WO2022270192A1 - カテーテル用バルーン - Google Patents

カテーテル用バルーン Download PDF

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Publication number
WO2022270192A1
WO2022270192A1 PCT/JP2022/021097 JP2022021097W WO2022270192A1 WO 2022270192 A1 WO2022270192 A1 WO 2022270192A1 JP 2022021097 W JP2022021097 W JP 2022021097W WO 2022270192 A1 WO2022270192 A1 WO 2022270192A1
Authority
WO
WIPO (PCT)
Prior art keywords
portions
extending
balloon
vertex
state
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/JP2022/021097
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
光正 岡本
祐太 中村
修平 山本
彰真 近藤
静也 吉永
嵩 國定
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.)
Filing date
Publication date
Application filed by Goodman Co Ltd filed Critical Goodman Co Ltd
Priority to KR1020247000184A priority Critical patent/KR20240017061A/ko
Priority to JP2023529709A priority patent/JP7640692B2/ja
Priority to AU2022298081A priority patent/AU2022298081B2/en
Priority to BR112023025231A priority patent/BR112023025231A2/pt
Priority to CN202280021598.5A priority patent/CN117015414A/zh
Priority to CA3221680A priority patent/CA3221680A1/en
Priority to EP22828111.9A priority patent/EP4360689A4/en
Publication of WO2022270192A1 publication Critical patent/WO2022270192A1/ja
Priority to US18/393,429 priority patent/US20240123198A1/en
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
    • A61M25/10—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
    • A61B17/32—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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • 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
    • A61B17/22—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
    • A61B2017/22001—Angioplasty, e.g. PCTA
    • 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
    • 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
    • A61M2025/1004—Balloons with folds, e.g. folded or multifolded
    • 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
    • A61M2025/1059—Balloon catheters with special features or adapted for special applications having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
    • 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
    • A61M2025/1084—Balloon catheters with special features or adapted for special applications having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
    • 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

Definitions

  • the present invention relates to catheter balloons.
  • the balloon catheter described in Patent Document 1 is held by a retainer in a state in which a folded balloon membrane is wrapped around a support member to minimize its diameter. The balloon catheter is taken out from the holder when used.
  • the diameter of the balloon is small even after being inflated during use in a blood vessel and then deflated.
  • Patent Document 1 the state in which the balloon thin film is wrapped around the supporting portion is held by the retainer, and the diameter is reduced. For this reason, there is a possibility that the diameter cannot be reduced when the balloon thin film is removed from the retainer. For this reason, for example, when the balloon thin film is removed from the retainer, is inflated during use, and is then contracted and pulled out of the body after use, the diameter of the contracted balloon thin film increases, making it difficult to pull out. .
  • An object of the present invention is to provide a balloon for a catheter whose diameter can be minimized even when it is contracted after being expanded.
  • a catheter balloon according to a first aspect of the present invention is a catheter balloon that can be inflated and contracted in accordance with changes in internal pressure, and in the process of being deformed from the contracted state to the expanded state, a predetermined an inflatable portion that expands by moving radially outward about a central axis extending in the extending direction of the inflating portion and becomes a tubular shape extending in the extending direction in the inflated state;
  • the inflatable portion includes a plurality of blades forming blades in the contracted state. a first portion and, in the inflated state, a plurality of second portions adjacent to the plurality of first portions in a circumferential direction about the central axis; In the process of transforming from the expanded state to the contracted state, by moving toward the central axis earlier than the plurality of first portions, a recess that is concave toward the central axis is formed. .
  • the plurality of second portions when deformed from the expanded state to the contracted state, the plurality of second portions move toward the central axis before the plurality of first portions, and each of the plurality of first portions moves toward the central axis.
  • a blade portion is formed by In this case, even if the catheter balloon is repeatedly deformed between an expanded state and a contracted state, the catheter balloon is always folded into a stable shape. Therefore, the diameter of the catheter balloon in the contracted state can be reduced.
  • a catheter balloon according to a second aspect of the present invention is a catheter balloon that can be inflated and contracted in response to changes in internal pressure, and in the process of being deformed from the contracted state to the expanded state, a predetermined an inflatable portion that expands by moving radially outward about a central axis extending in the extending direction of the inflating portion and becomes a tubular shape extending in the extending direction in the inflated state;
  • the inflatable portion includes a plurality of blades forming blades in the contracted state. a first portion; and a plurality of second portions adjacent to the plurality of first portions in a circumferential direction around the central axis in the inflated state; The radial distance from the central axis to each of the plurality of second portions is shorter than the radial distance to each of the plurality of first portions. .
  • the plurality of second portions having a short distance from the central axis in the inflated state moves first toward the central axis, and the plurality of second portions moves toward the central axis first.
  • a vane is formed by each of the first portions of the .
  • the distal connecting portion and the proximal connecting portion each have the plurality of first portions and the plurality of second portions, and the plurality of first portions and the plurality of Each of the second portions may extend along the extending direction from the other end of the distal connecting portion to the other end of the proximal connecting portion.
  • the plurality of second portions of each of the distal end connecting portion and the proximal end connecting portion as well as the inflating portion are first moved toward the central axis. can be made Therefore, in the catheter balloon, not only the inflatable portion but also each of the distal connecting portion and the proximal connecting portion can be folded into a stable shape.
  • the plurality of second portions also act as a tension bar during insertion of the deflated catheter balloon into the blood vessel. In this case, it is possible to prevent the distal end connecting portion and the proximal end connecting portion from expanding radially due to contraction of the catheter balloon in the extending direction. Furthermore, since the possibility that the diameters of the distal end connecting portion and the proximal end connecting portion become large when folded can be reduced, it is possible to improve the passageability of the catheter balloon through the blood vessel.
  • the distal connecting portion and the proximal connecting portion each have the plurality of first portions and the plurality of second portions, and the plurality of first portions and the plurality of second portions Each extends along the extending direction from the other end of the distal connecting portion to the other end of the proximal connecting portion, and is formed in the process of being deformed from the expanded state to the contracted state.
  • the amount of indentation provided may be greater in the bulging portion than in the distal connector portion and the proximal connector portion. In this case, when the catheter balloon is deflated, the time required for folding the large-diameter expansion portion can be shortened, and the folded shape can be stabilized.
  • each of the plurality of second portions may include a rigid portion having higher rigidity than the plurality of first portions.
  • the radial thickness of each of the plurality of second portions may be greater than the radial thickness of each of the plurality of first portions.
  • the speed at which the plurality of second portions move toward the central axis when the catheter balloon is deformed from the inflated state to the deflated state is slow immediately after the start of movement and then increases.
  • the plurality of second portions can stably fold the catheter balloon.
  • the distance between the inner surfaces of the plurality of second portions and the central axis is the distance between the inner surfaces of the plurality of first portions and the central axis. may be shorter than That is, the inner surface of each of the plurality of second portions is arranged at a position closer to the central axis than the inner surface of each of the plurality of first portions.
  • the plurality of second portions tend to move toward the central axis earlier than the plurality of first portions. Therefore, even when the catheter balloon is repeatedly deformed between an expanded state and a contracted state, the catheter balloon can always be folded into a stable shape.
  • the distance between the outer surface of the plurality of second portions and the central axis is the distance between the outer surface of the plurality of first portions and the central axis.
  • the outer surfaces of the plurality of second portions may be rounded. In this case, it is possible to prevent the plurality of second portions from being caught on the inner wall of the blood vessel when the catheter balloon passes through the blood vessel, so that the catheter balloon can pass through the blood vessel well.
  • the plurality of second portions may be arranged at equal intervals in the circumferential direction.
  • the wing portions formed by the plurality of first portions can be made uniform in size. Therefore, the catheter balloon can be deflated uniformly in the circumferential direction.
  • the shape may be memorized in a state in which the plurality of second portions are recessed toward the central axis.
  • the catheter balloon is deformed from the inflated state to the deflated state, it is possible to easily realize a configuration in which the plurality of second portions are first moved toward the central axis.
  • the plurality of first portions and the plurality of second portions may be made of the same material.
  • the catheter balloon can be easily manufactured.
  • one or more slits may be provided in a portion of the plurality of second portions located at the tip connecting portion.
  • one or more slits may be provided in a portion of the plurality of second portions located at the base end connecting portion.
  • one or more slits may be provided in the portion arranged in the inflating portion among the plurality of second portions.
  • the expanded portion does not expand when the folded catheter balloon is moved within the blood vessel. Therefore, the passability of the catheter balloon can be further improved.
  • each of the plurality of first portions includes a vertex having a maximum curvature in the process of being deformed from the expanded state to the contracted state and the first portion adjacent to one side in the circumferential direction.
  • a first extending portion extending from a connecting portion with two portions to the vertex; and a second extending portion extending from a connecting portion with the second portion adjacent to the other side in the circumferential direction to the vertex;
  • the length of the second extending portion may be longer than the length of the first extending portion. In this case, the catheter balloon can easily cover the second portion with the first portion when deformed from the expanded state to the contracted state.
  • each of the plurality of first portions has a vertex having a maximum curvature during deformation from the expanded state to the contracted state, and deforms from the expanded state to the contracted state.
  • the distance between the vertex and the second portion adjacent to the first portion having the vertex on one side in the circumferential direction is the distance between the vertex and the first portion having the vertex. may be shorter than the distance between the second portion adjacent to the other side in the circumferential direction. In this case, the catheter balloon can easily cover the second portion with the first portion when deformed from the expanded state to the contracted state.
  • each of the plurality of first portions includes a vertex having a maximum curvature in the process of being deformed from the expanded state to the contracted state and the first portion adjacent to one side in the circumferential direction.
  • a first extending portion extending from a connecting portion with two portions to the vertex; and a second extending portion extending from a connecting portion with the second portion adjacent to the other side in the circumferential direction to the vertex;
  • At least a portion of the first extending portion of the first portion having the vertex with respect to an imaginary plane passing through the central axis and the vertex and extending in the radial direction in the process of transforming from the expanded state to the contracted state. may be located on the other side in the circumferential direction.
  • each of the first portions more easily covers the second portion adjacent to one side in the circumferential direction. Therefore, when the catheter balloon is deformed from an inflated state to a deflated state, it is possible to more easily cover the second portion with the first portion.
  • Fig. 10 shows the balloon catheter 1A when the balloon 3 is inflated.
  • FIG. 4 shows the balloon 3 deforming from a deflated state to an inflated state;
  • FIG. 4 shows the balloon 3 deforming from an inflated state to a deflated state;
  • Fig. 10 is a diagram showing a balloon 3 in the balloon catheter 1B;
  • Fig. 10 is a diagram showing a balloon 3 in the balloon catheter 1C;
  • Fig. 10 shows a balloon 3 in the balloon catheter 1D;
  • Fig. 10 shows a balloon catheter 1E;
  • FIG. 10 is a diagram showing the balloon 3 of the balloon catheter 1F deforming from an expanded state to a contracted state.
  • Fig. 10 shows the balloon 3 of the balloon catheter 1F in a contracted state;
  • FIG. 10 shows the balloon 3 of the balloon catheter 1G deforming from an inflated state to a deflated state.
  • FIG. 10 shows the balloon 3 of the balloon catheter 1G in a contracted state;
  • Embodiments (1A to 1E) of the balloon catheter 1 according to the present invention will be described with reference to the drawings.
  • the referenced drawings are used to explain technical features that the present invention can employ.
  • the configuration and the like of the described apparatus are not intended to limit the scope of the present invention, but merely illustrative examples.
  • the balloon catheter 1 can dilate a stenotic lesion formed in a blood vessel. Furthermore, the balloon catheter 1 can pulverize or incise a lesion by applying a second portion 5A, which will be described later, to the lesion.
  • a balloon catheter 1A will be described with reference to FIG.
  • a balloon catheter 1A has a catheter shaft 2 and a balloon 3 .
  • a balloon 3 is connected to one end of the tubular catheter shaft 2 .
  • the balloon catheter 1A is used with a hub (not shown) connected to the other end of the catheter shaft 2 .
  • the hub can supply compressed fluid to the balloon 3 through the catheter shaft 2 .
  • the other side of both ends of the catheter shaft 2 is called the "tip side”.
  • the other side of both ends of the catheter shaft 2 is referred to as the "proximal side”.
  • a direction extending along the catheter shaft 2 is referred to as an "extending direction”.
  • An axis passing through the center of the catheter shaft 2 and extending in the extending direction is called a central axis C1.
  • the cross section taken along a plane orthogonal to the central axis C1 hereinafter simply referred to as "the cross section”
  • the side closer to the central axis C1 in the radial direction centering on the central axis C1 is referred to as the "inner side.”
  • the side away from the central axis C1 is called the "outside”.
  • the catheter shaft 2 has an outer tube 21 and an inner tube 22.
  • the outer tube 21 and the inner tube 22 each have flexibility.
  • the inner diameter of the outer tube 21 is larger than the outer diameter of the inner tube 22 .
  • the inner tube 22 is arranged in the lumen of the outer tube 21 except for a predetermined portion on the distal end side. A predetermined portion on the distal end side of the inner tube 22 protrudes toward the distal end side from the distal end of the outer tube 21 (hereinafter referred to as "the distal end 211").
  • the distal end of the inner tube 22 (hereinafter referred to as “the distal end 221 ”) is arranged further distally than the distal end 211 of the outer tube 21 .
  • a predetermined portion on the distal end side of the inner tube 22 is referred to as a "protruding portion 225".
  • Materials for the outer tube 21 and the inner tube 22 are not particularly limited. Polyamide-based resin is used as an example of the material of the outer tube 21 and the inner tube 22 .
  • a compressed fluid supplied from the hub flows through a space other than the inner tube 22 lumen of the outer tube 21 .
  • a guide wire (not shown) is passed through the lumen of the inner tube 22 .
  • the balloon 3 can be deformed between a deflated state and an inflated state by changing the internal pressure depending on whether compressed fluid is supplied by a hub (not shown).
  • Figure 1 shows the balloon 3 in an inflated state.
  • the balloon 3 is connected at its distal end (hereinafter referred to as “distal portion 3D”) to the vicinity of the distal end 221 of the projecting portion 225 of the inner tube 22 by heat welding.
  • the balloon 3 is connected to the vicinity of the distal end 211 of the outer tube 21 by heat welding at its proximal end (hereinafter referred to as "base end 3P").
  • base end 3P proximal end
  • the balloon 3 covers the projecting portion 225 of the inner tube 22 from the outside.
  • a material for the balloon 3 is not particularly limited.
  • a polyamide resin is used as an example of the material of the balloon 3 .
  • a distal connecting portion 3A, an expanding portion 3B, and a proximal connecting portion 3C are defined.
  • the distal connecting portion 3A is a region extending from the distal end portion 3D toward the proximal end portion 3P of the inflated balloon 3 while increasing in diameter.
  • the proximal connection portion 3C is a region that extends from the proximal end portion 3P toward the distal end portion 3D of the expanded balloon 3 while increasing in diameter.
  • the inflatable portion 3B is a region sandwiched between the distal end connecting portion 3A and the proximal end connecting portion 3C in the balloon 3 in the inflated state, and has substantially the same diameter along the extending direction. In the inflated state, the inflatable portion 3B has a tubular shape extending in the extending direction.
  • Balloon 3 has an inner surface 301 and an outer surface 302 .
  • the tip-side end of the inflatable portion 3B is referred to as “distal end 30D", and the proximal-side end is referred to as “base end 30P”.
  • the distal end connecting portion 3A extends from the end portion of the expansion portion 3B connected to the distal end portion 30D toward the distal end portion 3D toward the distal end side.
  • the diameter of the cross-section of the tip connecting portion 3A is the largest at the end connected to the tip portion 30D of the inflatable portion 3B and the smallest at the tip portion 3D.
  • the proximal connecting portion 3C extends proximally from the end connected to the distal end portion 30D of the inflatable portion 3B toward the proximal portion 3P.
  • the diameter of the cross section of the base end connecting portion 3C is the largest at the end connected to the base end portion 30P of the expansion portion 3B and the smallest at the base end portion 3P.
  • the distal connecting portion 3A, the inflating portion 3B, and the proximal connecting portion 3C of the balloon 3 respectively include first portions 41A, 42A, and 43A (hereinafter collectively referred to as the "first portion 4A") and a second portion. It has portions 51A, 52A, 53A (hereinafter collectively referred to as "second portion 5A").
  • the first portion 4A and the second portion 5A each extend in the extending direction between the distal end portion 3D of the distal connecting portion 3A and the proximal end portion 3P of the proximal connecting portion 3C.
  • the first portion 4A and the second portion 5A are made of the same material.
  • the first portion 4A and the second portion 5A are arranged in the circumferential direction E1 in the order of the second portion 51A, the first portion 41A, the second portion 52A, the first portion 42A, the second portion 53A, and the first portion 43A, respectively. are arranged in 4 A of 1st parts and 5 A of 2nd parts adjoin the circumferential direction E1, and are located in a line by turns.
  • the second portions 51A, 52A, 53A are arranged at regular intervals in the circumferential direction E1.
  • a portion of the inner surface 301 of the balloon 3 corresponding to the first portion 4A is called an inner surface 401, and a portion corresponding to the second portion 5A is called an inner surface 501.
  • a portion of the outer surface 302 of the balloon 3 corresponding to the first portion 4A is called an outer surface 402, and a portion corresponding to the second portion 5A is called an outer surface 502. As shown in FIG.
  • the first portion 4A and the second portion 5A differ in rigidity.
  • the second portion 5A has higher rigidity than the first portion 4A.
  • the difference in stiffness between the first portion 4A and the second portion 5A may be caused by at least one result of various well-known stiffness tests.
  • the first portion 4A and the second portion 5A are made of the same material, but have different thicknesses, resulting in a difference in rigidity.
  • the inner surface 401 and the outer surface 402 of the first portion 4A curve along an arc centered on the central axis C1.
  • a radial distance between the central axis C1 and the inner surface 401 of the first portion 4A is denoted as D11.
  • a radial distance between the central axis C1 and the outer surface 402 of the first portion 4A is denoted as D12.
  • the radial thickness of the first portion 4A corresponds to the radial distance between the inner surface 401 and the outer surface 402 of the first portion 4A and is denoted T11. More specifically, the curvature of both ends in the circumferential direction E1 of the inner surface 401 and the outer surface 402 is slightly larger than the curvature of the portions excluding the ends (see FIGS. 2(C) and 3(A)).
  • the outer surface 502 of the second portion 5A has a vertex 500 that protrudes radially outward the most.
  • Outer surface 502 has outer surfaces 502A, 502B corresponding in cross-section to two sides of a triangle.
  • the ends of the outer surfaces 502A and 502B opposite to the vertex 500 are connected to the ends of the first portion 4A adjacent in the circumferential direction E1.
  • a plane connecting the ends of the outer surfaces 502A and 502B opposite to the vertex 500 is referred to as a "bottom surface 503".
  • a direction extending perpendicularly to the bottom surface 503 and extending from the bottom surface 503 through the vertex 500 is referred to as a "projection direction Y1".
  • the projecting direction Y1 points radially outward.
  • the inner surface 501 of the second portion 5A is located radially inside the bottom surface 503 .
  • the distance between the central axis C1 and the inner surface 501 of the second portion 5A is denoted as D21.
  • the distance between the central axis C1 and the vertex 500 is denoted as D22.
  • the radial thickness of the second portion 5A corresponds to the radial distance between the inner surface 501 of the second portion 5A and the vertex 500 and is denoted T21.
  • the radial thickness T21 of the second portion 5A of the expansion portion 3B is the same in the extending direction.
  • the radial thickness T21 of the second portion 5A of the distal end connecting portion 3A is the largest at the portion connected to the distal end portion 30D of the inflatable portion 3B, and becomes smaller as it approaches the distal end portion 3D.
  • the radial thickness T21 of the second portion 5A of the base end connecting portion 3C is the largest at the portion connecting to the base end portion 30P of the inflatable portion 3B, and becomes smaller as it approaches the base end portion 3P.
  • the thickness T21 of the second portion 5A is greater than the thickness T11 of the first portion 4A in any cross section in the stretching direction.
  • the distance D21 between the inner surface 501 of the second portion 5A and the central axis C1 is shorter than the distance D11 between the inner surface 401 of the first portion 4A and the central axis C1. That is, the radial distance from the central axis C1 to the second portion 5A is shorter than the radial distance from the central axis C1 to the first portion 4A.
  • the distance D22 between the outer surface 502 of the second portion 5A and the central axis C1 is longer than the distance D12 between the outer surface 402 of the first portion 4A and the central axis C1.
  • a virtual virtual circle S is defined that contacts the first portions 41A to 43A from the outside.
  • both ends of each of the first portions 41A to 43A in the circumferential direction E1 and portions of each of the second portions 51A to 53A closer to the central axis C1 than the bottom surface 503 (see FIG. 1) are also located inside the virtual circle S. Therefore, the balloon 3 is formed with recesses 51B, 52B, and 53B (hereinafter collectively referred to as "recesses 5B") in which the second portions 51A, 52A, and 53A are recessed toward the central axis C1.
  • the shape of the balloon 3 is memorized so that the shape is stabilized with the depressions 51B, 52B, and 53B formed in the second portions 51A, 52A, and 53A.
  • the method for storing the shape of the first portion 4A is not particularly limited.
  • the balloon 3 may be produced by blow molding using a mold having the same shape as the shape of the balloon 3 with the recess 5B formed in the second portion 5A. In this case, it is possible to manufacture the balloon 3 having a shape memorized with the depression 5B formed in the second portion 5A.
  • the contracted balloon 3 has vanes 41B, 42B, and 43B (hereinafter collectively referred to as "vanes 4B").
  • the vanes 41B, 42B, 43B are formed by folding the first portions 41A, 42A, 43A of the balloon 3, respectively, and wrapping the second portions 52A, 53A, 51A from the outside.
  • the second portion 5A is covered from the outside by the blade portion 4B.
  • the blade portion 4B is also called a "flap" or a "wing".
  • FIG. 2 shows the process of deformation of the balloon 3 from a deflated state to an inflated state.
  • a compressed fluid is supplied from a hub (not shown) to the deflated balloon 3 shown in FIG. 2(A).
  • the first portions 41A-43A of the balloon 3 are extended, and the vanes 41B-43B (see FIG. 2(A)) are eliminated.
  • the second portions 51A-53A each move radially outward and away from the central axis C1.
  • the balloon 3 is inflated as shown in FIG. 2(C).
  • the depression amounts of the depressions 51B, 52B, and 53B are the actual depression amounts (the depression amounts of the depressions 51B, 52B, and 53B shown in FIG. 1). dent amount). The same applies to FIG. 3A, which will be described later.
  • FIG. 3 shows the process of deformation of the balloon 3 from the inflated state to the deflated state.
  • the compressed fluid is removed from the inflated balloon 3 shown in FIG. 3(A).
  • the shape of the balloon 3 is memorized in a state in which the depressions 51B to 53B are formed in the second portions 51A to 53A. Therefore, as shown in FIG. 3B, in response to the removal of the compressed fluid, the entire balloon 3 moves toward the central axis C1 by a predetermined amount, after which the second portions 51A to 53A move toward the first portions 41A to 43A. It moves toward the central axis C1 earlier than. Therefore, the amount of depression of the depressions 51B to 53B with respect to the virtual circle S is greater than in the expanded state.
  • the speed at which the second portions 51A to 53A move toward the central axis C1 is is slow immediately after the start of movement and then speeds up.
  • the amount of depression of the depressions 51B to 53B is larger in the expanding portion 3B than in the distal connecting portion 3A and the proximal connecting portion 3C. Therefore, the maximum diameter of the balloon 3, that is, the diameter of the inflatable portion 3B rapidly decreases.
  • the first parts 41A to 43A cover the second parts 51A to 53A from the outside in a folded state to form the wings 41B to 43B. As a result, the balloon 3 is contracted.
  • the second portion 5A which has a short radial distance from the central axis C1 in the inflated state, moves toward the central axis C1 earlier than the first portion 4A. do.
  • the first portion 4A forms the vane portion 4B, and the balloon 3 is finally contracted.
  • the balloon catheter 1A can stabilize the shape of the balloon 3 in the contracted state, the diameter of the balloon 3 in the contracted state can be reduced to maintain good passageability through the blood vessel.
  • the balloon catheter 1A can reduce the diameter of the balloon 3 in the deflated state.
  • the second portion 5A can suppress the application of local pressure to the portion corresponding to the inflatable portion 3B. Therefore, it is possible to prevent the balloon 3 from bursting during the manufacturing process.
  • the first portion 4A and the second portion 5A of the balloon 3 are provided at the distal connecting portion 3A, the expanding portion 3B, and the proximal connecting portion 3C.
  • the balloon catheter 1A when the balloon catheter 1A is deformed from an inflated state to a deflated state, the second portion 5A of each of the distal end connecting portion 3A, the inflating portion 3B, and the proximal end connecting portion 3C of the balloon 3 is aligned with the central axis C1. can be moved forward.
  • the balloon 3 can be folded into a stable shape at each of the distal connecting portion 3A, the inflatable portion 3B, and the proximal connecting portion 3C.
  • the diameter of the balloon 3 in the deflated state can be made small over the entire stretch direction. Moreover, since the possibility that the diameters of the distal connecting portion 3A and the proximal connecting portion 3C are increased when folded can be reduced, the passage of the balloon 3 through the blood vessel can be improved.
  • the recesses 51B to 53B formed in the process of deforming the balloon 3 from the inflated state to the contracted state are larger in the inflatable portion 3B than in the distal end connecting portion 3A and the proximal end connecting portion 3C. Therefore, the balloon 3 can shorten the folding time of the large-diameter inflatable portion 3B during deflation. Moreover, since the vanes 41B to 43B are formed smoothly, the folded shape of the balloon 3 can be stabilized.
  • the second portion 5A has higher rigidity than the first portion 4A.
  • a force tending to move the second portion 5A toward the central axis C1 earlier than the first portion 4A can be realized by adjusting the rigidity magnitude relationship with the first portion 4A.
  • the behavior of the deflated balloon 3 to spread outward in the radial direction can be suppressed by the second portion 5A having higher rigidity. Therefore, even when the balloon 3 is repeatedly deformed between the inflated state and the deflated state, the blade portions 4B can be stably formed by the first portion 4A. Therefore, the diameter of the contracted balloon 3 can be stably maintained small, and the blades 4B can be prevented from being flattened and folded.
  • the rigidity of the second portion 5A is higher than that of the first portion 4A, and the second portion 5A is provided over the entire region from the distal end portion 3D to the proximal end portion 3P of the balloon 3.
  • the second portion 5A serves as a tension rod when the deflated balloon 3 is inserted into the blood vessel. Therefore, the balloon catheter 1A can suppress radial expansion of the distal end connecting portion 3A and the proximal end connecting portion 3C due to contraction of the balloon 3 in the extending direction.
  • the thickness T21 of the second portion 5A is greater than the thickness T11 of the first portion 4A. In this case, the speed at which the second portion 5A moves toward the central axis C1 when the balloon 3 is deformed from the inflated state to the deflated state is slow immediately after the start of movement and then increases. Therefore, the balloon catheter 1A can stably fold the balloon 3 by the second portion 5A.
  • the distance D21 between the inner surface 501 of the second portion 5A and the central axis C1 is the distance between the inner surface 401 of the portion of the first portion 4A excluding both ends in the circumferential direction E1 and the central axis C1. Shorter than D11. That is, the inner surface 501 of the second portion 5A is arranged at a position closer to the central axis C1 than the inner surface 401 of the first portion 4A. Also, in the inflated state, the distance D22 between the outer surface 502 of the second portion 5A and the central axis C1 is longer than the distance D12 between the outer surface 402 of the first portion 4A and the central axis C1.
  • the second portion 5A tends to move toward the central axis C1 earlier than the first portion 4A. Therefore, even when the balloon 3 is repeatedly deformed between the inflated state and the deflated state, the balloon 3 can always be folded into a stable shape.
  • the distance D22 is longer than the distance D12, so the outer surface 502 of the second portion 5A protrudes outward from the outer surface 402 of the first portion 4A.
  • the balloon catheter 1A allows the second portion 5A of the balloon 3 to act favorably on the blood vessel.
  • the second portions 51A to 53A are arranged at equal intervals in the circumferential direction E1.
  • the vane portions 41B to 43B formed by the first portions 41A to 43A can be uniform in size. Therefore, the balloon catheter 1A can contract the balloon 3 uniformly in the circumferential direction E1.
  • the shape of the balloon 3 is stored in a state in which the recesses 51B to 53B recessed toward the central axis C1 are formed in the second portions 51A to 53A.
  • the configuration in which the second portion 5A is first moved toward the central axis C1 can be easily realized.
  • the first portion 4A and the second portion 5A of the balloon 3 are made of the same material. In this case, the balloon catheter 1A can be easily manufactured.
  • the present invention is not limited to the above embodiments, and various modifications are possible.
  • the number of the first portions 4A and the number of the second portions 5A of the balloon 3 is not limited to three each as in the above embodiment, and may be any other number.
  • the first portion 4A and the second portion 5A of the balloon 3 may be formed by separate members.
  • the balloon 3 may be provided with the second portion 5A on the outer surface of the tubular portion that becomes tubular in the inflated state. In this case, the portion between two adjacent second portions 5A of the cylindrical portion corresponds to the first portion 4A.
  • the second portion 5A moves toward the central axis C1 earlier than the first portion 4A.
  • the second portion 5A starts moving first and then moves toward the central axis C1 of the first portion 4A. Movement may be initiated. Alternatively, the first portion 4A may start moving first, and then the second portion 5A may start moving toward the central axis C1.
  • the first portion 4A and the second portion 5A may be provided only on the inflatable portion 3B of the balloon 3, and may not be provided on the distal end connecting portion 3A and the proximal end connecting portion 3C.
  • the second portion 5A may not extend from the distal end portion 30D to the proximal end portion 30P of the expansion portion 3B, and may be divided in the extending direction.
  • the first portion 4A and the second portion 5A may be provided on the inflation portion 3B of the balloon 3 and one of the distal connecting portion 3A and the proximal connecting portion 3C.
  • the second portion 5A may be composed of different members for the inner portion and the outer portion of the distance D12 in the radial direction.
  • the portion radially inside the distance D12 may be made of the same material as the first portion 4A, and the portion radially outside the distance D12 may be made of a material different from the first portion 4A. good.
  • a portion of the second portion 5A radially outside the distance D12 may have higher rigidity than a portion radially inside the distance D12. That is, the portion of the second portion 5A outside the distance D12 in the radial direction may form a rigid portion.
  • the thickness T11 of the first portion 4A and the thickness T21 of the second portion 5A may be the same. In this case, the outer surface 502 of the second portion 5A does not need to protrude outward with respect to the outer surface 402 of the first portion 4A.
  • the second portions 51A to 53A do not have to be evenly arranged in the circumferential direction E1.
  • the second portions 51A to 53A may be locally provided on a portion of the balloon 3 in the circumferential direction E1.
  • the recess 5B may not be provided in the inflated balloon 3.
  • the inner surface of the balloon 3 in the inflated state may be formed in a cylindrical shape without irregularities.
  • the first portion 4A and the second portion 5A of the balloon 3 may be made of different materials.
  • the second portion 5A may be formed by doping a new material to the material forming the first portion 4A.
  • each of the second portions 51A to 53A may be rounded like the balloon 3 of the balloon catheter 1B shown in FIG.
  • the balloon catheter 1B can improve the passageability of the balloon 3 in the blood vessel.
  • the shape of the outer surface 502 of the second portion 5A is not limited to the above, and can take various shapes depending on the application and function.
  • ⁇ Balloon catheter 1C> Like the balloon 3 of the balloon catheter 1C shown in FIG. 5, in the inflated state, the distance D11 between the inner surface 401 of the first portion 4A and the central axis C1, and the distance between the inner surface 501 of the second portion 5A and the central axis C1. may be the same as the distance D21 between them. In this case, no steps are formed on the inner surface 301 of the balloon 3, and the inner surfaces 401 and 501 form a perfect circle in cross section.
  • ⁇ Balloon catheter 1D> Like the balloon 3 of the balloon catheter 1D shown in FIG. 6, in the inflated state, the distance D12 between the outer surface 402 of the first portion 4A and the central axis C1 and the distance between the outer surface 502 of the second portion 5A and the central axis C1 may be the same as the distance D22 between them. In this case, no steps are formed on the outer surface 302 of the balloon 3, and the outer surfaces 402 and 502 form a perfect circle in cross section. Further, the inner surface 301 of the balloon 3 is formed with an inwardly projecting step at a portion corresponding to the inner surface 501 of the second portion 5A.
  • a slit 7A is provided in the second portion 5A arranged at the tip connecting portion 3A, and a slit 7B is provided in the second portion 5A arranged at the inflating portion 3B.
  • two slits 7C may be provided in the second portion 5A arranged at the proximal end connecting portion 3C.
  • the slits 7A-7C are cuts or notches extending from the outer surface 502 of the second portion 5A toward the central axis C1.
  • the slit 7A provided in the second portion 5A arranged in the tip connecting part 3A can maintain the flexibility of the tip connecting part 3A while suppressing the tip connecting part 3A from expanding in the contracted state. Therefore, the balloon catheter 1E can improve passageability when inserting the deflated balloon 3 into a blood vessel.
  • the slit 7C provided in the second portion 5A arranged in the proximal connecting portion 3C can maintain the flexibility of the proximal connecting portion 3C while suppressing the expansion of the proximal connecting portion 3C in the contracted state. Therefore, the balloon catheter 1E can improve passability when the deflated balloon 3 is pulled out of the blood vessel.
  • the two slits 7B provided in the second portion 5A arranged in the inflatable portion 3B can suppress the expansion of the inflatable portion 3B in the deflated state. Moreover, since the second portion 5A arranged in the inflatable portion 3B is not stretched in the curved blood vessel, the followability of the balloon 3 to the curved blood vessel can be improved.
  • the bottoms of the slits 7A to 7C in other words, the portions of the slits 7A to 7C that are closest to the central axis C1 are positioned radially outside the bottom surface 503 (see FIG. 1) of the second portion 5A. good.
  • the second portion 5A can effectively act as a tension rod. Only some of the slits 7A, 7B, and 7C in FIG. 7 may be provided in the second portion 5A.
  • the slit 7B may be provided only in the second portion 5A of the inflating portion 3B of the balloon 3, and the slits 7A and 7C may not be provided in the second portions 5A of the distal connecting portion 3A and the proximal connecting portion 3C.
  • FIG. 8 shows the process of deformation of the balloon 3 of the balloon catheter 1F from the inflated state to the deflated state. Assume that the compressed fluid is removed from the inflated balloon 3 shown in FIG. 8(A). Upon removal of the compressed fluid, the balloon 3 transforms from an inflated state to a deflated state.
  • the second portions 51A-53A move toward the central axis C1 earlier than the first portions 41A-43A.
  • the first portions 41A to 43A are pushed outward except for both ends in the circumferential direction E1 (see FIG. 1), and protrude outside the imaginary circle S.
  • the first portion 41A has the maximum curvature at the vertex P(1).
  • the first portion 42A has the maximum curvature at the vertex P(2).
  • the first portion 43A has the maximum curvature at the vertex P(3).
  • a virtual plane radially extending from the central axis C1 through the vertex P(1) of the first portion 41A is denoted as "W41".
  • a virtual plane radially extending from the central axis C1 through the vertex P(2) of the first portion 42A is denoted as "W42.”
  • a virtual plane radially extending from the central axis C1 through the vertex P(3) of the first portion 43A is denoted as "W43”.
  • a virtual plane radially extending from the central axis C1 through the vertex 500 of the second portion 51A is denoted as "W51”.
  • a virtual plane radially extending from the central axis C1 through the vertex 500 of the second portion 52A is denoted as "W52”.
  • a virtual plane radially extending from the central axis C1 through the vertex 500 of the second portion 53A is denoted as "W53".
  • a virtual plane equidistant from each of the planes W51 and W52 that is, a virtual plane that bisects the angle formed by the planes W51 and W52 is denoted as "plane W410".
  • a virtual plane that is equidistant from the planes W52 and W53 that is, a virtual plane that bisects the angle formed by the planes W52 and W53 is referred to as a "plane W420.”
  • a virtual plane that is equidistant from the planes W53 and W51 that is, a virtual plane that bisects the angle formed by the planes W53 and W51 is denoted as "plane W430.”
  • the counterclockwise side of the circumferential direction E1 is referred to as "one side E11 of the circumferential direction E1.”
  • the angle between planes W51 and W41, the angle between planes W52 and W42, and the angle between planes W53 and W43 are equal.
  • this angle will be referred to as " ⁇ a”.
  • the angle between the planes W41 and W52, the angle between the planes W42 and W53, and the angle between the planes W43 and W51 are equal.
  • This angle is hereinafter referred to as " ⁇ b”.
  • the angle ⁇ b is larger than the angle ⁇ a ( ⁇ a ⁇ b). That is, the vertex P(1) is arranged on one side E11 in the circumferential direction E1 with respect to the plane W410. Vertex P(2) is arranged on one side E11 in circumferential direction E1 with respect to plane W420. Vertex P(3) is arranged on one side E11 in circumferential direction E1 with respect to plane W430.
  • a portion of the first portion 41A that extends from the connection portion with the second portion 51A to the vertex P(1) is called a first extending portion 411.
  • a portion of the first portion 41A that extends from the connection portion with the second portion 52A to the vertex P(1) is referred to as a second extending portion 412 .
  • a portion of the first portion 42A that extends from the connection portion with the second portion 52A to the vertex P(2) is referred to as a first extending portion 421.
  • a portion of the first portion 42A that extends from the connection portion with the second portion 53A to the vertex P(2) is referred to as a second extending portion 422.
  • a portion of the first portion 43A extending from the connection portion with the second portion 53A to the vertex P(3) is referred to as a first extending portion 431.
  • a portion of the first portion 43A that extends from the connection portion with the second portion 51A to the vertex P(3) is referred to as a second extending portion 432 .
  • the lengths of the first extending portions 411, 421, 431 are equal. Hereinafter, this length is described as "La”. Also, the lengths of the second extensions 412, 422, 432 are equal. Hereinafter, this length is written as "Lb". In this case, the length Lb is longer than the length La (La ⁇ Lb). In addition, in FIG. 9, only the length La of the first extension portion 421 is shown, and the length La of the first extension portions 411 and 431 is omitted. Also, only the length Lb of the second extending portion 422 is shown, and the lengths Lb of the second extending portions 412 and 432 are omitted.
  • the distance between the vertex P(1) of the first portion 41A and the vertex 500 of the second portion 51A, the distance between the vertex P(2) of the first portion 42A and the vertex 500 of the second portion 52A, and The distance between vertex P(3) of first portion 43A and vertex 500 of second portion 53A is equal.
  • this distance is written as "Lc”.
  • the distance between the vertex P(1) of the first portion 41A and the vertex 500 of the second portion 52A, the distance between the vertex P(2) of the first portion 42A and the vertex 500 of the second portion 53A, and The distance between vertex P(3) of first portion 43A and vertex 500 of second portion 51A is equal.
  • this distance is written as "Ld”. In this case, the distance Ld is longer than the distance Lc (Lc ⁇ Ld).
  • FIG. 9 shows only the distance Lc between the vertex P(3) of the first portion 43A and the vertex 500 of the second portion 53A. and the distance Lc between the vertex P(2) of the first portion 42A and the vertex 500 of the second portion 52A are omitted. Also, only the distance Ld between the vertex P(3) of the first portion 43A and the vertex 500 of the second portion 51A is shown, and the distance between the vertex P(1) of the first portion 41A and the vertex 500 of the second portion 52A is shown. and the distance Ld between the vertex P(2) of the first portion 42A and the vertex 500 of the second portion 53A are omitted.
  • the first parts 41A to 43A are folded while the second parts 51A to 53A have moved to positions close to the inner tube 22.
  • the relationship between lengths La and Lb (La ⁇ Lb), the relationship between distances Lc and Ld (Lc ⁇ Ld), and the relationship between angles ⁇ a and ⁇ b ( ⁇ a ⁇ b) described in FIG. 9 are maintained. be.
  • the first parts 41A to 43A cover the second parts 51A to 53A from the outside in a folded state to form the wings 41B to 43B. As a result, the balloon 3 is contracted.
  • the length Lb of the second extension portion 412 of the first portion 41A is longer than the length La of the first extension portion 411 (La ⁇ Lb).
  • the distance between the vertex P(1) of the first portion 41A and the vertex 500 of the second portion 52A is greater than the distance Lc between the vertex P(1) of the first portion 41A and the vertex 500 of the second portion 51A.
  • Ld is longer (Lc ⁇ Ld).
  • Vertex P(1) is arranged on one side E11 in circumferential direction E1 with respect to plane W410. Therefore, when the balloon 3 is deformed from the inflated state to the deflated state, the first portion 41A is likely to be arranged at a position close to the second portion 51A adjacent to the one side E11 in the circumferential direction E1.
  • first portion 42A is likely to be arranged at a position close to the second portion 52A adjacent to the one side E11 in the circumferential direction E1.
  • 43 A of 1st parts tend to be arrange
  • the position of the first portion 4A is stabilized during the process in which the balloon 3 is deformed from the inflated state to the deflated state, and it is easily placed in a position covering the second portion 5A. Therefore, in the process of deforming the balloon 3 from the inflated state to the deflated state, the first portion 4A can easily cover the second portion 5A adjacent to the one side E11 in the circumferential direction E1. Further, the balloon catheter 1F can appropriately cover the second portion 5A with the first portion 4A in the deflated state even when the balloon 3 is repeatedly deformed between the inflated state and the deflated state.
  • the balloon catheter 1G differs from the balloon catheter 1F in the shape of the first portions 41A, 42A, 43A in the process of deforming the balloon 3 from the inflated state to the deflated state.
  • FIG. 10 shows the process of deformation of the balloon 3 of the balloon catheter 1G from the inflated state to the deflated state.
  • the states of FIGS. 10A and 10B are the same as those of FIGS. 8A and 8B.
  • the first portions 41A to 43A are pushed outward and protrude outside the imaginary circle S.
  • the first portion 41A has the maximum curvature at the vertex P(1).
  • the first portion 42A has the maximum curvature at the vertex P(2).
  • the first portion 43A has the maximum curvature at the vertex P(3).
  • the relationship between the lengths La and Lb (La ⁇ Lb) and the relationship between the distances Lc and Ld (Lc ⁇ Ld) in the balloon 3 are the same as in the case of the balloon catheter 1F (see FIG. 9) (see FIG. 11).
  • the positional relationship between the plane W410 and the vertex P(1), the positional relationship between the plane W420 and the vertex P(2), and the positional relationship between the plane W430 and the vertex P(3) are also shown in the balloon catheter 1F (Fig. 9) (see FIG. 11).
  • a portion of the first extension portion 411 of the first portion 41A (the portion within the frame line Q41) is on the side opposite to the one side E11 in the circumferential direction E1 (see FIG. 1) with respect to the plane W41. (Hereinafter referred to as “the other side E12 in the circumferential direction E1”), that is, it is arranged on the side where the second portion 52A is located with respect to the plane W41.
  • a portion of the first extending portion 421 of the first portion 42A (the portion within the frame line Q42) is the other side E12 in the circumferential direction E1 with respect to the plane W42, that is, the side on which the second portion 53A is located with respect to the plane W41.
  • a portion of the first extending portion 431 of the first portion 43A (the portion within the frame line Q43) is arranged on the other side E12 in the circumferential direction E1 with respect to the plane W43, that is, the side on which the second portion 51A is located.
  • a direction Y41 extending outward from the balloon 3 is defined perpendicular to the tangent line of the first portion 41A at the vertex P(1) of the first portion 41A.
  • the direction Y41 extends obliquely to one side E11 of the circumferential direction E1 with respect to the radial direction about the central axis C1.
  • a direction Y42 extending outward of the balloon 3 is defined perpendicular to the tangent of the first portion 42A at the vertex P(2) of the first portion 42A.
  • the direction Y42 extends obliquely to one side E11 in the circumferential direction E1 with respect to the radial direction about the central axis C1.
  • a direction Y43 extending outward of the balloon 3 is defined perpendicular to the tangent line of the first portion 43A at the vertex P(3) of the first portion 43A.
  • the direction Y43 extends obliquely to one side E11 in the circumferential direction E1 with respect to the radial direction about the central axis C1.
  • the first parts 41A to 43A are folded while the second parts 51A to 53A have moved to positions close to the inner tube 22.
  • the relationship between the lengths La and Lb (La ⁇ Lb) and the relationship between the distances Lc and Ld (Lc ⁇ Ld) described in FIG. 11 are maintained.
  • the planes W41 and W51 match, the planes W42 and W52 match, and the planes W43 and W53 match.
  • the first extending portion 411 of the first portion 41A is arranged on the other side E12 (see FIG. 11) in the circumferential direction E1 with respect to the plane W41 over the entire area.
  • the first extending portion 421 of the first portion 42A is arranged on the other side E12 in the circumferential direction E1 with respect to the plane W42 over the entire area.
  • the first extending portion 431 of the first portion 43A is arranged on the other side E12 in the circumferential direction E1 with respect to the plane W43 over the entire area.
  • the directions Y41, Y42, and Y43 are each inclined to one side E11 (see FIG. 11) of the circumferential direction E1 with respect to the radial direction.
  • the first parts 41A to 43A cover the second parts 51A to 53A from the outside in a folded state to form the wings 41B to 43B. As a result, the balloon 3 is contracted.
  • the vertex P(1) of the first portion 41A is arranged on one side E11 in the circumferential direction E1 with respect to the plane W410.
  • a part of the first extending portion 411 is arranged on the other side E12 in the circumferential direction E1 with respect to the plane W41, and the direction Y41 is inclined to the one side E11 in the circumferential direction E1 with respect to the plane W41. Therefore, when the balloon 3 is deformed from the inflated state to the deflated state, the first portion 41A is easily arranged at a position close to the second portion 51A adjacent to the one side E11 in the circumferential direction E1, It becomes easy to cover the portion 51A from the outside in the radial direction.
  • first portion 42A is easily arranged at a position close to the second portion 52A adjacent to the one side E11 in the circumferential direction E1, and easily covers the second portion 52A from the outside in the radial direction.
  • the first portion 43A is easily arranged at a position close to the second portion 53A adjacent to the one side E11 in the circumferential direction E1, and easily covers the second portion 53A from the outside in the radial direction.
  • the position of the first portion 4A is stabilized in the process in which the balloon 3 is deformed from the inflated state to the deflated state, and the second portion 4A adjacent to the one side E11 in the circumferential direction E1 can be easily positioned to cover the second portion 4A. placed.
  • the first portion 4A assumes a shape that easily covers the second portion 5A from the outside in the radial direction during the process in which the balloon 3 is deformed from the inflated state to the deflated state. Therefore, the balloon catheter 1G can easily cover the second portion 5A adjacent to the first portion 4A on one side E11 in the circumferential direction E1 with the first portion 4A. Further, the balloon catheter 1G can appropriately cover the second portion 5A with the first portion 4A in the deflated state even when the balloon 3 is repeatedly deformed between the inflated state and the deflated state.
  • the lengths of the first extending portions 411, 421, 431 may be different.
  • the lengths of the second extensions 412, 422, 432 may be different.
  • the second extending portion 412 should be longer than the first extending portion 411 in the first portion 41A. It is sufficient that the second extending portion 422 is longer than the first extending portion 421 in the first portion 42A. It is sufficient that the second extending portion 432 is longer than the first extending portion 431 in the first portion 43A.
  • the distance between the vertex P(1) of the first portion 41A and the vertex 500 of the second portion 51A, the distance between the vertex P(2) of the first portion 42A and the vertex 500 of the second portion 52A, and The distance between the vertex P(3) of the first portion 43A and the vertex 500 of the second portion 53A may be different.
  • the distance between the vertex P(1) of the first portion 41A and the vertex 500 of the second portion 52A, the distance between the vertex P(2) of the first portion 42A and the vertex 500 of the second portion 53A, and The distance between the vertex P(3) of the first portion 43A and the vertex 500 of the second portion 51A may be different.
  • the distance between the vertex P(1) of the first portion 41A and the vertex 500 of the second portion 52A is greater than the distance between the vertex P(1) of the first portion 41A and the vertex 500 of the second portion 51A.
  • the distance between the vertex P(2) of the first portion 42A and the vertex 500 of the second portion 53A is greater than the distance between the vertex P(2) of the first portion 42A and the vertex 500 of the second portion 52A. The longer the better.
  • the distance between the vertex P(3) of the first portion 43A and the vertex 500 of the second portion 51A is greater than the distance between the vertex P(3) of the first portion 43A and the vertex 500 of the second portion 53A. The longer the better.

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PCT/JP2022/021097 2021-06-22 2022-05-23 カテーテル用バルーン Ceased WO2022270192A1 (ja)

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KR1020247000184A KR20240017061A (ko) 2021-06-22 2022-05-23 카테터용 벌룬
JP2023529709A JP7640692B2 (ja) 2021-06-22 2022-05-23 カテーテル用バルーン
AU2022298081A AU2022298081B2 (en) 2021-06-22 2022-05-23 Balloon for catheter
BR112023025231A BR112023025231A2 (pt) 2021-06-22 2022-05-23 Balão para cateter
CN202280021598.5A CN117015414A (zh) 2021-06-22 2022-05-23 导管用球囊
CA3221680A CA3221680A1 (en) 2021-06-22 2022-05-23 Balloon for catheter
EP22828111.9A EP4360689A4 (en) 2021-06-22 2022-05-23 CATHETER BALLOON
US18/393,429 US20240123198A1 (en) 2021-06-22 2023-12-21 Balloon for Catheter

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JP2021103068 2021-06-22
JP2021-103068 2021-06-22

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US18/393,429 Continuation US20240123198A1 (en) 2021-06-22 2023-12-21 Balloon for Catheter

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KR (1) KR20240017061A (https=)
CN (1) CN117015414A (https=)
AU (1) AU2022298081B2 (https=)
BR (1) BR112023025231A2 (https=)
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JPS62114565A (ja) 1985-11-08 1987-05-26 デ−タスコ−プ　コ−ポレ−シヨン 予め折りたたまれたバル−ン・カテ−テル
JPH05293176A (ja) * 1992-04-17 1993-11-09 Interventional Technol Inc 血管狭窄部拡張装置
JPH10506296A (ja) * 1994-07-01 1998-06-23 ボストン サイエンティフィック コーポレーション 予定された形状に折り畳まれ得るバルーンを有するカテーテルとその製造方法
JP2006512952A (ja) * 2003-01-02 2006-04-20 ボストン サイエンティフィック リミテッド 医療器具
JP2008506454A (ja) * 2004-07-13 2008-03-06 ボストン サイエンティフィック リミテッド バルーン折畳み設計ならびにバルーンを製造するための方法および装置
JP2018171318A (ja) * 2017-03-31 2018-11-08 テルモ株式会社 医療用長尺体
WO2020195697A1 (ja) * 2019-03-28 2020-10-01 株式会社カネカ バルーンカテーテル

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US7753875B2 (en) * 2007-01-24 2010-07-13 Cook Incorporated Preform and balloon having a non-uniform thickness
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JP7175763B2 (ja) * 2016-05-26 2022-11-21 株式会社グッドマン バルーンカテーテル
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JPS62114565A (ja) 1985-11-08 1987-05-26 デ−タスコ−プ　コ−ポレ−シヨン 予め折りたたまれたバル−ン・カテ−テル
JPH05293176A (ja) * 1992-04-17 1993-11-09 Interventional Technol Inc 血管狭窄部拡張装置
JPH10506296A (ja) * 1994-07-01 1998-06-23 ボストン サイエンティフィック コーポレーション 予定された形状に折り畳まれ得るバルーンを有するカテーテルとその製造方法
JP2006512952A (ja) * 2003-01-02 2006-04-20 ボストン サイエンティフィック リミテッド 医療器具
JP2008506454A (ja) * 2004-07-13 2008-03-06 ボストン サイエンティフィック リミテッド バルーン折畳み設計ならびにバルーンを製造するための方法および装置
JP2018171318A (ja) * 2017-03-31 2018-11-08 テルモ株式会社 医療用長尺体
WO2020195697A1 (ja) * 2019-03-28 2020-10-01 株式会社カネカ バルーンカテーテル

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AU2022298081A1 (en) 2023-12-21
BR112023025231A2 (pt) 2024-02-27
JP7640692B2 (ja) 2025-03-05
KR20240017061A (ko) 2024-02-06
CA3221680A1 (en) 2022-12-29
EP4360689A4 (en) 2025-06-18
AU2022298081B2 (en) 2025-05-01
US20240123198A1 (en) 2024-04-18
CN117015414A (zh) 2023-11-07

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