WO2012035633A1 - Cathéter et ensemble cathéter - Google Patents

Cathéter et ensemble cathéter Download PDF

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Publication number
WO2012035633A1
WO2012035633A1 PCT/JP2010/066047 JP2010066047W WO2012035633A1 WO 2012035633 A1 WO2012035633 A1 WO 2012035633A1 JP 2010066047 W JP2010066047 W JP 2010066047W WO 2012035633 A1 WO2012035633 A1 WO 2012035633A1
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WO
WIPO (PCT)
Prior art keywords
catheter
tip
region
distal end
lumen
Prior art date
Application number
PCT/JP2010/066047
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English (en)
Japanese (ja)
Inventor
達道 藤原
圭 井澤
Original Assignee
株式会社グッドマン
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 株式会社グッドマン filed Critical 株式会社グッドマン
Priority to PCT/JP2010/066047 priority Critical patent/WO2012035633A1/fr
Priority to JP2012533788A priority patent/JPWO2012035633A1/ja
Publication of WO2012035633A1 publication Critical patent/WO2012035633A1/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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires

Definitions

  • the present invention relates to a catheter assembly in which a distal end side is introduced to a target introduction site such as a coronary artery in use.
  • Patent Document 1 discloses a technique in such a catheter assembly that facilitates relative insertion with respect to the outer catheter while assisting insertion of the catheter, and allows the guide wire to be exchanged even if preceded by the outer catheter. ing.
  • the present invention was created to solve the above-described conventional problems, and an object of the present invention is to provide a technique for improving the insertion property of a catheter into the lumen of a human body using a guide wire.
  • Means 1 A catheter guided by a guide wire, A guide portion having a tapered tapered tip, and a first wire lumen through which the guide wire is inserted; and An inner tip mounted inside the tip and having a second wire lumen formed in communication with the first wire lumen;
  • a catheter comprising:
  • the guide portion to the guide wire is determined by the elastic characteristics of the distal end portion, the elastic characteristics of the inner tip, and the mounting state (structure state) of both. It is possible to adjust the follow-up characteristic of the tip. Accordingly, it is possible to provide a degree of freedom in design for facilitating the passage of a region that is difficult to pass, such as a region that is extremely narrow due to a lesion or a region that has been calcified and hardened. Furthermore, in selecting the material of the inner tip, it is possible to make a selection with an emphasis on the low friction characteristic with the guide wire.
  • Means 2 The catheter according to means 1, wherein the inner tip includes a protruding portion that protrudes distally from the tip portion.
  • Means 2 includes a projecting portion in which the inner tip projects distally from the tip.
  • Means 3 The catheter according to means 2, wherein the inner tip has a larger longitudinal elastic modulus than the distal end portion.
  • the means 3 has a longitudinal elastic modulus larger than that of the tip portion, for example, a lateral load applied to the tip of the projecting portion of the inner tip is flexibly absorbed in the tapered region of the tip portion. Thereby, generation
  • Means 4 The catheter according to any one of means 1 to 3, wherein the inner tip and the distal end portion are fixed by a plurality of fixing portions with an unfixed portion interposed therebetween.
  • each part of the double tube structure constituted by the inner tip and the tip It is possible to improve the dynamic deformation behavior of the tip by adjusting the bending rigidity in the direction.
  • the present inventor has improved the dynamic deformation behavior of the protruding portion and the tip portion by configuring the inner tip and the tip portion.
  • Means 5 The means 4 of claim 4, wherein the plurality of securing portions includes a distal securing portion extending from a distal end of the tip portion and a proximal securing portion extending from a proximal end of the tip portion. catheter.
  • the means 5 is fixed by a plurality of fixing parts including a distal fixing part extending from the distal end of the tip part and a proximal fixing part extending from the proximal end of the tip part. It is possible to control elastic deformation in a wide region across the intermediate position of the tip.
  • Means 6 The catheter according to any one of means 1 to 5, wherein a plurality of markers for suppressing the transmission of radiation are attached to the inner tip.
  • the means 6 since the plurality of markers for suppressing the transmission of radiation are mounted on the inner chip, the accuracy of the mutual positional relationship between the plurality of markers can be improved.
  • Means 7 The catheter according to means 5, wherein a marker for suppressing transmission of radiation is attached between the distal end portion and the inner tip in the distal side fixing portion and the proximal side fixing portion.
  • a marker that suppresses transmission of radiation for example, X-rays
  • a highly accurate arrangement and a clear contour are provided.
  • a cylindrical marker region is formed at the tip using a resin containing powder made of a material that does not transmit radiation (X-rays) such as tungsten.
  • X-rays a material that does not transmit radiation
  • Means 8 The catheter according to any one of means 1 to 6, wherein the first wire lumen has a larger inner diameter than the second wire lumen.
  • the main wire lumen has a large inner diameter, it is possible to reduce the friction of the wire in a long region in the wire lumen.
  • the wire lumen in the inner tip can be narrowed in a short region of the tip to set an inner diameter that places importance on the ability to follow the wire. As a result, it is possible to realize both the reduction of the friction of the wire and the followability.
  • Means 9 A catheter for assisting insertion of the outer catheter, Any one of means 1 to 8, wherein the catheter is an inner catheter configured to be mounted in a state where at least a part of the tip portion protrudes distally from the distal end of the outer catheter.
  • the present invention can be applied to an inner catheter used for assisting insertion of an outer catheter, and is also applicable to the following catheter assembly.
  • Means 10 An inner catheter according to means 9, The outer catheter; A catheter assembly.
  • FIG. 3 is a front view showing members constituting the catheter assembly 10.
  • FIG. The expanded sectional view which shows the taper area
  • FIG. The longitudinal cross section of the catheter assembly 10 in the state penetrated in the guiding catheter 62.
  • FIG. 3 is a cross-sectional view of the catheter assembly 10 taken along the line AA.
  • the external view which shows the outer catheter 11a of a modification.
  • FIG. 1 is a front view showing members constituting the catheter assembly 10.
  • the catheter assembly 10 includes an outer catheter 11 and an inner catheter 12.
  • the outer catheter 11 is a delivery catheter that is used to introduce a balloon catheter or the like (not shown) into the peripheral stenotic lesion of the coronary artery.
  • the inner catheter 12 is an insertion assisting tool that assists the insertion of the outer catheter 11 by preceding the outer catheter 11.
  • the inner catheter 12 is used by being inserted into the outer catheter 11 when the outer catheter 11 is inserted into a lesion in a living body.
  • the outer catheter 11 includes an outer tube portion 41 and an outer shaft portion 42.
  • the outer tube portion 41 extends from the distal end to the middle position on the proximal end side (base end side) and constitutes the distal end side of the outer catheter 11.
  • the outer shaft portion 42 constitutes a proximal end side with respect to the outer pipe portion 41.
  • the outer pipe portion 41 has an outer pipe hole (outer lumen) 43 formed therein as an outer hole, and has a tubular shape as a whole.
  • the outer tube hole 43 is formed over the entire axial direction so as to be opened at both the distal end portion and the proximal end portion.
  • the outer tube hole 43 is used for inserting the inner catheter 12 and a guide wire (described later).
  • a catheter such as a balloon catheter (not shown) for performing treatment on a lesioned part is inserted into the outer tube hole 43.
  • the outer tube hole 43 is formed so that the hole diameter d is constant over substantially the entire axial direction.
  • the hole diameter d is slightly larger than the outer diameter of the region between the tapered region 25 a and the proximal end opening 23 b in the inner pipe portion 21, that is, the maximum outer diameter of the inner pipe portion 21.
  • the outer tube portion 41 is formed of a polyether block amide copolymer (PEBAX), so that flexibility that enables tracking of a bent blood vessel is secured.
  • the inner peripheral surface of the outer pipe portion 41 is made of a polytetrafluoroethylene (PTFE) friction reducing layer (not shown) in order to reduce resistance when the inner catheter 12 and other catheters slide in the outer pipe hole 43. Is formed.
  • the inner pipe portion 21 is also called a guide portion.
  • the material of the outer pipe portion 41 is not limited to polyamide elastomer such as PEBAX, and polyethylene, polyethylene terephthalate, polypropylene, polyurethane, polyimide, polyimide elastomer, silicone rubber, natural rubber, or the like may be used. These materials may be used for the inner pipe portion 21 described above. Further, the material for forming the friction reducing layer (not shown) is not limited to PTFE, and other fluorine-based resins and hydrophilic polymers such as maleic anhydride copolymers may be used.
  • the distal end portion of the outer tube portion 41 has an outer tip 46 that is more flexible than the outer tube portion 41. Thereby, even when the distal end portion of the outer tube portion 41 contacts the blood vessel wall, the load applied to the blood vessel wall at that time is reduced.
  • the outer side tip 46 is formed of the same material as that of the outer pipe portion 41, but may be formed of a different material.
  • the proximal end portion of the outer pipe portion 41 is connected to the outer shaft portion 42 using a joint ring 51.
  • the outer shaft portion 42 is formed in a cylindrical shape from a metal such as stainless steel or a Ni—Ti alloy, or a resin such as nylon.
  • the outer shaft portion 42 is provided with a tapered portion 53 at an end portion on the distal end side, and an outer knob portion 47 is provided at an end portion on the proximal end side.
  • the outer shaft portion 42 has a substantially constant outer diameter over the entire axial direction except for the tapered portion 53 and the outer knob portion 47.
  • the outer shaft portion 42 is provided with two markers 48a and 48b for visually confirming the insertion amount of the outer catheter 11 into the living body.
  • the marker 48a is formed, for example, by mounting a colored resin or platinum ring at a position 1000 mm proximal from the distal end of the outer catheter 11.
  • the position of the marker 48a corresponds to the position where the outer catheter 11 starts to come out from a guiding catheter (described later).
  • the marker 48 b is formed at a position 1200 mm proximal from the distal end of the outer catheter 11.
  • the position of the marker 48b is a position for confirming that another catheter such as a balloon catheter has reached the position of the outer opening 43a.
  • the joint ring 51 is embedded in the outer catheter 11 and is illustrated in FIG. 1 as a range of the embedded portion.
  • the joint ring 51 is formed in a cylindrical shape or a tubular shape from a metal such as stainless steel.
  • the joint ring 51 is embedded in the outer pipe portion 41 while being fixed to the tapered portion 53 of the outer shaft portion 42 by spot welding by laser irradiation. Thereby, the outer pipe part 41 and the outer shaft part 42 are mutually fixed.
  • the inner catheter 12 includes an inner tube portion 21, an inner shaft portion 22, and an inner knob portion 36.
  • the inner tube portion 21 is located from the distal end to the middle position on the proximal end side (base end side) and constitutes the distal end side of the inner catheter 12.
  • the inner shaft portion 22 constitutes a proximal end side with respect to the inner tube portion 21.
  • FIG. 2 is a longitudinal sectional view of the distal end side of the inner catheter 12.
  • FIG. 3 is an enlarged cross-sectional view showing the tapered region 25 a of the inner catheter 12.
  • the inner pipe portion 21 communicates with the tube hole 24a of the inner tip 24 on the distal end side, and guides the guide wire lumen 23 formed over the entire axial direction so as to be opened at the proximal end portion. It has as a hole and has a tubular shape as a whole.
  • the guide wire lumen 23 is used for inserting a guide wire.
  • the inner shaft portion 22 is fixed to the inner pipe portion 21 as shown in FIG.
  • the inner shaft part 22 includes a hypo pipe 31 and an extension pipe part 32 formed in a tubular shape.
  • the hypo pipe 31 is formed in a tubular shape with a metal such as stainless steel or a Ni—Ti alloy, or a resin such as polyimide
  • the extension pipe portion 32 is formed in a tubular shape with a synthetic resin such as polyamide.
  • the extension pipe part 32 is formed so as to cover the distal end part of the hypo pipe 31 from the outer peripheral side and to extend the inner shaft part 22 further to the distal end side than the hypo pipe 31.
  • the outer diameter of the hypo pipe 31 is 0.5 mm, and is the same as or substantially the same as the outer diameter of the outer shaft portion 42.
  • connection structure between the inner pipe portion 21 and the inner shaft portion 22 is as follows. Inside the base tube portion 25 of the inner tube portion 21, a connecting tube portion 27 is formed from the proximal end opening 23b of the guide wire lumen 23 to the position of the tapered region 25a.
  • the connecting pipe portion 27 is formed with a connecting pipe hole (connecting lumen) 28 extending in the axial direction.
  • the distal end side of the connecting tube hole 28 is closed by a wall portion constituting the tapered region 25a, while the proximal end side is opened.
  • the shaft side tube hole 33 is a tube hole made up of each tube hole (lumen) of the hypo tube 31 and the extension tube portion 32. This heat welding is reinforced by the core material 34.
  • the core member 34 is a wire formed of a metal such as stainless steel or Ni—Ti alloy, or a resin such as nylon, and is bonded to the inner peripheral surface of the hypo pipe 31. Alternatively, the core member 34 may be fixed to the inner knob 36 by extending the proximal end (base end) thereof.
  • the hypo pipe 31 is partially formed with a reduced rigidity region 35 (see FIG. 2) by a spiral slit 35a.
  • the proximal end opening 23b is formed such that the opening surface is inclined with respect to the axial direction, and a wide opening area is ensured.
  • an inner opening marker 37 formed in a cylindrical shape using a material that does not transmit radiation such as tungsten is provided as a contrast portion.
  • the distal end side of the inner catheter 12 is configured as follows in order to realize followability to a guide wire (described later) and smooth advancement to the lumen of the human body.
  • the inner pipe portion 21 has a tapered region 25a, and the outer diameter gradually decreases from the proximal end 21m toward the distal end 21e in the tapered region 25a.
  • the guide wire lumen 23 communicates with a tube hole 24 a formed inside the inner tip 24.
  • the tube hole 24a inside the inner tip 24 can be narrowed in a short region of the tip portion to set an inner diameter that emphasizes followability to the guide wire 61.
  • the guide wire lumen 23 is also referred to as a first wire lumen.
  • the tube hole 24a formed in the inner tip 24 is also called a second wire lumen.
  • the inner tip 24 is welded inside the inner pipe portion 21. Between the inner pipe portion 21 and the inner tip 24, two taper region markers 26a and 26b made of platinum rings (or cylinders) are embedded and attached. The inner pipe portion 21 and the inner tip 24 are welded at two locations, a welding region W1 that covers the taper region marker 26a and a welding region W2 that covers the taper region marker 26b. A non-welded region NW that is not welded remains between the two welded regions W1, W2.
  • the welding region W1 extends from the distal end 21e of the taper region 25a to a position proximal to the taper region marker 26a.
  • the welding region W2 extends from the proximal end 21m of the taper region 25a to a position more distal than the taper region marker 26b.
  • the taper area markers 26a and 26b are attached by the following method. First, the taper region markers 26 a and 26 b are fixed to the inner chip 24. Next, the inner tip 24 to which the taper region markers 26 a and 26 b are attached is inserted into the inner pipe portion 21. Finally, welding is performed in the welding regions W1 and W2 covering the range of the taper region markers 26a and 26b. Accordingly, the two taper region markers 26a and 26b are firmly attached in a state where the accuracy of the mutual positional relationship is remarkably improved.
  • the two welding regions W1, W2 are arranged in the tapered region 25a as follows.
  • the tapered region 25a is configured as a region whose outer shape changes with a constant gradient over the region T.
  • the two welding regions W1 and W2 are disposed on both the distal end side and the proximal end side of the intermediate position in the axial direction of the tapered region 25a, and the non-welding region NW straddles the intermediate position.
  • the intermediate position is an intermediate position between the distal end and the proximal end of the tapered region 25a, and is a position on the proximal end side by half (T / 2) of the region T from the distal end.
  • the gradient change may be non-linear (curved).
  • Both the inner chip 24 and the inner pipe part 21 are formed of a polyether block amide copolymer (PEBAX).
  • PEBAX polyether block amide copolymer
  • the inner tip 24 is made of a material having a longitudinal elastic modulus larger than that of the inner pipe portion 21 and having a friction coefficient smaller than that of the inner pipe portion 21.
  • the friction coefficient of the inner tip 24 is small, the friction with the guide wire 61 can be further reduced.
  • the inner tip 24 protrudes from the distal end 21e of the inner pipe portion 21 by a predetermined length ⁇ to form a protruding portion 24b.
  • the present inventor has found that such a double pipe structure of the inner tip 24 and the inner pipe portion 21 has the following elastic characteristics, and the elastic characteristics can be freely adjusted.
  • the first characteristic is that stress concentration hardly occurs at the distal end 21e that forms the boundary portion between the inner tip 24 and the inner pipe part 21.
  • the longitudinal elastic modulus of the inner tip 24 is set to be larger than that of the inner pipe portion 21, for example, a lateral load applied to the tip of the inner tip 24 is a tapered region of the inner pipe portion 21. It will be absorbed flexibly in the tip region of 25a. Thereby, suppression of bending can be made remarkable.
  • the second characteristic is that the double pipe structure is not fixed between the inner tip 24 and the inner pipe portion 21 due to the setting of the two welding regions W1, W2 and the non-welding region NW. It is the characteristic that the bending rigidity in each part of can be weakened. Since mutual sliding between the inner tip 24 and the inner pipe portion 21 during bending is allowed, bending rigidity in each part of the double pipe structure can be weakened, that is, relatively high flexibility can be maintained. It is a characteristic.
  • the third characteristic is that the two welding regions W1 and W2 and the non-welding region NW are set by the width of each of the two welding regions W1 and W2 in the axial direction of the inner pipe portion 21, each position in the taper region 25a, and the taper.
  • This is a characteristic of having many design degrees of freedom such as the shape and the width of the non-welded region NW.
  • the present double structure is configured by the dynamic deformation behavior of the protrusion and the tip by the inner tip and the tip. It has been created based on the knowledge that it has been improved, and that the induction into the body can be remarkably smoothed.
  • the welding region W1 is disposed at a position closer to the distal end 21e of the inner pipe portion 21 than the intermediate position, and the welding region W2 is disposed at a position closer to the proximal end than the intermediate position.
  • the two welding regions W1 and W2 are also called fixed portions.
  • the non-welded region NW is also called a non-fixed part.
  • the weld region W1 is also called a distal side fixing portion.
  • the welding region W2 is also referred to as a proximal side fixing portion.
  • FIG. 4 is a longitudinal sectional view of the catheter assembly 10 in a state of being inserted into the guiding catheter 62.
  • the catheter assembly 10 includes an outer catheter 11 and an inner catheter 12, and a guide wire 61 is inserted therethrough.
  • FIG. 5 is a cross-sectional view of the catheter assembly 10 taken along the line AA.
  • FIG. 6 is a schematic diagram for explaining a state where the catheter assembly 10 is introduced into the left coronary artery BV4.
  • the medical worker uses the guiding catheter 62 to guide the distal end of the catheter assembly 10 to the entrance of the left coronary artery BV4 as shown in FIG.
  • the entrance to the left coronary artery BV4 is guided through the descending aorta BV1, the aortic arch BV2, and the ascending aorta BV3 according to the shape previously formed in the guiding catheter 62.
  • the guiding catheter 62 through which the guide wire 61 is inserted is guided to the entrance of the left coronary artery BV4.
  • the medical staff guides the catheter assembly 10 to the entrance of the left coronary artery BV4 by the guiding catheter 62 and the guide wire 61.
  • the catheter assembly 10 passes through the inside of the guiding catheter 62 in the assembled state as shown in FIGS.
  • the catheter assembly 10 is in a state where the inner tube portion 21 of the inner catheter 12 is inserted into the outer tube hole 43 of the outer catheter 11.
  • the guiding catheter 62 may be inserted in a state where the guide wire 61 and the catheter assembly 10 are inserted.
  • the medical staff advances the guide wire 61 further into the back of the left coronary artery BV4.
  • the medical worker confirms that the guide wire 61 has been inserted through the back of the left coronary artery BV4 by a sufficient distance, and moves the inner catheter 12 into the back of the left coronary artery BV4 while causing the inner catheter 12 to follow the guide wire 61.
  • the medical worker can enter the outer catheter 11 to the target position using the inner catheter 12 that has entered the back of the left coronary artery BV4.
  • the medical worker pulls out the inner catheter 12 after confirming that the outer catheter 11 has entered the target position.
  • the medical staff has ensured the approach path
  • the present inventor has analyzed the situation in which the entry of the inner catheter 12 inside the left coronary artery BV4 is inhibited due to the lesion of the left coronary artery BV4. As a result of this analysis, it has been found that the soft tip is bent mainly, which causes an inaccessible state.
  • the soft chip is a member having an outer diameter corresponding to the protrusion 24b (see FIG. 3) in the prior art.
  • the soft tip is connected to the distal end of the base tube portion 25 by welding. It has been found by the present inventor that the bending of the soft chip is mainly caused by the stress concentration at the connection portion.
  • the inventor can create a double tube structure of the inner tip 24 and the inner tube portion 21 based on such an analysis, and suppress the inaccessible state caused by the bending of the protruding portion 24b. I found out.
  • the longitudinal elastic modulus is set to be larger than that of the inner pipe portion 21 in particular, for example, the lateral load applied to the tip of the inner tip 24 is the tip region of the tapered region 25a of the inner pipe portion 21. Will be absorbed flexibly. Thereby, the tolerance with respect to the bending of the protrusion part 24b can be strengthened.
  • the regions including the taper region markers 26a and 26b are welded at both ends of the taper region 25a.
  • the present invention is not limited to such a configuration. From the distal end 21e of the tapered region 25a to a position more distal than the tapered region marker 26a, and from the proximal end 21m of the tapered region 25a to the tapered region marker 26b. You may make it weld to the position of a proximal side. Even when welding is performed in this manner, since the taper region markers 26a and 26b are fixed to the inner chip 24, the taper region markers 26a and 26b do not shift.
  • the markers 26 a and 26 b of the inner pipe portion 21 are mounted as a platinum ring between the inner tip 24 and the inner pipe portion 21.
  • the present invention is not limited to such a configuration, and as shown in FIG. 7, a cylindrical marker region in the inner tube portion 21 using a resin mixed with powder made of a material that does not transmit radiation (X-rays) such as tungsten. 29a and 29b may be formed.
  • X-rays a material that does not transmit radiation
  • 29a and 29b may be formed.
  • the formation of the marker areas 29a and 29b generally tends to be difficult to place with high accuracy and the outline is unclear.
  • an outer catheter for delivering a device (balloon catheter or the like) is illustrated, but it may be configured as an outer catheter that functions as a suction catheter, for example.
  • the outer catheter 11a of the modified example is different from the tube structure 41a on the distal end side in which a lumen for suction (not shown) is formed, and the tube structure 41a.
  • the outer side tip 46a with increased flexibility, the tube structure 42a on the near end side, and the outer knob 47a are provided.
  • the outer catheter 11a has a lumen for suction inside, the outer catheter 11a can function as a suction catheter. Since the lumen for suction of the outer catheter 11a has a diameter sufficient to pass a device such as a balloon catheter, the outer catheter 11a can also function as a device delivery catheter.
  • the inner tip 24 is made of a material having a larger longitudinal elastic modulus than the inner tube portion 21, but the inner tube portion 21 has a larger longitudinal elastic modulus than the inner tip 24. You may make it comprise with material. By so doing, it is possible to reduce the burden on the human tissue when inserted with the inner chip 24.
  • the inner tip 24 is mounted in the axial direction of the inner pipe portion 21, but the inner tip 24 may be mounted inclined with respect to the axial direction of the inner pipe portion 21. good.
  • a rapid exchange type (Rx type) catheter assembly is illustrated, but the present invention is also applicable to an over-the-wire type (OTW type) catheter assembly.
  • Rx type rapid exchange type
  • OW type over-the-wire type
  • the catheter assembly is illustrated, but the present invention is not limited to the catheter assembly, and the present invention may be applied to the catheter.
  • a catheter for delivering a device has been described as an example.
  • the present invention is applied to a catheter such as an angiographic catheter, a blood vessel indwelling catheter, a suction catheter, or a penetration catheter. can do.
  • the present invention is generally applicable to catheters guided by a guide wire.
  • SYMBOLS 10 Catheter assembly, 11 ... Outer catheter, 12 ... Inner catheter, 21 ... Inner tube part, 21e ... Distal end, 22 ... Inner shaft part, 23 ... Guide wire lumen, 23b ... Proximal end opening, 24 ... Inner Tip, 24b ... projecting portion, 25 ... base tube portion, 25a ... tapered region.

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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

La présente invention a pour but de fournir une technique destinée à améliorer l'aptitude à l'introduction d'un cathéter dans une lumière du corps humain à l'aide d'un fil-guide. La présente invention porte sur un cathéter (12) qui est guidé par un fil-guide (61). Le cathéter (12) comprend : une section de guidage (21) ayant une extrémité conique (25a), la section de guidage comportant, formée dans celle-ci, une première lumière de fil (23) à travers laquelle le fil-guide (61) est amené à passer ; et une pointe interne (24) fixée à l'intérieur de l'extrémité (25a), la pointe interne comportant, formée dans celle-ci, une seconde lumière de fil (24a) en communication avec la première lumière de fil (23). Grâce à cette structure, il est possible d'offrir une souplesse de conception pour lisser un passage à travers un site à travers lequel il est difficile de passer, tel qu'une région extrêmement rétrécie par une lésion ou une région durcie par calcification.
PCT/JP2010/066047 2010-09-16 2010-09-16 Cathéter et ensemble cathéter WO2012035633A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/JP2010/066047 WO2012035633A1 (fr) 2010-09-16 2010-09-16 Cathéter et ensemble cathéter
JP2012533788A JPWO2012035633A1 (ja) 2010-09-16 2010-09-16 カテーテル及びカテーテル組立体

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2010/066047 WO2012035633A1 (fr) 2010-09-16 2010-09-16 Cathéter et ensemble cathéter

Publications (1)

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WO2012035633A1 true WO2012035633A1 (fr) 2012-03-22

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Country Link
JP (1) JPWO2012035633A1 (fr)
WO (1) WO2012035633A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015146408A1 (fr) * 2014-03-28 2015-10-01 テルモ株式会社 Ensemble cathéter et cathéter interne
EP2944344A1 (fr) * 2014-05-13 2015-11-18 Asahi Intecc Co., Ltd. Cathéter
US10322260B2 (en) 2013-05-30 2019-06-18 Terumo Kabushiki Kaisha Treatment method for treating lower limbs using multi-member catheter assembly
CN112155656A (zh) * 2015-02-04 2021-01-01 92号医疗公司 快速抽吸血栓清除系统和方法
US11793529B2 (en) 2015-02-04 2023-10-24 Route 92 Medical, Inc. Aspiration catheter systems and methods of use
US11871944B2 (en) 2011-08-05 2024-01-16 Route 92 Medical, Inc. Methods and systems for treatment of acute ischemic stroke
US11925770B2 (en) 2018-05-17 2024-03-12 Route 92 Medical, Inc. Aspiration catheter systems and methods of use

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JPH05503439A (ja) * 1989-11-13 1993-06-10 ボストン　サイエンティフィック　コーポレーション 可溶性チップを備えたカテーテル
JP2005501613A (ja) * 2001-08-31 2005-01-20 ボストン サイエンティフィック リミテッド 改良型遠位先端および移行部を備えたマイクロカテーテル
JP2008523891A (ja) * 2004-12-16 2008-07-10 ボストン サイエンティフィック リミテッド ワイヤの固着を低減するカテーテルチップ
JP2008543399A (ja) * 2005-06-16 2008-12-04 アンギオメット ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コムパニー メディツィンテヒニク コマンデイトゲゼルシャフト カテーテル装置

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JP5221032B2 (ja) * 2006-12-11 2013-06-26 株式会社グツドマン 挿入補助具、カテーテル組立体及びカテーテルセット

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05503439A (ja) * 1989-11-13 1993-06-10 ボストン　サイエンティフィック　コーポレーション 可溶性チップを備えたカテーテル
JP2005501613A (ja) * 2001-08-31 2005-01-20 ボストン サイエンティフィック リミテッド 改良型遠位先端および移行部を備えたマイクロカテーテル
JP2008523891A (ja) * 2004-12-16 2008-07-10 ボストン サイエンティフィック リミテッド ワイヤの固着を低減するカテーテルチップ
JP2008543399A (ja) * 2005-06-16 2008-12-04 アンギオメット ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コムパニー メディツィンテヒニク コマンデイトゲゼルシャフト カテーテル装置

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11871944B2 (en) 2011-08-05 2024-01-16 Route 92 Medical, Inc. Methods and systems for treatment of acute ischemic stroke
US11602614B2 (en) 2013-05-30 2023-03-14 Terumo Kabushiki Kaisha Treatment method using catheter assembly and catheter assembly
US10322260B2 (en) 2013-05-30 2019-06-18 Terumo Kabushiki Kaisha Treatment method for treating lower limbs using multi-member catheter assembly
JPWO2015146408A1 (ja) * 2014-03-28 2017-04-13 テルモ株式会社 カテーテル組立体および内カテーテル
WO2015146408A1 (fr) * 2014-03-28 2015-10-01 テルモ株式会社 Ensemble cathéter et cathéter interne
EP2944344A1 (fr) * 2014-05-13 2015-11-18 Asahi Intecc Co., Ltd. Cathéter
CN112155656A (zh) * 2015-02-04 2021-01-01 92号医疗公司 快速抽吸血栓清除系统和方法
EP4137070A1 (fr) * 2015-02-04 2023-02-22 Route 92 Medical, Inc. Système de thrombectomie par aspiration rapide
US11633571B2 (en) 2015-02-04 2023-04-25 Route 92 Medical, Inc. Rapid aspiration thrombectomy system and method
US11633570B2 (en) 2015-02-04 2023-04-25 Route 92 Medical, Inc. Rapid aspiration thrombectomy system and method
US11793972B2 (en) 2015-02-04 2023-10-24 Route 92 Medical, Inc. Rapid aspiration thrombectomy system and method
US11793529B2 (en) 2015-02-04 2023-10-24 Route 92 Medical, Inc. Aspiration catheter systems and methods of use
US11806032B2 (en) 2015-02-04 2023-11-07 Route 92 Medical, Inc. Aspiration catheter systems and methods of use
US11925770B2 (en) 2018-05-17 2024-03-12 Route 92 Medical, Inc. Aspiration catheter systems and methods of use

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