WO2017104465A1 - Cathéter et procédé de fabrication associé - Google Patents

Cathéter et procédé de fabrication associé Download PDF

Info

Publication number
WO2017104465A1
WO2017104465A1 PCT/JP2016/086063 JP2016086063W WO2017104465A1 WO 2017104465 A1 WO2017104465 A1 WO 2017104465A1 JP 2016086063 W JP2016086063 W JP 2016086063W WO 2017104465 A1 WO2017104465 A1 WO 2017104465A1
Authority
WO
WIPO (PCT)
Prior art keywords
marker
diameter portion
inner layer
small
reinforcing body
Prior art date
Application number
PCT/JP2016/086063
Other languages
English (en)
Japanese (ja)
Inventor
黒澤知兼
澤田明
伊藤隆史
久保田麻紀
寺沼政幸
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 WO2017104465A1 publication Critical patent/WO2017104465A1/fr

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes

Definitions

  • the present invention relates to a catheter used in a lumen such as a blood vessel and a manufacturing method thereof.
  • catheters that are selectively introduced into complex branched blood vessels in the body are typically selectively pushed along a guide wire that is pre-introduced into the blood vessel to provide therapeutic drugs and diagnostics.
  • the contrast agent for use is distributed from the proximal side (base end side) to the distal end side.
  • the catheter is provided with a radiopaque marker so that the position in the lumen can be recognized from outside the body.
  • a radiopaque marker so that the position in the lumen can be recognized from outside the body.
  • the catheter described in Patent Document 1 is formed to be thin so that it can be inserted into a blood vessel or the like, but a reinforcing body is provided inside to ensure pushability.
  • a marker is disposed between the inner layer and the outer layer of the distal end portion without providing a reinforcing body.
  • the marker in order to place the marker in the region where the reinforcing body is provided, the marker is placed on the outside of the reinforcing body in a state where the reinforcing body is placed on the outside of the inner layer, and the marker is swaged, adhered, fused, etc.
  • a method of temporarily fixing by a method and forming an outer layer on the outer side can be considered. In this method, since the marker is embedded inside the catheter, the marker can be prevented from falling off.
  • the outer layer is formed by extrusion molding on the outer side of the inner layer, the reinforcing body, and the marker, the marker may be washed away due to strong resistance by the molten resin having viscosity, and the position may be shifted.
  • a long member composed of an inner layer, a reinforcing body and a marker in the manufacturing process is covered with a tube body serving as an outer layer from the axial direction, and further, the outside is covered with a heat shrinkable tube and heated, thereby being softened by heating.
  • a method of forming the outer layer by bringing the tube into close contact with the inner layer, the reinforcing body and the marker by the contraction force of the heat-shrinkable tube is also conceivable. However, this method is complicated and inefficient.
  • the present invention has been made to solve the above-described problems, and provides a catheter that can appropriately arrange an X-ray impermeable marker on the outside of a reinforcing body and can be efficiently manufactured, and a method for manufacturing the same.
  • the purpose is to do.
  • a catheter that achieves the above object has an inner layer formed of a resin material and having a lumen therein, and a small-diameter portion that is formed in a tubular shape by a wire disposed on the radially outer side of the inner layer and partially has a small outer diameter.
  • a reinforcing body having, a marker having an X-ray contrast property arranged so as to enter the small diameter portion from the outside in the radial direction, an outer layer formed of a resin material and arranged on the outside in the radial direction of the inner layer and the reinforcing body, Have
  • a catheter manufacturing method that achieves the above object is a method for manufacturing a catheter that can be inserted into a living body lumen, the step of forming an inner layer having a lumen therein with a resin material, and a radially outer side of the inner layer.
  • the catheter configured as described above is arranged with the marker entering the small diameter portion of the reinforcing body, the marker can be arranged at an appropriate position without being displaced and can be efficiently manufactured.
  • the depth of the small diameter part may be half or more of the thickness in the radial direction of the marker. Thereby, half or more of the thickness of the marker can be accommodated in the small-diameter portion, the marker becomes difficult to drop off from the small-diameter portion, and the marker can be arranged at an appropriate position of the reinforcing body.
  • the depth of the small diameter portion may be equal to or greater than the thickness of the marker in the radial direction.
  • the depth of the small diameter portion may be half or more of the outer diameter of the wire constituting the reinforcing body.
  • an interval between adjacent wires may be locally widened in the small diameter portion. Accordingly, the reinforcing body becomes flexible at the small diameter portion, and it becomes easy to dispose the marker so that the marker enters the small diameter portion from the outside in the radial direction.
  • the outer diameter of the wire may be locally thinned at the small diameter portion. Accordingly, the reinforcing body becomes flexible at the small diameter portion, and it becomes easy to dispose the marker so that the marker enters the small diameter portion from the outside in the radial direction.
  • the outer layer may have a uniform outer diameter in the axial direction including the marker and the distal end side and the proximal end side of the marker.
  • an outer layer is formed of a resin material on the outside in the radial direction of the inner layer and the reinforcing body. Therefore, the marker can be arranged at an appropriate position without displacement and can be manufactured efficiently.
  • the inner layer may be formed by coating a resin material on the outside of the core wire.
  • the step of arranging the marker may be performed after the step of forming the small diameter portion. Thereby, after forming a small diameter part reliably, a marker can be arrange
  • the step of placing the marker simultaneously with the step of forming the small diameter portion may be performed by forming the small diameter portion on the reinforcing body by pressing with the marker.
  • the portion of the inner layer where the small-diameter portion is disposed may be locally flexible. Thereby, an inner layer becomes easy to deform
  • the outer diameter of the outer layer in the axial range including the marker and the distal end side and the proximal end side of the marker may be uniform.
  • the outer peripheral surface of a catheter can be formed smoothly and the passage property in a living body lumen improves.
  • FIG. 1 It is a top view which shows the catheter which concerns on embodiment. It is sectional drawing which shows the front-end
  • (A) is the state which covered the tubular body and the heat-shrinkable tube on the outer side of a reinforcement
  • (B) is shrinking
  • the state in which the outer layer is formed is shown.
  • It is a top view which shows the state which formed the small diameter part simultaneously by installing a marker.
  • the catheter 1 As shown in FIG. 1, the catheter 1 according to the present embodiment is inserted into a blood vessel, bile duct, trachea, esophagus, urethra, or other living body lumen or body cavity and used for treatment, diagnosis, or the like.
  • the catheter 1 includes a long catheter shaft 2, a hub 3 connected to the proximal end of the catheter shaft 2, and a kink protector 4 provided at a connection portion of the catheter shaft 2 and the hub 3.
  • the side to be inserted into the lumen is referred to as “tip” or “tip side”
  • the proximal side to be operated is referred to as “base end” or “base end side”.
  • the catheter shaft 2 is a flexible tubular member as shown in FIGS. 1 and 2, and a lumen 5 is formed inside from the proximal end to the distal end.
  • the lumen 5 is inserted with a guide wire when the catheter 1 is inserted into the living body lumen.
  • the lumen 5 can also be used as a passage for a chemical solution, an embolic material, a contrast medium, a medical instrument, or the like.
  • the catheter shaft 2 is composed of a plurality of layers, an inner layer 10 constituting the innermost layer, a reinforcing body 20 formed on the outer side of the inner layer 10, and a marker 30 arranged on the outer side in the radial direction of the reinforcing body 20 And the outer layer 40 formed on the outer side of the inner layer 10 and the reinforcing body 20.
  • the inner layer 10 has a lumen 5 formed therein.
  • a thermoplastic resin, a thermosetting resin, or the like can be applied, and a low friction material such as a fluorine-based resin or high-density polyethylene (HDPE) is preferable.
  • HDPE high-density polyethylene
  • the reinforcing body 20 is formed in a tubular shape by continuously winding the wire 21 around the outer periphery of the inner layer 10 with a braid having a predetermined interstitial distance.
  • the reinforcing body 20 is formed with a small-diameter portion 22 having a small outer diameter locally in order to arrange the marker 30.
  • the axial length of the small diameter portion 22 is preferably equal to or longer than the axial length of the marker 30 so that the marker 30 can be accommodated.
  • the reinforcing body 20 may wind the wire while changing the winding direction, such as horizontal winding in the same direction, right winding, left winding, etc., and the winding pitch, interstitial distance, inclination angle with respect to the circumferential direction, etc. are changed depending on the position.
  • the configuration is not particularly limited.
  • a metal wire such as stainless steel, platinum (Pt) / tungsten (W), resin fiber, carbon fiber, glass fiber, or the like can be applied, or a plurality of these wire materials can be used in combination. Also good.
  • the marker 30 is a member having an X-ray contrast property (X-ray impermeability) that enters the small diameter portion 22 from the outside in the radial direction.
  • the marker 30 is arranged by winding a wire 31 formed of a material containing a radiopaque substance around the small-diameter portion 22 from the outside in the radial direction of the inner layer 10.
  • the constituent material of the marker 30 is preferably a material kneaded with an X-ray contrast agent such as platinum, gold, silver, tungsten, or an alloy thereof, barium sulfate, bismuth oxide, or a coupling compound thereof. it can.
  • the outer diameter of the wire constituting the marker 30 is, for example, about 30 to 50 ⁇ m, but is not particularly limited as long as it has radiopacity.
  • the outer layer 40 is a tubular member that covers the outer periphery of the inner layer 10, the reinforcing body 20, and the marker 30.
  • the constituent material of the outer layer 40 is, for example, polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, A thermosetting resin such as a thermoplastic resin such as a polyamide, a polyester elastomer, a polyamide elastomer, a polyurethane, a polyurethane elastomer, a polyimide, a polymer material such as a fluorine resin, or a mixture thereof, or an epoxy resin can be applied.
  • the outer layer 40 may be mixed with a radiopaque material.
  • the hub 3 has a proximal end portion of the catheter shaft 2 fixed in a liquid-tight manner by an adhesive, heat fusion, a stopper (not shown) or the like.
  • the hub 3 functions as an insertion port for a guide wire or a medical instrument into the lumen 5, an injection port for a drug solution, an embolic material, a contrast medium, or the like into the lumen 5, and a grip portion for operating the catheter 1. Also works.
  • the constituent material of the hub 3 is not particularly limited.
  • a thermoplastic resin such as polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer can be preferably used.
  • the kink protector 4 is made of an elastic material provided so as to surround the periphery of the catheter shaft 2, and suppresses the kink of the catheter shaft 2 at the connection portion between the catheter shaft 2 and the hub 3.
  • a constituent material of the kink protector 4 for example, natural rubber, silicone resin, or the like can be preferably used.
  • a long core wire 50 having an outer diameter equal to the inner diameter of the inner layer 10 is prepared.
  • a metal wire that can be drawn such as copper wire and stainless soft wire, or a resin strand such as polyamide (PA) can be applied, and the cross section is not limited to a circle, but an ellipse, a semicircle, a polygon, etc. Any shape can be used.
  • the inner layer 10 is formed on the core wire 50.
  • the inner layer 10 is formed of a low friction material such as a fluorine-based resin, it is preferable that the outer surface of the inner layer 10 is roughened by chemical etching or the like so that other materials can be coated on the outer side.
  • thermoplastic resin When a thermoplastic resin is used as the material of the inner layer 10, it can be extruded at a predetermined take-up speed at a predetermined molding temperature (die temperature) with an extruder. Thereby, the extrusion molding (inner layer 10) of substantially the same thickness can be obtained. In addition, by adjusting the take-up speed, the wall thickness can be changed according to the part.
  • a thermoplastic resin layer (in this case, the inner layer 10) is formed on the core wire 50 by using a general extruder 100 as shown in FIG.
  • the extrusion molding machine 100 includes an extruder 101 for extruding the heated and melted material, a mold 103 for extruding the resin extruded from the extruder 101 from the extrusion port 102, and a position passing through the mold 103 at the center of the extrusion port 102.
  • a take-up machine 105 for picking up the core wire 50, a supply roll 106 for winding and holding the core wire 50 and supplying the core wire 50 to the mold 103, a collecting roll 107 for collecting the core wire 50 after extrusion molding, It has.
  • the material heated and melted by the extruder 101 is supplied to the mold 103, and the core wire 50 that is fed from the supply roll 106 and positioned at the extrusion port 102 is pulled by the take-up machine 105. While pulling, the material is continuously supplied onto the core wire 50 from the extrusion port 102 to cover the material on the core wire 50.
  • the core wire 50 coated with the material is wound around the collection roll 107 and collected after the coated material is solidified.
  • the supply roll 106 and the collection roll 107 may not be provided. Further, in the extrusion molding of the inner layer 10, when a fluororesin (PTFE or the like) is used as the resin, it is possible to extrude a mixture of resin powder with a fluorolubricant as an auxiliary agent.
  • PTFE fluororesin
  • the inner layer 10 may not be formed by extrusion molding.
  • the inner layer 10 may be formed by dip molding in which a resin is dipped in a solution and then pulled up and dried.
  • the reinforcing body 20 is formed so as to cover at least part of the inner layer 10 as shown in FIG.
  • the reinforcing body 20 is formed by continuously winding the wire 21 with a braid having a predetermined interstitial distance on the inner layer 10 using a braiding machine (blader).
  • the reinforcing body 20 may wind the wire 21 while changing the winding direction, such as horizontal winding in the same direction, right-hand winding, left-hand winding, etc. Also, depending on the position, the winding pitch, interstitial distance, inclination angle with respect to the circumferential direction, etc.
  • the configuration may be changed, and the configuration is not particularly limited.
  • the inner diameter D of the mold 200 may be smaller than the inner diameter of the marker 30.
  • the mold 200 is preferably heated. By heating the mold 200, the fluidity of the inner layer 10 is increased, and the small diameter portion 22 can be formed favorably. Moreover, you may form the material of the site
  • an X-ray contrast marker 30 is arranged so as to enter the small diameter portion 22 from the outside in the radial direction.
  • the marker 30 is arranged by winding a strand 31 formed of a material containing an X-ray opaque material so as to enter the small diameter portion 22 from the outside in the radial direction of the small diameter portion 22.
  • only one small-diameter portion 22 and marker 30 are provided, but a plurality may be provided.
  • the outer diameter of the strand 31 of the marker 30, that is, the thickness of the marker 30 wound in a tubular shape is preferably equal to the depth of the small diameter portion 22, but is not limited thereto.
  • the outer diameters of the reinforcing body 20 and the marker 30 coincide with each other, and the outer diameter of the outer layer 40 is smoothly increased in a later process. It is easy to form.
  • the depth of the small-diameter portion 22 is preferably at least half of the radial thickness of the tubular marker 30, that is, at least half of the outer diameter of the strand 31 constituting the marker 30. It is more preferable that the thickness is equal to or greater than the thickness in the radial direction, that is, equal to or greater than the outer diameter of the wire 31 constituting the marker 30. Thereby, it can suppress effectively that the marker 30 falls off from the small diameter part 22.
  • the depth of the small diameter part 22 is more than half of the outer diameter of the wire 21 which comprises the reinforcement body 20, and it is more more than the outer diameter of the wire 21 which comprises the reinforcement body 20. preferable. Thereby, it can suppress effectively that the marker 30 falls off from the small diameter part 22.
  • the reinforcing body 20, and the marker 30 is obtained on the core wire 50 by the above process, as shown in FIGS. 3 (E) and 6 (C), the marker 30 and the reinforcing body.
  • the outer layer 40 is formed by a method similar to the above-described extrusion molding (see FIG. 4) so as to cover 20.
  • the obtained structure is cut for each catheter.
  • the outer layer 40 may be formed so as to cover the marker 30 and the reinforcing body 20 after the structure before forming the outer layer 40 is cut for each catheter.
  • the outer diameter of the outer layer 40 can be made uniform by using a heat-shrinkable tube that shrinks into a memorized shape by heating.
  • the heat shrinkable tube is, for example, a fluorine resin.
  • the heat shrinkable tube 51 is shrunk while the outer layer 40 is softened or melted by hot air, a heater, or the like, and the outer diameter of the outer layer 40 is made uniform by the shrinkage force of the heat shrinkable tube 51. To. Thereafter, the heat-shrinkable tube 51 that has been heat-shrinked is removed.
  • the outer layer 40 is formed on the inner layer 10, the reinforcing body 20, and the marker 30 by extrusion molding.
  • the outer layer 40 can be formed by using a heat shrinkable tube instead of extrusion molding.
  • a heat-shrinkable tube first, as shown in FIG. 8 (A), on the core wire 50, after cutting out a structure composed of the inner layer 10, the reinforcing body 20, and the marker 30 for each catheter, The obtained structure is covered with a tube 60 having an inner diameter larger than the outer diameter of the structure. Next, the heat shrinkable tube 70 is put on the outside.
  • the tubular body 60 is a material that becomes the outer layer 40.
  • the heat shrinkable tube 70 is contracted while being heated or heated by hot air or a heater to soften or melt the tube 60, and the tube 60 is contracted by the contraction force of the heat shrinkable tube 70.
  • the outer layer 40 is pressed to the outer periphery of the reinforcing body 20, the marker 30 and the inner layer 10.
  • the heat-shrinkable tube 70 that has been heat-shrinked is formed after forming the tube body 60 as the outer layer 40 around the outer periphery of the reinforcing body 20, the marker 30, and the inner layer 10.
  • there is one tube body 60 that serves as the outer layer 40 but it may be divided into a plurality of parts in the axial direction, and in this case, each may be formed of different materials, characteristics, or dimensions. Can be designed in various ways.
  • the outer layer 40 can also be formed by dip molding.
  • a part of the covering at both ends of the cut core wire 50 is removed, a part of both ends of the core wire 50 is exposed and fixed to a stretching machine, and the entire core wire 50 is stretched. Reduce diameter. Thereafter, the core wire 50 is pulled out from the covering.
  • the hub 3 and the anti-kink protector 4 are attached to the catheter shaft 2, and other members (for example, tip tips) are attached as necessary, whereby the catheter 1 is completed.
  • the catheter 1 is formed into a tubular shape by the inner layer 10 that is formed of a resin material and has the lumen 5 therein, and the wire 21 that is disposed on the radially outer side of the inner layer 10.
  • a reinforcing body 20 having a small-diameter portion 22 having a small outer diameter
  • a marker 30 having an X-ray contrast property arranged so as to enter the small-diameter portion 22 from the outside in the radial direction
  • an inner layer 10 and a reinforcement formed by a resin material and an outer layer 40 disposed on the radially outer side of the body 20.
  • the marker 30 since the marker 30 is disposed so as to enter the small-diameter portion 22 of the reinforcing body 20, the marker 30 can be disposed at an appropriate position without displacement and the position of the marker 30 is not displaced. Can be manufactured. In particular, even if extrusion molding that can efficiently manufacture a plurality of tubular bodies is used, the marker 30 is not washed away by the melted material, and the marker 30 can be arranged at an appropriate position without being displaced.
  • the depth of the small-diameter portion 22 can be made more than half of the thickness of the marker 30 in the radial direction. Thereby, half or more of the thickness of the marker 30 can be accommodated in the small-diameter portion 22, and the marker 30 becomes difficult to drop off from the small-diameter portion 22, and the marker 30 can be disposed at an appropriate position of the reinforcing body 20.
  • the depth of the small diameter portion 22 can be set to be equal to or greater than the thickness of the marker 30 in the radial direction. Thereby, the whole marker 30 can be accommodated in the small diameter part 22, the marker 30 becomes difficult to drop off from the small diameter part 22, and the marker 30 can be arrange
  • the depth of the small diameter portion 22 can be set to more than half of the outer diameter of the wire constituting the reinforcing body 20. Thereby, it becomes difficult for the marker 30 to drop off from the small diameter portion 22, and the marker 30 can be disposed at an appropriate position of the reinforcing body 20.
  • the reinforcing body 20 can locally widen the interval between adjacent wires in the small diameter portion 22. Thereby, the reinforcement body 20 becomes flexible in the small diameter part 22, and it becomes easy to arrange
  • the reinforcing body 20 can locally reduce the outer diameter of the wire 21 at the small diameter portion 22. Thereby, the reinforcement body 20 becomes flexible in the small diameter part 22, and it becomes easy to arrange
  • the outer layer 40 can have a uniform outer diameter in the axial direction including the marker 30 and the distal end side and the proximal end side of the marker 30. Thereby, the outer peripheral surface of the catheter 1 becomes smooth, and the passability in the living body lumen is improved.
  • the catheter manufacturing method includes a step of forming the inner layer 10 having the lumen 5 therein with a resin material, and a step of forming the reinforcing body 20 by arranging the wire 21 on the radially outer side of the inner layer 10.
  • a step of forming the outer layer 40 with a resin material on the radially outer side of the reinforcing body 20 is arranged.
  • the marker 30 having X-ray contrast properties is arranged so as to enter the small-diameter portion 22 from the outside in the radial direction, and then the resin layer is used on the outside in the radial direction of the inner layer 10 and the reinforcing body 20. Since the outer layer 40 is formed, the marker 30 can be disposed at an appropriate position without being displaced and can be efficiently manufactured.
  • the inner layer 10 can be formed by covering the outside of the core wire 50 with a resin material. Thereby, even if it forms the small diameter part 22 in the reinforcement body 20, the internal diameter of the inner layer 10 does not change, but the permeability
  • the step of arranging the marker 30 can be performed after the step of forming the small diameter portion 22. Thereby, after forming the small diameter part 22 reliably, the marker 30 can be arrange
  • a portion where the small-diameter portion 22 of the inner layer 10 is disposed may be locally flexible. Thereby, the inner layer 10 is easily deformed, and the small diameter portion 22 is easily formed.
  • means for making the inner layer 10 flexible include heating the inner layer 10 and forming a portion where the small-diameter portion 22 of the inner layer 10 is arranged with a material that is more flexible than the surroundings.
  • the outer diameter of the outer layer 40 in the axial range including the marker 30 and the distal end side and the proximal end side of the marker 30 can be made uniform. Thereby, the outer peripheral surface of the catheter 1 can be formed smoothly, and the passage property in the living body lumen is improved.
  • the present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical idea of the present invention.
  • the marker 30 is attached to the small diameter portion 22 after the small diameter portion 22 is formed.
  • the marker 30 may be disposed at the same time while forming the small-diameter portion 22 by biting into the reinforcing body 20 and the inner layer 10. Thereby, a manufacturing process reduces and workability
  • the marker 30 is formed by winding the wire 31.
  • a marker 110 having a C-shaped cross section may be used.
  • the marker 110 has a substantially cylindrical shape and has a slit in the cylinder axis direction, and the shape in a cross section orthogonal to the cylinder axis is a C-type.
  • the marker 110 can be arranged by being plastically deformed so as to close the slit 111 after being attached to the inner layer 10 and the reinforcing body 20 from the outside in the radial direction via the slit 111.
  • the outer diameter of the small-diameter portion 22 formed in the inner layer 10 and the reinforcing body 20 is constant, but as shown in FIG. 11A, the outer diameter is on the distal end side and the proximal end side.
  • the outer diameter may be smaller than the central portion or may be smaller than the central portion on the distal end side and the proximal end side as shown in FIG.
  • Such a shape can be set according to the shape of the mold that forms the small diameter portion 22. Since the outer diameter of the small-diameter portion 22 becomes smaller on the distal end side and / or the proximal end side, the marker 30 can be more reliably prevented from falling off.
  • production of a kink etc. can be suppressed because the outer diameter of the small diameter part 22 becomes large at the front end side and / or the base end side.
  • the catheter may be further provided with other layers.
  • a hydrophilic polymer substance hydrophilic material
  • the hydrophilic polymer substance exhibits lubricity when it comes into contact with a liquid such as blood or physiological saline, reduces the frictional resistance of the catheter shaft 2 and further improves the slidability. Improve operability.
  • the cross-sectional shape of the catheter shaft in the cross section perpendicular to the axis may not be circular, and may be, for example, elliptical.
  • the lumen in the catheter shaft may not have a circular cross-sectional shape in the axial orthogonal cross section, and may be, for example, an ellipse or a semicircle.
  • the catheter shaft may be provided with a plurality of lumens. Further, the thickness of the marker 30 may be less than the depth of the small diameter portion 22.

Abstract

L'invention concerne un cathéter dans lequel un marqueur de contraste aux rayons X peut être disposé de manière appropriée à l'extérieur d'un corps de renforcement et qui peut être fabriqué de manière efficace, et son procédé de fabrication. Ce cathéter (1) comprend : une couche interne (10) qui est formée à partir d'un matériau de résine et comportant intérieurement une lumière (5) ; un corps de renforcement (20) qui se présente sous la forme d'un tube avec un fil (21) disposé sur le côté radialement externe de la couche interne (10) et qui présente localement une partie de petit diamètre (22) avec un diamètre extérieur réduit ; un marqueur (30) qui pénètre dans la partie de petit diamètre (22) depuis son côté radialement externe et qui possède des propriétés de contraste aux rayons X ; et une couche externe (40) qui est formée à partir d'un matériau de résine et est disposée sur le côté radialement externe de la couche interne (10) et du corps de renforcement (20).
PCT/JP2016/086063 2015-12-16 2016-12-05 Cathéter et procédé de fabrication associé WO2017104465A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2015244779A JP2019022538A (ja) 2015-12-16 2015-12-16 カテーテルおよびその製造方法
JP2015-244779 2015-12-16

Publications (1)

Publication Number Publication Date
WO2017104465A1 true WO2017104465A1 (fr) 2017-06-22

Family

ID=59056359

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2016/086063 WO2017104465A1 (fr) 2015-12-16 2016-12-05 Cathéter et procédé de fabrication associé

Country Status (2)

Country Link
JP (1) JP2019022538A (fr)
WO (1) WO2017104465A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI669136B (zh) * 2018-10-31 2019-08-21 林忠信 Medical safety infusion tube
WO2023095694A1 (fr) * 2021-11-25 2023-06-01 テルモ株式会社 Cathéter

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115666698A (zh) * 2020-06-12 2023-01-31 泰尔茂株式会社 导管

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014097088A (ja) * 2012-11-13 2014-05-29 Terumo Corp カテーテル
JP2014188338A (ja) * 2013-03-28 2014-10-06 Sumitomo Bakelite Co Ltd 医療機器

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014097088A (ja) * 2012-11-13 2014-05-29 Terumo Corp カテーテル
JP2014188338A (ja) * 2013-03-28 2014-10-06 Sumitomo Bakelite Co Ltd 医療機器

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI669136B (zh) * 2018-10-31 2019-08-21 林忠信 Medical safety infusion tube
WO2023095694A1 (fr) * 2021-11-25 2023-06-01 テルモ株式会社 Cathéter

Also Published As

Publication number Publication date
JP2019022538A (ja) 2019-02-14

Similar Documents

Publication Publication Date Title
US10065015B2 (en) Catheter devices and methods for making them
US10695532B2 (en) Catheter devices and methods for making them
WO2013146673A1 (fr) Procédé de fabrication d'instrument médical et instrument médical
CN103830824B (zh) 导管用软管的制造方法和导管用软管的连续体
KR20140127357A (ko) 의료 기기의 제조 방법 및 의료 기기
WO2017104465A1 (fr) Cathéter et procédé de fabrication associé
US10130794B2 (en) Medical instrument, and medical-instrument production method
JP6088809B2 (ja) カテーテル用チューブの製造方法、カテーテル用チューブの連続体およびカテーテル用チューブ製造用の芯線
JP6124563B2 (ja) カテーテル用チューブの製造方法およびカテーテル用チューブの連続体
JP6319390B2 (ja) 医療機器および医療機器の製造方法
JP2014100323A (ja) カテーテル用チューブの製造方法
JP2014100327A (ja) カテーテル用チューブの製造方法
JP2014100321A (ja) カテーテル用チューブの製造方法
JP2014100336A (ja) カテーテル用チューブの製造方法およびカテーテル用チューブの連続体
JP2014100330A (ja) カテーテル用チューブの製造方法
JP2013192717A (ja) 医療機器
JP2014100328A (ja) カテーテル用チューブの製造方法
JP2013192632A (ja) 医療機器の製造方法及び医療機器
JP2014100333A (ja) カテーテル用チューブの製造方法、カテーテル用チューブの連続体およびカテーテル用チューブ製造用の芯線
JP2014100337A (ja) カテーテル用チューブの製造方法
JP2014100332A (ja) カテーテル用チューブの製造方法、カテーテル用チューブの連続体、およびカテーテル用チューブ製造用の芯線
JP2014100326A (ja) カテーテル用チューブの製造方法
JP2014100338A (ja) カテーテル用チューブの製造方法およびカテーテル用チューブの連続体
JP2014100335A (ja) カテーテル用チューブの製造方法
JP2013192797A (ja) 医療機器及び医療機器の製造方法

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16875448

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 16875448

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: JP