他の実施形態に係るバルーンカテーテルの遠位端部の長手軸方向の断面図を表す。なお、図５、図６、及び図８のハッチングは断面を表すのではなく、わかりやすさのため内層露出部２０Ａをハッチングして示している。 Hereinafter, a balloon for a balloon catheter according to an embodiment of the present invention will be described with reference to Figs. 1 to 9. Fig. 1 is a side view of a balloon catheter according to an embodiment of the present invention. Fig. 2 shows a cross-sectional view of the balloon catheter shown in Fig. 1 taken along line II-II, which is a cross-sectional view perpendicular to the longitudinal axis of the straight tube portion. Fig. 3 shows a cross-sectional view of the balloon catheter shown in Fig. 1 taken along line III-III, which is a cross-sectional view perpendicular to the longitudinal axis of the distal sleeve portion. Fig. 4 shows an enlarged view of part P in Fig. 3, which is an enlarged cross-sectional view perpendicular to the longitudinal axis of a portion including the protruding portion of the distal sleeve portion. Fig. 5 shows a view of the portion shown in Fig. 4 as seen from the radially outer side. Fig. 6 shows a plan view of the balloon of the balloon catheter shown in Fig. 1 as seen from the protruding portion side, and Fig. 7 shows a cross-sectional view of the distal end portion of the balloon catheter shown in Fig. 1 in the longitudinal direction. Fig. 8 shows a plan view showing a modified example of Fig. 6, and Fig. 9 shows a cross-sectional view of the distal end portion of a balloon catheter according to another embodiment of the present invention in the longitudinal direction. Note that the hatching in Figures 5, 6, and 8 does not represent a cross section, but instead shows the exposed inner layer portion 20A for ease of understanding.
　図１に示すように、バルーン２はバルーンカテーテル１に用いられる。バルーン２はシャフト３０の遠位端部に接続され、シャフト３０の内腔を通じて流体を導入することによりバルーン２を拡張させ、流体を排出することでバルーン２を収縮させることができる。バルーン２の拡張と収縮を制御するために、インデフレーター（バルーン用加圧器）を用いて流体を導入又は排出することができる。流体は、ポンプ等により加圧された加圧流体であってもよい。バルーンカテーテル１については、「２．バルーンカテーテル」の項で詳述する。 As shown in FIG. 1, the balloon 2 is used in the balloon catheter 1. The balloon 2 is connected to the distal end of the shaft 30, and the balloon 2 can be expanded by introducing fluid through the inner cavity of the shaft 30, and can be deflated by discharging the fluid. To control the expansion and contraction of the balloon 2, the fluid can be introduced or discharged using an indeflator (balloon pressurizer). The fluid may be a pressurized fluid pressurized by a pump or the like. The balloon catheter 1 will be described in detail in the section "2. Balloon Catheter."
　バルーン２は、長手軸方向ｘ１と、長手軸方向ｘ１に垂直な断面においてバルーン２の外縁の図心と外縁上の点とを結ぶ径方向ｙ１と、長手軸方向ｘ１に垂直な断面においてバルーン２の外縁に沿う周方向ｚ１を有する。本明細書において、長手軸方向ｘ１において使用者の手元側の方向を近位側と称し、近位側とは反対側、即ち処置対象者の方向を遠位側と称する。 The balloon 2 has a longitudinal axis direction x1, a radial direction y1 connecting the centroid of the outer edge of the balloon 2 to a point on the outer edge in a cross section perpendicular to the longitudinal axis direction x1, and a circumferential direction z1 along the outer edge of the balloon 2 in a cross section perpendicular to the longitudinal axis direction x1. In this specification, the direction toward the user's hand in the longitudinal axis direction x1 is referred to as the proximal side, and the side opposite the proximal side, i.e., the direction toward the subject of treatment, is referred to as the distal side.
　バルーン２以外の部材や部分は、それぞれ長手軸方向、径方向、及び周方向を有し、それらはバルーン２の長手軸方向ｘ１、径方向ｙ１、及び周方向ｚ１とは同じである場合もあり異なる場合もあるが、本明細書においては理解のし易さのために全ての部材や部分がバルーン２の長手軸方向ｘ１、径方向ｙ１、及び周方向ｚ１と同じ長手軸方向、径方向、及び周方向を有しているとして説明する。 　The members and parts other than the balloon 2 each have a longitudinal axis direction, a radial direction, and a circumferential direction, which may or may not be the same as the longitudinal axis direction x1, radial direction y1, and circumferential direction z1 of the balloon 2. However, for ease of understanding, this specification describes all members and parts as having the same longitudinal axis direction, radial direction, and circumferential direction as the longitudinal axis direction x1, radial direction y1, and circumferential direction z1 of the balloon 2.
　図１～図５に示すように、バルーン２は、径方向ｙ１の外方に突出し長手軸方向ｘ１に延在している突出部２８を有している。突出部２８は、バルーン２の突出部２８が設けられていない部分の厚みよりも厚く形成されている部分である。即ち、図２及び図３に示すように、突出部２８は、バルーン２の突出部２８が設けられていない部分の厚みを有するバルーン本体部２０の外面よりも径方向ｙ１の外方に突出している部分であると言い換えることもできる。 As shown in Figures 1 to 5, the balloon 2 has a protrusion 28 that protrudes outward in the radial direction y1 and extends in the longitudinal axis direction x1. The protrusion 28 is a portion that is formed to be thicker than the thickness of the portion of the balloon 2 where the protrusion 28 is not provided. In other words, as shown in Figures 2 and 3, the protrusion 28 can be said to be a portion that protrudes outward in the radial direction y1 from the outer surface of the balloon body 20, which has the thickness of the portion of the balloon 2 where the protrusion 28 is not provided.
　バルーン２の突出部２８における厚みは、例えば、バルーン２の突出部２８が設けられていない部分の厚みの１．２倍以上であることが好ましく、１．５倍以上がより好ましく、１．８倍以上、２．０倍以上、２．５倍以上がさらに好ましい。バルーン２の突出部２８における厚みの上限は特に限定されず、例えば、バルーン２の突出部２８が設けられていない部分の厚みの３０倍以下、２０倍以下、１０倍以下であってもよい。 The thickness of the protruding portion 28 of the balloon 2 is, for example, preferably 1.2 times or more, more preferably 1.5 times or more, even more preferably 1.8 times or more, 2.0 times or more, or 2.5 times or more, the thickness of the portion of the balloon 2 where the protruding portion 28 is not provided. There is no particular upper limit to the thickness of the protruding portion 28 of the balloon 2, and it may be, for example, 30 times or less, 20 times or less, or 10 times or less, the thickness of the portion of the balloon 2 where the protruding portion 28 is not provided.
　バルーン本体部２０はバルーン２の基本形状を規定し、突出部２８はバルーン本体部２０の外側面に線状、点状、網状、らせん状等の任意のパターンで好ましく設けられている。突出部２８によりバルーン２はスコアリング機能が付与され、バルーン２は血管形成術において石灰化した狭窄部に亀裂を入れて拡張することが可能になる。また、突出部２８は、バルーン２の強度向上や加圧時の過拡張の抑制にも寄与できる。 The balloon body 20 defines the basic shape of the balloon 2, and the protrusions 28 are preferably provided on the outer surface of the balloon body 20 in any pattern, such as lines, dots, a mesh, or a spiral. The protrusions 28 provide the balloon 2 with a scoring function, making it possible to expand the balloon 2 by creating cracks in calcified stenotic areas during angioplasty. The protrusions 28 can also contribute to improving the strength of the balloon 2 and preventing overexpansion when pressurized.
　図２に示すように、突出部２８は周方向ｚ１に複数設けられていてもよいし、１つ設けられていてもよい。突出部２８の周方向ｚ１における数は、１以上、２以上、３以上、４以上、６以上であってもよく、また、２０以下、１５以下、１０以下であってもよい。突出部２８が周方向ｚ１において複数設けられる場合、複数の突出部２８は周方向ｚ１に離隔していることが好ましく、周方向ｚ１に等間隔に配されていることがより好ましい。離隔距離は、突出部２８の最大周長よりも長いことが好ましい。 As shown in FIG. 2, multiple protrusions 28 may be provided in the circumferential direction z1, or only one protrusion may be provided. The number of protrusions 28 in the circumferential direction z1 may be 1 or more, 2 or more, 3 or more, 4 or more, 6 or more, and may be 20 or less, 15 or less, or 10 or less. When multiple protrusions 28 are provided in the circumferential direction z1, it is preferable that the multiple protrusions 28 are spaced apart in the circumferential direction z1, and it is more preferable that the multiple protrusions 28 are arranged at equal intervals in the circumferential direction z1. The separation distance is preferably longer than the maximum circumferential length of the protrusions 28.
　長手軸方向ｘ１に垂直な断面における突出部２８の断面形状は任意であってよく、例えば、三角形、四角形、多角形、半円形、円形の一部、略円形、扇型、楔形、凸字形、紡錘形、及びそれらの組み合わせ等であってもよい。なお、三角形、四角形、及び多角形は、角部の頂点が明確であって辺部が直線であるものの他に、角部が丸みを帯びている所謂角丸多角形や、辺部の少なくとも一部が曲線となっているものも含むものとする。或いは、突出部２８の断面形状は、凹凸や欠け等を有した不定形な形状であってもよい。 The cross-sectional shape of the protrusion 28 in a cross section perpendicular to the longitudinal axis direction x1 may be any shape, such as a triangle, a rectangle, a polygon, a semicircle, a part of a circle, an approximate circle, a sector, a wedge, a convex shape, a spindle shape, or a combination thereof. Note that triangles, rectangles, and polygons include shapes with clearly defined corners and straight sides, as well as so-called rounded polygons with rounded corners and shapes with at least some of the sides curved. Alternatively, the cross-sectional shape of the protrusion 28 may be an irregular shape with irregularities, chips, etc.
　後述する内層露出部２０Ａが設けられている部分以外の突出部２８は、径方向ｙ１の外方端である頂部２８ｔを有していてもよい。突出部２８が頂部２８ｔを有していれば、突出部２８による切開効率を向上できる。 The protrusion 28 other than the portion where the inner layer exposed portion 20A described below is provided may have an apex 28t, which is the outer end in the radial direction y1. If the protrusion 28 has an apex 28t, the cutting efficiency by the protrusion 28 can be improved.
　突出部２８が線状又は点状に形成されている場合、突出部２８は長手軸方向ｘ１に沿って延在するように配されていることが好ましい。或いは、突出部２８は、長手軸周りにらせん状に延在するように配されていてもよい。 When the protrusions 28 are formed in a line or dot shape, it is preferable that the protrusions 28 are arranged so as to extend along the longitudinal axis direction x1. Alternatively, the protrusions 28 may be arranged so as to extend in a spiral shape around the longitudinal axis.
　図示していないが、バルーン２は、径方向ｙ１の内方に突出している内側突出部を有していてもよい。内側突出部は長手軸方向ｘ１に延在していることが好ましい。突出部２８と内側突出部は、バルーン２の長手方向ｘ１や周方向ｚ１において同じ位置に配置されていることが好ましく、これらは一体形成されていることが好ましい。突出部２８とバルーン本体部２０と内側突出部とが一体に厚く形成されていることにより、バルーン２が突出部２８と内側突出部とを有していてもよい。 Although not shown, the balloon 2 may have an inner protrusion that protrudes inward in the radial direction y1. The inner protrusion preferably extends in the longitudinal axis direction x1. The protrusion 28 and the inner protrusion are preferably located at the same position in the longitudinal direction x1 or the circumferential direction z1 of the balloon 2, and are preferably formed integrally. The protrusion 28, the balloon body 20, and the inner protrusion are formed integrally and thickly, so that the balloon 2 may have the protrusion 28 and the inner protrusion.
　バルーン２は、外層２０ｂと、外層２０ｂよりもショアＤ硬度が低い材料から構成されている内層２０ａとを有している。バルーン２は、後段にて詳述する内層露出部２０Ａ以外の部分において、全ての部分で内層２０ａと外層２０ｂからなる２層構造を有していることが好ましい。詳細には、内層露出部２０Ａが形成されている部分以外において、長手軸方向ｘ１の任意の位置における周方向ｚ１の３６０°全体にわたって内層２０ａと外層２０ｂが連続して存在していることが好ましい。また、長手軸方向ｘ１において内層露出部２０Ａが形成されている部分においても、内層露出部２０Ａ以外の部分全てが内層２０ａと外層２０ｂを含むことが好ましい。これにより、内層露出部２０Ａ以外ではバルーン２の外側面はショアＤ硬度の高い外層２０ｂで形成されるため、バルーン２の外側面が傷つきにくく強度を向上できる。また、突出部２８の外側面もショアＤ硬度の高い外層２０ｂで形成されるため、突出部２８のスコアリング機能を高めることができる。 The balloon 2 has an outer layer 20b and an inner layer 20a made of a material having a lower Shore D hardness than the outer layer 20b. The balloon 2 preferably has a two-layer structure consisting of the inner layer 20a and the outer layer 20b in all parts other than the inner layer exposed part 20A described in detail later. In detail, it is preferable that the inner layer 20a and the outer layer 20b are continuously present over the entire 360° of the circumferential direction z1 at any position in the longitudinal axis direction x1 except for the part where the inner layer exposed part 20A is formed. Also, it is preferable that all parts other than the inner layer exposed part 20A in the longitudinal axis direction x1 include the inner layer 20a and the outer layer 20b. As a result, the outer surface of the balloon 2 is formed of the outer layer 20b with a high Shore D hardness except for the inner layer exposed part 20A, so that the outer surface of the balloon 2 is less likely to be damaged and its strength can be improved. In addition, the outer surface of the protrusion 28 is also formed of the outer layer 20b, which has a high Shore D hardness, which enhances the scoring function of the protrusion 28.
　内層２０ａのショアＤ硬度は、２０以上、２５以上、３０以上、３５以上、４０以上であることが好ましく、また、７０以下、６５以下、６０以下、５５以下であることが好ましい。外層２０ｂのショアＤ硬度は、７０超、７２以上、７４以上、７５以上であることが好ましく、また、９０以下、８５以下、８０以下であることが好ましい。内層２０ａのショアＤ硬度が上記範囲であれば、バルーン２の柔軟性向上に寄与することができる。外層２０ｂのショアＤ硬度が上記範囲であれば、バルーン２の強度向上や突出部２８のスコアリング機能向上に寄与することができる。 The Shore D hardness of the inner layer 20a is preferably 20 or more, 25 or more, 30 or more, 35 or more, or 40 or more, and is preferably 70 or less, 65 or less, 60 or less, or 55 or less. The Shore D hardness of the outer layer 20b is preferably more than 70, 72 or more, 74 or more, or 75 or more, and is preferably 90 or less, 85 or less, or 80 or less. If the Shore D hardness of the inner layer 20a is within the above range, it can contribute to improving the flexibility of the balloon 2. If the Shore D hardness of the outer layer 20b is within the above range, it can contribute to improving the strength of the balloon 2 and the scoring function of the protrusion 28.
　ショアＤ硬度は、例えば、ＪＩＳ　Ｋ６２５３－２：２０１２の記載に基づきタイプＤデュロメータを用いて測定することができる。また、内層２０ａと外層２０ｂの各ショアＤ硬度は、バルーン２に成形する前の材料の段階のショアＤ硬度であってもよい。 The Shore D hardness can be measured, for example, using a Type D durometer based on the description of JIS K6253-2:2012. The Shore D hardness of each of the inner layer 20a and the outer layer 20b may be the Shore D hardness of the material before it is molded into the balloon 2.
　外層２０ｂの材料としては、ナイロン１１、ナイロン１２等のポリアミド樹脂；ポリエチレンテレフタレート、ポリブチレンテレフタレート等のポリエステル樹脂；ポリウレタン樹脂が好適に用いられる。内層２０ａの材料としては、ショアＤ硬度が小さい観点から熱可塑性エラストマーを用いることが好ましく、例えば、ポリエーテルブロックアミド共重合体等のポリアミドエラストマーが好適に用いられる。 The material of the outer layer 20b is preferably a polyamide resin such as nylon 11 or nylon 12; a polyester resin such as polyethylene terephthalate or polybutylene terephthalate; or a polyurethane resin. The material of the inner layer 20a is preferably a thermoplastic elastomer, which has a low Shore D hardness. For example, a polyamide elastomer such as a polyether block amide copolymer is preferably used.
　図１に示すように、バルーン２は、長手軸方向ｘ１に近位端と遠位端とを有しており、直管部２３と、直管部２３よりも近位側に位置している近位側テーパー部２２と、近位側テーパー部２２よりも近位側に位置している近位側スリーブ部２１と、直管部２３よりも遠位側に位置している遠位側テーパー部２４と、遠位側テーパー部２４よりも遠位側に位置している遠位側スリーブ部２５とを有している。直管部２３は、長手軸方向ｘ１においておよそ同じ径を有している略円柱状であることが好ましいが、長手軸方向ｘ１において異なる径を有していてもよい。近位側テーパー部２２及び遠位側テーパー部２４は、直管部２３から離れるにつれて縮径して略円錐状、円錐台状に形成されていることが好ましい。直管部２３が最大径を有することにより、バルーン２を狭窄部等の病変部において拡張させた際に、直管部２３が病変部に十分接触して病変部の拡張等の治療を行い易くできる。また、近位側テーパー部２２及び遠位側テーパー部２４が縮径されていることにより、バルーン２を収縮させた際に、バルーン２の近位端部及び遠位端部の外径を小さくしてシャフト３０とバルーン２との段差を小さくすることができるため、バルーン２を体腔内に挿通し易くすることができる。 As shown in FIG. 1, the balloon 2 has a proximal end and a distal end in the longitudinal axis direction x1, and has a straight tube section 23, a proximal taper section 22 located proximal to the straight tube section 23, a proximal sleeve section 21 located proximal to the proximal taper section 22, a distal taper section 24 located distal to the straight tube section 23, and a distal sleeve section 25 located distal to the distal taper section 24. The straight tube section 23 is preferably substantially cylindrical with approximately the same diameter in the longitudinal axis direction x1, but may have different diameters in the longitudinal axis direction x1. The proximal taper section 22 and the distal taper section 24 are preferably formed into a substantially conical or truncated conical shape with a reduced diameter as they move away from the straight tube section 23. The straight tube section 23 has the maximum diameter, so that when the balloon 2 is expanded at a lesion such as a stenosis, the straight tube section 23 can be in sufficient contact with the lesion, making it easier to perform treatment such as expansion of the lesion. In addition, because the proximal taper section 22 and the distal taper section 24 are reduced in diameter, when the balloon 2 is deflated, the outer diameter of the proximal and distal ends of the balloon 2 is reduced, thereby reducing the step between the shaft 30 and the balloon 2, making it easier to insert the balloon 2 into the body cavity.
　近位側テーパー部２２、直管部２３、及び遠位側テーパー部２４がバルーン２に流体を導入した際に拡張する部分であるのに対し、近位側スリーブ部２１及び遠位側スリーブ部２５は拡張しないことが好ましい。これにより、近位側スリーブ部２１の少なくとも一部をシャフト３０の遠位端部と固定し、遠位側スリーブ部２５の少なくとも一部を後述するインナーシャフト６０と固定する構成とすることができる。 While the proximal tapered section 22, the straight tube section 23, and the distal tapered section 24 are sections that expand when fluid is introduced into the balloon 2, it is preferable that the proximal sleeve section 21 and the distal sleeve section 25 do not expand. This allows for a configuration in which at least a portion of the proximal sleeve section 21 is fixed to the distal end of the shaft 30, and at least a portion of the distal sleeve section 25 is fixed to the inner shaft 60 described below.
　バルーン２は、近位側スリーブ部２１、近位側テーパー部２２、直管部２３、遠位側テーパー部２４、遠位側スリーブ部２５の各領域において、突出部２８を有していることが好ましい。これにより、直管部２３に設けられた突出部２８はスコアリング機能の向上に寄与でき、直管部２３以外に設けられた突出部２８はバルーン２の強度向上や加圧時の過拡張の抑制に寄与することができる。 The balloon 2 preferably has protrusions 28 in each of the regions of the proximal sleeve section 21, the proximal tapered section 22, the straight tube section 23, the distal tapered section 24, and the distal sleeve section 25. As a result, the protrusions 28 provided in the straight tube section 23 can contribute to improving the scoring function, and the protrusions 28 provided in other sections than the straight tube section 23 can contribute to improving the strength of the balloon 2 and preventing overexpansion when pressurized.
　図３～図５に示すように、バルーン２は、下記（１）及び（２）の少なくとも一方を満たしている。
　（１）近位側スリーブ部２１の突出部２８は、外層２０ｂが存在していない内層露出部２８Ａを有しており、径方向ｙ１の外方から見たとき周方向ｚ１において内層露出部２８Ａは外層２０ｂに挟まれている。
　（２）遠位側スリーブ部２５の突出部２８は、外層２０ｂが存在していない内層露出部２８Ａを有しており、径方向ｙ１の外方から見たとき周方向ｚ１において内層露出部２８Ａは外層２０ｂに挟まれている。 As shown in FIGS. 3 to 5, the balloon 2 satisfies at least one of the following (1) and (2).
(1) The protrusion 28 of the proximal sleeve portion 21 has an inner layer exposed portion 28A where the outer layer 20b is not present, and when viewed from the outside in the radial direction y1, the inner layer exposed portion 28A is sandwiched between the outer layer 20b in the circumferential direction z1.
(2) The protrusion 28 of the distal sleeve portion 25 has an inner layer exposed portion 28A where the outer layer 20b is not present, and when viewed from the outside in the radial direction y1, the inner layer exposed portion 28A is sandwiched between the outer layer 20b in the circumferential direction z1.
　図３及び図４に示すように、内層露出部２０Ａが設けられた突出部２８は、外層２０ｂが存在せず内層２０ａが突出部２８の表面となる部分を有している。図５に示すように、内層露出部２０Ａが設けられた突出部２８を径方向ｙ１の外方から見たとき、周方向ｚ１において内層露出部２０Ａは外層２０ｂに挟まれている。これにより、内層露出部２０Ａが設けられた突出部２８の径方向ｙ１の外端部には、内層２０ａが存在することができる。 As shown in Figures 3 and 4, the protrusion 28 provided with the inner layer exposed portion 20A has a portion where the outer layer 20b is not present and the inner layer 20a forms the surface of the protrusion 28. As shown in Figure 5, when the protrusion 28 provided with the inner layer exposed portion 20A is viewed from the outside in the radial direction y1, the inner layer exposed portion 20A is sandwiched between the outer layers 20b in the circumferential direction z1. This allows the inner layer 20a to be present at the outer end in the radial direction y1 of the protrusion 28 provided with the inner layer exposed portion 20A.
　近位側スリーブ部２１及び／又は遠位側スリーブ部２５に配される内層露出部２０Ａは、長手軸方向ｘ１の全てに連続して配されていてもよいし、長手軸方向ｘ１の一部に配されていてもよいし、複数の内層露出部２０Ａが長手軸方向ｘ１に不連続に配されていてもよい。 The exposed inner layer portion 20A arranged on the proximal sleeve portion 21 and/or the distal sleeve portion 25 may be arranged continuously in the entire longitudinal axis direction x1, may be arranged in a part of the longitudinal axis direction x1, or multiple exposed inner layer portions 20A may be arranged discontinuously in the longitudinal axis direction x1.
　図３～図５では、遠位側スリーブ部２５の内層露出部２８Ａを示したが、内層露出部２８Ａは近位側スリーブ部２１と遠位側スリーブ部２５の両方に設けられていてもよいし、近位側スリーブ部２１と遠位側スリーブ部２５のどちらか一方に設けられていてもよい。バルーン２が血管内腔を前進又は後退するとき、近位側スリーブ部２１と遠位側スリーブ部２５は先頭部分となる。そのため、近位側スリーブ部２１と遠位側スリーブ部２５に設けられた突出部２８が血管内腔に接触することにより血管内腔壁が損傷する虞があるが、バルーン２は近位側スリーブ部２１及び／又は遠位側スリーブ部２５にショアＤ硬度の低い内層露出部２０Ａを有しているため、血管内腔壁の損傷を防止することができる。このように、バルーン２の安全性を高めつつ、内層露出部２０Ａ以外の突出部２８の表面や突出部２８が設けられていない部分のバルーン２の表面はショアＤ硬度が高い外層２０ｂで形成されているため、バルーン２の血管内腔での挿通性や狭窄部の切開効率を向上でき、バルーン２の強度向上や過拡張の抑制も可能である。さらに、突出部２８を径方向ｙ１の外方から見たとき、内層露出部２０Ａは外層２０ｂに挟まれているため、内層露出部２０Ａが設けられてショアＤ硬度の低い内層２０ａが露出している近位側スリーブ部２１及び／又は遠位側スリーブ部２５においても、突出部２８は長手軸方向ｘ１の剛性を確保できるため、バルーン２の挿通性の向上に寄与できる。 3 to 5 show the exposed inner layer portion 28A of the distal sleeve portion 25, but the exposed inner layer portion 28A may be provided on both the proximal sleeve portion 21 and the distal sleeve portion 25, or on either the proximal sleeve portion 21 or the distal sleeve portion 25. When the balloon 2 advances or retreats through the blood vessel lumen, the proximal sleeve portion 21 and the distal sleeve portion 25 form the leading portion. Therefore, there is a risk that the protrusions 28 provided on the proximal sleeve portion 21 and the distal sleeve portion 25 may come into contact with the blood vessel lumen and damage the blood vessel lumen wall, but the balloon 2 has the exposed inner layer portion 20A with a low Shore D hardness on the proximal sleeve portion 21 and/or the distal sleeve portion 25, and therefore damage to the blood vessel lumen wall can be prevented. In this way, while improving the safety of the balloon 2, the surface of the protrusion 28 other than the inner layer exposed portion 20A and the surface of the balloon 2 in the portion where the protrusion 28 is not provided are formed of the outer layer 20b with a high Shore D hardness, so that the insertion property of the balloon 2 in the blood vessel lumen and the efficiency of cutting the stenosis part can be improved, and the strength of the balloon 2 can be improved and overexpansion can be suppressed. Furthermore, when the protrusion 28 is viewed from the outside in the radial direction y1, the inner layer exposed portion 20A is sandwiched between the outer layer 20b, so that even in the proximal sleeve portion 21 and/or the distal sleeve portion 25 where the inner layer exposed portion 20A is provided and the inner layer 20a with a low Shore D hardness is exposed, the protrusion 28 can ensure the rigidity in the longitudinal axis direction x1, which can contribute to improving the insertion property of the balloon 2.
　また、本発明の一実施形態において、狭窄部へのバルーン２の挿入時や体内からの抜去時には、バルーン２の内腔から流体を排出して収縮させ、シャフト３０にバルーン２の羽根形状部を巻きつけることによりバルーン２の外径を小さくする。このとき、スリーブ部は拡張しない部分であることから羽根形状部が形成されにくいため、スリーブ部に設けられた突出部２８は羽根形状部に覆われずに露出することがある。このような場合であっても、バルーン２はスリーブ部に内層露出部２０Ａを有しているため、血管内腔壁の損傷を防止することができる。 In addition, in one embodiment of the present invention, when the balloon 2 is inserted into the stenotic area or removed from the body, the fluid is discharged from the inner cavity of the balloon 2 to cause it to shrink, and the wing-shaped portion of the balloon 2 is wrapped around the shaft 30 to reduce the outer diameter of the balloon 2. At this time, since the sleeve portion is a portion that does not expand, it is difficult for the wing-shaped portion to form, and therefore the protrusion 28 provided on the sleeve portion may be exposed and not covered by the wing-shaped portion. Even in such a case, damage to the blood vessel lumen wall can be prevented because the balloon 2 has an inner layer exposed portion 20A on the sleeve portion.
　内層露出部２０Ａは、図２に示すような突出部２８の頂部２８ｔ側を長手軸方向ｘ１に沿って切除することで形成できる。内層露出部２０Ａを形成する方法については、「３．バルーンカテーテルの製造方法」の項で詳述する。 The exposed inner layer portion 20A can be formed by cutting the apex 28t side of the protrusion 28 along the longitudinal axis direction x1 as shown in FIG. 2. The method for forming the exposed inner layer portion 20A will be described in detail in the section "3. Method for manufacturing a balloon catheter."
　図２に示すように、内層露出部２０Ａが形成されていない状態においては、バルーン２は全体にわたって内層２０ａと外層２０ｂを含む。バルーン２は、内層２０ａと外層２０ｂからなる２層構造を有していることが好ましく、バルーン２の外表面が外層２０ｂにより形成されていることが好ましい。これにより、内層露出部２０Ａ以外の部分においては、バルーン２の突出部２８が設けられていない部分から突出部２８が設けられている部分にわたって内層２０ａと外層２０ｂが周方向ｚ１の３６０°全体に連続して存在できる。このため、ショアＤ硬度の高い外層２０ｂにより、突出部２８のスコアリング機能、バルーン２の強度及び挿通性を向上することができる。 As shown in FIG. 2, when the inner layer exposed portion 20A is not formed, the balloon 2 includes the inner layer 20a and the outer layer 20b throughout. The balloon 2 preferably has a two-layer structure consisting of the inner layer 20a and the outer layer 20b, and the outer surface of the balloon 2 is preferably formed by the outer layer 20b. This allows the inner layer 20a and the outer layer 20b to exist continuously over 360° in the circumferential direction z1 in the portions other than the inner layer exposed portion 20A, from the portion of the balloon 2 where the protrusion 28 is not provided to the portion where the protrusion 28 is provided. Therefore, the outer layer 20b, which has a high Shore D hardness, can improve the scoring function of the protrusion 28 and the strength and insertability of the balloon 2.
　図３に示すように内層露出部２０Ａが形成された場合であっても、内層２０ａは、長手軸方向ｘ１の任意の位置における垂直な断面において、周方向ｚ１の３６０°全体にわたって連続して存在することができる。このため、外層２０ｂよりもショアＤ硬度の低い内層２０ａによりバルーン２の柔軟性を向上することができる。 Even if the exposed inner layer portion 20A is formed as shown in FIG. 3, the inner layer 20a can be continuously present over the entire 360° of the circumferential direction z1 in a vertical cross section taken at any position in the longitudinal axis direction x1. Therefore, the flexibility of the balloon 2 can be improved by the inner layer 20a, which has a lower Shore D hardness than the outer layer 20b.
　また、図３に示すように、内層露出部２０Ａが形成されている位置における長手軸方向ｘ１に垂直な断面において、周方向ｚ１における内層露出部２０Ａと内層露出部２０Ａの間（内層露出部２０Ａが周方向ｚ１に１個の場合は内層露出部２０Ａ以外の部分）の外層２０ｂは周方向ｚ１に連続していることが好ましい。 Furthermore, as shown in FIG. 3, in a cross section perpendicular to the longitudinal axis direction x1 at the position where the inner layer exposed portion 20A is formed, it is preferable that the outer layer 20b between the inner layer exposed portions 20A in the circumferential direction z1 (parts other than the inner layer exposed portion 20A when there is one inner layer exposed portion 20A in the circumferential direction z1) is continuous in the circumferential direction z1.
　上記構成を有することにより、突出部２８とバルーン本体部２０とを一体成形することによりバルーン２を２層構造とすることができ、バルーン本体部２０からの突出部２８の脱落を防止することができる。 With the above configuration, the balloon 2 can be formed with a two-layer structure by integrally molding the protruding portion 28 and the balloon body portion 20, and it is possible to prevent the protruding portion 28 from falling off the balloon body portion 20.
　内側突出部が設けられる場合も、バルーン２の内側突出部が設けられていない部分と内側突出部が設けられている部分の内層２０ａと外層２０ｂは周方向ｚ１に連続していることが好ましい。これにより、内側突出部とバルーン本体部２０とを一体形成することができ、バルーン本体部２０からの内側突出部の脱落を防ぐことができる。 Even when an inner protrusion is provided, it is preferable that the inner layer 20a and the outer layer 20b in the portion of the balloon 2 where the inner protrusion is not provided and the portion where the inner protrusion is provided are continuous in the circumferential direction z1. This allows the inner protrusion and the balloon main body 20 to be integrally formed, and prevents the inner protrusion from falling off the balloon main body 20.
　図６～図９に示すように、直管部２３の突出部２８は、外層２０ｂが存在していない内層露出部２０Ａを有していないことが好ましい。直管部２３の突出部２８は狭窄部の切開に最も寄与する部分であることから、直管部２３の突出部２８が内層露出部２０Ａを有していないことにより直管部２３の突出部２８の表面はショアＤ硬度の高い外層２０ｂで形成することができるため、狭窄部の切開効率を高めることができる。 As shown in Figures 6 to 9, it is preferable that the protruding portion 28 of the straight pipe section 23 does not have an exposed inner layer portion 20A where the outer layer 20b is not present. Since the protruding portion 28 of the straight pipe section 23 is the portion that contributes most to the incision of the narrowed portion, by not having the exposed inner layer portion 20A, the surface of the protruding portion 28 of the straight pipe section 23 can be formed of the outer layer 20b with a high Shore D hardness, thereby improving the efficiency of incising the narrowed portion.
　図６に示すように、バルーン２は、下記（３）及び（４）の少なくとも一方を満たしていることが好ましい。
　（３）上記（１）を満たしており、長手軸方向ｘ１において、近位側スリーブ部２１の近位端を０％の位置ＳＰ０、近位側スリーブ部２１の近位側テーパー部２２側の端を１００％の位置ＳＰ１００としたとき、近位側スリーブ部２１の内層露出部２０Ａは位置ＳＰ０から７５％の位置ＳＰ７５までの区間の少なくとも一部に配されている。
　（４）上記（２）を満たしており、長手軸方向ｘ１において、遠位側スリーブ部２５の遠位端を０％の位置ＳＤ０、遠位側スリーブ部２５の遠位側テーパー部２４側の端を１００％の位置ＳＤ１００としたとき、遠位側スリーブ部２５の内層露出部２０Ａは位置ＳＤ０から７５％の位置ＳＤ７５までの区間の少なくとも一部に配されている。 As shown in FIG. 6, it is preferable that the balloon 2 satisfies at least one of the following (3) and (4).
(3) The above (1) is satisfied, and when, in the longitudinal axis direction x1, the proximal end of the proximal sleeve portion 21 is the 0% position S P0 and the end of the proximal sleeve portion 21 on the proximal taper portion 22 side is the 100% position S P100 , the exposed inner layer portion 20A of the proximal sleeve portion 21 is arranged in at least a part of the section from position S P0 to 75% position S P75 .
(4) The above (2) is satisfied, and in the longitudinal axis direction x1, when the distal end of the distal sleeve portion 25 is the 0% position S D0 and the end of the distal sleeve portion 25 on the distal taper portion 24 side is the 100% position S D100 , the exposed inner layer portion 20A of the distal sleeve portion 25 is arranged in at least a part of the section from position S D0 to 75% position S D75 .
　図６には近位側スリーブ部２１と遠位側スリーブ部２５の両方が上記（３）と（４）を満たしている態様を示したが、バルーン２は上記（３）及び（４）の少なくとも一方を満たしていればよい。 FIG. 6 shows an embodiment in which both the proximal sleeve portion 21 and the distal sleeve portion 25 satisfy the above (3) and (4), but it is sufficient for the balloon 2 to satisfy at least one of the above (3) and (4).
　近位側スリーブ部２１の位置ＳＰ０から位置ＳＰ７５までの近位側の区間及び／又は遠位側スリーブ部２５の位置ＳＤ０から位置ＳＤ７５までの遠位側の区間の少なくとも一部に内層露出部２０Ａが配されていることにより、バルーン２が血管内腔で前進又は後退するときに先頭となる部分の突出部２８においてショアＤ硬度の低い内層２０ａが露出させることができるため、血管内腔壁の損傷をより容易に防止できる。 By arranging the exposed inner layer portion 20A in at least a portion of the proximal section from position S P0 to position S P75 of the proximal sleeve portion 21 and/or the distal section from position S D0 to position S D75 of the distal sleeve portion 25, the inner layer 20a with a low Shore D hardness can be exposed at the protrusion 28 at the leading portion when the balloon 2 advances or retreats within the blood vessel lumen, making it easier to prevent damage to the blood vessel lumen wall.
　近位側スリーブ部２１及び／又は遠位側スリーブ部２５に配される内層露出部２０Ａは、上記区間において長手軸方向ｘ１の全てに連続して配されていてもよいし、長手軸方向ｘ１の一部に配されていてもよいし、複数の内層露出部２０Ａが長手軸方向ｘ１に不連続に配されていてもよい。 The exposed inner layer portion 20A arranged on the proximal sleeve portion 21 and/or the distal sleeve portion 25 may be arranged continuously in the entire longitudinal axis direction x1 in the above section, may be arranged in a part of the longitudinal axis direction x1, or multiple exposed inner layer portions 20A may be arranged discontinuously in the longitudinal axis direction x1.
　近位側スリーブ部２１の内層露出部２０Ａは位置ＳＰ０から５０％の位置までの区間の少なくとも一部に配されていることがより好ましい。また、遠位側スリーブ部２５の内層露出部２０Ａは位置ＳＤ０から５０％の位置までの区間の少なくとも一部に配されていることがより好ましい。 It is more preferable that the exposed inner layer portion 20A of the proximal sleeve portion 21 is disposed in at least a portion of the section from the position S P0 to the 50% position. It is also more preferable that the exposed inner layer portion 20A of the distal sleeve portion 25 is disposed in at least a portion of the section from the position S D0 to the 50% position.
　図６に示すように、バルーン２は、下記（５）及び（６）の少なくとも一方を満たしていることが好ましい。
　（５）上記（３）を満たしており、近位側スリーブ部２１の内層露出部２０Ａは位置ＳＰ０を含む区間に配されている。
　（６）上記（４）を満たしており、遠位側スリーブ部２５の内層露出部２０Ａは位置ＳＤ０を含む区間に配されている。 As shown in FIG. 6, it is preferable that the balloon 2 satisfies at least one of the following (5) and (6).
(5) The above condition (3) is satisfied, and the exposed inner layer portion 20A of the proximal sleeve portion 21 is disposed in a section including the position S P0 .
(6) The above (4) is satisfied, and the exposed inner layer portion 20A of the distal sleeve portion 25 is disposed in a section including the position S- D0 .
　図６には近位側スリーブ部２１と遠位側スリーブ部２５の両方が上記（５）と（６）を満たしている態様を示したが、バルーン２は上記（５）及び（６）の少なくとも一方を満たしていればよい。 FIG. 6 shows an embodiment in which both the proximal sleeve portion 21 and the distal sleeve portion 25 satisfy the above (5) and (6), but it is sufficient for the balloon 2 to satisfy at least one of the above (5) and (6).
　近位側スリーブ部２１の位置ＳＰ０を含む区間に内層露出部２０Ａが配されているとは、近位側スリーブ部２１の近位端（位置ＳＰ０）に内層露出部２０Ａが配されていることを意味する。遠位側スリーブ部２５の位置ＳＤ０を含む区間に内層露出部２０Ａが配されているとは、遠位側スリーブ部２５の遠位端（位置ＳＤ０）に内層露出部２０Ａが配されていることを意味する。これにより、バルーン２が血管内腔で前進又は後退するときに最も先頭となる部分の突出部２８においてショアＤ硬度の低い内層２０ａが露出しているため、血管内腔壁の損傷をさらに容易に防止できる。 The exposed inner layer portion 20A being disposed in a section including position S P0 of the proximal sleeve portion 21 means that the exposed inner layer portion 20A is disposed at the proximal end (position S P0 ) of the proximal sleeve portion 21. The exposed inner layer portion 20A being disposed in a section including position S D0 of the distal sleeve portion 25 means that the exposed inner layer portion 20A is disposed at the distal end (position S D0 ) of the distal sleeve portion 25. This makes it easier to prevent damage to the blood vessel lumen wall because the inner layer 20a with low Shore D hardness is exposed at the protruding portion 28, which is the foremost portion when the balloon 2 advances or retreats in the blood vessel lumen.
　図４及び図５に示すように、長手軸方向ｘ１に垂直な方向において、内層露出部２０Ａの周方向ｚ１の長さＬａは、内層露出部２０Ａの両側のそれぞれの外層２０ｂの周方向ｚ１の長さＬｂよりも長いことが好ましい。内層露出部２０Ａ、即ちショアＤ硬度が外層２０ｂよりも低い内層ｂが周方向ｚ１により多く存在することにより、血管内腔壁の損傷防止効果をより向上することができる。 As shown in Figures 4 and 5, in a direction perpendicular to the longitudinal axis direction x1, it is preferable that the length La of the exposed inner layer portion 20A in the circumferential direction z1 is longer than the length Lb of each of the outer layers 20b on both sides of the exposed inner layer portion 20A in the circumferential direction z1. By having more exposed inner layer portion 20A, i.e., the inner layer b having a lower Shore D hardness than the outer layer 20b, in the circumferential direction z1, the effect of preventing damage to the blood vessel lumen wall can be further improved.
　図示していないが、長手軸方向ｘ１に垂直な方向において、内層露出部２０Ａの周方向ｚ１の長さＬａは、内層露出部２０Ａの両側のそれぞれの外層２０ｂの周方向ｚ１の長さＬｂよりも短くてもよい。内層２０ａよりもショアＤ硬度が高い外層２０ｂが周方向ｚ１により多く存在することにより、剛性を向上でき、長手軸方向ｘ１の挿通性をより向上することができる。 Although not shown, in a direction perpendicular to the longitudinal axis direction x1, the length La in the circumferential direction z1 of the exposed inner layer portion 20A may be shorter than the length Lb in the circumferential direction z1 of each of the outer layers 20b on both sides of the exposed inner layer portion 20A. By having more of the outer layer 20b, which has a higher Shore D hardness than the inner layer 20a, in the circumferential direction z1, the rigidity can be improved, and the insertability in the longitudinal axis direction x1 can be further improved.
　図７に示すように、バルーン２は、下記（７）及び（８）の少なくとも一方を満たしていることが好ましい。
　（７）上記（１）を満たしており、近位側スリーブ部２１は、突出部２８が直管部２３の突出部２８の高さ以下の高さを有する低突出部領域２８Ｌを有している。
　（８）上記（２）を満たしており、遠位側スリーブ部２５は、突出部２８が直管部２３の突出部２８の高さ以下の高さを有する低突出部領域２８Ｌを有している。 As shown in FIG. 7, it is preferable that the balloon 2 satisfies at least one of the following (7) and (8).
(7) The above (1) is satisfied, and the proximal sleeve portion 21 has a low protrusion region 28L in which the protrusion 28 has a height equal to or less than the height of the protrusion 28 of the straight pipe portion 23.
(8) The above (2) is satisfied, and the distal sleeve portion 25 has a low protrusion region 28L in which the protrusion 28 has a height equal to or less than the height of the protrusion 28 of the straight pipe portion 23.
　突出部２８の高さは、長手軸方向ｘ１に垂直な断面において、突出部２８の両側の基端を結んだ線分から垂直方向に向けての突出部２８の外方端までの距離と定義できる。 The height of the protrusion 28 can be defined as the distance from the line segment connecting the base ends of both sides of the protrusion 28 to the outer end of the protrusion 28 in the vertical direction in a cross section perpendicular to the longitudinal axis direction x1.
　図７には近位側スリーブ部２１と遠位側スリーブ部２５の両方が上記（７）と（８）を満たしている態様を示したが、バルーン２は上記（７）及び（８）の少なくとも一方を満たしていればよい。 FIG. 7 shows an embodiment in which both the proximal sleeve portion 21 and the distal sleeve portion 25 satisfy the above (7) and (8), but it is sufficient for the balloon 2 to satisfy at least one of the above (7) and (8).
　バルーン２が血管内腔を前進又は後退するときに先頭となる近位側スリーブ部及び／又は遠位側スリーブ部２５の突出部２８が、直管部２３の突出部２８の高さよりも低い高さを有する低突出部領域２８Ｌを有していることにより、バルーン２の挿通性をより容易に向上できる。 The protruding portion 28 of the proximal sleeve portion and/or the distal sleeve portion 25, which is the leading portion when the balloon 2 advances or retreats through the blood vessel lumen, has a low protruding portion region 28L that has a height lower than the height of the protruding portion 28 of the straight tube portion 23, which makes it easier to improve the insertability of the balloon 2.
　低突出部領域２８Ｌは、近位側スリーブ部２１及び／又は遠位側スリーブ部２５において長手軸方向ｘ１に連続して設けられていてもよいし、不連続に設けられていてもよい。 The low protrusion region 28L may be provided continuously in the longitudinal axis direction x1 in the proximal sleeve portion 21 and/or the distal sleeve portion 25, or may be provided discontinuously.
　図７に示すように、バルーン２は、下記（９）及び（１０）の少なくとも一方を満たしていることが好ましい。
　（９）上記（７）を満たしており、内層露出部２０Ａは近位側スリーブ部２１の低突出部領域２８Ｌに配されている。
　（１０）上記（８）を満たしており、内層露出部２０Ａは遠位側スリーブ部２５の低突出部領域２８Ｌに配されている。 As shown in FIG. 7, it is preferable that the balloon 2 satisfies at least one of the following (9) and (10).
(9) The above (7) is satisfied, and the exposed inner layer portion 20A is disposed in the low protrusion region 28L of the proximal sleeve portion 21.
(10) The above (8) is satisfied, and the exposed inner layer portion 20A is disposed in the low protrusion region 28L of the distal sleeve portion 25.
　図７には近位側スリーブ部２１と遠位側スリーブ部２５の両方が上記（９）と（１０）を満たしている態様を示したが、バルーン２は上記（９）及び（１０）の少なくとも一方を満たしていればよい。 FIG. 7 shows an embodiment in which both the proximal sleeve portion 21 and the distal sleeve portion 25 satisfy the above (9) and (10), but it is sufficient for the balloon 2 to satisfy at least one of the above (9) and (10).
　近位側スリーブ部２１及び／又は遠位側スリーブ部２５の低突出部領域２８Ｌに内層露出部２０Ａが配されていることにより、バルーン２が血管内腔を前進又は後退するときに先頭となる近位側スリーブ部及び／又は遠位側スリーブ部２５の突出部２８を、高さが低く、且つ、柔らかい構成とできるため、バルーン２の挿通性を向上しつつ血管内腔壁の損傷防止効果を向上することがより容易になる。 By arranging the exposed inner layer portion 20A in the low protrusion region 28L of the proximal sleeve portion 21 and/or the distal sleeve portion 25, the protrusion 28 of the proximal sleeve portion and/or the distal sleeve portion 25, which is the leading portion when the balloon 2 advances or retreats through the blood vessel lumen, can be made low in height and soft, making it easier to improve the insertion ability of the balloon 2 while also improving the effect of preventing damage to the blood vessel lumen wall.
　図８及び図９に示すように、バルーン２は、下記（１１）及び（１２）の少なくとも一方を満たしていることが好ましい。
　（１１）近位側テーパー部２２の突出部２８は、外層２０ｂが存在していない内層露出部２０Ａを有しており、径方向ｙ１の外方から見たとき周方向ｚ１において内層露出部２０Ａは外層２０ｂに挟まれている。
　（１２）遠位側テーパー部２４の突出部２８は、外層２０ｂが存在していない内層露出部２０Ａを有しており、径方向ｙ１の外方から見たとき周方向ｚ１において内層露出部２０Ａは外層２０ｂに挟まれている。 As shown in FIGS. 8 and 9, it is preferable that the balloon 2 satisfies at least one of the following (11) and (12).
(11) The protrusion 28 of the proximal taper section 22 has an inner layer exposed portion 20A where the outer layer 20b is not present, and when viewed from the outside in the radial direction y1, the inner layer exposed portion 20A is sandwiched between the outer layer 20b in the circumferential direction z1.
(12) The protrusion 28 of the distal taper portion 24 has an inner layer exposed portion 20A where no outer layer 20b is present, and when viewed from the outside in the radial direction y1, the inner layer exposed portion 20A is sandwiched between the outer layer 20b in the circumferential direction z1.
　図８及び図９に示すように、内層露出部２０Ａが設けられた突出部２８は、外層２０ｂが存在せず内層２０ａが突出部２８の表面となる部分を有している。図８に示すように、内層露出部２０Ａが設けられたテーパー部の突出部２８を径方向ｙ１の外方から見たとき、周方向ｚ１において内層露出部２０Ａは外層２０ｂに挟まれている。これにより、内層露出部２０Ａが設けられたテーパー部の突出部２８の径方向ｙ１の外端部には内層２０ａが存在することができる。 As shown in Figures 8 and 9, the protrusion 28 provided with the inner layer exposed portion 20A has a portion where the outer layer 20b is not present and the inner layer 20a forms the surface of the protrusion 28. As shown in Figure 8, when the tapered protrusion 28 provided with the inner layer exposed portion 20A is viewed from the outside in the radial direction y1, the inner layer exposed portion 20A is sandwiched between the outer layers 20b in the circumferential direction z1. This allows the inner layer 20a to be present at the outer end in the radial direction y1 of the tapered protrusion 28 provided with the inner layer exposed portion 20A.
　テーパー部に配される内層露出部２０Ａは、長手軸方向ｘ１の全てに連続して配されていてもよいし、長手軸方向ｘ１の一部に配されていてもよいし、複数の内層露出部２０Ａが長手軸方向ｘ１に不連続に配されていてもよい。 The inner layer exposed portion 20A arranged in the tapered portion may be arranged continuously in the entire longitudinal axis direction x1, may be arranged in a part of the longitudinal axis direction x1, or multiple inner layer exposed portions 20A may be arranged discontinuously in the longitudinal axis direction x1.
　図８及び図９では、近位側テーパー部２２と遠位側テーパー部２４の両方に内層露出部２０Ａが設けられている態様を示したが、内層露出部２０Ａは近位側テーパー部２２と遠位側テーパー部２４の両方に設けられていてもよいし、近位側テーパー部２２と遠位側テーパー部２４のどちらか一方に設けられていてもよい。テーパー部は直管部２３よりも縮径しているため、狭窄部へのバルーン２の挿入時や体内からの抜去時にバルーン２の内腔から流体を排出して収縮させシャフト２にバルーン２の羽根形状部を巻き付けた際に、形成される羽根形状部が短く、羽根形状部から突出部２８が露出することがある。このような場合に、テーパー部の突出部２８が内層露出部２０Ａを有していることにより、血管内腔壁の損傷を防止することがより容易になる。また、テーパー部の突出部２８を径方向ｙ１の外方から見たとき、内層露出部２０Ａは外層２０ｂに挟まれているため、内層露出部２０Ａが形成されている部分においても突出部２８は長手軸方向ｘ１の剛性を確保できるため、バルーン２の挿通性を向上できる。 8 and 9 show an embodiment in which the inner layer exposed portion 20A is provided on both the proximal taper portion 22 and the distal taper portion 24, but the inner layer exposed portion 20A may be provided on both the proximal taper portion 22 and the distal taper portion 24, or on either the proximal taper portion 22 or the distal taper portion 24. Since the tapered portion has a smaller diameter than the straight tube portion 23, when the balloon 2 is inserted into the stenosis portion or removed from the body, fluid is discharged from the inner cavity of the balloon 2 to contract the balloon 2 and the wing-shaped portion of the balloon 2 is wrapped around the shaft 2. The wing-shaped portion formed is short, and the protruding portion 28 may be exposed from the wing-shaped portion. In such a case, since the protruding portion 28 of the tapered portion has the inner layer exposed portion 20A, it is easier to prevent damage to the blood vessel lumen wall. In addition, when the protruding portion 28 of the tapered portion is viewed from the outside in the radial direction y1, the exposed inner layer portion 20A is sandwiched between the outer layer 20b, so that the protruding portion 28 can ensure rigidity in the longitudinal axis direction x1 even in the portion where the exposed inner layer portion 20A is formed, improving the insertability of the balloon 2.
　テーパー部における内層露出部２０Ａを含む突出部２８の構成については、上記スリーブ部における説明の「スリーブ部」を「テーパー部」に読み替えることで理解することができる。 The configuration of the protrusion 28, including the exposed inner layer portion 20A in the tapered portion, can be understood by replacing the "sleeve portion" in the description of the sleeve portion above with "tapered portion."
　内層露出部２０Ａはスリーブ部から連続してテーパー部に形成されていてもよいし、スリーブ部の内層露出部２０Ａとテーパー部の内層露出部２０Ａは不連続に形成されていてもよい。或いは、例えば、近位側スリーブ部２１に内層露出部２０Ａが形成され遠位側スリーブ部２５には内層露出部２０Ａが形成されない態様（上記（１）のみを満たす態様）において、遠位側テーパー部２４に内層露出部２０Ａが形成されていてもよく、遠位側スリーブ部２５に内層露出部２０Ａが形成され近位側スリーブ部２１には内層露出部２０Ａが形成されない態様（上記（２）のみを満たす態様）において、近位側テーパー部２２に内層露出部２０Ａが形成されていてもよい。 The exposed inner layer portion 20A may be formed in the tapered portion continuously from the sleeve portion, or the exposed inner layer portion 20A of the sleeve portion and the exposed inner layer portion 20A of the tapered portion may be formed discontinuously. Alternatively, for example, in an embodiment where the exposed inner layer portion 20A is formed in the proximal sleeve portion 21 and the exposed inner layer portion 20A is not formed in the distal sleeve portion 25 (an embodiment that satisfies only (1) above), the exposed inner layer portion 20A may be formed in the distal tapered portion 24, and in an embodiment where the exposed inner layer portion 20A is formed in the distal sleeve portion 25 and the exposed inner layer portion 20A is not formed in the proximal sleeve portion 21 (an embodiment that satisfies only (2) above), the exposed inner layer portion 20A may be formed in the proximal tapered portion 22.
　内層露出部２０Ａにおいて、長手軸方向ｘ１に垂直な断面における内層露出部２０Ａ（内層２０ａ）の周方向ｚ１の長さは、長手軸方向ｘ１の位置により一定であってもよいし変化していてもよい。例えば、図６に示すように、内層露出部２０Ａ（内層２０ａ）の周方向ｚ１の長さは、長手軸方向ｘ１に沿って一定とすることができる。或いは、図８に示すように、内層露出部２０Ａ（内層２０ａ）の周方向ｚ１の長さは、長手軸方向ｘ１に沿って変化していてもよく、例えば、内層露出部２０Ａ（内層２０ａ）の周方向ｚ１の長さは、バルーン２の端部から直管部２３に近い側にかけて漸減していてもよい。 In the exposed inner layer portion 20A, the length in the circumferential direction z1 of the exposed inner layer portion 20A (inner layer 20a) in a cross section perpendicular to the longitudinal axis direction x1 may be constant or may vary depending on the position in the longitudinal axis direction x1. For example, as shown in FIG. 6, the length in the circumferential direction z1 of the exposed inner layer portion 20A (inner layer 20a) can be constant along the longitudinal axis direction x1. Alternatively, as shown in FIG. 8, the length in the circumferential direction z1 of the exposed inner layer portion 20A (inner layer 20a) may vary along the longitudinal axis direction x1, and for example, the length in the circumferential direction z1 of the exposed inner layer portion 20A (inner layer 20a) may gradually decrease from the end of the balloon 2 to the side closer to the straight tube portion 23.
　図８に示すように、バルーン２は、下記（１３）及び（１４）の少なくとも一方を満たしていることが好ましい。
　（１３）上記（１１）を満たしており、長手軸方向ｘ１において、近位側テーパー部２２の近位側スリーブ部２１側の端を０％の位置ＴＰ０、近位側テーパー部２２の直管部２３側の端を１００％の位置ＴＰ１００としたとき、近位側テーパー部２２の内層露出部２０Ａは位置ＴＰ０から７５％の位置ＴＰ７５までの区間の少なくとも一部に配されている。
　（１４）上記（１２）を満たしており、長手軸方向ｘ１において、遠位側テーパー部２４の遠位側スリーブ部２５側の端を０％の位置ＴＤ０、遠位側テーパー部２４の直管部２３側の端を１００％の位置ＴＤ１００としたとき、遠位側テーパー部２４の内層露出部２０Ａは位置ＴＤ０から７５％の位置ＴＤ７５までの区間の少なくとも一部に配されている。 As shown in FIG. 8, it is preferable that the balloon 2 satisfies at least one of the following (13) and (14).
(13) The above (11) is satisfied, and in the longitudinal axis direction x1, when the end of the proximal taper portion 22 on the proximal sleeve portion 21 side is defined as the 0% position T P0 and the end of the proximal taper portion 22 on the straight tube portion 23 side is defined as the 100% position T P100 , the exposed inner layer portion 20A of the proximal taper portion 22 is arranged in at least a part of the section from position T P0 to 75% position T P75 .
(14) The above (12) is satisfied, and in the longitudinal axis direction x1, when the end of the distal taper portion 24 on the distal sleeve portion 25 side is the 0% position T D0 and the end of the distal taper portion 24 on the straight tube portion 23 side is the 100% position T D100 , the exposed inner layer portion 20A of the distal taper portion 24 is arranged in at least a part of the section from position T D0 to 75% position T D75 .
　図８には近位側テーパー部２２と遠位側テーパー部２４の両方が上記（１３）と（１４）を満たしている態様を示したが、バルーン２は上記（１３）及び（１４）の少なくとも一方を満たしていればよい。 FIG. 8 shows an embodiment in which both the proximal taper portion 22 and the distal taper portion 24 satisfy the above (13) and (14), but it is sufficient for the balloon 2 to satisfy at least one of the above (13) and (14).
　近位側テーパー部２２の位置ＴＰ０から位置ＴＰ７５までの近位側の区間及び／又は遠位側テーパー部２４の位置ＴＤ０から位置ＴＤ７５までの区間は、テーパー部の中でもより縮径して形成されている部分であり、バルーン２を収縮させた際に羽根形状部から突出部２８が露出しやすくなる部分である。このような部分に内層露出部２０Ａが配されていることにより、血管内腔壁の損傷防止効果をより向上することができる。 The proximal section from position T P0 to position T P75 of proximal taper section 22 and/or the section from position T D0 to position T D75 of distal taper section 24 are portions that are formed with a smaller diameter than the other portions of the taper section, and are portions where protrusions 28 are more likely to be exposed from the wing-shaped portions when balloon 2 is deflated. By providing exposed inner layer portion 20A in such portions, the effect of preventing damage to the blood vessel lumen wall can be further improved.
　近位側テーパー部２２及び／又は遠位側テーパー部２４に配される内層露出部２０Ａは、上記区間において長手軸方向ｘ１の全てに連続して配されていてもよいし、長手軸方向ｘ１の一部に配されていてもよいし、複数の内層露出部２０Ａが長手軸方向ｘ１に不連続に配されていてもよい。 The exposed inner layer portion 20A arranged in the proximal taper portion 22 and/or the distal taper portion 24 may be arranged continuously in the entire longitudinal axis direction x1 in the above section, may be arranged in a part of the longitudinal axis direction x1, or multiple exposed inner layer portions 20A may be arranged discontinuously in the longitudinal axis direction x1.
　近位側テーパー部２２の内層露出部２０Ａは位置ＳＰ０から５０％の位置までの区間の少なくとも一部に配されていることがより好ましい。また、遠位側テーパー部２４の内層露出部２０Ａは位置ＳＤ０から５０％の位置までの区間の少なくとも一部に配されていることがより好ましい。 It is more preferable that the exposed inner layer portion 20A of the proximal tapered portion 22 is disposed in at least a portion of the section from the position S P0 to the 50% position. It is also more preferable that the exposed inner layer portion 20A of the distal tapered portion 24 is disposed in at least a portion of the section from the position S D0 to the 50% position.
　図８に示すように、バルーン２は、下記（１５）及び（１６）の少なくとも一方を満たしていることが好ましい。
　（１５）上記（１３）を満たしており、近位側テーパー部２２の内層露出部２０Ａは位置ＴＰ０を含む区間に配されている。
　（１６）上記（１４）を満たしており、遠位側テーパー部２４の内層露出部２０Ａは位置ＴＤ０を含む区間に配されている。 As shown in FIG. 8, it is preferable that the balloon 2 satisfies at least one of the following (15) and (16).
(15) The above (13) is satisfied, and the exposed inner layer portion 20A of the proximal taper portion 22 is disposed in a section including the position T P0 .
(16) The above (14) is satisfied, and the inner layer exposed portion 20A of the distal taper portion 24 is disposed in a section including the position T- D0 .
　図８には近位側テーパー部２２と遠位側テーパー部２４の両方が上記（１５）と（１６）を満たしている態様を示したが、バルーン２は上記（１５）及び（１６）の少なくとも一方を満たしていればよい。 FIG. 8 shows an embodiment in which both the proximal taper portion 22 and the distal taper portion 24 satisfy the above (15) and (16), but it is sufficient for the balloon 2 to satisfy at least one of the above (15) and (16).
　近位側テーパー部２２の位置ＴＰ０を含む区間に内層露出部２０Ａが配されているとは、近位側テーパー部２２の近位側スリーブ部２１側の端（位置ＴＰ０）に内層露出部２０Ａが配されていることを意味する。遠位側テーパー部２４の位置ＴＤ０を含む区間に内層露出部２０Ａが配されているとは、遠位側テーパー部２２の遠位側スリーブ部２５側の端（位置ＴＤ０）に内層露出部２０Ａが配されていることを意味する。これにより、テーパー部の中でも突出部２８が最も羽根形状部から露出しやすい部分においてショアＤ硬度の低い内層２０ａが露出できるため、血管内腔壁の損傷防止効果をより容易に向上できる。 That the exposed inner layer portion 20A is disposed in a section including position T P0 of the proximal taper portion 22 means that the exposed inner layer portion 20A is disposed at the end (position T P0 ) of the proximal sleeve portion 21 side of the proximal taper portion 22. That the exposed inner layer portion 20A is disposed in a section including position T D0 of the distal taper portion 24 means that the exposed inner layer portion 20A is disposed at the end (position T D0 ) of the distal sleeve portion 25 side of the distal taper portion 22. This allows the inner layer 20a, which has a low Shore D hardness, to be exposed in the portion of the taper portion where the protruding portion 28 is most likely to be exposed from the wing-shaped portion, making it easier to improve the effect of preventing damage to the blood vessel lumen wall.
　図９に示すように、バルーン２は、下記（１７）及び（１８）の少なくとも一方を満たしていることが好ましい。
　（１７）上記（１１）を満たしており、近位側テーパー部２２は、突出部２８が直管部２３の突出部２８の高さ以下の高さを有する低突出部領域２８Ｌを有している。
　（１８）上記（１２）を満たしており、遠位側テーパー部２４は、突出部２８が直管部２３の突出部２８の高さ以下の高さを有する低突出部領域２８Ｌを有している。 As shown in FIG. 9, it is preferable that the balloon 2 satisfies at least one of the following (17) and (18).
(17) The above (11) is satisfied, and the proximal taper section 22 has a low protrusion region 28L in which the protrusion 28 has a height equal to or less than the height of the protrusion 28 of the straight pipe section 23.
(18) The above (12) is satisfied, and the distal tapered section 24 has a low protrusion region 28L in which the protrusion 28 has a height equal to or less than the height of the protrusion 28 of the straight pipe section 23.
　図９には近位側テーパー部２２と遠位側テーパー部２４の両方が上記（１７）と（１８）を満たしている態様を示したが、バルーン２は上記（１７）及び（１８）の少なくとも一方を満たしていればよい。 FIG. 9 shows an embodiment in which both the proximal taper portion 22 and the distal taper portion 24 satisfy the above (17) and (18), but it is sufficient for the balloon 2 to satisfy at least one of the above (17) and (18).
　バルーン２が血管内腔を前進又は後退するときに、スリーブ部に次いで先頭となりスリーブ部よりも外径の大きなテーパー部の突出部２８が、直管部２３の突出部２８の高さよりも低い高さを有する低突出部領域２８Ｌを有していることにより、バルーン２の挿通性をさらに容易に向上できる。 When the balloon 2 advances or retreats within the blood vessel lumen, the protruding portion 28 of the tapered portion, which is the next leading portion after the sleeve portion and has a larger outer diameter than the sleeve portion, has a low protruding portion region 28L that has a height lower than the height of the protruding portion 28 of the straight tube portion 23, making it easier to improve the insertability of the balloon 2.
　低突出部領域２８Ｌは、近位側テーパー部２２及び／又は遠位側テーパー部２４において長手軸方向ｘ１に連続して設けられていてもよいし、不連続に設けられていてもよい。 The low protrusion region 28L may be provided continuously in the longitudinal axis direction x1 in the proximal taper section 22 and/or the distal taper section 24, or may be provided discontinuously.
　図９に示すように、バルーン２は、下記（１９）及び（２０）の少なくとも一方を満たしていることが好ましい。
　（１９）上記（１７）を満たしており、内層露出部２０Ａは近位側テーパー部２２の低突出部領域２８Ｌに配されている。
　（２０）上記（１８）を満たしており、内層露出部２０Ａは遠位側テーパー部２４の低突出部領域２８Ｌに配されている。 As shown in FIG. 9, it is preferable that the balloon 2 satisfies at least one of the following (19) and (20).
(19) The above (17) is satisfied, and the inner layer exposed portion 20A is arranged in the low protrusion region 28L of the proximal taper portion 22.
(20) The above (18) is satisfied, and the inner layer exposed portion 20A is arranged in the low protrusion region 28L of the distal taper portion 24.
　図９には近位側テーパー部２２と遠位側テーパー部２４の両方が上記（１９）と（２０）を満たしている態様を示したが、バルーン２は上記（１９）及び（２０）の少なくとも一方を満たしていればよい。 FIG. 9 shows an embodiment in which both the proximal taper portion 22 and the distal taper portion 24 satisfy the above (19) and (20), but it is sufficient for the balloon 2 to satisfy at least one of the above (19) and (20).
　近位側テーパー部２２及び／又は遠位側テーパー部２４の低突出部領域２８Ｌに内層露出部２０Ａが配されていることにより、バルーン２が血管内腔を前進又は後退するときに、スリーブ部に次いで先頭となりスリーブ部よりも外径の大きなテーパー部の突出部２８を、高さが低く、且つ、柔らかい構成とできるため、バルーン２の挿通性を向上しつつ血管内腔壁の損傷防止効果を向上することがさらに容易になる。 By arranging the exposed inner layer portion 20A in the low protrusion region 28L of the proximal taper portion 22 and/or the distal taper portion 24, when the balloon 2 advances or retreats through the blood vessel lumen, the protrusion 28 of the taper portion, which is the next leading portion after the sleeve portion and has a larger outer diameter than the sleeve portion, can be made low in height and soft, making it easier to improve the insertion ability of the balloon 2 while also improving the effect of preventing damage to the blood vessel lumen wall.
　２．バルーンカテーテル
　本発明の実施形態に係るバルーンカテーテル１は、上記バルーンカテーテル用バルーン２を備える。上記「１．バルーンカテーテル用バルーン」の項にも記載したが、図１に示すように、バルーン２はシャフト３０の遠位端部に接続されている。 2. Balloon Catheter The balloon catheter 1 according to the embodiment of the present invention includes the above-mentioned balloon for balloon catheter 2. As described in the above section "1. Balloon for balloon catheter", the balloon 2 is connected to the distal end of the shaft 30 as shown in FIG.
　図１には、シャフト３０の遠位側から近位側に至る途中にガイドワイヤポート５０を有し、ガイドワイヤポート５０からシャフト３０の遠位側までガイドワイヤ挿通路として機能するインナーシャフト６０を有する、所謂ラピッドエクスチェンジ型のバルーンカテーテル１を示している。バルーンカテーテル１は、遠位側シャフト３１と近位側シャフト３２を有していることが好ましく、遠位側シャフト３１と近位側シャフト３２は別部材であって、遠位側シャフト３１の近位端部が近位側シャフト３２の遠位端部に接続されることにより、バルーン２からバルーンカテーテル１の近位端部まで延在するシャフト３０が構成されていてもよい。或いは、１つのシャフト３０がバルーン２からバルーンカテーテル１の近位端部まで延在していてもよく、遠位側シャフト３１や近位側シャフト３２がさらに複数のチューブ部材から構成されていてもよい。 1 shows a so-called rapid exchange type balloon catheter 1 having a guidewire port 50 on the way from the distal side to the proximal side of the shaft 30, and an inner shaft 60 that functions as a guidewire insertion passage from the guidewire port 50 to the distal side of the shaft 30. The balloon catheter 1 preferably has a distal shaft 31 and a proximal shaft 32, and the distal shaft 31 and the proximal shaft 32 may be separate members, and the proximal end of the distal shaft 31 may be connected to the distal end of the proximal shaft 32 to form the shaft 30 that extends from the balloon 2 to the proximal end of the balloon catheter 1. Alternatively, one shaft 30 may extend from the balloon 2 to the proximal end of the balloon catheter 1, and the distal shaft 31 and the proximal shaft 32 may be further composed of multiple tube members.
　シャフト３０は内部に流体の流路とガイドワイヤ挿通路を有していることが好ましい。シャフト３０が内部に流体の流路及びガイドワイヤの挿通路を有する構成とするには、例えば、シャフト３０の内側に配置されているインナーシャフト６０がガイドワイヤ挿通路として機能し、シャフト３０とインナーシャフト６０の間の空間が流体の流路として機能する構成とすることが挙げられる。このような構成の場合、インナーシャフト６０がシャフト３０の遠位端から延出してバルーン２を貫通し、バルーン２の遠位側がインナーシャフト６０と接続され、バルーン２の近位側がシャフト３０と接続されることが好ましい。 It is preferable that the shaft 30 has a fluid flow path and a guidewire insertion path inside. For example, the shaft 30 can be configured to have a fluid flow path and a guidewire insertion path inside by configuring the inner shaft 60 disposed inside the shaft 30 to function as a guidewire insertion path, and the space between the shaft 30 and the inner shaft 60 to function as a fluid flow path. In such a configuration, it is preferable that the inner shaft 60 extends from the distal end of the shaft 30 and penetrates the balloon 2, the distal side of the balloon 2 is connected to the inner shaft 60, and the proximal side of the balloon 2 is connected to the shaft 30.
　シャフト３０は、樹脂、金属、又は樹脂と金属の組み合わせから構成されていることが好ましい。シャフトの構成材料として樹脂を用いることにより、シャフト３０に可撓性や弾性を付与し易くなる。また、シャフト３０の構成材料として金属を用いることにより、バルーンカテーテル１の送達性を向上できる。シャフト３０を構成する樹脂としては、例えば、ポリアミド系樹脂、ポリエステル系樹脂、ポリウレタン系樹脂、ポリオレフィン系樹脂、フッ素系樹脂、塩化ビニル系樹脂、シリコーン系樹脂、天然ゴム、合成ゴム等が挙げられる。これらは１種のみを用いてもよく、２種以上を併用してもよい。シャフト３０を構成する金属としては、例えば、ＳＵＳ３０４、ＳＵＳ３１６等のステンレス鋼、白金、ニッケル、コバルト、クロム、チタン、タングステン、金、Ｎｉ－Ｔｉ合金、Ｃｏ－Ｃｒ合金、又はこれらの組み合わせが挙げられる。シャフト３０が別部材の遠位側シャフト３１と近位側シャフト３２から構成される場合、例えば、遠位側シャフト３１が樹脂から形成され、近位側シャフト３２が金属から形成される構成とすることができる。また、シャフト３０は、異なる材料又は同じ材料による積層構造を有していてもよい。 The shaft 30 is preferably made of a resin, a metal, or a combination of a resin and a metal. By using a resin as the material for the shaft, it becomes easier to impart flexibility and elasticity to the shaft 30. In addition, by using a metal as the material for the shaft 30, the deliverability of the balloon catheter 1 can be improved. Examples of resins that make up the shaft 30 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorine resins, vinyl chloride resins, silicone resins, natural rubber, synthetic rubber, etc. These may be used alone or in combination of two or more. Examples of metals that make up the shaft 30 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloys, Co-Cr alloys, or combinations thereof. When the shaft 30 is made up of a distal shaft 31 and a proximal shaft 32 that are separate members, the distal shaft 31 may be made of a resin, and the proximal shaft 32 may be made of a metal, for example. The shaft 30 may also have a laminated structure made of different materials or the same materials.
　バルーン２とシャフト３０との接合は、接着剤による接着、溶着、バルーン２の端部とシャフト３０とが重なっている箇所にリング状部材を取り付けてかしめること等が挙げられる。中でも、バルーン２とシャフト３０とは、溶着により接合されていることが好ましい。バルーン２とシャフト３０とが溶着されていることにより、バルーン２を繰り返し拡張又は収縮させてもバルーン２とシャフト３０との接合が解除されにくく接合強度を向上できる。 The balloon 2 and the shaft 30 can be joined by bonding with an adhesive, welding, or by attaching a ring-shaped member to the overlapping portion of the end of the balloon 2 and the shaft 30 and crimping the end. Of these, it is preferable that the balloon 2 and the shaft 30 are joined by welding. By welding the balloon 2 and the shaft 30 together, the bond between the balloon 2 and the shaft 30 is less likely to come apart even if the balloon 2 is repeatedly expanded or contracted, and the strength of the bond can be improved.
　バルーンカテーテル１の遠位端部には、先端部材７０が設けられていることが好ましい。先端部材７０は、インナーシャフト６０とは別部材としてバルーン２の遠位端部に接続されることでバルーンカテーテル１の遠位端部に設けられてもよいし、バルーン２の遠位端よりも遠位側まで延在したインナーシャフト６０が先端部材７０として機能してもよい。 It is preferable that a tip member 70 is provided at the distal end of the balloon catheter 1. The tip member 70 may be provided at the distal end of the balloon catheter 1 by being connected to the distal end of the balloon 2 as a separate member from the inner shaft 60, or the inner shaft 60 that extends distally beyond the distal end of the balloon 2 may function as the tip member 70.
　バルーン２の内部のインナーシャフト６０上には、バルーン２の位置をＸ線透視化で確認できるように、長手軸方向ｘ１においてバルーン２が位置する部分にＸ線不透過マーカー８０が配置されていてもよい。Ｘ線不透過マーカー８０は、バルーン２の直管部２３の両端に相当する位置に配されることが好ましく、直管部２３の長手軸方向ｘ１の中央に相当する位置に配されてもよい。 On the inner shaft 60 inside the balloon 2, an X-ray opaque marker 80 may be placed at the portion where the balloon 2 is located in the longitudinal axis direction x1 so that the position of the balloon 2 can be confirmed by X-ray fluoroscopy. The X-ray opaque marker 80 is preferably placed at positions corresponding to both ends of the straight tube section 23 of the balloon 2, and may be placed at a position corresponding to the center of the straight tube section 23 in the longitudinal axis direction x1.
　シャフト３０の近位側にはハブ５が設けられていてもよく、ハブ５にはバルーン２の内部に供給される流体の流路と連通した流体注入部６が設けられていることが好ましい。 A hub 5 may be provided on the proximal side of the shaft 30, and the hub 5 is preferably provided with a fluid injection section 6 that is connected to a flow path for fluid to be supplied to the inside of the balloon 2.
　シャフト３０とハブ５との接合は、例えば、接着剤による接着、溶着等が挙げられる。中でも、シャフト３０とハブ５とは接着により接合されていることが好ましい。シャフト３０とハブ５とが接着されていることにより、例えば、シャフト３０は柔軟性の高い材料から構成され、ハブ５は剛性の高い材料から構成されている等、シャフト３０を構成する材料とハブ５を構成する材料とが異なっている場合に、シャフト３０とハブ５の接合強度を高めてバルーンカテーテル１の耐久性を向上できる。 The shaft 30 and the hub 5 can be joined by, for example, bonding with an adhesive, welding, etc. Among these, it is preferable that the shaft 30 and the hub 5 are joined by adhesion. By bonding the shaft 30 and the hub 5 together, the bond strength between the shaft 30 and the hub 5 can be increased and the durability of the balloon catheter 1 can be improved when the shaft 30 and the hub 5 are made of different materials, for example, when the shaft 30 is made of a highly flexible material and the hub 5 is made of a highly rigid material.
　図示していないが、本発明は、シャフトの遠位側から近位側にわたってガイドワイヤ挿通路を有している、所謂オーバーザワイヤ型のバルーンカテーテルにも適用できる。オーバーザワイヤ型の場合、インフレーションルーメン及びガイドワイヤルーメンが手元側に配置されるハブまで延在しており、各ルーメンの近位側開口が二又構造のハブに設けられていることが好ましい。 Although not shown, the present invention can also be applied to so-called over-the-wire type balloon catheters that have a guidewire passage from the distal side to the proximal side of the shaft. In the case of over-the-wire type, it is preferable that the inflation lumen and guidewire lumen extend to a hub located on the proximal side, and that the proximal opening of each lumen is provided in a bifurcated hub.
　ラピッドエクスチェンジ型のカテーテルの場合、遠位側シャフト３１及び／又は近位側シャフト３２の外壁に適宜コーティングが施されていることが好ましく、遠位側シャフト３１と近位側シャフト３２の両方にコーティングが施されていることがより好ましい。オーバーザワイヤ型のカテーテルの場合は、外側シャフトの外壁に適宜コーティングが施されていることが好ましい。 In the case of a rapid exchange type catheter, it is preferable that the outer wall of the distal shaft 31 and/or the proximal shaft 32 is appropriately coated, and it is more preferable that both the distal shaft 31 and the proximal shaft 32 are coated. In the case of an over-the-wire type catheter, it is preferable that the outer wall of the outer shaft is appropriately coated.
　コーティングは、目的に応じて親水性コーティング又は疎水性コーティングとすることができ、シャフト３０を親水性コーティング剤又は疎水性コーティング剤に浸漬したり、シャフト３０の外壁に親水性コーティング剤又は疎水性コーティング剤を塗布したり、シャフト３０の外壁を親水性コーティング剤又は疎水性コーティング剤で被覆したりすることにより施すことができる。コーティング剤は、薬剤や添加剤を含んでいてもよい。 The coating can be a hydrophilic coating or a hydrophobic coating depending on the purpose, and can be applied by immersing the shaft 30 in a hydrophilic coating agent or a hydrophobic coating agent, applying a hydrophilic coating agent or a hydrophobic coating agent to the outer wall of the shaft 30, or covering the outer wall of the shaft 30 with a hydrophilic coating agent or a hydrophobic coating agent. The coating agent may contain a drug or an additive.
　親水性コーティング剤としては、ポリビニルアルコール、ポリエチレングリコール、ポリアクリルアミド、ポリビニルピロリドン、メチルビニルエーテル無水マレイン酸共重合体などの親水性ポリマー、又はそれらの任意の組み合わせで作られた親水性コーティング剤等が挙げられる。 Hydrophilic coating agents include hydrophilic polymers such as polyvinyl alcohol, polyethylene glycol, polyacrylamide, polyvinylpyrrolidone, methyl vinyl ether maleic anhydride copolymer, or hydrophilic coating agents made from any combination thereof.
　疎水性コーティング剤としては、ポリテトラフルオロエチレン（ＰＴＦＥ）、フッ化エチレンプロピレン（ＦＥＰ）、パーフルオロアルコキシアルカン（ＰＦＡ）、シリコーンオイル、疎水性ウレタン樹脂、カーボンコート、ダイヤモンドコート、ダイヤモンドライクカーボン（ＤＬＣ）コート、セラミックコート、アルキル基やパーフルオロアルキル基で終端された表面自由エネルギーが小さい物質等が挙げられる。 Hydrophobic coating agents include polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), silicone oil, hydrophobic urethane resin, carbon coat, diamond coat, diamond-like carbon (DLC) coat, ceramic coat, and substances with low surface free energy terminated with alkyl groups or perfluoroalkyl groups.
　３．バルーンカテーテルの製造方法
　本発明の実施形態に係るバルーンカテーテルの製造方法は、上記バルーンカテーテルの製造方法であって、径方向、周方向、及び長手軸方向を有し、長手軸方向に延在する内腔を有しているパリソンを準備するステップと、パリソンを延伸して、近位側スリーブ部、近位側テーパー部、直管部、遠位側テーパー部、及び遠位側スリーブ部を有し、突出部を有するバルーンを製造するステップと、近位側スリーブ部及び／又は遠位側スリーブ部の突出部の頂部側を長手軸方向に沿って切除して内層露出部を形成するステップと、を有しており、パリソンは、外層と、外層よりもショアＤ硬度が低い材料から構成されている内層と、を有しており、径方向の外方に突出し長手軸方向に延在している突出部を含む突出領域と、突出領域以外の非突出領域と、を有しており、長手軸方向に垂直な断面において、内層は、非突出領域において小厚部を有しており突出領域において小厚部よりも厚い厚みを有している大厚部を有している方法である。 3. A method for manufacturing a balloon catheter according to an embodiment of the present invention is a method for manufacturing the balloon catheter, comprising the steps of: preparing a parison having a radial direction, a circumferential direction, and a longitudinal direction, and an inner lumen extending in the longitudinal direction; stretching the parison to manufacture a balloon having a proximal sleeve portion, a proximal tapered portion, a straight tube portion, a distal tapered portion, and a distal sleeve portion, and having a protruding portion; and cutting the top side of the protruding portion of the proximal sleeve portion and/or the distal sleeve portion along the longitudinal direction to form an exposed inner layer portion, wherein the parison has an outer layer and an inner layer made of a material having a Shore D hardness lower than that of the outer layer, and has a protruding region including the protruding portion protruding radially outward and extending in the longitudinal direction, and a non-protruding region other than the protruding region, and in a cross section perpendicular to the longitudinal direction, the inner layer has a thin portion in the non-protruding region and a thick portion having a thickness greater than the thin portion in the protruding region.
　本発明の実施形態に係る方法では、パリソンが、外層と外層よりもショアＤ硬度が低い材料から構成されている内層とを有しており、突出領域と非突出領域とを有しており、長手軸方向に垂直な断面において、内層が非突出領域において小厚部を有しており突出領域において大厚部を有している。このようなパリソンを延伸してバルーンを製造する方法において、パリソンの近位側スリーブ部及び／又は遠位側スリーブ部に相当する部分の突出領域の頂部側を長手軸方向に沿って切除するか、又は、バルーンに成形後の近位側スリーブ部及び／又は遠位側スリーブ部の突出部の頂部側を長手軸方向に沿って切除することにより、近位側スリーブ部及び／又は遠位側スリーブ部に内層露出部を形成し、径方向の外方から見たとき周方向において内層露出部が外層に挟まれている「１．バルーンカテーテル用バルーン」を備える「２．バルーンカテーテル」を製造することができる。 In the method according to the embodiment of the present invention, the parison has an outer layer and an inner layer made of a material having a lower Shore D hardness than the outer layer, and has a protruding region and a non-protruding region, and in a cross section perpendicular to the longitudinal axis, the inner layer has a thin portion in the non-protruding region and a thick portion in the protruding region. In the method for producing a balloon by stretching such a parison, the top side of the protruding region of the part corresponding to the proximal sleeve portion and/or the distal sleeve portion of the parison is cut along the longitudinal axis, or the top side of the protruding portion of the proximal sleeve portion and/or the distal sleeve portion after molding into a balloon is cut along the longitudinal axis, thereby forming an exposed inner layer portion in the proximal sleeve portion and/or the distal sleeve portion, and a "2. Balloon catheter" can be produced that includes a "1. Balloon for balloon catheter" in which the exposed inner layer portion is sandwiched between the outer layers in the circumferential direction when viewed from the outside in the radial direction.
　図１０～図１８を参照しつつ、本発明の実施形態に係るバルーンカテーテルの製造方法を説明する。図１０は、本発明の一実施形態に係る延伸前のパリソンの斜視図を表す。図１１は図１０に示したパリソンのＸＩ－ＸＩ断面図（中厚部のない構成）を表し、図１２は図１１に示したパリソンの製造に用いられるパリソン用金型の長手軸方向に垂直な断面図を表す。図１３はＸＩ－ＸＩ断面図の変形例を表し（中厚部のある構成）、図１４は図１３に示したパリソンの製造に用いられるパリソン用金型の長手軸方向に垂直な断面図を表す。図１５は、本発明の実施形態に係る製造方法においてパリソンの延伸に用いられる金型の長手軸方向の断面図を表す。図１６は図１５に示した金型のＸＶＩ－ＸＶＩ断面図、すなわち金型直管部の断面図を表し、図１７は図１５に示した金型のＸＶＩＩ－ＸＶＩＩ断面図、すなわち金型スリーブ部の断面図を表す。図１８は、ＸＶＩＩ－ＸＶＩＩ断面図の変形例を表す。 With reference to Figures 10 to 18, a method for manufacturing a balloon catheter according to an embodiment of the present invention will be described. Figure 10 shows a perspective view of a parison before stretching according to an embodiment of the present invention. Figure 11 shows a XI-XI cross-sectional view (without a middle thickness portion) of the parison shown in Figure 10, and Figure 12 shows a cross-sectional view perpendicular to the longitudinal axis of a parison mold used to manufacture the parison shown in Figure 11. Figure 13 shows a modified example of the XI-XI cross-sectional view (with a middle thickness portion), and Figure 14 shows a cross-sectional view perpendicular to the longitudinal axis of a parison mold used to manufacture the parison shown in Figure 13. Figure 15 shows a cross-sectional view in the longitudinal axis direction of a mold used to stretch a parison in a manufacturing method according to an embodiment of the present invention. Figure 16 shows a XVI-XVI cross-sectional view of the mold shown in Figure 15, i.e., a cross-sectional view of the straight tube portion of the mold, and Figure 17 shows a XVII-XVII cross-sectional view of the mold shown in Figure 15, i.e., a cross-sectional view of the mold sleeve portion. Figure 18 shows a modified example of the XVII-XVII cross section.
　まず、パリソン２００を準備する。図１０に示すように、パリソン２００は、樹脂から構成されており、内腔２０５を有する筒状の部材である。パリソン２００は、第１端２０１と第２端２０２を有しており、第１端２０１から第２端２０２に向かう長手軸方向ｘ２に延在している。パリソン２００は、バルーン２と同様に径方向ｙ２と周方向ｚ２を有している。 First, prepare the parison 200. As shown in FIG. 10, the parison 200 is made of resin and is a tubular member having an inner cavity 205. The parison 200 has a first end 201 and a second end 202, and extends in a longitudinal axis direction x2 from the first end 201 to the second end 202. The parison 200 has a radial direction y2 and a circumferential direction z2, similar to the balloon 2.
　図１１に示すように、パリソン２００は、外層２００ｂと、外層２００ｂよりもショアＤ硬度が低い材料から構成されている内層２００ａとを有している。内層２００ａ及び外層２００ｂを構成する材料、並びにそれらのショアＤ硬度については、「１．バルーンカテーテル用バルーン」の項に記載した内層２０ａ及び外層２０ｂを構成する樹脂の説明、並びにそれらのショアＤ硬度についての記載を参照できる。 As shown in FIG. 11, the parison 200 has an outer layer 200b and an inner layer 200a made of a material having a lower Shore D hardness than the outer layer 200b. For the materials constituting the inner layer 200a and the outer layer 200b and their Shore D hardness, please refer to the description of the resins constituting the inner layer 20a and the outer layer 20b in the section "1. Balloon for balloon catheter" and the description of their Shore D hardness.
　パリソン２００は、径方向ｙ２の外方に突出し長手軸方向ｘ２に延在している突出部２０８を含む突出領域Ｒ１と、突出領域Ｒ１以外の非突出領域Ｒ２とを有している。パリソン２００を延伸することにより、突出部２０８がバルーン２の突出部２８に、非突出領域Ｒ２の部分が突出部２８以外のバルーン本体部２０に成形されることができる。パリソン２００の延伸は、パリソン２００がブロー成形されることにより行われてもよいし、二軸延伸されることにより行われてもよい。 The parison 200 has a protruding region R1 including a protruding portion 208 that protrudes outward in the radial direction y2 and extends in the longitudinal direction x2, and a non-protruding region R2 other than the protruding region R1. By stretching the parison 200, the protruding portion 208 can be molded into the protruding portion 28 of the balloon 2, and the non-protruding region R2 can be molded into the balloon body portion 20 other than the protruding portion 28. The parison 200 can be stretched by blow molding the parison 200 or by biaxially stretching it.
　図１１に示すように突出部２０８は周方向ｚ２に複数設けられていてもよいし、図示していないが突出部２０８は周方向ｚ２に１つ設けられていてもよい。突出部２０８が周方向ｚ２に複数設けられている場合は、複数の突出部２０８は周方向ｚ２に離隔していることが好ましく、周方向ｚ２に等間隔に配されていることがより好ましい。 As shown in FIG. 11, multiple protrusions 208 may be provided in the circumferential direction z2, or, although not shown, one protrusion 208 may be provided in the circumferential direction z2. When multiple protrusions 208 are provided in the circumferential direction z2, it is preferable that the multiple protrusions 208 are spaced apart in the circumferential direction z2, and it is more preferable that they are arranged at equal intervals in the circumferential direction z2.
　図１１に示すように、長手軸方向ｘ２に垂直な断面において、内層２００ａは、非突出領域Ｒ２において小厚部２２０を有しており突出領域Ｒ１において小厚部２２０よりも厚い厚みを有している大厚部２１０を有している。突出領域Ｒ１において内層２００ａが大厚部２１０を有していることにより、後述する切除工程において突出部２０８の頂部側を長手軸方向ｘ２に沿って切除することにより内層露出部を形成することができる。 As shown in FIG. 11, in a cross section perpendicular to the longitudinal axis direction x2, the inner layer 200a has a thin portion 220 in the non-protruding region R2 and a thick portion 210 that is thicker than the thin portion 220 in the protruding region R1. Because the inner layer 200a has a thick portion 210 in the protruding region R1, the top side of the protruding portion 208 can be cut along the longitudinal axis direction x2 in the cutting process described below to form an exposed inner layer portion.
　このようなパリソン２００は、例えば、図１２に示すようなパリソン用金型２５０を用いて樹脂を押出成形することにより製造できる。図１２に示すように、パリソン用金型２５０は、第１筒状部材２５１、第２筒状部材２５２、及び第３筒状部材２５３を有しており、第１筒状部材２５１はパリソン２００の内腔２０５を形成できるように円筒形状を有しており、第２筒状部材２５２は内層２００ａの大厚部２１０と小厚部２２０を形成できるように突出部を有する筒形状を有しており、第３筒状部材２５３は突出部２０８を形成できるように突出部を有する筒形状を有していることが好ましい。これにより、第１筒状部材２５１の外側面と第２筒状部材２５２の内側面との間の空間に内層２００ａを形成する樹脂を導入し、第２筒状部材２５２の外側面と第３筒状部材２５３の内側面との間の空間に外層２００ｂを形成する樹脂を導入して押出成形することにより、内腔２０８、内層２００ａ、及び外層２００ｂを有し、突出領域Ｒ１において内層２００ａが大厚部２１０を有するパリソン２００を製造することができる。 Such a parison 200 can be manufactured, for example, by extrusion molding a resin using a parison mold 250 as shown in Fig. 12. As shown in Fig. 12, the parison mold 250 has a first tubular member 251, a second tubular member 252, and a third tubular member 253, and it is preferable that the first tubular member 251 has a cylindrical shape so as to form the inner cavity 205 of the parison 200, the second tubular member 252 has a tubular shape with a protrusion so as to form the large thickness portion 210 and the small thickness portion 220 of the inner layer 200a, and the third tubular member 253 has a tubular shape with a protrusion so as to form the protrusion 208. This allows the resin that forms the inner layer 200a to be introduced into the space between the outer surface of the first tubular member 251 and the inner surface of the second tubular member 252, and the resin that forms the outer layer 200b to be introduced into the space between the outer surface of the second tubular member 252 and the inner surface of the third tubular member 253, and extrusion molding to produce a parison 200 that has an inner cavity 208, an inner layer 200a, and an outer layer 200b, and in which the inner layer 200a has a large thickness portion 210 in the protruding region R1.
　パリソン用金型２５０を構成する材料は、金属であることが好ましく、鉄、銅、アルミニウム又はこれらの合金であることがより好ましい。例えば、鉄の合金としてはステンレス鋼等が挙げられ、銅の合金としては真鍮等が挙げられ、アルミニウムの合金としてはジュラルミン等が挙げられる。十分な導電性や強度を有する点や加工のし易さの点から、パリソン用金型２５０はステンレス鋼で構成されていることが好ましい。 The material constituting the parison mold 250 is preferably a metal, and more preferably iron, copper, aluminum, or an alloy of these. For example, an iron alloy may be stainless steel, an copper alloy may be brass, and an aluminum alloy may be duralumin. In terms of sufficient conductivity and strength, and ease of processing, the parison mold 250 is preferably made of stainless steel.
　或いは、パリソン２００は図１３に示すような構成を有していてもよい。すなわち、長手軸方向ｘ２に垂直な断面において、内層２００ａは、小厚部２２０よりも厚い厚みを有し大厚部２１０よりも薄い厚みを有する中厚部２３０を非突出領域Ｒ２において有しており、周方向ｚ２において小厚部２２０は大厚部２１０と中厚部２３０の間に位置していてもよい。これにより、パリソン２００を延伸した際にバルーン２の突出部２８における内層２０ａの厚みを厚くすることが容易になり、後述する切除工程においてバルーン２に成形した後に突出部２８の頂部側を切除して内層露出部２０Ａを形成することが容易になる。 Alternatively, the parison 200 may have a configuration as shown in FIG. 13. That is, in a cross section perpendicular to the longitudinal axis direction x2, the inner layer 200a may have a medium thickness portion 230 in the non-protruding region R2 that is thicker than the small thickness portion 220 and thinner than the large thickness portion 210, and the small thickness portion 220 may be located between the large thickness portion 210 and the medium thickness portion 230 in the circumferential direction z2. This makes it easier to increase the thickness of the inner layer 20a in the protruding portion 28 of the balloon 2 when the parison 200 is stretched, and makes it easier to form the inner layer exposed portion 20A by cutting the top side of the protruding portion 28 after molding into the balloon 2 in the cutting process described below.
　図１３に示すようなパリソン２００は、例えば、図１４に示すようなパリソン用金型２５０を用いて樹脂を押出成形することにより製造できる。図１４に示すパリソン用金型２５０は、第２筒状部材２５２が内層２００ａの大厚部２１０、小厚部２２０、及び中厚部２３０を形成できるように、突出領域Ｒ１を形成する部分に突出部を有し、非突出領域Ｒ２を形成する部分に上記突出部よりも低い高さを有する低突出部を有する筒形状を有していることが好ましい。これにより、上記と同様の方法により、内腔２０８、内層２００ａ、及び外層２００ｂを有し、突出領域Ｒ１において内層２００ａが大厚部２１０を有し、非突出領域Ｒ２において内層２００ａが小厚部２２０と中厚部２３０を有するパリソン２００を製造することができる。 The parison 200 as shown in FIG. 13 can be manufactured by extruding resin using a parison mold 250 as shown in FIG. 14. The parison mold 250 shown in FIG. 14 preferably has a cylindrical shape with a protruding portion in the portion forming the protruding region R1 and a low protruding portion having a lower height than the protruding portion in the portion forming the non-protruding region R2 so that the second cylindrical member 252 can form the large thickness portion 210, the small thickness portion 220, and the medium thickness portion 230 of the inner layer 200a. This allows the manufacture of a parison 200 having an inner cavity 208, an inner layer 200a, and an outer layer 200b, in which the inner layer 200a has the large thickness portion 210 in the protruding region R1 and the inner layer 200a has the small thickness portion 220 and the medium thickness portion 230 in the non-protruding region R2, by the same method as described above.
　パリソン２００を延伸することにより、近位側スリーブ部２１、近位側テーパー部２２、直管部２３、遠位側テーパー部２４、及び遠位側スリーブ部２５を有し、突出部２８を有するバルーン２を製造する。このとき、図１５に示すような金型３００を用いることができる。金型３００は、長手軸方向ｘ３、径方向ｙ３、及び周方向ｚ３を有し、長手軸方向ｘ３に延在しパリソン２００が挿入される内腔３０５を有している。金型３００の内腔３０５には、パリソン２００の長手軸方向ｘ２における一部が配置されることが好ましい。 By stretching the parison 200, a balloon 2 having a proximal sleeve portion 21, a proximal tapered portion 22, a straight tube portion 23, a distal tapered portion 24, and a distal sleeve portion 25, and a protruding portion 28 is manufactured. In this case, a mold 300 as shown in FIG. 15 can be used. The mold 300 has a longitudinal axis direction x3, a radial direction y3, and a circumferential direction z3, and has an inner cavity 305 extending in the longitudinal axis direction x3 and into which the parison 200 is inserted. It is preferable that a portion of the parison 200 in the longitudinal axis direction x2 is placed in the inner cavity 305 of the mold 300.
　金型３００は、長手軸方向ｘ３において、バルーン２の直管部を形成する金型直管部３００Ｃと、金型直管部３００Ｃの両側に配されバルーン２のテーパー部を形成する２つの金型テーパー部３００Ｔと、金型テーパー部３００Ｔよりも金型直管部３００Ｃから離れた側に配されバルーン２のスリーブ部を形成する２つの金型スリーブ部３００Ｓを有していることが好ましい。これにより、金型直管部３００Ｃによりバルーン２の直管部２３が形成され、金型テーパー部３００Ｔにより近位側テーパー部２２及び遠位側テーパー部２４が形成され、金型スリーブ部３００Ｓにより近位側スリーブ部２１及び遠位側スリーブ部２５が形成されることができる。 The mold 300 preferably has, in the longitudinal axis direction x3, a mold straight pipe section 300C that forms the straight pipe section of the balloon 2, two mold taper sections 300T arranged on both sides of the mold straight pipe section 300C that form the tapered section of the balloon 2, and two mold sleeve sections 300S arranged on the side farther from the mold straight pipe section 300C than the mold taper sections 300T that form the sleeve section of the balloon 2. As a result, the mold straight pipe section 300C forms the straight pipe section 23 of the balloon 2, the mold taper sections 300T form the proximal side taper section 22 and the distal side taper section 24, and the mold sleeve sections 300S form the proximal side sleeve section 21 and the distal side sleeve section 25.
　金型３００は、１つの部材から構成されていてもよく、複数の部材から構成されていてもよい。図１５に示すように、複数の金型部材が長手軸方向ｘ３において互いに接続されることにより構成されていてもよく、例えば、金型直管部３００Ｃ、金型テーパー部３００Ｔ、及び金型スリーブ部３００Ｓがそれぞれ異なる金型部材であり、これらが長手軸方向ｘ３において互いに接続されていてもよい。また、金型３００は、径方向ｙに分割可能であってもよい。これにより、金型３００の内腔３０５にパリソン２００を挿入しやすくなる。図１５に示すように、各金型部材は、隣り合う金型部材どうしを係合することにより接合されてもよいし、図示していないが隣り合う金型部材のそれぞれに磁石を取り付けて磁石の引力により接合されてもよい。 The mold 300 may be made of one member or may be made of multiple members. As shown in FIG. 15, multiple mold members may be connected to each other in the longitudinal axis direction x3. For example, the mold straight tube section 300C, the mold taper section 300T, and the mold sleeve section 300S may each be different mold members, and these may be connected to each other in the longitudinal axis direction x3. The mold 300 may also be separable in the radial direction y. This makes it easier to insert the parison 200 into the inner cavity 305 of the mold 300. As shown in FIG. 15, each mold member may be joined by engaging adjacent mold members with each other, or, although not shown, adjacent mold members may be attached with magnets and joined by the attractive force of the magnets.
　図１６に示すように、金型３００の内腔３０５は、径方向ｙ３の外方に凹み長手軸方向ｘ３に延在している溝部３１０と溝部３１０以外の円筒壁部３２０から形成されていることが好ましい。これにより、溝部３１０にパリソン２００の突出部２０８を入り込ませてバルーン２の突出部２８を形成することができる。溝部３１０は周方向ｚ３に複数設けられていてもよいし、図示していないが溝部３１０は周方向ｚ３に１つ設けられていてもよい。溝部３１０が周方向ｚ３に複数設けられている場合は、溝部３１０は周方向ｚ３に離隔していることが好ましく、周方向ｚ３に等間隔に配されていることがより好ましい。 As shown in FIG. 16, the inner cavity 305 of the mold 300 is preferably formed of a groove portion 310 recessed outward in the radial direction y3 and extending in the longitudinal axis direction x3, and a cylindrical wall portion 320 other than the groove portion 310. This allows the protrusion portion 208 of the parison 200 to enter the groove portion 310 to form the protrusion portion 28 of the balloon 2. A plurality of groove portions 310 may be provided in the circumferential direction z3, or, although not shown, one groove portion 310 may be provided in the circumferential direction z3. When a plurality of groove portions 310 are provided in the circumferential direction z3, the groove portions 310 are preferably spaced apart in the circumferential direction z3, and more preferably arranged at equal intervals in the circumferential direction z3.
　溝部３１０は、金型直管部３００Ｃに設けられていることが好ましく、金型テーパー部３００Ｔや金型スリーブ部３００Ｓに設けられていてもよい。溝部３１０が金型直管部３００Ｃに設けられていることにより、バルーン２の直管部２３に突出部２８を形成することができ、バルーン２による狭窄部の切開効率を高められる。金型テーパー部３００Ｔや金型スリーブ部３００Ｓに設けられる溝部３１０の深さは、金型直管部３００Ｃに設けられる溝部３１０の深さよりも浅くてもよいし同等であってもよく、後述する切除工程を行う順序により適宜選択できる。 The groove 310 is preferably provided in the mold straight pipe section 300C, and may be provided in the mold taper section 300T or mold sleeve section 300S. By providing the groove 310 in the mold straight pipe section 300C, a protrusion 28 can be formed in the straight pipe section 23 of the balloon 2, and the efficiency of cutting the narrowed part by the balloon 2 can be improved. The depth of the groove 310 provided in the mold taper section 300T or mold sleeve section 300S may be shallower than or equal to the depth of the groove 310 provided in the mold straight pipe section 300C, and can be appropriately selected depending on the order of performing the cutting process described below.
　金型３００を構成する材料は、金属であることが好ましく、鉄、銅、アルミニウム又はこれらの合金であることがより好ましい。例えば、鉄の合金としてはステンレス鋼等が挙げられ、銅の合金としては真鍮等が挙げられ、アルミニウムの合金としてはジュラルミン等が挙げられる。十分な導電性や強度を有する点や加工のし易さの点から、パリソン用金型３００はステンレス鋼で構成されていることが好ましい。 The material constituting the mold 300 is preferably a metal, and more preferably iron, copper, aluminum, or an alloy of these. For example, an iron alloy may be stainless steel, an copper alloy may be brass, and an aluminum alloy may be duralumin. In terms of sufficient conductivity and strength, and ease of processing, the parison mold 300 is preferably made of stainless steel.
　切除工程では、近位側スリーブ部２１及び／又は遠位側スリーブ部２５の突出部２８の頂部側を長手軸方向ｘ１に沿って切除することにより内層露出部２０Ａを形成する。切除工程は、パリソン２００を延伸してバルーン２に成形してから実施してもよい。このとき、突出部２８の外層２０ｂのみを切除してもよいし、突出部２８の外層２０ｂとともに内層２０ａの一部も切除してもよい。或いは、パリソン２００を延伸する前に、パリソン２００の近位側スリーブ部２１及び／又は遠位側スリーブ部２５に相当する部分の突出部２０８の頂部側を長手軸方向ｘ２に沿って切除し、この状態のパリソン２００を延伸することにより近位側スリーブ部２１及び／又は遠位側スリーブ部２５の突出部２８の頂部側が切除されたバルーン２としてもよい。このとき、突出部２０８の外層２００ｂのみを切除してもよいし、突出部２０８の外層２００ｂとともに内層２００ａの一部も切除してもよい。これにより、近位側スリーブ部２１及び／又は遠位側スリーブ部２５が、外層２０ｂが存在していない内層露出部２０Ａを有しており、径方向ｙ１の外方から見たとき周方向ｚ１において内層露出部２０Ａが外層２０ｂに挟まれるようにバルーン２を製造することができる。 In the cutting step, the top side of the protruding portion 28 of the proximal sleeve portion 21 and/or the distal sleeve portion 25 is cut along the longitudinal axis direction x1 to form the exposed inner layer portion 20A. The cutting step may be performed after the parison 200 is stretched to form the balloon 2. At this time, only the outer layer 20b of the protruding portion 28 may be cut, or a part of the inner layer 20a may be cut together with the outer layer 20b of the protruding portion 28. Alternatively, before stretching the parison 200, the top side of the protruding portion 208 of the parison 200 corresponding to the proximal sleeve portion 21 and/or the distal sleeve portion 25 may be cut along the longitudinal axis direction x2, and the parison 200 in this state may be stretched to form a balloon 2 in which the top side of the protruding portion 28 of the proximal sleeve portion 21 and/or the distal sleeve portion 25 has been cut off. At this time, only the outer layer 200b of the protruding portion 208 may be removed, or a part of the inner layer 200a may be removed together with the outer layer 200b of the protruding portion 208. This allows the proximal sleeve portion 21 and/or the distal sleeve portion 25 to have an inner layer exposed portion 20A where the outer layer 20b is not present, and the balloon 2 can be manufactured so that the inner layer exposed portion 20A is sandwiched between the outer layers 20b in the circumferential direction z1 when viewed from the outside in the radial direction y1.
　切除工程をバルーン２に成形してから実施する場合は、切除工程により近位側スリーブ部２１及び／又は遠位側スリーブ部２５の突出部２８の高さを低くできることから、図１７に示すように、バルーン２を成形する際の金型３００の金型スリーブ部３００Ｓにおける溝部３１０の深さは金型直管部３００Ｃの溝部の深さと同等であってもよい。 If the cutting process is performed after molding the balloon 2, the height of the protruding portion 28 of the proximal sleeve portion 21 and/or the distal sleeve portion 25 can be reduced by the cutting process, so that the depth of the groove portion 310 in the mold sleeve portion 300S of the mold 300 when molding the balloon 2 may be equal to the depth of the groove portion of the mold straight tube portion 300C, as shown in FIG. 17.
　切除工程をパリソン２００の段階で実施する場合は、切除工程により突出部２０８の高さが低くなった部分を近位側スリーブ部２１及び／又は遠位側スリーブ部２５に形成するため、図１８に示すように、バルーン２を成形する際の金型３００の金型スリーブ部３００Ｓにおける溝部３１０の深さは金型直管部３００Ｃの溝部の深さよりも浅くてもよい。 When the cutting process is performed at the parison 200 stage, the portion of the protrusion 208 whose height has been reduced by the cutting process is formed in the proximal sleeve portion 21 and/or the distal sleeve portion 25, so that, as shown in FIG. 18, the depth of the groove portion 310 in the mold sleeve portion 300S of the mold 300 when molding the balloon 2 may be shallower than the depth of the groove portion in the mold straight tube portion 300C.
　本発明の実施形態に係る製造方法は、近位側テーパー部２２及び／又は遠位側テーパー部２４の突出部２８の頂部側を長手軸方向ｘ１に沿って切除して内層露出部２０Ａを形成するステップをさらに有していてもよい。このテーパー部の切除工程についても、近位側スリーブ部２１及び／又は遠位側スリーブ部２５の場合と同様に、パリソン２００を延伸してバルーン２に成形してから実施してもよいし、パリソン２００の段階で実施してもよい。 The manufacturing method according to an embodiment of the present invention may further include a step of cutting the top side of the protruding portion 28 of the proximal taper portion 22 and/or the distal taper portion 24 along the longitudinal axis direction x1 to form the exposed inner layer portion 20A. As with the proximal sleeve portion 21 and/or the distal sleeve portion 25, this cutting step of the taper portion may be performed after the parison 200 is stretched and formed into the balloon 2, or may be performed at the parison 200 stage.
　テーパー部の切除工程をバルーン２に成形してから実施する場合は、切除工程により近位側テーパー部２２及び／又は遠位側テーパー部２４の突出部２８の高さを低くできることから、バルーン２を成形する際の金型３００の金型テーパー部３００Ｔにおける溝部３１０の深さは金型直管部３００Ｃの溝部の深さと同等であってもよい。 If the tapered portion cutting process is performed after the balloon 2 is molded, the height of the protruding portion 28 of the proximal tapered portion 22 and/or the distal tapered portion 24 can be reduced by the cutting process, so the depth of the groove portion 310 in the mold taper portion 300T of the mold 300 when molding the balloon 2 may be equal to the depth of the groove portion in the mold straight tube portion 300C.
　テーパー部の切除工程をパリソン２００の段階で実施する場合は、切除工程により突出部２０８の高さが低くなった部分を近位側テーパー部２２及び／又は遠位側テーパー部２４に形成するため、バルーン２を成形する際の金型３００の金型テーパー部３００Ｔにおける溝部３１０の深さは金型直管部３００Ｃの溝部の深さよりも浅くてもよい。 If the tapered portion cutting process is performed at the parison 200 stage, the portion of the protrusion 208 whose height has been reduced by the cutting process is formed in the proximal tapered portion 22 and/or the distal tapered portion 24, so the depth of the groove portion 310 in the mold taper portion 300T of the mold 300 when molding the balloon 2 may be shallower than the depth of the groove portion in the mold straight tube portion 300C.
　本願は、２０２２年１１月１６日に出願された日本国特許出願第２０２２－１８３５３９号に基づく優先権の利益を主張するものである。２０２２年１１月１６日に出願された日本国特許出願第２０２２－１８３５３９号の明細書の全内容が、本願に参考のため援用される。 This application claims the benefit of priority based on Japanese Patent Application No. 2022-183539, filed on November 16, 2022. The entire contents of the specification of Japanese Patent Application No. 2022-183539, filed on November 16, 2022, are incorporated by reference into this application.
１：バルーンカテーテル
２：バルーンカテーテル用バルーン
５：ハブ
６：流体注入部
２０：バルーン本体部
２０Ａ：内層露出部
２０ａ：内層
２０ｂ：外層
２１：近位側スリーブ部
２２：近位側テーパー部
２３：直管部
２４：遠位側テーパー部
２５：遠位側スリーブ部
２８：突出部
２８Ｌ：低突出部領域
２８ｔ：頂部
３０：シャフト
３１：遠位側シャフト
３２：近位側シャフト
５０：ガイドワイヤポート
６０：インナーシャフト
７０：先端部材
８０：マーカー
２００：パリソン
２００ａ：パリソンの内層
２００ｂ：パリソンの外層
２０１：パリソンの第１端
２０２：パリソンの第２端
２０５：パリソンの内腔
２０８：パリソンの突出部
２１０：大厚部
２２０：小厚部
２３０：中厚部
２５０：パリソン用金型
２５１：第１筒状部材
２５２：第２筒状部材
２５３：第３筒状部材
３００：金型
３００Ｃ：金型直管部
３００Ｓ：金型スリーブ部
３００Ｔ：金型テーパー部
３０５：金型の内腔
３１０：溝部
３２０：円筒壁部
Ｌａ：内層露出部の周方向の長さ
Ｌｂ：内層露出部の両側のそれぞれの外層の周方向の長さ  1: Balloon catheter 2: Balloon for balloon catheter 5: Hub 6: Fluid injection section 20: Balloon body section 20A: Inner layer exposed section 20a: Inner layer 20b: Outer layer 21: Proximal sleeve section 22: Proximal taper section 23: Straight tube section 24: Distal taper section 25: Distal sleeve section 28: Protruding section 28L: Low protruding section region 28t: Apex section 30: Shaft 31: Distal shaft 32: Proximal shaft 50: Guidewire port 60: Inner shaft 70: Tip member 80: Marker 200: Parison 200a: Inner layer of parison 200b: outer layer of parison 201: first end of parison 202: second end of parison 205: inner cavity of parison 208: protruding portion of parison 210: large thickness portion 220: small thickness portion 230: medium thickness portion 250: mold for parison 251: first cylindrical member 252: second cylindrical member 253: third cylindrical member 300: mold 300C: mold straight tube portion 300S: mold sleeve portion 300T: mold tapered portion 305: inner cavity of mold 310: groove portion 320: cylindrical wall portion La: circumferential length of exposed portion of inner layer Lb: circumferential length of each outer layer on both sides of exposed portion of inner layer

Claims (17)

  1. 　長手軸方向、径方向、及び周方向を有し、外層と、前記外層よりもショアＤ硬度が低い材料から構成されている内層とを有しているバルーンカテーテル用バルーンであって、
    　直管部と、前記直管部よりも近位側に位置している近位側テーパー部と、前記近位側テーパー部よりも近位側に位置している近位側スリーブ部と、前記直管部よりも遠位側に位置している遠位側テーパー部と、前記遠位側テーパー部よりも遠位側に位置している遠位側スリーブ部と、を有しており、
    　前記径方向の外方に突出し前記長手軸方向に延在している突出部を有しており、
    　下記（１）及び（２）の少なくとも一方を満たしているバルーンカテーテル用バルーン。
    　（１）前記近位側スリーブ部の前記突出部は、前記外層が存在していない内層露出部を有しており、前記径方向の外方から見たとき前記周方向において前記内層露出部は前記外層に挟まれている。
    　（２）前記遠位側スリーブ部の前記突出部は、前記外層が存在していない内層露出部を有しており、前記径方向の外方から見たとき前記周方向において前記内層露出部は前記外層に挟まれている。     A balloon for a balloon catheter having a longitudinal axis direction, a radial direction, and a circumferential direction, the balloon having an outer layer and an inner layer made of a material having a Shore D hardness lower than that of the outer layer,
    The endoscopic catheter has a straight pipe section, a proximal tapered section located proximally of the straight pipe section, a proximal sleeve section located proximally of the proximal tapered section, a distal tapered section located distally of the straight pipe section, and a distal sleeve section located distally of the distal tapered section,
    A protrusion protruding outward in the radial direction and extending in the longitudinal axis direction,
    A balloon for a balloon catheter, which satisfies at least one of the following (1) and (2):
    (1) The protruding portion of the proximal sleeve portion has an exposed inner layer portion where the outer layer is not present, and when viewed from the radial outside, the exposed inner layer portion is sandwiched between the outer layer in the circumferential direction.
    (2) The protrusion portion of the distal sleeve portion has an exposed inner layer portion where the outer layer is not present, and when viewed from the radially outward side, the exposed inner layer portion is sandwiched between the outer layer in the circumferential direction.
  2. 　前記直管部の前記突出部は、前記外層が存在していない内層露出部を有していない請求項１に記載のバルーンカテーテル用バルーン。 The balloon for a balloon catheter according to claim 1, wherein the protruding portion of the straight tube portion does not have an exposed portion of the inner layer where the outer layer is not present.
  3. 　下記（３）及び（４）の少なくとも一方を満たしている請求項１又は２に記載のバルーンカテーテル用バルーン。
    　（３）前記（１）を満たしており、前記長手軸方向において、前記近位側スリーブ部の近位端を０％の位置ＳＰ０、前記近位側スリーブ部の前記近位側テーパー部側の端を１００％の位置ＳＰ１００としたとき、前記近位側スリーブ部の前記内層露出部は位置ＳＰ０から７５％の位置ＳＰ７５までの区間の少なくとも一部に配されている。
    　（４）前記（２）を満たしており、前記長手軸方向において、前記遠位側スリーブ部の遠位端を０％の位置ＳＤ０、前記遠位側スリーブ部の前記遠位側テーパー部側の端を１００％の位置ＳＤ１００としたとき、前記遠位側スリーブ部の前記内層露出部は位置ＳＤ０から７５％の位置ＳＤ７５までの区間の少なくとも一部に配されている。     3. The balloon for a balloon catheter according to claim 1 or 2, which satisfies at least one of the following (3) and (4):
    (3) The condition (1) is satisfied, and when, in the longitudinal axis direction, the proximal end of the proximal sleeve portion is the 0% position S P0 and the end of the proximal sleeve portion on the proximal taper portion side is the 100% position S P100 , the exposed inner layer portion of the proximal sleeve portion is arranged in at least a part of the section from position S P0 to 75% position S P75 .
    (4) The condition (2) is satisfied, and when, in the longitudinal axis direction, the distal end of the distal sleeve portion is defined as the 0% position S D0 and the end of the distal sleeve portion on the distal taper portion side is defined as the 100% position S D100 , the exposed inner layer portion of the distal sleeve portion is arranged in at least a part of the section from position S D0 to 75% position S D75 .
  4. 　下記（５）及び（６）の少なくとも一方を満たしている請求項３に記載のバルーンカテーテル用バルーン。
    　（５）前記（３）を満たしており、前記近位側スリーブ部の前記内層露出部は前記位置ＳＰ０を含む区間に配されている。
    　（６）前記（４）を満たしており、前記遠位側スリーブ部の前記内層露出部は前記位置ＳＤ０を含む区間に配されている。     The balloon for a balloon catheter according to claim 3, which satisfies at least one of the following (5) and (6):
    (5) The above (3) is satisfied, and the exposed portion of the inner layer of the proximal sleeve portion is disposed in a section including the position S P0 .
    (6) The above (4) is satisfied, and the exposed portion of the inner layer of the distal sleeve portion is disposed in a section including the position S- D0 .
  5. 　前記長手軸方向に垂直な断面において、前記内層露出部の前記周方向の長さは、前記内層露出部の両側のそれぞれの前記外層の前記周方向の長さよりも長い請求項１又は２に記載のバルーンカテーテル用バルーン。 The balloon for a balloon catheter according to claim 1 or 2, wherein in a cross section perpendicular to the longitudinal axis, the circumferential length of the exposed inner layer portion is longer than the circumferential length of each of the outer layers on both sides of the exposed inner layer portion.
  6. 　前記長手軸方向に垂直な断面において、前記内層露出部の前記周方向の長さは、前記内層露出部の両側のそれぞれの前記外層の前記周方向の長さよりも短い請求項１又は２に記載のバルーンカテーテル用バルーン。 The balloon for a balloon catheter according to claim 1 or 2, wherein in a cross section perpendicular to the longitudinal axis, the circumferential length of the exposed inner layer portion is shorter than the circumferential length of each of the outer layers on both sides of the exposed inner layer portion.
  7. 　下記（７）及び（８）の少なくとも一方を満たしている請求項１又は２に記載のバルーンカテーテル用バルーン。
    　（７）前記（１）を満たしており、前記近位側スリーブ部は、前記突出部が前記直管部の前記突出部の高さ以下の高さを有する低突出部領域を有している。
    　（８）前記（２）を満たしており、前記遠位側スリーブ部は、前記突出部が前記直管部の前記突出部の高さ以下の高さを有する低突出部領域を有している。     3. The balloon for a balloon catheter according to claim 1 or 2, which satisfies at least one of the following (7) and (8):
    (7) The above (1) is satisfied, and the proximal sleeve portion has a low protrusion region in which the protrusion has a height equal to or less than the height of the protrusion of the straight pipe portion.
    (8) The above (2) is satisfied, and the distal sleeve portion has a low protrusion region in which the protrusion has a height equal to or less than the height of the protrusion of the straight tube portion.
  8. 　下記（９）及び（１０）の少なくとも一方を満たしている請求項７に記載のバルーンカテーテル用バルーン。
    　（９）前記（７）を満たしており、前記内層露出部は前記近位側スリーブ部の前記低突出部領域に配されている。
    　（１０）前記（８）を満たしており、前記内層露出部は前記遠位側スリーブ部の前記低突出部領域に配されている。     The balloon for a balloon catheter according to claim 7, which satisfies at least one of the following (9) and (10):
    (9) The above (7) is satisfied, and the exposed inner layer portion is disposed in the low protrusion region of the proximal sleeve portion.
    (10) The above (8) is satisfied, and the exposed inner layer portion is disposed in the low protrusion region of the distal sleeve portion.
  9. 　下記（１１）及び（１２）の少なくとも一方を満たしている請求項１又は２に記載のバルーンカテーテル用バルーン。
    　（１１）前記近位側テーパー部の前記突出部は、前記外層が存在していない内層露出部を有しており、前記径方向の外方から見たとき前記周方向において前記内層露出部は前記外層に挾まれている。
    　（１２）前記遠位側テーパー部の前記突出部は、前記外層が存在していない内層露出部を有しており、前記径方向の外方から見たとき前記周方向において前記内層露出部は前記外層に挟まれている。     3. The balloon for a balloon catheter according to claim 1 or 2, which satisfies at least one of the following (11) and (12):
    (11) The protruding portion of the proximal taper section has an inner layer exposed portion where the outer layer is not present, and when viewed from the radial outside, the inner layer exposed portion is sandwiched between the outer layer in the circumferential direction.
    (12) The protruding portion of the distal taper section has an inner layer exposed portion where the outer layer is not present, and when viewed from the radial outside, the inner layer exposed portion is sandwiched between the outer layer in the circumferential direction.
  10. 　下記（１３）及び（１４）の少なくとも一方を満たしている請求項９に記載のバルーンカテーテル用バルーン。
    　（１３）前記（１１）を満たしており、前記長手軸方向において、前記近位側テーパー部の近位側スリーブ部側の端を０％の位置ＴＰ０、前記近位側テーパー部の前記直管部側の端を１００％の位置ＴＰ１００としたとき、前記近位側テーパー部の前記内層露出部は位置ＴＰ０から７５％の位置ＴＰ７５までの区間の少なくとも一部に配されている。
    　（１４）前記（１２）を満たしており、前記長手軸方向において、前記遠位側テーパー部の遠位側スリーブ部側の端を０％の位置ＴＤ０、前記遠位側テーパー部の前記直管部側の端を１００％の位置ＴＤ１００としたとき、前記遠位側テーパー部の前記内層露出部は位置ＴＤ０から７５％の位置ＴＤ７５までの区間の少なくとも一部に配されている。     The balloon for a balloon catheter according to claim 9, which satisfies at least one of the following (13) and (14):
    (13) The condition (11) is satisfied, and when, in the longitudinal axis direction, the end of the proximal taper portion on the proximal sleeve portion side is defined as the 0% position T P0 and the end of the proximal taper portion on the straight tube portion side is defined as the 100% position T P100 , the exposed inner layer portion of the proximal taper portion is located in at least a part of the section from position T P0 to 75% position T P75 .
    (14) The condition (12) is satisfied, and when, in the longitudinal axis direction, the end of the distal taper portion on the distal sleeve portion side is defined as a 0% position T D0 and the end of the distal taper portion on the straight tube portion side is defined as a 100% position T D100 , the exposed inner layer portion of the distal taper portion is located in at least a part of the section from position T D0 to 75% position T D75 .
  11. 　下記（１５）及び（１６）の少なくとも一方を満たしている請求項１０に記載のバルーンカテーテル用バルーン。
    　（１５）前記（１３）を満たしており、前記近位側テーパー部の前記内層露出部は前記位置ＴＰ０を含む区間に配されている。
    　（１６）前記（１４）を満たしており、前記遠位側テーパー部の前記内層露出部は前記位置ＴＤ０を含む区間に配されている。     The balloon for a balloon catheter according to claim 10, which satisfies at least one of the following (15) and (16):
    (15) The above (13) is satisfied, and the inner layer exposed portion of the proximal taper portion is disposed in a section including the position T P0 .
    (16) The above (14) is satisfied, and the exposed inner layer portion of the distal taper portion is disposed in a section including the position T- D0 .
  12. 　下記（１７）及び（１８）の少なくとも一方を満たしている請求項９に記載のバルーンカテーテル用バルーン。
    　（１７）前記（１１）を満たしており、前記近位側テーパー部は、前記突出部が前記直管部の前記突出部の高さ以下の高さを有する低突出部領域を有している。
    　（１８）前記（１２）を満たしており、前記遠位側テーパー部は、前記突出部が前記直管部の前記突出部の高さ以下の高さを有する低突出部領域を有している。     The balloon for a balloon catheter according to claim 9, which satisfies at least one of the following (17) and (18).
    (17) The above (11) is satisfied, and the proximal taper portion has a low protrusion region in which the protrusion has a height equal to or less than the height of the protrusion of the straight pipe portion.
    (18) The condition (12) is satisfied, and the distal tapered portion has a low protrusion region in which the protrusion has a height equal to or less than the height of the protrusion of the straight tube portion.
  13. 　下記（１９）及び（２０）の少なくとも一方を満たしている請求項１２に記載のバルーンカテーテル用バルーン。
    　（１９）前記（１７）を満たしており、前記内層露出部は前記近位側テーパー部の前記低突出部領域に配されている。
    　（２０）前記（１８）を満たしており、前記内層露出部は前記遠位側テーパー部の前記低突出部領域に配されている。     The balloon for a balloon catheter according to claim 12, which satisfies at least one of the following (19) and (20):
    (19) The above (17) is satisfied, and the exposed inner layer portion is disposed in the low protrusion region of the proximal taper portion.
    (20) The above (18) is satisfied, and the exposed inner layer portion is disposed in the low protrusion region of the distal taper portion.
  14. 　請求項１又は２に記載のバルーンカテーテル用バルーンを備えるバルーンカテーテル。 A balloon catheter comprising the balloon for a balloon catheter according to claim 1 or 2.
  15. 　請求項１４に記載のバルーンカテーテルの製造方法であって、
    　長手軸方向、径方向、及び周方向を有し、前記長手軸方向に延在する内腔を有しているパリソンを準備するステップと、
    　前記パリソンを延伸して、前記近位側スリーブ部、前記近位側テーパー部、前記直管部、前記遠位側テーパー部、前記遠位側スリーブ部を有し、前記突出部を有するバルーンを製造するステップと、
    　前記近位側スリーブ部及び／又は前記遠位側スリーブ部の前記突出部の頂部側を前記長手軸方向に沿って切除して前記内腔露出部を形成するステップと、を有しており、
    　前記パリソンは、
    　外層と、前記外層よりもショアＤ硬度が低い材料から構成されている内層と、を有しており、
    　前記径方向の外方に突出し前記長手軸方向に延在している突出部を含む突出領域と、前記突出領域以外の非突出領域と、を有しており、
    　前記長手軸方向に垂直な断面において、前記内層は、前記非突出領域において小厚部を有しており前記突出領域において前記小厚部よりも厚い厚みを有している大厚部を有しているバルーンカテーテルの製造方法。     A method for manufacturing a balloon catheter according to claim 14, comprising the steps of:
    providing a parison having a longitudinal axis, a radial direction, and a circumferential direction, the parison having an internal lumen extending in the longitudinal direction;
    stretching the parison to produce a balloon having the proximal sleeve portion, the proximal tapered portion, the straight portion, the distal tapered portion, the distal sleeve portion, and having the protruding portion;
    and cutting off a top side of the proximal sleeve portion and/or the distal sleeve portion along the longitudinal axis direction to form the lumen exposed portion,
    The parison is
    The golf club has an outer layer and an inner layer made of a material having a Shore D hardness lower than that of the outer layer,
    A protruding region including a protruding portion protruding outward in the radial direction and extending in the longitudinal axis direction, and a non-protruding region other than the protruding region,
    A method for manufacturing a balloon catheter, wherein, in a cross section perpendicular to the longitudinal axis direction, the inner layer has a thin portion in the non-protruding region and a thick portion in the protruding region that is thicker than the thin portion.
  16. 　前記近位側テーパー部及び／又は前記遠位側テーパー部の前記突出部の頂部側を前記長手軸方向に沿って切除して前記内層露出部を形成するステップをさらに有する請求項１５に記載のバルーンカテーテルの製造方法。 The method for manufacturing a balloon catheter according to claim 15, further comprising the step of cutting the apex side of the protruding portion of the proximal taper portion and/or the distal taper portion along the longitudinal axis direction to form the exposed inner layer portion.
  17. 　前記長手軸方向に垂直な断面において、前記内層は、前記小厚部よりも厚い厚みを有し前記大厚部よりも薄い厚みを有する中厚部を前記非突出領域において有しており、前記周方向において前記小厚部は前記大厚部と前記中厚部の間に位置している請求項１５に記載のバルーンカテーテルの製造方法。
          16. The method for manufacturing a balloon catheter according to claim 15, wherein in a cross section perpendicular to the longitudinal axis direction, the inner layer has a medium thickness portion in the non-protruding region that is thicker than the small thickness portion and thinner than the large thickness portion, and the small thickness portion is located between the large thickness portion and the medium thickness portion in the circumferential direction.
PCT/JP2023/038878 2022-11-16 2023-10-27 Balloon for balloon-catheter, balloon catheter equipped with same, and method for manufacturing balloon catheter WO2024106176A1 (en)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005517474A (en) * 2002-02-14 2005-06-16 アヴェンテック ヴァスキュラー コーポレイション Balloon catheter and method for providing a longitudinal axial channel in a lesion
US20080300610A1 (en) * 2007-05-31 2008-12-04 Cook Incorporated Device for treating hardened lesions and method of use thereof
WO2017204042A1 (en) * 2016-05-26 2017-11-30 株式会社グッドマン Balloon catheter and method for manufacturing balloon body
JP2021053005A (en) * 2019-09-30 2021-04-08 テルモ株式会社 Balloon catheter, and manufacturing method of balloon
WO2021125103A1 (en) * 2019-12-20 2021-06-24 株式会社カネカ Balloon catheter
WO2022102766A1 (en) * 2020-11-16 2022-05-19 株式会社カネカ Balloon for balloon catheter

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005517474A (en) * 2002-02-14 2005-06-16 アヴェンテック ヴァスキュラー コーポレイション Balloon catheter and method for providing a longitudinal axial channel in a lesion
US20080300610A1 (en) * 2007-05-31 2008-12-04 Cook Incorporated Device for treating hardened lesions and method of use thereof
WO2017204042A1 (en) * 2016-05-26 2017-11-30 株式会社グッドマン Balloon catheter and method for manufacturing balloon body
JP2021053005A (en) * 2019-09-30 2021-04-08 テルモ株式会社 Balloon catheter, and manufacturing method of balloon
WO2021125103A1 (en) * 2019-12-20 2021-06-24 株式会社カネカ Balloon catheter
WO2022102766A1 (en) * 2020-11-16 2022-05-19 株式会社カネカ Balloon for balloon catheter

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