WO2024084745A1 - Balloon catheter - Google Patents

Balloon catheter Download PDF

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Publication number
WO2024084745A1
WO2024084745A1 PCT/JP2023/024124 JP2023024124W WO2024084745A1 WO 2024084745 A1 WO2024084745 A1 WO 2024084745A1 JP 2023024124 W JP2023024124 W JP 2023024124W WO 2024084745 A1 WO2024084745 A1 WO 2024084745A1
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Prior art keywords
balloon
tip
balloon catheter
marker
shaft
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PCT/JP2023/024124
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French (fr)
Japanese (ja)
Inventor
幸也 赤坂
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朝日インテック株式会社
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Publication of WO2024084745A1 publication Critical patent/WO2024084745A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the technology disclosed in this specification relates to balloon catheters.
  • Balloon catheters are used to expand narrowed or blocked areas (hereinafter referred to as "lesions") formed in biological lumens such as blood vessels.
  • Balloon catheters have a balloon whose outer diameter can be expanded, a hollow outer shaft, and a hollow inner shaft inserted into the outer shaft (see, for example, Patent Document 1).
  • the tip of the outer shaft and a longitudinal portion of the inner shaft are disposed inside the balloon.
  • the space between the outer peripheral surface of the inner shaft and the inner peripheral surface of the outer shaft is used as an expansion medium lumen through which an expansion medium for expanding the balloon flows.
  • a radiopaque marker may be provided at the tip of the balloon catheter.
  • providing a marker at the tip of the balloon catheter may increase the profile of the tip of the balloon catheter, which may reduce the passability of the balloon catheter. Also, providing a marker at the tip of the balloon catheter may damage the balloon by pinching it between the marker and tissue in the biological lumen (e.g., calcified lesions).
  • the balloon catheter disclosed in this specification comprises a balloon whose outer diameter can be expanded, a hollow outer shaft, a hollow inner shaft, and a radiopaque marker.
  • the tip of the outer shaft is disposed inside the balloon.
  • the inner shaft is inserted into the outer shaft, and a longitudinal portion of the inner shaft is disposed inside the balloon.
  • the marker is disposed so as to be sandwiched between the tip of the outer shaft and the inner shaft in the radial direction.
  • the marker is sandwiched between the tip of the outer shaft and the inner shaft in the radial direction. Therefore, compared to a configuration in which the marker is located distal to the tip of the outer shaft, it is possible to suppress an increase in the profile of the tip of the balloon catheter caused by the presence of the marker, and as a result, it is possible to suppress a decrease in the passability of the balloon catheter.
  • the outer shaft is interposed between the balloon and the marker in the radial direction, it is possible to prevent the balloon from being sandwiched between the lesion and the marker when the tip of the balloon catheter is inserted into the lesion in the biological lumen, and it is possible to suppress damage to the balloon.
  • the tip of the outer shaft and the inner shaft may be joined to each other at a joint, and at least the tip of the marker may be disposed within the joint.
  • the entire marker may be disposed within the joint.
  • the technology disclosed in this specification can be realized in various forms, such as balloon catheters, medical devices equipped with balloon catheters, and methods of manufacturing and using them.
  • FIG. 1 is an explanatory diagram showing a schematic configuration of a balloon catheter 100 according to an embodiment of the present invention.
  • FIG. 1 is an explanatory diagram showing a schematic configuration of a balloon catheter 100 according to an embodiment of the present invention.
  • FIG. 1 is an explanatory diagram showing an example of use of the balloon catheter 100 according to the present embodiment.
  • FIG. 1 is an explanatory diagram showing a detailed configuration of a tip portion of the balloon catheter 100 according to the present embodiment.
  • FIG. 1 and FIG. 2 are explanatory diagrams that show a schematic configuration of a balloon catheter 100 in this embodiment.
  • FIG. 1 and FIG. 2 show the configuration of a longitudinal section (YZ section) of the balloon catheter 100.
  • FIG. 1 shows a state in which a balloon 30 described later is expanded
  • FIG. 2 shows a state in which the balloon 30 is deflated.
  • the positive Z-axis direction side is the tip side (distal side) that is inserted into the body
  • the negative Z-axis direction side is the base end side (proximal side) that is operated by a technician such as a doctor.
  • illustration of a part of the balloon catheter 100 is omitted as appropriate.
  • each figure shows a state in which the balloon catheter 100 as a whole is linearly shaped approximately parallel to the Z-axis direction, but at least a part of the balloon catheter 100 has flexibility to the extent that it can be curved.
  • the balloon catheter 100 is a long medical device that is inserted into a biological lumen, such as a blood vessel, to expand a lesion (a narrowed or blocked area) in the biological lumen.
  • the balloon catheter 100 has an inner shaft 10, an outer shaft 20, a balloon 30, and a marker 50.
  • the balloon 30 is a bag-shaped member whose outer diameter can expand and contract in the radial direction.
  • the radial direction is the direction from the central axis of the balloon catheter 100 toward the outer periphery.
  • the balloon 30 is preferably made of a material that has a certain degree of flexibility.
  • Examples of materials that can be used to form the balloon 30 include polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or mixtures of two or more of these, soft polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, thermoplastic resins such as fluororesin, silicone rubber, latex rubber, etc.
  • polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or mixtures of two or more of these, soft polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, thermoplastic resins such as fluororesin, silicone rubber, latex rubber, etc.
  • the outer shaft 20 is a hollow tubular (e.g., cylindrical) member with an open tip and base end.
  • tubular does not mean a completely tubular shape with a constant outer diameter and inner diameter along the longitudinal direction, but means a generally cylindrical shape as a whole, including, for example, a shape in which the outer diameter and/or inner diameter change along the longitudinal direction, and a shape with unevenness on the outer circumferential surface and/or inner circumferential surface.
  • the tip portion 21 of the outer shaft 20 is arranged so as to be inserted into the balloon 30 from the base end side, and the shaft main body portion 22, which is the portion of the outer shaft 20 on the base end side from the tip portion 21, extends to the base end side while being exposed from the balloon 30.
  • the base end portion 34 of the balloon 30 is joined to the outer circumferential surface of the tip portion 21 of the outer shaft 20, for example, by welding.
  • the portion of the tip portion 21 of the outer shaft 20 joined to the balloon 30 is referred to as the balloon joining portion 23.
  • the outer shaft 20 is preferably made of a material that can be heat welded and has a certain degree of flexibility.
  • materials that can be used to form the outer shaft 20 include thermoplastic resins, more specifically, polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or mixtures of two or more of these, polyvinyl chloride resins, polyamides, polyamide elastomers, polyesters, polyester elastomers, thermoplastic polyurethanes, etc.
  • the core wire 29 is housed inside the shaft body 22 of the outer shaft 20.
  • the core wire 29 is a rod-shaped member with a thin diameter at the tip end and a thick diameter at the base end.
  • the presence of the core wire 29 gives the balloon catheter 100 a rigidity characteristic in which the rigidity changes along the longitudinal direction so that the distal end becomes more flexible.
  • materials for forming the core wire 29 include metal materials, more specifically, stainless steel (SUS302, SUS304, SUS316, etc.), Ni-Ti alloys, piano wire, nickel-chromium alloys, cobalt alloys, tungsten, etc.
  • the inner shaft 10 is a hollow tubular (e.g., cylindrical) member with an open tip and base end.
  • a guidewire lumen S1 through which a guidewire 60 (see FIG. 4 described later) is inserted is formed inside the inner shaft 10.
  • the outer diameter of the inner shaft 10 is smaller than the inner diameter of the outer shaft 20, and the inner shaft 10 is inserted into the outer shaft 20.
  • An expansion medium lumen S2 through which an expansion medium 200 for expanding the balloon 30 flows is formed between the outer peripheral surface of the inner shaft 10 and the inner peripheral surface of the outer shaft 20.
  • a gas such as helium gas, CO2 gas, or O2 gas, or a liquid such as saline or a contrast agent is used.
  • the tip 11 of the inner shaft 10 protrudes distally beyond the tip of the outer shaft 20 and is disposed inside the balloon 30.
  • the tip of the inner shaft 10 is provided with a tip tip 13 made of, for example, resin.
  • the tip tip 13 is a hollow tubular member with open distal and proximal ends.
  • the tip tip 13 has a tip guidewire port 14 formed at its tip and has a tapered shape with an outer diameter that gradually decreases toward the tip.
  • the tip 32 of the balloon 30 is joined, for example by welding, to the outer circumferential surface of the tip 11 of the inner shaft 10 and/or the outer circumferential surface of the tip tip 13.
  • the base end 12 of the inner shaft 10 is curved and connected to the side wall of the shaft body 22 of the outer shaft 20, and opens onto the outer peripheral surface of the shaft body 22. This opening functions as the base end guidewire port 16.
  • the balloon catheter 100 of this embodiment is a so-called rapid exchange type balloon catheter.
  • the inner shaft 10 is preferably made of a material that can be heat welded and has a certain degree of flexibility.
  • the material used to form the inner shaft 10 is, for example, the same material as the material used to form the outer shaft 20 described above.
  • the tip 21 of the outer shaft 20 and the inner shaft 10 are joined to each other at a joint P1. More specifically, the tip 21 of the outer shaft 20 has a reduced diameter section 24. The reduced diameter section 24 is located further distal than the balloon joint 23 and has a smaller outer diameter than the balloon joint 23. The reduced diameter section 24 of the outer shaft 20 is joined to the outer peripheral surface of the inner shaft 10, for example, by welding. The joint between the reduced diameter section 24 of the outer shaft 20 and the outer peripheral surface of the inner shaft 10 constitutes the joint P1.
  • one or more through holes 28 are formed in the portion between the balloon joint 23 and the reduced diameter portion 24 at the tip 21 of the outer shaft 20. Through these through holes 28, the expansion medium lumen S2 formed between the outer peripheral surface of the inner shaft 10 and the inner peripheral surface of the outer shaft 20 communicates with the internal space S3 of the balloon 30.
  • the marker 50 is, for example, a hollow tubular (e.g., cylindrical) member, and is formed from a radiopaque material such as gold, platinum, or tungsten.
  • the marker 50 is disposed at the tip of the balloon catheter 100, more specifically, inside the balloon 30.
  • the presence of the marker 50 makes it possible to identify the position of the balloon 30 using radiation from outside the living body when the balloon catheter 100 is inserted into a living body lumen.
  • the marker 50 is disposed on the base end side of the center position along the longitudinal direction of the balloon 30 (the position of the center line CL).
  • the marker 50 is arranged so as to be sandwiched between the tip 21 of the outer shaft 20 and the inner shaft 10 in the radial direction.
  • the state in which the marker 50 is sandwiched between the tip 21 of the outer shaft 20 and the inner shaft 10 in the radial direction means a state in which the outer peripheral surface of the marker 50 is in contact with the tip 21 of the outer shaft 20 and the inner peripheral surface of the marker 50 is in contact with the inner shaft 10.
  • at least the tip of the marker 50 is arranged within the joint P1, and more specifically, the entire marker 50 is arranged within the joint P1.
  • the surface of the marker 50 is covered by the outer shaft 20 or the inner shaft 10 and is not exposed to the internal space S3 of the balloon 30 or the guide wire lumen S1 of the inner shaft 10.
  • the surface of the marker 50 being covered by the outer shaft 20 or the inner shaft 10 is not limited to a state in which the surface of the marker 50 is in contact with the outer shaft 20 or the inner shaft 10, but includes a state in which a space exists between the surface of the marker 50 and the outer shaft 20 or the inner shaft 10.
  • the configuration in which the marker 50 is sandwiched between the tip 21 of the outer shaft 20 and the inner shaft 10 can be achieved, for example, by placing the marker 50 between the inner shaft 10 and the outer shaft 20 before joining, and joining the inner shaft 10 and the outer shaft 20, for example, by welding, to form the joint P1.
  • Examples of use of the balloon catheter 100 3 is an explanatory diagram showing an example of use of the balloon catheter 100 of this embodiment.
  • the guide wire 60 is inserted into the blood vessel 300 and penetrates the lesion 310 (see column A in FIG. 3).
  • the balloon catheter 100 whose balloon 30 is in a deflated state, is advanced distally through the blood vessel 300 along the guide wire 60.
  • the outer shaft 20 is pushed toward the tip side to insert the tip of the balloon catheter 100 into the lesion 310 (see column A in FIG. 3).
  • the expansion medium 200 is sent into the internal space S3 of the balloon 30 via the expansion medium lumen S2 (see Figures 1 and 2), thereby expanding the balloon 30 (see column B in Figure 3). This causes the expanded balloon 30 to push open the lesion 310.
  • the expansion medium 200 is discharged from the internal space S3 of the balloon 30 via the expansion medium lumen S2, thereby returning the balloon 30 from the expanded state to a contracted state again (see column C in Figure 3).
  • the outer shaft 20 is pushed toward the tip side, thereby advancing the tip of the balloon catheter 100 further distally of the lesion 310 (see column D in Figure 3).
  • the balloon 30 can be advanced distally of the lesion 310 while pushing open the lesion 310 with the balloon 30.
  • the balloon catheter 100 of this embodiment has the balloon 30 whose outer diameter is expandable, the hollow outer shaft 20, the hollow inner shaft 10, and the radiopaque marker 50.
  • the tip portion 21 of the outer shaft 20 is disposed inside the balloon 30.
  • the inner shaft 10 is inserted into the outer shaft 20.
  • a longitudinal portion of the inner shaft 10 is disposed inside the balloon 30.
  • the marker 50 is disposed so as to be sandwiched between the tip portion 21 of the outer shaft 20 and the inner shaft 10 in the radial direction.
  • FIG. 4 is an explanatory diagram showing the detailed configuration of the tip of the balloon catheter 100 of this embodiment.
  • the marker 50 is sandwiched between the tip 21 of the outer shaft 20 and the inner shaft 10 in the radial direction. Therefore, compared to a configuration in which the marker 50 is disposed distal to the tip 21 of the outer shaft 20, it is possible to suppress an increase in the profile of the tip of the balloon catheter 100 caused by the presence of the marker 50, and as a result, it is possible to suppress a decrease in the passability of the balloon catheter 100.
  • the outer shaft 20 is interposed between the balloon 30 and the marker 50 in the radial direction, when the tip of the balloon catheter 100 is inserted into the lesion 310 of the blood vessel 300, it is possible to avoid the balloon 30 being sandwiched between the lesion 310 (e.g., a calcified lesion) and the marker 50, and it is possible to suppress damage to the balloon 30.
  • the lesion 310 e.g., a calcified lesion
  • the tip 21 of the outer shaft 20 and the inner shaft 10 are joined to each other at the joint P1, and at least the tip of the marker 50 is disposed within the joint P1. Therefore, according to the balloon catheter 100 of this embodiment, the increase in the profile of the tip of the balloon catheter 100 due to the presence of the marker 50 can be effectively suppressed, and the decrease in the passability of the balloon catheter 100 can be effectively suppressed, and the balloon 30 can be effectively suppressed from being damaged by being pinched between the lesion 310 and the marker 50.
  • the position of the marker 50 can be brought closer to the expansion part of the balloon 30 compared to a configuration in which the marker 50 is disposed on the base end side of the joint P1, and the accuracy of grasping the position of the balloon 30 by referring to the position of the marker 50 can be improved.
  • the entire marker 50 is disposed within the joint P1. Therefore, with the balloon catheter 100 of this embodiment, damage to the balloon 30 caused by the balloon 30 being pinched between the lesion 310 and the marker 50 can be more effectively prevented.
  • the marker 50 is positioned on the base end side of the central position along the longitudinal direction of the balloon 30. Therefore, it is possible to effectively suppress an increase in the profile of the tip of the balloon catheter 100 caused by the presence of the marker 50, and effectively suppress a decrease in the passability of the balloon catheter 100.
  • the configuration of the balloon catheter 100 in the above embodiment is merely an example, and various modifications are possible.
  • the entire marker 50 is disposed within the joint P1, but the base end of the marker 50 may protrude from the joint P1 toward the base end.
  • the tip 21 of the outer shaft 20 and the inner shaft 10 are joined at the joint P1, but the tip 21 of the outer shaft 20 and the inner shaft 10 do not necessarily have to be joined.
  • the tip 21 of the outer shaft 20 and the inner shaft 10 are not joined, by arranging the marker 50 so that it is sandwiched between the tip 21 of the outer shaft 20 and the inner shaft 10 in the radial direction, it is possible to suppress an increase in the profile of the tip of the balloon catheter 100 caused by the presence of the marker 50, thereby suppressing a decrease in the passability of the balloon catheter 100, and it is possible to prevent the balloon 30 from being sandwiched between the lesion 310 and the marker 50, thereby suppressing damage to the balloon 30.
  • a rapid exchange type balloon catheter 100 has been used as an example, but the technology disclosed in this specification can be similarly applied to other types of balloon catheters, such as so-called over-the-wire type balloon catheters.
  • the balloon catheter 100 inserted into a blood vessel is used as an example, but the technology disclosed in this specification is similarly applicable to balloon catheters in general that are inserted into biological lumens (digestive organs such as the bile duct, gallbladder, pancreas, esophagus, duodenum, small intestine, large intestine, blood vessels, ureters, trachea, etc.).
  • biological lumens digestive organs such as the bile duct, gallbladder, pancreas, esophagus, duodenum, small intestine, large intestine, blood vessels, ureters, trachea, etc.

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Abstract

A balloon catheter according to the present invention comprises a balloon having an expandable outer diameter, a hollow outer shaft, a hollow inner shaft, and a radiopaque marker. The distal end of the outer shaft is disposed inside the balloon. The inner shaft is inserted into the outer shaft, and a portion of the inner shaft in the longitudinal direction is disposed inside the balloon. The marker is disposed so as to be interposed between the inner shaft and the distal end of the outer shaft in the radial direction.

Description

バルーンカテーテルBalloon catheter
　本明細書に開示される技術は、バルーンカテーテルに関する。 The technology disclosed in this specification relates to balloon catheters.
　血管等の生体管腔内に形成された狭窄部や閉塞部（以下、「病変部」という。）を拡張させるために、バルーンカテーテルが用いられる。バルーンカテーテルは、外径を拡張可能なバルーンと、中空のアウターシャフトと、アウターシャフト内に挿入された中空のインナーシャフトとを有する（例えば、特許文献１参照）。アウターシャフトの先端部、および、インナーシャフトにおける長手方向の一部分は、バルーンの内部に配置される。インナーシャフトの外周面とアウターシャフトの内周面との間の空間は、バルーンを拡張させるための拡張媒体が流通する拡張媒体ルーメンとして利用される。 Balloon catheters are used to expand narrowed or blocked areas (hereinafter referred to as "lesions") formed in biological lumens such as blood vessels. Balloon catheters have a balloon whose outer diameter can be expanded, a hollow outer shaft, and a hollow inner shaft inserted into the outer shaft (see, for example, Patent Document 1). The tip of the outer shaft and a longitudinal portion of the inner shaft are disposed inside the balloon. The space between the outer peripheral surface of the inner shaft and the inner peripheral surface of the outer shaft is used as an expansion medium lumen through which an expansion medium for expanding the balloon flows.
特開２００２－２９１８９７号公報JP 2002-291897 A
　生体管腔内に挿入されたバルーンカテーテルにおけるバルーンの位置を生体の外部から把握することを可能とするために、バルーンカテーテルの先端部に放射線不透過性のマーカーを設けることがある。 In order to make it possible to grasp the position of the balloon in a balloon catheter inserted into a biological lumen from outside the body, a radiopaque marker may be provided at the tip of the balloon catheter.
　しかしながら、バルーンカテーテルの先端部にマーカーを設けると、バルーンカテーテルの先端部のプロファイルが増大することによってバルーンカテーテルの通過性が低下するおそれがある。また、バルーンカテーテルの先端部にマーカーを設けると、生体管腔内の組織（例えば、石灰化病変）とマーカーとの間にバルーンが挟まれることによってバルーンが損傷するおそれがある。 However, providing a marker at the tip of the balloon catheter may increase the profile of the tip of the balloon catheter, which may reduce the passability of the balloon catheter. Also, providing a marker at the tip of the balloon catheter may damage the balloon by pinching it between the marker and tissue in the biological lumen (e.g., calcified lesions).
　本明細書では、上述した課題を解決することが可能な技術を開示する。 This specification discloses technology that can solve the problems mentioned above.
　本明細書に開示される技術は、例えば、以下の形態として実現することが可能である。 The technology disclosed in this specification can be realized, for example, in the following forms:
（１）本明細書に開示されるバルーンカテーテルは、外径を拡張可能なバルーンと、中空のアウターシャフトと、中空のインナーシャフトと、放射線不透過性のマーカーとを備える。アウターシャフトの先端部は、バルーンの内部に配置されている。インナーシャフトは、アウターシャフト内に挿入され、インナーシャフトにおける長手方向の一部分は、バルーンの内部に配置されている。マーカーは、径方向においてアウターシャフトの先端部とインナーシャフトとの間に挟まれるように配置されている。 (1) The balloon catheter disclosed in this specification comprises a balloon whose outer diameter can be expanded, a hollow outer shaft, a hollow inner shaft, and a radiopaque marker. The tip of the outer shaft is disposed inside the balloon. The inner shaft is inserted into the outer shaft, and a longitudinal portion of the inner shaft is disposed inside the balloon. The marker is disposed so as to be sandwiched between the tip of the outer shaft and the inner shaft in the radial direction.
　本バルーンカテーテルでは、マーカーが、径方向においてアウターシャフトの先端部とインナーシャフトとの間に挟まれている。そのため、マーカーがアウターシャフトの先端部より先端側に配置された構成と比較して、マーカーの存在に起因するバルーンカテーテルの先端部のプロファイルの増大を抑制することができ、その結果、バルーンカテーテルの通過性が低下することを抑制することができる。また、径方向においてバルーンとマーカーとの間にアウターシャフトが介在することとなるため、バルーンカテーテルの先端部が生体管腔の病変部に挿入される際に、病変部とマーカーとの間にバルーンが挟まれることを回避することができ、バルーンが損傷することを抑制することができる。 In this balloon catheter, the marker is sandwiched between the tip of the outer shaft and the inner shaft in the radial direction. Therefore, compared to a configuration in which the marker is located distal to the tip of the outer shaft, it is possible to suppress an increase in the profile of the tip of the balloon catheter caused by the presence of the marker, and as a result, it is possible to suppress a decrease in the passability of the balloon catheter. In addition, because the outer shaft is interposed between the balloon and the marker in the radial direction, it is possible to prevent the balloon from being sandwiched between the lesion and the marker when the tip of the balloon catheter is inserted into the lesion in the biological lumen, and it is possible to suppress damage to the balloon.
（２）上記バルーンカテーテルにおいて、前記アウターシャフトの前記先端部と前記インナーシャフトとは、接合部において互いに接合されており、前記マーカーの少なくとも先端部は、前記接合部内に配置されている構成としてもよい。本構成を採用すれば、マーカーの存在に起因するバルーンカテーテルの先端部のプロファイルの増大を効果的に抑制してバルーンカテーテルの通過性が低下することを効果的に抑制することができると共に、病変部とマーカーとの間にバルーンが挟まれることによってバルーンが損傷することを効果的に抑制することができる。 (2) In the above balloon catheter, the tip of the outer shaft and the inner shaft may be joined to each other at a joint, and at least the tip of the marker may be disposed within the joint. By adopting this configuration, it is possible to effectively suppress an increase in the profile of the tip of the balloon catheter caused by the presence of the marker, thereby effectively suppressing a decrease in the passability of the balloon catheter, and it is also possible to effectively suppress damage to the balloon caused by the balloon being pinched between the lesion and the marker.
（３）上記バルーンカテーテルにおいて、前記マーカーの全体が、前記接合部内に配置されている構成としてもよい。本構成を採用すれば、病変部とマーカーとの間にバルーンが挟まれることによってバルーンが損傷することをさらに効果的に抑制することができる。 (3) In the balloon catheter, the entire marker may be disposed within the joint. By adopting this configuration, it is possible to more effectively prevent the balloon from being damaged by being pinched between the lesion and the marker.
　なお、本明細書に開示される技術は、種々の形態で実現することが可能であり、例えば、バルーンカテーテル、バルーンカテーテルを備える医療機器、それらの製造方法や使用方法等の形態で実現することができる。 The technology disclosed in this specification can be realized in various forms, such as balloon catheters, medical devices equipped with balloon catheters, and methods of manufacturing and using them.
本実施形態におけるバルーンカテーテル１００の構成を概略的に示す説明図FIG. 1 is an explanatory diagram showing a schematic configuration of a balloon catheter 100 according to an embodiment of the present invention. 本実施形態におけるバルーンカテーテル１００の構成を概略的に示す説明図FIG. 1 is an explanatory diagram showing a schematic configuration of a balloon catheter 100 according to an embodiment of the present invention. 本実施形態のバルーンカテーテル１００の使用例を示す説明図FIG. 1 is an explanatory diagram showing an example of use of the balloon catheter 100 according to the present embodiment. 本実施形態のバルーンカテーテル１００の先端部の詳細構成を示す説明図FIG. 1 is an explanatory diagram showing a detailed configuration of a tip portion of the balloon catheter 100 according to the present embodiment.
Ａ．実施形態：
Ａ－１．バルーンカテーテル１００の構成：
　図１および図２は、本実施形態におけるバルーンカテーテル１００の構成を概略的に示す説明図である。図１および図２には、バルーンカテーテル１００の縦断面（ＹＺ断面）の構成を示している。図１には、後述のバルーン３０が拡張した状態を示しており、図２には、バルーン３０が収縮した状態を示している。各図において、Ｚ軸正方向側が、体内に挿入される先端側（遠位側）であり、Ｚ軸負方向側が、医師等の手技者によって操作される基端側（近位側）である。各図では、バルーンカテーテル１００の一部分の図示を適宜省略している。また、各図では、バルーンカテーテル１００が全体としてＺ軸方向に略平行な直線状となった状態を示しているが、バルーンカテーテル１００の少なくとも一部は、湾曲させることができる程度の柔軟性を有している。これらの点は、他の図面においても同様である。本明細書では、バルーンカテーテル１００およびその各構成部材について、先端側の端を「先端」といい、先端およびその近傍を「先端部」といい、基端側の端を「基端」といい、基端およびその近傍を「基端部」という。 A. Embodiments:
A-1. Configuration of the balloon catheter 100:
1 and 2 are explanatory diagrams that show a schematic configuration of a balloon catheter 100 in this embodiment. FIG. 1 and FIG. 2 show the configuration of a longitudinal section (YZ section) of the balloon catheter 100. FIG. 1 shows a state in which a balloon 30 described later is expanded, and FIG. 2 shows a state in which the balloon 30 is deflated. In each figure, the positive Z-axis direction side is the tip side (distal side) that is inserted into the body, and the negative Z-axis direction side is the base end side (proximal side) that is operated by a technician such as a doctor. In each figure, illustration of a part of the balloon catheter 100 is omitted as appropriate. In addition, each figure shows a state in which the balloon catheter 100 as a whole is linearly shaped approximately parallel to the Z-axis direction, but at least a part of the balloon catheter 100 has flexibility to the extent that it can be curved. These points are the same in the other figures. In this specification, the distal end of the balloon catheter 100 and each of its constituent parts will be referred to as the "tip," the distal end and its vicinity will be referred to as the "tip portion," the proximal end will be referred to as the "proximal end," and the proximal end and its vicinity will be referred to as the "proximal portion."
　バルーンカテーテル１００は、血管等の生体管腔における病変部（狭窄部や閉塞部）を押し広げるために、生体管腔に挿入される長尺状医療機器である。バルーンカテーテル１００は、インナーシャフト１０と、アウターシャフト２０と、バルーン３０と、マーカー５０とを有する。 The balloon catheter 100 is a long medical device that is inserted into a biological lumen, such as a blood vessel, to expand a lesion (a narrowed or blocked area) in the biological lumen. The balloon catheter 100 has an inner shaft 10, an outer shaft 20, a balloon 30, and a marker 50.
　バルーン３０は、外径を径方向に拡張および収縮可能な袋状の部材である。なお、径方向とは、バルーンカテーテル１００の中心軸から外周に向かう方向である。バルーン３０は、ある程度の可撓性を有する材料により形成されていることが好ましい。バルーン３０の形成材料としては、例えば、ポリエチレン、ポリプロピレン、ポリブテン、エチレン－プロピレン共重合体、エチレン－酢酸ビニル共重合体、アイオノマー、あるいはこれら二種以上の混合物等のポリオレフィンや、軟質ポリ塩化ビニル樹脂、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリエステルエラストマー、ポリウレタン、フッ素樹脂等の熱可塑性樹脂、シリコーンゴム、ラテックスゴム等が挙げられる。 The balloon 30 is a bag-shaped member whose outer diameter can expand and contract in the radial direction. The radial direction is the direction from the central axis of the balloon catheter 100 toward the outer periphery. The balloon 30 is preferably made of a material that has a certain degree of flexibility. Examples of materials that can be used to form the balloon 30 include polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or mixtures of two or more of these, soft polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, thermoplastic resins such as fluororesin, silicone rubber, latex rubber, etc.
　アウターシャフト２０は、先端および基端が開口した中空筒状（例えば円筒状）の部材である。なお、本明細書において「筒状」とは、長手方向に沿って外径および内径が一定である完全な筒形状に限られず、全体として略筒状であることを意味し、例えば、長手方向に沿って外径および／または内径が変化する形状や、外周面および／または内周面に凹凸がある形状等を含む。アウターシャフト２０の先端部２１は、基端側からバルーン３０の内部に挿入されるように配置されており、アウターシャフト２０の先端部２１より基端側の部分であるシャフト本体部２２は、バルーン３０から露出した状態で基端側に延びている。アウターシャフト２０の先端部２１の外周面には、バルーン３０の基端部３４が、例えば溶着により接合されている。以下、アウターシャフト２０の先端部２１におけるバルーン３０と接合された部分を、バルーン接合部２３という。 The outer shaft 20 is a hollow tubular (e.g., cylindrical) member with an open tip and base end. In this specification, "tubular" does not mean a completely tubular shape with a constant outer diameter and inner diameter along the longitudinal direction, but means a generally cylindrical shape as a whole, including, for example, a shape in which the outer diameter and/or inner diameter change along the longitudinal direction, and a shape with unevenness on the outer circumferential surface and/or inner circumferential surface. The tip portion 21 of the outer shaft 20 is arranged so as to be inserted into the balloon 30 from the base end side, and the shaft main body portion 22, which is the portion of the outer shaft 20 on the base end side from the tip portion 21, extends to the base end side while being exposed from the balloon 30. The base end portion 34 of the balloon 30 is joined to the outer circumferential surface of the tip portion 21 of the outer shaft 20, for example, by welding. Hereinafter, the portion of the tip portion 21 of the outer shaft 20 joined to the balloon 30 is referred to as the balloon joining portion 23.
　アウターシャフト２０は、熱溶着可能であり、かつ、ある程度の可撓性を有する材料により形成されていることが好ましい。アウターシャフト２０の形成材料としては、例えば、熱可塑性樹脂、より具体的には、ポリエチレン、ポリプロピレン、ポリブテン、エチレン－プロピレン共重合体、エチレン－酢酸ビニル共重合体、アイオノマー、あるいはこれら二種以上の混合物等のポリオレフィンや、ポリ塩化ビニル樹脂、ポリアミド、ポリアミドエラストマー、ポリエステル、ポリエステルエラストマー、熱可塑性ポリウレタン等が挙げられる。 The outer shaft 20 is preferably made of a material that can be heat welded and has a certain degree of flexibility. Examples of materials that can be used to form the outer shaft 20 include thermoplastic resins, more specifically, polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or mixtures of two or more of these, polyvinyl chloride resins, polyamides, polyamide elastomers, polyesters, polyester elastomers, thermoplastic polyurethanes, etc.
　なお、アウターシャフト２０のシャフト本体部２２の内部には、コアワイヤ２９が収容されている。コアワイヤ２９は、先端側が細径であり基端側が太径である棒状の部材である。コアワイヤ２９の存在により、バルーンカテーテル１００に対して、長手方向に沿って先端側ほど柔軟になるように剛性が変化する剛性特性が付与されている。コアワイヤ２９の形成材料としては、例えば、金属材料、より具体的には、ステンレス鋼（ＳＵＳ３０２、ＳＵＳ３０４、ＳＵＳ３１６等）、Ｎｉ－Ｔｉ合金、ピアノ線、ニッケル－クロム系合金、コバルト合金、タングステン等が挙げられる。 The core wire 29 is housed inside the shaft body 22 of the outer shaft 20. The core wire 29 is a rod-shaped member with a thin diameter at the tip end and a thick diameter at the base end. The presence of the core wire 29 gives the balloon catheter 100 a rigidity characteristic in which the rigidity changes along the longitudinal direction so that the distal end becomes more flexible. Examples of materials for forming the core wire 29 include metal materials, more specifically, stainless steel (SUS302, SUS304, SUS316, etc.), Ni-Ti alloys, piano wire, nickel-chromium alloys, cobalt alloys, tungsten, etc.
　インナーシャフト１０は、先端および基端が開口した中空筒状（例えば円筒状）の部材である。インナーシャフト１０の内部には、ガイドワイヤ６０（後述の図４参照）が挿通されるガイドワイヤルーメンＳ１が形成されている。インナーシャフト１０の外径は、アウターシャフト２０の内径より小さく、インナーシャフト１０は、アウターシャフト２０内に挿入されている。インナーシャフト１０の外周面とアウターシャフト２０の内周面との間には、バルーン３０を拡張させるための拡張媒体２００が流通する拡張媒体ルーメンＳ２が形成されている。なお、拡張媒体２００としては、例えば、ヘリウムガス、ＣＯ２ガス、Ｏ２ガス等の気体や、生理食塩水、造影剤等の液体が用いられる。 The inner shaft 10 is a hollow tubular (e.g., cylindrical) member with an open tip and base end. A guidewire lumen S1 through which a guidewire 60 (see FIG. 4 described later) is inserted is formed inside the inner shaft 10. The outer diameter of the inner shaft 10 is smaller than the inner diameter of the outer shaft 20, and the inner shaft 10 is inserted into the outer shaft 20. An expansion medium lumen S2 through which an expansion medium 200 for expanding the balloon 30 flows is formed between the outer peripheral surface of the inner shaft 10 and the inner peripheral surface of the outer shaft 20. As the expansion medium 200, for example, a gas such as helium gas, CO2 gas, or O2 gas, or a liquid such as saline or a contrast agent is used.
　インナーシャフト１０の先端部１１は、アウターシャフト２０の先端より先端側に突出しており、バルーン３０の内部に配置されている。なお、インナーシャフト１０の先端には、例えば樹脂によって形成された先端チップ１３が設けられている。先端チップ１３は、先端および基端が開口した中空筒状の部材である。先端チップ１３は、その先端に先端側ガイドワイヤポート１４が形成されると共に、先端に向かって外径が徐々に小さくなるテーパ状の形状を有している。インナーシャフト１０の先端部１１の外周面および／または先端チップ１３の外周面には、バルーン３０の先端部３２が、例えば溶着により接合されている。 The tip 11 of the inner shaft 10 protrudes distally beyond the tip of the outer shaft 20 and is disposed inside the balloon 30. The tip of the inner shaft 10 is provided with a tip tip 13 made of, for example, resin. The tip tip 13 is a hollow tubular member with open distal and proximal ends. The tip tip 13 has a tip guidewire port 14 formed at its tip and has a tapered shape with an outer diameter that gradually decreases toward the tip. The tip 32 of the balloon 30 is joined, for example by welding, to the outer circumferential surface of the tip 11 of the inner shaft 10 and/or the outer circumferential surface of the tip tip 13.
　インナーシャフト１０の基端部１２は、湾曲してアウターシャフト２０のシャフト本体部２２の側壁に接続される共に、シャフト本体部２２の外周面に開口している。この開口は、基端側ガイドワイヤポート１６として機能する。すなわち、本実施形態のバルーンカテーテル１００は、いわゆるラピッドエクスチェンジ型のバルーンカテーテルである。 The base end 12 of the inner shaft 10 is curved and connected to the side wall of the shaft body 22 of the outer shaft 20, and opens onto the outer peripheral surface of the shaft body 22. This opening functions as the base end guidewire port 16. In other words, the balloon catheter 100 of this embodiment is a so-called rapid exchange type balloon catheter.
　インナーシャフト１０は、熱溶着可能であり、かつ、ある程度の可撓性を有する材料により形成されていることが好ましい。インナーシャフト１０の形成材料としては、例えば、上述したアウターシャフト２０の形成材料と同様の材料が用いられる。 The inner shaft 10 is preferably made of a material that can be heat welded and has a certain degree of flexibility. The material used to form the inner shaft 10 is, for example, the same material as the material used to form the outer shaft 20 described above.
　アウターシャフト２０の先端部２１とインナーシャフト１０とは、接合部Ｐ１おいて互いに接合されている。より詳細には、アウターシャフト２０の先端部２１は、縮径部２４を有する。縮径部２４は、バルーン接合部２３より先端側に位置し、かつ、バルーン接合部２３より外径が小さい部分である。アウターシャフト２０の縮径部２４は、例えば溶着により、インナーシャフト１０の外周面に接合されている。アウターシャフト２０の縮径部２４とインナーシャフト１０の外周面とが接合した部分が、接合部Ｐ１を構成している。 The tip 21 of the outer shaft 20 and the inner shaft 10 are joined to each other at a joint P1. More specifically, the tip 21 of the outer shaft 20 has a reduced diameter section 24. The reduced diameter section 24 is located further distal than the balloon joint 23 and has a smaller outer diameter than the balloon joint 23. The reduced diameter section 24 of the outer shaft 20 is joined to the outer peripheral surface of the inner shaft 10, for example, by welding. The joint between the reduced diameter section 24 of the outer shaft 20 and the outer peripheral surface of the inner shaft 10 constitutes the joint P1.
　なお、アウターシャフト２０の先端部２１におけるバルーン接合部２３と縮径部２４との間の部分には、１つまたは複数の貫通孔２８が形成されている。この貫通孔２８を介して、インナーシャフト１０の外周面とアウターシャフト２０の内周面との間に形成された拡張媒体ルーメンＳ２と、バルーン３０の内部空間Ｓ３とが連通している。 In addition, one or more through holes 28 are formed in the portion between the balloon joint 23 and the reduced diameter portion 24 at the tip 21 of the outer shaft 20. Through these through holes 28, the expansion medium lumen S2 formed between the outer peripheral surface of the inner shaft 10 and the inner peripheral surface of the outer shaft 20 communicates with the internal space S3 of the balloon 30.
　マーカー５０は、例えば中空筒状（例えば円筒状）の部材であり、例えば、金、白金、タングステン等の放射線不透過性の材料により形成されている。マーカー５０は、バルーンカテーテル１００の先端部、より詳細には、バルーン３０の内部に配置されている。マーカー５０の存在により、バルーンカテーテル１００が生体管腔に挿入された状態において、生体の外部から放射線を用いてバルーン３０の位置を特定することができる。なお、本実施形態では、マーカー５０は、バルーン３０の長手方向に沿った中央の位置（中央線ＣＬの位置）より基端側に配置されている。 The marker 50 is, for example, a hollow tubular (e.g., cylindrical) member, and is formed from a radiopaque material such as gold, platinum, or tungsten. The marker 50 is disposed at the tip of the balloon catheter 100, more specifically, inside the balloon 30. The presence of the marker 50 makes it possible to identify the position of the balloon 30 using radiation from outside the living body when the balloon catheter 100 is inserted into a living body lumen. In this embodiment, the marker 50 is disposed on the base end side of the center position along the longitudinal direction of the balloon 30 (the position of the center line CL).
　マーカー５０は、径方向においてアウターシャフト２０の先端部２１とインナーシャフト１０との間に挟まれるように配置されている。ここで、マーカー５０が径方向においてアウターシャフト２０の先端部２１とインナーシャフト１０との間に挟まれた状態とは、マーカー５０の外周面がアウターシャフト２０の先端部２１と接し、かつ、マーカー５０の内周面がインナーシャフト１０と接した状態を意味する。本実施形態では、マーカー５０の少なくとも先端部が接合部Ｐ１内に配置されており、より詳細には、マーカー５０の全体が接合部Ｐ１内に配置されている。そのため、マーカー５０の表面は、アウターシャフト２０またはインナーシャフト１０に覆われており、バルーン３０の内部空間Ｓ３やインナーシャフト１０のガイドワイヤルーメンＳ１には露出していない。なお、マーカー５０の表面がアウターシャフト２０またはインナーシャフト１０に覆われているとは、マーカー５０の表面がアウターシャフト２０またはインナーシャフト１０に接している状態に限られず、マーカー５０の表面とアウターシャフト２０またはインナーシャフト１０との間に空間が存在する状態を含む。マーカー５０がアウターシャフト２０の先端部２１とインナーシャフト１０との間に挟まれた構成は、例えば、接合前のインナーシャフト１０とアウターシャフト２０との間にマーカー５０を配置し、インナーシャフト１０とアウターシャフト２０とを例えば溶着により接合して接合部Ｐ１を形成することにより実現することができる。 The marker 50 is arranged so as to be sandwiched between the tip 21 of the outer shaft 20 and the inner shaft 10 in the radial direction. Here, the state in which the marker 50 is sandwiched between the tip 21 of the outer shaft 20 and the inner shaft 10 in the radial direction means a state in which the outer peripheral surface of the marker 50 is in contact with the tip 21 of the outer shaft 20 and the inner peripheral surface of the marker 50 is in contact with the inner shaft 10. In this embodiment, at least the tip of the marker 50 is arranged within the joint P1, and more specifically, the entire marker 50 is arranged within the joint P1. Therefore, the surface of the marker 50 is covered by the outer shaft 20 or the inner shaft 10 and is not exposed to the internal space S3 of the balloon 30 or the guide wire lumen S1 of the inner shaft 10. Note that the surface of the marker 50 being covered by the outer shaft 20 or the inner shaft 10 is not limited to a state in which the surface of the marker 50 is in contact with the outer shaft 20 or the inner shaft 10, but includes a state in which a space exists between the surface of the marker 50 and the outer shaft 20 or the inner shaft 10. The configuration in which the marker 50 is sandwiched between the tip 21 of the outer shaft 20 and the inner shaft 10 can be achieved, for example, by placing the marker 50 between the inner shaft 10 and the outer shaft 20 before joining, and joining the inner shaft 10 and the outer shaft 20, for example, by welding, to form the joint P1.
Ａ－２．バルーンカテーテル１００の使用例：
　図３は、本実施形態のバルーンカテーテル１００の使用例を示す説明図である。バルーンカテーテル１００を用いた手技の際には、まず、ガイドワイヤ６０を血管３００内に挿入し、病変部３１０を貫通させる（図３のＡ欄参照）。そして、バルーン３０が収縮状態であるバルーンカテーテル１００を、ガイドワイヤ６０に沿って血管３００内を遠位側に進行させる。バルーンカテーテル１００の先端部が血管３００における病変部３１０の位置まで到達したら、アウターシャフト２０を先端側に押し込むことにより、バルーンカテーテル１００の先端部を病変部３１０内に挿入する（図３のＡ欄参照）。 A-2. Examples of use of the balloon catheter 100:
3 is an explanatory diagram showing an example of use of the balloon catheter 100 of this embodiment. In a procedure using the balloon catheter 100, first, the guide wire 60 is inserted into the blood vessel 300 and penetrates the lesion 310 (see column A in FIG. 3). Then, the balloon catheter 100, whose balloon 30 is in a deflated state, is advanced distally through the blood vessel 300 along the guide wire 60. When the tip of the balloon catheter 100 reaches the position of the lesion 310 in the blood vessel 300, the outer shaft 20 is pushed toward the tip side to insert the tip of the balloon catheter 100 into the lesion 310 (see column A in FIG. 3).
　次に、拡張媒体ルーメンＳ２（図１，２参照）を介してバルーン３０の内部空間Ｓ３に拡張媒体２００を送り込むことにより、バルーン３０を拡張させる（図３のＢ欄参照）。これにより、拡張したバルーン３０によって病変部３１０が押し広げられる。次に、拡張媒体ルーメンＳ２を介してバルーン３０の内部空間Ｓ３から拡張媒体２００を排出することにより、バルーン３０を拡張状態から再び収縮状態に戻す（図３のＣ欄参照）。さらに、アウターシャフト２０を先端側に押し込むことにより、バルーンカテーテル１００の先端部を病変部３１０のさらに遠位側まで進行させる（図３のＤ欄参照）。以上のような手順を繰り返すことにより、バルーン３０を病変部３１０の遠位側に進行させつつ、バルーン３０によって病変部３１０を押し広げていくことができる。 Next, the expansion medium 200 is sent into the internal space S3 of the balloon 30 via the expansion medium lumen S2 (see Figures 1 and 2), thereby expanding the balloon 30 (see column B in Figure 3). This causes the expanded balloon 30 to push open the lesion 310. Next, the expansion medium 200 is discharged from the internal space S3 of the balloon 30 via the expansion medium lumen S2, thereby returning the balloon 30 from the expanded state to a contracted state again (see column C in Figure 3). Furthermore, the outer shaft 20 is pushed toward the tip side, thereby advancing the tip of the balloon catheter 100 further distally of the lesion 310 (see column D in Figure 3). By repeating the above procedure, the balloon 30 can be advanced distally of the lesion 310 while pushing open the lesion 310 with the balloon 30.
Ａ－３．本実施形態の効果：
　以上説明したように、本実施形態のバルーンカテーテル１００は、外径を拡張可能なバルーン３０と、中空のアウターシャフト２０と、中空のインナーシャフト１０と、放射線不透過性のマーカー５０とを有する。アウターシャフト２０の先端部２１は、バルーン３０の内部に配置されている。インナーシャフト１０は、アウターシャフト２０内に挿入されている。インナーシャフト１０における長手方向の一部分は、バルーン３０の内部に配置されている。マーカー５０は、径方向においてアウターシャフト２０の先端部２１とインナーシャフト１０との間に挟まれるように配置されている。 A-3. Advantages of this embodiment:
As described above, the balloon catheter 100 of this embodiment has the balloon 30 whose outer diameter is expandable, the hollow outer shaft 20, the hollow inner shaft 10, and the radiopaque marker 50. The tip portion 21 of the outer shaft 20 is disposed inside the balloon 30. The inner shaft 10 is inserted into the outer shaft 20. A longitudinal portion of the inner shaft 10 is disposed inside the balloon 30. The marker 50 is disposed so as to be sandwiched between the tip portion 21 of the outer shaft 20 and the inner shaft 10 in the radial direction.
　図４は、本実施形態のバルーンカテーテル１００の先端部の詳細構成を示す説明図である。上述したように、本実施形態のバルーンカテーテル１００では、マーカー５０が、径方向においてアウターシャフト２０の先端部２１とインナーシャフト１０との間に挟まれている。そのため、マーカー５０がアウターシャフト２０の先端部２１より先端側に配置された構成と比較して、マーカー５０の存在に起因するバルーンカテーテル１００の先端部のプロファイルの増大を抑制することができ、その結果、バルーンカテーテル１００の通過性が低下することを抑制することができる。また、径方向においてバルーン３０とマーカー５０との間にアウターシャフト２０が介在することとなるため、バルーンカテーテル１００の先端部が血管３００の病変部３１０に挿入される際に、病変部３１０（例えば、石灰化病変）とマーカー５０との間にバルーン３０が挟まれることを回避することができ、バルーン３０が損傷することを抑制することができる。 FIG. 4 is an explanatory diagram showing the detailed configuration of the tip of the balloon catheter 100 of this embodiment. As described above, in the balloon catheter 100 of this embodiment, the marker 50 is sandwiched between the tip 21 of the outer shaft 20 and the inner shaft 10 in the radial direction. Therefore, compared to a configuration in which the marker 50 is disposed distal to the tip 21 of the outer shaft 20, it is possible to suppress an increase in the profile of the tip of the balloon catheter 100 caused by the presence of the marker 50, and as a result, it is possible to suppress a decrease in the passability of the balloon catheter 100. In addition, since the outer shaft 20 is interposed between the balloon 30 and the marker 50 in the radial direction, when the tip of the balloon catheter 100 is inserted into the lesion 310 of the blood vessel 300, it is possible to avoid the balloon 30 being sandwiched between the lesion 310 (e.g., a calcified lesion) and the marker 50, and it is possible to suppress damage to the balloon 30.
　また、本実施形態のバルーンカテーテル１００では、アウターシャフト２０の先端部２１とインナーシャフト１０とは、接合部Ｐ１において互いに接合されており、マーカー５０の少なくとも先端部は、接合部Ｐ１内に配置されている。そのため、本実施形態のバルーンカテーテル１００によれば、マーカー５０の存在に起因するバルーンカテーテル１００の先端部のプロファイルの増大を効果的に抑制してバルーンカテーテル１００の通過性が低下することを効果的に抑制することができると共に、病変部３１０とマーカー５０との間にバルーン３０が挟まれることによってバルーン３０が損傷することを効果的に抑制することができる。また、本実施形態のバルーンカテーテル１００によれば、マーカー５０が接合部Ｐ１より基端側に配置された構成と比較して、マーカー５０の位置をバルーン３０の拡張部に近付けることができ、マーカー５０の位置を参照したバルーン３０の位置の把握の精度を向上させることができる。 In addition, in the balloon catheter 100 of this embodiment, the tip 21 of the outer shaft 20 and the inner shaft 10 are joined to each other at the joint P1, and at least the tip of the marker 50 is disposed within the joint P1. Therefore, according to the balloon catheter 100 of this embodiment, the increase in the profile of the tip of the balloon catheter 100 due to the presence of the marker 50 can be effectively suppressed, and the decrease in the passability of the balloon catheter 100 can be effectively suppressed, and the balloon 30 can be effectively suppressed from being damaged by being pinched between the lesion 310 and the marker 50. In addition, according to the balloon catheter 100 of this embodiment, the position of the marker 50 can be brought closer to the expansion part of the balloon 30 compared to a configuration in which the marker 50 is disposed on the base end side of the joint P1, and the accuracy of grasping the position of the balloon 30 by referring to the position of the marker 50 can be improved.
　また、本実施形態のバルーンカテーテル１００では、マーカー５０の全体が、接合部Ｐ１内に配置されている。そのため、本実施形態のバルーンカテーテル１００によれば、病変部３１０とマーカー５０との間にバルーン３０が挟まれることによってバルーン３０が損傷することをさらに効果的に抑制することができる。 In addition, in the balloon catheter 100 of this embodiment, the entire marker 50 is disposed within the joint P1. Therefore, with the balloon catheter 100 of this embodiment, damage to the balloon 30 caused by the balloon 30 being pinched between the lesion 310 and the marker 50 can be more effectively prevented.
　また、本実施形態のバルーンカテーテル１００では、マーカー５０は、バルーン３０の長手方向に沿った中央の位置より基端側に配置されている。そのため、マーカー５０の存在に起因するバルーンカテーテル１００の先端部のプロファイルの増大を効果的に抑制して、バルーンカテーテル１００の通過性が低下することを効果的に抑制することができる。 In addition, in the balloon catheter 100 of this embodiment, the marker 50 is positioned on the base end side of the central position along the longitudinal direction of the balloon 30. Therefore, it is possible to effectively suppress an increase in the profile of the tip of the balloon catheter 100 caused by the presence of the marker 50, and effectively suppress a decrease in the passability of the balloon catheter 100.
Ｂ．変形例：
　本明細書で開示される技術は、上述の実施形態に限られるものではなく、その要旨を逸脱しない範囲において種々の形態に変形することができ、例えば次のような変形も可能である。 B. Variations:
The technology disclosed in this specification is not limited to the above-described embodiments, and can be modified in various forms without departing from the spirit of the invention. For example, the following modifications are also possible.
　上記実施形態におけるバルーンカテーテル１００の構成は、あくまで一例であり、種々変形可能である。例えば、上記実施形態では、マーカー５０の全体が接合部Ｐ１内に配置されているが、マーカー５０の基端部が接合部Ｐ１から基端側に突出していてもよい。 The configuration of the balloon catheter 100 in the above embodiment is merely an example, and various modifications are possible. For example, in the above embodiment, the entire marker 50 is disposed within the joint P1, but the base end of the marker 50 may protrude from the joint P1 toward the base end.
　上記実施形態では、アウターシャフト２０の先端部２１とインナーシャフト１０とが接合部Ｐ１において接合されているが、必ずしもアウターシャフト２０の先端部２１とインナーシャフト１０とが接合されている必要はない。アウターシャフト２０の先端部２１とインナーシャフト１０とが接合されていない構成においても、径方向においてアウターシャフト２０の先端部２１とインナーシャフト１０との間に挟まれるようにマーカー５０を配置することにより、マーカー５０の存在に起因するバルーンカテーテル１００の先端部のプロファイルの増大を抑制してバルーンカテーテル１００の通過性が低下することを抑制することができると共に、病変部３１０とマーカー５０との間にバルーン３０が挟まれることを回避してバルーン３０が損傷することを抑制することができる。 In the above embodiment, the tip 21 of the outer shaft 20 and the inner shaft 10 are joined at the joint P1, but the tip 21 of the outer shaft 20 and the inner shaft 10 do not necessarily have to be joined. Even in a configuration in which the tip 21 of the outer shaft 20 and the inner shaft 10 are not joined, by arranging the marker 50 so that it is sandwiched between the tip 21 of the outer shaft 20 and the inner shaft 10 in the radial direction, it is possible to suppress an increase in the profile of the tip of the balloon catheter 100 caused by the presence of the marker 50, thereby suppressing a decrease in the passability of the balloon catheter 100, and it is possible to prevent the balloon 30 from being sandwiched between the lesion 310 and the marker 50, thereby suppressing damage to the balloon 30.
　上記実施形態における各部材の形成材料は、あくまで一例であり、種々変形可能である。 The materials used to form each component in the above embodiment are merely examples and can be modified in various ways.
　上記実施形態では、ラピッドエクスチェンジ型のバルーンカテーテル１００を例に用いて説明したが、本明細書に開示される技術は、いわゆるオーバーザワイヤ型のバルーンカテーテル等の他のタイプのバルーンカテーテルにも同様に適用可能である。 In the above embodiment, a rapid exchange type balloon catheter 100 has been used as an example, but the technology disclosed in this specification can be similarly applied to other types of balloon catheters, such as so-called over-the-wire type balloon catheters.
　上記実施形態では、血管に挿入されるバルーンカテーテル１００を例に用いて説明したが、本明細書に開示される技術は、生体管腔（胆管、胆嚢、膵臓、食道、十二指腸、小腸、大腸等の消化器官、血管、尿管、気管等）内に挿入されるバルーンカテーテル一般について、同様に適用可能である。 In the above embodiment, the balloon catheter 100 inserted into a blood vessel is used as an example, but the technology disclosed in this specification is similarly applicable to balloon catheters in general that are inserted into biological lumens (digestive organs such as the bile duct, gallbladder, pancreas, esophagus, duodenum, small intestine, large intestine, blood vessels, ureters, trachea, etc.).
１０：インナーシャフト　１１：先端部　１２：基端部　１３：先端チップ　１４：先端側ガイドワイヤポート　１６：基端側ガイドワイヤポート　２０：アウターシャフト　２１：先端部　２２：シャフト本体部　２３：バルーン接合部　２４：縮径部　２８：貫通孔　２９：コアワイヤ　３０：バルーン　３２：先端部　３４：基端部　５０：マーカー　６０：ガイドワイヤ　１００：バルーンカテーテル　２００：拡張媒体　３００：血管　３１０：病変部　Ｐ１：接合部　Ｓ１：ガイドワイヤルーメン　Ｓ２：拡張媒体ルーメン　Ｓ３：内部空間 10: Inner shaft 11: Distal section 12: Base section 13: Distal tip 14: Distal guidewire port 16: Base guidewire port 20: Outer shaft 21: Distal section 22: Shaft body 23: Balloon joint 24: Reduced diameter section 28: Through hole 29: Core wire 30: Balloon 32: Distal section 34: Base section 50: Marker 60: Guidewire 100: Balloon catheter 200: Expansion medium 300: Blood vessel 310: Lesion P1: Joint S1: Guidewire lumen S2: Expansion medium lumen S3: Internal space

Claims (3)

  1. 　バルーンカテーテルであって、
    　外径を拡張可能なバルーンと、
    　先端部が前記バルーンの内部に配置された中空のアウターシャフトと、
    　前記アウターシャフト内に挿入され、長手方向の一部分が前記バルーンの内部に配置された中空のインナーシャフトと、
    　径方向において前記アウターシャフトの前記先端部と前記インナーシャフトとの間に挟まれるように配置された放射線不透過性のマーカーと、
    を備える、バルーンカテーテル。     A balloon catheter,
    A balloon whose outer diameter can be expanded;
    A hollow outer shaft having a tip portion disposed inside the balloon;
    a hollow inner shaft inserted into the outer shaft and a portion of the inner shaft in a longitudinal direction disposed inside the balloon;
    A radiopaque marker disposed so as to be sandwiched between the tip portion of the outer shaft and the inner shaft in a radial direction;
    A balloon catheter comprising:
  2. 　請求項１に記載のバルーンカテーテルであって、
    　前記アウターシャフトの前記先端部と前記インナーシャフトとは、接合部において互いに接合されており、
    　前記マーカーの少なくとも先端部は、前記接合部内に配置されている、バルーンカテーテル。     2. The balloon catheter according to claim 1,
    The tip end of the outer shaft and the inner shaft are joined to each other at a joint,
    A balloon catheter, wherein at least the tip of the marker is positioned within the junction.
  3. 　請求項２に記載のバルーンカテーテルであって、
    　前記マーカーの全体が、前記接合部内に配置されている、バルーンカテーテル。     3. The balloon catheter according to claim 2,
    A balloon catheter, wherein the marker is disposed entirely within the junction.
PCT/JP2023/024124 2022-10-18 2023-06-29 Balloon catheter WO2024084745A1 (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6066157A (en) * 1998-09-16 2000-05-23 Medtronics Ave, Inc. Anchor joint for coaxial balloon dilatation catheter
US20050273052A1 (en) * 2001-11-30 2005-12-08 Abbott Laboratories Vascular Entities Limited Catheter having enhanced distal pushability
WO2006126642A1 (en) * 2005-05-26 2006-11-30 Kaneka Corporation Catheter
JP2021006123A (en) * 2019-06-28 2021-01-21 朝日インテック株式会社 Balloon catheter

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6066157A (en) * 1998-09-16 2000-05-23 Medtronics Ave, Inc. Anchor joint for coaxial balloon dilatation catheter
US20050273052A1 (en) * 2001-11-30 2005-12-08 Abbott Laboratories Vascular Entities Limited Catheter having enhanced distal pushability
WO2006126642A1 (en) * 2005-05-26 2006-11-30 Kaneka Corporation Catheter
JP2021006123A (en) * 2019-06-28 2021-01-21 朝日インテック株式会社 Balloon catheter

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