WO2020255736A1 - カテーテル、及びカテーテルの製造方法 - Google Patents

カテーテル、及びカテーテルの製造方法 Download PDF

Info

Publication number
WO2020255736A1
WO2020255736A1 PCT/JP2020/022151 JP2020022151W WO2020255736A1 WO 2020255736 A1 WO2020255736 A1 WO 2020255736A1 JP 2020022151 W JP2020022151 W JP 2020022151W WO 2020255736 A1 WO2020255736 A1 WO 2020255736A1
Authority
WO
WIPO (PCT)
Prior art keywords
lumen
proximal end
tubular member
reinforcing
inner diameter
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2020/022151
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
知也 加藤
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kaneka Corp
Original Assignee
Kaneka Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kaneka Corp filed Critical Kaneka Corp
Priority to JP2021527575A priority Critical patent/JP7444879B2/ja
Priority to CN202080044309.4A priority patent/CN114025819A/zh
Priority to US17/619,303 priority patent/US12465722B2/en
Publication of WO2020255736A1 publication Critical patent/WO2020255736A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Images

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
    • A61M25/0043—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
    • A61M25/0052—Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • 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
    • A61M25/0009—Making of catheters or other medical or surgical 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/0014—Connecting a tube to a hub
    • 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
    • A61M25/0071—Multiple separate lumens
    • 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
    • A61M25/0133—Tip steering devices
    • A61M25/0136—Handles therefor
    • 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
    • A61M25/0051—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids made from fenestrated or weakened tubing layer

Definitions

  • the present invention relates to a catheter and a method for manufacturing the catheter.
  • Patent Document 1 provides a catheter assembly comprising an elongated flexible tubular shaft having a lumen extending in the longitudinal direction, covering at least a proximal portion of the outer surface of the tubular shaft.
  • those comprising a polymeric tubular sleeve that extends proximally and that include a hub that is located around the tubular shaft and covers at least the polymeric tubular sleeve.
  • Patent Document 1 in manufacturing a catheter having a hub as a handle portion by injection molding, the tubular shaft is coated with a polymer tubular sleeve in order to protect the tubular shaft from heat generated during the injection molding process.
  • the polymer tubular sleeve when the polymer tubular sleeve is coated so as to extend toward the proximal side from the proximal end of the tubular shaft, the proximal end of the tubular shaft is It becomes easy to be protected from the above heat.
  • the tip of the guide wire or the like may be caught in the proximal end of the tubular shaft in the lumen of the polymer tubular sleeve.
  • the polymer tubular sleeve is coated by aligning the proximal end of the tubular shaft with the proximal end of the polymer tubular sleeve, the proximal end of the tubular shaft is poorly protected and heat is generated during the injection molding process. It is considered that unevenness or the like is likely to occur due to dissolution or modification caused by the above, and it may be difficult to insert the wire.
  • the present invention has been made by paying attention to the above problems, and an object of the present invention is to provide a catheter in which a wire can be easily inserted from a handle portion and a method for manufacturing the same.
  • the catheter according to the present invention that has been able to solve the above problems has the following configuration.
  • a tubular member extending in the longitudinal direction and having a distal end and a proximal end, and a handle portion connected to the proximal end of the tubular member.
  • the tubular member has a reinforcing portion including a reinforcing member and a non-reinforcing portion not including a reinforcing member on the proximal side of the reinforcing portion.
  • the non-reinforcing portion has a tapered portion whose inner diameter increases toward the proximal side.
  • the handle portion has a first lumen and a second lumen proximal to the first lumen.
  • the inner diameter of the proximal end of the first lumen is larger than the inner diameter of the distal end of the second lumen.
  • the non-reinforcing portion is fixed to the first lumen so that the proximal end of the non-reinforcing portion is located at the proximal end of the first lumen, and the following equations (1) to (3) are used.
  • a catheter characterized by filling. a ⁇ b ... (1) a ⁇ c ⁇ ⁇ ⁇ (2) b ⁇ c ⁇ ⁇ ⁇ (3)
  • a is the inner diameter (mm) at a position 1 mm away from the proximal end of the reinforcing portion of the tubular member.
  • b is the inner diameter (mm) at the proximal end of the non-reinforcing portion of the tubular member.
  • c is the inner diameter (mm) at the distal end of the second lumen of the handle portion.
  • tubular member having a reinforcing portion including a reinforcing member, a first lumen and a second lumen proximal to the first lumen, and the inner diameter of the proximal end of the first lumen is the second.
  • the inner diameter does not include a reinforcing member on the proximal side of the reinforcing portion and the inner diameter increases toward the proximal side.
  • a non-reinforcing portion having a tapered portion is formed, and the non-reinforcing portion is fixed so that the proximal end thereof is located at the proximal end of the first lumen, and the above equations (1) to (3) are performed.
  • the catheter according to the present invention preferably includes the following configurations [2] to [13].
  • the present invention also includes the method for manufacturing a catheter according to [14] below.
  • [2] The catheter according to [1], wherein the second lumen of the handle portion has a tapered portion whose diameter is reduced toward the distal side.
  • it is provided with a resin sleeve that covers the outer surface of the proximal end portion of the reinforcing portion and extends to the proximal side to form the tapered portion of the non-reinforced portion [3]. 1] or [2].
  • the axial length from the proximal end of the reinforcing portion to the distal end of the sleeve is 2 of the inner diameter a at a position 1 mm away from the proximal end of the reinforcing portion of the tubular member.
  • the thermoplastic resin is at least one selected from the group consisting of polyethylene, polyamide elastomer, polyamide, and polyurethane.
  • the present invention it is possible to provide a catheter in which a wire can be easily inserted from a handle portion and a method for manufacturing the catheter according to the above configuration.
  • FIG. 1 is a cross-sectional view of a catheter according to an embodiment.
  • FIG. 2 is a partially enlarged view of the region R1 of FIG.
  • FIG. 3 is a sectional view taken along line III-III of FIG.
  • FIG. 4 is a partially enlarged view of a cross section of the region R2 of FIG.
  • FIG. 5 is a sectional view taken along line VV of FIG.
  • FIG. 6 is a side view of the catheter according to another embodiment.
  • FIG. 7 is a sectional view taken along line VII-VII of FIG.
  • FIG. 8 is a cross-sectional view showing a manufacturing process of the catheter according to the embodiment.
  • FIG. 9 is a cross-sectional view showing a manufacturing process of the catheter according to the embodiment.
  • the catheter of the present invention has a tubular member extending in the longitudinal direction and having a distal end and a proximal end, and a handle portion connected to the proximal end of the tubular member, and has the tubular shape.
  • the member has a reinforcing portion including a reinforcing member and a non-reinforcing portion not including the reinforcing member on the proximal side of the reinforcing portion, and the inner diameter of the non-reinforcing portion increases toward the proximal side.
  • the handle portion has a tapered portion, and the handle portion has a first lumen and a second lumen proximal to the first lumen, and the inner diameter of the proximal end of the first lumen is
  • the non-reinforcing portion is larger than the inner diameter of the distal end of the second lumen and is located in the first lumen so that the proximal end of the non-reinforcing portion is located at the proximal end of the first lumen. Is fixed and satisfies the following equations (1) to (3). a ⁇ b ...
  • a is the inner diameter (mm) at a position 1 mm away from the proximal end of the reinforcing portion of the tubular member.
  • b is the inner diameter (mm) at the proximal end of the non-reinforcing portion of the tubular member.
  • c is the inner diameter (mm) at the distal end of the second lumen of the handle portion.
  • the present inventor has a tubular member having a reinforcing portion including a reinforcing member, a first lumen and a second lumen proximal to the first lumen, and a proximal end of the first lumen.
  • a catheter provided with a handle portion (hub) having an inner diameter larger than the inner diameter of the distal end of the second lumen, a structure for easily inserting a wire was intensively studied.
  • a non-reinforcing portion is formed on the proximal side of the reinforcing portion and has a tapered portion whose inner diameter increases toward the proximal side without including a reinforcing member, and the proximal end of the non-reinforcing portion is formed. It was found that if the catheter is fixed so as to be located at the proximal end of the first lumen and the above formulas (1) to (3) are satisfied, a catheter in which a wire can be easily inserted from the handle portion can be obtained.
  • the tip As a wire to be inserted into a catheter, the tip is bent in advance and angled in order to search for the entrance of a stenosis in a blood vessel, select a blood vessel, and control the direction of the distal end of the catheter. Guide wires were sometimes used.
  • Such a tip bending wire has a large movement resistance because its tip easily comes into contact with the inner wall of the handle portion (hub) and the inner wall of the tubular member, and is easily caught by unevenness, steps, etc. According to the above configuration, it is possible to easily insert such a tip bending wire that is difficult to insert.
  • FIG. 1 is a cross-sectional view of a catheter according to an embodiment.
  • FIG. 2 is a partially enlarged view of the region R1 of FIG.
  • FIG. 3 is a sectional view taken along line III-III of FIG.
  • the catheter 1 extends in the longitudinal direction X and is attached to a tubular member 10 having a distal end 10A and a proximal end 10B and a proximal end portion 10b of the tubular member 10. It has a handle portion 70 that is connected to the handle portion 70.
  • the tubular member 10 has a reinforcing portion 14 including the reinforcing member 12, and a non-reinforcing portion 15 not including the reinforcing member 12 on the proximal side of the reinforcing portion 14. Further, the non-reinforcing portion 15 has a tapered portion 15T whose inner diameter increases toward the proximal side.
  • the handle portion 70 has a first lumen 71 and a second lumen 72 proximal to the first lumen 71, and the inner diameter of the proximal end 71B of the first lumen 71 is the second inner diameter. It is larger than the inner diameter of the distal end 72A of the cavity 72. Further, the non-reinforcing portion 15 is fixed to the first cavity 71 so that the proximal end 15B of the non-reinforcing portion 15 is located at the proximal end 71B of the first lumen 71.
  • the non-reinforcing portion 15 of the tubular member 10 is arranged in the first lumen 71, and the second lumen 72 communicates with the lumen of the non-reinforcing portion 15 and the reinforcing portion 14.
  • the catheter 1 is configured to satisfy the following formulas (1) to (3) in order to facilitate the insertion of the wire from the second lumen 72 into the lumen of the tubular member 10.
  • a is the inner diameter (mm) at the position 14C 1 mm away from the proximal end 14B of the reinforcing portion 14 of the tubular member 10.
  • b is the inner diameter (mm) at the proximal end 15B of the non-reinforcing portion 15 of the tubular member 10.
  • the inner diameter b (mm) at the proximal end 15B of the non-reinforcing portion 15 is larger than the inner diameter a (mm) at the position 14C 1 mm away from the proximal end 14B of the reinforcing portion 14 to the distal side.
  • the diameter of 15 is expanded toward the proximal side.
  • the inner diameter b is preferably 1.1 times or more, more preferably 1.2 times or more, still more preferably 1.3 times or more the inner diameter a.
  • the upper limit is not particularly limited, but for example, the inner diameter b may be 10 times or less, 5 times or less, or 2 times or less the inner diameter a.
  • the inner diameter a (mm) is preferably 0.1 mm or more and 0.8 mm or less, and more preferably 0.3 mm or more and 0.55 mm or less.
  • a is the inner diameter (mm) at the position 14C 1 mm away from the proximal end 14B of the reinforcing portion 14 of the tubular member 10.
  • c is the inner diameter (mm) at the distal end 72A of the second lumen 72 of the handle 70.
  • the inner diameter c (mm) at the distal end 72A of the second lumen 72 of the handle portion 70 is the inner diameter a (mm) at the position 14C distal to the proximal end 14B of the reinforcing portion 14 of the tubular member 10.
  • the inner diameter c is preferably 1.1 times or more, more preferably 1.2 times or more, still more preferably 1.3 times or more the inner diameter a.
  • the upper limit is not particularly limited, but for example, the inner diameter c may be 5 times or less, 4 times or less, or 3 times or less the inner diameter a.
  • b is the inner diameter (mm) at the proximal end 15B of the non-reinforcing portion 15 of the tubular member 10.
  • c is the inner diameter (mm) at the distal end 72A of the second lumen 72 of the handle 70.
  • the inner diameter b is preferably 1.1 times or more, more preferably 1.2 times or more, still more preferably 1.3 times or more the inner diameter c.
  • the inner diameter b is 2.0 times or less the inner diameter c, it is possible to prevent the wire from being caught by the distal end 72A of the second lumen 72 when the wire is pulled back toward the proximal side. Therefore, the inner diameter b is preferably 2.0 times or less, more preferably 1.7 times or less, still more preferably 1.5 times or less the inner diameter c.
  • the second lumen 72 of the handle portion 70 has a tapered portion 72T whose diameter is reduced toward the distal side as shown in FIGS. 1 and 2.
  • the tip bending wire 50 is inserted toward the distal side with respect to the tapered portion 72T whose diameter is reduced toward the distal side, the bent portion of the tip bending wire 50 is extended to some extent. , The tip bending wire 50 can be easily inserted into the lumen of the tubular member 10.
  • the inner wall of the tapered portion 72T of the second lumen 72 of the handle portion 70 is inclined at an angle of 5 ° or more and 85 ° or less with respect to the axial direction of the tubular member 10.
  • the inclination angle is 5 ° or more, the bent portion of the tip bending wire 50 can be easily extended to some extent.
  • the inclination angle is 85 ° or less, it is possible to easily reduce the movement resistance of the wire due to contact with the inner wall of the tapered portion 72T of the second lumen 72. Therefore, the inclination angle is more preferably 70 ° or less, still more preferably 60 ° or less, and even more preferably 50 ° or less.
  • the first lumen 71 of the handle portion 70 has a barrel shape having a diameter substantially constant in the longitudinal direction X, but may include a step portion or the like.
  • the first lumen 71 may have a stepped portion having a large diameter on the distal side.
  • the outer shape of the handle portion 70 is preferably shaped so that the practitioner can grasp it with a finger.
  • the handle portion 70 is preferably a resin molded product obtained by injection molding or the like.
  • the resin include polyolefin-based resins such as polyethylene and polypropylene, polycarbonate-based resins, and (meth) acrylic-based resins. Of these resins, transparent resins such as polycarbonate and polymethyl methacrylate are preferable. As a result, the inside of the handle portion 70 can be easily seen, and the wire can be easily inserted.
  • the reinforcing portion 14 has an inner layer 11 and an outer layer 13, and further includes a reinforcing member 12 between the inner layer 11 and the outer layer 13.
  • the inner layer 11 contains at least one selected from the group consisting of polyamide-based resin, polyester-based resin, polyurethane-based resin, polyolefin-based resin, fluorine-based resin, vinyl chloride-based resin, silicone-based resin, and natural rubber. Is preferable. Of these, at least one selected from the group consisting of polyester-based resins, polyolefin-based resins, fluororesins, silicone-based resins, and natural rubbers is more preferable. Of these, fluororesins are particularly preferable because they are excellent in chemical resistance, non-adhesiveness, and low friction.
  • the outer layer 13 preferably contains at least one selected from the group consisting of polyethylene, polyamide elastomer, polyamide, and polyurethane. Of these, at least one selected from the group consisting of polyamide elastomers, polyamides, and polyurethanes is more preferable, and polyurethanes are even more preferable.
  • the outer layer 13 preferably contains fine particles in a portion fixed by the adhesive 73 or the like. As a result, minute irregularities are likely to be formed on the surface of the outer layer 13, and it is easy to be fixed by the adhesive 73 or the like.
  • the fine particles include pigments, and examples of the pigments include inorganic fine particles, organic fine particles, and synthetic inorganic pigments.
  • the major axis of the fine particles is preferably 0.1 ⁇ m or more, more preferably 0.5 ⁇ m or more, still more preferably 0.8 ⁇ m or more, preferably 50 ⁇ m or less, more preferably 10 ⁇ m or less, still more preferably 5 ⁇ m or less.
  • the outer layer 13 preferably contains a barium salt in a portion located in the first lumen 71.
  • a barium salt at least one selected from the group consisting of barium sulfate, barium carbonate, barium hydroxide, barium chloride, barium nitrate, and barium acetate is preferable, and barium sulfate is more preferable.
  • the reinforcing member 12 is preferably a braided body in which the wire rod is braided, or a coil body in which the wire rod is spirally wound. As a result, it is possible to easily prevent the tubular member 10 from being pierced by the wire. Of these, the reinforcing member 12 is more preferably a braided body because the braided body tends to improve the rigidity.
  • Examples of the wire material constituting the reinforcing member 12 include metal wire and fiber.
  • As the material constituting the metal wire for example, stainless steel, titanium, nickel-titanium alloy, cobalt-chromium alloy and the like, tungsten alloy and the like are preferable. Of these, stainless steel is more preferable.
  • the metal wire may be a single wire or a stranded wire.
  • Examples of the fiber include polyarylate fiber, aramid fiber, ultra-high molecular weight polyethylene fiber, PBO fiber, carbon fiber and the like.
  • the fibers may be monofilaments or multifilaments.
  • the reinforcing member 12 may contain a radiation opaque substance in order to make it easier to confirm the position of the tubular member 10 under fluoroscopy or the like.
  • a radiation opaque substance for example, at least one selected from the group consisting of lead, barium, iodine, tungsten, gold, platinum, iridium, platinum iridium alloy, stainless steel, titanium, cobalt-chromium alloy, palladium, and tantalum is selected. Can be mentioned.
  • the non-reinforcing portion 15 is a portion of the proximal end portion 10b of the tubular member 10 that does not have the reinforcing member 12. As described above, the non-reinforcing portion 15 has a tapered portion 15T whose inner diameter increases toward the proximal side. If the tapered portion 15T is provided in this way, even if there is a step between the distal end of the tapered portion 15T and the proximal end 14B of the reinforcing portion 14, the tapered portion 15T causes the tip of the wire to fall. Since it is guided away from the step, it becomes difficult to get caught.
  • the inner wall of the tapered portion 15T of the non-reinforcing portion 15 is preferably inclined at an angle of 3 ° or more and 85 ° or less with respect to the axial direction of the tubular member 10.
  • the inclination angle is 3 ° or more, for example, the bent portion of the tip bending wire 50 as shown in FIG. 1 is extended to some extent, so that the tip bending wire 50 is inserted into the lumen of the tubular member 10. It can be made easier.
  • the inclination angle is 85 ° or less, it is possible to easily reduce the movement resistance of the wire due to contact with the inner wall of the tapered portion 15T. Therefore, the inclination angle is more preferably 70 ° or less, still more preferably 60 ° or less, even more preferably 50 ° or less, and particularly preferably 20 ° or less.
  • the distal end of the tapered portion 15T whose inner diameter increases toward the proximal side of the non-reinforcing portion 15 is preferably located at the proximal end 14B of the reinforcing portion 14.
  • the non-reinforcing portion 15 may have a plurality of tapered portions whose inner diameter increases toward the proximal side. Further, it is preferable that the non-reinforcing portion 15 does not have a tapered portion and a stepped portion whose inner diameter is reduced toward the proximal side.
  • the inner diameter of the non-reinforcing portion 15 at the distal end of the tapered portion 15T is preferably 0.9 times or more and 1.3 times or less the inner diameter of the proximal end 14B of the reinforcing portion 14.
  • the inner diameter of the non-reinforcing portion 15 at the distal end of the tapered portion 15T is preferably 0.9 times or more and 1.3 times or less the inner diameter of the proximal end 14B of the reinforcing portion 14.
  • the step between the lumen between the distal end of the tapered portion 15T and the proximal end 14B of the reinforcing portion 14 is reduced, and the wire can be easily inserted toward the distal side. be able to.
  • It is more preferably 1.2 times or less, still more preferably 1.1 times or less.
  • the resistance due to the contact of the tapered portion 15T of the non-reinforcing portion 15 with the inner wall can be reduced. More preferably, it is 1.0 times or more.
  • the catheter 1 is made of a resin that further covers the outer surface of the proximal end portion 14b of the reinforcing portion 14 and extends to the proximal side to form the tapered portion 15T of the non-reinforcing portion 15.
  • the sleeve 16 is provided.
  • the proximal end 14B of the reinforcing portion 14 is a portion where the reinforcing member 12 is easily deformed toward the outside, but the above deformation can be achieved by covering the proximal end portion 14b of the reinforcing portion 14 with the resin sleeve 16. It can be easily prevented.
  • the inner surface of the distal end portion of the sleeve 16 is connected to the outer surface of the proximal end portion 14b of the reinforcing portion 14 by heating and melting or the like.
  • the axial length from the proximal end 14B of the reinforcing portion 14 to the distal end 16A of the sleeve 16 (hereinafter, may be simply referred to as the covering length) is the proximal end 14B of the reinforcing portion 14 of the tubular member 10. It is preferably 2 times or more and 35 times or less the inner diameter a at the position 14C 1 mm away from the distal side.
  • the coating length is more preferably 3 times or more the inner diameter a, and further preferably 4 times or more the inner diameter a.
  • the coating length is 35 times or less the inner diameter a and the vicinity of the distal end 16A of the sleeve 16 is fixed in the first cavity 71 using, for example, an adhesive 73, the distal end 16A
  • the coating length is more preferably 28 times or less of the inner diameter a, further preferably 20 times or less of the inner diameter a, further preferably 15 times or less of the inner diameter a, and 10 times the inner diameter a.
  • the following is particularly preferable.
  • the sleeve 16 preferably contains a thermoplastic resin. It is more preferable that the thermoplastic resin contained in the sleeve 16 contains the same resin as the resin contained in the outer layer 13.
  • the thermoplastic resin contained in the sleeve 16 is preferably at least one selected from the group consisting of polyethylene, polyamide elastomer, polyamide, and polyurethane. Of these, at least one selected from the group consisting of polyamide elastomers, polyamides, and polyurethanes is more preferable, and polyurethanes are even more preferable.
  • the outer shape of the sleeve 16 is preferably tapered so that the diameter increases toward the proximal side. As shown in FIG. 2, the sleeve 16 is fixed to the second cavity 72 of the handle portion 70 by an adhesive 73, but if the outer shape of the sleeve 16 is tapered, it has an anchor effect on the force acting in the axial direction. Is more likely to be exhibited, so that the sleeve 16 is less likely to be fixed.
  • the adhesive 73 is preferably at least one selected from the group consisting of cyanoacrylate adhesives, acrylic adhesives, epoxy adhesives, and urethane adhesives, and is preferably an acrylic adhesive and a urethane adhesive. More preferably, it is at least one selected from the group consisting of adhesives. Of these, urethane-based adhesives are even more preferably urethane-based adhesives because they are excellent in durability and adhesion to resins. Further, when the handle portion 70 is formed around the reinforcing portion 14 by injection molding, pressure is applied to the reinforcing portion 14 and the reinforcing portion 14 is easily damaged. However, the handle portion 70 is obtained by molding the reinforcing portion 70 in advance. By fixing the reinforcing portion 14 inside using an adhesive, it is possible to easily avoid damage due to the above pressure.
  • the tubular member 10 may be provided with a radiation opaque marker.
  • a radiation opaque marker For example, it is preferable to provide the tubular member 10 at a portion within 50 mm in the longitudinal direction X from the distal end. This makes it easier to confirm the position of the distal end of the tubular member 10 in the artery. It is more preferably 20 mm or less, and further preferably 5 mm or less.
  • the shape of the radiation opaque marker is not particularly limited, and examples thereof include a band shape and a spiral shape.
  • Examples of the material constituting the radiation opaque marker include the radiation opaque substance.
  • Catheter 1 can be suitably used for treatment of dilating a narrowing or occluded site of a passage such as a blood vessel in the body.
  • FIG. 4 is a partially enlarged view of a cross section of the region R2 of FIG.
  • FIG. 5 is a sectional view taken along line VV of FIG.
  • FIG. 6 is a side view of the catheter according to another embodiment.
  • FIG. 7 is a sectional view taken along line VII-VII of FIG.
  • those having the same reference numerals as those in FIGS. 1 to 3 indicate the same elements, and the description thereof will be omitted as appropriate.
  • the catheter 2 has a tubular member 10 having a longitudinal direction X and a handle portion 70 connected to a proximal end portion 10b of the tubular member 10.
  • the catheter 2 has an inner diameter larger than the outer diameter of the tubular member 10, extends in the longitudinal direction X, and has an outer tubular member 17 having a distal end 17A and a proximal end 17B.
  • the tubular member 10 is arranged in the lumen of the outer tubular member 17.
  • the catheter 2 has a so-called double-tube structure (coaxial structure) in which the tubular member 10 and the outer tubular member 17 are arranged concentrically in this way.
  • the first lumen 71 of the handle portion 70 of the catheter 2 has a stepped portion having a large diameter on the distal side.
  • the proximal end portion of the double tube structure (coaxial structure) of the catheter 2 can be easily fixed in the first lumen 71.
  • the shape of the first lumen 71 is in the longitudinal direction X as shown in FIG. It may have a barrel shape having a substantially constant diameter.
  • the handle portion 70 may be provided with a through hole 74 for fluid injection that communicates with the first lumen 71 from the outer surface of the handle portion 70.
  • a heated fluid or a bactericidal fluid can be injected into the lumen of the outer tubular member 17 through the through hole 74 for sterilization.
  • the handle portion 70 may be provided with a through hole 75 for injecting an adhesive that communicates from the outer surface of the handle portion 70 to the first cavity 71.
  • the adhesive 73 can be injected from the outside to fix the non-reinforcing portion 15 and the like.
  • the outer surface of the outer tubular member 17 may be fixed to the lumen of the first lumen 71 by the adhesive 73.
  • the proximal end of the outer tubular member 17 is not sealed with the adhesive 73.
  • the outer tubular member 17 does not necessarily have to be fixed in the first cavity 71 via the adhesive 73 as shown in FIG.
  • the outer tubular member 17 may be fixed outside the first lumen 71 by adhering the adhesive 73 to the outer surface of the distal end portion of the handle portion 70.
  • the catheter 2 may include another tubular member 20 adjacent to the tubular member 10 in the radial direction.
  • the distal end of the tubular member 10 is located proximal to the distal end of the other tubular member 20, and the proximal end of the tubular member 10 is the other tubular member 20. It is preferably located proximal to the proximal end.
  • the other tubular member 20 has an inner layer 11 and an outer layer 13 as shown in FIG. Further, a reinforcing member 12 may be provided between the inner layer 11 and the outer layer 13.
  • the inner layer 11, the reinforcing member 12, and the outer layer 13 of the tubular member 10 can be referred to.
  • the catheter 2 preferably includes another outer tubular member 18 at the distal portion of the tubular member 10, and the tubular member 10 is placed in the lumen of the other outer tubular member 18.
  • another tubular member 20 are preferably arranged.
  • the outer tubular member 17 and the other outer tubular member 18 preferably contain at least one selected from the group consisting of polyethylene, polyamide elastomer, polyamide, and polyurethane. Of these, at least one selected from the group consisting of polyamide elastomers, polyamides, and polyurethanes is more preferable, and polyamides are even more preferable.
  • the outer tubular member 17 preferably contains the same material as the other outer tubular member 18. Further, it is preferable that the distal end of the outer tubular member 17 and the proximal end of the other outer tubular member 18 are integrated.
  • the outer tubular member 17 preferably contains fine particles in a portion fixed by the adhesive 73 or the like.
  • the description of the outer layer 13 can be referred to.
  • the outer tubular member 17 preferably contains a barium salt in a portion located in the first cavity 71.
  • a barium salt the description of the outer layer 13 can be referred to.
  • a linear metal reinforcing wire 19 exists between the tubular member 10 and the outer tubular member 17 along the axial direction of the tubular member 10.
  • the number of metal reinforcing wires 19 may be one or two or more.
  • the shape of the metal reinforcing wire 19 may be a barrel shape from the proximal side to the distal side, or a tapered shape that tapers toward the distal side. It is preferable that the metal reinforcing wire 19 exists at least from the distal side to the proximal end 14B of the reinforcing portion 14 of the tubular member 10 to the proximal end of the other tubular member 20.
  • Examples of the material of the metal reinforcing wire 19 include stainless steel, nickel titanium, cobalt chrome and the like.
  • the proximal end 17B of the outer tubular member 17 is preferably located on the distal side of the proximal end 14B of the reinforcing portion 14.
  • the outer surface of the reinforcing portion 14 can also be fixed by the adhesive 73 or the like, and the fixing force can be easily improved.
  • the catheter 2 can be suitably used for treatment that dilates a narrowing or occluded site of a passage such as a blood vessel in the body.
  • the catheter 2 can be suitably used for performing coronary intervention (PCI), particularly for a bifurcation lesion of a coronary artery.
  • PCI coronary intervention
  • a wire is inserted into another tubular member 20 to reach a position distal to the origin of the bifurcation in the main blood vessel.
  • the tip bending wire 50 can be inserted to the narrowed portion of the branch portion through the tubular member 10 to search for the entrance of the narrowed portion or to penetrate the narrowed portion.
  • a wire is inserted into another tubular member 20 to guide the catheter 2 into the bifurcation, and the tip bending wire 50 is inserted into the main blood vessel through the tubular member 10. It can be inserted up to the narrowed part of the body to search for the entrance of the narrowed part or to penetrate the narrowed part.
  • the present invention also includes a method for manufacturing a catheter.
  • the method for manufacturing a catheter of the present invention is a step of covering one end of a tubular body including a reinforcing member with one end of a resin sleeve, heating a metal body having a tapered portion, and starting from the other end of the sleeve. It is characterized by including a step of inserting the metal body toward the one end portion.
  • FIGS. 8 and 9 are cross-sectional views showing a manufacturing process of the catheter 1 according to the embodiment.
  • those having the same reference numerals as those in FIGS. 1 to 7 indicate the same elements, and the description thereof will be omitted as appropriate.
  • the method for manufacturing the catheter 1 includes a step of coating one end portion 16a of the resin sleeve 16 with one end portion 100b of the tubular body 100 including the reinforcing member 12.
  • the coating length in the axial direction is preferably twice or more and 35 times or less the inner diameter at a position 1 mm away from one end 100b of the tubular body 100 on the distal side.
  • the metal body 90 having the tapered portion is heated, and the metal body is directed from the other end 16b of the resin sleeve 16 toward the one end 16a.
  • the step of inserting 90 It is difficult to form a tapered portion in the portion including the reinforcing member 12, but since the sleeve 16 is made of resin that does not include the reinforcing member 12, the tapered portion can be easily formed by the heated metal body 90.
  • the above-mentioned step can be eliminated or reduced as shown in FIG. Further, by inserting the heated metal body 90, the inner wall of the sleeve 16 is thermally melted and fixed to the outer peripheral surface of one end portion 100b of the tubular body 100.
  • an adhesive or the like is applied to the tubular body 100, the outer peripheral surface of the sleeve 16, and the like, and as shown in FIGS. 1 and 2, the proximal end 15B of the non-reinforcing portion 15 is applied to the proximal end 71B of the first lumen 71.
  • the non-reinforcing portion 15 may be arranged in the first cavity 71 of the handle portion 70 and fixed so as to be positioned. Further, as shown in FIG. 4, the non-reinforcing portion 15 may be fixed by providing the handle portion 70 with a through hole 75 for injecting an adhesive in advance and injecting the adhesive through the through hole 75.

Landscapes

  • 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)
PCT/JP2020/022151 2019-06-19 2020-06-04 カテーテル、及びカテーテルの製造方法 Ceased WO2020255736A1 (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2021527575A JP7444879B2 (ja) 2019-06-19 2020-06-04 カテーテル、及びカテーテルの製造方法
CN202080044309.4A CN114025819A (zh) 2019-06-19 2020-06-04 导管和导管的制造方法
US17/619,303 US12465722B2 (en) 2019-06-19 2020-06-04 Reinforced catheter with tapered proximal lumen

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2019-114064 2019-06-19
JP2019114064 2019-06-19

Publications (1)

Publication Number Publication Date
WO2020255736A1 true WO2020255736A1 (ja) 2020-12-24

Family

ID=74040028

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2020/022151 Ceased WO2020255736A1 (ja) 2019-06-19 2020-06-04 カテーテル、及びカテーテルの製造方法

Country Status (4)

Country Link
US (1) US12465722B2 (https=)
JP (1) JP7444879B2 (https=)
CN (1) CN114025819A (https=)
WO (1) WO2020255736A1 (https=)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPWO2023089973A1 (https=) * 2021-11-16 2023-05-25
WO2025028186A1 (ja) * 2023-08-01 2025-02-06 株式会社カネカ カテーテル

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210275778A1 (en) * 2020-03-03 2021-09-09 Intuitive Surgical Operations, Inc. Elongate instrument and elongate instrument guard member compatibility

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4806182A (en) * 1985-10-15 1989-02-21 Schneider-Shiley (U.S.A.) Inc. Method of bonding a hub to a Teflon-lined catheter body
JPH02107273A (ja) * 1988-08-31 1990-04-19 Edward Weck Inc カテーテル
JP2014140565A (ja) * 2013-01-25 2014-08-07 Kaneka Corp 医療用チューブの製造方法およびカテーテル
JP2017093868A (ja) * 2015-11-26 2017-06-01 テルモ株式会社 カテーテル
WO2018169030A1 (ja) * 2017-03-17 2018-09-20 テルモ株式会社 カテーテル

Family Cites Families (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3530349C1 (de) * 1985-08-24 1987-04-02 Braun Melsungen Ag Vorrichtung zur Einfuehrung von Fluessigkeiten oder Kanuelen,Mandrins und Kathetern in einen Koerperhohlraum
US4781703A (en) * 1985-10-17 1988-11-01 Menlo Care, Inc. Catheter assembly
US4802947A (en) * 1986-07-16 1989-02-07 Becton Dickinson And Company Apparatus for attaching a catheter to a hub
US5156792A (en) * 1989-12-18 1992-10-20 Critikon, Inc. Method of producing catheter assemblies for prevention of blood leakage
US5380301A (en) * 1992-07-10 1995-01-10 Sherwood Medical Company Catheter/hub strain relief and method of manufacture thereof
US5830189A (en) * 1995-06-07 1998-11-03 Johnson & Johnson Medical, Inc. Catheter hub to nose engagement
US6130406A (en) * 1998-01-08 2000-10-10 Adam Spence Corporation Method for forming a medical tubing device
US6355027B1 (en) * 1999-06-09 2002-03-12 Possis Medical, Inc. Flexible microcatheter
US6575959B1 (en) * 1999-12-27 2003-06-10 Scimed Life Systems, Inc. Catheter incorporating an insert molded hub and method of manufacturing
CA2555464C (en) * 2003-02-12 2011-11-08 Signe Thorning Mejlhede A medical connector and a method of injection moulding such a connector
JP3864925B2 (ja) * 2003-04-08 2007-01-10 ニプロ株式会社 留置用カテーテルセット
US7713260B2 (en) * 2003-09-11 2010-05-11 Cook Incorporated Catheter having an overmolded hub
US7662144B2 (en) * 2004-06-22 2010-02-16 Boston Scientific Scimed, Inc. Catheter shaft with improved manifold bond
US20060264904A1 (en) * 2005-05-09 2006-11-23 Kerby Walter L Medical device
US7608063B2 (en) * 2006-02-23 2009-10-27 Medrad, Inc. Dual lumen aspiration catheter system
EP2022421B1 (en) * 2007-08-01 2011-04-06 Tradinco AB A peripheral catheter assembly with haemostasis valve
US8152791B2 (en) * 2008-11-13 2012-04-10 Cook Medical Technologies Llc Catheter locking mechanism
JP6383663B2 (ja) * 2012-11-30 2018-08-29 テルモ株式会社 カテーテル
CA2903269A1 (en) * 2013-03-07 2014-09-12 Circulite, Inc. Transseptal cannula, tip, delivery system, and method
WO2015099168A1 (ja) * 2013-12-27 2015-07-02 株式会社ハイレックスコーポレーション 医療用装置
US10449332B2 (en) * 2015-08-05 2019-10-22 Biosense Webster (Israel) Ltd. Guide wire luer hub
US10568991B2 (en) * 2015-08-12 2020-02-25 Covidien Lp Catheter including leak resistant proximal shaft
US20170340860A1 (en) * 2016-05-26 2017-11-30 Terumo Medical Corporation Welded on catheter hub
AU2017312325B2 (en) * 2016-08-19 2022-11-17 B. Braun Melsungen Ag Needle assemblies and related methods
EP3512589B1 (en) * 2016-09-14 2024-01-17 Boston Scientific Scimed, Inc. Catheter hubs
WO2018092386A1 (ja) * 2016-11-21 2018-05-24 テルモ株式会社 カテーテルおよびカテーテルの製造方法
EP3576829B1 (en) * 2018-03-05 2021-01-06 Poly Medicure Limited Intravenous catheter assembly
EP3536371B1 (en) * 2018-03-06 2023-01-25 Phenox Ltd. Catheter with catheter hub
US10946167B2 (en) * 2018-06-14 2021-03-16 Covidien Lp Catheter hub and strain relief
WO2020189466A1 (ja) * 2019-03-18 2020-09-24 テルモ株式会社 カテーテル組立体

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4806182A (en) * 1985-10-15 1989-02-21 Schneider-Shiley (U.S.A.) Inc. Method of bonding a hub to a Teflon-lined catheter body
JPH02107273A (ja) * 1988-08-31 1990-04-19 Edward Weck Inc カテーテル
JP2014140565A (ja) * 2013-01-25 2014-08-07 Kaneka Corp 医療用チューブの製造方法およびカテーテル
JP2017093868A (ja) * 2015-11-26 2017-06-01 テルモ株式会社 カテーテル
WO2018169030A1 (ja) * 2017-03-17 2018-09-20 テルモ株式会社 カテーテル

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPWO2023089973A1 (https=) * 2021-11-16 2023-05-25
JP7607793B2 (ja) 2021-11-16 2024-12-27 株式会社グッドマン カテーテル
WO2025028186A1 (ja) * 2023-08-01 2025-02-06 株式会社カネカ カテーテル

Also Published As

Publication number Publication date
JPWO2020255736A1 (https=) 2020-12-24
US20220096791A1 (en) 2022-03-31
CN114025819A (zh) 2022-02-08
JP7444879B2 (ja) 2024-03-06
US12465722B2 (en) 2025-11-11

Similar Documents

Publication Publication Date Title
US20200023159A1 (en) Integrated catheter system
KR102184238B1 (ko) 장척 의료용 부재
EP3395395A1 (en) Balloon catheter and medical elongated body
EP1088570B1 (en) Reinforced balloon catheter
EP1938859A1 (en) Guide wire
JP2006513774A (ja) 多重編組型外装チューブ
KR20180048436A (ko) 카테터
CN106573130A (zh) 导管
WO2020255736A1 (ja) カテーテル、及びカテーテルの製造方法
JPWO2020162287A1 (ja) 延長カテーテル、及びその製造方法
US11484687B2 (en) Catheter
WO2016035740A1 (ja) カテーテル
JP7524080B2 (ja) 延長カテーテル、及びその製造方法
JP5027651B2 (ja) 脈管カテーテル
CN113993569B (zh) 导管
EP3744379B1 (en) Catheter
JP7060454B2 (ja) 医療用チューブ
WO2023062984A1 (ja) 延長ガイドカテーテル
EP4029555A1 (en) Support catheter and tube
JP6882482B2 (ja) バルーンカテーテル
WO2025028185A1 (ja) カテーテル
WO2025033067A1 (ja) カテーテル
WO2025028184A1 (ja) カテーテル
WO2025204429A1 (ja) カテーテル、およびその製造方法
JP2021097853A (ja) バルーンカテーテル

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: 20826150

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2021527575

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 20826150

Country of ref document: EP

Kind code of ref document: A1

WWG Wipo information: grant in national office

Ref document number: 17619303

Country of ref document: US