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WO2018012399A1 - Sonde à ballonnet. - Google Patents

Sonde à ballonnet. Download PDF

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Publication number
WO2018012399A1
WO2018012399A1 PCT/JP2017/024808 JP2017024808W WO2018012399A1 WO 2018012399 A1 WO2018012399 A1 WO 2018012399A1 JP 2017024808 W JP2017024808 W JP 2017024808W WO 2018012399 A1 WO2018012399 A1 WO 2018012399A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
wire
blade
balloon catheter
shaft
Prior art date
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.)
Ceased
Application number
PCT/JP2017/024808
Other languages
English (en)
Japanese (ja)
Inventor
荒平翔太
杉本健洋
吉田篤徳
須藤健
志賀啓教
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.)
Terumo Corp
Original Assignee
Terumo Corp
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.)
Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Publication of WO2018012399A1 publication Critical patent/WO2018012399A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0136—Handles therefor
    • 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
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00323—Cables or rods
    • 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
    • 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
    • A61B2017/22065—Functions of balloons
    • A61B2017/22071—Steering
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • 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

Definitions

  • the present invention relates to a balloon catheter having a balloon that can be bent along the axial direction at the distal end portion of the catheter shaft.
  • vascular lesions using catheters are widely performed because of less surgical invasion.
  • a balloon catheter is used to expand the coronary lesion and improve blood flow.
  • a balloon catheter is also used to perform PTA (Percutaneous Transluminal Angioplasty) to treat arteriosclerosis that has occurred in the femoral artery, iliac artery, popliteal artery, inferior arteries, etc. of the lower limbs.
  • PTA Percutaneous Transluminal Angioplasty
  • a scoring balloon catheter in which a blade is provided on a balloon is known as a device that enables treatment.
  • the scoring balloon catheter has a blade-like or linear blade provided on the balloon, and a calcified site can be cracked by this blade so that the lumen can be easily expanded.
  • An example of a balloon catheter having such a blade is disclosed in Patent Document 1.
  • the balloon catheter is formed so that the outer diameter at the time of expansion is larger than the inner diameter of the blood vessel. If the balloon is left expanded in the blood vessel for a long time, the patient may feel pain and the time for treatment is limited.
  • the scoring balloon has blades arranged at a plurality of locations along the circumferential direction of the balloon, and is effective for blood vessels that have been calcified over the entire circumference, but only a part of the circumferential direction has been calcified. It has been difficult to selectively bring a blade into contact with only a blood vessel site.
  • the present invention has been made in order to solve the above-described problems, and provides a balloon catheter that does not block blood flow even when the balloon is expanded, and has selectivity in the circumferential direction of the blood vessel wall that the blade contacts.
  • the purpose is to provide.
  • a balloon catheter according to the present invention that achieves the above object is a balloon catheter having a balloon at a distal end portion of a long shaft and a handle at a proximal end portion,
  • the balloon has a wire along the axial direction of the outer surface, and a blade disposed at a position different from the wire in the circumferential direction,
  • the proximal end of the wire extends along the shaft to the handle;
  • the handle includes an operation unit that exposes the blade by pulling the wire to bend the balloon.
  • the balloon catheter configured as described above can expand the living body lumen by bending the balloon with the wire even if the outer diameter of the balloon when expanded is smaller than the inner diameter of the living body lumen to be inserted. Treatment can be performed without completely occluding the body lumen.
  • the blade is disposed in an outer peripheral portion facing a region where the wire is disposed in the circumferential direction of the balloon.
  • the blade is disposed in a recess formed when the balloon is expanded without receiving a force from the outside. If the recess has a depth larger than the height of the blade, the blade is Therefore, the blade can be prevented from unexpectedly contacting the inner wall surface of the living body lumen before the blade is brought into contact with the inner wall surface of the living body lumen. On the other hand, the peripheral part of the recess is pressed against the inner wall surface of the living body lumen, so that the blade can be brought into contact with the inner wall surface of the living body lumen and a crack can be made in the calcified site.
  • the shaft has a pull wire lumen through which the wire is inserted in the outer peripheral portion, the wire is not exposed to the outside of the shaft, and the pull operation can be performed reliably.
  • the balloon has a wire cover portion that covers the wire. If the wire cover portion has an uneven shape along the axial direction on the surface, the wire is curved on the wire side when the wire is pulled. It can be surely bent so as to be on the inner peripheral side.
  • the balloon when the balloon is bent in the living body lumen, the balloon is bent if it has an anchor portion having a higher frictional resistance than the other area in the region in contact with the inner wall surface of the living body lumen. At this time, the balloon can be fixed to the inner wall surface of the living body lumen to prevent rotation and displacement of the balloon.
  • the balloon can be prevented from being twisted when the wire is pulled.
  • FIG. 2 is an enlarged view of the vicinity of a joint between a shaft and a balloon in FIG. 1. It is a front view of the balloon vicinity. It is an expanded sectional view of the wire cover part fixed to the balloon. It is a front view of the balloon vicinity of the state expanded and curved. It is sectional drawing of the balloon of a contracted state.
  • FIG. 6 is an AA end view of FIG. 5. It is a front view of the balloon vicinity of the state expanded and curved in the blood vessel.
  • FIG. 9 is an AA end view of FIG. 8. It is an enlarged view of an anchor part. It is an end view of a balloon when there is one pulling wire.
  • the side of the shaft 10 to be inserted into the living body lumen is referred to as “tip” or “tip side”
  • the proximal side for operation is referred to as “base end” or “base end side”.
  • the balloon catheter 1 has a long shaft 10, a balloon 11 provided at the distal end portion of the shaft 10, and a handle 12 provided at the proximal end portion of the shaft 10. .
  • an outer tube 20 and an inner tube 21 each formed in a long hollow shape are arranged concentrically.
  • the inner diameter of the outer tube 20 is larger than the outer diameter of the inner tube 21, and the inner tube 21 is accommodated in the hollow interior of the outer tube 20.
  • a hollow interior of the inner tube 21 forms a guide wire lumen 24 through which a guide wire (not shown) is inserted.
  • an expansion lumen 23 through which the expansion fluid of the balloon 11 is circulated is formed inside the outer tube 20 and outside the inner tube 21.
  • the inner tube 21 protrudes further to the distal end side than the distal end of the outer tube 20.
  • the balloon 11 has a proximal end portion fixed to the distal end portion of the outer tube 20, and a distal end portion fixed to the distal end portion of the inner tube 21. Thereby, the inside of the balloon 11 communicates with the expansion lumen 23.
  • the balloon 11 can be expanded by injecting an expansion fluid into the balloon 11 via the expansion lumen 23.
  • the expansion fluid may be a gas or a liquid.
  • a gas such as helium gas, CO 2 gas, or O 2 gas, or a liquid such as physiological saline or contrast medium can be used.
  • the outer tube 20 and the inner tube 21 are preferably formed of a material having a certain degree of flexibility.
  • a material having a certain degree of flexibility include polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these, soft polyvinyl chloride resin, Examples thereof include fluororesins such as polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polytetrafluoroethylene, silicone rubber, and latex rubber.
  • the shaft 10 has an auxiliary pipe 22 on the outer peripheral portion of the outer pipe 20.
  • a pull wire lumen 25 through which the pull wire 13 is inserted is formed in the hollow interior of the auxiliary tube 22.
  • the pulling wire 13 extends from the handle 12 to the balloon 11 through the pulling wire lumen 25 of the shaft 10, and its distal end is fixed near the distal end of the balloon 11.
  • the balloon 11 is 4 to 20 cm in length in the axial direction, and is formed so that the diameter when expanded is smaller than the inner diameter of the blood vessel to be inserted.
  • the length of the balloon 11 is not particularly limited to the above length.
  • a metal blade 31 is provided on the outer surface of the balloon 11 at the central portion in the axial direction.
  • the blade 31 is provided at one place in the circumferential direction of the balloon 11.
  • the blade 31 may be provided at a plurality of locations as long as it is within a predetermined range in the circumferential direction of the balloon 11.
  • the handle 12 has a main body portion 40 having a port 41 for injecting an expansion fluid, and a handle portion 42 that can be held by an operator.
  • the handle portion 42 is provided with a dial-like operation portion 43 to which the proximal end portion of the pull wire 13 is fixed.
  • the operation unit 43 can be pulled or loosened by rotating the operation unit 43.
  • the pull wire 13 is inserted into the handle 12, and the distal end portion 13a is fixed to the outer surface of the balloon 11 through the pull wire lumen 25 of the shaft 10 as described above. For this reason, when the pulling wire 13 is pulled by operating the operating portion 43, the side of the balloon 11 where the pulling wire 13 is disposed is compressed in the axial direction, and the side opposite to the side where the pulling wire 13 is disposed is convex.
  • the balloon 11 can be curved.
  • the distal end portion 13a of the pull wire 13 is fixed to the outer surface of the balloon 11 by adhesion or heat fusion.
  • the tip end portion 13a may be fixed to the balloon 11 by other means.
  • the wire cover portion 14 when the wire cover portion 14 is provided on the outer surface of the balloon 11, the distal end portion 13a of the pulling wire 13 is not directly fixed to the balloon 11, and the distal end portion 13a of the pulling wire 13 is connected to the wire cover portion. 14 may be an engaging portion that is caught by the opening on the tip side.
  • the balloon catheter 1 has a long shaft 10 inserted into a living body lumen, and a balloon 11 provided at the distal end thereof is expanded at a lesioned portion, and the balloon 11 is bent by a pulling wire 13 so as to The part can be spread and treated.
  • the balloon catheter 1 of the present embodiment is used for a procedure in which the inner surface is inserted into a femoral artery with a calcified inner surface and then spread.
  • the blade 31 provided on the balloon 11 contacts the calcified portion of the blood vessel, and the expansion can be promoted while making a crack.
  • the auxiliary tube 22 through which the pull wire 13 is inserted extends to a position closer to the base end side than the base end of the balloon 11, and the pull wire 13 on the distal end side from the auxiliary tube 22 is connected to the balloon 11. It extends toward the side surface.
  • the anchor portion 34 is provided on the outer surface of the balloon 11 on the opposite side in the circumferential direction from the side where the blade 31 is provided and in the vicinity of the proximal end of the balloon 11.
  • the anchor portion 34 is formed by affixing a material different from that of the balloon 11 so that the frictional resistance with respect to the inner wall surface of the blood vessel is larger than that of other regions on the outer surface of the balloon 11. Details will be described later.
  • a root reinforcing material 38 is provided at a joint portion between the proximal end portion of the balloon 11 and the distal end portion of the outer tube 20 so as to cover the joint portion.
  • the root reinforcing material 38 is formed of a flexible material such as polyethylene or nylon.
  • a wire cover portion 14 is provided on the outer surface of the balloon 11 so as to cover the pulling wire 13 along its length direction.
  • the wire cover portion 14 is formed of a flexible material, and has an uneven shape along the length direction as shown in FIG.
  • the wire cover portion 14 having an uneven shape can be bent together with the balloon 11.
  • the distal end portion 13a of the pulling wire 13 is not directly fixed on the balloon 11, but is held in a state of protruding from the distal end opening of the wire cover portion 14, and when the pulling wire 13 is pulled, the wire cover portion 14 You may become an engaging part engaged with a front-end
  • the shape of the engaging portion may be any shape that can be engaged with the tip opening of the wire cover portion 14.
  • the engaging portion has an outer diameter larger than the inner diameter of the lumen through which the pulling wire 13 of the wire cover portion 14 is inserted.
  • the spherical shape which has is mentioned. Thereby, it is possible to suppress the influence of external force such as rubbing applied to the balloon 11 by pulling the pull wire 13 as compared with the case where the pull wire 13 is directly fixed on the balloon 11, and to bend the balloon 11 more reliably. Can do.
  • the balloon 11 when the pulling wire 13 is pulled in a state where the balloon 11 is expanded, the balloon 11 is provided with a blade 31 on the side opposite to the curved inner peripheral side on the side where the pulling wire 13 is provided. The whole is curved along the axial direction so that the formed side becomes the curved outer peripheral side. As described above, since the surface of the wire cover portion 14 is formed with an uneven shape along the axial direction, the wire cover portion 14 is reliably bent by pulling the pulling wire 13, and accordingly, the balloon 11 is also curved.
  • two pulling wires 13 are provided at different positions in the circumferential direction of the balloon 11.
  • the balloon 11 in the contracted state is in a state in which the membrane of the balloon 11 is folded in a state where the pulling wire 13 and the blade 31 are close to the inner tube 22. For this reason, the maximum diameter of the balloon 11 in the deflated state is small, and it is possible to improve the passability when inserting the balloon 11 into the blood vessel.
  • two pull wires 13 provided in the circumferential direction of the balloon 11 are arranged in the lower half region in the expanded state of the balloon 11.
  • the blade 31 is disposed on the side facing the pulling wire 13 in the circumferential direction of the balloon 11, that is, in the upper half region of the balloon 11 in FIG. Since the two pulling wires 13 are provided in the circumferential direction of the balloon 11, the twisting of the balloon 11 can be suppressed when the pulling wire 13 is pulled, and the balloon 11 is bent while being stably expanded. Can be made.
  • the blade 31 is disposed so as to be accommodated in the recess 30 formed in the balloon 11 at the time of expansion.
  • the recess 30 has a depth larger than the height of the blade 31, and when the expanded balloon 11 is not receiving external force as shown in FIG. It is arranged not to exceed 30. Thereby, it can prevent that the braid
  • the balloon 11 in the expanded state has an outer diameter smaller than the inner diameter of the blood vessel 50 to be inserted, the balloon 11 can be bent in the blood vessel 50 when the pulling wire 13 is pulled. it can.
  • both ends in the axial direction on the curved inner peripheral side (small bay) and the central portion in the axial direction on the curved outer peripheral side (large bay) are in contact with the inner wall surface of the blood vessel 50, respectively. .
  • the balloon 11 has an outer diameter smaller than the inner diameter of the blood vessel 50 in the expanded state, and the balloon 11 is curved in the blood vessel 50, so that the blood vessel 50 is expanded and the blood vessel 50 is not completely occluded. That is, it is possible to perform the treatment for expanding the blood vessel 50 while securing the blood flow, so that the pain associated with the ischemic state caused by the procedure can be prevented.
  • the blade 31 protrudes outward from the balloon 11 only when the large bay portion of the balloon 11 is pressed against the inner wall surface of the blood vessel 50, the blade 31 is inserted into the inner wall surface of the blood vessel 50 when the balloon 11 is inserted. Can be kept out of contact. Further, since the blade 31 is provided only in the region of the large bay portion of the balloon 11, the blade 31 can be protruded toward the intended circumferential direction in the blood vessel 50. For this reason, with respect to the blood vessel 50 in which a partial region in the circumferential direction is calcified, the blade 31 can be selectively brought into contact with only the calcified portion.
  • the anchor portion 34 having a higher frictional resistance than the other regions is provided at the proximal end portion in the curved inner peripheral side of the curved balloon 11.
  • the anchor portion 34 can be formed by sticking a surface of the balloon 11 having a small friction coefficient to which urethane or the like having a large friction coefficient is formed in a square shape. .
  • the shape of the anchor part can be various other forms.
  • the anchor portion 35 shown in FIG. 10B is formed by linearly forming urethane or the like having a large friction coefficient and arranging a plurality of them in parallel.
  • the anchor portion 36 shown in FIG. 10C is formed by forming urethane or the like having a large friction coefficient in a wave shape and arranging a plurality of them in parallel.
  • the anchor portion 37 shown in FIG. 10 (d) is formed by forming urethane or the like having a large friction coefficient into a small square shape and arranging a plurality of them in a lattice shape.
  • each shape of the anchor portion may be formed of a material different from that of the balloon 11 as described above, or may be formed by providing irregularities on the surface of the balloon 11.
  • the material of the anchor portion polyimide or the like can be used in addition to urethane.
  • the anchor portion is formed at the proximal end portion in the curved inner peripheral side of the curved balloon 11, when the balloon 11 is curved in the blood vessel 50, the proximal end portion of the balloon 11 is inside the blood vessel 50. It is fixed to the wall surface and can prevent the balloon 11 from rotating or misaligned.
  • the balloon catheter 1 is a balloon catheter 1 having the balloon 11 at the distal end portion of the elongated shaft 10 and the handle 12 at the proximal end portion. It has a wire 13 along the axial direction of the outer surface, and a blade 31 disposed at a position different from the wire 13 in the circumferential direction, and the proximal end side of the wire 13 extends to the handle 12 along the shaft 10.
  • the blade 31 is disposed on the curved outer peripheral portion facing the region where the wire 13 is disposed in the circumferential direction of the balloon 11.
  • the blade 31 is disposed in the concave portion 30 formed when the balloon 11 is expanded without receiving a force from the outside, and the concave portion 30 has a depth larger than the height of the blade 31.
  • the blade 31 does not protrude outward of the balloon 11, it is possible to prevent the blade 31 from unexpectedly contacting the inner wall surface of the living body lumen.
  • the peripheral part of the concave part 30 is pressed against the inner wall surface of the living body lumen, so that the blade 31 can be brought into contact with the inner wall surface of the living body lumen and a crack can be made in the calcified site.
  • the shaft 10 has a pull wire lumen 25 through which the wire 13 is inserted on the outer peripheral portion. As a result, the wire 13 is not exposed to the outside of the shaft 10 and the pulling operation can be performed reliably.
  • the balloon 11 has a wire cover portion 14 that covers the wire 13, and the wire cover portion 14 has an uneven shape along the axial direction on the surface. Thereby, when the wire 13 is pulled, the balloon 11 can be reliably bent so that the wire 13 side is on the bending inner peripheral side.
  • the balloon 11 When the balloon 11 is curved in the living body lumen 50, the balloon 11 has an anchor portion 34 having a higher frictional resistance than the other area in the area in contact with the inner wall surface of the living body lumen 50. Thereby, when the balloon 11 is bent, the proximal end side of the balloon 11 is fixed to the inner wall surface of the living body lumen, and the rotation and displacement of the balloon 11 can be prevented.
  • a plurality of wires 13 are provided in the circumferential direction of the balloon 11. Thereby, it is possible to prevent the balloon 11 from being twisted when the wire 13 is pulled.
  • a root reinforcing material 38 is provided at a joint portion between the base end portion of the balloon 11 and the shaft 10.
  • the present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical idea of the present invention.
  • the balloon catheter 1 of this embodiment treats the calcified lesion of the lower limb artery
  • the present invention can also be applied to a balloon catheter that treats other sites.
  • it can be used for the treatment of coronary arteries, carotid arteries, shunts, leg veins, esophagus and respiratory system.
  • the two pulling wires 13 are provided on the balloon 11, but the pulling wire 13 may be one as shown in FIG.
  • the balloon 11 can be bent more stably by using two pull wires 13.
  • the root reinforcing material 38 is provided at the joint between the proximal end portion of the balloon 11 and the shaft 10, but the root reinforcing material 38 may not be provided.
  • one blade 31 is provided in the circumferential direction of the balloon 11, but two or more blades 31 may be provided in the circumferential direction. Further, the blade 31 is not limited to the blade shape as in the present embodiment, and may be another shape such as a linear shape.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biophysics (AREA)
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  • Child & Adolescent Psychology (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne une sonde à ballonnet qui ne bloque pas le flux sanguin même lorsqu'il est dilaté. Il permet la sélection d'une position, dans la circonférence de la paroi de vaisseau sanguin, avec laquelle la lame doit entrer en contact. La sonde comprend un ballonnet sur l'extrémité distale d'une tige, et une poignée sur l'extrémité proximale de la tige. Le ballon (11) a un fil (13) et une lame (31) autour du fil (13). L'extrémité proximale du fil (13) s'étend le long de la tige (10) jusqu'au manche (12). La poignée (12) a un système (43) qui tire le fil (13) de manière à courber le ballon (11), ce qui provoque l'exposition de la lame (31).
PCT/JP2017/024808 2016-07-11 2017-07-06 Sonde à ballonnet. Ceased WO2018012399A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016-136864 2016-07-11
JP2016136864A JP2019146599A (ja) 2016-07-11 2016-07-11 バルーンカテーテル

Publications (1)

Publication Number Publication Date
WO2018012399A1 true WO2018012399A1 (fr) 2018-01-18

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CN114096303A (zh) * 2019-06-11 2022-02-25 株式会社钟化 球囊导管用球囊以及球囊导管的制造方法
CN116115889A (zh) * 2023-01-04 2023-05-16 健源医疗科技(无锡)有限公司 刻痕结构及介入治疗装置
CN118846348A (zh) * 2024-09-27 2024-10-29 鼎科医疗技术（苏州）有限公司 一种刻痕球囊扩张导管
CN118903652A (zh) * 2024-09-14 2024-11-08 泽理氪医学科技(北京)有限公司 一种基于弹性球囊的医用导管及其制作方法

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JP2023141918A (ja) * 2022-03-24 2023-10-05 株式会社グッドマン 医療器具、及びバルーンカテーテル

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Publication number Priority date Publication date Assignee Title
CN114096303A (zh) * 2019-06-11 2022-02-25 株式会社钟化 球囊导管用球囊以及球囊导管的制造方法
US12186507B2 (en) 2019-06-11 2025-01-07 Kaneka Corporation Balloon for balloon catheter and method for manufacturing balloon catheter
CN114096303B (zh) * 2019-06-11 2025-02-11 株式会社钟化 球囊导管用球囊以及球囊导管的制造方法
CN116115889A (zh) * 2023-01-04 2023-05-16 健源医疗科技(无锡)有限公司 刻痕结构及介入治疗装置
CN116115889B (zh) * 2023-01-04 2024-05-14 健源医疗科技(无锡)有限公司 刻痕结构及介入治疗装置
CN118903652A (zh) * 2024-09-14 2024-11-08 泽理氪医学科技(北京)有限公司 一种基于弹性球囊的医用导管及其制作方法
CN118846348A (zh) * 2024-09-27 2024-10-29 鼎科医疗技术（苏州）有限公司 一种刻痕球囊扩张导管

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