WO2024080003A1 - カテーテル及びカテーテルシステム - Google Patents

カテーテル及びカテーテルシステム Download PDF

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Publication number
WO2024080003A1
WO2024080003A1 PCT/JP2023/030567 JP2023030567W WO2024080003A1 WO 2024080003 A1 WO2024080003 A1 WO 2024080003A1 JP 2023030567 W JP2023030567 W JP 2023030567W WO 2024080003 A1 WO2024080003 A1 WO 2024080003A1
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WO
WIPO (PCT)
Prior art keywords
catheter
marker
lumen
tip
distal end
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/JP2023/030567
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English (en)
French (fr)
Japanese (ja)
Inventor
伊藤隆史
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Priority to JP2024551269A priority Critical patent/JPWO2024080003A1/ja
Publication of WO2024080003A1 publication Critical patent/WO2024080003A1/ja
Priority to US19/174,542 priority patent/US20250235663A1/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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00305—Constructional details of the flexible means
    • 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
    • A61B2017/22038—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 a guide wire
    • A61B2017/22042—Details of the tip of the guide wire
    • A61B2017/22044—Details of the tip of the guide wire with a pointed tip
    • 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
    • A61B2017/22094—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 for crossing total occlusions, i.e. piercing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/32—General characteristics of the apparatus with radio-opaque indicia

Definitions

  • the present invention relates to a catheter and catheter system for insertion into a lumen of a living body.
  • JP 2010-279546 A discloses a catheter system equipped with a radiopaque marker at the tip.
  • the catheter system comprises a flexible catheter body and a radiopaque marker embedded in the tip of the catheter body.
  • the radiopaque marker is a cylindrical body made of a metal material.
  • the tip of the catheter When there is a lesion (narrowed area) in the patient's lumen, the tip of the catheter is advanced along the lumen under X-ray contrast. The position of the catheter tip is confirmed using a contrast marker, and the tip of the catheter is delivered to the lesion to perform treatment.
  • an antegrade catheter is first inserted into the blood vessel using an antegrade approach, and then another retrograde catheter is inserted into the blood vessel using a retrograde approach from the opposite direction to the antegrade catheter.
  • the tips of the antegrade catheter and retrograde catheter are positioned at predetermined positions near the lesion, and a balloon catheter is delivered to the lesion through the antegrade catheter.
  • the catheter of JP 2010-279546 A has a contrast marker located away from the tip of the catheter body, so when the catheter of JP 2010-279546 A is used as an antegrade catheter and a retrograde catheter, it is difficult to align and insert the tip of the retrograde approach catheter with the tip of the catheter inserted using the antegrade approach under X-ray contrast.
  • a first aspect of the present invention is a catheter that can be inserted into a lumen of a living body and advanced along the lumen, the catheter comprising a tubular catheter body having a lumen, and a cylindrical marker that includes a radiopaque material and is disposed at the tip of the catheter body, the marker being formed in an inverted taper shape that expands in diameter toward the tip of the catheter body, and the distance between the most distal end of the marker and the most distal end of the catheter body in the axial direction of the catheter body being 0.5 mm or less.
  • the axial distance between the most distal end of the marker located at the tip of the catheter and the most distal end of the catheter body is 0.5 mm or less, so that the position of the catheter tip can be confirmed with high accuracy under radioscopy when the catheter is advanced along the lumen of the living body. Because the marker is formed in an inverted tapered shape, it is easy to identify the marker based on its shape that can be confirmed under radioscopy, and the marker is prevented from falling off the catheter body.
  • the catheter may be an antegrade catheter that advances along the lumen toward the peripheral side of the living body, or a retrograde catheter that advances along the lumen toward the central side of the living body and whose tip can be inserted into the tip of the antegrade catheter.
  • the catheter may be an antegrade catheter that advances along the lumen toward the peripheral side of the living body.
  • the tip of the catheter body may have an inner surface that is part of the lumen and has a reverse tapered shape that expands in diameter toward the tip, and the marker may be arranged along the inner surface.
  • the inner surface of the tip of the catheter body can improve the insertability of the tip of the antegrade catheter and the tip of the retrograde catheter into each other.
  • the catheter is a retrograde catheter that advances along the lumen toward the central side of the living body
  • the tip of the retrograde catheter can be inserted into the lumen of the tip of an antegrade catheter that advances along the lumen toward the peripheral side of the living body
  • the outer circumferential surface of the tip of the retrograde catheter may have a tapered outer surface portion that narrows in diameter toward the tip.
  • the outer surface portion can improve the insertability of the retrograde catheter into the antegrade catheter.
  • a second aspect of the present invention is a catheter system including a catheter that can be inserted into a lumen of a living body and advanced along the lumen, the catheter system including an antegrade catheter that advances along the lumen toward the peripheral side of the living body, and a retrograde catheter that advances along the lumen toward the central side of the living body, the antegrade catheter including a tubular first catheter body having a first lumen, and a cylindrical first marker that includes a radiopaque material and is disposed at the tip of the first catheter body, the first marker being formed in an inverted taper shape that expands in diameter toward the tip of the first catheter body, and the tip of the first marker in the axial direction of the first catheter body and the tip of the first catheter body being in a axial direction of the first catheter body being in a axial direction of the first catheter body being in a axial direction of the first catheter body being in a axial direction of the first catheter body.
  • the distance between the tip of the retrograde catheter and the tip of the antegrade catheter is 0.5 mm or less
  • the tip of the retrograde catheter can be inserted into the tip of the antegrade catheter
  • the retrograde catheter includes a tubular second catheter body having a second lumen, and a cylindrical second marker that includes a radiopaque material and is arranged at the tip of the second catheter body, the second marker is formed in an inverted taper shape that expands in diameter toward the tip of the second catheter body, the tip of the second marker is arranged on the base end side of the tip of the second catheter body, and the distance between the tip of the second marker and the tip of the second catheter body in the axial direction of the second catheter body is 0.5 mm or less.
  • a third aspect of the present invention is a method for treating a lesion in a lumen by using an antegrade catheter that advances along a lumen of a living body toward the peripheral side of the living body and a retrograde catheter that advances along the lumen toward the central side of the living body, the antegrade catheter comprising a tubular first catheter body having a first lumen and a cylindrical first marker that includes a radiopaque material and is arranged at the tip of the first catheter body, the first marker being formed in an inverted taper shape that expands in diameter toward the tip of the first catheter body, the distance between the most distal end of the first marker and the most distal end of the first catheter body in the axial direction of the first catheter body being 0.5 mm or less, the retrograde catheter comprising a tubular second catheter body having a second lumen and a cylindrical first marker that includes a radiopaque material and is arranged at the tip of the second catheter body.
  • the second marker is formed in a reverse tapered shape that expands in diameter toward the distal end of the second catheter body, the distal end of the second marker is disposed on the proximal side of the distal end of the second catheter body, and the distance between the distal end of the second marker and the distal end of the second catheter body in the axial direction of the second catheter body is 0.5 mm or less, and when the antegrade catheter advances to the peripheral side and the retrograde catheter advances to the central side in the lumen of the living body, the positions of the first marker and the second marker are confirmed under radioscopy, and the first marker and the second marker are aligned to align the positions of the distal end of the antegrade catheter and the distal end of the retrograde catheter, and the distal end of the retrograde catheter is inserted into the distal end of the antegrade catheter.
  • a marker is placed at the tip of the catheter, and the axial distance between the most distal end of the marker and the most distal end of the catheter body is 0.5 mm or less. This allows the position of the catheter tip to be confirmed with high accuracy under radioscopy when the catheter is advanced along the lumen of the living body. Because the marker is formed in an inverted taper shape, it is easy to identify the marker based on its shape that can be confirmed under radioscopy, and the marker is prevented from falling off the catheter body.
  • FIG. 1 is a diagram showing the overall configuration of a catheter system according to an embodiment of the present invention.
  • FIG. 2 is an enlarged cross-sectional view showing the distal end of the antegrade catheter.
  • FIG. 3 is a cross-sectional view taken along line III-III in FIG.
  • FIG. 4 is an enlarged cross-sectional view showing the distal end of the retrograde catheter.
  • FIG. 5 is a cross-sectional view taken along line VV in FIG.
  • FIG. 6 is an explanatory diagram showing an initial state when a treatment is performed using the catheter system.
  • FIG. 7 is an explanatory diagram showing the state in which the tip of the antegrade catheter has been delivered to the upstream end of the lesion (CTO).
  • FIG. 8 is an explanatory diagram showing the state in which the tip portion of a retrograde catheter is inserted into the tip portion of an antegrade catheter at a lesion (CTO).
  • the catheter system 10 is used, for example, to treat a lesion 16 (such as a stenosis or occlusion) that has occurred in a blood vessel 14 of a living body 12.
  • a lesion 16 such as a stenosis or occlusion
  • the catheter system 10 is used in lower limb vascular treatment to treat a CTO 16a (chronic total occlusion, lesion) that has occurred in a blood vessel 14 of the lower limb of the living body 12 using an antegrade approach and a retrograde approach.
  • CTO 16a chronic total occlusion, lesion
  • the catheter system 10 may also be used to treat a lesion 16 in a lumen other than a blood vessel 14, for example, in a living organ such as a bile duct, trachea, esophagus, urethra, or other organ.
  • a living organ such as a bile duct, trachea, esophagus, urethra, or other organ.
  • the catheter system 10 can be inserted into a blood vessel 14 of a living body 12 and advanced along the blood vessel 14.
  • the catheter system 10 has an antegrade catheter 18 used for an antegrade approach in lower limb vascular treatment, and another retrograde catheter 20 used for a retrograde approach in lower limb vascular treatment.
  • Antegrade catheter 18 is a catheter that advances along blood vessels 14 of living body 12 toward the peripheral side of living body 12 (ankle side, in the direction of arrow A) in lower limb vascular treatment.
  • the antegrade catheter 18 comprises a tubular first catheter body 24 having a first lumen 22 and a first marker 26 disposed at the tip 24a of the first catheter body 24.
  • the first catheter body 24 is formed from a resin material having flexibility.
  • the first catheter body 24 is made of a resin material having a certain degree of flexibility, such as polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymers, polyesters such as polyethylene terephthalate and polybutylene terephthalate, polystyrene, polyvinyl chloride, polyurethane, polyamide, or various elastomers such as polyolefin elastomers, polyester elastomers, polyurethane elastomers, and polyamide elastomers, and may be blended, laminated, or arranged in multiple stages in the axial direction, or a reinforcing member may be arranged.
  • polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymers
  • polyesters such as polyethylene terephthalate and polybutylene terephthalate
  • polystyrene polyvinyl
  • the first lumen 22 is arranged inside the first catheter body 24.
  • the first lumen 22 extends along the first catheter body 24. Since the antegrade catheter 18 is used to treat the CTO 16a, the tip 24a of the first catheter body 24 is not made of a soft material such as a rubber material (elastomer material), but has a hardness suitable for treating the CTO 16a.
  • the tip portion 24a of the first catheter body 24 comprises a first inner surface portion 28 and a first outer surface portion 30.
  • the first inner surface portion 28 is a part of the first lumen 22 and has an inverse tapered shape that expands in diameter toward the tip (in the direction of arrow A). In other words, the first inner surface portion 28 has a tapered shape that gradually reduces in diameter from the most distal end 24b of the first catheter body 24 toward the base end.
  • the tip portion 24a of the first catheter body 24 is the end portion that is in the direction of advancement when the antegrade catheter 18 is inserted and advanced in the blood vessel 14.
  • the first inner surface portion 28 is disposed within a predetermined range from the most distal end 24b of the first catheter body 24 toward the base end.
  • the first outer surface portion 30 is disposed on the outer peripheral surface of the first catheter body 24.
  • the first outer surface portion 30 is tapered in diameter toward the tip of the first catheter body 24 (in the direction of arrow A).
  • the first outer surface portion 30 is disposed within a predetermined range from the most distal end 24b of the first catheter body 24 toward the base end. In other words, the tip portion 24a of the first catheter body 24 gradually tapers toward the most distal end 24b (in the tip direction, in the direction of arrow A).
  • the first marker 26 is formed into a cylindrical shape (see FIG. 3) from a radiopaque material (e.g., gold, platinum, tungsten, or a mixture of these).
  • a radiopaque material e.g., gold, platinum, tungsten, or a mixture of these.
  • the first marker 26 allows the tip position (leading end 24b) of the antegrade catheter 18 to be visible under X-ray (radiation) imaging within the living body 12.
  • the first marker 26 is embedded in the tip 24a of the first catheter body 24.
  • the first marker 26 is formed in an inverted taper shape that expands in diameter toward the tip direction (arrow A direction) of the first catheter body 24.
  • the first marker 26 is arranged along the first inner surface portion 28 of the first catheter body 24.
  • the first inner surface portion 28 of the first catheter body 24 and the first marker 26 are approximately parallel. A portion of the first marker 26 may be exposed to the first inner surface portion 28.
  • the inverted taper shape of the first marker 26 prevents the first marker 26 from falling off from the tip 24a of the first catheter body 24 toward the tip direction (arrow A direction).
  • the tip 26a of the first marker 26 has a leading end 26b that is located in the most distal direction (arrow A direction).
  • the leading end 26b of the first marker 26 is located on the base end side (arrow B direction) of the leading end 24b of the first catheter body 24.
  • the axial distance L1 between the leading end 26b of the first marker 26 and the leading end 24b of the first catheter body 24 is 0.5 mm or less. That is, the leading end 26b of the first marker 26 is located within 0.5 mm on the base end side (arrow B direction) from the leading end 24b of the first catheter body 24.
  • the leading end 26b of the first marker 26 is not exposed to the outside from the leading end 24b of the first catheter body 24.
  • the axial length of the first marker 26 is, for example, about 0.5 mm to 1.0 mm along the extension direction of the first catheter body 24.
  • the base end of the first catheter body 24 includes a first hub 32.
  • the first hub 32 is cylindrical.
  • the base end of the first hub 32 is open.
  • the retrograde catheter 20 advances along the blood vessels 14 of the living body 12 toward the central side of the living body 12 (toward the heart, in the direction of arrow B).
  • the tip 36a of the retrograde catheter 20 can be inserted into the tip 24a of the antegrade catheter 18.
  • the retrograde catheter 20 comprises a tubular second catheter body 36 having a second lumen 34 and a second marker 38 disposed at the tip 36a of the second catheter body 36.
  • the second catheter body 36 is formed from a resin material having flexibility.
  • the second catheter body 36 is made of a resin material having a certain degree of flexibility, such as polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymers, polyesters such as polyethylene terephthalate and polybutylene terephthalate, polystyrene, polyvinyl chloride, polyurethane, polyamide, or various elastomers such as polyolefin elastomers, polyester elastomers, polyurethane elastomers, and polyamide elastomers, and may be blended, laminated, or arranged in multiple stages in the axial direction, or a reinforcing body may be arranged.
  • polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymers
  • polyesters such as polyethylene terephthalate and polybutylene terephthalate
  • polystyrene polyvinyl
  • the diameter of the second catheter body 36 is smaller than the diameter of the first catheter body 24.
  • the second lumen 34 is arranged inside the second catheter body 36.
  • the second lumen 34 extends along the second catheter body 36.
  • the second lumen 34 is a passage through which the guide wire 40 can be inserted. Because the retrograde catheter 20 is used to treat the CTO 16a, the tip 36a of the second catheter body 36 is not made of a soft material such as rubber (elastomer material) and has a hardness suitable for treating the CTO 16a.
  • the tip portion 36a of the second catheter body 36 has a second inner surface portion 42 and a second outer surface portion 44.
  • the second inner surface portion 42 is part of the second lumen 34 and has an inverse tapered shape that expands in diameter toward the tip (in the direction of arrow B).
  • the second inner surface portion 42 has a tapered shape that gradually reduces in diameter from the tip end 36b of the second catheter body 36 toward the base end.
  • the tip 36a of the second catheter body 36 is the end that is in the direction of advancement (the direction of arrow B) when the retrograde catheter 20 is inserted and advanced into the blood vessel 14.
  • the second inner surface portion 42 is disposed within a predetermined range from the tip 36b of the second catheter body 36 toward the base end.
  • the second outer surface portion 44 is disposed on the outer peripheral surface of the second catheter body 36.
  • the second outer surface portion 44 is tapered in diameter toward the tip of the second catheter body 36 (in the direction of arrow B).
  • the second outer surface portion 44 is disposed within a predetermined range from the most distal end 36b of the second catheter body 36 toward the base end. In other words, the tip portion 36a of the second catheter body 36 gradually tapers toward the most distal end 36b (in the tip direction, in the direction of arrow B).
  • the second marker 38 is formed into a cylindrical shape from a radiopaque material (e.g., gold, platinum, tungsten, or a mixture of these, etc.) (see FIG. 5).
  • the second marker 38 makes the tip position of the retrograde catheter 20 visible under X-ray (radiation) imaging within the living body 12.
  • the second marker 38 is embedded in the tip 36a of the second catheter body 36.
  • the second marker 38 is formed in an inverted taper shape that expands in diameter toward the tip of the second catheter body 36.
  • the second marker 38 is arranged along the second inner surface 42 of the second catheter body 36.
  • the second marker 38 and the second inner surface 42 of the second catheter body 36 are approximately parallel. A portion of the second marker 38 may be exposed to the second inner surface 42.
  • the inverted taper shape of the second marker 38 prevents the second marker 38 from falling off from the tip 36a of the second catheter body 36 toward the tip (direction of arrow B).
  • the tip 38a of the second marker 38 has a leading end 38b that is located in the most distal direction (arrow B direction).
  • the leading end 38b of the second marker 38 is located on the base end side (arrow A direction) of the leading end 36b of the second catheter body 36.
  • the axial distance L2 between the leading end 38b of the second marker 38 and the leading end 36b of the second catheter body 36 is 0.5 mm or less. That is, the leading end 38b of the second marker 38 is located within 0.5 mm on the base end side (arrow A direction) from the leading end 36b of the second catheter body 36.
  • the leading end 38b of the second marker 38 is not exposed to the outside from the leading end 36b of the second catheter body 36.
  • the axial length of the second marker 38 is, for example, about 0.5 mm to 1.0 mm along the extension direction of the second catheter body 36.
  • the base end of the second catheter body 36 includes a second hub 46.
  • the second hub 46 is cylindrical.
  • the base end of the second hub 46 is open.
  • the guidewire 40 can be inserted into the second lumen 34 through the second hub 46.
  • Figure 1 is a schematic cross-sectional view showing the peripheral portion of a CTO 16a (lesion 16) that occurs in a blood vessel 14 in the lower limb.
  • a CTO 16a occurs in blood vessel 14 along the extension direction of blood vessel 14, and the left side of CTO 16a is the central side (heart side) and the upstream side of the blood flow.
  • the right side of CTO 16a is the peripheral side (ankle side) and the downstream side of the blood flow.
  • the blood vessel 14 upstream (left) of CTO 16a will be referred to as the upstream blood vessel section 14a
  • the blood vessel 14 downstream (right) of CTO 16a will be referred to as the downstream blood vessel section 14b.
  • the upstream blood vessel section 14a is an artery with a relatively large diameter of blood vessel 14.
  • the downstream blood vessel section 14b is a peripheral blood vessel with a smaller diameter of blood vessel 14 than the upstream blood vessel section 14a.
  • the diameter of the antegrade catheter 18 is suitable for the diameter of the upstream blood vessel 14a.
  • the diameter of the retrograde catheter 20 is suitable for the diameter of the downstream blood vessel 14b. In other words, the diameter of the antegrade catheter 18 is larger than the diameter of the retrograde catheter 20.
  • an antegrade approach is performed with the antegrade catheter 18 to the blood vessel 14 of the lower limb of the living body 12.
  • a medical professional percutaneously inserts the tip 24a of the antegrade catheter 18 into the upstream vascular portion 14a of the blood vessel 14.
  • the tip 24a of the antegrade catheter 18 is advanced toward the peripheral side (in the direction of arrow A) toward the CTO 16a along a guide wire (not shown) within the blood vessel 14.
  • the medical professional can perform the procedure while visually checking the tip position (leading edge 24b) of the antegrade catheter 18 by visually checking the first marker 26 through a display or the like under X-ray contrast.
  • the cylindrical first marker 26 makes it possible to visually check the first marker 26 from any circumferential position of the tip 24a of the antegrade catheter 18 (see FIG. 3).
  • the tip 24a (leading edge 24b) of the antegrade catheter 18 is delivered to the upstream end of the CTO 16a along the upstream blood vessel portion 14a.
  • the upstream end of the CTO 16a has a protruding portion 48 that is convex toward the upstream blood vessel portion 14a (in the direction of arrow B).
  • the leading edge 24b of the antegrade catheter 18 comes into contact with the protruding portion 48.
  • a medical professional (not shown) can confirm the position of the tip 24a of the antegrade catheter 18 on a display or the like using the first marker 26.
  • a retrograde approach is performed to deliver the tip 36a of the retrograde catheter 20 along the downstream vascular portion 14b to the CTO 16a.
  • the tip 36a of the retrograde catheter 20 is percutaneously inserted into the downstream vascular portion 14b of the blood vessel 14.
  • a guidewire 40 is inserted into the second lumen 34 of the retrograde catheter 20.
  • the tip 36a of the retrograde catheter 20 is advanced toward the central side (arrow B direction) along the guidewire 40 toward the CTO 16a.
  • the direction of advancement of the antegrade catheter 18 first direction, toward the peripheral side
  • the direction of advancement of the retrograde catheter 20 second direction, toward the central side
  • the tip 36a of the retrograde catheter 20 advances toward the tip 24a of the antegrade catheter 18.
  • the tip 36a of the retrograde catheter 20 is delivered to the downstream end of the CTO 16a along the downstream vascular section 14b.
  • the downstream end of the CTO 16a has a recess 50 that is recessed toward the upstream vascular section 14a.
  • the leading edge 36b of the retrograde catheter 20 is inserted into the recess 50 and contacts the bottom of the recess 50. The bottom is located at the most upstream vascular section 14a side of the recess 50.
  • the tip 36a of the retrograde catheter 20 advances from the recess 50 into the interior of the CTO 16a.
  • the tip 36a (leading edge 36b) of the retrograde catheter 20 excavates the CTO 16a to form a perforation 52.
  • the perforation 52 is formed from the bottom of the recess 50 toward the protrusion 48. As the retrograde catheter 20 advances, the perforation 52 penetrates all the way to the upstream end (protrusion 48) of the CTO 16a.
  • the upstream end of the CTO 16a is convex (projection 48) toward the central side, it is difficult to excavate the CTO 16a toward the peripheral side with the antegrade catheter 18.
  • the downstream end of the CTO 16a is concave (depression 50) toward the central side, it is easy to excavate the CTO 16a toward the central side with the retrograde catheter 20, and it is also easy to advance the CTO 16a or the vicinity of the center of the blood vessel 14.
  • a medical professional (not shown) checks the relative positions of the first marker 26 of the antegrade catheter 18 and the second marker 38 of the retrograde catheter 20 under X-ray fluoroscopy, and aligns the first marker 26 and the second marker 38 so that they are positioned in a straight line along the extension direction of the blood vessel 14 (direction of arrows A and B). By aligning the first marker 26 and the second marker 38, the most distal end 24b of the antegrade catheter 18 and the most distal end 36b of the retrograde catheter 20 are positioned in a straight line at the CTO 16a.
  • the tip 24a (leading end 24b) of the antegrade catheter 18 advances along the perforation 52 into the interior of the CTO 16a.
  • the tip 36a of the retrograde catheter 20 is inserted into the first lumen 22 of the tip 24a of the antegrade catheter 18.
  • the tip 24a of the antegrade catheter 18 is smoothly inserted into the CTO 16a along the perforation 52.
  • the tip 24a of the antegrade catheter 18 pushes the perforation 52 outward in the radial direction.
  • the first outer surface portion 30 allows the antegrade catheter 18 to be easily inserted into the perforation 52.
  • the retrograde catheter 20 is removed.
  • a balloon catheter (not shown) is inserted into the first lumen 22 of the antegrade catheter 18, and the balloon catheter is delivered to the CTO 16a.
  • the CTO 16a is treated with the balloon catheter. Note that after an antegrade guidewire (not shown) is inserted into the first lumen 22 of the antegrade catheter 18, the antegrade catheter 18 may be removed to leave the antegrade guidewire in place, and the balloon catheter may be delivered to the CTO 16a along the antegrade guidewire (not shown).
  • the insertion of the tip 36a of the retrograde catheter 20 into the tip 24a of the antegrade catheter 18 is not limited to being performed inside the CTO 16a.
  • the tip 36a of the retrograde catheter 20 may be inserted into the tip 24a of the antegrade catheter 18 in the upstream vascular section 14a or downstream vascular section 14b near the CTO 16a.
  • the axial distance L1 between the most distal end 26b of the first marker 26 disposed at the tip 24a of the antegrade catheter 18 and the most distal end 24b of the first catheter body 24 is 0.5 mm or less, so that when the antegrade catheter 18 is advanced along the blood vessel 14 toward the peripheral side (arrow A direction), the tip position (most distal end 24b) of the antegrade catheter 18 can be accurately confirmed under X-ray imaging.
  • the tip position (most distal end 36b) of the retrograde catheter 20 can be accurately confirmed under X-ray imaging. Because the first and second markers 26, 38 are formed in an inverted taper shape, the first and second markers 26, 38 are easy to identify based on their shapes that can be confirmed under X-ray imaging, and the first and second markers 26, 38 are effectively prevented from falling off the first and second catheter bodies 24, 36.
  • the tip 24a of the antegrade catheter 18 and the second marker 38 at the tip 36a of the retrograde catheter 20 it is easy to align the tip 24a (leading edge 24b) of the antegrade catheter 18 with the tip 36a (leading edge 36b) of the retrograde catheter 20.
  • the first inner surface 28 of the first catheter body 24 allows the tip 36a of the retrograde catheter 20 to be smoothly inserted into the first lumen 22. This improves the insertability of the tip 24a of the antegrade catheter 18 and the tip 36a of the retrograde catheter 20.
  • the second outer surface 44 of the retrograde catheter 20 can improve the insertability of the retrograde catheter 20 into the first lumen 22.
  • the present invention is not limited to the above disclosure, and various configurations may be adopted without departing from the gist of the present invention.
  • the lesion 16 does not have to be a typical CTO 16a, but may be a severely stenosed lesion where a certain degree of blood flow is observed, or may be a mildly stenosed lesion to reduce the burden on the patient.

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PCT/JP2023/030567 2022-10-11 2023-08-24 カテーテル及びカテーテルシステム Ceased WO2024080003A1 (ja)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008229160A (ja) * 2007-03-22 2008-10-02 Kaneka Corp カテーテル
JP2010279546A (ja) * 2009-06-04 2010-12-16 Terumo Corp 造影マーカおよびカテーテル
US20110218528A1 (en) * 2010-03-05 2011-09-08 Retro Vascular, Inc. Anatomical structure access and penetration
US20150196360A1 (en) * 2013-12-18 2015-07-16 James Aaron Grantham Medical Device for Revascularization of Vascular Occlusion and Method for Using Same
JP2020072769A (ja) * 2017-03-07 2020-05-14 テルモ株式会社 カテーテル

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008229160A (ja) * 2007-03-22 2008-10-02 Kaneka Corp カテーテル
JP2010279546A (ja) * 2009-06-04 2010-12-16 Terumo Corp 造影マーカおよびカテーテル
US20110218528A1 (en) * 2010-03-05 2011-09-08 Retro Vascular, Inc. Anatomical structure access and penetration
US20150196360A1 (en) * 2013-12-18 2015-07-16 James Aaron Grantham Medical Device for Revascularization of Vascular Occlusion and Method for Using Same
JP2020072769A (ja) * 2017-03-07 2020-05-14 テルモ株式会社 カテーテル

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