WO2024157689A1 - Ensemble cathéter et cathéter - Google Patents

Ensemble cathéter et cathéter Download PDF

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Publication number
WO2024157689A1
WO2024157689A1 PCT/JP2023/045929 JP2023045929W WO2024157689A1 WO 2024157689 A1 WO2024157689 A1 WO 2024157689A1 JP 2023045929 W JP2023045929 W JP 2023045929W WO 2024157689 A1 WO2024157689 A1 WO 2024157689A1
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WO
WIPO (PCT)
Prior art keywords
catheter
guidewire
load value
bending load
tip
Prior art date
Application number
PCT/JP2023/045929
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English (en)
Japanese (ja)
Inventor
亮太 大橋
健一 堀場
智往 村田
Original Assignee
テルモ株式会社
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Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2024157689A1 publication Critical patent/WO2024157689A1/fr

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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
    • 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
    • A61M25/06—Body-piercing guide needles or the like

Definitions

  • the present invention relates to a catheter assembly and a catheter.
  • TACE transcatheter arterial chemoembolization
  • a guidewire is used to advance the catheter.
  • a commonly used technique is to advance the catheter while having it follow a guidewire that has been placed ahead of it.
  • a common technique is to use an integrated catheter assembly in which the guidewire is inserted into the catheter, and advance both the guidewire and the catheter together.
  • the integrated structure type catheter assembly has a catheter hub attached to the base end of the catheter, and a guidewire hub attached to the base end of the guidewire and removably connected to the catheter hub.
  • the catheter hub and guidewire hub are connected with a predetermined area of the guidewire exposed from the tip of the catheter.
  • Biolumina have complex curved or meandering shapes.
  • a guidewire is known that has a rigidity varying section in which the rigidity gradually decreases from the base end to the tip end.
  • the rigidity of the rigidity varying section is changed by gradually reducing the diameter of the core wire.
  • Patent Document 1 discloses a catheter assembly that can reduce discomfort in use and improve operability.
  • the present inventors have found that in the catheter assembly disclosed in Patent Document 1, as shown in FIG. 3A of Patent Document 1, the bending load value of the integrated catheter/guidewire increases significantly, for example, by about 35 gf in the range of 300 mm to 360 mm from the tip, and this may result in a lack of pushability that allows the pushing force to be efficiently transmitted to the tip side.
  • the present invention aims to solve the above problems and provide a catheter assembly that has good pushability.
  • a catheter assembly comprising a catheter and a guidewire,
  • the guide wire is supported at two points spaced 5 mm apart, and the supported central portion is vertically pressed down 0.3 mm with a pressing tool moving at a speed of 5 mm/min to measure the load.
  • the bending load value y of the guide wire obtained by measuring the bending load value is expressed by a quadratic or higher approximation equation of x, where x is the length from the tip of the guide wire, When the guidewire is inserted into the lumen of the catheter and the guidewire is projected from the tip opening of the catheter, or when the tip opening of the catheter and the tip of the guidewire are aligned, A catheter assembly, wherein the catheter is supported at two points spaced 5 mm apart, and the bending load value of the catheter obtained by measuring the load at the time when the supported central part is pushed vertically down 0.3 mm with a push-down jig moving at a speed of 5 mm/min is smaller than the bending load value of the guide wire.
  • the catheter includes, in order from the tip, a tip portion, a first intermediate portion, a second intermediate portion, and a base portion;
  • the bending load value of the tip portion is 30 gf or less,
  • the bending load value of the first intermediate portion is 50 gf or less,
  • the bending load value of the second intermediate portion is 80 gf or less,
  • the catheter assembly according to any one of (1) to (4), wherein the bending load value of the base portion is 140 gf or less.
  • the bending load value of the guidewire is expressed by an approximation equation of the second degree or higher of the length x, and when the guidewire is inserted into the lumen of the catheter and protrudes from the tip opening of the catheter, or when the tip opening of the catheter and the tip of the guidewire are aligned, the catheter is supported at two points spaced 5 mm apart, and the supported central part is pushed down vertically 0.3 mm with a push-down jig moving at a speed of 5 mm/min.
  • the bending load value of the catheter obtained by measuring the bending load value is smaller than the bending load value of the guidewire, so that the change in bending load value can be made gradual, and a catheter assembly with favorable pushability can be provided.
  • FIG. 1 is a schematic diagram showing an integrated structure type catheter assembly according to an embodiment of the present invention.
  • FIG. 2 is a schematic diagram showing the catheter assembly with the catheter hub and guidewire hub disconnected.
  • FIG. 2 is an enlarged axial cross-sectional view of a tip portion of the catheter assembly.
  • FIG. 2 is an axial cross-sectional view of the guidewire.
  • FIG. 2 is an enlarged axial cross-sectional view of a distal end portion of the guidewire.
  • FIG. 1 is a schematic diagram showing the advancement of an integrated catheter assembly in transarterial chemoembolization.
  • 1 is a graph showing bending load values of the catheter alone and the guidewire alone along the axial position of the guidewire when the tip opening of the catheter and the tip of the guidewire are coincident.
  • FIG. 13 is a graph showing bending load values of a catheter assembly along the axial position of the guidewire when the guidewire protrudes 20 mm, 50 mm, and 100 mm from the tip opening of the catheter.
  • 1 is a graph showing bending load values of a catheter and a guidewire along the axial position of the guidewire when the guidewire protrudes 20 mm from the tip opening of the catheter.
  • FIG. 2 is a cross-sectional view showing a schematic configuration of a measurement test device for measuring bending load values.
  • Figure 1 is a schematic diagram showing an integrated catheter assembly 100 according to this embodiment.
  • Figure 2 is a schematic diagram showing the catheter assembly 100 with the catheter hub 110 and the guidewire hub 120 disconnected.
  • Figure 3 is an axial cross-sectional view showing an enlarged tip portion of the catheter assembly 100.
  • Figure 4 is an axial cross-sectional view of the guidewire 10.
  • Figure 5 is an axial cross-sectional view showing an enlarged tip portion of the guidewire 10.
  • Figure 6 is a schematic diagram showing a catheter 60 being advanced along the guidewire 10 during hepatic arterial chemoembolization.
  • the longitudinal direction (left-right direction in FIG. 1A) in which the shaft portion 70 of the catheter 60 and the core wire 20 of the guidewire 10 extend is defined as the axial direction, and is indicated by the arrow X in each figure.
  • the direction perpendicular to the axial direction is defined as the radial direction, and is indicated by the arrow R in FIGS. 3 and 5.
  • the side of the catheter assembly 100 that is inserted into the living body is defined as the tip side (distal side, left side in FIG. 1A) and indicated by the arrow X1 in each figure, and the side opposite the tip side that is operated by the hand is defined as the base side (proximal side, right side in FIG.
  • the tip portion means a portion that includes a certain range in the axial direction from the tip (most distal end), and the base end portion means a portion that includes a certain range in the axial direction from the base end (most proximal end).
  • the catheter assembly 100 comprises a catheter 60 having a shaft portion 70 with an inner lumen 71, a catheter hub 110 attached to the base end of the catheter 60, a guidewire 10 having a flexible core wire 20 that can be inserted into the inner lumen 71 of the shaft portion 70, and a guidewire hub 120 attached to the base end of the guidewire 10 and detachably connected to the catheter hub 110.
  • the guidewire 10 has a guidewire stiffness changing portion 35 whose stiffness gradually decreases from the base end to the tip end.
  • the catheter 60 has a catheter stiffness changing portion 85 whose stiffness gradually decreases from the base end to the tip end.
  • the integrated catheter assembly 100 is inserted into a biological lumen and is used to guide both the guidewire 10 and the catheter 60 together to a target site in the biological lumen.
  • transcatheter arterial chemoembolization is a treatment method in which a catheter 60 is advanced from an artery 91 in a liver 90 to a location close to a tumor 92, and an anticancer drug or an embolic substance is injected to selectively necrotize the tumor.
  • an integrated catheter assembly 100 is used in transcatheter arterial chemoembolization.
  • Body lumens have complex curved or meandering shapes. For this reason, when the catheter assembly 100 passes through a body lumen, it needs to have pushability that can efficiently transmit a pushing force to the tip side.
  • the catheter 60 has a generally circular cross section, an elongated shaft portion 70 that can be introduced into a living body, and a catheter hub 110 that is connected to the base end of the shaft portion 70.
  • the catheter 60 has a kink-resistant protector (strain relief) 115 near the connection between the shaft portion 70 and the catheter hub 110. Note that the catheter 60 is not limited to the form shown in FIG. 1A, and may not have the kink-resistant protector 115.
  • the shaft portion 70 is configured as a flexible tubular member having an inner cavity 71 extending in the axial direction.
  • the length of the shaft portion 70 varies depending on the location, thickness, etc. of the blood vessel to which it is applied, but is set, for example, to about 700 mm to 2000 mm, and preferably to about 1000 mm to 1500 mm.
  • the outer diameter (thickness) of the shaft portion 70 varies depending on the location, thickness, etc. of the blood vessel to which it is applied, but is set, for example, to about 0.4 mm to 3.0 mm, preferably to about 0.5 mm to 1.1 mm, and more preferably to about 0.85 mm to 0.91 mm.
  • the inner diameter of the shaft portion 70 (outer diameter of the lumen 71) varies depending on the thickness of the guidewire 10 to be inserted, the position of the blood vessel to be used, the thickness, and other factors, but is set to, for example, approximately 0.3 mm to 2.3 mm, preferably approximately 0.4 mm to 0.8 mm, and more preferably approximately 0.68 mm to 0.72 mm.
  • the shaft portion 70 has a tubular inner layer 72 and an outer layer 73 arranged to cover the outer surface of the inner layer 72.
  • a contrast portion 74 made of an X-ray opaque material is arranged between the inner layer 72 and the outer layer 73 at a part of the tip of the shaft portion 70.
  • the shaft portion 70 has a reinforcing body 75 formed by braiding wire material on the base end side of the part where the contrast portion 74 is formed.
  • the inner layer 72 is made of a material softer than the guidewire 10 described below, and may be made of resins such as fluorine-containing ethylenic polymers such as PTFE (polytetrafluoroethylene), PFA (tetrafluoroethylene-perfluoroalkylvinylether copolymer), FEP (tetrafluoroethylene-hexafluoropropylene copolymer), and ETFE (ethylene-tetrafluoroethylene copolymer), polyamides such as nylon, and polyamide elastomers such as nylon elastomers.
  • fluorine-containing ethylenic polymers such as PTFE (polytetrafluoroethylene), PFA (tetrafluoroethylene-perfluoroalkylvinylether copolymer), FEP (tetrafluoroethylene-hexafluoropropylene copolymer), and ETFE (ethylene-tetrafluoroethylene copolymer), poly
  • PTFE polytetrafluoroethylene
  • PFA tetrafluoroethylene-perfluoroalkylvinylether copolymer
  • the constituent material of the outer layer 73 may be, for example, a polymer material such as polyolefin (e.g., polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these), polyvinyl chloride, polyamide, polyester, polyester elastomer, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, or fluororesin, or a mixture of these.
  • the outer layer 73 may have a multi-layer structure formed by laminating different resin materials. It is also possible to form a hydrophilic coating layer by coating the outer surface of the outer layer 73 with a material made of a hydrophilic polymer.
  • the contrast portion 74 is made of a metal material or a resin material that has higher X-ray opacity than the inner layer 72 and the outer layer 73.
  • the metal material that is X-ray opaque can be made of, for example, platinum, gold, silver, tungsten, or an alloy of these.
  • the resin material that is X-ray opaque can be made by coating or containing an X-ray contrast substance in a resin material that does not have X-ray opacity. Examples of X-ray contrast substances include powdered inorganic materials such as tungsten, barium sulfate, and bismuth oxide.
  • the catheter hub 110 is attached liquid-tight to the base end of the shaft portion 70 by adhesive or a fastener (not shown). As shown in FIG. 1, the catheter hub 110 has a main body portion 111 having an inner cavity, and a pair of handle portions 112 formed by protruding from the sides of the main body portion 111.
  • the catheter hub 110 functions as an insertion port for the guide wire 10 into the inner cavity 71 of the shaft portion 70, and an injection port for contrast medium, medicinal liquid, embolic material, etc.
  • the catheter hub 110 functions as a grip portion when operating the catheter 60.
  • a male thread portion 113 is formed at the base end of the main body portion 111.
  • the catheter hub 110 may be made of synthetic resins such as polycarbonate, polyolefin, styrene resin, polyamide, and polyester, stainless steel, aluminum, or aluminum alloy.
  • synthetic resins such as polycarbonate, polyolefin, styrene resin, polyamide, and polyester, stainless steel, aluminum, or aluminum alloy.
  • polyolefins include polyethylene, polypropylene, and ethylene-propylene copolymer.
  • the kink-resistant protector 115 can be made of an elastic material that surrounds a portion of the base end of the shaft portion 70.
  • the kink-resistant protector 115 can be made of, for example, natural rubber, silicone resin, etc.
  • the catheter 60 has a catheter stiffness change section 85 whose stiffness gradually decreases from the base end to the tip end. As shown in FIG. 7, the bending load value in the catheter stiffness change section 85 increases in a stepwise manner from the tip end to the base end.
  • the catheter stiffness change section 85 gradually reduces the stiffness of the shaft section 70 of the catheter 60 from the base end side toward the tip end side.
  • the catheter stiffness change section 85 is divided into four regions, in order from the base end side toward the tip end side of the shaft section 70: a base section 81, a second intermediate section 82, a first intermediate section 83, and a tip section 84.
  • the base region 80 which is continuous with the base end of the base section 81, has a constant stiffness along the axial direction.
  • the base 81 is indicated by the reference numeral 81a
  • the second intermediate portion 82 is indicated by the reference numeral 82a
  • the first intermediate portion 83 is indicated by the reference numeral 83a
  • the tip portion 84 is indicated by the reference numeral 84a.
  • the catheter stiffness change portion 85 can be constructed, for example, by arranging multiple materials with different hardness along the axial direction.
  • the outer layer 73 in the shaft portion 70 has multiple regions with different hardness along the axial direction, and the hardness of the material constituting each region decreases toward the tip side (flexibility increases toward the tip side).
  • the hardness of the material constituting the outer layer 73 in the tip portion 84 is lower than the hardness of the material constituting the outer layer 73 in the first intermediate portion 83.
  • the hardness of the material constituting the outer layer 73 in the first intermediate portion 83 is lower than the hardness of the material constituting the outer layer 73 in the second intermediate portion 82.
  • the hardness of the material constituting the outer layer 73 in the second intermediate portion 82 is lower than the hardness of the material constituting the outer layer 73 in the base portion 81.
  • the hardness of the material constituting the outer layer 73 in the base portion 81 is lower than the hardness of the material constituting the outer layer 73 in the base region 80.
  • the shaft portion 70 of the catheter 60 is configured such that the tip portion 84 is more flexible than the first intermediate portion 83, the first intermediate portion 83 is more flexible than the second intermediate portion 82, the second intermediate portion 82 is more flexible than the base portion 81, and the base portion 81 is more flexible than the base region 80.
  • the hardness of the constituent materials is a value measured using a type D durometer conforming to ASTM D2240.
  • the tip portion 84 is located at the most distal end of the catheter 60 and is therefore the most flexible, and the hardness of the constituent material is preferably 20D to 40D, and more preferably 25D to 35D.
  • the first intermediate portion 83 is the second most flexible after the tip portion 84 and the hardness of the constituent material is preferably 25D to 60D, and more preferably 30D to 40D.
  • the second intermediate portion 82 is the second most flexible after the first intermediate portion 83 and the hardness of the constituent material is preferably 25D to 60D, and more preferably 30D to 40D.
  • the base portion 81 requires a moderate hardness to transmit the surgeon's operation from the base end side to the tip side, and the hardness of the constituent material is preferably 40D to 80D, and more preferably 60D to 70D.
  • the base region 80 must be sufficiently hard to allow the surgeon to directly manipulate it, and the hardness of its constituent material is preferably 50D to 90D, and more preferably 70D to 80D.
  • the bending load value of the tip portion 84 is preferably 30 gf or less.
  • the bending load value of the first intermediate portion 83 is preferably 50 gf or less.
  • the bending load value of the second intermediate portion 82 is preferably 80 gf or less.
  • the bending load value of the base portion 81 is preferably 140 gf or less. The method for measuring the bending load value will be described later.
  • the above-mentioned constituent materials are used for the outer layer 73, but multiple types of these may be combined. Also, additives may be added to the constituent materials to adjust the hardness to an optimal range. The thickness of the outer layer 73 may also be changed to adjust the hardness.
  • the preferred axial length of each region in the catheter stiffness changing portion 85 varies depending on the configuration (number of regions, axial length of each region, etc.) of the guidewire stiffness changing portion 35 in the guidewire 10 that is inserted and connected to the catheter 60.
  • the preferred axial length of each region in the catheter stiffness changing portion 85 also varies depending on the dimensions of the tip side of the guidewire 10 exposed from the tip of the shaft portion 70.
  • the axial length of the base portion 81 is 50 mm
  • the axial length of the second intermediate portion 82 is 150 mm
  • the axial length of the first intermediate portion 83 is 150 mm
  • the axial length of the tip portion 84 is 100 mm.
  • the axial length of the base region 80 varies depending on the product length.
  • the thickness of the inner layer 72 in the shaft portion 70 is constant throughout the entire axial length.
  • the thickness of the inner layer 72 is not particularly limited, but is, for example, 0.015 mm.
  • the guidewire 10 has a core wire 20 extending in the axial direction, and a guidewire hub 120 connected to the proximal end of the core wire 20.
  • the guidewire 10 has a marker portion 40 disposed at the distal end of the core wire 20, and a coating layer 50 that coats the core wire 20.
  • the preferred length of the guidewire 10 varies depending on the location and thickness of the blood vessel to which it is applied, but is preferably 500 to 4000 mm, for example.
  • the preferred outer diameter (thickness) of the main body 30 varies depending on the location and thickness of the blood vessel to which it is applied, but is preferably 0.15 to 2.0 mm, for example.
  • the base end of the guidewire 10 is attached to the wall of the tip of the guidewire hub 120.
  • the guidewire hub 120 has a body portion 121 having an inner cavity and a ring portion 122 arranged on the tip side of the body portion 121. The base end of the guidewire 10 is inserted when the body portion 121 is injection molded.
  • the guidewire hub 120 is used in connection with the catheter hub 110, and functions as an inlet for injecting a liquid such as a contrast agent into the inner cavity 71 of the shaft portion 70. The liquid can be injected or removed while the guidewire 10 is inserted in the inner cavity 71 of the shaft portion 70.
  • the ring portion 122 has a female thread portion (not shown) formed on its inner surface that is screwed into the male thread portion 113 of the catheter hub 110.
  • the ring portion 122 can rotate relative to the main body portion 121, but is prevented from slipping out of the main body portion 121 in the distal direction by engaging with a protrusion (not shown) formed on the outer periphery of the main body portion 121.
  • the tip of the guidewire hub 120 is fitted into the inner cavity of the catheter hub 110, and the ring portion 122 is rotated to screw the male threaded portion 113 into the female threaded portion and tightened with a certain amount of torque.
  • the male threaded portion 113 and the ring portion 122 having a female threaded portion constitute a locking means that fixes the connected state of the catheter hub 110 and the guidewire hub 120.
  • the guidewire hub 120 is made of synthetic resins such as polycarbonate, polyolefin, styrene resin, polyamide, and polyester.
  • polyolefins include polyethylene, polypropylene, and ethylene-propylene copolymers.
  • the marker portion 40 is arranged so as to cover a certain range of the tip core portion 34 in the axial direction.
  • the marker portion 40 is composed of a wire wound in a spiral shape around the tip core portion 34.
  • the tip portion of the marker portion 40 is fixed near the tip portion of the tip core portion 34 via a fixing material 41.
  • the base end portion of the marker portion 40 is fixed near the base end portion of the tip core portion 34 via a fixing material 42.
  • the fixing materials 41 and 42 can be composed of, for example, various adhesives, solder, etc.
  • the marker portion 40 is made of a material that is X-ray opaque (X-ray contrast).
  • materials that are X-ray opaque include metallic materials such as precious metals such as gold, platinum, and tungsten, or alloys containing these metals (e.g., platinum-iridium alloys).
  • the coating layer 50 is made of a resin material and is formed to cover the entire core wire 20 including the marker portion 40. It is preferable that the tip of the coating layer 50 has a rounded shape so as not to damage the inner wall of the biological lumen.
  • the coating layer 50 is preferably made of a material that can reduce friction. This reduces frictional resistance (sliding resistance) between the guidewire 10 and the catheter 60 or biological lumen through which the guidewire 10 is inserted, improving sliding properties and improving the operability of the guidewire 10. Furthermore, by reducing the sliding resistance of the guidewire 10, kinking (bending) and twisting of the guidewire 10 can be more reliably prevented.
  • the resin material constituting the coating layer 50 is preferably a material with relatively high flexibility, such as polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyesters (PET, PBT, etc.), polyamides, polyimides, polyurethanes, polystyrene, polycarbonates, silicone resins, fluorine-based resins (PTFE, ETFE, PFA, etc.), composite materials of these, various rubber materials such as latex rubber and silicone rubber, or composite materials combining two or more of these.
  • polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyesters (PET, PBT, etc.), polyamides, polyimides, polyurethanes, polystyrene, polycarbonates, silicone resins, fluorine-based resins (PTFE, ETFE, PFA, etc.), composite materials of these, various rubber materials such as latex rubber and silicone rubber, or composite materials combining two or more of these.
  • the thickness of the coating layer 50 is not particularly limited, but is preferably, for example, 5 to 500 ⁇ m. Note that the coating layer 50 is not limited to a single-layer structure, and may be configured by laminating multiple layers.
  • the coating layer 50 is preferably covered with a hydrophilic coating layer (not shown). Covering it with a hydrophilic coating layer improves the sliding properties, which further prevents the guidewire 10 from getting caught on the inner wall of the biological lumen or the catheter 60.
  • the material constituting the hydrophilic coating layer is not particularly limited, but examples include known hydrophilic materials such as cellulose-based polymeric substances, polyethylene oxide-based polymeric substances, maleic anhydride-based polymeric substances (e.g., maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymer), acrylamide-based polymeric substances (e.g., polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA) block copolymers), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone, etc.
  • hydrophilic materials such as cellulose-based polymeric substances, polyethylene oxide-based polymeric substances, maleic anhydride-based polymeric substances (e.g., maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymer), acrylamide-based polymeric substances (e.g., polyacrylamide, polyglycidyl methacrylate-di
  • the thickness of the hydrophilic coating layer is not particularly limited, but is preferably, for example, 0.1 to 100 ⁇ m.
  • the guidewire 10 has a guidewire stiffness change section 35 whose stiffness gradually decreases from the base end to the tip end.
  • the guidewire stiffness varying section 35 gradually reduces the stiffness of the core wire 20 from the base end to the tip end.
  • the main body section 30 has a constant stiffness along the axial direction.
  • the guidewire stiffness changing section 35 can be constructed, for example, by varying the diameter of the core wire 20 along the axial direction.
  • the guidewire stiffness changing section 35 has a diameter d5 that gradually decreases from the main body section 30 toward the tip core section 34.
  • FIG. 7 a graph is shown showing the bending load value of the core wire 20 of the guide wire 10 along the axial position of the core wire 20.
  • the coating layer 50 that covers the core wire 20 does not substantially contribute to the rigidity of the guide wire 10. Therefore, the rigidity of the core wire 20 can be regarded as the rigidity of the guide wire 10, and the guide wire rigidity change portion 35 also represents the rigidity change portion of the core wire 20.
  • the core wire 20 is flexible. As shown in Figures 4 and 5, the core wire 20 has a distal core portion 34, a main body portion 30, and a guidewire stiffness change portion 35.
  • the distal core portion 34 is the most flexible portion of the entire length of the core wire 20, including the most distal end.
  • the main body portion 30 is located on the proximal side of the distal core portion 34, and has a constant diameter d0 along the axial direction.
  • the guidewire stiffness change portion 35 is located from the distal end of the main body portion 30 to the proximal end of the distal core portion 34, and has a gradually decreasing stiffness from the main body portion 30 toward the distal core portion 34.
  • the core wire 20 is formed from a single material.
  • the diameter of the core wire 20 varies along the axial direction. This causes the stiffness of the core wire 20 to vary along the axial direction.
  • the material of the core wire 20 is not particularly limited, but may be, for example, a Ni-Ti alloy, stainless steel, or a superelastic alloy.
  • the main body portion 30 has a constant diameter d0 along the axial direction.
  • the tip core portion 34 also has a constant diameter d4 along the axial direction.
  • having a constant diameter along the axial direction is not limited to having the same physical diameter. It is sufficient to have a substantially constant outer diameter within a range that allows the rigidity (bending rigidity and torsional rigidity) of the main body portion 30 and the tip core portion 34 to be substantially constant.
  • the guidewire stiffness changing section 35 can be constructed, for example, by varying the diameter of the core wire 20 along the axial direction.
  • the guidewire stiffness changing section 35 has a diameter d5 that gradually decreases from the main body section 30 toward the tip core section 34.
  • the range of the stiffness change portion in the core wire is up to 500 mm from the tip of the core wire, but is not limited to this.
  • the core wire disclosed in WO 2018/181177 A1 has, in order from the base end, a first taper section, a second taper section, and a third taper section, and is configured so that the gradient of the diameter change in the first taper section is greater than the gradient of the diameter change in the second taper section. Therefore, as shown in FIG. 3B of WO 2018/181177 A1, a bending point is created at the boundary between the first taper section and the second taper section, where the gradient of the diameter bends and changes.
  • the bending load value y increases.
  • the bending load value y can be expressed by a quadratic or higher approximation of the distance x.
  • the inventors calculated an approximation equation that corresponds to the correlation between the distance x from the tip of the guidewire 10 and the bending load value y in the guidewire stiffness changing section 35. As a result, the following approximation equation was calculated.
  • the bending load value of one guidewire 10 has been described as an example. However, as long as the bending load value y can be expressed by a quadratic or higher approximation of the distance x, the bending load value of the guidewire 10 can be expressed by the above approximation. It is not limited to 10.
  • the bending load value increases with increasing distance from the tip of the core wire 20, improving pushability.
  • the bending load value y is expressed by an approximation of the second degree or higher when the length from the tip of the core wire is x, so the diameter of the core wire also changes continuously, and no boundary is formed as in the guidewire disclosed in comparison. This improves pushability. From the above, it is possible to provide a guidewire 10 that is suitably equipped with pushability.
  • the diameter d5 of the base end of the guidewire stiffness changing section 35 is approximately the same as the diameter d0 of the main body section 30 so that the boundary between the main body section 30 and the guidewire stiffness changing section 35 is a continuous surface.
  • the diameter d5 of the tip end of the guidewire stiffness changing section 35 is approximately the same as the diameter d4 of the tip core section 34.
  • continuous surface means that the outer surface of the core wire 20 is smooth enough that the guidewire 10 does not get caught on the inner wall of the biological lumen or the catheter 60.
  • the coating layer 50 makes the outer surface of the guidewire 10 substantially smooth, and there are cases where the guidewire 10 does not get caught on the inner wall of the biological lumen or the like. In such a case, even if a slight step occurs in the core wire 20, the outer surface of the core wire 20 can be considered to be a "continuous surface.”
  • the core wire 20 is formed by subjecting the forming material to cutting and polishing processes.
  • the main body portion 30, the guide wire stiffness changing portion 35, and the tip core portion 34 can be formed simultaneously. Each region can also be formed separately and sequentially.
  • the manufacturing process of the core wire 20 is not limited to cutting and polishing processes, and it can also be formed by etching or laser processing.
  • Figure 8 is a graph showing the bending load values of the catheter assembly 100 along the axial position of the guidewire 10 when the guidewire 10 protrudes 20 mm, 50 mm, and 100 mm from the tip opening of the catheter 60.
  • Figure 9 is a graph showing the bending load values of the catheter 60 and the guidewire 10 along the axial position of the guidewire 10 when the guidewire 10 protrudes 20 mm from the tip opening of the catheter 60.
  • the bending load value of the guidewire 10 is higher than the bending load value of the catheter 60 over the entire area.
  • an increased portion M that locally increases the bending load value of the catheter assembly is generated, as shown in the comparative example of FIG. 8. The generation of the increased portion M makes the catheter assembly more susceptible to kinking, reducing operability.
  • the catheter assembly 100 when the guidewire 10 is protruded 20 mm from the tip opening of the catheter 60, the bending load value of the guidewire 10 is higher than the bending load value of the catheter 60, so no increased portion is generated and it is possible to prevent a decrease in operability.
  • FIG. 10 is a cross-sectional view showing the schematic configuration of a measurement test device 200 for measuring bending load values.
  • the measurement test device 200 has a fixed jig 201 that supports a long measurement object 205, and a push-down jig 202 arranged above the fixed jig 201.
  • the fixed jig 201 has a pair of support legs 203 that support the measurement object 205 at two points.
  • the distance Ld between the support legs 203 is 5 mm.
  • a groove 204 into which the measurement object 205 fits is formed on the upper surface of the support leg 203.
  • the push-down jig 202 is configured to be freely raised and lowered relative to the fixed jig 201.
  • the push-down jig 202 is configured to be freely adjustable in terms of the speed at which the measurement object 205 is pushed down and the size by which the measurement object 205 is pushed down.
  • the measurement object 205 is the guidewire 10, the shaft portion 70 of the catheter 60, and the catheter assembly 100 that connects the catheter 60 and the guidewire 10.
  • the measurement test device 200 was used to measure the bending load value under the following conditions, and the bending load value was obtained. That is, the measurement object 205 is supported at two points spaced 5 mm apart. The push-down jig 202 moves at a speed of 5 mm/min. The supported central portion of the measurement object 205 is pushed down vertically by the push-down jig 202. The bending load value was measured as the load at the point when the measurement object 205 was pushed down 0.3 mm.
  • the axial length of the core wire 20 is a length used for hepatic artery chemoembolization.
  • the axial length L of the guidewire stiffness change section 35 is preferably 360 to 450 mm, and more preferably 360 to 400 mm.
  • the catheter assembly 100 is a catheter assembly 100 including a catheter 60 and a guidewire 10.
  • the bending load value y of the guidewire 10 obtained by measuring the load when the guidewire 10 is supported at two points spaced 5 mm apart and the supported central portion is pushed down vertically 0.3 mm with a push-down jig moving at a speed of 5 mm/min is expressed by a quadratic or higher approximation of x, where x is the length from the tip of the guidewire 10, and when the guidewire 10 is inserted into the lumen of the catheter 60 and protrudes from the tip opening of the catheter 60, the bending load value of the catheter 60 obtained by measuring the load when the catheter 60 is supported at two points spaced 5 mm apart and the supported central portion is pushed down vertically 0.3 mm with a push-down jig moving at a speed of 5 mm/min is smaller than the bending load value of the guidewire 10.
  • the catheter assembly 100 according to the present invention has been described above through an embodiment, but the present invention is not limited to the configurations described in the specification, and can be modified as appropriate based on the claims.
  • the catheter assembly 100 used for hepatic artery chemoembolization has been given as an example, but it goes without saying that the catheter assembly 100 of the present invention can be used for other procedures.
  • the catheter 60 and the guidewire 10 each need only have an appropriate length according to the procedure to be applied.
  • the guidewire 10 has been described as being formed from a single material, with the core wire 20 being changed in diameter along the axial direction (i.e., tapered), thereby changing the rigidity along the axial direction, but the present invention is not limited to this case.
  • the rigidity can be changed along the axial direction by using different materials for the main body portion 30, the guidewire rigidity changing portion 35, and the tip core portion 34.
  • the main body portion 30, the guidewire rigidity changing portion 35, and the tip core portion 34, which are made of different materials, can be joined by any suitable known method such as welding, melting, or adhesive bonding.
  • Each portion of the core wire 20 may be formed by combining the use of different materials and a tapered shape.
  • the catheter 60 has been described as having a configuration in which the stiffness is changed along the axial direction by changing the hardness of the outer layer 73 in the shaft portion 70 along the axial direction, but the present invention is not limited to this case.
  • the shaft portion 70 can be made of the same material, but the thickness of the material can be changed along the axial direction to change the stiffness along the axial direction.
  • the outer layer 73 in the shaft portion 70 can have multiple regions of different thickness along the axial direction, with the thickness of each region decreasing toward the tip (flexibility increasing toward the tip).
  • the stiffness of the catheter 60 can be changed by a combination of both the hardness and thickness of the material.
  • the bending load value of the catheter 60 is smaller than the bending load value of the guidewire 10.
  • the tip opening of the catheter 60 and the tip of the guidewire 10 are aligned, the bending load value of the catheter 60 may be smaller than the bending load value of the guidewire 10.
  • the bending load value of the catheter 60 is smaller than the bending load value of the guidewire 10.
  • the bending load value of the catheter 60 may be smaller than the bending load value of the guidewire 10.

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Abstract

Le problème décrit par la présente invention est de fournir un ensemble cathéter ayant une aptitude à la poussée appropriée. La solution proposée par l'invention comprend un ensemble cathéter dans lequel : la valeur de charge de flexion y d'un fil-guide est exprimée par une formule d'approximation d'un second ordre ou supérieur à x, x étant la longueur du fil-guide à partir de la pointe ; et lorsque le fil-guide est inséré dans la lumière du cathéter et faisant saillie à travers l'ouverture de pointe du cathéter, la valeur de charge de flexion du cathéter est inférieure à la valeur de charge de flexion du fil-guide.
PCT/JP2023/045929 2023-01-23 2023-12-21 Ensemble cathéter et cathéter WO2024157689A1 (fr)

Applications Claiming Priority (2)

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JP2023-008120 2023-01-23
JP2023008120 2023-01-23

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WO2024157689A1 true WO2024157689A1 (fr) 2024-08-02

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013523282A (ja) * 2010-03-31 2013-06-17 ボストン サイエンティフィック サイムド，インコーポレイテッド 曲げ剛性プロファイルを有するガイドワイヤ
WO2018181178A1 (fr) * 2017-03-29 2018-10-04 テルモ株式会社 Ensemble cathéter

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013523282A (ja) * 2010-03-31 2013-06-17 ボストン サイエンティフィック サイムド，インコーポレイテッド 曲げ剛性プロファイルを有するガイドワイヤ
WO2018181178A1 (fr) * 2017-03-29 2018-10-04 テルモ株式会社 Ensemble cathéter

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