WO2014199519A1 - Cathéter et méthode d'utilisation de cathéter - Google Patents

Cathéter et méthode d'utilisation de cathéter Download PDF

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Publication number
WO2014199519A1
WO2014199519A1 PCT/JP2013/066506 JP2013066506W WO2014199519A1 WO 2014199519 A1 WO2014199519 A1 WO 2014199519A1 JP 2013066506 W JP2013066506 W JP 2013066506W WO 2014199519 A1 WO2014199519 A1 WO 2014199519A1
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WO
WIPO (PCT)
Prior art keywords
catheter
inner layer
tip
soft
shaft
Prior art date
Application number
PCT/JP2013/066506
Other languages
English (en)
Japanese (ja)
Inventor
福岡徹也
江畑勝紀
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
Priority to PCT/JP2013/066506 priority Critical patent/WO2014199519A1/fr
Priority to JP2015522375A priority patent/JP6162802B2/ja
Publication of WO2014199519A1 publication Critical patent/WO2014199519A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008—Strength or flexibility characteristics of the catheter tip
    • 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
    • A61M25/008—Strength or flexibility characteristics of the catheter tip
    • A61M2025/0081—Soft tip
    • 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

Definitions

  • the present invention relates to a catheter having a soft tip at the tip of a shaft and a method for using the catheter.
  • the catheter is inserted into a blood vessel or body cavity, for example, for injecting a therapeutic drug or injecting a contrast medium for diagnosis, or a therapeutic device (balloon catheter, microcatheter, stent, etc.) in a target position in the blood vessel.
  • a therapeutic device balloon catheter, microcatheter, stent, etc.
  • the catheter needs to be selectively advanced along a guide wire introduced in advance in a blood vessel or a body cavity branched in a complicated manner in the body.
  • the soft tip has sufficient flexibility so as not to damage the inner wall of the blood vessel.
  • the catheter is advanced in the blood vessel, if the soft tip is deformed (collapsed) in the axial direction, the moving distance of the distal end portion becomes shorter than the pushing distance of the proximal end portion of the catheter, and the operability is deteriorated. .
  • the present invention has been made in consideration of the above-mentioned problems, and prevents or suppresses the soft tip from being crushed in the axial direction by smoothly changing the flexibility in the connection region between the shaft and the soft tip. It is an object of the present invention to provide a catheter that can be used and a method of using the catheter.
  • a catheter comprising a tubular shaft and a soft tip provided at the tip of the shaft, the shaft comprising an inner layer and an outer layer provided outside the inner layer And at least a part of the tip portion of the inner layer exists inside the soft chip, and an inner layer existence region where the inner layer exists along a circumferential direction in a cross section including the tip portion of the inner layer. And an inner layer non-existing region in which the inner layer does not exist.
  • the inner layer existing region and the inner layer non-existing region are formed in the cross section including the tip portion of the inner layer, the change in flexibility along the axial direction in the connecting region between the shaft and the soft tip. Can be smoothed.
  • the boundary between the soft tip and the inner layer is larger than the catheter in which the boundary between the soft tip and the inner layer is the same axial position in the entire circumference, the bonding strength can be increased. .
  • the inner layer existence region and the soft tip may be in direct contact with each other in the radial direction. According to this configuration, the bonding strength between the soft tip and the shaft can be obtained by simple bonding.
  • the diameters of the soft tip and the outer layer that exist on the outer side in the radial direction of the portion where the inner layer existing region and the inner layer non-existing region are formed along the circumferential direction may be constant in the axial direction.
  • the joint surface between the soft tip and the outer layer may be formed only on a plane perpendicular to the axial direction.
  • a plurality of the inner layer existing region and the inner layer non-existing region may be formed. According to this configuration, it is possible to further smooth the change in flexibility along the axial direction in the connection region between the shaft and the soft tip, and to increase the area of the coupling surface between the soft tip and the inner layer. And the bond strength can be further increased.
  • a plurality of protrusions protruding in the distal direction may be provided in the circumferential direction at the distal end of the inner layer.
  • the distal end portion may have an end surface perpendicular to the axial direction between the adjacent protruding portions, and the end surface may have a portion extending in the circumferential direction.
  • the plurality of protrusions may have at least a portion having a constant width along the axis of the soft tip.
  • the plurality of protrusions may have at least a portion whose width decreases in the distal direction.
  • the plurality of protruding portions may have different protruding lengths at least in part.
  • the plurality of protruding portions may have different circumferential intervals at least in part.
  • a part of the inner layer non-existing region may be formed inside the outer layer.
  • the shaft may have a reinforcing layer between the outer layer and the inner layer.
  • the present invention also relates to a method of using a catheter for running a catheter in a blood vessel or body cavity of a living body, the catheter comprising a tube-shaped shaft and a soft tip provided at the tip of the shaft.
  • FIG. 5 is a transverse sectional view taken along line VV in FIG. 3.
  • 6A is a perspective view of the distal end portion of the catheter according to the second embodiment of the present invention
  • FIG. 6B is a longitudinal sectional view of the distal end portion of the catheter shown in FIG. 6A.
  • FIG. 6B is a cross-sectional view taken along line VII-VII in FIG. 6B.
  • FIG. 8A is a longitudinal sectional view of the distal end portion of the catheter according to the third embodiment of the present invention
  • FIG. 8B is a transverse sectional view taken along line VIIIB-VIIIB in FIG. 8A
  • FIG. 9A is a longitudinal sectional view of a distal end portion of a catheter according to a fourth embodiment of the present invention
  • FIG. 9B is a transverse sectional view taken along line IXB-IXB in FIG. 9A.
  • FIG. 1 is a partially omitted side view showing the configuration of the catheter 10A according to the first embodiment of the present invention.
  • the catheter 10A is inserted into a blood vessel or body cavity, for example, for injecting a therapeutic drug or injecting a contrast medium for diagnosis, or a therapeutic device (balloon catheter, microcatheter, stent, etc.) in a target position in the blood vessel.
  • a therapeutic device balloon catheter, microcatheter, stent, etc.
  • the catheter 10A can be configured as, for example, a diagnostic catheter, a guiding catheter, or the like.
  • the catheter 10A can be configured, for example, for intracerebral therapy, cardiac therapy, or peripheral vascular therapy.
  • the catheter 10 ⁇ / b> A includes a thin and long shaft 12, a soft tip 14 provided at the distal end of the shaft 12, a hub 16 connected to the proximal end of the shaft 12, And a strain relief 18 provided at a connection portion to the hub 16.
  • the hub 16 side is also referred to as a proximal end side
  • the side opposite to the side to which the hub 16 is connected is also referred to as a distal end side, and the same applies to other drawings.
  • the shaft 12 constitutes a catheter main body inserted into a living body lumen such as a blood vessel, and has a flexibility in which a lumen 13 (see also FIG. 3) communicating from the distal end to the proximal end is formed. It is a long and thin tubular member.
  • the length of the shaft 12 is about 500 mm to 2000 mm, preferably about 1000 mm to 1500 mm.
  • the shaft is formed in a straight line shape, but the tip portion of the shaft may have a specific shape (for example, Judkins shape) that is curved or bent in advance. Details of the structure of the shaft 12 will be described later.
  • FIG. 2 is a perspective view of the distal end portion of the catheter 10A.
  • the soft tip 14 is a hollow member (in the illustrated example, a hollow cylindrical shape) connected to the tip of the shaft 12.
  • the soft chip 14 is made of a flexible material, and its tip is preferably rounded.
  • the length of the soft chip 14 is not particularly limited, but is set to, for example, about 0.1 mm to 10 mm, preferably about 0.5 mm to 2 mm.
  • Examples of the constituent material of the soft chip 14 include various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, chloroprene rubber, silicone rubber, fluorine rubber, styrene-butadiene rubber, styrene, polyolefin, polyurethane, polyester. And various thermoplastic elastomers such as polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene.
  • rubber materials such as natural rubber, isoprene rubber, butadiene rubber, chloroprene rubber, silicone rubber, fluorine rubber, styrene-butadiene rubber, styrene, polyolefin, polyurethane, polyester.
  • thermoplastic elastomers such as polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene.
  • the hub 16 holds the proximal end of the shaft 12 at the distal end, and other instruments such as a syringe can be connected to the proximal end.
  • the hub 16 can be made of, for example, a hard resin such as polycarbonate, polyethylene, polypropylene, or nylon.
  • the strain relief 18 is for preventing bending (kinking) at the connection portion of the shaft 12 to the hub 16.
  • the strain relief 18 is formed of a resin having moderate flexibility and rigidity formed in a tapered tube shape. It is a member.
  • the strain relief 18 can be made of a material similar to that of the shaft 12.
  • FIG. 3 is a longitudinal sectional view of the distal end portion of the catheter 10A.
  • the shaft 12 has an inner layer 20 in which a lumen 13 is formed, and an outer layer 22 formed on the outer side in the radial direction of the inner layer 20.
  • the inner layer 20 is a long tubular body.
  • the inner layer 20 may be continuously formed of the same material and seamlessly over the entire length, or may be formed by connecting a plurality of regions having different hardnesses in the axial direction.
  • the inner layer 20 can be made of, for example, a synthetic resin having moderate flexibility.
  • the inner layer 20 may be made of a low friction material.
  • low friction materials include polyamide, polyether polyamide, polyester polyamide, polyester (polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, etc.), polyurethane, soft polyvinyl chloride, ABS resin, AS resin, polytetrafluoroethylene.
  • Various resin materials such as fluorine-based resins such as (PTFE) can be used.
  • the outer layer 22 is a long tubular body.
  • the outer layer 22 may be formed continuously with the same material over its entire length, or may be formed by connecting a plurality of regions having different hardness in the axial direction.
  • the plurality of regions having different hardnesses may be arranged such that the hardness decreases (flexibility increases) toward the distal direction.
  • the outer layer 22 can be made of a synthetic resin having moderate flexibility.
  • the constituent material of the outer layer 22 include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, and the like.
  • the inner layer 20 and the outer layer 22 may be made of other materials.
  • the cross-sectional shapes of the inner layer 20 and the outer layer 22 in a natural state are substantially circular.
  • the inner diameter of the shaft 12 (the inner diameter of the inner layer 20) may be constant over the entire length of the shaft 12, or may change midway.
  • the inner diameter of the shaft 12 may be reduced toward the distal end.
  • the inner diameter of the shaft 12 is set to about 0.2 mm to 10 mm, and preferably about 0.5 mm to 2.8 mm.
  • the outer diameter of the shaft 12 (the outer diameter of the outer layer 22) may be constant over the entire length of the shaft 12, or may change in the middle.
  • the outer diameter of the shaft 12 may decrease in the distal direction.
  • the outer diameter of the shaft 12 is set to, for example, about 1 mm to 10 mm, preferably about 1 mm to 3 mm.
  • the inner layer 20 protrudes to the tip side from the outer layer 22.
  • the front end portion 20 a of the inner layer 20 extends beyond the boundary portion 23 between the soft chip 14 and the outer layer 22 to the inside of the soft chip 14.
  • the most advanced position of the tip 20a of the inner layer 20 reaches halfway in the axial direction of the soft tip 14 and does not reach the tip of the soft tip 14.
  • the inner layer 20 may have a portion that reaches the tip of the soft tip 14.
  • the radial thickness of the tip 20a of the inner layer 20 is constant in the axial direction.
  • the inner diameters of the soft tip 14 and the inner layer 20 are constant in the axial direction.
  • the tip portion 20a of the inner layer 20 is different in at least a part of the circumferential direction in the axial position of the most distal portion at each circumferential position.
  • the tip portion 20a of the inner layer 20 is provided with a plurality of protruding portions 24 protruding in the tip direction at intervals in the circumferential direction. 2 and 3, the plurality of protrusions 24 have a constant width along the axial direction of the soft chip 14. Accordingly, the plurality of protrusions 24 extend in parallel to each other.
  • Each protrusion 24 is not limited to a shape having a constant width along the axial direction of the soft chip 14 over the entire length of the protrusion 24, and has at least a portion having a constant width along the axial direction. If you do.
  • the plurality of protrusions 24 have a relatively long protrusion 24a and a relatively short protrusion 24b.
  • the relatively long protrusions 24a and the relatively short protrusions 24b are alternately arranged in the circumferential direction.
  • the length of the protrusions 24 is not limited to two patterns, and three or more protrusions 24 having different lengths may be provided. Alternatively, the lengths of the plurality of protrusions 24 may all be the same.
  • the relatively long protrusions 24a may be arranged adjacent to each other at intervals in the circumferential direction.
  • the relatively short protrusions 24b may be arranged adjacent to each other at intervals in the circumferential direction.
  • some of the plurality of protrusions 24 are inclined with respect to the other protrusions 24, that is, extend non-parallel to the other protrusions 24. Also good.
  • the plurality of protrusions 24 may have different circumferential intervals at least in part. Accordingly, in FIG. 2 and FIG. 3, the intervals in the circumferential direction of the plurality of protrusions 24 are all the same, but the intervals may be partially different.
  • the axial distance from the most advanced position of the inner layer 20 (the most advanced position of the relatively long protruding portion 24a in this embodiment) to the base end surface 14a of the soft chip 14 is, for example, 5 to 90% of the entire length of the soft chip 14.
  • the length is preferably set to 20 to 50%.
  • the axial position of the root 25 of the projecting portion 24 substantially coincides with the proximal end surface 14a of the soft tip 14 (the boundary portion 23 between the soft tip 14 and the outer layer 22).
  • the root 25 of the protruding portion 24 may be disposed inside the outer layer 22. That is, the protruding portion 24 may extend from a position inside the outer layer 22 and may reach the inside of the soft chip 14 beyond the boundary portion 23 between the soft chip 14 and the outer layer 22.
  • the tip 20a has an end face 24c (see FIG.
  • the end surface 24 c perpendicular to the axial direction has a portion extending in the circumferential direction along the boundary portion 23 between the soft chip 14 and the outer layer 22.
  • the distal end portion 20 a of the inner layer 20 may be integrally formed with a portion closer to the proximal end than the distal end portion 20 a of the inner layer 20 (hereinafter referred to as “long tubular inner layer 21”).
  • tip part 20a of the inner layer 20 is comprised as a member different from the elongate tubular inner layer 21, and may be joined to the elongate tubular inner layer 21 by the junction part 26 shown with a virtual line in FIG.
  • the joint portion 26 may be disposed on the inner side of the outer layer 22 (the proximal end side with respect to the boundary portion 23 between the soft chip 14 and the outer layer 22), and on the inner side of the boundary portion 23 between the soft chip 14 and the outer layer 22. It may be arranged on the inner side of the soft chip 14 (the tip side of the boundary part 23 between the soft chip 14 and the outer layer 22).
  • All of the boundary portion 23 (joint surface) between the soft chip 14 and the outer layer 22 is formed only in the circumferential direction and not in the axial direction. That is, all the boundary portions 23 are formed only on a plane perpendicular to the axial direction of the catheter 10A.
  • the soft chip 14 and the outer layer 22 are joined at the end surfaces without overlapping in the axial direction. Therefore, the outer layer 22 does not exist inside the soft tip 14 in the radial direction. Further, the outer layer 22 is not present at the forefront of the catheter 10A.
  • the soft tip 14 is present at the tip of the catheter 10 ⁇ / b> A, and the tip of the outer layer 22 is located on the proximal side of the tip of the soft tip 14.
  • FIG. 5 is a cross-sectional view taken along line VV in FIG.
  • an inner layer existence region 30 where the inner layer 20 exists and an inner layer non-existence region 32 where the inner layer 20 does not exist are formed along the circumferential direction in the cross section including the tip 20 a of the inner layer 20.
  • the inner layer existence region 30 is formed by the protrusion 24, and the soft chip 14 existing between the protrusions 24 adjacent in the circumferential direction is arranged in the inner layer non-existence region 32.
  • the some protrusion part 24 is provided, the some inner layer presence area
  • the inner diameter and the outer diameter of the catheter 10A are constant in the circumferential direction. Note that the soft chip 14 may not be present between the protrusions 24 adjacent in the circumferential direction.
  • the inner layer existence region 30 formed by the protrusion 24 and the soft tip 14 are in direct contact with each other in the radial direction. That is, the outer layer 22 does not exist between the inner layer existence region 30 and the soft chip 14 in the radial direction.
  • the shaft 12 and the soft tip are formed only by the joint portion between the soft tip 14 and the inner layer existence region 30 formed by the protrusion 24 and the joint portion (boundary portion 23) between the soft tip 14 and the outer layer 22.
  • a bond strength of 14 is obtained. Therefore, the flexibility along the axial direction in the connection region between the shaft 12 and the soft tip 14 can be adjusted by simple joining.
  • the surface on the inner cavity 13 side of the soft chip 14 is in contact with the inner layer 20 to form an inner layer existence area 30 or is exposed to the inner cavity 13 to form an inner layer nonexistence area 32.
  • a portion of the soft chip 14 forming the inner layer non-existing region 32 adjacent to the inner layer existing region 30 in the circumferential direction is directly exposed to the inner cavity 13.
  • the respective thicknesses of the soft tip 14 and the outer layer 22 in the radial direction existing outside the soft chip 14 and the outer layer 22 in the radial direction of the portion where the inner layer existing region 30 and the inner layer non-existing region 32 are formed along the circumferential direction. Is constant in the axial direction.
  • the radially outer side of the inner layer existing region 30 and the radially inner side of the soft tip 14 are in direct contact, and the outer layer 22 exists between the radially outer side of the inner layer existing region 30 and the radially inner side of the soft chip 14. do not do.
  • the insertion of the catheter 10A into the body is performed while confirming the position under X-ray fluoroscopy. Therefore, the X-ray (radiation) is not contained in the constituent material of the shaft 12 (one or both of the inner layer 20 and the outer layer 22).
  • a permeable material may be blended. Examples of the radiopaque material include barium sulfate, bismuth oxide, and tungsten.
  • An X-ray opaque material may be blended in the material constituting the soft chip 14 described above. Note that a marker made of an X-opaque material or including an X-ray-opaque material may be provided at the tip of the shaft 12.
  • the shaft 12 further includes a reinforcing layer 27 between the inner layer 20 and the outer layer 22.
  • the reinforcing layer 27 has a reinforcing member 28 composed of one or a plurality of reinforcing wires 29 (linear bodies) that reinforce the shaft 12.
  • a reinforcing wire 29 having a spiral shape or a net shape may be used.
  • a stainless steel wire is crushed into a flat plate shape (strip shape) so that the thickness of the shaft 12 in the radial direction is reduced, and a spiral or knitted product (braided body).
  • the constituent material of the reinforcing wire 29 include a metal, a polymer, a composite of metal and polymer, a metal alloy (for example, stainless steel), or a combination thereof.
  • a method of using a catheter for running the catheter 10A in a blood vessel or body cavity of a living body includes a providing step for providing the catheter 10A configured as described above, and a running for inserting the catheter 10A into a blood vessel or body cavity and running it. Steps.
  • a portion of the catheter 10A exposed from the outside of the body is grasped, and the portion is operated (pushed or rotated), so that the distal end portion of the catheter 10A reaches the target position in the blood vessel or body cavity.
  • the guide wire is advanced and the catheter 10A is run along the guide wire.
  • catheters 10B to 10D described later can also be used in the same manner as the catheter 10A.
  • the catheter 10A according to the present embodiment is basically configured as described above, and the operation and effect thereof will be described below.
  • the axial direction is provided along the axial direction in the connection region between the shaft 12 and the soft tip 14.
  • the change in flexibility can be smoothed.
  • the soft tip 14 can be prevented or suppressed from being deformed (collapsed) in the axial direction. That is, unlike the present embodiment, in the case of a catheter in which the boundary between the soft tip and the inner layer is the same axial position on the entire circumference, the change in flexibility in the axial direction is large. As it advances, the soft tip collapses in the axial direction.
  • the area of the coupling surface between the soft tip 14 and the inner layer 20 is compared with the catheter in which the boundary between the soft tip and the inner layer is the same axial position on the entire circumference in the circumferential direction. Therefore, the bond strength can be increased.
  • a plurality of inner layer existence regions 30 and a plurality of inner layer non-existence regions 32 are formed. According to this configuration, the change in flexibility along the axial direction can be further smoothed in the connection region between the shaft 12 and the soft tip 14. Further, the area of the bonding surface between the soft chip 14 and the inner layer 20 can be increased, and the bonding strength can be further increased.
  • a plurality of protrusions 24 protruding in the distal direction are provided in the distal end portion 20a of the inner layer 20 in the circumferential direction, so that a plurality of inner layer existence regions 30 and inner layer non-existence regions 32 are provided inside the soft chip 14. Can be easily formed.
  • the plurality of protrusions 24 extend in a columnar shape along the axis of the soft chip 14, so that the area of the coupling surface between the soft chip 14 and the inner layer 20 can be increased, and the coupling strength can be increased. Can be further enhanced.
  • the change in flexibility along the axial direction in the connection region between the shaft 12 and the soft tip 14 is further smoothed. Can do.
  • FIG. 6A is a perspective view of the distal end portion of the catheter 10B according to the second embodiment of the present invention.
  • FIG. 6B is a longitudinal sectional view of the distal end portion of the catheter 10B.
  • elements having the same or similar functions and effects as those of the catheter 10A according to the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted.
  • each protrusion 34 has a width (circumferential dimension) that decreases in the distal direction. That is, each protrusion 34 has a substantially triangular shape.
  • Each protrusion 34 is not limited to a shape in which the width decreases toward the distal end direction over the entire length of the protrusion 34, and it is only necessary to have at least a portion in which the width decreases.
  • the tip shape of the inner layer 20 is zigzag in the circumferential direction.
  • the protruding lengths of the plurality of protruding portions 34 are all the same, but among the plurality of protruding portions 34, some protruding portions 34 may have different protruding lengths.
  • the thickness of each protrusion 34 (the dimension along the radial direction of the soft tip 14) may be constant in the axial direction or may vary. Therefore, at least one or a plurality of protrusions 34 may have a shape whose thickness decreases toward the distal end, for example, a triangular pyramid, a cone, or the like.
  • the intervals in the circumferential direction of the top portion 35 of each protrusion 34 are all the same, but some intervals may be different from the intervals in other portions.
  • the axial distance from the most advanced position of the inner layer 20 (in this embodiment, the position of the top portion 35 of the protruding portion 34) to the base end surface 14a of the soft tip 14 is, for example, 5 to 90% of the total length of the soft tip 14. And is preferably set to a length of 10 to 70%.
  • the axial position of the base 34a of the projecting portion 34 (the most proximal end portion of the projecting portion 34) substantially coincides with the base end surface 14a of the soft tip 14 (the boundary portion 23 between the soft tip 14 and the outer layer 22).
  • the root 34a of the projecting portion 34 (the most proximal end portion of the projecting portion 34) may be disposed on the inner side of the outer layer 22. That is, the protruding portion 34 may extend from a position inside the outer layer 22 and reach the inside of the soft chip 14 beyond the boundary portion 23 between the soft chip 14 and the outer layer 22.
  • an inner layer existing region 36 where the inner layer 20 exists and an inner layer non-existing region 38 where the inner layer 20 does not exist are formed along the circumferential direction.
  • the inner layer existence region 36 is formed by the protrusions 34, and the soft chip 14 existing between the protrusions 34 adjacent in the circumferential direction is arranged in the inner layer non-existence region 38.
  • the some protrusion part 34 is provided, the some inner layer presence area
  • the inner layer existence region 36 formed by the protrusion 34 and the soft tip 14 are in direct contact with each other in the radial direction. That is, the outer layer 22 does not exist between the inner layer existence region 36 and the soft tip 14 in the radial direction.
  • the surface of the soft chip 14 on the inner cavity 13 side is in contact with the inner layer 20 to form an inner layer existence area 36 or is exposed to the inner cavity 13 to form an inner layer nonexistence area 38.
  • a portion of the soft chip 14 that forms the inner layer non-existing region 38 adjacent to the inner layer existing region 36 in the circumferential direction is directly exposed to the inner cavity 13.
  • the respective thicknesses of the soft tip 14 and the outer layer 22 in the radial direction existing outside the soft chip 14 and the outer layer 22 in the radial direction of the portion where the inner layer existing region 36 and the inner layer non-existing region 38 are formed along the circumferential direction. Is constant in the axial direction.
  • the inner layer existing region 36 and the inner layer non-existing region 38 are formed in the cross section including the distal end portion 20b of the inner layer 20, so that the connection between the shaft 12 and the soft tip 14 is achieved.
  • the change in flexibility along the axial direction can be smoothed in the region. Therefore, similarly to the first embodiment, when the catheter 10B is advanced in the blood vessel, the soft tip 14 can be prevented or suppressed from being deformed (collapsed) in the axial direction.
  • the area of the coupling surface between the soft chip 14 and the inner layer 20 can be increased, the coupling strength can be increased.
  • the same effects as those of the first embodiment can be obtained by the second embodiment.
  • FIG. 8A is a longitudinal sectional view of a distal end portion of a catheter 10C according to a third embodiment of the present invention.
  • 8B is a lateral end view taken along line VIIIB-VIIIB in FIG. 8A. Note that, in the catheter 10C according to the third embodiment, elements having the same or similar functions and effects as those of the catheter 10A according to the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted.
  • a part of the tip 20c of the inner layer 20 exists inside the soft tip 14.
  • a plurality of projecting portions 40 projecting in the distal direction are provided on the distal end portion 20c of the inner layer 20 in the circumferential direction.
  • the plurality of protrusions 40 extend in a direction inclined with respect to the axial direction of the soft tip 14.
  • the protruding lengths of the plurality of protruding portions 40 are all the same, but at least some of the protruding portions 40 among the plurality of protruding portions 40 may have different protruding lengths.
  • the intervals in the circumferential direction of the top portions 41 of the protrusions 40 are all the same, but some intervals may be different from the intervals in other portions.
  • the axial distance from the most advanced position of the inner layer 20 (in this embodiment, the position of the top 41 of the protrusion 40) to the base end surface 14a of the soft tip 14 is, for example, 5 to 95% of the total length of the soft tip 14. And is preferably set to a length of 10 to 90%.
  • the axial position of the base 40a of the protrusion 40 substantially coincides with the base end surface 14a of the soft tip 14 (the boundary 23 between the soft tip 14 and the outer layer 22).
  • the root 40a of the protruding portion 40 (the most proximal end portion of the protruding portion 40) may be disposed on the inner side of the outer layer 22. That is, the protrusion 40 may extend from a position inside the outer layer 22 and may reach the inside of the soft chip 14 beyond the boundary 23 between the soft chip 14 and the outer layer 22.
  • an inner layer existing region 42 where the inner layer 20 exists and an inner layer non-existing region 44 where the inner layer 20 does not exist are formed along the circumferential direction.
  • the inner layer existence region 42 is formed by the protrusion 40, and the soft chip 14 existing between the protrusions 40 adjacent in the circumferential direction is arranged in the inner layer non-existence region 44.
  • the some protrusion part 40 is provided, the some inner layer presence area
  • the inner layer existence region 42 formed by the protrusion 40 and the soft tip 14 are in direct contact with each other in the radial direction. That is, the outer layer 22 does not exist between the inner layer existence region 42 and the soft chip 14 in the radial direction.
  • the surface on the inner cavity 13 side of the soft chip 14 is in contact with the inner layer 20 to form an inner layer existence area 42 or is exposed to the inner cavity 13 to form an inner layer nonexistence area 44.
  • a portion of the soft chip 14 forming the inner layer non-existing region 44 adjacent to the inner layer existing region 42 in the circumferential direction is directly exposed to the inner cavity 13.
  • Each thickness of the soft tip 14 and the outer layer 22 in the radial direction of the soft chip 14 and the outer layer 22 that are present on the radially outer side of the portion where the inner layer existing region 42 and the inner layer non-existing region 44 are formed along the circumferential direction. Is constant in the axial direction.
  • the inner layer existing region 42 and the inner layer non-existing region 44 are formed in the cross section including the distal end portion 20c of the inner layer 20, so that the connection between the shaft 12 and the soft tip 14 is achieved.
  • the change in flexibility along the axial direction can be smoothed in the region. Therefore, similarly to the first embodiment, when the catheter 10C is advanced in the blood vessel, the soft tip 14 can be prevented or suppressed from being deformed (collapsed) in the axial direction.
  • the area of the coupling surface between the soft chip 14 and the inner layer 20 can be increased, the coupling strength can be increased.
  • the same effects as those of the first embodiment can be obtained by the third embodiment.
  • FIG. 9A is a longitudinal sectional view of a distal end portion of a catheter 10D according to the fourth embodiment of the present invention.
  • 9B is a lateral end view taken along line IXB-IXB in FIG. 9A.
  • elements having the same or similar functions and effects as those of the catheter 10A according to the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted.
  • a part of the tip 20d of the inner layer 20 exists inside the soft tip 14.
  • a spiral-shaped portion 46 that spirally extends along the inner periphery of the soft chip 14 is provided at the tip portion 20 d of the inner layer 20.
  • a plurality of spiral-shaped portions 46 are provided at intervals in the circumferential direction. Only one spiral-shaped portion 46 may be provided.
  • the leading edge positions of the plurality of spiral-shaped portions 46 are all the same, but the leading edge positions between the plurality of spiral-shaped portions 46 may be different.
  • the intervals in the circumferential direction of the plurality of spiral-shaped portions 46 are all the same, but some intervals may be different from the intervals in other portions.
  • the axial distance from the most advanced position of the inner layer 20 (the most advanced position of the spiral-shaped portion 46 in this embodiment) to the base end surface 14a of the soft chip 14 is, for example, 5 to 95% of the total length of the soft chip 14. And is preferably set to a length of 10 to 90%.
  • the axial position of the root 46a of the spiral-shaped portion 46 (the most proximal end portion of the spiral-shaped portion 46) is substantially coincident with the proximal end surface 14a of the soft tip 14 (the boundary portion 23 between the soft tip 14 and the outer layer 22).
  • the root 46a of the spiral-shaped portion 46 may be disposed inside the outer layer 22. That is, the spiral-shaped portion 46 may extend from a position inside the outer layer 22 and reach the inside of the soft chip 14 beyond the boundary portion 23 between the soft chip 14 and the outer layer 22.
  • an inner layer existing region 48 where the inner layer 20 exists and an inner layer non-existing region 50 where the inner layer 20 does not exist are formed along the circumferential direction.
  • the inner layer existence region 48 is formed by the spiral shape portion 46, and the soft chip 14 existing between the spiral shape portions 46 adjacent in the circumferential direction is arranged in the inner layer non-existence region 50.
  • the soft chip 14 since the plurality of spiral-shaped portions 46 are provided, a plurality of inner layer existence regions 48 and a plurality of inner layer non-existence regions 50 are formed. Note that the soft chip 14 may not be present between the spiral-shaped portions 46 adjacent in the circumferential direction.
  • the inner layer existence region 48 formed by the spiral-shaped portion 46 and the soft tip 14 are in direct contact with each other in the radial direction. That is, the outer layer 22 does not exist between the inner layer existence region 48 and the soft chip 14 in the radial direction.
  • the surface on the inner cavity 13 side of the soft chip 14 is in contact with the inner layer 20 to form an inner layer existence area 48 or is exposed to the inner cavity 13 to form an inner layer nonexistence area 50.
  • a portion of the soft chip 14 that forms the inner layer non-existing region 50 adjacent to the inner layer existing region 48 in the circumferential direction is directly exposed to the lumen 13. Thicknesses in the radial direction of the soft chip 14 and the outer layer 22 existing on the radially outer side of the portion where the inner layer existing region 48 and the inner layer non-existing region 50 are formed along the circumferential direction of the soft chip 14 and the outer layer 22. Is constant in the axial direction.
  • the inner layer existing region 48 and the inner layer non-existing region 50 are formed in the cross section including the distal end portion 20d of the inner layer 20, so that the connection between the shaft 12 and the soft tip 14 is achieved.
  • the change in flexibility along the axial direction can be smoothed in the region. Therefore, similarly to the first embodiment, when the catheter 10D is advanced in the blood vessel, the soft tip 14 can be prevented or suppressed from being deformed (collapsed) in the axial direction.
  • the area of the coupling surface between the soft chip 14 and the inner layer 20 can be increased, the coupling strength can be increased.
  • the same effects as those of the first embodiment can be obtained by the fourth embodiment.

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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

Selon l'invention, le tube (12) d'un cathéter (10A) présente une couche interne (20) et une couche externe (22) mise en place à l'extérieur de la couche interne (20). Au moins une portion de l'extrémité de tête (20a) de la couche interne (20) est présente à l'intérieur d'une pointe molle (14). Dans une section transversale comprenant l'extrémité de tête (20a) de la couche interne (20), des régions comprenant la couche interne (30) dans lesquelles la couche interne (20) est présente et des régions ne comprenant pas la couche interne (32) dans lesquelles la couche interne (20) est absente sont formées le long de la direction de circonférence. La méthode d'utilisation du cathéter comprend une étape de présentation pour la présentation du cathéter (10A) et une étape de fonctionnement dans laquelle le cathéter (10A) est inséré et mis en fonctionnement dans un vaisseau sanguin ou une cavité corporelle.
PCT/JP2013/066506 2013-06-14 2013-06-14 Cathéter et méthode d'utilisation de cathéter WO2014199519A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/JP2013/066506 WO2014199519A1 (fr) 2013-06-14 2013-06-14 Cathéter et méthode d'utilisation de cathéter
JP2015522375A JP6162802B2 (ja) 2013-06-14 2013-06-14 カテーテル

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2013/066506 WO2014199519A1 (fr) 2013-06-14 2013-06-14 Cathéter et méthode d'utilisation de cathéter

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WO2014199519A1 true WO2014199519A1 (fr) 2014-12-18

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11883003B2 (en) 2018-03-26 2024-01-30 Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America Compliant, atraumatic sheath tips

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001137347A (ja) * 1999-11-15 2001-05-22 Nippon Cable Syst Inc 医療用チューブ
JP2001190680A (ja) * 2000-01-12 2001-07-17 Terumo Corp 医療用チューブ
JP2006516218A (ja) * 2003-01-17 2006-06-29 ボストン サイエンティフィック リミテッド 軟性を備えた先頭を有するカテーテルの形成方法

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3345147B2 (ja) * 1993-01-26 2002-11-18 テルモ株式会社 血管拡張器具およびカテーテル
JPH09322940A (ja) * 1996-06-05 1997-12-16 Nippon Zeon Co Ltd カテーテルチューブ及びバルーンカテーテル
JP5225848B2 (ja) * 2006-09-13 2013-07-03 川澄化学工業株式会社 マイクロカテーテル
JP5317566B2 (ja) * 2008-07-30 2013-10-16 テルモ株式会社 カテーテル組立体

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001137347A (ja) * 1999-11-15 2001-05-22 Nippon Cable Syst Inc 医療用チューブ
JP2001190680A (ja) * 2000-01-12 2001-07-17 Terumo Corp 医療用チューブ
JP2006516218A (ja) * 2003-01-17 2006-06-29 ボストン サイエンティフィック リミテッド 軟性を備えた先頭を有するカテーテルの形成方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11883003B2 (en) 2018-03-26 2024-01-30 Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America Compliant, atraumatic sheath tips

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