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WO2024185681A1 - Ensemble cathéter - Google Patents

Ensemble cathéter Download PDF

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Publication number
WO2024185681A1
WO2024185681A1 PCT/JP2024/007752 JP2024007752W WO2024185681A1 WO 2024185681 A1 WO2024185681 A1 WO 2024185681A1 JP 2024007752 W JP2024007752 W JP 2024007752W WO 2024185681 A1 WO2024185681 A1 WO 2024185681A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
hub
tip
stylet
base end
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.)
Pending
Application number
PCT/JP2024/007752
Other languages
English (en)
Japanese (ja)
Inventor
梓佑子 角田
紗弓 廣▲瀬▼
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.)
Terumo Corp
Original Assignee
Terumo 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 Terumo Corp filed Critical Terumo Corp
Publication of WO2024185681A1 publication Critical patent/WO2024185681A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • 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

Definitions

  • the present invention relates to a catheter assembly having a catheter and a stylet that can be inserted into the catheter.
  • Patent Document 1 discloses a device that includes a rapid exchange type suction catheter and a core wire that can be inserted into the suction catheter. By inserting the core wire into the suction catheter, kinking of the suction catheter is suppressed when the suction catheter is moved to the desired position.
  • the core wire is inserted only partway from the base end of the suction catheter to the tip.
  • the pushability of a device refers to the transferability of force applied to the base end of the device to the tip, and is thought to be largely contributed to by the rigidity of the device. For this reason, in the tip portion of the suction catheter where the core wire is not inserted, pushability decreases and kinking may occur.
  • the rigidity of the entire device with the core wire inserted into the suction catheter becomes too high, and blood vessel tracking ability decreases.
  • Blood vessel tracking ability refers to the ease of insertion into and passing through curved blood vessels, and is thought to be largely contributed to by the flexibility of the device.
  • the present invention was made to solve the above-mentioned problems, and aims to provide a catheter assembly that can suppress kinking and improves pushability and blood vessel tracking ability.
  • One aspect of the catheter assembly according to the present invention is a catheter assembly including a catheter and a stylet that can be inserted into the catheter, the catheter including a catheter hub disposed at a base end of the catheter, a catheter body extending from the catheter hub in a distal direction and having a lumen formed therein, and a guide tube fixed to the distal end of the catheter body and having a guidewire lumen that opens at a proximal opening of the guidewire lumen that is more flexible than the base tube and is fixed to the distal end of the catheter body.
  • the catheter body includes a base tube extending from the catheter hub in a distal direction, and a guide tube that is flexible and is fixed to the distal end of the base tube.
  • the stylet has a stylet hub connectable to the catheter hub, a shaft extending from the stylet hub in the distal direction, and a coil fixed to the distal end of the shaft, the shaft has a proximal shaft extending from the stylet hub in the distal direction, and a tapered section having an outer diameter that gradually decreases from the tip of the proximal shaft in the distal direction, and in an assembled state in which the catheter hub and the stylet hub are connected, the proximal end of the tapered section is located at a position distal to the proximal opening of the guidewire lumen and is located distal to the tip of the proximal tube.
  • catheter assembly including a catheter and a stylet that can be inserted into the catheter, the catheter including a catheter hub disposed at the base end of the catheter, a catheter body that extends from the catheter hub in a distal direction and has a lumen formed therein, and a guide tube that is fixed to the distal end of the catheter body and has a guidewire lumen that opens at a proximal opening of the guidewire lumen that is distal to the catheter hub, the catheter body including a base end tube that extends from the catheter hub in a distal direction, and a tip end tube that is softer than the base end tube and extends from the tip of the base end tube in a distal direction.
  • the stylet has a stylet hub connectable to the catheter hub, a shaft extending from the stylet hub in the distal direction, and a coil fixed to the distal end of the shaft, and the shaft has a base-side shaft extending from the stylet hub in the distal direction and a tapered section having an outer diameter that gradually decreases from the tip of the base-side shaft in the distal direction, and in an assembled state in which the catheter hub and the stylet hub are connected, the base end of the tapered section is positioned in the longitudinal direction at a position that coincides with the base-side opening of the guidewire lumen or at a position closer to the base end than the base-side opening of the guidewire lumen, and is positioned closer to the distal end than the tip of the base-side tubular body.
  • the base end of the tapered section is located distal to the tip of the base-side tubular body, so the tapered section, which reduces bending rigidity, does not overlap the base-side tubular body, which contributes highly to the pushability of the catheter assembly.
  • the tapered section which gradually reduces bending rigidity, overlaps a portion of the catheter assembly distal to the base-side tubular body, which contributes highly to blood vessel tracking, so the catheter assembly can improve blood vessel tracking by the tapered section while suppressing kinking due to the presence of the stylet.
  • the catheter assembly can improve blood vessel tracking in a portion distal to the base-end opening of the guidewire lumen from which the guidewire is led out.
  • the base end of the tapered portion is disposed distally of the tip of the proximal tube, so that the tapered portion, which reduces bending stiffness, does not overlap the proximal tube, which contributes highly to the pushability of the catheter assembly.
  • the tapered portion which gradually reduces bending stiffness, overlaps the portion of the catheter assembly that contributes highly to blood vessel tracking distally of the proximal tube, so that the catheter assembly can improve blood vessel tracking by the tapered portion while suppressing kinking due to the presence of the stylet.
  • the base end of the tapered portion is disposed at a position that coincides with the guidewire lumen proximal opening in the long axis direction, or proximal to the guidewire lumen proximal opening, so that the tapered portion is disposed so as to overlap the portion of the guide tube from the guidewire lumen proximal opening to the tip side. This allows the catheter assembly to improve blood vessel tracking in the portion including the guidewire lumen proximal opening to the tip side of the guidewire lumen proximal opening.
  • the catheter may be capable of applying suction force to the opening at the tip side of the lumen from the catheter hub via the lumen. This makes it possible to suppress kinking of the catheter assembly having a catheter capable of applying suction force, and to improve pushability and blood vessel tracking ability.
  • FIG. 2 is a plan view showing a catheter and a stylet of the catheter assembly according to the embodiment in an assembled state.
  • FIG. 2 is a plan view showing a state in which the catheter and the stylet of the catheter assembly according to the embodiment are separated.
  • FIG. 2 is a cross-sectional view showing a base end portion of the catheter assembly according to the embodiment.
  • 1 is a cross-sectional view showing a distal end portion of a catheter assembly according to an embodiment.
  • 13 is a cross-sectional view showing a tip portion of a catheter assembly according to a modified example.
  • the side of the catheter assembly that is operated will be referred to as the "base end side,” and the side that is inserted into the living body will be referred to as the "tip side.”
  • the catheter assembly 10 is a device that is long in the longitudinal direction X, and includes a catheter 20 and a stylet 30, as shown in Figs. 1 to 4.
  • the catheter 20 is used to aspirate and remove thrombi in cardiac blood vessels.
  • the object to be aspirated by the catheter 20 is not limited to thrombi, and may be, for example, plaque, atheroma, calcified lesions, etc.
  • the stylet 30 prevents the catheter 20 from kinking when the catheter 20 reaches the target position.
  • the catheter assembly 10 moves through the lumen of a device such as a guiding catheter or sheath that is percutaneously inserted into a blood vessel, and is pushed to the vicinity of the lesion in the blood vessel. After the tip of the catheter assembly 10 reaches the vicinity of the lesion in the blood vessel, the stylet 30 is removed from the catheter 20. After this, the lumen 41 of the catheter 20 is used to aspirate the thrombi in the blood vessel.
  • a device such as a guiding catheter or sheath that is percutaneously inserted into a blood vessel
  • the catheter 20 is a rapid exchange type in which a guidewire is inserted only into the tip, and is equipped with a flexible tubular catheter body 40, a guide tube 60 fixed to the tip of the catheter body 40, a catheter hub 70 fixed to the base end of the catheter body 40, and a kink-resistant protector 80.
  • the catheter body 40 is a flexible tubular body, and a lumen 41 is formed in the center thereof over the entire length of the catheter body 40.
  • the lumen 41 opens at a catheter tip opening 42 formed at the tip of the catheter body 40.
  • the catheter body 40 comprises a base end tube 43, a distal end tube 44, and a distal tip 45.
  • the base end of the base end tube 43 is fixed to the catheter hub 70 and extends from the catheter hub 70 toward the distal end.
  • the base end tube 43 is formed of an inner layer 46 that forms the inner surface of the base end tube 43, a base end outer layer 47 that forms the outer surface of the base end tube 43, and a reinforcing layer 48 located between the inner layer 46 and the base end outer layer 47.
  • Depth markers 58 of different colors are arranged on the outer surface of the base end outer layer 47 to allow the surgeon to grasp the amount of insertion of the catheter 20 into the blood vessel.
  • the distal tube 44 is formed of an inner layer 46 that forms the inner surface of the distal tube 44, a distal outer layer 49 that forms the outer surface of the distal tube 44, and a reinforcing layer 48 located between the inner layer 46 and the distal outer layer 49.
  • the inner layer 46 of the distal tube 44 is integrally formed with the inner layer 46 of the base tube 43.
  • the reinforcing layer 48 of the distal tube 44 is also integrally formed with the reinforcing layer 48 of the base tube 43.
  • the distal outer layer 49 includes a first outer layer 50, a second outer layer 51, a third outer layer 52, and a fourth outer layer 53.
  • the first outer layer 50, the second outer layer 51, the third outer layer 52, and the fourth outer layer 53 are aligned from the distal side to the base side to form one tube.
  • the fourth outer layer 53 has a lower Shore hardness than the base outer layer 47 adjacent to the base side.
  • the third outer layer 52 has a lower Shore hardness than the fourth outer layer 53 adjacent to the base end side.
  • the second outer layer 51 has a lower Shore hardness than the third outer layer 52 adjacent to the base end side.
  • the first outer layer 50 has a lower Shore hardness than the second outer layer 51 adjacent to the base end side.
  • the reinforcing layer 48 is for reinforcing the catheter body 40 and has a plurality of reinforcing wires 57.
  • the gaps between the plurality of reinforcing wires 57 in the reinforcing layer 48 are filled with the material of the base end outer layer 47, the tip end outer layer 49, or the inner layer 46.
  • the reinforcing layer 48 may be, for example, a tubular braid of reinforcing wires 57.
  • the reinforcing layer 48 may be formed by winding one or more reinforcing wires 57 in a spiral (coil) shape.
  • the reinforcing wires 57 are made of metals such as stainless steel and NiTi.
  • the cross-sectional shape of the reinforcing wires 57 is not particularly limited, and may be, for example, rectangular, square, circular, or elliptical. In addition, one reinforcing wire 57 may be a bundle of two or more wires.
  • the catheter body 40 having the reinforcing layer 48 can ensure sufficient rigidity and strength without increasing the wall thickness, i.e., while making the inner diameter of the catheter body 40 relatively large.
  • the tip tip 45 is flexible and reduces damage to blood vessels caused by the tip of the catheter body 40 when the catheter 20 is inserted into the body.
  • the tip tip 45 is formed of a tip tip inner layer 54 that forms the inner surface of the tip tip 45 and a tip tip outer layer 55 that forms the outer surface of the tip tip 45.
  • the tip surface 56 of the tip tip 45 is inclined at an angle of more than 0 degrees and less than 90 degrees with respect to a plane perpendicular to the long axis direction X.
  • the tip surface 56 is inclined so that the side of the outer surface of the catheter body 40 to which the guide tube 60 is fixed protrudes toward the tip.
  • the distal tip outer layer 55 is formed to be more flexible than the first outer layer 50 adjacent to the base end side.
  • the distal tip inner layer 54 is disposed on the distal side of the inner layer 46.
  • the distal tip inner layer 54 may be formed integrally with the inner layer 46 or may be formed as a separate member.
  • the distal tip inner layer 54 may be formed from the same material as the inner layer 46 or from a different material.
  • the distal tip 45 may be formed in a single layer.
  • the inner layer 46 and the tip tip inner layer 54 are preferably formed from a low-friction material.
  • a low-friction material include fluororesin materials such as polytetrafluoroethylene (PTFE) and tetrafluoroethylene-perfluoroalkoxyethylene copolymer (PFA), and in this embodiment, PFA is used.
  • the constituent materials of the base end outer layer 47 and the tip end outer layer 49 include, for example, various thermoplastic elastomers such as styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, and chlorinated polyethylene-based, and may include one or a combination of two or more of these (polymer alloy, polymer blend, laminate, etc.), preferably mixed with a contrast agent, and in this embodiment, a polyamide elastomer is mixed with barium sulfate and a pigment.
  • various thermoplastic elastomers such as styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, and chlorinated polyethylene-based, and may include
  • the materials constituting the tip outer layer 55 include various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, chloroprene rubber, silicone rubber, fluororubber, and styrene-butadiene rubber, as well as various thermoplastic elastomers such as styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, and chlorinated polyethylene-based, and in this embodiment, it is a mixture of polyamide elastomer, barium sulfate, and pigment.
  • the guide tube 60 is a tube in which a guidewire lumen 61 into which a guidewire can be inserted is formed.
  • the guide tube 60 is fixed to the outer surface of the tip of the catheter body 40 so as to be aligned with the longitudinal axis of the catheter body 40.
  • the guide tube 60 has a guidewire lumen tip opening 62 formed on the tip side and a guidewire lumen base end opening 63 formed on the base end side.
  • the tip of the guide tube 60 is positioned at a position that is approximately the same as the tip of the catheter body 40.
  • the tip of the guide tube 60 may be positioned further distal than the tip of the catheter body 40.
  • the guidewire lumen tip opening 62 is located at the tip of the catheter 20.
  • the guidewire lumen base end opening 63 is located distal than the catheter hub 70. Furthermore, the guidewire lumen base end opening 63 is located near the base end of the tip side tube 44.
  • the guidewire lumen proximal end opening 63 may be disposed distal to the proximal end of the distal end tube 44 in the longitudinal axis direction X, proximal to the proximal end, or at a position coinciding with the proximal end of the distal end tube 44. In this embodiment, the guidewire lumen proximal end opening 63 is disposed at a position overlapping with the third outer layer 52 of the distal end tube 44 in the longitudinal axis direction X, but is not limited thereto.
  • the constituent material of the guide tube 60 may be, for example, a material that can be used for the base end outer layer 47, the distal end outer layer 49, or the distal tip outer layer 55 described above.
  • the outer diameter of the catheter body 40 in the first embodiment is what is known as 6 Fr, for example 1.40 mm to 1.70 mm, for example 1.70 mm. If the outer diameter is too large, the operability of moving the catheter body 40 within the blood vessel may decrease, and the burden on the patient may increase.
  • the inner diameter of the catheter body 40 is, for example, 0.99 mm to 1.10 mm, for example 0.99 mm. If the inner diameter is too small, the ability to suck up objects such as blood clots decreases accordingly, which is undesirable.
  • the effective length L1 of the catheter 20 is, for example, 1400 mm. This allows the surgeon to insert the catheter 20 from the femoral artery and reach the coronary artery while maintaining operability.
  • the effective length L1 of the catheter 20 is the length of the portion that can be inserted into a blood vessel or other device such as a guiding catheter or sheath.
  • the effective length L1 of the catheter 20 is the length from the tip of the anti-kink protector 80 to the tip of the guide tube 60 in the longitudinal direction X.
  • the dimensions of each part of the catheter 20 are not particularly limited.
  • the length L2 in the longitudinal direction X of the distal tip 45 is, for example, 9 mm.
  • the length L3 in the longitudinal direction X of the first outer layer 50 is, for example, 70 mm.
  • the length L4 in the longitudinal direction X of the second outer layer 51 is, for example, 60 mm.
  • the length L5 in the longitudinal direction X of the third outer layer 52 is, for example, 100 mm.
  • the length L6 in the longitudinal direction X of the fourth outer layer 53 is, for example, 60 mm.
  • the length L7 in the longitudinal direction X of the base end side tube 43 is, for example, 1100 mm.
  • the length L10 in the longitudinal direction X of the depth marker 58 is, for example, 100 mm.
  • the materials constituting the catheter hub 70 include, for example, various resins such as styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, and chlorinated polyethylene-based resins, and various thermoplastic elastomers, as well as combinations of one or more of these (polymer alloys, polymer blends, laminates, etc.).
  • various resins such as styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, and chlorinated polyethylene-based resins
  • various thermoplastic elastomers as well as combinations of one or more of these (polymer alloys, polymer blends, laminates, etc.).
  • the length L9 of the catheter hub 70 in the longitudinal direction X (the length from the base end of the kink-resistant protector 80 to the base end of the catheter hub 70) is, for example, 22.3 mm.
  • the kink-resistant protector 80 is attached to cover the portion connecting the catheter body 40 and the catheter hub 70, and prevents kinking of the catheter body 40 at that portion.
  • the length L8 of the anti-kink protector 80 in the longitudinal direction X is, for example, 37.5 mm.
  • the stylet 30 comprises a shaft 90 that can be inserted into the catheter body 40, a stylet hub 100 that is fixed to the base end of the shaft 90, and a coil 110 that is fixed to the tip end of the shaft 90.
  • the shaft 90 includes a base end shaft 91 extending from the stylet hub 100 toward the distal end, a tapered section 92 extending from the tip of the base end shaft 91 toward the distal end, and a fixed section 93 fixed to the coil 110 at the tip of the tapered section 92.
  • the base end shaft 91 has a substantially constant outer diameter along the longitudinal axis direction X.
  • the tapered section 92 has an outer diameter that tapers from the tip of the base end shaft 91 toward the distal end.
  • the tapered section 92 is incorporated into the catheter assembly 10 to gradually reduce the bending stiffness of the catheter assembly 10 toward the distal end, thereby suppressing the occurrence of kinks due to local changes in bending stiffness and providing appropriate flexibility to improve blood vessel tracking.
  • the shaft 90 becomes too soft and the pushing ability decreases.
  • the fixing portion 93 is located at the tip of the shaft 90 and is fixed to the tip of the coil 110.
  • the fixing portion 93 is, for example, a member that is melted and solidified by soldering, brazing, welding, or the like, but may also be an adhesive.
  • the shaft 90 may have a portion on the tip side of the tapered portion 92 that has a constant outer diameter in the longitudinal axis direction X.
  • the coil 110 is arranged to surround the thin portion of the tip of the shaft 90 in order to reduce the bending rigidity of the tip of the stylet 30 while ensuring the outer diameter.
  • the tip of the coil 110 is fixed to the fixed portion 93 of the shaft 90.
  • the base end of the coil 110 overlaps with the tapered portion 92 in the longitudinal axis direction X.
  • the shaft 90 and coil 110 may be made of metals such as stainless steel and NiTi.
  • each part of the stylet 30 are not particularly limited.
  • the outer diameter of the base-end shaft 91 is, for example, 0.42 mm.
  • the length L11 in the longitudinal direction X from the tip of the shaft 90 to the base end of the tapered portion 92 is, for example, 170 mm to 200 mm.
  • the outer diameter of the coil 110 is, for example, 0.4 mm.
  • the length L12 in the longitudinal direction X of the coil 110 is, for example, 50 mm to 60 mm.
  • the effective length L13 of the stylet 30 in the longitudinal direction X is, for example, 1412 mm. In this embodiment, the effective length L13 of the stylet 30 is the length from the tip of the stylet hub 100 to the tip of the shaft 90 in the longitudinal direction X.
  • the stylet hub 100 comprises a stylet hub body 101 and a rotary coupling 102 that is rotatable relative to the stylet hub body 101.
  • the stylet hub body 101 is fixed to the base end of the shaft 90, and a stylet hub lumen 103 is formed that penetrates in the longitudinal direction X.
  • a stylet hub male thread portion 107 is formed on the outer surface of the base end of the stylet hub 100.
  • the stylet hub lumen 103 opens at a stylet hub tip opening 104 on the tip side of the stylet hub body 101, and at a stylet hub base opening 105 on the base end side. In the assembled state, the outer surface of the stylet hub body 101 can be in close contact with the inner surface of the catheter hub lumen 71.
  • the rotating connector 102 is connected to the outer surface of the stylet hub body 101 so as to be rotatable around the long axis of the stylet hub body 101.
  • a female threaded portion 106 that can be screwed into the male threaded portion 73 of the catheter hub 70 is formed on the inner peripheral surface of the rotating connector 102.
  • the stylet hub 100 can be made of, for example, materials that can be used for the catheter hub 70 described above.
  • the catheter assembly 10 is assembled by inserting the stylet 30 into the lumen 41 of the catheter 20 and connecting the stylet hub 100 to the catheter hub 70. In the assembled catheter assembly 10, the catheter 20 and the stylet 30 cannot be separated until they are released from the connection.
  • the stylet 30 When assembling the catheter 20 and stylet 30, the stylet 30 is inserted into the catheter hub opening 72 from the tip side, and the stylet 30 is pushed forward until the outer surface of the tip of the stylet hub body 101 comes into close contact with the inner surface of the catheter hub lumen 71. Next, when the rotating coupling part 102 is rotated, the male thread part 73 screws into the female thread part 106, as shown in FIG. 3, and the catheter hub 70 and the stylet hub 100 are connected in an assembled state. In the assembled state, the catheter 20 and the stylet 30 are restricted in relative movement and rotation. This allows the surgeon to operate the catheter 20 and the stylet 30 as a unit when inserting the catheter assembly 10 into a blood vessel. This makes it easier to operate the catheter assembly 10, and improves safety by preventing the catheter 20 and the stylet 30 from coming off unexpectedly.
  • the tip of the stylet 30 is located closer to the base end than the tip of the catheter 20, does not protrude to the outside from the catheter tip opening 42, and is located inside the lumen 41. Therefore, when the catheter assembly 10 is inserted into a blood vessel, the thin tip of the stylet 30 does not hit the blood vessel, reducing damage to the blood vessel.
  • the tip of the stylet 30 is positioned in a position overlapping the first outer layer 50 in the longitudinal direction X.
  • the length L14 in the longitudinal direction X from the tip of the catheter 20 in the proximal direction to the tip of the stylet 30 is, for example, 41 mm.
  • the base end of the coil 110 overlaps the second outer layer 51 in the longitudinal direction X.
  • the base end of the tapered portion 92 of the stylet 30, the base end of the guide tube 60, and the base end of the tip tube 44 are positioned at approximately the same position in the longitudinal axis direction X.
  • the base end of the tapered section 92 of the stylet 30 is located further distal than the tip of the base-side tubular body 43 of the catheter 20.
  • the base end of the tapered section 92 overlaps the third outer layer 52 in the longitudinal direction X.
  • the tapered section 92 does not overlap the base-side tubular body 43, which has high rigidity and contributes greatly to the pushability of the catheter assembly 10, and the catheter assembly 10 has high pushability.
  • the tapered section 92 whose bending rigidity gradually decreases toward the tip side, overlaps the tip-side tubular body 44, which is more easily bent than the base-side tubular body 43, and therefore the presence of the stylet 30 suppresses kinking, while the tapered section 92 improves blood vessel tracking.
  • the base end of the tapered portion 92 is located near the guidewire lumen base end opening 63.
  • the base end of the tapered portion 92 is located distal to the guidewire lumen base end opening 63, coincident with the guidewire lumen base end opening 63 in the longitudinal direction X, or proximal to the guidewire lumen base end opening 63.
  • the guide tube 60 is fixed to the catheter main body 40, so that the bending rigidity is increased by the guide tube 60, and blood vessel tracking ability may be reduced.
  • the base end of the tapered portion 92 of the stylet 30 is located proximal to the guidewire lumen base end opening 63 in the longitudinal direction X, so that the tapered portion 92, whose bending rigidity gradually decreases toward the tip side, overlaps with the range in which the guide tube 60 of the catheter assembly 10 is disposed.
  • the catheter assembly 10 changes smoothly without becoming too stiff, improving its pushability and blood vessel tracking ability.
  • the tapered portion 92 of the stylet 30 When the base end of the tapered portion 92 of the stylet 30 is positioned distal to the guidewire lumen proximal end opening 63 in the assembled state, the tapered portion 92 is positioned in the longitudinal direction X without overlapping with the base end of the guide tube 60. As a result, the catheter assembly 10 can improve the blood vessel tracking ability of the area distal to the guidewire lumen proximal end opening 63 from which the guidewire is led out.
  • the tapered section 92 can mitigate local changes in the bending stiffness of the catheter assembly 10 at the position where the base end of the guide tube 60, where bending stiffness is prone to change significantly, is located. Therefore, the catheter assembly 10 can be smoothly curved, thereby improving blood vessel tracking ability while suppressing kinking.
  • the length L14 from the tip of the catheter 20 in the proximal direction to the base end of the tapered section 92 is, for example, 211 mm to 241 mm.
  • the surgeon prepares the catheter 20 and stylet 30 in an assembled state, and inserts a syringe filled with saline into the stylet hub proximal end opening 105.
  • the surgeon injects saline from the syringe into the lumen 41 of the catheter 20 via the stylet hub lumen 103. This allows the lumen 41 of the catheter 20 to be primed while the catheter 20 and stylet 30 remain in the assembled state.
  • the method of priming the lumen 41 is not limited to this.
  • the surgeon passes a guidewire through the guidewire lumen 61 and inserts the guidewire and catheter assembly 10 into the opening at the base end of the guiding catheter or sheath that has been percutaneously inserted into the blood vessel. Because the catheter 20 and stylet 30 are in an assembled state as the catheter assembly 10, the surgeon can smoothly insert the catheter assembly 10 into the blood vessel.
  • the surgeon guides the vicinity of the tip of the catheter assembly 10 along a guidewire (not shown) inserted into the guiding lumen 41 to the target location where a lesion such as a thrombus is present.
  • a guidewire not shown
  • the stylet 30 is inserted inside the catheter 20
  • kinking of the catheter 20 passing through a curved blood vessel can be suppressed.
  • the surgeon stops pushing the catheter assembly 10.
  • the surgeon rotates the rotating coupling portion 102 to release the screw engagement between the male thread portion 73 and the female thread portion 106. This releases the connection between the stylet hub 100 and the catheter hub 70.
  • the surgeon removes the stylet 30 from the catheter 20, leaving the catheter 20 in the blood vessel.
  • the surgeon directly or indirectly connects a syringe or the like to the base end opening of the catheter 20 and applies suction (negative pressure) to the lumen 41.
  • suction negative pressure
  • the catheter assembly 10 is a catheter assembly 10 including a catheter 20 and a stylet 30 that can be inserted into the catheter 20,
  • the catheter 20 includes a catheter hub 70 disposed at the base end of the catheter 20, a catheter body 40 that extends from the catheter hub 70 in the distal direction and has a lumen 41 formed therein, and a guide tube 60 that is fixed to the distal end of the catheter body 40 and has a guidewire lumen 61 that opens at a guidewire lumen proximal opening 63 that is more distal than the catheter hub 70
  • the catheter body 40 includes a base end tube 43 that extends from the catheter hub 70 in the distal direction, and a guide tube 60 that is more flexible than the base end tube 43 and is fixed to the distal end of the catheter body 40.
  • the stylet 30 has a stylet hub 100 connectable to a catheter hub 70, a shaft 90 extending distally from the stylet hub 100, and a coil 110 fixed to the tip of the shaft 90, and the shaft 90 has a base-side shaft 91 extending distally from the stylet hub 100, and a tapered section 92 having an outer diameter that gradually decreases from the tip of the base-side shaft 91 in the distal direction, and in the assembled state in which the catheter hub 70 and the stylet hub 100 are connected, the base end of the tapered section 92 is positioned at a position distal to the base-end opening 63 of the guidewire lumen, and may also be positioned distal to the tip of the base-side tubular body 43.
  • the base end of the tapered section 92 is disposed distally of the tip of the proximal tube 43, and the tapered section 92, which reduces bending stiffness, does not overlap the proximal tube 43, which contributes highly to the pushability of the catheter assembly 10.
  • the catheter assembly 10 can obtain high pushability.
  • the tapered section 92 which gradually reduces bending stiffness, overlaps a portion of the catheter assembly 10 that contributes highly to blood vessel tracking distally of the proximal tube 43, and therefore the catheter assembly 10 can improve blood vessel tracking by the tapered section 92 while suppressing kinking due to the presence of the stylet 30.
  • the catheter assembly 10 can improve blood vessel tracking at a portion distally of the guidewire lumen proximal opening 63 from which the guidewire is led out.
  • the base end of the tapered section 92 may be positioned in a position that coincides with the guidewire lumen base end opening 63 in the longitudinal direction X, or at a position more proximal than the guidewire lumen base end opening 63, and more distal than the tip of the base end tubular body 43.
  • the base end of the tapered section 92 is positioned more distal than the tip of the base end tubular body 43, so that the tapered section 92, which reduces bending rigidity, does not overlap the base end tubular body 43, which contributes greatly to the pushability of the catheter assembly 10.
  • the catheter assembly 10 can obtain high pushability.
  • the tapered portion 92 which gradually reduces bending stiffness, overlaps with the portion of the catheter assembly 10 that contributes more to blood vessel tracking on the distal side than the proximal tube 43, so that the catheter assembly 10 can improve blood vessel tracking by the tapered portion 92 while suppressing kinking due to the presence of the stylet 30.
  • the proximal end of the tapered portion 92 is positioned at a position that coincides with the guidewire lumen proximal opening 63 in the long axis direction X, or is positioned on the proximal side of the guidewire lumen proximal opening 63, so that the tapered portion 92 is positioned so as to overlap with the portion of the guide tube 60 that is distal from the guidewire lumen proximal opening 63. Therefore, the catheter assembly 10 can improve blood vessel tracking in the portion distal to the guidewire lumen proximal opening 63, including the guidewire lumen proximal opening 63.
  • the catheter 20 is also capable of applying suction force from the catheter hub 70 through the lumen 41 to the opening at the tip side of the lumen 41. This makes it possible to suppress kinking of the catheter assembly 10 having the catheter 20 capable of applying suction force, and improves pushability and blood vessel tracking.
  • At least one of the catheter body 40 and the shaft 90 may be curved in a natural state in which no external force is acting.
  • the number of tubular members having different bending stiffnesses lined up in the longitudinal axis direction X to form the distal outer layer 49 of the catheter 20 is not limited.
  • the modified example shown in FIG. 5 includes a first outer layer 50, a second outer layer 51, and a third outer layer 52, as in the above-described embodiment, but does not include a fourth outer layer 53.
  • the first outer layer 50, the second outer layer 51, and the third outer layer 52 are lined up from the distal side to the proximal side to form a single tube.
  • the third outer layer 52 has a bending stiffness lower than that of the proximal outer layer 47 adjacent to the proximal side.
  • the tip of the stylet 30 overlaps the first outer layer 50
  • the base end of the coil 110 overlaps the second outer layer 51
  • the base end of the tapered portion 92 also overlaps the second outer layer 51.
  • the outer diameter is, for example, 1.60 mm to 1.96 mm, for example 1.96 mm.
  • the inner diameter of the catheter body 40 is, for example, 1.24 mm to 1.30 mm, for example 1.24 mm.
  • the length L3 of the first outer layer 50 in the longitudinal direction X is, for example, 70 mm.
  • the length L4 of the second outer layer 51 in the longitudinal direction X is, for example, 150 mm.
  • the length L5 of the third outer layer 52 in the longitudinal direction X is, for example, 60 mm.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un ensemble cathéter conçu pour éviter les nœuds et améliorer la poussée et le suivi des vaisseaux sanguins.　Cet ensemble cathéter (10) comprend un cathéter (20) et un stylet (30), une extrémité proximale d'une partie conique (92) fournie au stylet (30) étant disposée, dans un état d'assemblage dans lequel un embase de cathéter (70) et un embase de stylet (100) sont raccordés, à une position coïncidant avec une ouverture proximale de lumière de fil-guide (63) fournie au cathéter (20) dans une direction d'axe long (X), ou à une position plus sur le côté d'extrémité proximale que l'ouverture proximale de lumière de fil de guidage (63), et disposée plus du côté de l'extrémité distale que l'extrémité distale d'un corps de tube du côté proximal (43) s'étendant dans la direction de l'extrémité distale à partir de l'embase du cathéter (70).
PCT/JP2024/007752 2023-03-03 2024-03-01 Ensemble cathéter Pending WO2024185681A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2023033030 2023-03-03
JP2023-033030 2023-03-03

Publications (1)

Publication Number Publication Date
WO2024185681A1 true WO2024185681A1 (fr) 2024-09-12

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2024/007752 Pending WO2024185681A1 (fr) 2023-03-03 2024-03-01 Ensemble cathéter

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Country Link
WO (1) WO2024185681A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024544167A (ja) * 2022-11-17 2024-11-28 上海瑛泰医療器械股▲ふん▼有限公司 切断ガイドワイヤ及び血栓吸引システム

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005044359A1 (fr) * 2003-11-07 2005-05-19 Kaneka Corporation Catheter d'aspiration
JP2005211308A (ja) * 2004-01-29 2005-08-11 Terumo Corp カテーテルおよびその製造方法
JP2007089724A (ja) * 2005-09-28 2007-04-12 Nipro Corp カテーテル
JP2007236633A (ja) * 2006-03-08 2007-09-20 Kaneka Corp カテーテル
WO2010067875A1 (fr) * 2008-12-11 2010-06-17 株式会社カネカ Tube médical
WO2021033673A1 (fr) * 2019-08-20 2021-02-25 株式会社グッドマン Cathéter

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005044359A1 (fr) * 2003-11-07 2005-05-19 Kaneka Corporation Catheter d'aspiration
JP2005211308A (ja) * 2004-01-29 2005-08-11 Terumo Corp カテーテルおよびその製造方法
JP2007089724A (ja) * 2005-09-28 2007-04-12 Nipro Corp カテーテル
JP2007236633A (ja) * 2006-03-08 2007-09-20 Kaneka Corp カテーテル
WO2010067875A1 (fr) * 2008-12-11 2010-06-17 株式会社カネカ Tube médical
WO2021033673A1 (fr) * 2019-08-20 2021-02-25 株式会社グッドマン Cathéter

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024544167A (ja) * 2022-11-17 2024-11-28 上海瑛泰医療器械股▲ふん▼有限公司 切断ガイドワイヤ及び血栓吸引システム
JP7755068B2 (ja) 2022-11-17 2025-10-15 上海瑛泰医療器械股▲ふん▼有限公司 切断ガイドワイヤ及び血栓吸引システム

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