WO2022158418A1 - Cathéter - Google Patents

Cathéter Download PDF

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Publication number
WO2022158418A1
WO2022158418A1 PCT/JP2022/001383 JP2022001383W WO2022158418A1 WO 2022158418 A1 WO2022158418 A1 WO 2022158418A1 JP 2022001383 W JP2022001383 W JP 2022001383W WO 2022158418 A1 WO2022158418 A1 WO 2022158418A1
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WO
WIPO (PCT)
Prior art keywords
catheter
tip
tube
distal
tip tube
Prior art date
Application number
PCT/JP2022/001383
Other languages
English (en)
Japanese (ja)
Inventor
健一 堀場
大 冨田
春佳 杉村
光則 吉川
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2022158418A1 publication Critical patent/WO2022158418A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters

Definitions

  • the present invention relates to a catheter having an intermediate opening having a tip tube and a linear shaft connected to the tip tube and extending proximally from the tip tube.
  • Guiding catheters are used to guide therapeutic catheters (balloon catheters, stent placement catheters, etc.) that are inserted into biological lumens such as blood vessels for treatment and diagnosis, etc., to the target site.
  • therapeutic catheters balloon catheters, stent placement catheters, etc.
  • PTCA percutaneous transluminal coronary angioplasty
  • a guide wire for a guiding catheter is inserted through the skin of the wrist or thigh into the artery, and then to the entrance of the coronary artery. reach.
  • a guiding catheter is inserted along the guidewire into the artery, and the guidewire for the guiding catheter is subsequently withdrawn to engage the coronary ostia.
  • a thinner guidewire for a therapeutic catheter is inserted into the lumen of the guiding catheter and passed through the lesion in the coronary artery.
  • a balloon catheter is inserted along the guide wire for the treatment catheter, the tip of the balloon catheter is protruded from the tip opening of the guiding catheter, and advanced through the coronary artery to the periphery along the guide wire that has passed through the lesion, and the balloon is is placed on the lesion and the balloon is inflated for treatment.
  • a guide extension catheter is used to smoothly advance the therapeutic catheter from the opening of the tip of the guiding catheter to the affected area within the curved or bent coronary artery.
  • a guide extension catheter can be inserted closer to the lesion than the guiding catheter, and can provide a stable backup force to the therapeutic catheter.
  • the guide extension catheter has a tip tube that moves in the lumen of the guiding catheter and protrudes from the tip opening of the guiding catheter to the distal side, and a linear tube that is connected to the tip tube and extends from the tip tube to the proximal side.
  • the length of the guide wire protruding proximally beyond the guiding catheter is longer than the length of the tubular portion of the guide extension catheter. Since the guide extension catheter has a linear shaft, the length of the tubular portion can be shortened, so there is no need to use an unnecessarily long guide wire, which facilitates the procedure.
  • Patent Documents 1 to 3 describe catheters in which a shaft is embedded in a tip tube.
  • a shaft is embedded in a tip tube.
  • it is necessary to increase the thickness of the tip tube.
  • reducing the outer diameter of the shaft to reduce the thickness of the tip tube can reduce the push and pull strength of the catheter.
  • the present invention has been made to solve the above-described problems, and provides a catheter having an intermediate opening that can improve the pushing strength and the pulling strength while suppressing an increase in the thickness of the tip tube. for the purpose.
  • a catheter having an intermediate opening for achieving the above object is a catheter having an intermediate opening having a distal tube and a linear shaft extending proximally from the distal tube, wherein the linear shaft of the distal tube is embedded.
  • the portion where the projection is formed forms a convex portion on the outer surface of the tip tube in a cross section perpendicular to the axial center of the tip tube, and the thickness of the portion where the convex portion of the tip tube is formed is the thickness of the axial center greater than the thickness of the tip tube on the side opposite to the tip tube.
  • the catheter having the intermediate opening configured as described above partially increases the thickness of the tip tube, it is possible to suppress an increase in the thickness of the tip tube as a whole.
  • the tip tube by partially thickening the tip tube, it is not necessary to make the linear shaft too thin, so the pushing strength and the pulling strength can be effectively improved.
  • the linear shaft has a linearly extending base portion, and a tip-shaped portion disposed on the distal side of the base portion and extending from the base portion toward the distal side while bending toward the proximal side.
  • the tip tube may have a portion in which the two protrusions are formed in a cross section perpendicular to the axial center of the tip tube.
  • the tip tube may have, in a cross section orthogonal to the axial center of the tip tube, a part where two of the convex parts are formed and a part where one of the convex parts is formed.
  • the catheter protrudes from the distal end opening of the guiding catheter and is advanced through the coronary artery to the periphery along the therapeutic catheter. and a guide extension catheter for arranging a treatment portion for performing treatment on a lesion portion provided on the treatment catheter.
  • the guide extension catheter can effectively transmit pushing force, withdrawal force and rotational force to the tip tube, and the tip can be used during surgery. Separation of the tube and the linear shaft can be prevented.
  • FIG. 2 is a plan view showing a guide extension catheter, a dilator, and a guiding catheter, which are catheters having intermediate openings according to the present embodiment. It is a figure which shows a guide extension catheter, (A) is a side view, (B) is a top view, (C) is a partially enlarged view of a linear shaft.
  • FIG. 2 shows a guide extension catheter, (A) is a cross-sectional view along line AA in FIG. 2, (B) is a cross-sectional view along line BB in FIG. 2, and (C) is C- in FIG. It is sectional drawing which follows C line.
  • FIG. 1 shows a guide extension catheter
  • A) is a cross-sectional view along line AA in FIG. 2
  • (B) is a cross-sectional view along line BB in FIG. 2
  • (C) is C- in FIG. It is sectional drawing which follows C line.
  • FIG. 4 is an enlarged plan view of the tip tube; It is a figure which shows a dilator, (A) is a side view, (B) is a top view, (C) is a partially enlarged view of a dilator linear shaft. is.
  • FIG. 6 is a cross-sectional view taken along line DD of FIG. 5;
  • FIG. 4 is a side view showing a catheter assembly in which a dilator is assembled with a guide extension catheter;
  • FIG. 4A is a side view of a catheter having an intermediate opening showing a first modified example, and
  • FIG. 11 is a side view of a catheter and dilator having an intermediate opening showing a second modification;
  • FIG. 11 is a side view of a catheter and dilator having an intermediate opening showing a third modification; It is a side view of a dilator which shows a 4th modification.
  • distal side the side of the device that is inserted into a blood vessel
  • proximal side the side of the device that is manipulated
  • the catheter having an intermediate opening is inserted into a guiding catheter 100 having a distal soft tip 100A, protrudes from a distal opening 101 of the guiding catheter 100, and guides the therapeutic catheter.
  • a guide extension catheter 10 used to extend a tube for endoscopic surgery from a guiding catheter 100 to the distal side.
  • a rapid exchange dilator 50 can be inserted into the guide extension catheter 10 .
  • the guide extension catheter 10 includes a tubular tip tube 20 and a linear shaft 30 connected to the tip tube 20 and extending from the tip tube 20 to the proximal side.
  • the tip tube 20 can move through the lumen of the guiding catheter 100 and protrude from the tip opening 101 of the guiding catheter 100 to the tip side.
  • the tip tube 20 thereby provides a continuous lumen from the guiding catheter 100 . That is, in the procedure, the tip tube 20 of the guide extension catheter 10 is inserted closer to the lesion site than the guiding catheter 100, so that the treatment catheter can be stably backed up.
  • the distal tube 20 is a tubular body having a lumen penetrating from the distal end to the proximal end, and includes a tubular portion 21 arranged on the distal side and a semi-tubular portion 22 arranged on the proximal side of the tubular portion 21 .
  • the tubular portion 21 is formed in a circular tubular shape by providing a material in a range of 360 degrees in the circumferential direction.
  • the semi-pipe portion 22 is formed in a half-pipe shape by providing material in a range of approximately 180 degrees in the circumferential direction.
  • the angular range in which the material of the semi-tube portion 22 is provided is not particularly limited as long as it is less than 360 degrees, and may be less than 180 degrees, for example.
  • the half tube portion 22 may not be provided.
  • the axial length of the tubular portion 21 is not particularly limited, but is, for example, 200 mm to 400 mm.
  • the axial length of the semi-tubular portion 22 is not particularly limited, but is, for example, 5 mm to 200 mm.
  • the inner diameter of the tip tube 20 is not particularly limited, but is, for example, 1.3 mm to 1.5 mm.
  • the outer diameter of the tip tube 20 is not particularly limited, but is, for example, 1.55 mm to 1.75 mm.
  • the rigidity of the distal tube 20 decreases stepwise or gradually from the proximal side toward the distal side.
  • the distal end tube 20 has a softer structure with less rigidity toward the distal end, so that flexibility can be imparted to the distal end portion and high pushability can be imparted to the proximal end portion.
  • the rigidity of the distal tube 20 does not have to change from the proximal side toward the distal side.
  • the distal end tube 20 has a distal tip 21A formed of a flexible material such as polyurethane at its distal end.
  • the distal tube 20 includes an inner layer 23 , a reinforcing layer 24 , a middle layer 25 , an outer layer 26 , a distal marker 27 and a proximal marker 28 .
  • Tubular portion 21 is formed by inner layer 23 , reinforcing layer 24 , middle layer 25 , outer layer 26 , distal marker 27 and proximal marker 28 .
  • the half tube 22 is formed by an inner layer 23 , a middle layer 25 and an outer layer 26 .
  • the inner layer 23 is a layer that forms the inner peripheral surfaces of the tubular portion 21 and the semi-tubular portion 22 of the tip tube 20 .
  • the inner layer 23 is arranged radially inside the reinforcing layer 24 .
  • the inner layer 23 is preferably made of a low-friction material so that the guide wire, therapeutic catheter, dilator 50 or the like can easily slide inside.
  • the low-friction material is, for example, fluorine-based resin such as PTFE (polytetrafluoroethylene), PFA (tetrafluoroethylene-perfluoroalkoxyethylene copolymer), or silicone resin, but is not limited to these.
  • the thickness of the inner layer 23 is not particularly limited, but is, for example, 0.0001 mm to 0.1 mm, preferably 0.005 mm to 0.05 mm, and more preferably 0.01 mm to 0.03 mm.
  • the reinforcing layer 24 is formed of a coil formed by spirally winding at least one wire or a plurality of braids formed by braiding a plurality of wires in order to reinforce the tubular portion 21 of the tip tube 20 .
  • the reinforcing layer 24 is arranged radially outside the inner layer 23 and radially inside the intermediate layer 25 .
  • Coils and braids are made of wires made of metal materials such as stainless steel and tungsten wires. It is not particularly limited and is set as appropriate.
  • the crossing angle between the long axis and the wire is not particularly limited, and may be set appropriately and may be constant or variable along the long axis direction.
  • the reinforcing layer 24 When the reinforcing layer 24 is formed by a braid, the number of picks with one of the stitches as a pick, the number of ends that is the number of strands included in one pick, and the picks in one round
  • the number of spindles which is the number of spindles, is set as appropriate.
  • the shape and dimensions of the reinforcing wire may vary depending on the winding direction.
  • the wire rods forming the coils or braids of the reinforcing layer 24 may be arranged at a sparse pitch with gaps or at a fine pitch without gaps.
  • the reinforcing layer 24 can be used as a contrast marker that improves contrast when the tungsten wires are arranged at a dense pitch.
  • the intermediate layer 25 is a layer that surrounds the outer peripheral surfaces of the inner layer 23 and the reinforcing layer 24 of the tubular portion 21 and the semi-tubular portion 22 of the tip tube 20 .
  • the middle layer 25 is arranged radially outside the reinforcing layer 24 and radially inside the outer layer 26 .
  • the middle layer 25 is joined to the inner layer 23 in the range where the reinforcing layer 24 is not provided.
  • the middle layer 25 is arranged radially inside the linear shaft 30 .
  • the intermediate layer 25 may be formed all around in the circumferential direction of the tip tube 20, or may be formed partially including at least the range where the linear shaft 30 is arranged.
  • the intermediate layer 25 is formed partially in the circumferential direction in the semi-tubular portion 22 and formed entirely in the circumferential direction in the tubular portion 21 , but may also be partially formed in the tubular portion 21 in the circumferential direction. .
  • the intermediate layer 25 is adhesively fixed to the linear shaft 30 .
  • a method of fixing the intermediate layer 25 and the linear shaft 30 is not particularly limited.
  • the constituent material of the middle layer 25 is not particularly limited, but for example, various thermoplastics such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene.
  • various thermoplastics such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene.
  • Elastomers, polyether ketones, polyimides, etc. may be used, and one or more of these may be used in combination (polymer alloys, polymer blends, laminates, etc.).
  • polyester elastomers, polyamide elastomers, and the like can be preferably used.
  • the thickness of the intermediate layer 25 is not particularly limited, but is, for example, 0.0001 mm to 0.1 mm, preferably 0.005 mm to 0.05 mm, more preferably 0.01 mm to 0.03 mm.
  • the middle layer 25 may also include an X-opaque material (contrast agent) in the material.
  • Radiopaque metals include, for example, gold, platinum, silver, bismuth, tungsten or alloys of two or more of these (eg platinum-tungsten), barium sulfate, or alloys with other metals (eg gold -iridium, platinum-iridium, platinum-nickel) and the like.
  • the material of the intermediate layer 25 may be a metallic material such as stainless steel, nickel-titanium alloy, or the like.
  • the outer layer 26 is a layer that forms the outer peripheral surfaces of the tubular portion 21 and the semi-tubular portion 22 of the tip tube 20, as shown in FIGS.
  • Outer layer 26 surrounds the outer peripheral surface of middle layer 25 of tubular portion 21 and semi-tubular portion 22 . That is, the outer layer 26 is arranged radially outside the middle layer 25 and fixed to the middle layer 25 .
  • Outer layer 26 also surrounds the outer peripheral surface of distal marker 27 and proximal marker 28 provided on tubular portion 21 .
  • the outer layer 26 is fixed to the middle layer 25 by sandwiching the linear shaft 30 therebetween. Therefore, the linear shaft 30 does not directly contact the reinforcing layer 24 .
  • the linear shaft 30 and the reinforcing layer 24 are made of a metal material, they are likely to slip and wear when they come into contact with each other.
  • the intermediate layer 25 made of a resin material is provided between the reinforcing layer 24 and the linear shaft 30, slippage and abrasion of the linear shaft 30 and the reinforcing layer 24 can be suppressed.
  • the push-in strength, pull-out strength, and torsion strength of the guide extension catheter 10 can be improved.
  • the outer layer 26 has protrusions 29 on the outer surface of the portion where the linear shaft 30 is embedded.
  • the protrusion 29 protrudes radially outward in a cross section perpendicular to the axial center of the tip tube 20 .
  • the convex portion 29 is formed at a position corresponding to the linear shaft 30 that is bent so as to be folded back. Therefore, the outer layer 26 does not become too thin at the portion where the linear shaft 30 is embedded inside the tip tube 20 . Therefore, the strength of the distal end tube 20 can be improved, the linear shaft 30 can be prevented from coming off from the distal end tube 20, the linear shaft 30 need not be too thin, and the pushing strength and the pulling strength of the guide extension catheter 10 can be improved. can.
  • the outer layer 26 has, in a cross section orthogonal to the axial center of the tip tube 20, a portion where two convex portions 29 are formed and a portion where one convex portion 29 is formed.
  • the part where two protrusions 29 are formed is arranged on the tip side of the part where one protrusion 29 is formed.
  • the portion of the distal end portion of the linear shaft 30 that is folded back and exists so as to line up the two wire rods is embedded.
  • a portion where one convex portion 29 is formed, a portion where one wire is present is embedded on the proximal end side of the folded portion of the distal end portion of the linear shaft 30 .
  • a concave portion 29A is formed between the two convex portions 29 .
  • the two projections 29 are continuously connected at the tip of the linear shaft 30 where the semicircular portion 34 described later is located. Note that the convex portion 29 may not be formed.
  • the constituent material of the outer layer 26 is not particularly limited, but for example, various thermoplastics such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene.
  • various thermoplastics such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene.
  • Elastomers, polyether ketones, polyimides, etc. may be used, and one or more of these may be used in combination (polymer alloys, polymer blends, laminates, etc.).
  • polyester elastomers, polyamide elastomers, and the like can be preferably used.
  • the thickness of the outer layer 26 is not particularly limited, but is, for example, 0.0001 mm to 0.1 mm, preferably 0.005 mm to 0.05 mm, more preferably 0.01 mm to 0.03 mm. is.
  • the outer peripheral surface of the outer layer 26 may be coated with a lubricious material in order to improve passageability with the blood vessel and the inner wall surface of the guiding catheter 100 .
  • Lubricating materials include epoxy group-containing monomers such as glycidyl acrylate, glycidyl methacrylate, 3,4-epoxycyclohexylmethyl acrylate, 3,4-epoxycyclohexylmethyl methacrylate, ⁇ -methylglycidyl methacrylate, allyl glycidyl ether, and N - copolymers with hydrophilic monomers such as methylacrylamide, N,N-dimethylacrylamide and acrylamide; (co)polymers composed of the above hydrophilic monomers; celluloses such as hydroxypropyl cellulose and carboxymethyl cellulose high-molecular substances; polysaccharides, polyvinyl alcohol, methyl vinyl ether-maleic anhydride copolymer, water-soluble polyamide, poly(2-hydroxyethyl (meth)acrylate), polyethylene glycol, polyacrylamide, polyvinylpyrrolidone and the like. Hydrophilic lubricating polymers such as poly
  • the outer layer 26 and the middle layer 25 are made of, for example, a resin material instead of a metal material. Thereby, the outer layer 26 and the middle layer 25 can have high bonding strength. Therefore, the outer layer 26 and the intermediate layer 25 can firmly fix the sandwiched linear shaft 30 to the tip tube 20 . Also, the outer layer 26 and the middle layer 25 may be made of the same material, or may be made of different colors or different hardnesses.
  • the distal marker 27 and the proximal marker 28 contain radiopaque metal that is visible under fluoroscopy.
  • the distal end marker 27 and the proximal end marker 28 are, for example, ring-shaped members, but may be members with a C-shaped cross section, coils, or the like.
  • Radiopaque metals include, for example, gold, platinum, silver, bismuth, tungsten or alloys of two or more of these (eg platinum-tungsten), barium sulfate, or alloys with other metals (eg gold -iridium, platinum-iridium, platinum-nickel) and the like.
  • the tip marker 27 is sandwiched between the middle layer 25 and the outer layer 26 at the tip of the tubular portion 21, as shown in FIGS.
  • the position where the tip marker 27 is arranged is not limited to between the middle layer 25 and the outer layer 26, and may be arranged between the inner layer 23 and the middle layer 25 or outside the outer layer 26, for example.
  • the tip marker 27 is arranged on the tip side of the reinforcing layer 24 . Therefore, tip marker 27 does not overlap reinforcing layer 24 in the axial direction of tip tube 20 . As a result, the thickness of the tip tube 20 can be reduced and the outer diameter can be reduced.
  • the tip marker 27 may overlap the reinforcing layer 24 in the axial direction of the tip tube 20 . Also, the tip marker 27 may not be provided.
  • the proximal marker 28 is sandwiched between the middle layer 25 and the outer layer 26 at the proximal end of the tubular portion 21, as shown in FIGS.
  • the position where the base end marker 28 is arranged is not limited to between the middle layer 25 and the outer layer 26, and may be arranged between the inner layer 23 and the middle layer 25 or outside the outer layer 26, for example.
  • the proximal marker 28 is located proximal to the reinforcing layer 24 . Therefore, proximal marker 28 does not overlap reinforcing layer 24 in the axial direction of distal tube 20 . As a result, the thickness of the tip tube 20 can be reduced and the outer diameter can be reduced. Note that the proximal end marker 28 may overlap the reinforcing layer 24 in the axial direction of the distal tube 20 . Also, the proximal marker 28 may not be provided.
  • the linear shaft 30 is, as shown in FIGS. extends proximally from the
  • the linear shaft 30 includes a linear base portion 31 and a shaped distal end portion 32 disposed on the distal end side of the base portion 31 .
  • the tip shape portion 32 includes an intermediate straight portion 33 extending from the base portion 31 to the tip side, a semicircular portion 34 arranged on the tip side of the intermediate straight portion 33, and the intermediate straight portion 33 arranged from the semicircular portion 34. and a tip straight portion 35 extending to the side opposite to the side of the tip.
  • the intermediate straight portion 33 reaches from the base end surface of the semi-tubular portion 22 to the base end portion of the tubular portion 21 . Therefore, the distal end of the intermediate straight portion 33 is positioned at the tubular portion 21 .
  • the intermediate straight portion 33 is inclined at a minute angle exceeding 0 degrees with respect to an extension line L1 located on the axis of the base portion 31 and extending from the base portion 31 toward the distal end side. Therefore, the intermediate straight portion 33 is arranged to be shifted to one side from the extension line L1.
  • the proximal end of the intermediate straight portion 33 may be located on the proximal side of the proximal end of the semi-tubular portion 22 or may be located on the distal side of the semi-tubular portion 22 .
  • the starting point at which the intermediate straight portion 33 is positioned on the axis of the base portion 31 and inclined with respect to the extension line L1 extending from the base portion 31 to the distal side may be inside the semi-tubular portion 22 or inside the tubular portion 21 .
  • the semicircular portion 34 is bent by changing the direction by about 180 degrees so as to draw a substantially semicircular shape at the proximal end of the tubular portion 21 .
  • the semicircular portion 34 is arranged so as to intersect the extension line L1. Note that the semicircular portion 34 does not have to strictly intersect the extension line.
  • the semicircular portion 34 is arranged at a position overlapping the reinforcing layer 24 in the axial direction of the tip tube 20 . That is, both the semicircular portion 34 and the reinforcing layer 24 are provided within a predetermined range in the axial direction of the tip tube 20 .
  • the distal linear portion 35 extends from the end of the tubular portion 21 opposite to the side in contact with the intermediate linear portion 33 toward the proximal end.
  • the straight tip portion 35 is substantially parallel to the extension line L1, but does not have to be strictly parallel.
  • An extension line L1 is arranged between the intermediate straight portion 33 and the tip straight portion 35 .
  • the intermediate straight portion 33, the semicircular portion 34 and the tip straight portion 35 are arranged on the same plane.
  • a terminal end portion 36 located on the opposite side of the straight tip portion 35 from the side in contact with the semicircular portion 34 is located in the tubular portion 21 . It should be noted that the terminal end portion 36 may be located at the half tube portion 22 .
  • the terminal end portion 36 is arranged on the proximal side of the reinforcing layer 24 in the axial direction of the distal tube 20 .
  • the tip shape portion 32 may engage the wire forming the reinforcing layer 24 so as to be hooked.
  • the state in which the tip shaped portion 32 is caught by the wire forming the reinforcing layer 24 is, for example, when the tip shaped portion 32 moves from the inner peripheral surface side to the outer peripheral surface side of the reinforcing layer 24, or from the outer peripheral surface side to the inner peripheral surface side.
  • a state in which the wires that constitute the reinforcing layer 24 pass through is exemplified. This can prevent the linear shaft 30 from falling off from the tip tube 20 .
  • the radius of curvature of the semi-circular portion 34 may not be constant, and may be semi-elliptical or the direction of the semi-circular portion may exceed 180 degrees, or conversely may be less than 180 degrees.
  • the portion of the linear shaft 30 embedded in the tip tube 20 is arranged between the outer layer 26 and the intermediate layer 25 and is spaced radially outward from the reinforcing layer 24 .
  • the distance between the linear shaft 30 and the reinforcing layer 24 is not particularly limited, but is, for example, 0.01 to 0.03 mm in the thickness direction of the tip tube 20 (the radial direction of the tubular portion 21).
  • the linear shaft 30 preferably does not contact the reinforcing layer 24 at all, but may partially contact the tip tube 20 in the axial direction.
  • the linear shaft 30 may be coated with a low-friction material on all or at least part of the portion exposed to the outside so that it can slide on the inner wall surface of the guiding catheter 100 with low friction.
  • the low-friction material is, for example, fluorine-based resin or silicone resin, but is not limited to these. All or at least a portion of the portion of the linear shaft 30 exposed to the outside may be coated with a lubricating material in order to improve slidability with the inner wall surface of the guiding catheter 100 .
  • the linear shaft 30 has a first straight portion 40 with a constant outer diameter and a first tapered portion 40 with a decreasing outer diameter from the proximal side to the distal side. It has a portion 41, a second linear portion 42 with a constant outer diameter, a second tapered portion 43 with a decreasing outer diameter, and a third linear portion 44 with a constant outer diameter.
  • the first straight portion 40 forms the base portion 31 .
  • the first tapered portion 41 forms a portion including the boundary between the base portion 31 and the intermediate straight portion 33 . Part of the base end side of the second straight portion 42 , the second tapered portion 43 , and the third straight portion 44 forms the intermediate straight portion 33 .
  • the third straight portion 44 forms the semicircular portion 34 and the tip straight portion 35 .
  • the tip straight portion 35, the semicircular portion 34, and the intermediate straight portion 33 may be located on the tip side of the second taper portion 43, that is, the tip shape portion 32 may have a smaller outer diameter than the base portion 31 and may be constant.
  • the linear shaft 30 is connected to the tip tube 20 after the tip shape portion 32 is shaped into a predetermined shape.
  • the linear shaft 30 is adhered to the outer peripheral surface or inner peripheral surface of the base end marker 28 with an adhesive 90.
  • the constituent material of the adhesive 90 is not particularly limited. , modified polyolefins (e.g., ethylene-vinyl acetate copolymer, ethylene-methyl methacrylate copolymer, ethylene-ethyl acrylate copolymer, ethylene-methyl acrylate copolymer, ethylene-ethyl acrylate-maleic anhydride copolymer, Adhesive polymeric materials such as ethylene-acrylic acid copolymers, i-monomers, MAH-g-polyolefins, chlorinated polyolefins, etc., or contrast-enhancing adhesives such as gold paste, or contrast-enhancing adhesives can be used. A mixture of an adhesive having contrast properties and an adhesive having no contrast properties may be used.
  • the linear shaft 30 is adhered to the base end marker 28 at, for example, the intermediate straight portion 33 and the distal straight portion 35, but the adhered portions are not particularly limited.
  • the adhered proximal marker 28 and linear shaft 30 can be incorporated in the adhered state at the time of manufacture, which facilitates manufacture. Further, when the linear shaft 30 and the base end marker 28 are fixed by caulking, welding, or the like, the linear shaft 30 and the base end marker 28 are likely to be deformed. In contrast, when the base end marker 28 and the linear shaft 30 are fixed by adhesion, they are less likely to be deformed. Therefore, the shape of the catheter can be stabilized and can be manufactured at low cost.
  • the linear shaft 30 and the base end marker 28 may be fixed by a method other than adhesion, for example, by caulking, welding, or the like.
  • the tip of the linear shaft 30 is arranged at a position overlapping the reinforcing layer 24 in the axial direction of the tip tube 20 .
  • a middle layer 25 is arranged between the tip of the linear shaft 30 and the reinforcing layer 24 . Note that the distal end portion of the linear shaft 30 and the reinforcing layer 24 may be in direct contact with each other without the middle layer 25 interposed therebetween.
  • the outer diameter of the linear shaft 30 is not particularly limited, it is, for example, 0.05 mm to 1 mm.
  • the axial length of the base portion 31 of the linear shaft 30 is not particularly limited, but is, for example, 1100 mm to 1300 mm.
  • the material of the linear shaft 30 is not particularly limited, for example, stainless steel, nickel-titanium alloy, etc. can be suitably used.
  • the cross-sectional shape of the linear shaft 30 is not limited to circular, and may be, for example, rectangular, square, elliptical, or the like, and may have different shapes depending on the part.
  • the linear shaft 30 may have depth markers visible on the base 31 for tracking the length of insertion into the guiding catheter 100 .
  • the rapid exchange dilator 50 includes a tubular dilator tip tube 60 and a linear dilator shaft 70 connected to and extending proximally from the dilator tip tube 60, as shown in FIGS. and That is, like the guide extension catheter 10, the dilator 50 is also a catheter having an intermediate opening with a tip tube and a linear shaft.
  • the dilator 50 can be called an instrument that is inserted into the coronary artery together with the guide extension catheter 10 and smoothly guided to a lesion such as a stenosis that occurs in the coronary artery.
  • the dilator 50 can be called an instrument that is inserted into the coronary artery together with the guide extension catheter 10 and smoothly guides it beyond a lesion such as a stenosis that occurs in the coronary artery, thereby dilating the stenosis.
  • the dilator distal tube 60 is a tubular body having a lumen penetrating from the distal end to the proximal end. and an inclined portion 63 arranged on the base end side of the tubular portion 62 .
  • the tip tapered portion 61 is tapered toward the tip side.
  • the tip tapered portion 61 may taper toward the tip side, and may have a cylindrical portion with a constant outer diameter at the tip.
  • Tubular portion 62 is a cylinder having a uniform outer diameter and inner diameter.
  • the outer diameter of the tubular portion 62 is smaller than the inner diameter of the tip tube 20 by, for example, 0.05 mm. This allows the tubular portion 62 to move smoothly through the lumen of the distal tube 20 .
  • the inner diameter of the tubular portion 62 is larger than the outer diameter of the inserted guidewire. This allows the tubular portion 62 to move smoothly along the guidewire.
  • the inclined portion 63 has a base end surface that is inclined with respect to a cross section perpendicular to the axis. Note that the inclined portion 63 may not be provided.
  • the axial length of the tip tapered portion 61 is not particularly limited, it is, for example, 3 mm to 30 mm.
  • the overall axial length of the dilator tip tube 60 is not particularly limited, but is, for example, 100 mm to 450 mm.
  • Dilator tip tube 60 is preferably flexible with some degree of flexibility.
  • the constituent material of the dilator tip tube 60 is, for example, various thermoplastics such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene. Elastomers, polyether ketones, polyimides, etc.
  • the dilator tip tube 60 may include an X-opaque material (contrast agent) as described above.
  • the dilator tip tube 60 may include the X-opaque material (contrast agent) described above in the material, or may have markers made of X-ray opaque metal.
  • Radiopaque metals include, for example, gold, platinum, silver, bismuth, tungsten or alloys of two or more of these (eg platinum-tungsten), barium sulfate, or alloys with other metals (eg gold -iridium, platinum-iridium, platinum-nickel) and the like. If a distal marker or a proximal marker (not shown) containing radiopaque metal is provided, the operator can grasp the position of the dilator distal tube 60 inserted into the body under radiography. can do.
  • the dilator tip tube 60 is formed, for example, by insert-molding the dilator linear shaft 70 in a mold.
  • the dilator linear shaft 70 is a flexible wire, is connected to the dilator tip tube 60, and extends from the dilator tip tube 60 to the proximal side.
  • the dilator linear shaft 70 includes a linear shaft base portion 71 and a shaft tip shape portion 72 arranged and shaped on the tip side of the shaft base portion 71 .
  • the shaft tip shape portion 72 includes a shaft intermediate straight portion 73 extending from the shaft base portion 71 to the tip side, a shaft semicircular portion 74 disposed on the tip side of the shaft intermediate straight portion 73, and a shaft extending from the shaft semicircular portion 74. and a shaft tip straight portion 75 extending to the side opposite to the side where the intermediate straight portion 73 is provided.
  • the shaft intermediate straight portion 73 reaches the cylindrical portion 62 from the proximal end surface of the portion of the inclined portion 63 of the dilator tip tube 60 that protrudes toward the proximal end side. Therefore, the tip of the shaft intermediate straight portion 73 is positioned at the cylindrical portion 62 .
  • the shaft intermediate straight portion 73 is positioned on the axis of the shaft base portion 71 and is inclined at a minute angle exceeding 0 degrees with respect to an extension line L2 extending from the shaft base portion 71 to the tip side. Therefore, the shaft intermediate straight portion 73 is arranged to be shifted to one side from the extension line L2.
  • the shaft semicircular portion 74 is bent by changing its direction by about 180 degrees so as to draw a substantially semicircular shape at the proximal end of the cylindrical portion 62 .
  • the shaft semicircular portion 74 is arranged to intersect the extension line L2. It should be noted that the shaft semicircular portion 74 does not have to strictly intersect the extension line L2.
  • the shaft distal straight portion 75 extends from the end of the shaft semicircular portion 74 opposite to the side in contact with the shaft intermediate straight portion 73 toward the proximal side.
  • the shaft tip straight portion 75 is substantially parallel to the extension line L2, but does not have to be strictly parallel.
  • An extension line L2 is arranged between the shaft intermediate straight portion 73 and the shaft tip straight portion 75 .
  • the shaft intermediate straight portion 73, the shaft semicircular portion 74, and the shaft tip straight portion 75 are arranged on the same plane.
  • a shaft terminal end portion 76 on the side opposite to the side of the shaft tip straight portion 75 in contact with the shaft semicircular portion 74 is located on the cylindrical portion 62 or the inclined portion 63 .
  • the shaft semi-circular portion 74 may not have a constant radius of curvature, may be semi-elliptical, or may have a direction greater than 180 degrees or less than 180 degrees.
  • the dilator linear shaft 70 includes a dilator straight portion 80 having a constant outer diameter and a dilator straight portion 80 having a constant outer diameter and a dilator straight portion 80 extending from the proximal end to the distal end. and a dilator tapered portion 81 whose outer diameter decreases to the tip of the linear shaft 70 .
  • the dilator straight portion 80 forms the shaft base portion 71 .
  • the dilator tapered portion 81 forms a tip portion of the shaft base portion 71 , a shaft intermediate straight portion 73 , a shaft semicircular portion 74 and a shaft tip straight portion 75 .
  • the boundary between the dilator straight portion 80 and the dilator tapered portion 81 is arranged on the proximal side of the dilator distal tube 60 , but may be arranged on the proximal end of the dilator distal tube 60 or inside the dilator distal tube 60 .
  • the dilator linear shaft 70 is connected to the dilator tip tube 60 after the shaft tip profile 72 is shaped into a predetermined shape.
  • the outer diameter of the dilator linear shaft 70 is not particularly limited, it is, for example, 0.05 mm to 1 mm.
  • the axial length of the base portion 31 of the dilator linear shaft 70 is not particularly limited, but is, for example, 1000 mm to 1400 mm.
  • the constituent material of the dilator linear shaft 70 is not particularly limited, but for example, stainless steel, nickel-titanium alloy, etc. can be suitably used.
  • the cross-sectional shape of the dilator linear shaft 70 is not limited to a circular shape, and may be, for example, rectangular, square, elliptical, or the like, and may have different shapes depending on the part.
  • the dilator linear shaft 70 may have depth markers that can be visually confirmed to track the length of insertion into the guiding catheter 100 .
  • the guide extension catheter 10 and the dilator 50 can be used with the dilator 50 inserted into the guide extension catheter 10 as shown in FIG.
  • Guide extension catheter 10 and dilator 50 may be packaged in a combined catheter assembly. As a result, the convenience of the procedure is improved, and the procedure can be performed immediately after opening the package.
  • the dilator tip tube 60 can move through the lumen of the tip tube 20 of the guide extension catheter 10 and partially protrude from the tip opening 201 of the tip tube 20 to the tip side. At this time, the tip tapered portion 61 of the dilator tip tube 60 protrudes from the tip opening 201 of the tip tube 20 to the tip side. After engaging the tip of the guiding catheter 100 with the ostium of the coronary artery, the operator projects the guide extension catheter 10 with the dilator 50 inserted through the tip opening 101 of the guiding catheter 100 .
  • the dilator tip tube 60 plays a role of smoothly guiding the guide extension catheter 10 to the target position along the guidewire.
  • the target position may be guided to a position in front of the lesion or beyond the lesion.
  • the dilator tip tube 60 is removed from the guide extension catheter 10 while fixing the position of the guide wire.
  • the therapeutic catheter is passed through the lumen of the guiding catheter 100 and the guide extension catheter 10 to reach the lesion along the guidewire.
  • the operator can treat the lesion (for example, expansion with a balloon or placement of a stent) using the treatment catheter.
  • the catheter having an intermediate opening is a catheter having an intermediate opening having the distal tube 20 and the linear shaft 30 extending proximally from the distal tube 20.
  • the portion where the linear shaft 30 is embedded is the portion where the protrusion 29 is formed on the outer surface of the tip tube 20 in the cross section orthogonal to the axis of the tip tube 20, and the protrusion 29 of the tip tube 20 is formed. is greater than the thickness of tip tube 20 on the opposite side of the axis.
  • the projection 29 is formed in the portion of the tip tube 20 where the linear shaft 30 is embedded, so that only the necessary portion of the tip tube 20 is formed thick, and the entire , an increase in the outer diameter of the tip tube 20 can be suppressed. Further, by partially thickening the tip tube 20, it is not necessary to make the linear shaft 30 too thin, so that the pushing strength, the pulling strength and the torsional strength can be effectively improved.
  • the linear shaft 30 includes a base portion 31 that extends linearly, and a tip shape portion 32 that is arranged on the distal side of the base portion 31 and extends from the base portion 31 toward the distal side while bending toward the proximal side.
  • the tip tube 20 has a portion in which two projections 29 are formed in a cross section orthogonal to the axial center of the tip tube 20 .
  • the protrusion 29 can be formed corresponding to the linear shaft 30 that is bent so as to be folded back, thereby suppressing an increase in the overall thickness of the tip tube 20 and improving the pushing strength, the pulling strength, and the torsional strength. It can be improved further.
  • the tip tube 20 has, in a cross section orthogonal to the axial center of the tip tube 20, a portion where two convex portions 29 are formed and a portion where one convex portion 29' is formed.
  • the number of wires of the linear shaft 30 embedded corresponding to the convex portion 29 varies depending on the site, so that the linear shaft 30 functions as an anchor inside the tip tube 20, and push-in strength, pull-out strength, and The torsional strength can be further improved.
  • the portion where the linear shaft 70 is embedded in the tip tube 60 of the dilator 50 has a convex portion (not shown) formed on the outer surface of the tip tube 60 in a cross section orthogonal to the axis of the tip tube 60. good too. Since the convex portion creates a gap with the inner surface of the guide extension catheter 10, the contact portion is reduced and the frictional resistance is reduced, so that the slidability of the dilator 50 is improved.
  • the guide extension catheter 10 may be a guide extension catheter 10 for advancing the inner part to the periphery and arranging the treatment part provided on the treatment catheter to the lesion for treatment.
  • the guide extension catheter 10 can effectively transmit a pushing force, a pulling force, and a rotating force to the distal tube 20, and can be used during the operation. It is possible to prevent the tip tube 20 and the linear shaft 30 from being separated during the operation.
  • the treatment portion provided in the treatment catheter for treatment is, for example, a balloon or a stent.
  • the catheter having an intermediate opening protrudes from the distal end opening 101 of the guiding catheter 100 and moves along the coronary artery along the therapeutic catheter.
  • It may be a rapid exchange type dilator 50 inserted into the guide extension catheter 10 for arranging the treatment portion provided on the treatment catheter to the affected area.
  • the dilator 50 can effectively transmit the pushing force, the pulling force, and the rotational force to the dilator distal tube 60, and can be used during the operation. Separation of the dilator tip tube 60 and the dilator linear shaft 70 can be prevented.
  • the axial center of the tip shape portion 32 may be three-dimensionally arranged beyond the same plane.
  • terminal end 36 is positioned away from the plane in which intermediate straight portion 33 and semi-circular portion 34 lie.
  • the intermediate layer 25 may be arranged between the three-dimensional tip shape portion 32 of the linear shaft 30 and the reinforcing layer 24 so that the tip shape portion 32 is separated from the reinforcing layer 24 .
  • the distal end tube 20 of the guide extension catheter 10 includes a proximal end lumen 20A having a substantially uniform inner diameter, and a distal end disposed on the distal side of the proximal end lumen 20A.
  • a distal lumen 20B may be provided having a laterally tapering, decreasing inner diameter.
  • the distal end tube 20 can have the tubular portion 62 having a larger outer diameter than normal in the proximal end lumen 20A, the pushability and penetrating force of the dilator distal end tube 60 can be improved.
  • the dilator distal tube 60 of the dilator 50 may have a proximal opening 64 that tapers toward the proximal side.
  • the dilator tip tube 60 may also have a large diameter portion 65 at its proximal end that has a larger outer diameter than the distal end. The dilator 50 can be prevented from protruding too much from the guide extension catheter 10 by abutting the large diameter portion 65 against the distal end tube 20 of the guide extension catheter 10 to interfere with it.
  • the dilator tip tube 60 of the dilator 50 may have a plurality of X-ray contrast markers 66 arranged at predetermined intervals (for example, 5 mm intervals) in the axial direction. .
  • the length can be estimated based on the X-ray contrast marker 66 under X-ray fluoroscopy. Therefore, the operator can easily determine the size of the therapeutic catheter to be inserted later.
  • linear shaft 30 of the guide extension catheter 10 and the dilator linear shaft 70 of the dilator 50 may be partially or wholly different in color. As a result, it becomes easy to distinguish between the two, and the convenience of the procedure can be improved.
  • linear shaft 30 or the dilator linear shaft 70 may be coated with a lubricant such as silicon to prevent the shafts from entangling with each other.
  • guide extension catheter (catheter) 20 distal tube 21 tubular portion 22 semi-tubular portion 23 inner layer 24 reinforcing layer 25 intermediate layer 26 outer layer 27 distal marker 28 proximal marker 29, 29' convex portion 30 linear shaft 31 proximal portion 32 distal shaped portion 50 dilator (catheter) 60 dilator tip tube (tip tube) 70 dilator linear shaft (linear shaft) 90 Adhesive 100 Guiding Catheter 101 Tip Opening

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un cathéter ayant une ouverture intermédiaire, le cathéter étant capable d'améliorer la résistance à la poussée et la résistance à l'arrachement tout en supprimant une augmentation de l'épaisseur d'un tube d'extrémité distale.　Ce cathéter ayant une ouverture intermédiaire a un tube d'extrémité distale (20) et un arbre linéaire (30) s'étendant à partir du tube d'extrémité distale (20) vers le côté d'extrémité de base. La partie du tube d'extrémité distale (20) dans laquelle l'arbre linéaire (30) est incorporé forme, dans la section transversale perpendiculaire au centre axial du tube d'extrémité distale (20), une partie convexe (29) sur la surface externe du tube d'extrémité distale (20). L'épaisseur du tube d'extrémité distale (20) au niveau de la partie dans laquelle la partie convexe (29) est formée est plus grande que l'épaisseur du tube d'extrémité distale (20) opposé à ladite partie à travers le centre axial.
PCT/JP2022/001383 2021-01-20 2022-01-17 Cathéter WO2022158418A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2021-007433 2021-01-20
JP2021007433A JP2024036702A (ja) 2021-01-20 2021-01-20 カテーテル

Publications (1)

Publication Number Publication Date
WO2022158418A1 true WO2022158418A1 (fr) 2022-07-28

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PCT/JP2022/001383 WO2022158418A1 (fr) 2021-01-20 2022-01-17 Cathéter

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JP (1) JP2024036702A (fr)
WO (1) WO2022158418A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024166551A1 (fr) * 2023-02-09 2024-08-15 テルモ株式会社 Dispositif médical et son procédé de fabrication

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012135379A (ja) * 2010-12-24 2012-07-19 Nipro Corp 子カテーテル
WO2018030075A1 (fr) * 2016-08-10 2018-02-15 ニプロ株式会社 Cathéter de support.
WO2020162287A1 (fr) * 2019-02-06 2020-08-13 株式会社カネカ Cathéter prolongé, et procédé de fabrication de celui-ci

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012135379A (ja) * 2010-12-24 2012-07-19 Nipro Corp 子カテーテル
WO2018030075A1 (fr) * 2016-08-10 2018-02-15 ニプロ株式会社 Cathéter de support.
WO2020162287A1 (fr) * 2019-02-06 2020-08-13 株式会社カネカ Cathéter prolongé, et procédé de fabrication de celui-ci

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024166551A1 (fr) * 2023-02-09 2024-08-15 テルモ株式会社 Dispositif médical et son procédé de fabrication

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