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US20210077790A1 - Balloon Catheter - Google Patents

  • ️Thu Mar 18 2021

US20210077790A1 - Balloon Catheter - Google Patents

Balloon Catheter Download PDF

Info

Publication number
US20210077790A1
US20210077790A1 US17/102,512 US202017102512A US2021077790A1 US 20210077790 A1 US20210077790 A1 US 20210077790A1 US 202017102512 A US202017102512 A US 202017102512A US 2021077790 A1 US2021077790 A1 US 2021077790A1 Authority
US
United States
Prior art keywords
balloon
end side
linear member
proximal end
distal end
Prior art date
2015-04-10
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US17/102,512
Inventor
Kenshi Iwano
Takamasa Miyake
Takafumi Mizuno
Tomokazu OGAWA
Keisuke Ogawa
Soichiro Fujisawa
Mitsuhiro Ota
Yuki Nakagawa
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Goodman Co Ltd
Original Assignee
Goodman Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
2015-04-10
Filing date
2020-11-24
Publication date
2021-03-18
2020-11-24 Application filed by Goodman Co Ltd filed Critical Goodman Co Ltd
2020-11-24 Priority to US17/102,512 priority Critical patent/US20210077790A1/en
2020-11-24 Assigned to GOODMAN CO., LTD. reassignment GOODMAN CO., LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: FUJISAWA, SOICHIRO, IWANO, KENSHI, MIYAKE, TAKAMASA, MIZUNO, TAKAFUMI, NAKAGAWA, YUKI, OGAWA, KEISUKE, OGAWA, TOMOKAZU, OTA, MITSUHIRO
2021-03-18 Publication of US20210077790A1 publication Critical patent/US20210077790A1/en
Status Abandoned legal-status Critical Current

Links

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Images

Classifications

    • 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
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • 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
    • A61M25/1006—Balloons formed between concentric tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22061—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation for spreading elements apart
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/107—Balloon catheters with special features or adapted for special applications having a longitudinal slit in the balloon
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
    • 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
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • 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
    • A61M25/1027—Making of balloon catheters
    • A61M25/1038—Wrapping or folding devices for use with balloon catheters

Definitions

  • the present disclosure relates to a balloon catheter.
  • a balloon catheter is known that is used in treatments that dilate a constricted location of a blood vessel.
  • the known balloon catheter is provided with a catheter tube, a balloon, three linear members, and a fixed cone-shaped portion.
  • the catheter tube (sometimes also referred to as a “catheter shaft”) has an inner tube and an outer tube.
  • the balloon is joined to the outer tube and the inner tube.
  • the balloon inflates when a compressed fluid is supplied.
  • the three linear members are disposed on the outer peripheral side of the balloon.
  • a distal end side of the fixed cone-shaped portion is joined to a distal end of the inner tube.
  • a proximal end side of the fixed cone-shaped portion is joined to the three linear members.
  • the fixed cone-shaped portion is elastically deformable.
  • the three linear members move in a direction away from the inner tube in accordance with the inflation of the balloon.
  • the fixed cone-shaped portion extends in response to the movement of the three linear members in the direction away from the inner tube.
  • the fixed cone-shaped portion contracts in accordance with the deflation of the balloon, and the three linear members move in a direction approaching the inner tube.
  • the fixed cone-shaped portion joined to the distal end of the inner tube has an outer diameter that is sufficiently larger than the inner tube even in a deflated state.
  • Embodiments provide a balloon catheter that includes a balloon/shaft assembly and a linear member.
  • the balloon/shaft assembly includes a catheter shaft extending from a proximal end to a distal end and a balloon connected to the catheter shaft.
  • the balloon has an inflatable region configured to inflate outward in a radial direction around the catheter shaft.
  • the linear member straddles the inflatable region of the balloon and is mounted on the balloon/shaft assembly at a distal end position located further toward the distal end side than the inflatable region and at a proximal end position located further toward the proximal end side than the inflatable region.
  • the linear member includes a hard portion and a flexible portion.
  • the hard portion includes at least an outer portion disposed on an opposite side to an inner portion facing the inflatable region, of a portion disposed along an outer peripheral surface of the inflatable region in an inflated state.
  • the flexible portion is a portion other than the hard portion.
  • the flexible portion is extendable and has a lower hardness than the hard portion.
  • FIG. 1 is a side view of a balloon catheter according to a first embodiment
  • FIG. 2 is a side view of a balloon and a linear member in a deflated state
  • FIG. 3 is a cross-sectional view in the direction of arrows along a line I-I shown in FIG. 2 ;
  • FIG. 4 is a cross-sectional view of the balloon and the linear member in the deflated state
  • FIG. 5 is a side view of the balloon and the linear member in an inflated state
  • FIG. 6 is a cross-sectional view in the direction of arrows along a line II-II shown in FIG. 5 ;
  • FIG. 7 is a cross-sectional view of the balloon and the linear member in the inflated state
  • FIG. 8 shows a side view and cross-sectional views of the linear member 4 ;
  • FIG. 9 is a cross-sectional view of the balloon and the linear member according to a second embodiment.
  • FIG. 10 is a cross-sectional view of the balloon and a linear member according to a third embodiment
  • FIG. 11 shows a side view and cross-sectional views of the linear member
  • FIG. 12 is a cross-sectional view of the balloon and a linear member according to a fourth embodiment
  • FIG. 13 shows a side view and cross-sectional views of the linear member
  • FIG. 14 is a cross-sectional view of the balloon and a linear member according to a fifth embodiment
  • FIG. 15 shows a side view and cross-sectional views of the linear member
  • FIG. 16 is a side view of the balloon and a linear member according to a sixth embodiment
  • FIG. 17 is a cross-sectional view in the direction of arrows along a line III-III shown in FIG. 16 ;
  • FIG. 18 is a cross-sectional view of the balloon and the linear member in the inflated state
  • FIG. 19 shows a side view and cross-sectional views of the linear member
  • FIG. 20 is a cross-sectional view of an expanded part of the linear member according to a seventh embodiment
  • FIG. 21 is a cross-sectional view of an expanded part of the linear member according to an eighth embodiment.
  • FIG. 22 is a cross-sectional view of an expanded part of the linear member according to a ninth embodiment.
  • the balloon catheter 10 has a catheter shaft 2 , a balloon 3 , and linear members 4 A, 4 B, and 4 C (refer to FIG. 3 , hereinafter collectively referred to as “linear members 4 ”).
  • the catheter shaft 2 and the balloon 3 are collectively referred to as a “balloon/shaft assembly 25 .”
  • the balloon 3 is connected to an end portion on one side of the catheter shaft 2 .
  • the linear members 4 are disposed on the outside of the balloon 3 in an inflated state.
  • the balloon catheter 10 is used in a state in which a hub 5 is connected to an end portion on the other side of the catheter shaft 2 .
  • the hub 5 can supply compressed fluid to the balloon 3 via the catheter shaft 2 .
  • the one end (of both ends) of the catheter shaft 2 on the one side is referred to as a “distal end.”
  • the other end (of both ends) of the catheter shaft 2 is referred to as a “proximal end.”
  • a direction extending along the catheter shaft 2 is referred to as an “extending direction.”
  • a side closer to the center of the cross section of the catheter shaft 2 is referred to as an “inner side” and a side further away from the center of the cross section of the catheter shaft 2 is referred to as an “outer side.”
  • the catheter shaft 2 has an outer tube 21 and an inner tube 22 .
  • the outer tube 21 and the inner tube 22 are both flexible tubular members.
  • the outer tube 21 has a lumen 213 , which is a space surrounded by an inner surface 212 , which is a surface on the inner side of the outer tube 21 .
  • the inner tube 22 has a lumen 223 , which is a space surrounded by an inner surface 222 , which is a surface on the inner side of the inner tube 22 .
  • the outer tube 21 and the inner tube 22 are formed of a polyamide resin.
  • the inner diameter of the outer tube 21 is larger than the outer diameter of the inner tube 22 .
  • the inner tube 22 is disposed inside the lumen 213 of the outer tube 21 .
  • the predetermined portion on the distal end side of the inner tube 22 protrudes toward the distal end side from an end (hereinafter referred to as a “distal end 211 ”) on the distal end side of the outer tube 21 .
  • the end (hereinafter referred to as a “distal end 221 ”) on the distal end side of the inner tube 22 is disposed further toward the distal end side than the distal end 211 of the outer tube 21 .
  • Radiopaque markers 22 A and 22 B are fitted to the protruding portion 225 of the inner tube 22 . Resin into which a radiopaque material is mixed is used as the material of the markers 22 A and 22 B.
  • the markers 22 A and 22 B are fixed to an outer surface 224 , which is an outer peripheral surface of the inner tube 22 , as a result of cylindrical members formed of the above-described material being crimped onto the protruding portion 225 of the inner tube 22 .
  • the markers 22 A and 22 B have a predetermined length in the extending direction. The markers 22 A and 22 B do not allow the passage of radiation.
  • the marker 22 A is disposed further toward the distal end side than the marker 22 B.
  • the markers 22 A and 22 B are separated from each other in the extending direction.
  • a mounting member 21 A is mounted on a portion further toward the proximal end side than the distal end 211 .
  • the mounting member 21 A is a cylindrical member that can move along the extending direction.
  • the inner diameter of the mounting member 21 A is larger than the outer diameter of the outer tube 21 .
  • a thermoplastic resin such as a polyamide resin or the like, is used as the material of the mounting member 21 A.
  • the compressed fluid supplied from the hub 5 flows through a space of the lumen 213 of the outer tube 21 other than the lumen 223 of the inner tube 22 .
  • the balloon 3 inflates (refer to FIG. 5 to FIG. 7 ) in accordance with the supply of the compressed fluid.
  • a guide wire that is not shown in the drawings is inserted through the lumen 223 of the inner tube 22
  • the material of the outer tube 21 and the inner tube 22 is not limited to the polyamide resin, and can be changed to another flexible material.
  • a synthetic resin material such as a polyethylene resin, a polypropylene resin, a polyurethane resin, a polyimide resin and the like, may be used as the material of the outer tube 21 and the inner tube 22 .
  • Additives may be mixed with the synthetic resin material. Different synthetic resin materials may be used as the materials of the outer tube 21 and the inner tube 22 , respectively.
  • the material of the markers 22 A and 22 B is not limited to the resin into which the radiopaque material is mixed, and can be changed to another material that does not allow the passage of radiation.
  • a resin on which a radiopaque material is deposited, or a material such as metal or the like that does not allow the passage of radiation may be used as the material of the markers 22 A and 22 B.
  • the balloon 3 deflates to the inner side when the compressed fluid is not supplied. As shown in FIG. 5 to FIG. 7 , the balloon 3 inflates to the outer side when the compressed fluid is supplied.
  • the balloon 3 is formed of a polyamide resin. As shown in FIG. 2 , FIG. 4 , FIG. 5 , and FIG. 7 , the balloon 3 includes a proximal end side leg portion 31 , a proximal end side cone region 32 , an inflatable region 33 , a distal end side cone region 34 , and a distal end side leg portion 35 .
  • the proximal end side leg portion 31 , the proximal end side cone region 32 , the inflatable region 33 , the distal end side cone region 34 , and the distal end side leg portion 35 respectively correspond to portions of the balloon 3 divided into five in the extending direction.
  • the length of the inflatable region 33 in the extending direction is longer than the respective lengths in the extending direction of the proximal end side leg portion 31 , the proximal end side cone region 32 , the distal end side cone region 34 , and the distal end side leg portion 35 .
  • the proximal end side leg portion 31 is connected, by thermal welding, to the outer surface 214 that is the outer peripheral surface of the outer tube 21 , at a portion located further toward the proximal end side than the distal end 211 and further toward the distal end side than the portion on which the mounting member 21 A is mounted.
  • the proximal end side cone region 32 is adjacent to the distal end side of the proximal end side leg portion 31 .
  • the inflatable region 33 is adjacent to the distal end side of the proximal end side cone region 32 .
  • the distal end side cone region 34 is adjacent to the distal end side of the inflatable region 33 .
  • the distal end side leg portion 35 is adjacent to the distal end side of the distal end side cone region 34 .
  • the distal end side leg portion 35 is connected, by thermal welding, to the outer surface 224 of the protruding portion 225 of the inner tube 22 , at a portion located further toward the proximal end side than the distal end 221 .
  • the proximal end side leg portion 31 , the proximal end side cone region 32 , the inflatable region 33 , the distal end side cone region 34 , and the distal end side leg portion 35 are disposed side by side in that order from the proximal end side toward the distal end side.
  • the proximal end side cone region 32 , the inflatable region 33 , the distal end side cone region 34 , and the distal end side leg portion 35 cover the protruding portion 225 of the inner tube 22 from outside.
  • the balloon 3 is a three pleat type balloon.
  • the balloon 3 in the deflated state, the balloon 3 is folded over so as to form three pleats 3 A, 3 B, and 3 C.
  • Each of the pleats 3 A, 3 B, and 3 C is wrapped around the protruding portion 225 of the inner tube 22 .
  • the pleat 3 A covers the linear member 4 A, which will be described later, from outside.
  • the pleat 3 B covers the linear member 4 B, which will be described later, from outside.
  • the pleat 3 C covers the linear member 4 C, which will be described later, from outside.
  • the pleats 3 A, 3 B, and 3 C are also called “flaps” and “wings.”
  • the cross-sectional shape of the balloon 3 is circular.
  • the proximal end side cone region 32 has a tapered shape.
  • the diameter of the proximal end side cone region 32 increases continuously and linearly from the proximal end side toward the distal end side.
  • the diameter of the inflatable region 33 is the same across the whole length in the extending direction.
  • the distal end side cone region 34 has a tapered shape. The diameter of the distal end side cone region 34 decreases continuously and linearly from the proximal end side toward the distal end side.
  • the diameter of the cross section of the balloon 3 changes in a stepped manner between the proximal end side cone region 32 , the inflatable region 33 , and the distal end side cone region 34 .
  • the inflatable region 33 is a portion of the balloon 3 having the maximum diameter.
  • a boundary of the inflatable region 33 on the distal end side is aligned, in the extending direction, with a position P 11 of an end portion on the distal end side of the marker 22 A.
  • the boundary of the inflatable region 33 on the distal end side is a position of a boundary between the inflatable region 33 and the distal end side cone region 34 .
  • a boundary of the inflatable region 33 on the proximal end side is aligned, in the extending direction, with a position P 21 of an end portion on the proximal end side of the marker 22 B.
  • the boundary of the inflatable region 33 on the proximal end side is a position of a boundary between the inflatable region 33 and the proximal end side cone region 32 .
  • the material of the balloon 3 is not limited to the polyamide resin, and can be changed to another flexible material.
  • a polyethylene resin, a polypropylene resin, a polyurethane resin, a polyimide resin, silicone rubber, natural rubber, and the like may be used as the material of the balloon 3 .
  • the method of connecting the outer tube 21 and the inner tube 22 to the balloon 3 is not limited to the thermal welding.
  • each of the outer tube 21 and the inner tube 22 may be connected using an adhesive.
  • the linear member 4 will be explained with reference to FIG. 4 to FIG. 8 .
  • the linear member 4 has a restoring force with respect to bending deformation.
  • the linear member 4 is a monofilament-shaped elastic body.
  • the linear members 4 A, 4 B, and 4 C have the same shape.
  • the linear member 4 extends along the extending direction.
  • an end portion on the distal end side of the linear member 4 is connected, by thermal welding, to a portion of the outer peripheral surface of the distal end side leg portion 35 of the balloon 3 that is further to the distal end side than the center in the extending direction.
  • a position at which the end portion on the distal end side of the linear member 4 is connected, in the extending direction of the balloon catheter 10 is referred to as a “distal end position M 1 .”
  • the distal end position M 1 is disposed further toward the distal end side than the inflatable region 33 of the balloon 3 in the inflated state.
  • the distal end position M 1 corresponds to a position further toward the distal end side than the center, in the extending direction, of the distal end side leg portion 35 of the balloon 3 .
  • the end portions on the distal end side of each of the linear members 4 A, 4 B, and 4 C are connected, respectively, to positions that divide the outer peripheral surface of the distal end side leg portion 35 of the balloon 3 into three equal parts in the circumferential direction.
  • proximal end position M 2 a position at which the end portion on the proximal end side of the linear member 4 is connected, in the extending direction of the balloon catheter 10 , is referred to as a “proximal end position M 2 .”
  • the proximal end position M 2 is disposed further toward the proximal end side than the inflatable region 33 of the balloon 3 in the inflated state.
  • each of the linear members 4 A, 4 B, and 4 C are connected, respectively, to positions that divide the outer peripheral surface of the mounting member 21 A into three equal parts in the circumferential direction.
  • the linear member 4 is connected at the distal end position M 1 and the proximal end position M 2 , and is not connected to the balloon 3 at other portions thereof.
  • the linear member 4 is disposed between the distal end position M 1 and the proximal end position M 2 so as to straddle the inflatable region 33 of the balloon 3 .
  • the linear members 4 A, 4 B, and 4 C extend in straight lines in the extending direction, respectively, at positions that divide the outer peripheral surface of the inflatable region 33 of the balloon 3 into three approximately equal parts in the circumferential direction.
  • the linear member 4 has a flexible portion 41 , and a hard portion 42 .
  • the flexible portion 41 extends between the proximal end position M 2 and the distal end position M 1 .
  • the flexible portion 41 includes a first portion 411 , a second portion 412 , and a third portion 413 .
  • the first portion 411 , the second portion 412 , and the third portion 413 respectively correspond to portions of the flexible portion 41 that is divided into three in the extending direction.
  • An end portion on the proximal end side of the first portion 411 is connected to the outer peripheral surface of the mounting member 21 A, at the proximal end position M 2 .
  • the second portion 412 is adjacent to the distal end side of the first portion 411 .
  • the third portion 413 is adjacent to the distal end side of the second portion 412 .
  • An end portion on the distal end side of the third portion 413 is connected to the outer peripheral surface of the distal end side leg portion 35 of the balloon 3 , at the distal end position M 1 .
  • the hard portion 42 is laminated on the second portion 412 of the flexible portion 41 , at a portion on the opposite side to a portion facing the balloon 3 .
  • FIG. 8 shows cross sections of the linear member 4 at each of a line A 1 -A 1 , a line B 1 -B 1 , and a line C 1 -C 1 .
  • the cross-sectional shape of the linear member 4 is a trapezoid shape or a triangular shape. This is explained more specifically below.
  • the cross-sectional shape of the flexible portion 41 (the first portion 411 to the third portion 413 ) is a trapezoid shape.
  • a portion facing the balloon 3 in the inflated state (refer to FIG.
  • the inner portions 411 A, 412 A, and 413 A and the outer portions 411 B, 412 B, and 413 B respectively correspond to a lower base and an upper base of the trapezoid that is the cross-sectional shape
  • a length between the inner portion 413 A and the outer portion 413 B of the third portion 413 namely, a thickness R 13 of a portion of the flexible portion 41 located further toward the distal end side than the hard portion 42 , is 0.15 mm.
  • a length between the inner portion 411 A and the outer portion 411 B of the first portion 411 namely, a thickness R 11 of a portion of the flexible portion 41 located further toward the proximal end side than the hard portion 42 , is 0.23 mm.
  • the thickness R 13 is narrower than the thickness R 11 .
  • the shape of the cross section of the hard portion 42 is an equilateral triangle shape having the outer portion 412 B of the second portion 412 as one side.
  • the hard portion 42 protrudes to the outside from the outer portion 412 B of the second portion 412 of the flexible portion 41 .
  • an end portion on the outside of the hard portion 42 is referred to as an “outer portion 42 B.”
  • the outer portion 42 B corresponds to an apex of the equilateral triangle shape.
  • the outer portion 42 B is peaked.
  • a length between the inner portion 412 A and the outer portion 42 B, namely a thickness R 12 of the portion at which the second portion 412 of the flexible portion 41 and the hard portion 42 are laminated, is 0.4 mm.
  • An end surface on the distal end side of the hard portion 42 is referred to as a “distal end surface 42 S.”
  • a virtual first direction D 11 is defined that extends toward the outside along the distal end surface 42 S of the hard portion 42 .
  • the first direction D 11 is inclined toward the proximal end side with respect to a direction orthogonal to the extending direction.
  • An end surface on the proximal end side of the hard portion 42 is referred to as a “proximal end surface 42 K.”
  • a virtual second direction D 12 is defined that extends toward the outside along the proximal end surface 42 K of the hard portion 42 .
  • the second direction D 12 is inclined toward the distal end side with respect to the direction orthogonal to the extending direction.
  • An acute angle, of angles formed between the first direction D 11 and the extending direction is defined as a first angle ⁇ 11 .
  • the first angle ⁇ 11 is an angle between 4 to 13 degrees, for example.
  • the first angle ⁇ 11 is preferably 5 degrees.
  • An acute angle, of angles formed between the second direction D 12 and the extending direction is defined as a second angle ⁇ 12 .
  • the second angle ⁇ 12 is an angle between 5 to 16 degrees, for example.
  • the second angle ⁇ 12 is preferably 16 degrees.
  • the preferable five degrees of the first angle ⁇ 11 is smaller than the preferable sixteen degrees of the second angle ⁇ 12 .
  • a position of a boundary on the distal end side of the second portion 412 of the flexible portion 41 namely, a position of a boundary between the second portion 412 and the third portion 413 , is aligned, in the extending direction, with the position P 11 of the end portion on the distal end side of the marker 22 A.
  • a position of a boundary on the proximal end side of the second portion 412 of the flexible portion 41 namely, a position of a boundary between the first portion 411 and the second portion 412 , is aligned, in the extending direction, with the position P 21 of the end portion on the proximal end side of the marker 22 B.
  • the boundary on the distal end side of the inflatable region 33 is aligned, in the extending direction, with the position P 11 of the end portion on the distal end side of the marker 22 A.
  • the boundary on the proximal end side of the inflatable region 33 is aligned, in the extending direction, with the position P 21 of the end portion on the proximal end side of the marker 22 B.
  • the inner portion 412 A of the second portion 412 of the flexible portion 41 faces the inflatable region 33 of the balloon 3 .
  • the hard portion 42 is disposed on the opposite side to the portion facing the inflatable region 33 of the balloon 3 , namely, on the opposite side to the inner portion 412 A of the second portion 412 of the flexible portion 41 .
  • the linear member 4 is formed of a polyamide resin. More specifically, the flexible portion 41 is formed of a polyamide elastomer. The hardness of the flexible portion 41 is a value within a range of D 25 to D 63 as prescribed in ISO 868.
  • the hard portion 42 is formed of a polyamide resin. The hardness of the hard portion 42 is a value within a range of D 70 to D 95 as prescribed in ISO 868.
  • the flexible portion 41 is softer than the hard portion 42 . In comparison to the hard portion 42 , the flexible portion 41 has excellent extendability.
  • the inner surface 412 A of the second portion 412 of the flexible portion 41 is disposed along the outer peripheral surface of the inflatable region 33 of the balloon 3 .
  • the outer portion 42 B (refer to FIG. 8 ) of the hard portion 42 protrudes to the outside from the outer portion 412 B of the second portion 412 of the flexible portion 41 (refer to FIG. 6 ).
  • the hard portion 42 does not easily extend.
  • the second portion 412 of the flexible portion 41 of the linear member 4 does not extend to the same extent as the first portion 411 and the third portion 413 of the flexible portion 41 .
  • a state of the linear member 4 when the balloon 3 deflates as a result of the compressed fluid being discharged from the balloon 3 in the inflated state will be explained.
  • the hard portion 42 of the linear member 4 approaches the protruding portion 225 of the inner tube 22 (refer to FIG. 4 ). Warping of the linear member 4 is suppressed by the contraction of the first portion 411 and the third portion 413 of the flexible portion 41 .
  • the linear member 4 A is covered from the outside by the pleat 3 A.
  • the linear member 4 B is covered from the outside by the pleat 3 B.
  • the linear member 4 C is covered from the outside by the pleat 3 C (refer to FIG. 3 ).
  • the material thereof is not limited to the polyamide resin, and another synthetic resin can be used.
  • the material is not limited to the synthetic resin, and stainless steel, a Ni—Ti alloy, or carbon fiber may be used.
  • the hard portion 42 of the linear member 4 that is disposed along the outer peripheral surface of the inflatable region 33 also tries to move to the outside.
  • the hard portion 42 can easily move to the outside.
  • the outer portion 42 B of the hard portion 42 of the linear member 4 protrudes to the outside from the outer portion 412 B on the opposite side to the inner portion 412 A that faces the outer peripheral surface of the balloon 3 .
  • the hard portion 42 has a higher hardness than the flexible portion 41 .
  • the hard portion 42 acts appropriately on the constricted portion of the blood vessel.
  • the hard portion 42 is peaked at the outer portion 42 B, and thus the hard portion 42 can easily bite into a lesioned part (not shown in the drawings) of the blood vessel.
  • the lesioned part can be expanded from the inside by the inflation of the balloon 3 .
  • the first portion 411 and the third portion 413 of the flexible portion 41 are caused to extend in accordance with the inflation of the balloon 3 , and the hard portion 42 is caused to move to the outside.
  • the balloon catheter 10 can cause the hard portion 42 to act on the constricted portion inside the blood vessel.
  • the balloon catheter 10 does not require a member that is necessary to be able to move the hard portion 42 to the outside.
  • the balloon catheter 10 can inhibit obstruction of the movement of the balloon 3 by the member other than the linear members 4 . In this way, the balloon catheter 10 can cause the balloon 3 to appropriately approach and be disposed at the constricted portion of the blood vessel.
  • the flexible portion 41 of the linear member 4 extends between the distal end position M 1 and the proximal end position M 2 .
  • the hard portion 42 is laminated on the second portion 412 that is disposed along the outer peripheral surface of the inflatable region 33 in the inflated state.
  • the balloon catheter 10 can inhibit the hard portion 42 from obstructing the extending of the first portion 411 and the third portion 413 of the flexible portion 41 , on which the hard portion 42 is not laminated.
  • the flexible portion 41 extends appropriately at the first portion 411 and the third portion 413 .
  • the balloon catheter 10 can easily move the hard portion 42 to the outside in accordance with the inflation of the balloon 3 .
  • the first direction D 11 which extends to the outside along the distal end surface 42 S that is the end portion of the hard portion 42 on the distal end side, is inclined toward the proximal end side.
  • the linear member 4 can be inhibited from catching on the inner wall of the blood vessel.
  • the user can smoothly move the balloon 3 as far as the constricted portion of the blood vessel.
  • the second direction D 12 which extends to the outside along the proximal end surface 42 K that is the end portion of the hard portion 42 on the proximal end side, is inclined toward the distal end side.
  • the linear member 4 can be inhibited from catching on the inner wall of the blood vessel.
  • the user can easily pull the balloon catheter 10 out from the blood vessel.
  • the thickness R 13 of the third portion 413 located further toward the distal end side than the hard portion 42 is narrower than the thickness R 11 of the first portion 411 located further toward the proximal end side than the hard portion 42 .
  • the balloon catheter 10 can make the diameter of the distal end portion smaller.
  • the user can cause the balloon 3 of the balloon catheter 10 to move as far as the constricted portion of the blood vessel using less force.
  • the first angle ⁇ 11 which is the acute angle of the angles formed between the extending direction and the first direction D 11
  • the second angle ⁇ 12 which is the acute angle of the angles formed between the extending direction and the second direction D 12 .
  • the balloon catheter 10 can use the portion of the distal end surface 42 S to reduce a rate of change of the hardness in the extending direction of the linear member 4 .
  • the balloon catheter 10 can inhibit the linear members 4 from catching on the inner wall of the blood vessel when the user moves the balloon catheter 10 as far as the constricted portion inside the blood vessel. In this way, the user can easily move the balloon 3 as far as the constricted portion of the blood vessel.
  • the protruding portion 225 of the inner tube 22 is provided with the markers 22 A and 22 B in the positions separated from each other in the extending direction.
  • the position P 11 of the distal end side of the distal end side marker 22 A is aligned with the position of the boundary of the distal end side of the inflatable region 33 .
  • the position P 21 of the proximal end side of the proximal end side marker 22 B is aligned with the position of the boundary of the proximal end side of the inflatable region 33 .
  • the user can correctly determine the inflatable region 33 when the balloon 3 is inflated, using the markers 22 A and 22 B.
  • the hard portion 42 is disposed so as to correspond to the inflatable region 33 identified by the markers 22 A and 22 B.
  • the user can easily ascertain that the hard portion 42 of the linear member 4 is acting appropriately on the blood vessel at the inflatable region 33 identified by the markers 22 A and 22 B.
  • the proximal end side leg portion 31 of the balloon 3 is connected to the outer tube 21 further toward the distal end side than the proximal end position M 2 .
  • the proximal end position M 2 corresponds to the position at which the end portion on the proximal end side of the linear member 4 is connected to the outer tube 21 via the mounting member 21 A.
  • the balloon catheter 10 can cause the linear member 4 to be separated from the end portion on the proximal end side of the balloon 3 .
  • the end portion on the proximal end side of the linear member 4 is strongly fixed to the outer tube 21 .
  • the balloon catheter 10 can suppress an impact on the proximal end side leg portion 31 of the balloon 3 caused by tension acting on the linear member 4 .
  • the linear member 4 is formed of the synthetic resin.
  • the linear member 4 that includes the flexible portion 41 and the hard portion 42 can easily be manufactured by injection molding, extrusion molding or the like.
  • a balloon catheter 20 according to a second embodiment of the present disclosure will be explained with reference to FIG. 9 .
  • Points in which the second embodiment differs from the first embodiment are as follows:
  • the end portion on the proximal end side of the linear member 4 is connected, by thermal welding, further toward the proximal end side than the center in the extending direction of the outer peripheral surface of the proximal end side leg portion 31 of the balloon 3 .
  • the proximal end position M 2 that shows the position at which the end portion on the proximal end side of the linear member 4 is connected corresponds to a position, of the proximal end side leg portion 31 of the balloon 3 , which is located further toward the proximal end side than the center in the extending direction.
  • the linear member 4 can be fixed to the outer tube 21 without needing the mounting member 21 A.
  • the costs of the balloon catheter 10 can be reduced.
  • the linear member 4 in comparison to a case in which the linear member 4 is connected directly to the outer tube 21 , the linear member 4 can be reliably connected to the outer tube 21 by connecting the linear member 4 to the outer tube 21 via the balloon 3 .
  • a balloon catheter 30 according to a third embodiment of the present disclosure will be explained with reference to FIG. 10 and FIG. 11 .
  • a point in which the third embodiment differs from the second embodiment is that a linear member 6 is provided in place of the linear member 4 .
  • the same reference numerals are assigned and an explanation thereof is omitted.
  • the linear member 6 includes a flexible portion 61 , and a hard portion 62 .
  • the end portion on the proximal end side of the flexible portion 61 is connected to the outer peripheral surface of the proximal end side leg portion 31 of the balloon 3 , at the proximal end position M 2 .
  • the hard portion 62 includes a first portion 621 and a second portion 622 .
  • the first portion 621 is adjacent to the distal end side of the flexible portion 61 .
  • the second portion 622 is adjacent to the distal end side of the first portion 621 .
  • the end portion on the distal end side of the second portion 622 is connected to the outer peripheral surface of the distal end side leg portion 35 of the balloon 3 , at the distal end position M 1 .
  • the flexible portion 61 , the first portion 621 of the hard portion 62 , and the second portion 622 of the hard portion 62 are disposed side by side in that order from the proximal end toward the distal end along the extending direction.
  • the flexible portion 61 corresponds to the first portion 411 (refer to FIG. 8 ) of the flexible portion 41 according to the first embodiment.
  • the first portion 621 of the hard portion 62 corresponds to the laminated portion (refer to FIG. 8 ) according to the first embodiment, in which the second portion 412 of the flexible portion 41 and the hard portion 42 are laminated.
  • the second portion 622 of the hard portion 62 corresponds to the third portion 413 (refer to FIG. 8 ) of the flexible portion 41 according to the first embodiment.
  • the shape of each of the portions is the same.
  • the material of the flexible portion 61 is the same as the material of the flexible portion 41 according to the first embodiment.
  • the material of the hard portion 62 is the same as the material of the hard portion 42 according to the first embodiment.
  • FIG. 11 shows cross sections of the linear member 6 at each of a line A 2 -A 2 , a line B 2 -B 2 , and a line C 2 -C 2 .
  • the shape of the cross section of the flexible portion 61 is a trapezoid shape.
  • An inner portion 61 A and an outer portion 61 B respectively correspond to the inner portion 411 A and the outer portion 411 B (refer to FIG. 8 ) of the flexible portion 41 .
  • a length between the inner portion 61 A and the outer portion 61 B of the flexible portion 61 namely, a thickness R 21 of the flexible portion 61 , is the same as the thickness R 11 in the linear member 4 .
  • the shape of the cross section of the first portion 621 of the hard portion 62 is an equilateral triangle shape.
  • An inner portion 621 A and an outer portion 621 B respectively correspond to the inner portion 412 A and the outer portion 42 B (refer to FIG. 8 ) of the flexible portion 41 .
  • a length between the inner portion 621 A and the outer portion 621 B, namely, a thickness R 22 of the first portion 621 of the hard portion 62 is the same as the thickness R 12 in the linear member 4 .
  • the shape of the cross section of the second portion 622 of the hard portion 62 is a trapezoid shape.
  • An inner portion 622 A and an outer portion 622 B respectively correspond to the inner portion 413 A and the outer portion 413 B (refer to FIG.
  • a distal end surface 62 S and a proximal end surface 62 K respectively correspond to the distal end surface 42 S and the proximal end surface 42 K (refer to FIG. 8 ) of the hard portion 42 .
  • a first direction D 21 and a second direction D 22 respectively correspond to the first direction D 11 and the second direction D 12 (refer to FIG. 8 ).
  • a first angle ⁇ 21 and a second angle ⁇ 22 respectively correspond to the first angle ⁇ 11 and the second angle ⁇ 12 (refer to FIG. 8 ).
  • the preferable five degrees of the first angle ⁇ 21 is smaller than the preferable sixteen degrees of the second angle ⁇ 22 .
  • the first portion 621 of the hard portion 62 of the linear member 6 tries to move away from the protruding portion 225 of the inner tube 22 .
  • the flexible portion 61 of the linear member 6 elastically deforms so as to extend along the extending direction.
  • the first portion 621 of the hard portion 62 easily separates from the protruding portion 225 of the inner tube 22 .
  • the outer portion 621 B of the first portion 621 of the hard portion 62 protrudes to the outside with respect to the balloon 3 .
  • the first portion 621 of the hard portion 62 is disposed in a portion, of the linear member 6 , that is aligned with the position, in the extending direction, of the inflatable region 33 of the balloon 3 in the inflated state.
  • the flexible portion 61 of the linear member 6 elastically deforms so as to extend along the extending direction.
  • the first portion 621 of the hard portion 62 moves away from the protruding portion 225 of the inner tube 22 .
  • the outer portion 621 B is disposed on the opposite side to the inner portion 621 A that faces the outer peripheral surface of the balloon 3 .
  • the first portion 621 of the hard portion 62 is provided from the inside, which faces the inflatable region 33 of the balloon 3 , to the outside.
  • the linear member 6 can orient the hard portion 62 toward the outside.
  • the hard portion 62 is disposed not only at the portion corresponding to the inflatable region 33 of the balloon 3 , but also at the portion corresponding further toward the distal end side than the inflatable region 33 .
  • the balloon catheter 30 can cause the second portion 622 of the hard portion 62 to act on the constricted portion of the blood vessel further toward the distal end side than the inflatable region 33 , when the balloon 3 is inflated in the state in which the balloon 3 is disposed at the constricted portion of the blood vessel.
  • the flexible portion 61 and the hard portion 62 are adjacent in the extending direction.
  • the linear member 6 can be easily manufactured by connecting the respective end portions of the flexible portion 61 and the hard portion 62 in the extending direction.
  • a balloon catheter 40 according to a fourth embodiment of the present disclosure will be explained with reference to FIG. 12 and FIG. 13 .
  • a point in which the fourth embodiment differs from the second embodiment is that a linear member 7 is provided in place of the linear member 4 .
  • the same reference numerals are assigned and an explanation thereof is omitted.
  • the linear member 7 includes a hard portion 71 and a flexible portion 72 .
  • the hard portion 71 includes a first portion 711 and a second portion 712 .
  • the end portion on the proximal end side of the first portion 711 is connected to the outer peripheral surface of the proximal end side leg portion 31 of the balloon 3 , at the proximal end position M 2 .
  • the second portion 712 is adjacent to the distal end side of the first portion 711 .
  • the flexible portion 72 is adjacent to the distal end side of the second portion 712 of the hard portion 71 .
  • the end portion on the distal end side of the flexible portion 72 is connected to the outer peripheral surface of the distal end side leg portion 35 of the balloon 3 , at the distal end position M 1 .
  • the first portion 711 of the hard portion 71 , the second portion 712 of the hard portion 71 , and the flexible portion 72 are disposed side by side in that order from the proximal end toward the distal end along the extending direction.
  • the first portion 711 of the hard portion 71 corresponds to the first portion 411 (refer to FIG. 8 ) of the flexible portion 41 according to the first embodiment.
  • the second portion 712 of the hard portion 71 corresponds to the laminated portion (refer to FIG. 8 ) according to the first embodiment, in which the second portion 412 of the flexible portion 41 and the hard portion 42 are laminated.
  • the flexible portion 72 corresponds to the third portion 413 (refer to FIG. 8 ) of the flexible portion 41 according to the first embodiment.
  • the shape of each of the portions is the same.
  • the material of the flexible portion 72 is the same as the material of the flexible portion 41 according to the first embodiment.
  • the material of the hard portion 71 is the same as the material of the hard portion 42 according to the first embodiment.
  • FIG. 13 shows cross sections of the linear member 7 at each of a line A 3 -A 3 , a line B 3 -B 3 , and a line C 3 -C 3 .
  • the cross-sectional shape of the first portion 711 of the hard portion 71 is a trapezoid shape.
  • An inner portion 711 A and an outer portion 711 B of the first portion 711 respectively correspond to the inner portion 411 A and the outer portion 411 B (refer to FIG. 8 ) of the flexible portion 41 .
  • a length between the inner portion 711 A and the outer portion 711 B, namely, a thickness R 31 of the first portion 711 is the same as the thickness R 11 in the linear member 4 .
  • the shape of the cross section of the second portion 712 of the hard portion 71 is an equilateral triangle shape.
  • An inner portion 712 A and an outer portion 712 B of the second portion 712 respectively correspond to the inner portion 412 A and the outer portion 42 B (refer to FIG. 8 ) of the flexible portion 41 .
  • a length between the inner portion 712 A and the outer portion 712 B, namely, a thickness R 32 of the second portion 712 is the same as the thickness R 12 in the linear member 4 .
  • the shape of the cross section of the flexible portion 72 is a trapezoid shape.
  • An inner portion 72 A and an outer portion 72 B of the flexible portion 72 respectively correspond to the inner portion 413 A and the outer portion 413 B (refer to FIG.
  • a distal end surface 72 S and a proximal end surface 72 K respectively correspond to the distal end surface 42 S and the proximal end surface 42 K (refer to FIG. 8 ) of the hard portion 42 .
  • a first direction D 31 and a second direction D 32 respectively correspond to the first direction D 11 and the second direction D 12 (refer to FIG. 8 ).
  • a first angle ⁇ 31 and a second angle ⁇ 32 respectively correspond to the first angle ⁇ 11 and the second angle ⁇ 12 (refer to FIG. 8 ).
  • the preferable five degrees of the first angle ⁇ 31 is smaller than the preferable sixteen degrees of the second angle ⁇ 32 .
  • the second portion 712 of the hard portion 71 of the linear member 7 tries to move away from the protruding portion 225 of the inner tube 22 .
  • the flexible portion 72 of the linear member 7 elastically deforms so as to extend along the extending direction.
  • the second portion 712 of the hard portion 71 easily separates from the protruding portion 225 of the inner tube 22 .
  • the outer portion 712 B of the second portion 712 of the hard portion 71 protrudes to the outside with respect to the balloon 3 .
  • the second portion 712 of the hard portion 71 is disposed in a portion, of the linear member 7 , that is aligned with the position, in the extending direction, of the inflatable region 33 of the balloon 3 in the inflated state.
  • the flexible portion 72 of the linear member 7 elastically deforms so as to extend along the extending direction.
  • the second portion 712 of the hard portion 71 moves away from the protruding portion 225 of the inner tube 22 .
  • the outer portion 712 B is disposed on the opposite side to the inner portion 712 A that faces the outer peripheral surface of the balloon 3 .
  • the second portion 712 of the hard portion 71 is provided from the inside, which faces the inflatable region 33 of the balloon 3 , to the outside.
  • the linear member 7 can orient the hard portion 71 toward the outside.
  • the hard portion 71 is disposed not only at the portion corresponding to the inflatable region 33 of the balloon 3 , but also at the portion corresponding further toward the proximal end side than the inflatable region 33 .
  • the balloon catheter 40 can cause the first portion 711 of the hard portion 71 to act on the constricted portion of the blood vessel further toward the proximal end side than the inflatable region 33 , when the balloon 3 is inflated in the state in which the balloon 3 is disposed at the constricted portion of the blood vessel.
  • the hard portion 71 and the flexible portion 72 are adjacent in the extending direction.
  • the linear member 7 can be easily manufactured by connecting the respective end portions of the hard portion 71 and the flexible portion 72 in the extending direction.
  • a balloon catheter 50 according to a fifth embodiment of the present disclosure will be explained with reference to FIG. 14 and FIG. 15 .
  • a point in which the fifth embodiment differs from the second embodiment is that a linear member 8 is provided in place of the linear member 4 .
  • the same reference numerals are assigned and an explanation thereof is omitted.
  • the linear member 8 includes flexible portions 81 and 83 , and a hard portion 82 .
  • the end portion on the proximal end side of the flexible portion 81 is connected to the outer peripheral surface of the proximal end side leg portion 31 of the balloon 3 , at the proximal end position M 2 .
  • the hard portion 82 is adjacent to the distal end side of the flexible portion 81 .
  • the flexible portion 83 is adjacent to the distal end side of the hard portion 82 .
  • the end portion on the distal end side of the flexible portion 83 is connected to the outer peripheral surface of the distal end side leg portion 35 of the balloon 3 , at the distal end position M 1 .
  • the flexible portion 81 , the hard portion 82 , and the flexible portion 83 are disposed side by side in that order from the proximal end toward the distal end along the extending direction.
  • the flexible portion 81 corresponds to the first portion 411 (refer to FIG. 8 ) of the flexible portion 41 according to the first embodiment.
  • the hard portion 82 corresponds to the laminated portion (refer to FIG. 8 ) according to the first embodiment, in which the second portion 412 of the flexible portion 41 and the hard portion 42 are laminated.
  • the flexible portion 83 corresponds to the third portion 413 (refer to FIG. 8 ) of the flexible portion 41 according to the first embodiment.
  • the shape of each of the portions is the same.
  • the material of the flexible portions 81 and 83 is the same as the material of the flexible portion 41 according to the first embodiment.
  • the material of the hard portion 82 is the same as the material of the hard portion 42 according to the first embodiment.
  • FIG. 15 shows cross sections of the linear member 8 at each of a line A 4 -A 4 , a line B 4 -B 4 , and a line C 4 -C 4 .
  • the cross-sectional shape of the flexible portion 81 is a trapezoid shape.
  • An inner portion 81 A and an outer portion 81 B of the flexible portion 81 respectively correspond to the inner portion 411 A and the outer portion 411 B (refer to FIG. 8 ) of the flexible portion 41 .
  • a length between the inner portion 81 A and the outer portion 81 B, namely, a thickness R 41 of the flexible portion 81 is the same as the thickness R 11 in the linear member 4 .
  • the shape of the cross section of the hard portion 82 is an equilateral triangle shape.
  • An inner portion 82 A and an outer portion 82 B of the hard portion 82 respectively correspond to the inner portion 412 A and the outer portion 42 B (refer to FIG. 8 ) of the flexible portion 41 .
  • a length between the inner portion 82 A and the outer portion 82 B, namely, a thickness R 42 of the hard portion 82 is the same as the thickness R 12 in the linear member 4 .
  • the shape of the cross section of the flexible portion 83 is a trapezoid shape.
  • An inner portion 83 A and an outer portion 83 B of the flexible portion 83 respectively correspond to the inner portion 413 A and the outer portion 413 B (refer to FIG. 8 ) of the flexible portion 41 .
  • a distal end surface 82 S and a proximal end surface 82 K respectively correspond to the distal end surface 42 S and the proximal end surface 42 K (refer to FIG. 8 ) of the hard portion 42 .
  • a first direction D 41 and a second direction D 42 respectively correspond to the first direction D 11 and the second direction D 12 (refer to FIG. 8 ).
  • a first angle ⁇ 41 and a second angle ⁇ 42 respectively correspond to the first angle ⁇ 11 and the second angle ⁇ 12 (refer to FIG. 8 ).
  • the preferable five degrees of the first angle ⁇ 41 is smaller than the preferable sixteen degrees of the second angle ⁇ 42 .
  • the hard portion 82 of the linear member 8 tries to move away from the protruding portion 225 of the inner tube 22 .
  • the flexible portions 81 and 83 of the linear member 8 elastically deform so as to extend along the extending direction.
  • the hard portion 82 easily separates from the protruding portion 225 of the inner tube 22 .
  • the outer portion 82 B of the hard portion 82 protrudes to the outside with respect to the balloon 3 .
  • the hard portion 82 is disposed in a portion, of the linear member 8 , that is aligned with the position, in the extending direction, of the inflatable region 33 of the balloon 3 in the inflated state.
  • the flexible portions 81 and 83 of the linear member 8 elastically deform so as to extend along the extending direction. In this way, the hard portion 82 moves away from the protruding portion 225 of the inner tube 22 .
  • the outer portion 82 B is disposed on the opposite side to the inner portion 82 A that faces the outer peripheral surface of the balloon 3 .
  • the flexible portions 81 and 83 are provided on the distal end side and the proximal end side of the hard portion 82 .
  • the linear member 8 easily extends in the extending direction when the balloon 3 is inflated.
  • the balloon catheter 50 can easily cause the hard portion 82 to separate from the protruding portion 225 of the inner tube 22 .
  • the linear member 8 the flexible portion 81 , the hard portion 82 , and the flexible portion 83 are adjacent to each other in the extending direction.
  • the linear member 8 can be easily manufactured by connecting the respective end portions in the extending direction of the flexible portions 81 and 81 , and the hard portion 82 .
  • a balloon catheter 90 according to a sixth embodiment will be explained with reference to FIG. 16 to FIG. 19 .
  • Points in which the sixth embodiment differs from the second embodiment are as follows:
  • Linear members 9 A, 9 B, and 9 C respectively correspond to the linear members 4 A, 4 B, and 4 C according to the second embodiment.
  • the linear member 9 is bonded to the outer peripheral surface of the balloon 3 across the whole length of the linear member 9 from the proximal end position M 2 to the distal end position M 1 .
  • the linear member 9 is bonded to the outer peripheral surface of the balloon 3 using thermal welding.
  • the linear member 9 may be bonded to the outer peripheral surface of the balloon 3 using another method, such as adhesive or the like. As shown in FIG.
  • the linear members 9 A, 9 B, and 9 C extend in straight lines in the extending direction, at positions respectively dividing the balloon 3 into three approximately equal parts in the circumferential direction.
  • a force in a direction to try and elongate the linear member 9 in the extending direction acts on the linear member 9 .
  • the force in the elongation direction does not act on the linear member 9 .
  • the linear member 9 includes a flexible portion 91 and a hard portion 92 .
  • the flexible portion 91 extends between the proximal end position M 2 and the distal end position M 1 .
  • the flexible portion 91 includes a first portion 911 , a second portion 912 , and a third portion 913 .
  • the first portion 911 , the second portion 912 , and the third portion 913 respectively correspond to sections of the flexible portion 91 that is divided into three in the extending direction.
  • the first portion 911 is bonded to the outer peripheral surfaces of the proximal end side leg portion 31 and the proximal end side cone region 32 of the balloon 3 .
  • the second portion 912 is adjacent to the distal end side of the first portion 911 .
  • the second portion 912 is bonded to the outer peripheral surface of the inflatable region 33 of the balloon 3 .
  • the third portion 913 is adjacent to the distal end side of the second portion 912 .
  • the third portion 913 is bonded to the outer peripheral surfaces of the distal end side cone region 34 and the distal end side leg portion 35 of the balloon 3 .
  • the hard portion 92 is laminated to a portion, of the second portion 912 of the flexible portion 91 , on the opposite side to the portion bonded to the balloon 3 .
  • FIG. 19 shows cross sections of the linear member 9 at each of a line A 5 -A 5 , a line B 5 -B 5 , and a line C 5 -C 5 in a state in which the force in the elongation direction is not acting on the linear member 9 .
  • the cross-sectional shape of the linear member 9 is a trapezoid shape or an equilateral triangle shape. Specifically, it is as described below.
  • the shape of the cross section of the flexible portion 91 (the first portion 911 to the third portion 913 ) is the trapezoid shape.
  • a portion bonded to the balloon 3 (refer to FIG.
  • the shape of the cross section of the hard portion 92 is an equilateral triangle shape having the boundary 912 B of the second portion 912 as one side.
  • the hard portion 92 protrudes to the outside from the boundary 912 B of the second portion 912 of the flexible portion 91 .
  • an end portion on the outside of the hard portion 92 is referred to as an “outer portion 92 B.”
  • the outer portion 92 B corresponds to an apex of the equilateral triangle shape, and thus is peaked.
  • a length between the inner portion 911 A and the outer portion 911 B of the first portion 911 namely, a thickness of a portion of the flexible portion 91 further toward the proximal end side than the hard portion 92 , is denoted as a thickness R 51 .
  • a length between the inner portion 912 A and the boundary 912 B of the second portion 912 namely, a thickness of a portion of the flexible portion 91 that overlaps with the hard portion 92 in the extending direction, is denoted as R 52 .
  • a length between the inner portion 913 A and the outer portion 913 B of the third portion 913 namely, a thickness of a portion of the flexible portion 91 further toward the distal end side than the hard portion 92 , is denoted as R 53 .
  • the thicknesses R 51 , R 52 , and R 53 are equal.
  • An end surface on the distal end side of the hard portion 92 is referred to a “distal end surface 92 S.”
  • a virtual first direction D 51 is defined that extends toward the outside along the distal end surface 92 S of the hard portion 92 .
  • the first direction D 51 is inclined toward the proximal end side with respect to the direction orthogonal to the extending direction.
  • An end surface on the proximal end side of the hard portion 92 is referred to as a “proximal end surface 92 K.”
  • a virtual second direction D 52 is defined that extends toward the outside along the proximal end surface 92 K of the hard portion 92 .
  • the second direction D 52 is inclined toward the distal end side with respect to the direction orthogonal to the extending direction.
  • An acute angle, of angles formed between the first direction D 51 and the extending direction, is defined as a first angle ⁇ 51 .
  • the first angle 051 is an angle between 4 to 13 degrees, for example.
  • the first angle ⁇ 51 is preferably 5 degrees.
  • An acute angle, of angles formed between the second direction D 52 and the extending direction is defined as a second angle ⁇ 52 .
  • the second angle ⁇ 52 is an angle between 5 to 16 degrees, for example.
  • the second angle ⁇ 52 is preferably 16 degrees.
  • the preferable five degrees of the first angle ⁇ 51 is smaller than the preferable sixteen degrees of the second angle ⁇ 52 .
  • a position of a boundary on the distal end side of the second portion 912 of the flexible portion 91 is aligned, in the extending direction, with the position P 11 of the end portion on the distal end side of the marker 22 A.
  • a position of a boundary on the proximal end side of the second portion 912 of the flexible portion 91 is aligned, in the extending direction, with the position P 21 of the end portion on the proximal end side of the marker 22 B.
  • the hard portion 92 of the linear member 9 is laminated on the second portion 912 of the flexible portion 91 .
  • the inflatable region 33 of the balloon 3 , the second portion 912 of the flexible portion 91 , and the hard portion 92 are all disposed in the same position in the extending direction.
  • two notches 51 which extend toward the inside in the radial direction from the outer portion 92 B of the hard portion 92 , are formed in the linear member 9 .
  • Each of the two notches 51 is formed by cutting out a part of the linear member 9 .
  • a cross-sectional shape of each of the notches 51 is a wedge shape.
  • the two notches 51 are disposed side by side at an equal interval in the extending direction.
  • Each of the notches 51 includes surfaces 51 A and 51 B that face each other in the extending direction.
  • a direction that extends to the outside along the surface 51 A is inclined toward the proximal end side with respect to the direction orthogonal to the extending direction.
  • a direction that extends to the outside along the surface 51 B is inclined toward the distal end side with respect to the direction orthogonal to the extending direction.
  • the surfaces 51 A and 51 B are disposed with an interval therebetween in the extending direction. A gap is formed between the surfaces 51 A and 51 B.
  • the surfaces 51 A and 51 B are connected by respective inside end portions thereof.
  • the end portions that connect the surfaces 51 A and 51 B are, in other words, an end portion (hereinafter referred to as a “bottom portion”) 51 C of the inside of the notch 51 .
  • the bottom portion 51 C is positioned further to the inside, in the radial direction, than the boundary 912 B that represents the boundary between the second portion 912 of the flexible portion 91 and the hard portion 92 .
  • the force in the elongation direction acts on the first portion 911 and the third portion 913 of the flexible portion 91 of the linear member 9 .
  • the first portion 911 and the third portion 913 elastically deform so as to extend along the extending direction.
  • the force in the extending direction also acts on the section at which the second portion 912 of the flexible portion 91 and the hard portion 92 are laminated.
  • the hard portion 92 does not easily extend.
  • the linear member 9 even the section in which the second portion 912 of the flexible portion 91 and the hard portion 92 are laminated elastically deforms so as to extend in the extending direction in accordance with the inflation of the balloon 3 .
  • the linear member 9 follows the inflation of the balloon 3 and extends in the extending direction across the whole length of the linear member 9 in the extending direction.
  • the flexible portion 91 of the linear member 9 that is extended in the extending direction contracts due to a restoring force.
  • the surfaces 51 A and 51 B of the notches 51 of the hard portion 92 of the linear member 9 approach each other with a space therebetween in the extending direction.
  • the linear member 9 A is covered from the outside by the pleat 3 A
  • the linear member 9 B is covered from the outside by the pleat 3 B
  • the linear member 9 C is covered from the outside by the pleat 3 C.
  • the force that tries to elongate acts on the linear member 9 . If the linear member 9 does not extend well even when this force is acting, the linear member 9 cannot follow the inflation of the balloon 3 and there is a possibility that the linear member 9 may break away from the balloon 3 . Further, there is a case in which the inflation of the balloon 3 is obstructed by the linear member 9 . Thus, it is preferable that the extendability of the linear member 9 be high. On the other hand, in order to cause the linear member 9 to act appropriately on the blood vessel when the balloon 3 is inflated, it is preferable that the hardness of the linear member 9 be harder.
  • the outer portion 92 B of the hard portion 92 of the linear member 9 protrudes to the outside with respect to the balloon 3 .
  • the hardness of the hard portion 92 is harder than the flexible portion 91 .
  • the linear member 9 can cause the hard portion 92 to act appropriately on the blood vessel when the balloon 3 is inflated.
  • the outer portion 92 B of the hard portion 92 is peaked, the hard portion 92 easily bites into the lesioned part (not shown in the drawings) of the blood vessel.
  • the lesioned part can be expanded from inside by the inflation of the balloon 3 .
  • the flexible portion 91 of the linear member 9 can extend.
  • the first portion 911 and the third portion 913 , of the flexible portion 91 , on which the hard portion 92 is not laminated extend in a favorable manner, and follow the balloon 3 .
  • the two notches 51 are formed in the linear member 9 .
  • the surfaces 51 A and 51 B of each of the notches 51 separate from each other, thus suppressing the hard portion 92 from obstructing the extending of the second portion 912 of the flexible portion 91 .
  • the linear member 9 can extend appropriately across the whole length of the linear member 9 in accordance with the inflation of the balloon 3 , and can follow the inflation of the balloon 3 .
  • the balloon catheter 90 can inhibit the linear member 9 from breaking away from the balloon 3 when the balloon 3 is inflated, or inhibit the linear member 9 from obstructing the inflation of the balloon 3 .
  • each of the notches 51 is positioned further to the inside, in the radial direction, than the boundary 912 B between the second portion 912 of the flexible portion 91 and the hard portion 92 .
  • the hard portion 92 is divided into three by the two notches 51 .
  • the linear member 9 can appropriately suppress the hard portion 92 from obstructing the extending of the second portion 912 of the flexible portion 91 .
  • the balloon catheter 90 can even more appropriately inhibit the linear member 9 from breaking away from the balloon 3 when the balloon 3 is inflated, or inhibit the linear member 9 from obstructing the inflation of the balloon 3 .
  • the surfaces 51 A and 51 B of each of the two notches 51 are disposed so as to be separated from each other in the extending direction.
  • the linear member 9 can easily bend in the direction orthogonal to the extending direction at the section in which the notches 51 are formed.
  • the balloon catheter 90 can cause the linear member 9 to follow the balloon 3 and bend.
  • the balloon catheter 90 can suppress the linear member 9 from breaking away from the balloon 3 when the balloon 3 bends.
  • the linear member 9 is bonded to the outer peripheral surface of the balloon 3 between the distal end position M 1 and the proximal end position M 2 . As a result, the linear member 9 is held in a fixed position with respect to the balloon 3 .
  • the balloon catheter 90 can cause the linear member 9 to act on the blood vessel when the balloon 3 is inflated, while the linear member 9 is held in a correct position with respect to the balloon 3 .
  • the balloon catheter 90 can inhibit the position of the linear member 9 with respect to the balloon 3 from changing in accordance with the inflation of the balloon 3 .
  • the first direction D 51 which extends to the outside along the distal end surface 92 S that is the end portion of the hard portion 92 on the distal end side, is inclined toward the proximal end side.
  • the linear member 9 can be inhibited from catching on the inner wall of the blood vessel.
  • the user can smoothly move the balloon 3 as far as the constricted portion of the blood vessel.
  • the second direction D 52 which extends to the outside along the proximal end surface 92 K that is the end portion of the hard portion 92 on the proximal end side, is inclined toward the distal end side.
  • the linear member 9 can be inhibited from catching on the inner wall of the blood vessel.
  • the user can easily pull the balloon catheter 90 out from the blood vessel.
  • the linear member 9 is formed of a synthetic resin.
  • the linear member 9 that includes the flexible portion 91 and the hard portion 92 can be easily manufactured by injection molding, extrusion molding or the like.
  • a seventh embodiment and an eighth embodiment will be explained with reference to FIG. 20 and FIG. 21 .
  • notches 52 in place of the notches 51 of the sixth embodiment, notches 52 (refer to FIG. 20 ) are formed in the linear member 9 .
  • notches 53 in place of the notches 51 of the sixth embodiment, notches 53 (refer to FIG. 21 ) are formed in the linear member 9 .
  • Other parts of the configuration are the same as those of the sixth embodiment.
  • the same reference numerals are assigned and an explanation thereof is omitted.
  • the notch 52 includes surfaces 52 A and 52 B.
  • the end portion on the inside of the notch 52 is referred to as a “bottom portion 52 C.”
  • the surfaces 52 A and 52 B, and the bottom portion 52 C respectively correspond to the surfaces 51 A and 51 B, and the bottom portion 51 C of the notch 51 of the sixth embodiment.
  • a position of the bottom portion 52 C in the radial direction is different to that of the notch 51 .
  • the bottom portion 52 C is positioned in substantially the same position as the boundary 912 B between the second portion 912 of the flexible portion 91 and the hard portion 92 .
  • the hard portion 92 is divided into three in the extending direction by two of the notches 52 .
  • the linear member 9 can appropriately suppress the extending of the second portion 912 of the flexible portion 91 from being obstructed by the hard portion 92 .
  • the balloon catheter 90 can even more appropriately inhibit the linear member 9 from breaking away from the balloon 3 when the balloon 3 is inflated, or inhibit the linear member 9 from obstructing the inflation of the balloon 3 .
  • a part of the notch 52 is not formed in the flexible portion 91 . Therefore, in comparison to the case in which the part of the notch 51 is formed in the second portion 912 of the flexible portion 91 as in the sixth embodiment, the strength of the second portion 912 of the flexible portion 91 is maintained when extending.
  • the notch 53 includes surfaces 53 A and 53 B.
  • the end portion on the inside of the notch 53 is referred to as a “bottom portion 53 C.”
  • the surfaces 53 A and 53 B, and the bottom portion 53 C respectively correspond to the surfaces 51 A and 51 B, and the bottom portion 51 C of the notch 51 of the above-described embodiment.
  • a position of the bottom portion 53 C in the radial direction is different to that of the notches 51 and 52 .
  • the bottom portion 53 C is positioned further to the outside than the boundary 912 B between the second portion 912 of the flexible portion 91 and the hard portion 92 .
  • the hard portion 92 is not divided in the extending direction by the notch 53 .
  • a portion further to the inside than the bottom portion 53 C of the notch 53 extends easily in the extending direction, compared to a portion in which the notch 53 is not formed. Therefore, of the linear member 9 , the portion in which the second portion 912 of the flexible portion 91 and the hard portion 92 are laminated extends in the extending direction in accordance with the inflation of the balloon 3 .
  • the balloon catheter 90 can inhibit the linear member 9 from breaking away from the balloon 3 when the balloon 3 is inflated, or inhibit the linear member 9 from obstructing the inflation of the balloon 3 .
  • the depth of the notch 53 is smaller than that of the notches 51 and 52 , and therefore, the space between the surfaces 53 A and 53 B can be minimized when the surfaces 53 A and 53 B separate from each other in accordance with the inflation of the balloon 3 .
  • an area of the outer portion 92 B of the hard portion 92 can be made larger than in the case of the sixth embodiment and the seventh embodiment. Note that, when the balloon 3 is inflated, the outer portion 92 B of the hard portion 92 comes into contact with the blood vessel wall.
  • the balloon catheter 90 can increase the area of the portion (the outer portion 92 B of the hard portion 92 ) of the linear member 9 that comes into contact with the blood vessel wall, the balloon catheter 90 can cause the linear member 9 to act appropriately on the blood vessel when the balloon 3 is inflated.
  • a ninth embodiment will be explained with reference to FIG. 22 .
  • incisions 54 are formed in place of the notches 51 of the sixth embodiment.
  • Other parts of the configuration are the same as those of the sixth to eighth embodiments.
  • the same reference numerals are assigned and an explanation thereof is omitted.
  • the incision 54 extends to the inside along the radial direction, from the outer portion 92 B of the hard portion 92 .
  • the incision 54 includes surfaces 54 A and 54 B that face each other in the extending direction.
  • An end portion (hereinafter referred to as a “bottom portion”) MC on the inside of each of the incisions 54 is positioned further to the inside, in the radial direction, than the boundary 912 B between the second portion 912 of the flexible portion 91 and the hard portion 92 .
  • the force in the elongation direction does not act on the linear member 9 .
  • the surfaces 54 A and 54 B are in contact with each other.
  • a gap is not formed between the surfaces 54 A and 54 B.
  • the force in the elongation direction acts on the portion, of the linear member 9 , at which the second portion 912 of the flexible portion 91 and the hard portion 92 are laminated.
  • the surfaces 54 A and 54 B of the incision 54 separate from each other in the extending direction, as a result of the elastic deformation of the second portion 912 of the flexible portion 91 .
  • the hard portion 92 is divided in the extending direction by the incisions 54 .
  • the elastic deformation of the second portion 912 of the flexible portion 91 is not easily suppressed by the hard portion 92 .
  • the portion of the linear member 9 at which the second portion 912 of the flexible portion 91 and the hard portion 92 are laminated extends in the extending direction in accordance with the inflation of the balloon 3 .
  • the flexible portion 91 of the linear member 9 that is extended in the extending direction contracts due to the restoring force.
  • the surfaces 54 A and 54 B of the incision 54 of the hard portion 92 once more come into contact with each other.
  • the surfaces 54 A and 54 B return to the state in which the gap is not formed therebetween.
  • the surfaces 54 A and 54 B of the incision 54 are in contact with each other when the balloon 3 is not inflated and the gap between them is not formed.
  • the gap between the surfaces 54 A and 54 B can be suppressed to a minimum
  • the area of the outer portion 92 B of the hard portion 92 of the linear member 9 can be made as large as possible.
  • the balloon catheter 90 can make the area of the portion (the outer portion 92 B of the hard portion 92 ) of the linear member 9 that comes into contact with the blood vessel wall as large as possible, the balloon catheter 90 can cause the linear member 9 to act even more appropriately on the blood vessel when the balloon 3 is inflated.
  • the bottom portion 54 C may be positioned in substantially the same position as the boundary 912 B between the second portion 912 of the flexible portion 91 and the hard portion 92 . Further, in the ninth embodiment, similarly to the case of the notch 53 (refer to FIG. 21 ) of the eighth embodiment, the bottom portion 54 C may be positioned further to the outside than the boundary 912 B between the second portion 912 of the flexible portion 91 and the hard portion 92 .
  • the notch 51 of the sixth embodiment, the notch 52 of the seventh embodiment, the notch 53 of the eighth embodiment, and the incision 54 of the ninth embodiment may also be formed in the linear members 4 , 6 , 7 , and 8 of the balloon catheters 10 , 20 , 40 , and 50 according to the first to fifth embodiments.
  • a state of the linear member 4 will be explained when the balloon 3 inflates as a result of the compressed fluid being supplied from the hub 5 , in a case in which a plurality of the notches 51 are formed in the linear member 4 of the balloon catheter 10 according to the first embodiment.
  • the hard portion 42 of the linear member 4 tries to move away from the protruding portion 225 of the inner tube 22 .
  • the force in the elongation direction acts on the first portion 411 and the third portion 413 of the flexible portion 41 of the linear member 4 .
  • the first portion 411 and the third portion 413 elastically deform so as to extend in the extending direction.
  • the hard portion 42 separates easily from the protruding portion 225 of the inner tube 22 .
  • the force in the extending direction also acts on the section of the linear member 4 at which the second portion 412 of the flexible portion 41 and the hard portion 42 are laminated.
  • the respective surfaces 51 A and 51 B of the plurality of notches 51 of the flexible portion 41 separate from each other in the extending direction in accordance with the elastic deformation of the second portion 412 of the flexible portion 41 caused by the force in the extending direction.
  • the elastic deformation of the second portion 412 of the flexible portion 41 is not easily suppressed by the hard portion 42 .
  • the section of the linear member 4 at which the second portion 412 of the flexible portion 41 and the hard portion 42 are laminated also elastically deforms so as to extend in the extending direction in accordance with the inflation of the balloon 3 .
  • the linear member 4 extends in the extending direction over the whole length of the linear member 4 in the extending direction.
  • the flexible portion 41 of the linear member 4 that is extended in the extending direction contracts due to the restoring force.
  • the surfaces 51 A and 51 B of the notches 51 of the hard portion 42 of the linear member 4 approach each other with the space therebetween in the extending direction.
  • the hard portion 42 of the linear member 4 moves closer to the protruding portion 225 of the inner tube 22 .
  • the warping of the linear member 4 is suppressed by the linear member 4 contracting.
  • the linear member 4 can be caused to appropriately extend over the whole length of the linear member 4 in accordance with the inflation of the balloon 3 .
  • the balloon catheter 10 can inhibit the linear member 4 from breaking away from the balloon 3 when the balloon 3 is inflated, or inhibit the linear member 4 from obstructing the inflation of the balloon 3 .
  • the end portion on the distal end side of the linear member 4 is connected to the balloon 3
  • the end portion on the proximal end side of the linear member 4 is connected to the catheter shaft 2 via the mounting member 21 A.
  • Other portions of the linear member 4 are not bonded to the balloon 3 .
  • a manufacturing process is easier than when the linear member 4 is bonded to the balloon 3 .
  • the manufacturing of the balloon catheter 10 can be simplified.
  • a part of the portion of the linear member 4 excepting both the end portions on the distal end side and the proximal end side may be bonded to the balloon 3 .
  • the second portion 412 of the flexible portion 41 of the linear member 4 may be bonded to the inflatable region 33 of the balloon 3 .
  • the present disclosure is not limited to the above-described embodiments and various modifications are possible.
  • the number of the linear members 4 , 6 , 7 , 8 , and 9 is not limited to three, and may be another quantity.
  • the linear members 4 , 6 , 7 , 8 , and 9 are members that extend in a substantially straight line along the extending direction.
  • the linear members 4 , 6 , 7 , 8 , and 9 may be members that extend in a spiral shape along the extending direction.
  • the hard portions 42 and 92 may be provided across the whole length of the flexible portions 41 and 91 in the extending direction.
  • the outer portions of the hard portions 42 , 62 , 71 , 82 , and 92 have the function of suppressing the slipping of the balloon 3 .
  • the shape of the outer portions of the hard portions 42 , 62 , 71 , 82 , and 92 is not limited to that of the above-described embodiments.
  • an angle of the outer portions of the hard portions 42 , 62 , 71 , 82 , and 92 may be steep.
  • the outer portions of the hard portions 42 , 62 , 71 , 82 , and 92 may function, for example, as a cutting blade for cutting open the lesioned part when the balloon 3 is in the inflated state.
  • the cross-sectional shape of the linear members 4 , 6 , 7 , 8 , and 9 is not limited to the above-described examples.
  • the cross-sectional shape of the hard portions 42 , 62 , 71 , 82 , and 92 may be an isosceles triangle shape or a triangle shape having three sides of mutually differing lengths.
  • the cross-sectional shape of the flexible portion 41 may be a semi-circle that is cut out from the outside, or may be a polygonal shape.
  • the cross-sectional shape including the flexible portion 41 and the hard portion 42 may be a circular shape, or may be a polygonal shape. Note that this also applies to the second to ninth embodiments.
  • the end portions on the distal end side of the linear members 4 , 6 , 7 , 8 , and 9 are connected to the distal end side leg portion 35 , at the distal end position M 1 .
  • the end portions on the distal end side of the linear members 4 , 6 , 7 , 8 , and 9 may be connected to the inner tube 22 .
  • the end portion on the proximal end side of the linear member 4 is connected to the mounting member 21 A.
  • the end portions on the proximal end side of the linear members 6 , 7 , 8 , and 9 are connected to the proximal end side leg portion 31 .
  • the end portions on the proximal end side of the linear members 4 , 6 , 7 , 8 , and 9 may be connected to the outer tube 21 .
  • the end portion on the proximal end side of the linear member 4 need not necessarily be able to move along the extending direction.
  • the end portion on the proximal end side of the linear member 4 may be connected to the outer peripheral surface of the outer tube 21 , further toward the proximal end side than the portion, of the outer tube 21 , at which the proximal end side leg portion 31 of the balloon 3 is connected.
  • Each of the first directions D 11 , D 21 , D 31 , D 41 , and D 51 is inclined toward the proximal end side with respect to the direction orthogonal to the extending direction.
  • Each of the second directions D 12 , D 22 , D 32 , D 42 , and D 52 is inclined toward the distal end side with respect to the direction orthogonal to the extending direction.
  • the first directions D 11 , D 21 , D 31 , D 41 , and D 51 and the second directions D 12 , D 22 , D 32 , D 42 , and D 52 may extend in the direction orthogonal to the extending direction.
  • the preferable five degrees of each of the first angles ⁇ 11 , ⁇ 21 , ⁇ 31 , ⁇ 41 , and ⁇ 51 is smaller than the preferable sixteen degrees of each of the second angles ⁇ 12 , ⁇ 22 , ⁇ 32 , ⁇ 42 , and ⁇ 52 .
  • a preferable value of each of the first angles ⁇ 11 , ⁇ 21 , ⁇ 31 , ⁇ 41 , and ⁇ 51 may be the same as a preferable value of each of the second angles ⁇ 12 , ⁇ 22 , ⁇ 32 , ⁇ 42 , and ⁇ 52 .
  • each of the first angles ⁇ 11 , ⁇ 21 , ⁇ 31 , ⁇ 41 , and ⁇ 51 may be larger than the preferable value of each of the second angles ⁇ 12 , ⁇ 22 , ⁇ 32 , ⁇ 42 , and ⁇ 52 .
  • the proximal end side thicknesses R 11 , R 21 , R 31 , and R 41 are larger than the distal end side thicknesses R 13 , R 23 , R 33 , and R 43 .
  • the proximal end side thicknesses R 11 , R 21 , R 31 , and R 41 may be the same as the distal end side thicknesses R 13 , R 23 , R 33 , and R 43 .
  • the proximal end side thicknesses R 11 , R 21 , R 31 , and R 41 may be smaller than the distal end side thicknesses R 13 , R 23 , R 33 , and R 43 .
  • the proximal end side thickness R 51 may be larger or smaller than the distal end side thickness R 53 .
  • the position of the boundary on the distal end side of the inflatable region 33 is aligned, in the extending direction, with the position P 11 of the end portion on the distal end side of the marker 22 A.
  • the position of the boundary on the proximal end side of the inflatable region 33 is aligned, in the extending direction, with the position P 21 of the end portion on the proximal end side of the marker 22 B.
  • the position of the boundary on the distal end side of the inflatable region 33 need not necessarily be completely aligned, in the extending direction, with the position P 11 on the distal end side of the marker 22 A.
  • the position of the boundary on the distal end side of the inflatable region 33 may be aligned, in the extending direction, with any position between the position P 11 of the end portion on the distal end side of the marker 22 A and a position P 12 of the end portion on the proximal end side of the marker 22 A.
  • the position of the boundary on the proximal end side of the inflatable region 33 need not necessarily be completely aligned, in the extending direction, with the position P 21 on the proximal end side of the marker 22 B.
  • the position of the boundary on the proximal end side of the inflatable region 33 may be aligned, in the extending direction, with any position between the position P 21 of the end portion on the proximal end side of the marker 22 B and a position P 22 of the end portion on the distal end side of the marker 22 B.
  • the positions of the marker 22 A and the marker 22 B respectively correspond to the position of the boundary on the distal end side of the inflatable region 33 and the position of the boundary on the proximal end side of the inflatable region 33 .
  • the number of the markers is not limited to two, and may be three or more.
  • Each of the boundary portion between the proximal end side cone region 32 and the inflatable region 33 and the boundary portion between the inflatable region 33 and the distal end side cone region 34 of the balloon 3 in the inflated state may be curved.
  • positions of the boundary portions that touch the virtual plane, of the plurality of virtual planes, that forms an acute angle of 45 degrees with the extending direction may be the positions of each of the boundaries.
  • each of the proximal end side cone region 32 and the distal end side cone region 34 is a region whose diameter changes linearly from the proximal end side toward the distal end side.
  • each of the proximal end side cone region 32 and the distal end side cone region 34 may be a region whose diameter changes in a curved manner from the proximal end side toward the distal end side.
  • one of the proximal end side cone region 32 and the distal end side cone region 34 may be the region whose diameter changes in the curved manner and the other may be the region whose diameter changes linearly.
  • the distal end surfaces 42 S, 62 S, 72 S, 82 S, and 92 S, and the proximal end surfaces 42 K, 62 K, 72 K, 82 K, and 92 K of the linear members 4 , 6 , 7 , 8 , and 9 need not necessarily have a straight line shape.
  • at least either of the distal end surfaces 42 S, 62 S, 72 S, 82 S, and 92 S, or the proximal end surfaces 42 K, 62 K, 72 K, 82 K, and 92 K may have level differences.
  • the outer portions 412 B and 912 B have a straight line shape.
  • the outer portions 412 B and 912 B may have a curved shape.
  • the hard portions 42 and 92 may have a circular arc-shaped cross section.
  • the present disclosure can be applied to a device other than the balloon catheter that includes the balloon 3 that is inflated by the supply of the compressed fluid.
  • the linear members 4 , 6 , 7 , 8 , and 9 may be applied to a device that has a mechanically expanding mechanism in place of the balloon 3 .
  • the example is given of the catheter shaft 2 that has the outer tube 21 and the inner tube 22 .
  • the catheter shaft 2 need not necessarily have the outer tube 21 and the inner tube 22 .
  • the catheter shaft 2 may have only one flexible tube.
  • the positions in the radial direction of the bottom portions 51 C to 53 C of each of the notches 51 to 53 , and the bottom portions 54 C of the incisions 54 may be positions that are substantially the same position as the inner portion 912 A of the second portion 912 of the flexible portion 91 .
  • the linear member 9 may be divided in the extending direction by the notches 51 to 53 or the incisions 54 .
  • the cross-sectional shape of the notches 51 to 53 is not limited to the wedge shape.
  • a notch may be a slit whose cross-sectional shape is a semi-circular shape, a rectangular shape, a trapezoid shape or the like, or may be a slit whose outside end portions are rounded.
  • a plurality of slits having mutually different cross-sectional shapes may be formed in the linear member 9 .
  • the position of a bottom portion thereof may be further to the inside or to the outside, in the radial direction, than the boundary 912 B between the second portion 912 of the flexible portion 91 and the hard portion 92 .
  • the position of the bottom portion may be a position that is substantially the same position as the boundary 912 B in the radial direction.
  • the number of the notches 51 to 53 formed in the linear member 9 is not limited to two, and may be another quantity, such as one or more, for example.
  • the incision 54 may extend in a direction intersecting with the radial direction, to the inside from the outer portion 92 B of the hard portion 92 .
  • the shape of the incision 54 is not limited to the straight line and may be a curved line.
  • the incision may be a slit whose outside end portions are rounded. Further, a plurality of slits including the notches and the incisions having mutually different shapes may be formed in the linear member 9 .
  • the linear member 9 may be bonded to the balloon 3 only in the vicinity of each of the distal end position M 1 and the proximal end position M 2 .
  • a section excluding the vicinity of each of the distal end position M 1 and the proximal end position M 2 need not necessarily be bonded to the balloon 3 .
  • the end portion on the distal end side of the linear member 9 may be connected to the inner tube 22 .
  • the end portion on the proximal end side of the linear member 9 may be connected to the outer tube 21 .
  • the flexible portion 91 of the linear member 9 includes the first portion 911 , the second portion 912 , and the third portion 913 .
  • the flexible portion 91 need not necessarily include the first portion 911 and the third portion 913 .
  • the linear member 9 may be configured by the hard portion 92 and the second portion 912 .
  • the second portion 912 is bonded with the outer peripheral surface of the inflatable region 33 of the balloon 3 using adhesive or the like.
  • the flexible portion 91 of the linear member 9 may be configured by the second portion 912 and one of the first portion 911 and the third portion 913 .

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Abstract

A balloon catheter includes a balloon/shaft assembly and a linear member. The balloon/shaft assembly includes a catheter shaft extending from a proximal end to a distal end and a balloon connected to the catheter shaft. The linear member straddles an inflatable region of the balloon and is mounted on the balloon/shaft assembly. The linear member includes a hard portion and a flexible portion. The hard portion includes at least an outer portion disposed on an opposite side to an inner portion facing the inflatable region, of a portion disposed along an outer peripheral surface of the inflatable region in an inflated state. The flexible portion is a portion other than the hard portion. The flexible portion is extendable and has a lower hardness than the hard portion.

Description

    CROSS-REFERENCE TO RELATED APPLICATION

  • This application is a continuation of prior application Ser. No. 15/727,665, filed Oct. 9, 2017, which is a continuation-in-part of International Application No. PCT/JP2016/061484, filed Apr. 8, 2016, which claims priority from Japanese Patent Applications No. 2015-080627, filed on Apr. 10, 2015 and No. 2015-248540, filed on Dec. 21, 2015. The disclosure of the foregoing applications is hereby incorporated by reference in its entirety.

    • BACKGROUND

  • The present disclosure relates to a balloon catheter.

  • A balloon catheter is known that is used in treatments that dilate a constricted location of a blood vessel. For example, the known balloon catheter is provided with a catheter tube, a balloon, three linear members, and a fixed cone-shaped portion. The catheter tube (sometimes also referred to as a “catheter shaft”) has an inner tube and an outer tube. The balloon is joined to the outer tube and the inner tube. The balloon inflates when a compressed fluid is supplied. The three linear members are disposed on the outer peripheral side of the balloon. A distal end side of the fixed cone-shaped portion is joined to a distal end of the inner tube. A proximal end side of the fixed cone-shaped portion is joined to the three linear members. The fixed cone-shaped portion is elastically deformable. The three linear members move in a direction away from the inner tube in accordance with the inflation of the balloon. The fixed cone-shaped portion extends in response to the movement of the three linear members in the direction away from the inner tube. The fixed cone-shaped portion contracts in accordance with the deflation of the balloon, and the three linear members move in a direction approaching the inner tube.

    • SUMMARY

  • In the case of the known balloon catheter, the fixed cone-shaped portion joined to the distal end of the inner tube has an outer diameter that is sufficiently larger than the inner tube even in a deflated state. Thus, from the point of view of crossability, there is room for improvement.

  • Various embodiments of the broad principles derived herein provide a balloon catheter having superior crossability.

  • Embodiments provide a balloon catheter that includes a balloon/shaft assembly and a linear member. The balloon/shaft assembly includes a catheter shaft extending from a proximal end to a distal end and a balloon connected to the catheter shaft. The balloon has an inflatable region configured to inflate outward in a radial direction around the catheter shaft. The linear member straddles the inflatable region of the balloon and is mounted on the balloon/shaft assembly at a distal end position located further toward the distal end side than the inflatable region and at a proximal end position located further toward the proximal end side than the inflatable region. The linear member includes a hard portion and a flexible portion. The hard portion includes at least an outer portion disposed on an opposite side to an inner portion facing the inflatable region, of a portion disposed along an outer peripheral surface of the inflatable region in an inflated state. The flexible portion is a portion other than the hard portion. The flexible portion is extendable and has a lower hardness than the hard portion.

    • BRIEF DESCRIPTION OF THE DRAWINGS

  • Embodiments will be described below in detail with reference to the accompanying drawings in which:

  • FIG. 1

    is a side view of a balloon catheter according to a first embodiment;

  • FIG. 2

    is a side view of a balloon and a linear member in a deflated state;

  • FIG. 3

    is a cross-sectional view in the direction of arrows along a line I-I shown in

    FIG. 2

    ;

  • FIG. 4

    is a cross-sectional view of the balloon and the linear member in the deflated state;

  • FIG. 5

    is a side view of the balloon and the linear member in an inflated state;

  • FIG. 6

    is a cross-sectional view in the direction of arrows along a line II-II shown in

    FIG. 5

    ;

  • FIG. 7

    is a cross-sectional view of the balloon and the linear member in the inflated state;

  • FIG. 8

    shows a side view and cross-sectional views of the

    linear member

    4;

  • FIG. 9

    is a cross-sectional view of the balloon and the linear member according to a second embodiment;

  • FIG. 10

    is a cross-sectional view of the balloon and a linear member according to a third embodiment;

  • FIG. 11

    shows a side view and cross-sectional views of the linear member;

  • FIG. 12

    is a cross-sectional view of the balloon and a linear member according to a fourth embodiment;

  • FIG. 13

    shows a side view and cross-sectional views of the linear member;

  • FIG. 14

    is a cross-sectional view of the balloon and a linear member according to a fifth embodiment;

  • FIG. 15

    shows a side view and cross-sectional views of the linear member;

  • FIG. 16

    is a side view of the balloon and a linear member according to a sixth embodiment;

  • FIG. 17

    is a cross-sectional view in the direction of arrows along a line III-III shown in

    FIG. 16

    ;

  • FIG. 18

    is a cross-sectional view of the balloon and the linear member in the inflated state;

  • FIG. 19

    shows a side view and cross-sectional views of the linear member;

  • FIG. 20

    is a cross-sectional view of an expanded part of the linear member according to a seventh embodiment;

  • FIG. 21

    is a cross-sectional view of an expanded part of the linear member according to an eighth embodiment; and

  • FIG. 22

    is a cross-sectional view of an expanded part of the linear member according to a ninth embodiment.

    • DETAILED DESCRIPTION First Embodiment

  • Hereinafter, a

    balloon catheter

    10 according to a first embodiment of the present disclosure will be explained with reference to

    FIG. 1

    to

    FIG. 8

    . As shown in

    FIG. 1

    , the

    balloon catheter

    10 has a

    catheter shaft

    2, a

    balloon

    3, and

    linear members

    4A, 4B, and 4C (refer to

    FIG. 3

    , hereinafter collectively referred to as “

    linear members

    4”). Hereinafter, the

    catheter shaft

    2 and the

    balloon

    3 are collectively referred to as a “balloon/

    shaft assembly

    25.” The

    balloon

    3 is connected to an end portion on one side of the

    catheter shaft

    2. The

    linear members

    4 are disposed on the outside of the

    balloon

    3 in an inflated state. The

    balloon catheter

    10 is used in a state in which a

    hub

    5 is connected to an end portion on the other side of the

    catheter shaft

    2. The

    hub

    5 can supply compressed fluid to the

    balloon

    3 via the

    catheter shaft

    2. Hereinafter, the one end (of both ends) of the

    catheter shaft

    2 on the one side is referred to as a “distal end.” The other end (of both ends) of the

    catheter shaft

    2 is referred to as a “proximal end.” A direction extending along the

    catheter shaft

    2 is referred to as an “extending direction.” In a plane orthogonal to the extending direction, of a radial direction taking a center of a cross section of the

    catheter shaft

    2 as a reference, a side closer to the center of the cross section of the

    catheter shaft

    2 is referred to as an “inner side” and a side further away from the center of the cross section of the

    catheter shaft

    2 is referred to as an “outer side.”

    • Catheter Shaft 2

  • As shown in

    FIG. 4

    and

    FIG. 7

    , the

    catheter shaft

    2 has an

    outer tube

    21 and an

    inner tube

    22. The

    outer tube

    21 and the

    inner tube

    22 are both flexible tubular members. The

    outer tube

    21 has a

    lumen

    213, which is a space surrounded by an

    inner surface

    212, which is a surface on the inner side of the

    outer tube

    21. The

    inner tube

    22 has a

    lumen

    223, which is a space surrounded by an

    inner surface

    222, which is a surface on the inner side of the

    inner tube

    22. The

    outer tube

    21 and the

    inner tube

    22 are formed of a polyamide resin. The inner diameter of the

    outer tube

    21 is larger than the outer diameter of the

    inner tube

    22.

  • Apart from a predetermined portion on the distal end side, the

    inner tube

    22 is disposed inside the

    lumen

    213 of the

    outer tube

    21. The predetermined portion on the distal end side of the

    inner tube

    22 protrudes toward the distal end side from an end (hereinafter referred to as a “

    distal end

    211”) on the distal end side of the

    outer tube

    21. The end (hereinafter referred to as a “

    distal end

    221”) on the distal end side of the

    inner tube

    22 is disposed further toward the distal end side than the

    distal end

    211 of the

    outer tube

    21. Hereinafter, the predetermined portion on the distal end side of the

    inner tube

    22 is referred to as a “protruding

    portion

    225.” Radiopaque markers (hereinafter simply referred to as “markers”) 22A and 22B are fitted to the protruding

    portion

    225 of the

    inner tube

    22. Resin into which a radiopaque material is mixed is used as the material of the

    markers

    22A and 22B. The

    markers

    22A and 22B are fixed to an

    outer surface

    224, which is an outer peripheral surface of the

    inner tube

    22, as a result of cylindrical members formed of the above-described material being crimped onto the protruding

    portion

    225 of the

    inner tube

    22. The

    markers

    22A and 22B have a predetermined length in the extending direction. The

    markers

    22A and 22B do not allow the passage of radiation. The

    marker

    22A is disposed further toward the distal end side than the

    marker

    22B. The

    markers

    22A and 22B are separated from each other in the extending direction.

  • As shown in

    FIG. 2

    ,

    FIG. 4

    ,

    FIG. 5

    , and

    FIG. 7

    , of an

    outer surface

    214, which is the outer peripheral surface of the

    outer tube

    21, a mounting

    member

    21A is mounted on a portion further toward the proximal end side than the

    distal end

    211. The mounting

    member

    21A is a cylindrical member that can move along the extending direction. The inner diameter of the mounting

    member

    21A is larger than the outer diameter of the

    outer tube

    21. A thermoplastic resin, such as a polyamide resin or the like, is used as the material of the mounting

    member

    21A.

  • As shown in

    FIG. 4

    and

    FIG. 7

    , the compressed fluid supplied from the hub 5 (refer to

    FIG. 1

    ) flows through a space of the

    lumen

    213 of the

    outer tube

    21 other than the

    lumen

    223 of the

    inner tube

    22. The

    balloon

    3 inflates (refer to

    FIG. 5

    to

    FIG. 7

    ) in accordance with the supply of the compressed fluid. A guide wire that is not shown in the drawings is inserted through the

    lumen

    223 of the

    inner tube

    22

  • The material of the

    outer tube

    21 and the

    inner tube

    22 is not limited to the polyamide resin, and can be changed to another flexible material. For example, a synthetic resin material, such as a polyethylene resin, a polypropylene resin, a polyurethane resin, a polyimide resin and the like, may be used as the material of the

    outer tube

    21 and the

    inner tube

    22. Additives may be mixed with the synthetic resin material. Different synthetic resin materials may be used as the materials of the

    outer tube

    21 and the

    inner tube

    22, respectively. The material of the

    markers

    22A and 22B is not limited to the resin into which the radiopaque material is mixed, and can be changed to another material that does not allow the passage of radiation. For example, a resin on which a radiopaque material is deposited, or a material such as metal or the like that does not allow the passage of radiation may be used as the material of the

    markers

    22A and 22B.

    • Balloon 3

  • As shown in

    FIG. 2

    to

    FIG. 4

    , the

    balloon

    3 deflates to the inner side when the compressed fluid is not supplied. As shown in

    FIG. 5

    to

    FIG. 7

    , the

    balloon

    3 inflates to the outer side when the compressed fluid is supplied. The

    balloon

    3 is formed of a polyamide resin. As shown in

    FIG. 2

    ,

    FIG. 4

    ,

    FIG. 5

    , and

    FIG. 7

    , the

    balloon

    3 includes a proximal end

    side leg portion

    31, a proximal end

    side cone region

    32, an

    inflatable region

    33, a distal end

    side cone region

    34, and a distal end

    side leg portion

    35. The proximal end

    side leg portion

    31, the proximal end

    side cone region

    32, the

    inflatable region

    33, the distal end

    side cone region

    34, and the distal end

    side leg portion

    35 respectively correspond to portions of the

    balloon

    3 divided into five in the extending direction. The length of the

    inflatable region

    33 in the extending direction is longer than the respective lengths in the extending direction of the proximal end

    side leg portion

    31, the proximal end

    side cone region

    32, the distal end

    side cone region

    34, and the distal end

    side leg portion

    35.

  • As shown in

    FIG. 4

    and

    FIG. 7

    , the proximal end

    side leg portion

    31 is connected, by thermal welding, to the

    outer surface

    214 that is the outer peripheral surface of the

    outer tube

    21, at a portion located further toward the proximal end side than the

    distal end

    211 and further toward the distal end side than the portion on which the mounting

    member

    21A is mounted. The proximal end

    side cone region

    32 is adjacent to the distal end side of the proximal end

    side leg portion

    31. The

    inflatable region

    33 is adjacent to the distal end side of the proximal end

    side cone region

    32. The distal end

    side cone region

    34 is adjacent to the distal end side of the

    inflatable region

    33. The distal end

    side leg portion

    35 is adjacent to the distal end side of the distal end

    side cone region

    34. The distal end

    side leg portion

    35 is connected, by thermal welding, to the

    outer surface

    224 of the protruding

    portion

    225 of the

    inner tube

    22, at a portion located further toward the proximal end side than the

    distal end

    221. The proximal end

    side leg portion

    31, the proximal end

    side cone region

    32, the

    inflatable region

    33, the distal end

    side cone region

    34, and the distal end

    side leg portion

    35 are disposed side by side in that order from the proximal end side toward the distal end side. The proximal end

    side cone region

    32, the

    inflatable region

    33, the distal end

    side cone region

    34, and the distal end

    side leg portion

    35 cover the protruding

    portion

    225 of the

    inner tube

    22 from outside.

  • As shown in

    FIG. 2

    to

    FIG. 4

    , three pleats are formed by the

    balloon

    3 in the deflated state. The

    balloon

    3 is a three pleat type balloon. As shown in

    FIG. 3

    , in the deflated state, the

    balloon

    3 is folded over so as to form three

    pleats

    3A, 3B, and 3C. Each of the

    pleats

    3A, 3B, and 3C is wrapped around the protruding

    portion

    225 of the

    inner tube

    22. In this state, the

    pleat

    3A covers the

    linear member

    4A, which will be described later, from outside. The

    pleat

    3B covers the

    linear member

    4B, which will be described later, from outside. The

    pleat

    3C covers the

    linear member

    4C, which will be described later, from outside. The

    pleats

    3A, 3B, and 3C are also called “flaps” and “wings.”

  • The inflated state of the

    balloon

    3 will be explained with reference to

    FIG. 5

    to

    FIG. 7

    . As shown in

    FIG. 6

    , the cross-sectional shape of the

    balloon

    3 is circular. As shown in

    FIG. 5

    and

    FIG. 7

    , the proximal end

    side cone region

    32 has a tapered shape. The diameter of the proximal end

    side cone region

    32 increases continuously and linearly from the proximal end side toward the distal end side. The diameter of the

    inflatable region

    33 is the same across the whole length in the extending direction. The distal end

    side cone region

    34 has a tapered shape. The diameter of the distal end

    side cone region

    34 decreases continuously and linearly from the proximal end side toward the distal end side. The diameter of the cross section of the

    balloon

    3 changes in a stepped manner between the proximal end

    side cone region

    32, the

    inflatable region

    33, and the distal end

    side cone region

    34. The

    inflatable region

    33 is a portion of the

    balloon

    3 having the maximum diameter.

  • As shown in

    FIG. 7

    , a boundary of the

    inflatable region

    33 on the distal end side is aligned, in the extending direction, with a position P11 of an end portion on the distal end side of the

    marker

    22A. In other words, the boundary of the

    inflatable region

    33 on the distal end side is a position of a boundary between the

    inflatable region

    33 and the distal end

    side cone region

    34. A boundary of the

    inflatable region

    33 on the proximal end side is aligned, in the extending direction, with a position P21 of an end portion on the proximal end side of the

    marker

    22B. In other words, the boundary of the

    inflatable region

    33 on the proximal end side is a position of a boundary between the

    inflatable region

    33 and the proximal end

    side cone region

    32.

  • The material of the

    balloon

    3 is not limited to the polyamide resin, and can be changed to another flexible material. For example, a polyethylene resin, a polypropylene resin, a polyurethane resin, a polyimide resin, silicone rubber, natural rubber, and the like may be used as the material of the

    balloon

    3. In the above description, the method of connecting the

    outer tube

    21 and the

    inner tube

    22 to the

    balloon

    3 is not limited to the thermal welding. For example, each of the

    outer tube

    21 and the

    inner tube

    22 may be connected using an adhesive.

    • Linear Member 4

  • The

    linear member

    4 will be explained with reference to

    FIG. 4

    to

    FIG. 8

    . The

    linear member

    4 has a restoring force with respect to bending deformation. The

    linear member

    4 is a monofilament-shaped elastic body. The

    linear members

    4A, 4B, and 4C have the same shape. The

    linear member

    4 extends along the extending direction.

  • As shown in

    FIG. 4

    ,

    FIG. 5

    , and

    FIG. 7

    , an end portion on the distal end side of the

    linear member

    4 is connected, by thermal welding, to a portion of the outer peripheral surface of the distal end

    side leg portion

    35 of the

    balloon

    3 that is further to the distal end side than the center in the extending direction. Hereinafter, a position at which the end portion on the distal end side of the

    linear member

    4 is connected, in the extending direction of the

    balloon catheter

    10, is referred to as a “distal end position M1.” In the extending direction, the distal end position M1 is disposed further toward the distal end side than the

    inflatable region

    33 of the

    balloon

    3 in the inflated state. The distal end position M1 corresponds to a position further toward the distal end side than the center, in the extending direction, of the distal end

    side leg portion

    35 of the

    balloon

    3. The end portions on the distal end side of each of the

    linear members

    4A, 4B, and 4C are connected, respectively, to positions that divide the outer peripheral surface of the distal end

    side leg portion

    35 of the

    balloon

    3 into three equal parts in the circumferential direction.

  • An end portion on the proximal end side of the

    linear member

    4 is connected, by thermal welding, to a portion of the outer peripheral surface of the mounting

    member

    21A located further toward the proximal end side than the center in the extending direction. Hereinafter, a position at which the end portion on the proximal end side of the

    linear member

    4 is connected, in the extending direction of the

    balloon catheter

    10, is referred to as a “proximal end position M2.” In the extending direction, the proximal end position M2 is disposed further toward the proximal end side than the

    inflatable region

    33 of the

    balloon

    3 in the inflated state. The end portions on the proximal end side of each of the

    linear members

    4A, 4B, and 4C are connected, respectively, to positions that divide the outer peripheral surface of the mounting

    member

    21A into three equal parts in the circumferential direction. The

    linear member

    4 is connected at the distal end position M1 and the proximal end position M2, and is not connected to the

    balloon

    3 at other portions thereof.

  • The

    linear member

    4 is disposed between the distal end position M1 and the proximal end position M2 so as to straddle the

    inflatable region

    33 of the

    balloon

    3. As shown in

    FIG. 6

    , when the

    balloon

    3 is in the inflated state, the

    linear members

    4A, 4B, and 4C extend in straight lines in the extending direction, respectively, at positions that divide the outer peripheral surface of the

    inflatable region

    33 of the

    balloon

    3 into three approximately equal parts in the circumferential direction.

  • As shown in

    FIG. 4

    ,

    FIG. 5

    , and

    FIG. 7

    , the

    linear member

    4 has a

    flexible portion

    41, and a

    hard portion

    42. The

    flexible portion

    41 extends between the proximal end position M2 and the distal end position M1. The

    flexible portion

    41 includes a

    first portion

    411, a

    second portion

    412, and a

    third portion

    413. The

    first portion

    411, the

    second portion

    412, and the

    third portion

    413 respectively correspond to portions of the

    flexible portion

    41 that is divided into three in the extending direction. An end portion on the proximal end side of the

    first portion

    411 is connected to the outer peripheral surface of the mounting

    member

    21A, at the proximal end position M2. The

    second portion

    412 is adjacent to the distal end side of the

    first portion

    411. The

    third portion

    413 is adjacent to the distal end side of the

    second portion

    412. An end portion on the distal end side of the

    third portion

    413 is connected to the outer peripheral surface of the distal end

    side leg portion

    35 of the

    balloon

    3, at the distal end position M1. The

    hard portion

    42 is laminated on the

    second portion

    412 of the

    flexible portion

    41, at a portion on the opposite side to a portion facing the

    balloon

    3.

  • FIG. 8

    shows cross sections of the

    linear member

    4 at each of a line A1-A1, a line B1-B1, and a line C1-C1. The cross-sectional shape of the

    linear member

    4 is a trapezoid shape or a triangular shape. This is explained more specifically below.

  • The cross-sectional shape of the flexible portion 41 (the

    first portion

    411 to the third portion 413) is a trapezoid shape. Hereinafter, of the

    first portion

    411 of the

    flexible portion

    41, a portion facing the

    balloon

    3 in the inflated state (refer to

    FIG. 6

    ) is referred to as an “

    inner portion

    411A.” Of the

    first portion

    411, a portion on the opposite side to the

    inner portion

    411A is referred to as an “

    outer portion

    411B.” Of the

    second portion

    412 of the

    flexible portion

    41, a portion facing the

    balloon

    3 in the inflated state is referred to as an “

    inner portion

    412A.” Of the

    first portion

    412, a portion on the opposite side to the

    inner portion

    412A is referred to as an “

    outer portion

    412B.” Of the

    third portion

    413 of the

    flexible portion

    41, a portion facing the

    balloon

    3 is referred to as an “

    inner portion

    413A.” Of the

    third portion

    413, a portion on the opposite side to the

    inner portion

    413A is referred to as an “

    outer portion

    413B.” The

    inner portions

    411A, 412A, and 413A and the

    outer portions

    411B, 412B, and 413B respectively correspond to a lower base and an upper base of the trapezoid that is the cross-sectional shape.

  • A length between the

    inner portion

    413A and the

    outer portion

    413B of the

    third portion

    413, namely, a thickness R13 of a portion of the

    flexible portion

    41 located further toward the distal end side than the

    hard portion

    42, is 0.15 mm. A length between the

    inner portion

    411A and the

    outer portion

    411B of the

    first portion

    411, namely, a thickness R11 of a portion of the

    flexible portion

    41 located further toward the proximal end side than the

    hard portion

    42, is 0.23 mm. The thickness R13 is narrower than the thickness R11.

  • The shape of the cross section of the

    hard portion

    42 is an equilateral triangle shape having the

    outer portion

    412B of the

    second portion

    412 as one side. The

    hard portion

    42 protrudes to the outside from the

    outer portion

    412B of the

    second portion

    412 of the

    flexible portion

    41. Hereinafter, an end portion on the outside of the

    hard portion

    42 is referred to as an “

    outer portion

    42B.” The

    outer portion

    42B corresponds to an apex of the equilateral triangle shape. The

    outer portion

    42B is peaked. A length between the

    inner portion

    412A and the

    outer portion

    42B, namely a thickness R12 of the portion at which the

    second portion

    412 of the

    flexible portion

    41 and the

    hard portion

    42 are laminated, is 0.4 mm.

  • An end surface on the distal end side of the

    hard portion

    42 is referred to as a “

    distal end surface

    42S.” A virtual first direction D11 is defined that extends toward the outside along the

    distal end surface

    42S of the

    hard portion

    42. The first direction D11 is inclined toward the proximal end side with respect to a direction orthogonal to the extending direction. An end surface on the proximal end side of the

    hard portion

    42 is referred to as a “

    proximal end surface

    42K.” A virtual second direction D12 is defined that extends toward the outside along the

    proximal end surface

    42K of the

    hard portion

    42. The second direction D12 is inclined toward the distal end side with respect to the direction orthogonal to the extending direction. An acute angle, of angles formed between the first direction D11 and the extending direction, is defined as a first angle θ11. The first angle θ11 is an angle between 4 to 13 degrees, for example. The first angle θ11 is preferably 5 degrees. An acute angle, of angles formed between the second direction D12 and the extending direction, is defined as a second angle θ12. The second angle θ12 is an angle between 5 to 16 degrees, for example. The second angle θ12 is preferably 16 degrees. The preferable five degrees of the first angle θ11 is smaller than the preferable sixteen degrees of the second angle θ12.

  • As shown in

    FIG. 7

    , when the

    balloon

    3 is in the inflated state, a position of a boundary on the distal end side of the

    second portion

    412 of the

    flexible portion

    41, namely, a position of a boundary between the

    second portion

    412 and the

    third portion

    413, is aligned, in the extending direction, with the position P11 of the end portion on the distal end side of the

    marker

    22A. A position of a boundary on the proximal end side of the

    second portion

    412 of the

    flexible portion

    41, namely, a position of a boundary between the

    first portion

    411 and the

    second portion

    412, is aligned, in the extending direction, with the position P21 of the end portion on the proximal end side of the

    marker

    22B.

  • As described above, the boundary on the distal end side of the

    inflatable region

    33 is aligned, in the extending direction, with the position P11 of the end portion on the distal end side of the

    marker

    22A. The boundary on the proximal end side of the

    inflatable region

    33 is aligned, in the extending direction, with the position P21 of the end portion on the proximal end side of the

    marker

    22B. Thus, when the

    balloon

    3 is in the inflated state, the

    inflatable region

    33 of the

    balloon

    3, the

    second portion

    412 of the

    flexible portion

    41, and the

    hard portion

    42 are all disposed in the same position in the extending direction. The

    second portion

    412 of the

    flexible portion

    41 is disposed along the outer peripheral surface of the

    inflatable region

    33 of the

    balloon

    3. The

    inner portion

    412A of the

    second portion

    412 of the

    flexible portion

    41 faces the

    inflatable region

    33 of the

    balloon

    3. The

    hard portion

    42 is disposed on the opposite side to the portion facing the

    inflatable region

    33 of the

    balloon

    3, namely, on the opposite side to the

    inner portion

    412A of the

    second portion

    412 of the

    flexible portion

    41.

  • The

    linear member

    4 is formed of a polyamide resin. More specifically, the

    flexible portion

    41 is formed of a polyamide elastomer. The hardness of the

    flexible portion

    41 is a value within a range of D25 to D63 as prescribed in ISO 868. The

    hard portion

    42 is formed of a polyamide resin. The hardness of the

    hard portion

    42 is a value within a range of D70 to D95 as prescribed in ISO 868.The

    flexible portion

    41 is softer than the

    hard portion

    42. In comparison to the

    hard portion

    42, the

    flexible portion

    41 has excellent extendability.

  • A state of the

    linear member

    4 when the

    balloon

    3 inflates as a result of the compressed fluid being supplied from the

    hub

    5 will be explained. In accordance with the inflation of the

    balloon

    3, the

    hard portion

    42 of the

    linear member

    4 separates from the protruding

    portion

    225 of the inner tube 22 (refer to

    FIG. 7

    ). At that time, of the

    flexible portion

    41 of the

    linear member

    4, the

    first portion

    411 and the

    third portion

    413 elastically deform so as to extend along the extending direction, while the

    second portion

    412 on which the

    hard portion

    42 is laminated does not. As a result, the

    hard portion

    42 easily separates from the protruding

    portion

    225 of the

    inner tube

    22. The

    inner surface

    412A of the

    second portion

    412 of the

    flexible portion

    41 is disposed along the outer peripheral surface of the

    inflatable region

    33 of the

    balloon

    3. The

    outer portion

    42B (refer to

    FIG. 8

    ) of the

    hard portion

    42 protrudes to the outside from the

    outer portion

    412B of the

    second portion

    412 of the flexible portion 41 (refer to

    FIG. 6

    ). As described above, in comparison to the

    flexible portion

    41, the

    hard portion

    42 does not easily extend. Thus, even when the

    balloon

    3 inflates, the

    second portion

    412 of the

    flexible portion

    41 of the

    linear member

    4 does not extend to the same extent as the

    first portion

    411 and the

    third portion

    413 of the

    flexible portion

    41.

  • A state of the

    linear member

    4 when the

    balloon

    3 deflates as a result of the compressed fluid being discharged from the

    balloon

    3 in the inflated state will be explained. When the

    balloon

    3 is deflated, the

    first portion

    411 and the

    third portion

    413 of the

    flexible portion

    41 of the

    linear member

    4 that have extended in the extending direction contract due to the restoring force. The

    hard portion

    42 of the

    linear member

    4 approaches the protruding

    portion

    225 of the inner tube 22 (refer to

    FIG. 4

    ). Warping of the

    linear member

    4 is suppressed by the contraction of the

    first portion

    411 and the

    third portion

    413 of the

    flexible portion

    41. The

    linear member

    4A is covered from the outside by the

    pleat

    3A. The

    linear member

    4B is covered from the outside by the

    pleat

    3B. The

    linear member

    4C is covered from the outside by the

    pleat

    3C (refer to

    FIG. 3

    ).

  • As long as the

    flexible portion

    41 and the

    hard portion

    42 of the

    linear member

    4 have favorable hardness and extendability, the material thereof is not limited to the polyamide resin, and another synthetic resin can be used. The material is not limited to the synthetic resin, and stainless steel, a Ni—Ti alloy, or carbon fiber may be used.

    • Main Operations and Effects of First Embodiment

  • In the

    balloon catheter

    10 of the first embodiment, when the

    balloon

    3 inflates, since the

    inflatable region

    33 moves to the outside, the

    hard portion

    42 of the

    linear member

    4 that is disposed along the outer peripheral surface of the

    inflatable region

    33 also tries to move to the outside. In response to this, of the

    flexible portion

    41 of the

    linear member

    4, the

    first portion

    411 and the

    third portion

    413 on which the

    hard portion

    42 is not laminated elastically deform so as to extend along the extending direction. As a result, the

    hard portion

    42 can easily move to the outside. The

    outer portion

    42B of the

    hard portion

    42 of the

    linear member

    4 protrudes to the outside from the

    outer portion

    412B on the opposite side to the

    inner portion

    412A that faces the outer peripheral surface of the

    balloon

    3. The

    hard portion

    42 has a higher hardness than the

    flexible portion

    41. Thus, in a state in which the

    balloon

    3 is disposed in a constricted portion of a blood vessel, when the

    balloon

    3 is inflated, the

    hard portion

    42 acts appropriately on the constricted portion of the blood vessel. For example, the

    hard portion

    42 is peaked at the

    outer portion

    42B, and thus the

    hard portion

    42 can easily bite into a lesioned part (not shown in the drawings) of the blood vessel. As a result, in a state in which the

    linear member

    4 causes the

    balloon

    3 to be in a state of not easily slipping with respect to the lesioned part of the blood vessel, the lesioned part can be expanded from the inside by the inflation of the

    balloon

    3.

  • In the

    balloon catheter

    10, the

    first portion

    411 and the

    third portion

    413 of the

    flexible portion

    41 are caused to extend in accordance with the inflation of the

    balloon

    3, and the

    hard portion

    42 is caused to move to the outside. In this way, the

    balloon catheter

    10 can cause the

    hard portion

    42 to act on the constricted portion inside the blood vessel. As a result, other than the

    linear members

    4, the

    balloon catheter

    10 does not require a member that is necessary to be able to move the

    hard portion

    42 to the outside. Thus, when a user tries to move the

    balloon

    3 as far as the constricted portion of the blood vessel, the

    balloon catheter

    10 can inhibit obstruction of the movement of the

    balloon

    3 by the member other than the

    linear members

    4. In this way, the

    balloon catheter

    10 can cause the

    balloon

    3 to appropriately approach and be disposed at the constricted portion of the blood vessel.

  • The

    flexible portion

    41 of the

    linear member

    4 extends between the distal end position M1 and the proximal end position M2. Of the

    flexible portion

    41, the

    hard portion

    42 is laminated on the

    second portion

    412 that is disposed along the outer peripheral surface of the

    inflatable region

    33 in the inflated state. When the

    balloon

    3 is in the inflated state, the

    hard portion

    42 protrudes to the outside from the

    outer portion

    412B of the

    second portion

    412 of the

    flexible portion

    41. Thus, the

    balloon catheter

    10 can inhibit the

    hard portion

    42 from obstructing the extending of the

    first portion

    411 and the

    third portion

    413 of the

    flexible portion

    41, on which the

    hard portion

    42 is not laminated. The

    flexible portion

    41 extends appropriately at the

    first portion

    411 and the

    third portion

    413. Thus, the

    balloon catheter

    10 can easily move the

    hard portion

    42 to the outside in accordance with the inflation of the

    balloon

    3.

  • The first direction D11, which extends to the outside along the

    distal end surface

    42S that is the end portion of the

    hard portion

    42 on the distal end side, is inclined toward the proximal end side. In this case, when the

    balloon catheter

    10 moves inside the blood vessel in the course of the user causing the

    balloon

    3 to approach the constricted portion of the blood vessel, the

    linear member

    4 can be inhibited from catching on the inner wall of the blood vessel. Thus, the user can smoothly move the

    balloon

    3 as far as the constricted portion of the blood vessel. Further, the second direction D12, which extends to the outside along the

    proximal end surface

    42K that is the end portion of the

    hard portion

    42 on the proximal end side, is inclined toward the distal end side. In this case, when the

    balloon catheter

    10 moves inside the blood vessel in the course of the user pulling the

    balloon catheter

    10 out from the blood vessel, the

    linear member

    4 can be inhibited from catching on the inner wall of the blood vessel. Thus, the user can easily pull the

    balloon catheter

    10 out from the blood vessel.

  • With respect to the

    flexible portion

    41, the thickness R13 of the

    third portion

    413 located further toward the distal end side than the

    hard portion

    42 is narrower than the thickness R11 of the

    first portion

    411 located further toward the proximal end side than the

    hard portion

    42. In this case, in comparison to a case in which the thickness R13 is thicker than the thickness R11, or a case in which the thicknesses R11 and R13 are the same as each other, the

    balloon catheter

    10 can make the diameter of the distal end portion smaller. Thus, the user can cause the

    balloon

    3 of the

    balloon catheter

    10 to move as far as the constricted portion of the blood vessel using less force.

  • The first angle θ11, which is the acute angle of the angles formed between the extending direction and the first direction D11, is smaller than the second angle θ12, which is the acute angle of the angles formed between the extending direction and the second direction D12. In this case, the

    balloon catheter

    10 can use the portion of the

    distal end surface

    42S to reduce a rate of change of the hardness in the extending direction of the

    linear member

    4. Further, since the first angle θ11 is small, the

    balloon catheter

    10 can inhibit the

    linear members

    4 from catching on the inner wall of the blood vessel when the user moves the

    balloon catheter

    10 as far as the constricted portion inside the blood vessel. In this way, the user can easily move the

    balloon

    3 as far as the constricted portion of the blood vessel.

  • The protruding

    portion

    225 of the

    inner tube

    22 is provided with the

    markers

    22A and 22B in the positions separated from each other in the extending direction. The position P11 of the distal end side of the distal

    end side marker

    22A is aligned with the position of the boundary of the distal end side of the

    inflatable region

    33. The position P21 of the proximal end side of the proximal

    end side marker

    22B is aligned with the position of the boundary of the proximal end side of the

    inflatable region

    33. In this case, the user can correctly determine the

    inflatable region

    33 when the

    balloon

    3 is inflated, using the

    markers

    22A and 22B. Further, the

    hard portion

    42 is disposed so as to correspond to the

    inflatable region

    33 identified by the

    markers

    22A and 22B. Thus, the user can easily ascertain that the

    hard portion

    42 of the

    linear member

    4 is acting appropriately on the blood vessel at the

    inflatable region

    33 identified by the

    markers

    22A and 22B.

  • The proximal end

    side leg portion

    31 of the

    balloon

    3 is connected to the

    outer tube

    21 further toward the distal end side than the proximal end position M2. The proximal end position M2 corresponds to the position at which the end portion on the proximal end side of the

    linear member

    4 is connected to the

    outer tube

    21 via the mounting

    member

    21A. Thus, the

    balloon catheter

    10 can cause the

    linear member

    4 to be separated from the end portion on the proximal end side of the

    balloon

    3. In this case, the end portion on the proximal end side of the

    linear member

    4 is strongly fixed to the

    outer tube

    21. Further, the

    balloon catheter

    10 can suppress an impact on the proximal end

    side leg portion

    31 of the

    balloon

    3 caused by tension acting on the

    linear member

    4.

  • The

    linear member

    4 is formed of the synthetic resin. In this case, the

    linear member

    4 that includes the

    flexible portion

    41 and the

    hard portion

    42 can easily be manufactured by injection molding, extrusion molding or the like.

    • Second Embodiment

  • A

    balloon catheter

    20 according to a second embodiment of the present disclosure will be explained with reference to

    FIG. 9

    . Points in which the second embodiment differs from the first embodiment are as follows:

      • The mounting member 21A (refer to FIG. 2 and the like) is not mounted on the outer tube 21, and
      • The end portion on the proximal end side of the linear member 4 is connected further toward the proximal end side than the center in the extending direction of the proximal end side leg portion 31 of the balloon 3.

  • Hereinafter, where the configuration is the same as that of the first embodiment, the same reference numerals are assigned and an explanation thereof is omitted.

  • As shown in

    FIG. 9

    , the end portion on the proximal end side of the

    linear member

    4 is connected, by thermal welding, further toward the proximal end side than the center in the extending direction of the outer peripheral surface of the proximal end

    side leg portion

    31 of the

    balloon

    3. The proximal end position M2 that shows the position at which the end portion on the proximal end side of the

    linear member

    4 is connected corresponds to a position, of the proximal end

    side leg portion

    31 of the

    balloon

    3, which is located further toward the proximal end side than the center in the extending direction.

    • Main Operations and Effects of Second Embodiment

  • In the

    balloon catheter

    20 according to the second embodiment, the

    linear member

    4 can be fixed to the

    outer tube

    21 without needing the mounting

    member

    21A. Thus, the costs of the

    balloon catheter

    10 can be reduced. Further, in comparison to a case in which the

    linear member

    4 is connected directly to the

    outer tube

    21, the

    linear member

    4 can be reliably connected to the

    outer tube

    21 by connecting the

    linear member

    4 to the

    outer tube

    21 via the

    balloon

    3.

    • Third Embodiment

  • A

    balloon catheter

    30 according to a third embodiment of the present disclosure will be explained with reference to

    FIG. 10

    and

    FIG. 11

    . A point in which the third embodiment differs from the second embodiment is that a

    linear member

    6 is provided in place of the

    linear member

    4. Hereinafter, where the configuration is the same as that of the first embodiment and the second embodiment, the same reference numerals are assigned and an explanation thereof is omitted.

  • As shown in

    FIG. 10

    , the

    linear member

    6 includes a

    flexible portion

    61, and a

    hard portion

    62. The end portion on the proximal end side of the

    flexible portion

    61 is connected to the outer peripheral surface of the proximal end

    side leg portion

    31 of the

    balloon

    3, at the proximal end position M2. The

    hard portion

    62 includes a

    first portion

    621 and a

    second portion

    622. The

    first portion

    621 is adjacent to the distal end side of the

    flexible portion

    61. The

    second portion

    622 is adjacent to the distal end side of the

    first portion

    621. The end portion on the distal end side of the

    second portion

    622 is connected to the outer peripheral surface of the distal end

    side leg portion

    35 of the

    balloon

    3, at the distal end position M1. The

    flexible portion

    61, the

    first portion

    621 of the

    hard portion

    62, and the

    second portion

    622 of the

    hard portion

    62 are disposed side by side in that order from the proximal end toward the distal end along the extending direction.

  • The

    flexible portion

    61 corresponds to the first portion 411 (refer to

    FIG. 8

    ) of the

    flexible portion

    41 according to the first embodiment. The

    first portion

    621 of the

    hard portion

    62 corresponds to the laminated portion (refer to

    FIG. 8

    ) according to the first embodiment, in which the

    second portion

    412 of the

    flexible portion

    41 and the

    hard portion

    42 are laminated. The

    second portion

    622 of the

    hard portion

    62 corresponds to the third portion 413 (refer to

    FIG. 8

    ) of the

    flexible portion

    41 according to the first embodiment. The shape of each of the portions is the same. The material of the

    flexible portion

    61 is the same as the material of the

    flexible portion

    41 according to the first embodiment. The material of the

    hard portion

    62 is the same as the material of the

    hard portion

    42 according to the first embodiment.

  • FIG. 11

    shows cross sections of the

    linear member

    6 at each of a line A2-A2, a line B2-B2, and a line C2-C2. The shape of the cross section of the

    flexible portion

    61 is a trapezoid shape. An

    inner portion

    61A and an

    outer portion

    61B respectively correspond to the

    inner portion

    411A and the

    outer portion

    411B (refer to

    FIG. 8

    ) of the

    flexible portion

    41. A length between the

    inner portion

    61A and the

    outer portion

    61B of the

    flexible portion

    61, namely, a thickness R21 of the

    flexible portion

    61, is the same as the thickness R11 in the

    linear member

    4. The shape of the cross section of the

    first portion

    621 of the

    hard portion

    62 is an equilateral triangle shape. An

    inner portion

    621A and an

    outer portion

    621B respectively correspond to the

    inner portion

    412A and the

    outer portion

    42B (refer to

    FIG. 8

    ) of the

    flexible portion

    41. A length between the

    inner portion

    621A and the

    outer portion

    621B, namely, a thickness R22 of the

    first portion

    621 of the

    hard portion

    62, is the same as the thickness R12 in the

    linear member

    4. The shape of the cross section of the

    second portion

    622 of the

    hard portion

    62 is a trapezoid shape. An

    inner portion

    622A and an

    outer portion

    622B respectively correspond to the

    inner portion

    413A and the

    outer portion

    413B (refer to

    FIG. 8

    ) of the

    flexible portion

    41. A length between the

    inner portion

    622A and the

    outer portion

    622B of the

    hard portion

    62, namely, a thickness R23 of the

    second portion

    622, is the same as the thickness R13 in the

    linear member

    4. A

    distal end surface

    62S and a

    proximal end surface

    62K respectively correspond to the

    distal end surface

    42S and the

    proximal end surface

    42K (refer to

    FIG. 8

    ) of the

    hard portion

    42. A first direction D21 and a second direction D22 respectively correspond to the first direction D11 and the second direction D12 (refer to

    FIG. 8

    ). A first angle θ21 and a second angle θ22 respectively correspond to the first angle θ11 and the second angle θ12 (refer to

    FIG. 8

    ). The preferable five degrees of the first angle θ21 is smaller than the preferable sixteen degrees of the second angle θ22.

  • In accordance with the inflation of the

    balloon

    3, the

    first portion

    621 of the

    hard portion

    62 of the

    linear member

    6 tries to move away from the protruding

    portion

    225 of the

    inner tube

    22. At this time, the

    flexible portion

    61 of the

    linear member

    6 elastically deforms so as to extend along the extending direction. Thus, the

    first portion

    621 of the

    hard portion

    62 easily separates from the protruding

    portion

    225 of the

    inner tube

    22. The

    outer portion

    621B of the

    first portion

    621 of the

    hard portion

    62 protrudes to the outside with respect to the

    balloon

    3.

    • Main Operations and Effects of Third Embodiment

  • In the

    balloon catheter

    30 according to the third embodiment, the

    first portion

    621 of the

    hard portion

    62 is disposed in a portion, of the

    linear member

    6, that is aligned with the position, in the extending direction, of the

    inflatable region

    33 of the

    balloon

    3 in the inflated state. When the

    balloon

    3 is inflated, the

    flexible portion

    61 of the

    linear member

    6 elastically deforms so as to extend along the extending direction. In this way, the

    first portion

    621 of the

    hard portion

    62 moves away from the protruding

    portion

    225 of the

    inner tube

    22. The

    outer portion

    621B is disposed on the opposite side to the

    inner portion

    621A that faces the outer peripheral surface of the

    balloon

    3. Thus, with the

    balloon catheter

    30, when the

    balloon

    3 is inflated in the state in which the

    balloon

    3 is disposed at the constricted portion of the blood vessel, the

    hard portion

    62 acts appropriately on the constricted portion of the blood vessel.

  • In the

    balloon catheter

    30, the

    first portion

    621 of the

    hard portion

    62 is provided from the inside, which faces the

    inflatable region

    33 of the

    balloon

    3, to the outside. Thus, even if the

    linear member

    6 rotates with respect to the

    balloon

    3, the

    linear member

    6 can orient the

    hard portion

    62 toward the outside. Further, the

    hard portion

    62 is disposed not only at the portion corresponding to the

    inflatable region

    33 of the

    balloon

    3, but also at the portion corresponding further toward the distal end side than the

    inflatable region

    33. Thus, the

    balloon catheter

    30 can cause the

    second portion

    622 of the

    hard portion

    62 to act on the constricted portion of the blood vessel further toward the distal end side than the

    inflatable region

    33, when the

    balloon

    3 is inflated in the state in which the

    balloon

    3 is disposed at the constricted portion of the blood vessel.

  • In the

    linear member

    6, the

    flexible portion

    61 and the

    hard portion

    62 are adjacent in the extending direction. Thus, the

    linear member

    6 can be easily manufactured by connecting the respective end portions of the

    flexible portion

    61 and the

    hard portion

    62 in the extending direction.

    • Fourth Embodiment

  • A

    balloon catheter

    40 according to a fourth embodiment of the present disclosure will be explained with reference to

    FIG. 12

    and

    FIG. 13

    . A point in which the fourth embodiment differs from the second embodiment is that a

    linear member

    7 is provided in place of the

    linear member

    4. Hereinafter, where the configuration is the same as that of the first embodiment to the third embodiment, the same reference numerals are assigned and an explanation thereof is omitted.

  • As shown in

    FIG. 12

    , the

    linear member

    7 includes a

    hard portion

    71 and a

    flexible portion

    72. The

    hard portion

    71 includes a

    first portion

    711 and a

    second portion

    712. The end portion on the proximal end side of the

    first portion

    711 is connected to the outer peripheral surface of the proximal end

    side leg portion

    31 of the

    balloon

    3, at the proximal end position M2. The

    second portion

    712 is adjacent to the distal end side of the

    first portion

    711. The

    flexible portion

    72 is adjacent to the distal end side of the

    second portion

    712 of the

    hard portion

    71. The end portion on the distal end side of the

    flexible portion

    72 is connected to the outer peripheral surface of the distal end

    side leg portion

    35 of the

    balloon

    3, at the distal end position M1. The

    first portion

    711 of the

    hard portion

    71, the

    second portion

    712 of the

    hard portion

    71, and the

    flexible portion

    72 are disposed side by side in that order from the proximal end toward the distal end along the extending direction.

  • The

    first portion

    711 of the

    hard portion

    71 corresponds to the first portion 411 (refer to

    FIG. 8

    ) of the

    flexible portion

    41 according to the first embodiment. The

    second portion

    712 of the

    hard portion

    71 corresponds to the laminated portion (refer to

    FIG. 8

    ) according to the first embodiment, in which the

    second portion

    412 of the

    flexible portion

    41 and the

    hard portion

    42 are laminated. The

    flexible portion

    72 corresponds to the third portion 413 (refer to

    FIG. 8

    ) of the

    flexible portion

    41 according to the first embodiment. The shape of each of the portions is the same. The material of the

    flexible portion

    72 is the same as the material of the

    flexible portion

    41 according to the first embodiment. The material of the

    hard portion

    71 is the same as the material of the

    hard portion

    42 according to the first embodiment.

  • FIG. 13

    shows cross sections of the

    linear member

    7 at each of a line A3-A3, a line B3-B3, and a line C3-C3. The cross-sectional shape of the

    first portion

    711 of the

    hard portion

    71 is a trapezoid shape. An

    inner portion

    711A and an

    outer portion

    711B of the

    first portion

    711 respectively correspond to the

    inner portion

    411A and the

    outer portion

    411B (refer to

    FIG. 8

    ) of the

    flexible portion

    41. A length between the

    inner portion

    711A and the

    outer portion

    711B, namely, a thickness R31 of the

    first portion

    711, is the same as the thickness R11 in the

    linear member

    4. The shape of the cross section of the

    second portion

    712 of the

    hard portion

    71 is an equilateral triangle shape. An

    inner portion

    712A and an

    outer portion

    712B of the

    second portion

    712 respectively correspond to the

    inner portion

    412A and the

    outer portion

    42B (refer to

    FIG. 8

    ) of the

    flexible portion

    41. A length between the

    inner portion

    712A and the

    outer portion

    712B, namely, a thickness R32 of the

    second portion

    712, is the same as the thickness R12 in the

    linear member

    4. The shape of the cross section of the

    flexible portion

    72 is a trapezoid shape. An

    inner portion

    72A and an

    outer portion

    72B of the

    flexible portion

    72 respectively correspond to the

    inner portion

    413A and the

    outer portion

    413B (refer to

    FIG. 8

    ) of the

    flexible portion

    41. A length between the

    inner portion

    72A and the

    outer portion

    72B, namely, a thickness R33 of the

    flexible portion

    72, is the same as the thickness R13 in the

    linear member

    4. A distal end surface 72S and a

    proximal end surface

    72K respectively correspond to the

    distal end surface

    42S and the

    proximal end surface

    42K (refer to

    FIG. 8

    ) of the

    hard portion

    42. A first direction D31 and a second direction D32 respectively correspond to the first direction D11 and the second direction D12 (refer to

    FIG. 8

    ). A first angle θ31 and a second angle θ32 respectively correspond to the first angle θ11 and the second angle θ12 (refer to

    FIG. 8

    ). The preferable five degrees of the first angle θ31 is smaller than the preferable sixteen degrees of the second angle θ32.

  • In accordance with the inflation of the

    balloon

    3, the

    second portion

    712 of the

    hard portion

    71 of the

    linear member

    7 tries to move away from the protruding

    portion

    225 of the

    inner tube

    22. At this time, the

    flexible portion

    72 of the

    linear member

    7 elastically deforms so as to extend along the extending direction. Thus, the

    second portion

    712 of the

    hard portion

    71 easily separates from the protruding

    portion

    225 of the

    inner tube

    22. The

    outer portion

    712B of the

    second portion

    712 of the

    hard portion

    71 protrudes to the outside with respect to the

    balloon

    3.

    • Main Operations and Effects of Fourth Embodiment

  • In the

    balloon catheter

    40 according to the fourth embodiment, the

    second portion

    712 of the

    hard portion

    71 is disposed in a portion, of the

    linear member

    7, that is aligned with the position, in the extending direction, of the

    inflatable region

    33 of the

    balloon

    3 in the inflated state. When the

    balloon

    3 is inflated, the

    flexible portion

    72 of the

    linear member

    7 elastically deforms so as to extend along the extending direction. In this way, the

    second portion

    712 of the

    hard portion

    71 moves away from the protruding

    portion

    225 of the

    inner tube

    22. The

    outer portion

    712B is disposed on the opposite side to the

    inner portion

    712A that faces the outer peripheral surface of the

    balloon

    3. Thus, with the

    balloon catheter

    40, when the

    balloon

    3 is inflated in the state in which the

    balloon

    3 is disposed at the constricted portion of the blood vessel, the

    hard portion

    71 acts appropriately on the constricted portion of the blood vessel.

  • In the

    balloon catheter

    40, the

    second portion

    712 of the

    hard portion

    71 is provided from the inside, which faces the

    inflatable region

    33 of the

    balloon

    3, to the outside. Thus, even if the

    linear member

    7 rotates with respect to the

    balloon

    3, the

    linear member

    7 can orient the

    hard portion

    71 toward the outside. Further, the

    hard portion

    71 is disposed not only at the portion corresponding to the

    inflatable region

    33 of the

    balloon

    3, but also at the portion corresponding further toward the proximal end side than the

    inflatable region

    33. Thus, the

    balloon catheter

    40 can cause the

    first portion

    711 of the

    hard portion

    71 to act on the constricted portion of the blood vessel further toward the proximal end side than the

    inflatable region

    33, when the

    balloon

    3 is inflated in the state in which the

    balloon

    3 is disposed at the constricted portion of the blood vessel.

  • In the

    linear member

    7, the

    hard portion

    71 and the

    flexible portion

    72 are adjacent in the extending direction. Thus, the

    linear member

    7 can be easily manufactured by connecting the respective end portions of the

    hard portion

    71 and the

    flexible portion

    72 in the extending direction.

    • Fifth Embodiment

  • A

    balloon catheter

    50 according to a fifth embodiment of the present disclosure will be explained with reference to

    FIG. 14

    and

    FIG. 15

    . A point in which the fifth embodiment differs from the second embodiment is that a

    linear member

    8 is provided in place of the

    linear member

    4. Hereinafter, where the configuration is the same as that of the first embodiment to the fourth embodiment, the same reference numerals are assigned and an explanation thereof is omitted.

  • As shown in

    FIG. 14

    , the

    linear member

    8 includes

    flexible portions

    81 and 83, and a

    hard portion

    82. The end portion on the proximal end side of the

    flexible portion

    81 is connected to the outer peripheral surface of the proximal end

    side leg portion

    31 of the

    balloon

    3, at the proximal end position M2. The

    hard portion

    82 is adjacent to the distal end side of the

    flexible portion

    81. The

    flexible portion

    83 is adjacent to the distal end side of the

    hard portion

    82. The end portion on the distal end side of the

    flexible portion

    83 is connected to the outer peripheral surface of the distal end

    side leg portion

    35 of the

    balloon

    3, at the distal end position M1. The

    flexible portion

    81, the

    hard portion

    82, and the

    flexible portion

    83 are disposed side by side in that order from the proximal end toward the distal end along the extending direction.

  • The

    flexible portion

    81 corresponds to the first portion 411 (refer to

    FIG. 8

    ) of the

    flexible portion

    41 according to the first embodiment. The

    hard portion

    82 corresponds to the laminated portion (refer to

    FIG. 8

    ) according to the first embodiment, in which the

    second portion

    412 of the

    flexible portion

    41 and the

    hard portion

    42 are laminated. The

    flexible portion

    83 corresponds to the third portion 413 (refer to

    FIG. 8

    ) of the

    flexible portion

    41 according to the first embodiment. The shape of each of the portions is the same. The material of the

    flexible portions

    81 and 83 is the same as the material of the

    flexible portion

    41 according to the first embodiment. The material of the

    hard portion

    82 is the same as the material of the

    hard portion

    42 according to the first embodiment.

  • FIG. 15

    shows cross sections of the

    linear member

    8 at each of a line A4-A4, a line B4-B4, and a line C4-C4. The cross-sectional shape of the

    flexible portion

    81 is a trapezoid shape. An

    inner portion

    81A and an

    outer portion

    81B of the

    flexible portion

    81 respectively correspond to the

    inner portion

    411A and the

    outer portion

    411B (refer to

    FIG. 8

    ) of the

    flexible portion

    41. A length between the

    inner portion

    81A and the

    outer portion

    81B, namely, a thickness R41 of the

    flexible portion

    81, is the same as the thickness R11 in the

    linear member

    4. The shape of the cross section of the

    hard portion

    82 is an equilateral triangle shape. An

    inner portion

    82A and an

    outer portion

    82B of the

    hard portion

    82 respectively correspond to the

    inner portion

    412A and the

    outer portion

    42B (refer to

    FIG. 8

    ) of the

    flexible portion

    41. A length between the

    inner portion

    82A and the

    outer portion

    82B, namely, a thickness R42 of the

    hard portion

    82, is the same as the thickness R12 in the

    linear member

    4. The shape of the cross section of the

    flexible portion

    83 is a trapezoid shape. An

    inner portion

    83A and an

    outer portion

    83B of the

    flexible portion

    83 respectively correspond to the

    inner portion

    413A and the

    outer portion

    413B (refer to

    FIG. 8

    ) of the

    flexible portion

    41. A length between the

    inner portion

    83A and the

    outer portion

    83B, namely, a thickness R43 of the

    flexible portion

    83, is the same as the thickness R13 in the

    linear member

    4. A distal end surface 82S and a

    proximal end surface

    82K respectively correspond to the

    distal end surface

    42S and the

    proximal end surface

    42K (refer to

    FIG. 8

    ) of the

    hard portion

    42. A first direction D41 and a second direction D42 respectively correspond to the first direction D11 and the second direction D12 (refer to

    FIG. 8

    ). A first angle θ41 and a second angle θ42 respectively correspond to the first angle θ11 and the second angle θ12 (refer to

    FIG. 8

    ). The preferable five degrees of the first angle θ41 is smaller than the preferable sixteen degrees of the second angle θ42.

  • In accordance with the inflation of the

    balloon

    3, the

    hard portion

    82 of the

    linear member

    8 tries to move away from the protruding

    portion

    225 of the

    inner tube

    22. At this time, the

    flexible portions

    81 and 83 of the

    linear member

    8 elastically deform so as to extend along the extending direction. Thus, the

    hard portion

    82 easily separates from the protruding

    portion

    225 of the

    inner tube

    22. The

    outer portion

    82B of the

    hard portion

    82 protrudes to the outside with respect to the

    balloon

    3.

    • Main Operations and Effects of Fifth Embodiment

  • In the

    balloon catheter

    50 according to the fifth embodiment, the

    hard portion

    82 is disposed in a portion, of the

    linear member

    8, that is aligned with the position, in the extending direction, of the

    inflatable region

    33 of the

    balloon

    3 in the inflated state. When the

    balloon

    3 is inflated, the

    flexible portions

    81 and 83 of the

    linear member

    8 elastically deform so as to extend along the extending direction. In this way, the

    hard portion

    82 moves away from the protruding

    portion

    225 of the

    inner tube

    22. The

    outer portion

    82B is disposed on the opposite side to the

    inner portion

    82A that faces the outer peripheral surface of the

    balloon

    3. Thus, when the

    balloon

    3 is inflated in the state in which the

    balloon

    3 is disposed at the constricted portion of the blood vessel, the

    hard portion

    82 acts appropriately on the constricted portion of the blood vessel.

  • In the

    balloon catheter

    50, the

    flexible portions

    81 and 83 are provided on the distal end side and the proximal end side of the

    hard portion

    82. Thus, the

    linear member

    8 easily extends in the extending direction when the

    balloon

    3 is inflated. As a result, the

    balloon catheter

    50 can easily cause the

    hard portion

    82 to separate from the protruding

    portion

    225 of the

    inner tube

    22.

  • In the

    linear member

    8, the

    flexible portion

    81, the

    hard portion

    82, and the

    flexible portion

    83 are adjacent to each other in the extending direction. Thus, the

    linear member

    8 can be easily manufactured by connecting the respective end portions in the extending direction of the

    flexible portions

    81 and 81, and the

    hard portion

    82.

    • Sixth Embodiment

  • A

    balloon catheter

    90 according to a sixth embodiment will be explained with reference to

    FIG. 16

    to

    FIG. 19

    . Points in which the sixth embodiment differs from the second embodiment are as follows:

      • A linear member 9 is provided in place of the linear member 4, and
      • The linear member 9 is bonded to the balloon 3 across the whole length of the linear member 9 in the extending direction.

  • Hereinafter, where the configuration is the same as that of the first embodiment to the fifth embodiment, the same reference numerals are assigned and an explanation thereof is omitted.

    • Linear Member 9

  • The

    linear member

    9 will be explained with reference to

    FIG. 16

    to

    FIG. 19

    .

    Linear members

    9A, 9B, and 9C respectively correspond to the

    linear members

    4A, 4B, and 4C according to the second embodiment. As shown in

    FIG. 16

    to

    FIG. 18

    , the

    linear member

    9 is bonded to the outer peripheral surface of the

    balloon

    3 across the whole length of the

    linear member

    9 from the proximal end position M2 to the distal end position M1. For example, the

    linear member

    9 is bonded to the outer peripheral surface of the

    balloon

    3 using thermal welding. However, the

    linear member

    9 may be bonded to the outer peripheral surface of the

    balloon

    3 using another method, such as adhesive or the like. As shown in

    FIG. 17

    , when the

    balloon

    3 is in the inflated state, the

    linear members

    9A, 9B, and 9C extend in straight lines in the extending direction, at positions respectively dividing the

    balloon

    3 into three approximately equal parts in the circumferential direction. At that time, a force in a direction to try and elongate the

    linear member

    9 in the extending direction (hereinafter referred to as a “force in an elongation direction”) acts on the

    linear member

    9. In contrast to this, when the

    balloon

    3 is in the deflated state, the force in the elongation direction does not act on the

    linear member

    9.

  • As shown in

    FIG. 16

    and

    FIG. 18

    , the

    linear member

    9 includes a

    flexible portion

    91 and a

    hard portion

    92. The

    flexible portion

    91 extends between the proximal end position M2 and the distal end position M1. The

    flexible portion

    91 includes a

    first portion

    911, a

    second portion

    912, and a

    third portion

    913. The

    first portion

    911, the

    second portion

    912, and the

    third portion

    913 respectively correspond to sections of the

    flexible portion

    91 that is divided into three in the extending direction. The

    first portion

    911 is bonded to the outer peripheral surfaces of the proximal end

    side leg portion

    31 and the proximal end

    side cone region

    32 of the

    balloon

    3. The

    second portion

    912 is adjacent to the distal end side of the

    first portion

    911. The

    second portion

    912 is bonded to the outer peripheral surface of the

    inflatable region

    33 of the

    balloon

    3. The

    third portion

    913 is adjacent to the distal end side of the

    second portion

    912. The

    third portion

    913 is bonded to the outer peripheral surfaces of the distal end

    side cone region

    34 and the distal end

    side leg portion

    35 of the

    balloon

    3. The

    hard portion

    92 is laminated to a portion, of the

    second portion

    912 of the

    flexible portion

    91, on the opposite side to the portion bonded to the

    balloon

    3.

  • FIG. 19

    shows cross sections of the

    linear member

    9 at each of a line A5-A5, a line B5-B5, and a line C5-C5 in a state in which the force in the elongation direction is not acting on the

    linear member

    9. The cross-sectional shape of the

    linear member

    9 is a trapezoid shape or an equilateral triangle shape. Specifically, it is as described below.

  • The shape of the cross section of the flexible portion 91 (the

    first portion

    911 to the third portion 913) is the trapezoid shape. Hereinafter, of the

    first portion

    911 of the

    flexible portion

    91, a portion bonded to the balloon 3 (refer to

    FIG. 16

    ) is referred to as an “

    inner portion

    911A.” Of the

    first portion

    911, a portion on the opposite side to the

    inner portion

    911A is referred to as an “

    outer portion

    911B.” Of the

    second portion

    912 of the

    flexible portion

    91, a portion bonded to the

    balloon

    3 is referred to as an “

    inner portion

    912A.” Of the

    second portion

    912, a portion on the opposite side to the

    inner portion

    912A is referred to as a “

    boundary

    912B.” Of the

    third portion

    913 of the

    flexible portion

    91, a portion bonded to the

    balloon

    3 is referred to as an “

    inner portion

    913A.” Of the

    third portion

    913, a portion on the opposite side to the

    inner portion

    913A is referred to as an “

    outer portion

    913B.” The

    inner portions

    911A, 912A, and 913A respectively correspond to the lower base of the trapezoid that is the cross-sectional shape. The

    outer portions

    911B and 913B, and the

    boundary

    912B respectively correspond to the upper base of the trapezoid that is the cross-sectional shape.

  • The shape of the cross section of the

    hard portion

    92 is an equilateral triangle shape having the

    boundary

    912B of the

    second portion

    912 as one side. The

    hard portion

    92 protrudes to the outside from the

    boundary

    912B of the

    second portion

    912 of the

    flexible portion

    91. Hereinafter, an end portion on the outside of the

    hard portion

    92 is referred to as an “

    outer portion

    92B.” The

    outer portion

    92B corresponds to an apex of the equilateral triangle shape, and thus is peaked.

  • A length between the

    inner portion

    911A and the

    outer portion

    911B of the

    first portion

    911, namely, a thickness of a portion of the

    flexible portion

    91 further toward the proximal end side than the

    hard portion

    92, is denoted as a thickness R51. A length between the

    inner portion

    912A and the

    boundary

    912B of the

    second portion

    912, namely, a thickness of a portion of the

    flexible portion

    91 that overlaps with the

    hard portion

    92 in the extending direction, is denoted as R52. A length between the

    inner portion

    913A and the

    outer portion

    913B of the

    third portion

    913, namely, a thickness of a portion of the

    flexible portion

    91 further toward the distal end side than the

    hard portion

    92, is denoted as R53. In this case, the thicknesses R51, R52, and R53 are equal.

  • An end surface on the distal end side of the

    hard portion

    92 is referred to a “

    distal end surface

    92S.” A virtual first direction D51 is defined that extends toward the outside along the

    distal end surface

    92S of the

    hard portion

    92. The first direction D51 is inclined toward the proximal end side with respect to the direction orthogonal to the extending direction. An end surface on the proximal end side of the

    hard portion

    92 is referred to as a “

    proximal end surface

    92K.” A virtual second direction D52 is defined that extends toward the outside along the

    proximal end surface

    92K of the

    hard portion

    92. The second direction D52 is inclined toward the distal end side with respect to the direction orthogonal to the extending direction. An acute angle, of angles formed between the first direction D51 and the extending direction, is defined as a first angle θ51. The

    first angle

    051 is an angle between 4 to 13 degrees, for example. The first angle θ51 is preferably 5 degrees. An acute angle, of angles formed between the second direction D52 and the extending direction is defined as a second angle θ52. The second angle θ52 is an angle between 5 to 16 degrees, for example. The second angle θ52 is preferably 16 degrees. The preferable five degrees of the first angle θ51 is smaller than the preferable sixteen degrees of the second angle θ52.

  • As shown in

    FIG. 18

    , a position of a boundary on the distal end side of the

    second portion

    912 of the

    flexible portion

    91, in other words, a position of a boundary between the

    second portion

    912 and the

    third portion

    913, is aligned, in the extending direction, with the position P11 of the end portion on the distal end side of the

    marker

    22A. A position of a boundary on the proximal end side of the

    second portion

    912 of the

    flexible portion

    91, in other words, a position of a boundary between the

    first portion

    911 and the

    second portion

    912, is aligned, in the extending direction, with the position P21 of the end portion on the proximal end side of the

    marker

    22B. Note that the

    hard portion

    92 of the

    linear member

    9 is laminated on the

    second portion

    912 of the

    flexible portion

    91. Thus, the

    inflatable region

    33 of the

    balloon

    3, the

    second portion

    912 of the

    flexible portion

    91, and the

    hard portion

    92 are all disposed in the same position in the extending direction.

  • As shown in

    FIG. 19

    , two

    notches

    51, which extend toward the inside in the radial direction from the

    outer portion

    92B of the

    hard portion

    92, are formed in the

    linear member

    9. Each of the two

    notches

    51 is formed by cutting out a part of the

    linear member

    9. A cross-sectional shape of each of the

    notches

    51 is a wedge shape. The two

    notches

    51 are disposed side by side at an equal interval in the extending direction.

  • Each of the

    notches

    51 includes

    surfaces

    51A and 51B that face each other in the extending direction. When the

    balloon

    3 is not in the inflated state, namely, in the state in which the force in the elongation direction is not acting on the

    linear member

    9, a direction that extends to the outside along the

    surface

    51A is inclined toward the proximal end side with respect to the direction orthogonal to the extending direction. A direction that extends to the outside along the

    surface

    51B is inclined toward the distal end side with respect to the direction orthogonal to the extending direction. The

    surfaces

    51A and 51B are disposed with an interval therebetween in the extending direction. A gap is formed between the

    surfaces

    51A and 51B. The

    surfaces

    51A and 51B are connected by respective inside end portions thereof. The end portions that connect the

    surfaces

    51A and 51B are, in other words, an end portion (hereinafter referred to as a “bottom portion”) 51C of the inside of the

    notch

    51. The

    bottom portion

    51C is positioned further to the inside, in the radial direction, than the

    boundary

    912B that represents the boundary between the

    second portion

    912 of the

    flexible portion

    91 and the

    hard portion

    92.

  • When the

    balloon

    3 inflates as a result of the compressed fluid being supplied from the

    hub

    5, the force in the elongation direction acts on the

    first portion

    911 and the

    third portion

    913 of the

    flexible portion

    91 of the

    linear member

    9. As a result, the

    first portion

    911 and the

    third portion

    913 elastically deform so as to extend along the extending direction. Further, of the

    linear member

    9, the force in the extending direction also acts on the section at which the

    second portion

    912 of the

    flexible portion

    91 and the

    hard portion

    92 are laminated. Here, in comparison to the

    flexible portion

    91, the

    hard portion

    92 does not easily extend. As a result of the

    second portion

    912 of the

    flexible portion

    91 elastically deforming due to the force in the extending direction, the

    respective surfaces

    51A and 51B of the plurality of

    notches

    51 separate from each other in the extending direction. As a result, the elastic deformation of the

    second portion

    912 of the

    flexible portion

    91 is not easily suppressed by the

    hard portion

    92. Thus, of the

    linear member

    9, even the section in which the

    second portion

    912 of the

    flexible portion

    91 and the

    hard portion

    92 are laminated elastically deforms so as to extend in the extending direction in accordance with the inflation of the

    balloon

    3. As a result of the above, the

    linear member

    9 follows the inflation of the

    balloon

    3 and extends in the extending direction across the whole length of the

    linear member

    9 in the extending direction.

  • Meanwhile, when the

    balloon

    3 deflates as a result of the compressed fluid being discharged from the

    balloon

    3 in the inflated state, the

    flexible portion

    91 of the

    linear member

    9 that is extended in the extending direction contracts due to a restoring force. The

    surfaces

    51A and 51B of the

    notches

    51 of the

    hard portion

    92 of the

    linear member

    9 approach each other with a space therebetween in the extending direction. The

    linear member

    9A is covered from the outside by the

    pleat

    3A, the

    linear member

    9B is covered from the outside by the

    pleat

    3B, and the linear member 9C is covered from the outside by the

    pleat

    3C.

    • Main Operations and Effects of Sixth Embodiment

  • In the

    balloon catheter

    90, when the

    balloon

    3 is inflated, the force that tries to elongate acts on the

    linear member

    9. If the

    linear member

    9 does not extend well even when this force is acting, the

    linear member

    9 cannot follow the inflation of the

    balloon

    3 and there is a possibility that the

    linear member

    9 may break away from the

    balloon

    3. Further, there is a case in which the inflation of the

    balloon

    3 is obstructed by the

    linear member

    9. Thus, it is preferable that the extendability of the

    linear member

    9 be high. On the other hand, in order to cause the

    linear member

    9 to act appropriately on the blood vessel when the

    balloon

    3 is inflated, it is preferable that the hardness of the

    linear member

    9 be harder.

  • In response to this, in the

    balloon catheter

    90, when the

    balloon

    3 is inflated, the

    outer portion

    92B of the

    hard portion

    92 of the

    linear member

    9 protrudes to the outside with respect to the

    balloon

    3. The hardness of the

    hard portion

    92 is harder than the

    flexible portion

    91. Thus, the

    linear member

    9 can cause the

    hard portion

    92 to act appropriately on the blood vessel when the

    balloon

    3 is inflated. For example, since the

    outer portion

    92B of the

    hard portion

    92 is peaked, the

    hard portion

    92 easily bites into the lesioned part (not shown in the drawings) of the blood vessel. As a result, in a state in which the

    linear member

    9 causes the

    balloon

    3 to be in a state of not easily slipping with respect to the lesioned part of the blood vessel, the lesioned part can be expanded from inside by the inflation of the

    balloon

    3.

  • The

    flexible portion

    91 of the

    linear member

    9 can extend. Thus, when the

    linear member

    9 tries to extend in accordance with the inflation of the

    balloon

    3, the

    first portion

    911 and the

    third portion

    913, of the

    flexible portion

    91, on which the

    hard portion

    92 is not laminated extend in a favorable manner, and follow the

    balloon

    3. Further, the two

    notches

    51 are formed in the

    linear member

    9. Thus, when the

    second portion

    912 of the

    flexible portion

    91 tries to extend in accordance with the inflation of the

    balloon

    3, the

    surfaces

    51A and 51B of each of the

    notches

    51 separate from each other, thus suppressing the

    hard portion

    92 from obstructing the extending of the

    second portion

    912 of the

    flexible portion

    91. As a result, the

    linear member

    9 can extend appropriately across the whole length of the

    linear member

    9 in accordance with the inflation of the

    balloon

    3, and can follow the inflation of the

    balloon

    3. Thus, the

    balloon catheter

    90 can inhibit the

    linear member

    9 from breaking away from the

    balloon

    3 when the

    balloon

    3 is inflated, or inhibit the

    linear member

    9 from obstructing the inflation of the

    balloon

    3.

  • The

    bottom portion

    51C of each of the

    notches

    51 is positioned further to the inside, in the radial direction, than the

    boundary

    912B between the

    second portion

    912 of the

    flexible portion

    91 and the

    hard portion

    92. In this case, the

    hard portion

    92 is divided into three by the two

    notches

    51. Thus, the

    linear member

    9 can appropriately suppress the

    hard portion

    92 from obstructing the extending of the

    second portion

    912 of the

    flexible portion

    91. As a result, the

    balloon catheter

    90 can even more appropriately inhibit the

    linear member

    9 from breaking away from the

    balloon

    3 when the

    balloon

    3 is inflated, or inhibit the

    linear member

    9 from obstructing the inflation of the

    balloon

    3.

  • The

    surfaces

    51A and 51B of each of the two

    notches

    51 are disposed so as to be separated from each other in the extending direction. In this case, the

    linear member

    9 can easily bend in the direction orthogonal to the extending direction at the section in which the

    notches

    51 are formed. As a result, when the

    balloon

    3 bends in the direction orthogonal to the extending direction, the

    balloon catheter

    90 can cause the

    linear member

    9 to follow the

    balloon

    3 and bend. Thus, the

    balloon catheter

    90 can suppress the

    linear member

    9 from breaking away from the

    balloon

    3 when the

    balloon

    3 bends.

  • The

    linear member

    9 is bonded to the outer peripheral surface of the

    balloon

    3 between the distal end position M1 and the proximal end position M2. As a result, the

    linear member

    9 is held in a fixed position with respect to the

    balloon

    3. Thus, the

    balloon catheter

    90 can cause the

    linear member

    9 to act on the blood vessel when the

    balloon

    3 is inflated, while the

    linear member

    9 is held in a correct position with respect to the

    balloon

    3. Further, by directly bonding the

    linear member

    9 to the

    balloon

    3, the

    balloon catheter

    90 can inhibit the position of the

    linear member

    9 with respect to the

    balloon

    3 from changing in accordance with the inflation of the

    balloon

    3.

  • The first direction D51, which extends to the outside along the

    distal end surface

    92S that is the end portion of the

    hard portion

    92 on the distal end side, is inclined toward the proximal end side. In this case, when the

    balloon catheter

    90 moves inside the blood vessel in the course of the user causing the

    balloon

    3 to approach the constricted portion of the blood vessel, the

    linear member

    9 can be inhibited from catching on the inner wall of the blood vessel. Thus, the user can smoothly move the

    balloon

    3 as far as the constricted portion of the blood vessel. Further, the second direction D52, which extends to the outside along the

    proximal end surface

    92K that is the end portion of the

    hard portion

    92 on the proximal end side, is inclined toward the distal end side. In this case, when the

    balloon catheter

    90 moves inside the blood vessel in the course of the user pulling the

    balloon catheter

    90 out from the blood vessel, the

    linear member

    9 can be inhibited from catching on the inner wall of the blood vessel. Thus, the user can easily pull the

    balloon catheter

    90 out from the blood vessel.

  • The

    linear member

    9 is formed of a synthetic resin. In this case, the

    linear member

    9 that includes the

    flexible portion

    91 and the

    hard portion

    92 can be easily manufactured by injection molding, extrusion molding or the like.

    • Seventh Embodiment and Eighth Embodiment

  • A seventh embodiment and an eighth embodiment will be explained with reference to FIG. 20 and

    FIG. 21

    . In the seventh embodiment, in place of the

    notches

    51 of the sixth embodiment, notches 52 (refer to

    FIG. 20

    ) are formed in the

    linear member

    9. In the eighth embodiment, in place of the

    notches

    51 of the sixth embodiment, notches 53 (refer to

    FIG. 21

    ) are formed in the

    linear member

    9. Other parts of the configuration are the same as those of the sixth embodiment. Hereinafter, where the configuration is the same as that of the above-described embodiments, the same reference numerals are assigned and an explanation thereof is omitted.

  • As shown in

    FIG. 20

    , in the seventh embodiment, the

    notch

    52 includes

    surfaces

    52A and 52B. The end portion on the inside of the

    notch

    52 is referred to as a “bottom portion 52C.” The

    surfaces

    52A and 52B, and the bottom portion 52C respectively correspond to the

    surfaces

    51A and 51B, and the

    bottom portion

    51C of the

    notch

    51 of the sixth embodiment. In the

    notch

    52, a position of the bottom portion 52C in the radial direction is different to that of the

    notch

    51. In the

    notch

    52, the bottom portion 52C is positioned in substantially the same position as the

    boundary

    912B between the

    second portion

    912 of the

    flexible portion

    91 and the

    hard portion

    92. In this case, similarly to the sixth embodiment, the

    hard portion

    92 is divided into three in the extending direction by two of the

    notches

    52. As a result, the

    linear member

    9 can appropriately suppress the extending of the

    second portion

    912 of the

    flexible portion

    91 from being obstructed by the

    hard portion

    92. Thus, similarly to the sixth embodiment, the

    balloon catheter

    90 can even more appropriately inhibit the

    linear member

    9 from breaking away from the

    balloon

    3 when the

    balloon

    3 is inflated, or inhibit the

    linear member

    9 from obstructing the inflation of the

    balloon

    3. In addition, in contrast to the sixth embodiment, a part of the

    notch

    52 is not formed in the

    flexible portion

    91. Therefore, in comparison to the case in which the part of the

    notch

    51 is formed in the

    second portion

    912 of the

    flexible portion

    91 as in the sixth embodiment, the strength of the

    second portion

    912 of the

    flexible portion

    91 is maintained when extending.

  • As shown in

    FIG. 21

    , in the eighth embodiment, the

    notch

    53 includes

    surfaces

    53A and 53B. The end portion on the inside of the

    notch

    53 is referred to as a “bottom portion 53C.” The

    surfaces

    53A and 53B, and the bottom portion 53C respectively correspond to the

    surfaces

    51A and 51B, and the

    bottom portion

    51C of the

    notch

    51 of the above-described embodiment. In the

    notch

    53, a position of the bottom portion 53C in the radial direction is different to that of the

    notches

    51 and 52. In the

    notch

    53, the bottom portion 53C is positioned further to the outside than the

    boundary

    912B between the

    second portion

    912 of the

    flexible portion

    91 and the

    hard portion

    92.

  • When the

    notch

    53 is formed in the

    linear member

    9, in contrast to the sixth embodiment and the seventh embodiment, the

    hard portion

    92 is not divided in the extending direction by the

    notch

    53. However, of the

    hard portion

    92, a portion further to the inside than the bottom portion 53C of the

    notch

    53 extends easily in the extending direction, compared to a portion in which the

    notch

    53 is not formed. Therefore, of the

    linear member

    9, the portion in which the

    second portion

    912 of the

    flexible portion

    91 and the

    hard portion

    92 are laminated extends in the extending direction in accordance with the inflation of the

    balloon

    3. Thus, similarly to the sixth embodiment and the seventh embodiment, the

    balloon catheter

    90 can inhibit the

    linear member

    9 from breaking away from the

    balloon

    3 when the

    balloon

    3 is inflated, or inhibit the

    linear member

    9 from obstructing the inflation of the

    balloon

    3.

  • The depth of the

    notch

    53 is smaller than that of the

    notches

    51 and 52, and therefore, the space between the

    surfaces

    53A and 53B can be minimized when the

    surfaces

    53A and 53B separate from each other in accordance with the inflation of the

    balloon

    3. As a result, an area of the

    outer portion

    92B of the

    hard portion

    92 can be made larger than in the case of the sixth embodiment and the seventh embodiment. Note that, when the

    balloon

    3 is inflated, the

    outer portion

    92B of the

    hard portion

    92 comes into contact with the blood vessel wall. Thus, since the

    balloon catheter

    90 can increase the area of the portion (the

    outer portion

    92B of the hard portion 92) of the

    linear member

    9 that comes into contact with the blood vessel wall, the

    balloon catheter

    90 can cause the

    linear member

    9 to act appropriately on the blood vessel when the

    balloon

    3 is inflated.

    • Ninth Embodiment

  • A ninth embodiment will be explained with reference to

    FIG. 22

    . In the ninth embodiment,

    incisions

    54 are formed in place of the

    notches

    51 of the sixth embodiment. Other parts of the configuration are the same as those of the sixth to eighth embodiments. Hereinafter, where the configuration is the same as that of the above-described embodiments, the same reference numerals are assigned and an explanation thereof is omitted.

  • As shown in

    FIG. 22

    , the

    incision

    54 extends to the inside along the radial direction, from the

    outer portion

    92B of the

    hard portion

    92. The

    incision

    54 includes

    surfaces

    54A and 54B that face each other in the extending direction. An end portion (hereinafter referred to as a “bottom portion”) MC on the inside of each of the

    incisions

    54 is positioned further to the inside, in the radial direction, than the

    boundary

    912B between the

    second portion

    912 of the

    flexible portion

    91 and the

    hard portion

    92.

  • When the compressed fluid is not supplied from the

    hub

    5 and the

    balloon

    3 is not in the inflated state, the force in the elongation direction does not act on the

    linear member

    9. In this case, as shown in

    FIG. 22

    , the

    surfaces

    54A and 54B are in contact with each other. A gap is not formed between the

    surfaces

    54A and 54B. On the other hand, when the

    balloon

    3 is inflated as a result of the compressed fluid being supplied from the

    hub

    5, the force in the elongation direction acts on the portion, of the

    linear member

    9, at which the

    second portion

    912 of the

    flexible portion

    91 and the

    hard portion

    92 are laminated. The

    surfaces

    54A and 54B of the

    incision

    54 separate from each other in the extending direction, as a result of the elastic deformation of the

    second portion

    912 of the

    flexible portion

    91. The

    hard portion

    92 is divided in the extending direction by the

    incisions

    54. Thus, the elastic deformation of the

    second portion

    912 of the

    flexible portion

    91 is not easily suppressed by the

    hard portion

    92. As a result, the portion of the

    linear member

    9 at which the

    second portion

    912 of the

    flexible portion

    91 and the

    hard portion

    92 are laminated extends in the extending direction in accordance with the inflation of the

    balloon

    3. Meanwhile, when the

    balloon

    3 is deflated as a result of the compressed fluid being discharged from the

    balloon

    3 in the inflated state, the

    flexible portion

    91 of the

    linear member

    9 that is extended in the extending direction contracts due to the restoring force. The

    surfaces

    54A and 54B of the

    incision

    54 of the

    hard portion

    92 once more come into contact with each other. The

    surfaces

    54A and 54B return to the state in which the gap is not formed therebetween.

    • Main Operations and Effects of Ninth Embodiment

  • As described above, in the ninth embodiment, the

    surfaces

    54A and 54B of the

    incision

    54 are in contact with each other when the

    balloon

    3 is not inflated and the gap between them is not formed. In this case, even when the

    surfaces

    54A and 54B separate from each other as a result of the inflation of the

    balloon

    3, the gap between the

    surfaces

    54A and 54B can be suppressed to a minimum Thus, the area of the

    outer portion

    92B of the

    hard portion

    92 of the

    linear member

    9 can be made as large as possible. As a result, since the

    balloon catheter

    90 can make the area of the portion (the

    outer portion

    92B of the hard portion 92) of the

    linear member

    9 that comes into contact with the blood vessel wall as large as possible, the

    balloon catheter

    90 can cause the

    linear member

    9 to act even more appropriately on the blood vessel when the

    balloon

    3 is inflated.

  • It should be noted that, in the ninth embodiment, similarly to the case of the notch 52 (refer to

    FIG. 20

    ) of the seventh embodiment, the

    bottom portion

    54C may be positioned in substantially the same position as the

    boundary

    912B between the

    second portion

    912 of the

    flexible portion

    91 and the

    hard portion

    92. Further, in the ninth embodiment, similarly to the case of the notch 53 (refer to

    FIG. 21

    ) of the eighth embodiment, the

    bottom portion

    54C may be positioned further to the outside than the

    boundary

    912B between the

    second portion

    912 of the

    flexible portion

    91 and the

    hard portion

    92.

  • The

    notch

    51 of the sixth embodiment, the

    notch

    52 of the seventh embodiment, the

    notch

    53 of the eighth embodiment, and the

    incision

    54 of the ninth embodiment may also be formed in the

    linear members

    4, 6, 7, and 8 of the

    balloon catheters

    10, 20, 40, and 50 according to the first to fifth embodiments.

  • For example, a state of the

    linear member

    4 will be explained when the

    balloon

    3 inflates as a result of the compressed fluid being supplied from the

    hub

    5, in a case in which a plurality of the

    notches

    51 are formed in the

    linear member

    4 of the

    balloon catheter

    10 according to the first embodiment. In accordance with the inflation of the

    balloon

    3, the

    hard portion

    42 of the

    linear member

    4 tries to move away from the protruding

    portion

    225 of the

    inner tube

    22. At this time, the force in the elongation direction acts on the

    first portion

    411 and the

    third portion

    413 of the

    flexible portion

    41 of the

    linear member

    4. As a result, the

    first portion

    411 and the

    third portion

    413 elastically deform so as to extend in the extending direction. Thus, the

    hard portion

    42 separates easily from the protruding

    portion

    225 of the

    inner tube

    22. Further, the force in the extending direction also acts on the section of the

    linear member

    4 at which the

    second portion

    412 of the

    flexible portion

    41 and the

    hard portion

    42 are laminated. Here, the

    respective surfaces

    51A and 51B of the plurality of

    notches

    51 of the

    flexible portion

    41 separate from each other in the extending direction in accordance with the elastic deformation of the

    second portion

    412 of the

    flexible portion

    41 caused by the force in the extending direction. As a result, the elastic deformation of the

    second portion

    412 of the

    flexible portion

    41 is not easily suppressed by the

    hard portion

    42. Therefore, the section of the

    linear member

    4 at which the

    second portion

    412 of the

    flexible portion

    41 and the

    hard portion

    42 are laminated also elastically deforms so as to extend in the extending direction in accordance with the inflation of the

    balloon

    3. As a result of the above, the

    linear member

    4 extends in the extending direction over the whole length of the

    linear member

    4 in the extending direction.

  • Meanwhile, when the

    balloon

    3 deflates as a result of the compressed fluid being discharged from the

    balloon

    3 in the inflated state, the

    flexible portion

    41 of the

    linear member

    4 that is extended in the extending direction contracts due to the restoring force. The

    surfaces

    51A and 51B of the

    notches

    51 of the

    hard portion

    42 of the

    linear member

    4 approach each other with the space therebetween in the extending direction. The

    hard portion

    42 of the

    linear member

    4 moves closer to the protruding

    portion

    225 of the

    inner tube

    22. The warping of the

    linear member

    4 is suppressed by the

    linear member

    4 contracting.

  • As described above, when the

    notches

    51 are formed in the

    linear member

    4 of the

    balloon catheter

    10, the

    linear member

    4 can be caused to appropriately extend over the whole length of the

    linear member

    4 in accordance with the inflation of the

    balloon

    3. As a result, the

    balloon catheter

    10 can inhibit the

    linear member

    4 from breaking away from the

    balloon

    3 when the

    balloon

    3 is inflated, or inhibit the

    linear member

    4 from obstructing the inflation of the

    balloon

    3. Further, in the case of the

    balloon catheter

    10, the end portion on the distal end side of the

    linear member

    4 is connected to the

    balloon

    3, and the end portion on the proximal end side of the

    linear member

    4 is connected to the

    catheter shaft

    2 via the mounting

    member

    21A. Other portions of the

    linear member

    4 are not bonded to the

    balloon

    3. Further, when the

    linear member

    4 is bonded to the

    catheter shaft

    2, a manufacturing process is easier than when the

    linear member

    4 is bonded to the

    balloon

    3. Thus, the manufacturing of the

    balloon catheter

    10 can be simplified.

  • In the above description, a part of the portion of the

    linear member

    4 excepting both the end portions on the distal end side and the proximal end side may be bonded to the

    balloon

    3. For example, the

    second portion

    412 of the

    flexible portion

    41 of the

    linear member

    4 may be bonded to the

    inflatable region

    33 of the

    balloon

    3.

    • Modified Examples

  • The present disclosure is not limited to the above-described embodiments and various modifications are possible. The number of the

    linear members

    4, 6, 7, 8, and 9 is not limited to three, and may be another quantity. The

    linear members

    4, 6, 7, 8, and 9 are members that extend in a substantially straight line along the extending direction. In contrast, the

    linear members

    4, 6, 7, 8, and 9 may be members that extend in a spiral shape along the extending direction. The

    hard portions

    42 and 92 may be provided across the whole length of the

    flexible portions

    41 and 91 in the extending direction.

  • The outer portions of the

    hard portions

    42, 62 (the first portion 621), 71 (the second portion 712), 82, and 92, which are each disposed in a position corresponding to the

    inflatable region

    33 of the

    balloon

    3, correspond to the equilateral triangle shape and are peaked. The outer portions of the

    hard portions

    42, 62, 71, 82, and 92 have the function of suppressing the slipping of the

    balloon

    3. The shape of the outer portions of the

    hard portions

    42, 62, 71, 82, and 92 is not limited to that of the above-described embodiments. For example, an angle of the outer portions of the

    hard portions

    42, 62, 71, 82, and 92 may be steep. In this case, the outer portions of the

    hard portions

    42, 62, 71, 82, and 92 may function, for example, as a cutting blade for cutting open the lesioned part when the

    balloon

    3 is in the inflated state.

  • The cross-sectional shape of the

    linear members

    4, 6, 7, 8, and 9 is not limited to the above-described examples. For example, the cross-sectional shape of the

    hard portions

    42, 62, 71, 82, and 92 may be an isosceles triangle shape or a triangle shape having three sides of mutually differing lengths. In the first embodiment, the cross-sectional shape of the

    flexible portion

    41 may be a semi-circle that is cut out from the outside, or may be a polygonal shape. The cross-sectional shape including the

    flexible portion

    41 and the

    hard portion

    42 may be a circular shape, or may be a polygonal shape. Note that this also applies to the second to ninth embodiments.

  • In the above-described embodiments, the end portions on the distal end side of the

    linear members

    4, 6, 7, 8, and 9 are connected to the distal end

    side leg portion

    35, at the distal end position M1. In contrast to this, the end portions on the distal end side of the

    linear members

    4, 6, 7, 8, and 9 may be connected to the

    inner tube

    22. The end portion on the proximal end side of the

    linear member

    4 is connected to the mounting

    member

    21A. The end portions on the proximal end side of the

    linear members

    6, 7, 8, and 9 are connected to the proximal end

    side leg portion

    31. In contrast to this, the end portions on the proximal end side of the

    linear members

    4, 6, 7, 8, and 9 may be connected to the

    outer tube

    21.

  • The end portion on the proximal end side of the

    linear member

    4 need not necessarily be able to move along the extending direction. Specifically, for example, the end portion on the proximal end side of the

    linear member

    4 may be connected to the outer peripheral surface of the

    outer tube

    21, further toward the proximal end side than the portion, of the

    outer tube

    21, at which the proximal end

    side leg portion

    31 of the

    balloon

    3 is connected.

  • Each of the first directions D11, D21, D31, D41, and D51 is inclined toward the proximal end side with respect to the direction orthogonal to the extending direction. Each of the second directions D12, D22, D32, D42, and D52 is inclined toward the distal end side with respect to the direction orthogonal to the extending direction. In contrast to this, the first directions D11, D21, D31, D41, and D51 and the second directions D12, D22, D32, D42, and D52 may extend in the direction orthogonal to the extending direction. The preferable five degrees of each of the first angles θ11, θ21, θ31, θ41, and θ51 is smaller than the preferable sixteen degrees of each of the second angles θ12, θ22, θ32, θ42, and θ52. In contrast to this, a preferable value of each of the first angles θ11, θ21, θ31, θ41, and θ51 may be the same as a preferable value of each of the second angles θ12, θ22, θ32, θ42, and θ52. Further, the preferable value of each of the first angles θ11, θ21, θ31, θ41, and θ51 may be larger than the preferable value of each of the second angles θ12, θ22, θ32, θ42, and θ52.

  • The proximal end side thicknesses R11, R21, R31, and R41 are larger than the distal end side thicknesses R13, R23, R33, and R43. In contrast to this, the proximal end side thicknesses R11, R21, R31, and R41 may be the same as the distal end side thicknesses R13, R23, R33, and R43. The proximal end side thicknesses R11, R21, R31, and R41 may be smaller than the distal end side thicknesses R13, R23, R33, and R43. The proximal end side thickness R51 may be larger or smaller than the distal end side thickness R53.

  • The position of the boundary on the distal end side of the

    inflatable region

    33 is aligned, in the extending direction, with the position P11 of the end portion on the distal end side of the

    marker

    22A. The position of the boundary on the proximal end side of the

    inflatable region

    33 is aligned, in the extending direction, with the position P21 of the end portion on the proximal end side of the

    marker

    22B. However, the position of the boundary on the distal end side of the

    inflatable region

    33 need not necessarily be completely aligned, in the extending direction, with the position P11 on the distal end side of the

    marker

    22A. For example, the position of the boundary on the distal end side of the

    inflatable region

    33 may be aligned, in the extending direction, with any position between the position P11 of the end portion on the distal end side of the

    marker

    22A and a position P12 of the end portion on the proximal end side of the

    marker

    22A. The position of the boundary on the proximal end side of the

    inflatable region

    33 need not necessarily be completely aligned, in the extending direction, with the position P21 on the proximal end side of the

    marker

    22B. For example, the position of the boundary on the proximal end side of the

    inflatable region

    33 may be aligned, in the extending direction, with any position between the position P21 of the end portion on the proximal end side of the

    marker

    22B and a position P22 of the end portion on the distal end side of the

    marker

    22B. In other words, it is sufficient that the positions of the

    marker

    22A and the

    marker

    22B respectively correspond to the position of the boundary on the distal end side of the

    inflatable region

    33 and the position of the boundary on the proximal end side of the

    inflatable region

    33. Further, the number of the markers is not limited to two, and may be three or more.

  • Each of the boundary portion between the proximal end

    side cone region

    32 and the

    inflatable region

    33 and the boundary portion between the

    inflatable region

    33 and the distal end

    side cone region

    34 of the

    balloon

    3 in the inflated state may be curved. In this case, for example, with respect to the positions of each of the boundaries, when a plurality of virtual planes that touch the respectively curved boundary portions are defined, positions of the boundary portions that touch the virtual plane, of the plurality of virtual planes, that forms an acute angle of 45 degrees with the extending direction may be the positions of each of the boundaries. Further, in the above-described embodiments, each of the proximal end

    side cone region

    32 and the distal end

    side cone region

    34 is a region whose diameter changes linearly from the proximal end side toward the distal end side. However, each of the proximal end

    side cone region

    32 and the distal end

    side cone region

    34 may be a region whose diameter changes in a curved manner from the proximal end side toward the distal end side. In addition, one of the proximal end

    side cone region

    32 and the distal end

    side cone region

    34 may be the region whose diameter changes in the curved manner and the other may be the region whose diameter changes linearly.

  • The distal end surfaces 42S, 62S, 72S, 82S, and 92S, and the proximal end surfaces 42K, 62K, 72K, 82K, and 92K of the

    linear members

    4, 6, 7, 8, and 9 need not necessarily have a straight line shape. For example, at least either of the distal end surfaces 42S, 62S, 72S, 82S, and 92S, or the proximal end surfaces 42K, 62K, 72K, 82K, and 92K may have level differences.

  • The

    outer portions

    412B and 912B have a straight line shape. The

    outer portions

    412B and 912B may have a curved shape. In other words, for example, the

    hard portions

    42 and 92 may have a circular arc-shaped cross section.

  • The present disclosure can be applied to a device other than the balloon catheter that includes the

    balloon

    3 that is inflated by the supply of the compressed fluid. For example, the

    linear members

    4, 6, 7, 8, and 9 may be applied to a device that has a mechanically expanding mechanism in place of the

    balloon

    3. In the above-described embodiments, the example is given of the

    catheter shaft

    2 that has the

    outer tube

    21 and the

    inner tube

    22. In the present disclosure, the

    catheter shaft

    2 need not necessarily have the

    outer tube

    21 and the

    inner tube

    22. For example, the

    catheter shaft

    2 may have only one flexible tube.

  • In the sixth to ninth embodiments, the positions in the radial direction of the

    bottom portions

    51C to 53C of each of the

    notches

    51 to 53, and the

    bottom portions

    54C of the

    incisions

    54 may be positions that are substantially the same position as the

    inner portion

    912A of the

    second portion

    912 of the

    flexible portion

    91. In other words, the

    linear member

    9 may be divided in the extending direction by the

    notches

    51 to 53 or the

    incisions

    54.

  • In the sixth to eighth embodiments, the cross-sectional shape of the

    notches

    51 to 53 is not limited to the wedge shape. For example, a notch may be a slit whose cross-sectional shape is a semi-circular shape, a rectangular shape, a trapezoid shape or the like, or may be a slit whose outside end portions are rounded. Further, a plurality of slits having mutually different cross-sectional shapes may be formed in the

    linear member

    9. When the notch has the semi-circular shape, the rectangular shape, the trapezoid shape or the like, the position of a bottom portion thereof may be further to the inside or to the outside, in the radial direction, than the

    boundary

    912B between the

    second portion

    912 of the

    flexible portion

    91 and the

    hard portion

    92. In addition, the position of the bottom portion may be a position that is substantially the same position as the

    boundary

    912B in the radial direction. The number of the

    notches

    51 to 53 formed in the

    linear member

    9 is not limited to two, and may be another quantity, such as one or more, for example.

  • In the ninth embodiment, the

    incision

    54 may extend in a direction intersecting with the radial direction, to the inside from the

    outer portion

    92B of the

    hard portion

    92. The shape of the

    incision

    54 is not limited to the straight line and may be a curved line. The incision may be a slit whose outside end portions are rounded. Further, a plurality of slits including the notches and the incisions having mutually different shapes may be formed in the

    linear member

    9.

  • In the sixth to ninth embodiments, the

    linear member

    9 may be bonded to the

    balloon

    3 only in the vicinity of each of the distal end position M1 and the proximal end position M2. Of the

    linear member

    9, a section excluding the vicinity of each of the distal end position M1 and the proximal end position M2 need not necessarily be bonded to the

    balloon

    3. The end portion on the distal end side of the

    linear member

    9 may be connected to the

    inner tube

    22. The end portion on the proximal end side of the

    linear member

    9 may be connected to the

    outer tube

    21.

  • In the sixth to ninth embodiments, the

    flexible portion

    91 of the

    linear member

    9 includes the

    first portion

    911, the

    second portion

    912, and the

    third portion

    913. However, the

    flexible portion

    91 need not necessarily include the

    first portion

    911 and the

    third portion

    913. For example, the

    linear member

    9 may be configured by the

    hard portion

    92 and the

    second portion

    912. In this case, the

    second portion

    912 is bonded with the outer peripheral surface of the

    inflatable region

    33 of the

    balloon

    3 using adhesive or the like. In addition, the

    flexible portion

    91 of the

    linear member

    9 may be configured by the

    second portion

    912 and one of the

    first portion

    911 and the

    third portion

    913.

  • The apparatus and methods described above with reference to the various embodiments are merely examples. It goes without saying that they are not confined to the depicted embodiments. While various features have been described in conjunction with the examples outlined above, various alternatives, modifications, variations, and/or improvements of those features and/or examples may be possible. Accordingly, the examples, as set forth above, are intended to be illustrative. Various changes may be made without departing from the broad spirit and scope of the underlying principles.

Claims (15)

What is claimed is:

1. A balloon catheter comprising:

a balloon/shaft assembly that includes a catheter shaft extending from a proximal end to a distal end and a balloon connected to the catheter shaft, the balloon having an inflatable region configured to inflate outward in a radial direction around the catheter shaft; and

a linear member straddling the inflatable region of the balloon and being mounted on the balloon/shaft assembly at a distal end position located further toward a distal end side than the inflatable region and at a proximal end position located further toward a proximal end side than the inflatable region,

wherein the linear member includes:

a hard portion that includes at least an outer portion disposed on an opposite side to an inner portion facing the inflatable region, of a portion disposed along an outer peripheral surface of the inflatable region in an inflated state, and

a flexible portion that is a portion other than the hard portion, the flexible portion being extendable and having a hardness lower than the hard portion,

wherein the flexible portion extends between the distal end position and the proximal end position,

wherein the hard portion protrudes to the outside from the outer portion of a portion of the flexible portion that is disposed along the outer peripheral surface of the inflatable region in the inflated state, and

wherein, a thickness of a portion of the flexible portion, which is located further toward the distal end side than the hard portion, is narrower than a thickness of a portion of the flexible portion located further toward the proximal end side than the hard portion.

2. The balloon catheter according to

claim 1

, wherein a slit is formed extending toward the inside in the radial direction from an end portion on the outside of the hard portion.

3. The balloon catheter according to

claim 1

, wherein a direction extending to the outside along a distal end portion is inclined toward a proximal end side, the distal end portion being an end portion on the distal end side of the hard portion.

4. The balloon catheter according to

claim 1

, wherein a direction extending to the outside along a proximal end portion is inclined toward the distal end side, the proximal end portion being an end portion on the proximal end side of the hard portion.

5. The balloon catheter according to

claim 1

, wherein

a first direction extending to the outside along a distal end portion is inclined toward the proximal end side, the distal end portion being an end portion on the distal end side of the hard portion,

a second direction extending to the outside along a proximal end portion is inclined toward the distal end side, the proximal end portion being an end portion on the proximal end side of the hard portion, and

an angle of the first direction with respect to an extending direction of the catheter shaft is smaller than an angle of the second direction with respect to the extending direction of the catheter shaft.

6. The balloon catheter according to

claim 2

, wherein the slit is a notch where a part of the linear member is cut out.

7. The balloon catheter according to

claim 2

, wherein the slit is an incision having two surfaces that face each other and are in contact with each other.

8. The balloon catheter according to

claim 1

, wherein at least a part of the flexible portion of the linear member is bonded to the balloon.

9. The balloon catheter according to

claim 1

, wherein the linear member is disposed along an outer peripheral surface of the balloon in the inflated state.

10. The balloon catheter according to

claim 1

, wherein

two radiopaque markers are respectively provided in two positions separated from each other in an extending direction of the catheter shaft,

of the two radiopaque markers, a position of a marker provided on the distal end side corresponds to a position of a boundary of the inflatable region on the distal end side, in the extending direction of the catheter shaft, and

of the two radiopaque markers, a position of a marker provided on the proximal end side corresponds to a position of a boundary of the inflatable region on the proximal end side, in the extending direction of the catheter shaft.

11. The balloon catheter according to

claim 1

, wherein

the balloon includes a proximal end side leg portion bonded to the catheter shaft at a position further toward the distal end side than the proximal end position, and

an end portion on the proximal end side of the linear member is bonded to the balloon/shaft assembly at the proximal end position.

12. The balloon catheter according to

claim 1

, wherein

the balloon includes a proximal end side leg portion bonded to the catheter shaft at the proximal end position, and

an end portion on the proximal end side of the linear member is bonded to an outer peripheral surface of the proximal end side leg portion.

13. The balloon catheter according to

claim 1

, wherein the linear member is formed of a synthetic resin.

14. The balloon catheter according to

claim 1

, wherein the linear member includes end portions in an extending direction, at least one of the end portions being connected to the catheter shaft.

15. The balloon catheter according to

claim 1

, wherein the thickness of the portion of the flexible portion located further toward the distal end side than the hard portion is constant.

US17/102,512 2015-04-10 2020-11-24 Balloon Catheter Abandoned US20210077790A1 (en)

Priority Applications (1)

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US17/102,512 US20210077790A1 (en) 2015-04-10 2020-11-24 Balloon Catheter

Applications Claiming Priority (7)

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JP2015080627 2015-04-10
JP2015-080627 2015-04-10
JP2015248540 2015-12-21
JP2015-248540 2015-12-21
PCT/JP2016/061484 WO2016163495A1 (en) 2015-04-10 2016-04-08 Balloon catheter
US15/727,665 US10874837B2 (en) 2015-04-10 2017-10-09 Balloon catheter
US17/102,512 US20210077790A1 (en) 2015-04-10 2020-11-24 Balloon Catheter

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US15/727,665 Continuation US10874837B2 (en) 2015-04-10 2017-10-09 Balloon catheter

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US20210077790A1 true US20210077790A1 (en) 2021-03-18

Family

ID=57073210

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US15/727,665 Active 2037-02-11 US10874837B2 (en) 2015-04-10 2017-10-09 Balloon catheter
US17/102,512 Abandoned US20210077790A1 (en) 2015-04-10 2020-11-24 Balloon Catheter

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US15/727,665 Active 2037-02-11 US10874837B2 (en) 2015-04-10 2017-10-09 Balloon catheter

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US (2) US10874837B2 (en)
EP (1) EP3281669B1 (en)
JP (1) JP6793636B2 (en)
CN (1) CN107405473A (en)
ES (1) ES2802244T3 (en)
WO (1) WO2016163495A1 (en)

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US20180043140A1 (en) 2018-02-15
EP3281669B1 (en) 2020-05-27
EP3281669A4 (en) 2018-11-14
JPWO2016163495A1 (en) 2018-07-05
ES2802244T3 (en) 2021-01-18
US10874837B2 (en) 2020-12-29
EP3281669A1 (en) 2018-02-14
CN107405473A (en) 2017-11-28
JP6793636B2 (en) 2020-12-02
WO2016163495A1 (en) 2016-10-13

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