WO2006126642A1 - Catheter - Google Patents

Catheter Download PDF

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Publication number
WO2006126642A1
WO2006126642A1 PCT/JP2006/310466 JP2006310466W WO2006126642A1 WO 2006126642 A1 WO2006126642 A1 WO 2006126642A1 JP 2006310466 W JP2006310466 W JP 2006310466W WO 2006126642 A1 WO2006126642 A1 WO 2006126642A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
distal
proximal
lumen
proximal end
Prior art date
Application number
PCT/JP2006/310466
Other languages
English (en)
Japanese (ja)
Inventor
Masayuki Takatera
Original Assignee
Kaneka Corporation
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 Kaneka Corporation filed Critical Kaneka Corporation
Priority to JP2007517897A priority Critical patent/JPWO2006126642A1/ja
Publication of WO2006126642A1 publication Critical patent/WO2006126642A1/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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0029—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • 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
    • A61M2025/0183—Rapid exchange or monorail catheters
    • 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
    • A61M25/0097—Catheters; Hollow probes characterised by the hub

Definitions

  • the present invention introduces or moves other vascular treatment catheters or medical devices accompanying the body, particularly peripheral blood vessels, branches in the coronary vasculature, or obstructed lesions.
  • the present invention relates to a medical catheter that can be suitably used for various functions such as introduction of a guide wire for injection, injection of a drug into a lesioned part, and use during blood pressure measurement.
  • a treatment method for expanding a stenosis or occlusion in a body passage using a medical dilatation catheter is widely known.
  • an expanded body portion of a catheter is inserted into a stenotic site via a patient's internal passage, and then a site where the stenosis or occlusion is caused by the expanded body is introduced by introducing pressure fluid therein. .
  • the catheter is a dual lumen catheter having two lumens, a monorail and an over-the-the-wire, and the mono-rail lumen opens at the tip of the catheter, and the over-the-the-wire lumen is about 5 mm from the tip. It opens on the side of the position.
  • the catheter can be introduced to the periphery beyond the lesion in the coronary artery using a monorail lumen, and on top of that, it is possible to perform some operation using an over-the-the-wire lumen. It is a function.
  • the guide wire is introduced into the branch through the over-the-wire device, the drug is reliably injected into the periphery from the lesion, and the peripheral pressure is measured from the lesion. Can be used over a wide range (Background Art Item of Patent Document 3).
  • an over-the-wire type medical dilatation catheter can be used only as a guide wire passing catheter, or a simple tube-shaped catheter with no dilator (for example, to the cerebral blood vessel) It is costly to use two angiographic micro force tapes used for injecting drug solutions for the main trunk and branch of the blood vessel branch.
  • the material used for the inner surface of the lumen of the tip member is a material with high surface friction resistance, the operability of the guide wire is poor, and fourth, when inserting the catheter into the body.
  • a metal stylet separated from the catheter must be inserted into the catheter separately, and the catheter was positioned near the bifurcation lesion Later, when the guide wire is inserted into the over-the-wire lumen, it must be removed and the operation becomes complicated.
  • Patent Document 1 Japanese Unexamined Patent Application Publication No. 2004-154195
  • Patent Document 2 Japanese Translation of Special Publication 2002-508987
  • Patent Document 3 Japanese Translation of Special Publication 2004-522525
  • the problem to be solved by the present invention is to provide a medical catheter that has excellent kink resistance, excellent track following ability, pushing force transmission ability, and guide wire operability.
  • the present invention provides the following:
  • a medical catheter comprising:
  • the distal shaft (a) is a first shaft
  • the distal end of the distal shaft is configured to increase in rigidity continuously or intermittently toward the proximal end
  • (a-1) A first portion having a distal end side opening and a proximal end side opening, which extends from the distal end portion of the distal end side shaft (a) to the proximal end portion of the distal end side shaft (a).
  • (A-2) a position force that is proximal to the distal end of the first lumen (a-1) and extends to the proximal end of the distal shaft (a), and a distal opening
  • a second lumen having a proximal opening
  • the proximal shaft (b) is
  • the proximal end portion of the second lumen (a-2) of the distal end side shaft (a) and the distal end portion of the inner tube (b-1) of the proximal end side shaft (b) are connected to the guide wire. Can be inserted, and the proximal end of the outer tube (b-2) and the proximal end of the inner tube (b-1) of the proximal shaft (b) can be inserted into the guide wire.
  • the hub (d) made of resin
  • the inner tube (b-1) and the outer tube (b-2) of the proximal shaft (b) at least over the entire length of the proximal shaft (b) Between the base material of the distal end side shaft (a) and the proximal end side shaft (b). Is fixed to the grease material at the tip of the
  • a medical catheter comprising a resin shaft that also has two section forces on the distal side and proximal side, a metal core layer, and a resin knob,
  • the tip side shaft has a dual lumen structure having a first lumen and a second lumen at least at a part thereof,
  • the first lumen extends to the proximal end side of the distal end force of the distal end shaft, and the first lumen includes a distal end opening and a proximal end opening at the distal end and the proximal end.
  • the second lumen has a proximal force at the distal end of the distal shaft over the proximal end of the distal shaft, and the second lumen has a distal opening and a proximal end at the distal end and the proximal end. Having side openings,
  • the distal shaft is configured to increase in rigidity continuously or intermittently toward the proximal end
  • the base end side shaft is coaxial with at least a portion having an inner tube and an outer tube having different diameters.
  • the inner tube is over the proximal end of the proximal shaft
  • the outer tube is over the proximal force of the proximal shaft
  • a proximal end portion of the second lumen of the distal end side shaft and a distal end portion of the inner tube of the proximal end side shaft are connected so that a guide wire can be inserted therethrough.
  • the proximal end of the outer tube and the proximal end of the inner tube are connected to the resin hub so that a guide wire can be inserted therethrough,
  • the core wire is disposed between the outer tube and the inner tube of the proximal shaft at least over the entire length of the proximal shaft to adjust the flexibility of the catheter,
  • the medical catheter is characterized in that the core wire is fixed to a proximal end portion of the distal end side shaft and a grease material of the distal end portion of the proximal end side shaft.
  • the material of the outer layer of the tip side shaft is low density polyethylene, polyamide elast
  • the material of the inner layer of the tip side shaft is at least one selected from the group consisting of high density polyethylene, polytetrafluoroethylene, and tetrafluoroethylene perfluoroalkyl vinyl ether copolymer force.
  • the medical catheter according to (2) which is formed of a material.
  • the material of the outer layer of the tip of the tip side shaft is a flexural modulus (ASTM D790,
  • the medical catheter according to (3) characterized in that it is 150 kgZcm 2 or more and 2000 kgZcm 2 or less.
  • 90, 23 ° C) is 2000 kg / cm 2 or more and lOOOOkg / cm 2 or less.
  • the material of the outer layer of the tip portion of the tip side shaft is a polyamide elastomer, the polyamide elastomer force S, a block copolymer including a hard segment and a soft segment, and the polyamide elastomer
  • the material of the outer layer other than the tip of the shaft on the tip side is a polyamide elastomer, and the polyamide elastomer also has a block copolymer force including a hard segment and a soft segment, and the polyamide elastomer
  • the central axis of the distal end portion of the second lumen is the second lumen in the radial direction of the first lumen.
  • the outer tube of the proximal end shaft is composed of a distal end portion and a proximal end portion, and the material of the distal end portion of the outer tube is lower in hardness than the material of the inner tube.
  • the outer tube is at least partially reinforced with metal
  • the distal end force of the catheter is provided with a hydrophilic coating on the proximal end side.
  • V The medical catheter according to any one of (1) to (20), characterized in that it is V.
  • the proximal shaft has a coaxial double tube structure having an inner tube and an outer tube having different diameters at least in part, and the core wire is at least By being arranged between the outer tube and the inner tube with the proximal shaft over the entire length of the proximal shaft, it has excellent kink resistance, curved path followability, pushing force transmission performance, and guide wire operability. An excellent medical catheter is provided.
  • the tip side shaft is configured to have at least two or more layers of force, so that the guide wire operability and the curve followability are further improved according to the purpose of use. be able to.
  • the operability of the guide wire can be further improved by selecting the material of the inner layer of the distal shaft as in the present invention (4).
  • the guide wire is further slippery.
  • the central axis of the distal end portion of the second lumen is curved in the radial direction of the first lumen so as to be separated from the central axial force of the first lumen.
  • the guide wire can be easily inserted into the branched blood vessel.
  • the hardness of the proximal shaft is adjusted, so that the kink resistance is excellent, the curve following ability, the pushing force transmission ability, In addition, the operability of the guide wire is further improved.
  • the core wire is easily fixed to the inner tube, the outer tube and the second lumen, the kink resistance is excellent, the curve following property, the pushing force transmitting property, and the guide Wire The operability is further improved.
  • FIG. 1 is a schematic cross-sectional view showing the overall structure of a medical catheter according to the present invention (hereinafter also simply referred to as a catheter).
  • FIG. 2 is a schematic cross-sectional view showing the distal end side shaft structure of the catheter according to the present invention.
  • FIG. 2 (b) is a cross-sectional view taken along the line II in FIG. 2 (a).
  • FIG. 3 is a schematic cross-sectional view showing the structure of the connecting portion between the distal shaft and the proximal shaft of the catheter according to the present invention.
  • Fig. 3 (b) is a cross-sectional view taken along line II-II in Fig. 3 (a)
  • Fig. 3 (c) is a cross-sectional view taken along line III-III in Fig. 3 (a).
  • FIG. 4 is a schematic cross-sectional view showing a proximal-end shaft structure of a catheter according to the present invention.
  • Fig. 4 (c) is a sectional view taken along the line IV-IV in Fig. 4 (b).
  • FIG. 5 is a schematic cross-sectional view showing the structure of the connecting portion between the proximal end shaft of the catheter according to the present invention and the resin-made nodule and bush.
  • FIG. 6 is a schematic cross-sectional view showing another example of the distal shaft structure of the catheter according to the present invention.
  • FIG. 6 (b) is a cross-sectional view taken along the line V-V in FIG. 6 (a).
  • FIG. 7 is a schematic cross-sectional view showing a state in which a guide wire protrudes from the lumen of a conventional catheter.
  • FIG. 8 is a schematic sectional view showing a state in which a guide wire protrudes from the lumen of the catheter according to the present invention.
  • FIG. 9 is a continuous diagram showing the curve following ability when the guide wire is placed in the first lumen of the medical catheter obtained in the examples and comparative examples, and the catheter is caused to follow the bent circuit. It is a graph which shows the data of a load value.
  • FIG. 10 Proximal force when the guide wire is placed in the first lumen of the medical catheter obtained in the examples and comparative examples when the catheter follows the bent circuit. It is a graph which shows the result of a load transmissibility.
  • Proximal shaft (outer tube) proximal end Proximal side
  • the tip side shaft may be formed by using a plastic tube having two or more layers of different structural forces between the inner surface of the two lumens and the outer surface of the shaft. From the viewpoint of improving the slipperiness of the guide wire by arranging a flexible material in the outer layer part of the structure to improve the curve followability and further arranging a material with low surface friction resistance in the material of the inner layer part. ,preferable. In this case, it is possible to obtain a higher track followability.
  • the proximal shaft is formed by an outer tube arranged in a coaxial double tube and an inner tube forming a lumen through which the guide wire passes, thereby improving the operability of the guide wire.
  • the base end portion of the outer tube is made of polyimide resin, particularly when a part of the polyimide resin is reinforced with metal, it is possible to obtain high indentation force transmission.
  • a taper-shaped metal core wire having an outer diameter that increases from the distal end side to the proximal end side is disposed between the outer tube and the inner tube on the proximal end shaft over the entire length of the proximal end shaft.
  • further kink resistance and pushing force transmission can be improved.
  • the metal core wire into the shaft, it is possible to eliminate the trouble of attaching and detaching a metal stylet that has been used in the past, and to prevent the troublesome operation of a conventional commercial product.
  • the entire catheter is configured so that the rigidity increases continuously or intermittently from the distal end side toward the proximal end side. Backing up the guide wire can be facilitated by balancing the contradictory properties of the guide wire.
  • a central axial force at the distal end of the second lumen is provided with a curved portion in the radial direction of the first lumen so that the central axial force of the first lumen is also separated.
  • a guide wire is inserted into the lumen in the distal direction from the proximal end of the catheter proximal end opening and advanced, and when the distal end of the guide wire protrudes from the distal opening, it is inclined by the curved portion. Deflection and protruding.
  • the structure provided with the curved portion makes it easy to introduce a guide wire into the branch as well as the main force of the branch lesion.
  • a hydrophilic coating is applied to the polyimide tube portion of the proximal end portion of the proximal end shaft of the catheter to reduce contact with the inner surface of the blood vessel, thereby further improving the curve following ability.
  • the catheter body is composed of a resin shaft having two section forces, a distal shaft 1 and a proximal shaft 2, a metal core wire 3, and a proximal shaft 2. It consists of a resin hub 4 connected to the base end of
  • the proximal side means the direction in which the hub is attached to the catheter
  • the distal direction means the direction opposite to the proximal direction.
  • the distal shaft 1 has a dual lumen structure having a first lumen 5 and a second lumen 6 as shown in FIGS.
  • the first lumen 5 is provided with a distal end opening 8 at the most distal end 7 of the distal shaft 1 and extends to the proximal opening 9 formed in the middle of the distal shaft 1 toward the proximal end.
  • the second lumen 6 includes a distal end opening 10 at a position closer to the proximal end than the distal opening 8 of the first lumen 5, and extends from there to the proximal end of the distal shaft 1.
  • the distal end side shaft has at least part of the first lumen and the second lumen when the distal end opening 8 of the first lumen 5 and the distal opening 10 of the second lumen 6 are A configuration in which the shaft does not have the same cross-sectional shape, in particular, the distal end opening 8 of the first lumen 5 is disposed on the distal end side of the shaft, and the distal end opening 10 of the second lumen 5 is first in cross section. Shows a configuration that is formed in a slanted shape facing the end direction, and it is possible to prevent the guide wire from becoming trapped and to improve the followability when inserting the catheter (preventing scratching). There is an advantage that can be made.
  • the cross section of the tip opening part of the first lumen and the second lumen may be on the same plane.
  • the first lumen is a lumen for introducing a catheter
  • the second lumen is for introducing a guide wire, or for introducing a device used for various purposes such as drug injection, a removable coil, or pressure measurement.
  • This is a so-called lumen for multi-function catheters. Therefore, the diameters of these lumens may be within a known range depending on the respective use. The purpose of use of these lumens can be changed based on technical matters well known to those skilled in the art.
  • the front shaft 1 is composed of inner layers 11 and 12 that form the inner surfaces of the two lumens of the first lumen 5 and the second lumen 6, and the outer layer 13 of the shaft, and these layers also have different plastic material forces.
  • the outer layer 13 should be made of a material that is more flexible than the material that forms the inner layers 11 and 12! /, Characterized by that!
  • the material of the outer layer 13 portion of the distal shaft is not particularly limited as long as it is a resin. Specifically, nylon, polyamide elastomer, polyester, polyester elastomer, polyurethane elastomer, polyolefin, polyimide, polyimide Examples thereof include amide and polyetherimide resin materials. Among these, it is preferable that the material is formed of at least one material selected from the group consisting of low density polyethylene, polyamide elastomer and polyamide.
  • the distal shaft 1 is intermittently rigid with the distal end 14, the intermediate portion 15, and the proximal end 16 from the distal end toward the proximal end (hand side). ( Figures 2 and 3). Further, the distal end shaft may be manufactured by means of switching extrusion molding well known to those skilled in the art, and the distal end force may be continuously increased in rigidity toward the proximal end side.
  • the rigidity of the distal shaft indicates the rigidity of the outer layer portion of the distal shaft, and is evaluated by, for example, the flexural modulus.
  • the flexural modulus (ASTM D790, 23 ° C, the same shall apply hereinafter) of the outer layer material of the tip 14 of the tip side shaft 1 is preferably 150 kgZcm 2 or more and 2000 kgZcm 2 or less. Ri preferably about lOOOkgZcm 2. Further, the flexural modulus of the outer layer portion material other than the tip portion 14 from the intermediate portion 15 to the base end portion 16 is preferably 2000 kgZcm 2 or more and 10 OOOkg / cm 2 or less, more preferably 2000 to It is 5000 kg / cm 2 , and the base end 16 is about lOOOOkgZcm 2 .
  • the polyamide elastomer when the material forming the outer layer 13 portion of the shaft is a polyamide elastomer, the polyamide elastomer preferably has a block copolymer power including a hard segment and a soft segment. More preferably, the proportion of the soft segment in the polyamide elastomer at the distal end portion 14 is 10 wt% or more and 30 wt% or less, and the intermediate portion 15 and the base end portion 16 are 10 wt% or less. In a particularly preferred embodiment, according to the NMR spectrum analysis of the polyamide elastomer used for the distal end portion 14 and the proximal end portion 16, the hard / soft segment ratio was calculated. The weight ratio of part 16 was 83Z17.
  • the material of the tip side shaft inner layers 11 and 12 is not particularly limited.
  • the force is preferably a high-strength polyethylene, polytetrafluoroethylene, and tetrafluoroethylene perfluoroalkyl butyl ether.
  • One or more materials selected from polymers more preferably a flexural modulus of 5000 kgZcm 2 or more and 15000 kgZcm 2 or less, most preferably a material having a flexural modulus higher than the outer layer 13 of the shaft, for example, , the scope of 11000 ⁇ 14000kg / cm 2, preferably ⁇ or, 12500kg / cm 2 force ⁇ good! ⁇ .
  • the distal shaft inner layer or the proximal shaft inner tube is made of a resin material with a high degree of lubrication with respect to a guide wire having a surface energy of 50 dynZcm or less, specifically, a polyolefin-based bottle containing polyethylene is used. It is preferable that the oil material or the fluorine-based resin material is manufactured.
  • the rough surface with fine unevenness means a state in which the frictional resistance is lowered and the slip property is improved, and in this way, making the “rough surface with fine unevenness” This can be achieved by a lumen manufacturing method well known to those skilled in the art.
  • the tip side shaft is composed of an inner layer and an outer layer having a lumen as described above. It is also preferred that the force is composed of 2 or 3 layers or more.
  • the inner layer is made of polyamide elastomer (product name: PEBAX (manufactured by ARKEMA)), the intermediate layer between the inner layer and the outer tank is low density polyethylene, and the outer layer is high density polyethylene. Can be adopted.
  • X-ray opaque marker of gold or platinum for the purpose of confirming the position of the tip of the catheter by X-ray contrast in the form of covering the outer layer 13 on the inner layer 11 at the position of the most advanced portion 7. 17 may be fixed.
  • the outer layer 13 covers the outer periphery of the shaft on the inner layer 12 and is semi-circular X-ray opaque. It is preferable that the marker 18 is fixed. This is to easily confirm the positional relationship when a guide wire is introduced into the main force branch of the bifurcation lesion during surgery.
  • the number of radiopaque markers is not particularly limited, and may be 1 or 2 or more.
  • the guide shaft is operated by curving the central axis of the distal end portion of the second lumen so as to be separated from the central axis of the first lumen in the radial direction of the first lumen. It can be made more excellent in properties. Specifically, as shown in FIG.
  • the proximal shaft 2 has an outer tube 19 and an inner tube 20 having different diameters at least partially, and these are coaxial double tube structures. I'm stuck.
  • the inner tube 20 and the outer tube 19 extend from the distal end of the proximal shaft 2 to the proximal end, and in the example of this figure, the inner tube 20 is disposed in the outer tube 19 longer than the entire length of the outer tube 19. .
  • the total length of the inner tube and the total length of the outer tube may be set to be substantially the same length.
  • the distal end 22 of the proximal shaft 2 is connected to the proximal end 21 of the distal shaft 1, where the proximal end 23 of the inner layer 12 of the second lumen 6 of the distal shaft 1 and the inner tube are connected. It is also connected to the tip 24 of the 20.
  • the base end 25 of the outer pipe 19 and the base end 26 of the inner pipe 20 are connected to the front end 27 of the resin hub 4 so that the inner pipe 20 protrudes to the base end side. It communicates with the wire port 28 of the resin knob 4. Therefore, the guide wire can be passed through the inner tube 20 from the wire port portion 28 of the resin knob 4.
  • the outer tube 19 includes a distal end portion 29 that is a distal end portion and a proximal end portion 30 that is a proximal end portion.
  • the inner diameter is expanded from the tip side 32 reduced in diameter from the outer diameter, and they are fixed in an overlapping manner.
  • the material of the distal end portion 29 of the outer tube 19 include nylon, polyamide elastomer, polyester, polyester elastomer, polyurethane elastomer, polyolefin, and the like.
  • the flexural modulus of the material of the tip portion 29 is 3500 kgZcm 2 or more and 1200 OkgZcm 2 or less. More preferably, the material strength at the distal end portion 29 of the outer tube 19 should be lower than the material of the inner tube 20.
  • the base end 30 of the outer tube 19 is made of polyimide resin! /, In which case the length may be set to about 1000 to 1200 mm! /.
  • At least a part of the outer tube is reinforced with metal in order to obtain a higher indentation force transmission ability by applying a larger load in the direction toward the distal end. May be.
  • a metal body 33 such as a cache or a coil
  • the material of the inner tube 20 can be formed of polyethylene.
  • the inner tube 20 and the outer tube 19 can be heat-welded in a state where a material compatible with both materials is disposed at the position of the distal end portion 22 of the proximal end side shaft 2. Or glue between them It is preferable that the heat-welded with the modified polyethylene.
  • the metal core wire 3 is disposed over the entire length of the proximal shaft in the space 34 between the outer tube 19 and the inner tube 20 disposed concentrically.
  • the flexibility of the catheter can be adjusted.
  • the metal component constituting the metal core wire include stainless steel, nickel titanium, cobalt chrome, and the like.
  • the metal core wire 3 is located from the proximal end portion 30 of the proximal end side shaft 2 to the proximal end portion 21 of the distal end side shaft 1.
  • the outer diameter of the metal core wire 3 can have a tapered shape that increases from the distal end 35 toward the proximal end.
  • the metal core wire 3 is made of a shaft grease material (base end and base end of the distal shaft) at the position of the proximal end 21 of the distal shaft 1 and the distal end 22 of the proximal shaft 2. It is fixed in the form of embedding in the grease material at the tip of the side shaft.
  • the entire catheter is configured so that the rigidity is intermittently increased toward the proximal end side from the distal end side force by these configurations, thereby satisfying the contradictory properties of pushing force transmission and curved path followability.
  • the guide wire can be easily backed up.
  • the specific configuration, size, and appearance of the distal shaft, proximal shaft, metal core wire, and resin knob depend on the use of the catheter. Set as appropriate.
  • the medical catheter of the present invention has at least a hydrophilic coating on the distal end portion of the catheter.
  • the hydrophilic coating is composed of polyacrylamide copolymer and polybutyropyrrolidone copolymer having photoreactive functional groups, photoreactive quaternary ammonium salt as a cross-linking material, and polyvinylpyrrolidone, and contains the above coating agent. More preferably, the coating is applied by dipping the catheter into the solution, air drying, and curing by UV irradiation. In terms of efficacy, it exhibits wettability with the catheter inserted into the blood vessel, and plays a role in improving the operability and passage of the catheter.
  • the scope of coating extends to the polyimide part of the proximal shaft 2, which is the proximal side of the catheter, especially when it is used in the blood vessels of the coronary arteries. To show its effect.
  • the coating range extends to the entire tip side shaft portion.
  • the tip shaft is divided into three portions in the length direction, and polyamide elastomers having different hardnesses are arranged in the outer layer, and high-density polyethylene is arranged in the inner layer. .
  • the length, inner / outer diameter, and outer layer hardness of each part are as shown in Table 1.
  • the comparative example is a configuration in which the shaft tip has only a single hardness of a polyamide elastomer, and the outer diameter is changed in each part.
  • the examples and comparative examples are The same.
  • Items for confirming the effects of the invention include a curved path following ability and a pushing force transmitting ability.
  • the measurement methods for each performance are described below.
  • These performances are evaluated by our evaluation device, which is a model that simulates the aortic arch and coronary vascular runway in the body, placed in a water tank section and a simulation circuit so that it is kept at 37 ° C in water. It consists of a control unit that combines a slider with a load meter to perform a certain fixed operation, a control box that activates the input program, and a personal computer that records the load transmitted to the hand side.
  • a guide wire is placed in a simulated circuit of a coronary artery blood vessel (here, L CX: Left CircumflexArtery), and the guide wire is passed through the wire lumen of the catheter to be constant.
  • the load received on the hand side when it was pushed in at a speed of was recorded.
  • For pushing force transmission set the catheter in the aortic arch model of the same evaluation device, connect it to the load meter at the catheter tip and hand part, and apply it at the tip and hand when pushed for a certain length from the hand direction.
  • Table 1 shows the results of comparing the load value in the three-point bending test and the outer diameter and length of each part of the tip end shaft as a contrast between the change in outer diameter and the continuity of bending rigidity.
  • Figures 9 and 10 show the data of continuous load values indicating the track following ability when following, and the data of load transfer rate from the base end to the tip.
  • the object of the present invention is good.
  • a catheter that achieves the purpose of knock-up of the guide wire with both push force transmission and curved path follow-up characteristics has been realized.

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  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un cathéter médical muni d'une tige en résine comportant deux sections, dont une tige distale et une tige proximale, un fil à noyau métallique, et un embout en résine. La tige distale est construite de façon à ce que sa rigidité augmente depuis son extrémité distale vers son extrémité proximale, et est formée dans une structure à double lumière comportant une première lumière de l'extrémité distale à l'extrémité proximale de la tige distale et une deuxième lumière d’un endroit situé plus près du côté de l'extrémité proximale que de l'extrémité distale de la première lumière à l'extrémité proximale de l'extrémité proximale de la tige distale. La tige proximale est formée dans une structure de tube double coaxial ayant, de l'extrémité distale à l'extrémité proximale de la tige proximale, un tube intérieur et un tube extérieur. L'extrémité proximale de la deuxième lumière de la tige distale et l'extrémité distale du tube intérieur de la tige proximale sont raccordées de façon à pouvoir y insérer un fil guide, et l'extrémité proximale du tube extérieur ainsi que l'extrémité proximale du tube intérieur de la tige proximale sont raccordées à l'embout en résine de façon à pouvoir y insérer le fil guide. Le fil à noyau métallique est placé entre le tube intérieur et le tube extérieur, sur toute la longueur de la tige proximale, et est fixé à un matériau en résine de l'extrémité proximale de la tige distale et à un matériau en résine de l'extrémité distale de la tige proximale.
PCT/JP2006/310466 2005-05-26 2006-05-25 Catheter WO2006126642A1 (fr)

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JP2007517897A JPWO2006126642A1 (ja) 2005-05-26 2006-05-25 カテーテル

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JP2005-154032 2005-05-26
JP2005154032 2005-05-26

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WO2006126642A1 true WO2006126642A1 (fr) 2006-11-30

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PCT/JP2006/310466 WO2006126642A1 (fr) 2005-05-26 2006-05-25 Catheter

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JP (1) JPWO2006126642A1 (fr)
TW (1) TW200706199A (fr)
WO (1) WO2006126642A1 (fr)

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JP2008264134A (ja) * 2007-04-18 2008-11-06 Kaneka Corp バルーンカテーテル
JP2009082566A (ja) * 2007-10-01 2009-04-23 Kaneka Corp カテーテル
JP2012024478A (ja) * 2010-07-27 2012-02-09 Kaneka Corp ステントデリバリーシステム
EP2441482A1 (fr) * 2010-09-24 2012-04-18 Tyco Healthcare Group LP Cathéter de dialyse
JP2012231969A (ja) * 2011-05-02 2012-11-29 Nipro Corp ダブルルーメンダイレータ
JP2013138789A (ja) * 2012-01-05 2013-07-18 Goodman Co Ltd カテーテル及びカテーテルの製造方法
WO2013111774A1 (fr) * 2012-01-26 2013-08-01 日本ライフライン株式会社 Cathéter à ballonnet
EP2910273A1 (fr) 2014-02-24 2015-08-26 Asahi Intecc Co., Ltd. Cathéter
EP2944344A1 (fr) 2014-05-13 2015-11-18 Asahi Intecc Co., Ltd. Cathéter
EP2979721A1 (fr) 2014-07-29 2016-02-03 Asahi Intecc Co., Ltd. Cathéter
JP2016116926A (ja) * 2016-02-23 2016-06-30 ニプロ株式会社 ダブルルーメンダイレータ
JP2018020168A (ja) * 2017-09-29 2018-02-08 朝日インテック株式会社 カテーテル
CN107802939A (zh) * 2016-09-08 2018-03-16 先健科技(深圳)有限公司 双腔造影导管
WO2018079083A1 (fr) * 2016-10-27 2018-05-03 株式会社カネカ Ensemble cathéter et récipient
WO2018083905A1 (fr) * 2016-11-01 2018-05-11 株式会社カネカ Cathéter et ensemble cathéter
JP2019063002A (ja) * 2017-09-28 2019-04-25 株式会社カネカ カテーテル
CN110273188A (zh) * 2018-03-15 2019-09-24 北京普益盛济科技有限公司 一种快速制作介入医学微导管管体的方法
JP2020114421A (ja) * 2014-09-04 2020-07-30 シルク・ロード・メディカル・インコーポレイテッドＳｉｌｋ Ｒｏａｄ Ｍｅｄｉｃａｌ， Ｉｎｃ． 経頸動脈アクセスのための方法およびデバイス
JP2020199113A (ja) * 2019-06-11 2020-12-17 株式会社東海メディカルプロダクツ カテーテル
WO2020255737A1 (fr) * 2019-06-19 2020-12-24 株式会社カネカ Cathéter
US11103627B2 (en) 2008-12-23 2021-08-31 Silk Road Medical, Inc. Methods and systems for treatment of acute ischemic stroke
US11291799B2 (en) 2013-12-23 2022-04-05 Silk Road Medical, Inc. Transcarotid neurovascular catheter
CN114939225A (zh) * 2022-06-10 2022-08-26 惠州市顺美医疗科技有限公司 一种球囊扩张导管
WO2024035786A1 (fr) * 2022-08-12 2024-02-15 Boston Scientific Scimed, Inc. Cathéter à port de fil-guide à échange rapide et procédé de fabrication
EP4335479A1 (fr) * 2022-09-07 2024-03-13 Asahi Intecc Co., Ltd. Cathéter
WO2024084745A1 (fr) * 2022-10-18 2024-04-25 朝日インテック株式会社 Cathéter à ballonnet

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CN112386780A (zh) * 2019-08-16 2021-02-23 上海交通大学医学院附属瑞金医院 双腔微导管

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS58218966A (ja) * 1982-06-04 1983-12-20 マリンクロツド・インコ−ポレイテツド 薬剤供給用血管カテ−テルおよびその製造法
JPH0857035A (ja) * 1994-08-24 1996-03-05 Terumo Corp カテーテルチューブおよびその製造方法
JPH09507391A (ja) * 1991-07-24 1997-07-29 アドヴァンスト・カーディオヴァスキュラー・システムズ・インコーポレイテッド 低プロフィール灌流形式拡張カテーテル
JP2002282349A (ja) * 2001-03-28 2002-10-02 Nippon Zeon Co Ltd 潤滑性医療用器具及びその製造方法
JP2003517901A (ja) * 1999-12-21 2003-06-03 アドヴァンスト カーディオヴァスキュラー システムズ インコーポレーテッド 支持マンドレルを備えた高速交換カテーテル
JP2004130110A (ja) * 2002-08-27 2004-04-30 Terumo Corp カテーテル

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS58218966A (ja) * 1982-06-04 1983-12-20 マリンクロツド・インコ−ポレイテツド 薬剤供給用血管カテ−テルおよびその製造法
JPH09507391A (ja) * 1991-07-24 1997-07-29 アドヴァンスト・カーディオヴァスキュラー・システムズ・インコーポレイテッド 低プロフィール灌流形式拡張カテーテル
JPH0857035A (ja) * 1994-08-24 1996-03-05 Terumo Corp カテーテルチューブおよびその製造方法
JP2003517901A (ja) * 1999-12-21 2003-06-03 アドヴァンスト カーディオヴァスキュラー システムズ インコーポレーテッド 支持マンドレルを備えた高速交換カテーテル
JP2002282349A (ja) * 2001-03-28 2002-10-02 Nippon Zeon Co Ltd 潤滑性医療用器具及びその製造方法
JP2004130110A (ja) * 2002-08-27 2004-04-30 Terumo Corp カテーテル

Cited By (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008264134A (ja) * 2007-04-18 2008-11-06 Kaneka Corp バルーンカテーテル
JP2009082566A (ja) * 2007-10-01 2009-04-23 Kaneka Corp カテーテル
US11654222B2 (en) 2008-12-23 2023-05-23 Silk Road Medical, Inc. Methods and systems for treatment of acute ischemic stroke
US11103627B2 (en) 2008-12-23 2021-08-31 Silk Road Medical, Inc. Methods and systems for treatment of acute ischemic stroke
JP2012024478A (ja) * 2010-07-27 2012-02-09 Kaneka Corp ステントデリバリーシステム
EP2441482A1 (fr) * 2010-09-24 2012-04-18 Tyco Healthcare Group LP Cathéter de dialyse
US8876752B2 (en) 2010-09-24 2014-11-04 Covidien Lp Dialysis catheter
JP2012231969A (ja) * 2011-05-02 2012-11-29 Nipro Corp ダブルルーメンダイレータ
JP2013138789A (ja) * 2012-01-05 2013-07-18 Goodman Co Ltd カテーテル及びカテーテルの製造方法
WO2013111774A1 (fr) * 2012-01-26 2013-08-01 日本ライフライン株式会社 Cathéter à ballonnet
JP2013150747A (ja) * 2012-01-26 2013-08-08 Japan Lifeline Co Ltd バルーンカテーテル
US11291799B2 (en) 2013-12-23 2022-04-05 Silk Road Medical, Inc. Transcarotid neurovascular catheter
EP2910273A1 (fr) 2014-02-24 2015-08-26 Asahi Intecc Co., Ltd. Cathéter
US9446217B2 (en) 2014-02-24 2016-09-20 Asahi Intecc Co., Ltd. Catheter
EP2944344A1 (fr) 2014-05-13 2015-11-18 Asahi Intecc Co., Ltd. Cathéter
US10363391B2 (en) 2014-07-29 2019-07-30 Asahi Intecc Co., Ltd. Catheter
US9919128B2 (en) 2014-07-29 2018-03-20 Asahi Intecc Co., Ltd. Catheter
EP2979721A1 (fr) 2014-07-29 2016-02-03 Asahi Intecc Co., Ltd. Cathéter
JP6995914B2 (ja) 2014-09-04 2022-01-17 シルク・ロード・メディカル・インコーポレイテッド 経頸動脈アクセスのための方法およびデバイス
US11759613B2 (en) 2014-09-04 2023-09-19 Silk Road Medical, Inc. Methods and devices for transcarotid access
JP2022033972A (ja) * 2014-09-04 2022-03-02 シルク・ロード・メディカル・インコーポレイテッド 経頸動脈アクセスのための方法およびデバイス
CN112545591A (zh) * 2014-09-04 2021-03-26 丝绸之路医药公司 用于经颈动脉进入的方法和装置
JP7331076B2 (ja) 2014-09-04 2023-08-22 シルク・ロード・メディカル・インコーポレイテッド 経頸動脈アクセスのための方法およびデバイス
JP2020114421A (ja) * 2014-09-04 2020-07-30 シルク・ロード・メディカル・インコーポレイテッドＳｉｌｋ Ｒｏａｄ Ｍｅｄｉｃａｌ， Ｉｎｃ． 経頸動脈アクセスのための方法およびデバイス
JP2016116926A (ja) * 2016-02-23 2016-06-30 ニプロ株式会社 ダブルルーメンダイレータ
CN107802939A (zh) * 2016-09-08 2018-03-16 先健科技(深圳)有限公司 双腔造影导管
WO2018079083A1 (fr) * 2016-10-27 2018-05-03 株式会社カネカ Ensemble cathéter et récipient
WO2018083905A1 (fr) * 2016-11-01 2018-05-11 株式会社カネカ Cathéter et ensemble cathéter
JPWO2018083905A1 (ja) * 2016-11-01 2019-09-19 株式会社カネカ カテーテル及びカテーテル組み立て体
JP7018398B2 (ja) 2016-11-01 2022-02-10 株式会社カネカ カテーテル及びカテーテル組み立て体
JP2019063002A (ja) * 2017-09-28 2019-04-25 株式会社カネカ カテーテル
JP7013186B2 (ja) 2017-09-28 2022-01-31 株式会社カネカ カテーテル
JP2018020168A (ja) * 2017-09-29 2018-02-08 朝日インテック株式会社 カテーテル
CN110273188A (zh) * 2018-03-15 2019-09-24 北京普益盛济科技有限公司 一种快速制作介入医学微导管管体的方法
JP2020199113A (ja) * 2019-06-11 2020-12-17 株式会社東海メディカルプロダクツ カテーテル
CN113993569A (zh) * 2019-06-19 2022-01-28 株式会社钟化 导管
WO2020255737A1 (fr) * 2019-06-19 2020-12-24 株式会社カネカ Cathéter
JP7498709B2 (ja) 2019-06-19 2024-06-12 株式会社カネカ カテーテル
CN114939225A (zh) * 2022-06-10 2022-08-26 惠州市顺美医疗科技有限公司 一种球囊扩张导管
WO2024035786A1 (fr) * 2022-08-12 2024-02-15 Boston Scientific Scimed, Inc. Cathéter à port de fil-guide à échange rapide et procédé de fabrication
EP4335479A1 (fr) * 2022-09-07 2024-03-13 Asahi Intecc Co., Ltd. Cathéter
WO2024084745A1 (fr) * 2022-10-18 2024-04-25 朝日インテック株式会社 Cathéter à ballonnet

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