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WO2024084745A1 - Cathéter à ballonnet - Google Patents

Cathéter à ballonnet 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
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
tip
balloon catheter
marker
shaft
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2023/024124
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English (en)
Japanese (ja)
Inventor
幸也 赤坂
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.)
Asahi Intecc Co Ltd
Original Assignee
Asahi Intecc 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 Asahi Intecc Co Ltd filed Critical Asahi Intecc Co Ltd
Publication of WO2024084745A1 publication Critical patent/WO2024084745A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108—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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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Un cathéter à ballonnet selon la présente invention comprend un ballonnet ayant un diamètre externe extensible, une tige externe creuse, une tige interne creuse et un marqueur radio-opaque. L'extrémité distale de la tige externe est disposée à l'intérieur du ballonnet. La tige interne est insérée dans la tige externe, et une partie de la tige interne dans la direction longitudinale est disposée à l'intérieur du ballonnet. Le marqueur est disposé de façon à être interposé entre la tige interne et l'extrémité distale de la tige externe dans la direction radiale.
PCT/JP2023/024124 2022-10-18 2023-06-29 Cathéter à ballonnet Ceased WO2024084745A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2022166605A JP2024059135A (ja) 2022-10-18 2022-10-18 バルーンカテーテル
JP2022-166605 2022-10-18

Publications (1)

Publication Number Publication Date
WO2024084745A1 true WO2024084745A1 (fr) 2024-04-25

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PCT/JP2023/024124 Ceased WO2024084745A1 (fr) 2022-10-18 2023-06-29 Cathéter à ballonnet

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JP (1) JP2024059135A (fr)
WO (1) WO2024084745A1 (fr)

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 (fr) * 2005-05-26 2006-11-30 Kaneka Corporation Catheter
JP2021006123A (ja) * 2019-06-28 2021-01-21 朝日インテック株式会社 バルーンカテーテル

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 (fr) * 2005-05-26 2006-11-30 Kaneka Corporation Catheter
JP2021006123A (ja) * 2019-06-28 2021-01-21 朝日インテック株式会社 バルーンカテーテル

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