WO2015141392A1 - Catheter and catheter set - Google Patents

Catheter and catheter set Download PDF

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Publication number
WO2015141392A1
WO2015141392A1 PCT/JP2015/054919 JP2015054919W WO2015141392A1 WO 2015141392 A1 WO2015141392 A1 WO 2015141392A1 JP 2015054919 W JP2015054919 W JP 2015054919W WO 2015141392 A1 WO2015141392 A1 WO 2015141392A1
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WO
WIPO (PCT)
Prior art keywords
catheter
shaft
connecting portion
extension shaft
guide wire
Prior art date
Application number
PCT/JP2015/054919
Other languages
French (fr)
Japanese (ja)
Inventor
伊藤隆史
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 JP2016508617A priority Critical patent/JP6633513B2/en
Publication of WO2015141392A1 publication Critical patent/WO2015141392A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0177Introducing, guiding, advancing, emplacing or holding catheters having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183Rapid exchange or monorail catheters

Definitions

  • the present invention relates to a rapid exchange type catheter and catheter set capable of extending the effective length.
  • the rapid exchange type catheter is provided with a guide wire lumen only at its distal end, and the catheter can be exchanged more easily than an over-the-wire type catheter.
  • a penetrating catheter for penetrating a stenosis portion generated in a living body lumen such as a blood vessel is known (for example, see Japanese Patent Application Laid-Open No. 2004-275435).
  • a stenosis is formed by inserting a guide wire through a stenosis or occlusion (such as stenosis and occlusion), which may occur in a living body lumen such as a blood vessel.
  • a stenosis or occlusion such as stenosis and occlusion
  • Treatment of the department is extensive.
  • a penetration catheter for penetrating the stenosis part there are a penetration catheter for penetrating the stenosis part and a support catheter for assisting the tip part to suppress bending of the tip part of the guide wire. used.
  • the stenosis in the living body lumen is longer than expected by the operator, or the living body tube
  • the effective length of the catheter may be insufficient. Then, it is necessary to remove the catheter inserted into the living body lumen and insert a different catheter having a longer overall length than the removed catheter into the living body lumen, which increases the cost and the treatment time. End up.
  • a catheter having a longer effective length than the catheter provided in the operating room may be required.
  • the patient may not be reliably treated.
  • the present invention has been made in consideration of such problems, and can reduce the treatment time and cost, and can reliably treat a stenosis in a living body lumen. And it aims at providing a catheter set.
  • a catheter according to the present invention is a rapid exchange type catheter, and includes a cylindrical body, and a flexible shaft that is formed longer than the cylindrical body and provided at a proximal end portion of the cylindrical body.
  • the shaft has a shaft body, and a connection portion provided at a proximal end portion of the shaft body to which an extension shaft for extending an effective length of the catheter can be connected. To do.
  • the effective length of the catheter is increased by connecting the extension shaft to the connecting portion. Since it can be extended, the stenosis can be reached without exchanging the catheter. As a result, the treatment time can be shortened and the cost can be reduced, and the stenosis can be reliably treated.
  • the connecting portion may be a male portion or a female portion.
  • the extension shaft can be easily connected to the connection portion by fitting and coupling.
  • the connecting portion may be a male portion made of a material having shape memory characteristics.
  • the connecting portion may be formed in a wavy shape.
  • the connecting portion can be elastically deformed so that the height of the wavy portion of the connecting portion is lowered in a state where the connecting portion and the extension shaft are fitted, the restoring force (elasticity) The connecting portion and the extension shaft can be firmly connected by the force).
  • the connecting portion may be a female portion made of a plastically deformable metal material.
  • connection portion and the extension shaft can be firmly connected by crimping the connection portion in a state where the connection portion and the extension shaft are fitted.
  • the catheter may further include an operation device that is detachably provided on the shaft body and the extension shaft.
  • the operability of the catheter can be improved by mounting the operation device on the shaft body. Further, since the operation device can be changed from the shaft to the extension shaft in a state where the extension shaft is connected to the connection portion, the operability can be improved while extending the effective length of the catheter.
  • the operation device may be provided with a wire holding portion that holds a guide wire that is inserted through the lumen of the cylindrical body.
  • the operation device by holding the guide wire in the wire holding portion of the operation device, the operation device can be grasped and the catheter and the guide wire can be operated simultaneously.
  • a catheter set according to the present invention is a catheter set comprising a rapid exchange type catheter and an extension shaft for extending the effective length of the catheter, wherein the catheter is the catheter described above.
  • the treatment time can be shortened and the cost can be reduced, and the stenosis in the living body lumen can be achieved.
  • the part can be treated reliably.
  • FIG. 2 is a transverse sectional view taken along line II-II in FIG.
  • FIG. 3A is an enlarged partial cross-sectional view of a first connection portion of a catheter and a second connection portion of an extension shaft constituting the catheter set
  • FIG. 3B is a connection of the first connection portion and the second connection portion.
  • FIG. 4A is an explanatory view showing a state in which a guide wire is passed through the first constriction
  • FIG. 4B is an explanatory view showing a state in which the guide wire is guided to the second constriction.
  • FIG. 7A is a partially omitted explanatory view of the catheter set according to the second embodiment
  • FIG. 7B is a partially omitted explanatory view of the catheter set according to the third embodiment
  • FIG. 7C is a catheter according to the fourth embodiment. It is a partially omitted illustration of the set.
  • the catheter set 10 ⁇ / b> A includes a catheter 12 and an extension shaft 14.
  • the catheter 12 assists the distal end in order to suppress bending of the distal end of the guide wire GW that passes through a narrowed portion in a biological lumen such as a blood vessel, bile duct, trachea, esophagus, or urethra.
  • a biological lumen such as a blood vessel, bile duct, trachea, esophagus, or urethra.
  • This is a rapid exchange type support catheter.
  • the catheter 12 may be a rapid exchange type penetrating catheter that penetrates the narrowed portion.
  • the catheter 12 includes a thin and long shaft 16, an operation device 18 that is detachably provided on the proximal end side of the shaft 16, and a cylindrical body 20 that is provided on the distal end portion of the shaft 16.
  • the shaft 16 has a shaft main body 22 and a first connection portion 24 provided at a base end portion of the shaft main body 22.
  • the shaft body 22 is a solid linear member that is formed to be longer (thinner and longer) than the cylindrical body 20, and has flexibility.
  • the shaft body 22 can be made of any material, but can be made of a metal material such as stainless steel, Ni—Ti alloy, or cobalt alloy.
  • the catheter 12 is configured as a penetrating catheter, if the shaft main body 22 is formed of a solid metal wire, an appropriate rigidity is obtained in the shaft main body 22 and a pushing force acting on the proximal end side of the shaft main body 22 is obtained. Can be efficiently transmitted to the cylindrical body 20.
  • the first connecting portion 24 is configured such that the extension shaft 14 for extending the effective length of the catheter 12 can be connected.
  • the configuration of the first connection unit 24 will be described later.
  • the operation device 18 is formed in a size that can be easily operated by a human hand, and includes a cylindrical handle 28 having a lumen 26 through which the shaft 16 is inserted, a chuck 30 disposed at a distal end opening of the handle 28, A cap 32 that is screw-fitted to the distal end side of the handle 28.
  • the chuck 30 has a through-hole through which the shaft 16 is inserted at the center thereof, and the large-diameter portion on the distal end side is the handle 28 with the small-diameter portion on the proximal end side disposed in the distal-end opening of the handle 28. Exposed from the lumen.
  • the outer surface of the large diameter portion is formed in a tapered shape that gradually decreases in diameter toward the small diameter portion.
  • the chuck 30 is formed with a plurality of slits 38 (not shown) extending in the axial direction and communicating with the through holes in the circumferential direction. Each slit 38 extends from the tip of the large diameter portion to the middle of the small diameter portion.
  • the operation device 18 having such a configuration, when the screw fitting force of the cap 32 with respect to the handle 28 is increased with the shaft body 22 being passed through the lumen 26 of the handle 28 through the through hole of the chuck 30, the size of the chuck 30 is increased. The diameter portion is pressed toward the handle 28 and the through hole of the chuck 30 is reduced in diameter. If it does so, since the wall surface which comprises a through-hole is pressed on the outer surface of the shaft main body 22, the operation device 18 will be fixed with respect to the shaft main body 22.
  • the operation device 18 further includes a wire holding portion 34 that is fixed to the proximal end side of the handle 28 and holds the guide wire GW.
  • the wire holding part 34 can be comprised with a rubber material, for example.
  • the wire holding part 34 is formed with a circular hole 36 and a slit 38 that communicates with the hole 36 and opens on the surface opposite to the handle 28.
  • Each of the hole 36 and the slit 38 passes through the wire holding portion 34 along the axial direction of the handle 28 (see FIG. 1).
  • the hole 36 has a hole diameter that is smaller than the outer diameter of the guide wire GW.
  • the slit 38 is formed so as to gradually narrow toward the hole 36.
  • the wall of the hole 36 is pushed outward in the radial direction by the guide wire GW by inserting the guide wire GW into the hole 36 through the slit 38. Therefore, the guide wire GW is held on the wall surface forming the hole 36 by the restoring force of the wire holding portion 34.
  • the cylindrical body 20 is configured in a cylindrical shape, and a distal end portion of the shaft 16 is fixed to a proximal end portion thereof.
  • the cylindrical body 20 is disposed between an inner layer 42 having a lumen (guide wire lumen) 40 through which the guide wire GW can be inserted, an outer layer 44 provided on the outer peripheral side of the inner layer 42, and the inner layer 42 and the outer layer 44. Reinforcing body (blade) 46.
  • the distal end portion of the cylindrical body 20 is located at the boundary between the outer peripheral surface of the guide wire GW and the outer peripheral surface of the distal end of the cylindrical body 20 from the viewpoint of entering into the constricted portion and preventing damage to the living body lumen.
  • the tapered surface is tapered toward the tip so that the formed step surface is small.
  • the radial thickness of the tapered distal end portion of the cylindrical body 20 is larger than the radial thickness of the proximal end portion of the cylindrical body 20 so that the distal end portion of the guide wire can be easily assisted. It is preferable that the thickness is too thick.
  • the inner layer 42 can be made of any material, but can be made of, for example, a fluorine resin such as PTFE (polytetrafluoroethylene).
  • PTFE polytetrafluoroethylene
  • the outer layer 44 can be composed of any material, but can be composed of, for example, various thermoplastic elastomers such as polyurethane elastomer, polyester elastomer, polyamide elastomer, and mixtures thereof. Further, a tapered portion is formed at the tip of the outer layer 44. By tapering the distal end in this manner, the catheter 12 can easily pass through the stenosis.
  • the reinforcing body 46 is embedded in the outer layer 44 in a net-like state.
  • the reinforcing body 46 can be made of any material, but for example, tungsten, stainless steel, or the like can be used.
  • the reinforcing body 46 may be formed in a spiral coil shape or a rod shape.
  • an X-ray opaque marker or the like on the cylinder 20 so that the position of the catheter 12 in the living body lumen can be confirmed.
  • an X-ray opaque material such as barium sulfate, bismuth oxide, tungsten or the like is added to the material constituting the cylinder 20 in order to grasp the position of the cylinder 20 in the living body lumen. You may keep it.
  • the cylindrical body 20 may be provided with an X-ray opaque marker such as platinum on the distal end portion and the proximal end portion of the cylindrical body 20 in order to measure the stenosis portion in the living body lumen.
  • the first connecting portion 24 folds a linear member made of a material having shape memory characteristics, such as a Ti—Ni shape memory alloy, into a wave shape from the approximate center of the base end surface of the shaft body 22. It is formed so as to bend. That is, the 1st connection part 24 is comprised as a male part.
  • shape memory characteristics such as a Ti—Ni shape memory alloy
  • the width dimension (interval between wave peaks and valleys) W of the first connection portion 24 is formed to be approximately the same as the outer diameter D1 of the shaft body 22.
  • the extension shaft 14 is a tubular member having a lumen 48 opened from the distal end to the proximal end thereof, and is provided integrally with the extension shaft main body 50 and the distal end portion of the extension shaft main body 50 so that the first connection of the catheter 12 is achieved. And a second connecting portion 52 connectable to the portion 24.
  • the extension shaft 14 can be made of the same material as that of the shaft body 22 and can be set to an arbitrary length.
  • the second connection portion 52 is configured as a female portion that is fitted and coupled to the first connection portion 24 that is a male portion.
  • the hole diameter D ⁇ b> 2 of the second connection portion 52 is smaller than the width dimension W of the first connection portion 24. Therefore, when the first connection portion 24 is inserted into the lumen 48 of the second connection portion 52, the first connection portion 24 has a narrow width (the height of the crest of the first connection portion 24 is reduced). Since it is elastically deformed (to be lowered), the restoring force of the first connecting portion 24 can be applied to the inner surface of the second connecting portion 52. Thereby, the 1st connection part 24 and the 2nd connection part 52 can be firmly fittingly joined (refer FIG. 3B).
  • the outer diameter D3 of the second connection portion 52 is formed substantially the same as the outer diameter D1 of the shaft body 22.
  • an X-ray opaque marker such as platinum
  • an X-ray contrast marker may also be provided at the distal end portion of the extension shaft 14 or the second connection portion 52.
  • the catheter set 10A according to the present embodiment is basically configured as described above, and the effects will be described below.
  • the catheter set 10 ⁇ / b> A continues, for example, a first stenosis part 202 and a second stenosis part 204 that are lesions with a high degree of stenosis or chronic total occlusion lesions (CTO: Chronic Total Occlusion) occurring in the blood vessel 200.
  • CTO Chronic Total Occlusion
  • a sheath introducer (not shown) is punctured into a blood vessel (for example, radial artery or femoral artery) by the Seldinger method, and a guide wire is inserted.
  • the GW is introduced in advance and the guiding catheter 206 is placed at a predetermined position in the predetermined blood vessel 200. At this time, since the guide wire GW cannot pass through the first constricted portion 202 alone, the guide wire GW is positioned on the near side (the central side and the right side in FIG. 4A) of the first constricted portion 202.
  • the guide wire GW is passed through the lumen 40 of the cylindrical body 20 of the catheter 12 as a support catheter, the catheter 12 is advanced through the lumen of the guiding catheter 206 along the guide wire GW, and the distal end thereof is guided. It is located near the tip of the wire GW.
  • the extension shaft 14 is not attached to the catheter 12, and the operation device 18 is attached to the proximal end portion of the shaft body 22.
  • the surgeon passes the guide wire GW through the first constricted portion 202 while assisting the distal end portion of the guide wire GW with the catheter 12 (see FIG. 4A).
  • the operator may operate to push the guide wire GW and the catheter 12 alternately to the first stenosis part 202 by a predetermined length alternately, or the guide wire GW and the catheter 12 together to the first stenosis part 202. You may operate so that it may push forward.
  • the proximal end side of the guide wire GW is fixed to the operation device 18 by inserting it into the hole 36 through the slit 38 of the wire holding portion 34.
  • the operator can easily operate both the guide wire GW and the catheter 12 simultaneously by grasping the operation device 18.
  • the treatment of the first stenosis 202 is completed.
  • the second stenosis part 204 is present on the distal side of the treated first stenosis part 202, sufficient blood perfusion may not be obtained on the distal side of the first stenosis part 202. . In this case, the treatment of the second stenosis 204 is continued.
  • the surgeon operates the guide wire GW and presses the distal end thereof against the second constricted portion 204 (see FIG. 4B).
  • the guide wire GW is operated after the guide wire GW is removed from the wire holding portion 34 of the operation device 18. To do.
  • the distal end of the catheter 12 is positioned in the vicinity of the distal end of the guide wire GW. At this time, when the distance between the first stenosis part 202 and the second stenosis part 204 is relatively long, the catheter 12 may not reach the second stenosis part 204.
  • the effective length of the catheter 12 is extended by connecting the extension shaft 14 to the first connection portion 24 of the catheter 12. That is, the first connection portion 24 formed to be bent in a wave shape is inserted into the lumen 48 of the second connection portion 52. Then, the first connecting portion 24 is elastically deformed so that the height of the wavy mountain is lowered and the restoring force acts on the inner surface of the second connecting portion 52, so that the first connecting portion 24 and the second connecting portion 52 are It is firmly fitted and connected. At this time, it goes without saying that the operator selects the extension shaft 14 having a length corresponding to the distance from the first stenosis part 202 to the second stenosis part 204 and connects it to the catheter 12.
  • the operator releases the fixation of the operation device 18 to the shaft 16 by operating the cap 32 of the operation device 18 to weaken the screw fitting force to the handle 28. Thereafter, the operating device 18 is moved with respect to the extension shaft 14 by operating the cap 32 in a state where the operating device 18 is moved to an arbitrary position on the proximal end side of the extension shaft main body 50 to increase the screw fitting force with respect to the handle 28. (See FIG. 5).
  • the guide wire GW is passed through the second constricted portion 204 while assisting the distal end portion of the guide wire GW with the catheter 12 (see FIG. 6). Since the treatment of the second stenosis part 204 is the same as the treatment of the first stenosis part 202 described above, detailed description thereof is omitted. After the treatment of the second stenosis 204, the catheter 12 and the guide wire GW are removed from the blood vessel 200.
  • the effective length of the catheter 12 can be extended by connecting the second connection portion 52 of the extension shaft 14 to the first connection portion 24 of the catheter 12. Therefore, after treating the first stenosis 202 on the near side (central side), the effective length of the catheter 12 is used when treating the second stenosis 204 present on the distal side of the first stenosis 202. Even if this is insufficient, the catheter 12 can reach the second constricted portion 204 by connecting the extension shaft 14 to the catheter 12. This eliminates the need to replace the catheter 12 with a different catheter having a long effective length after treating the first stenosis 202, thereby reducing the treatment time and reducing the cost and the first stenosis 202. And the 2nd constriction part 204 can be treated reliably.
  • the first connecting portion 24 of the catheter 12 is a male portion and the second connecting portion 52 of the extension shaft 14 is a female portion, the first connecting portion 24 and the second connecting portion 52 are fitted and joined.
  • the extension shaft 14 can be easily connected to the catheter 12.
  • the 1st connection part 24 is comprised with the material which has a shape memory characteristic, breakage of the 1st connection part 24 can be suppressed.
  • the first connecting portion 24 is formed in a wave shape, when the first connecting portion 24 is inserted into the inner cavity 48 of the second connecting portion 52, the height of the wave mountain of the first connecting portion 24 is increased.
  • the first connecting portion 24 can be elastically deformed so that the height is low. Thereby, since the restoring force of the 1st connection part 24 can be made to act on the inner surface of the 2nd connection part 52, the 1st connection part 24 and the 2nd connection part 52 can be connected firmly.
  • the operation device 18 can be attached to the shaft 16, the operability of the catheter 12 can be improved. Further, since the operation device 18 can be changed from the shaft 16 to the extension shaft 14 in a state where the extension shaft 14 is connected to the first connection portion 24, the operability can be improved while extending the effective length of the catheter 12. it can.
  • the operation device 18 can be held and the catheter 12 and the guide wire GW can be operated simultaneously.
  • the catheter set 10A according to the present embodiment is not limited to the configuration described above.
  • the extension shaft 14 may be configured, for example, by providing a tubular second connection portion 52 at the distal end portion of a thin and solid extension shaft main body 50. In this case, since the rigidity of the extension shaft main body 50 is increased, the pushing force applied to the extension shaft main body 50 can be efficiently transmitted to the shaft 16.
  • the second connection portion 52 may be made of a plastically deformable metal material. In this case, it is possible to clamp the second connecting portion 52 with forceps or the like while the first connecting portion 24 is inserted into the lumen 48 of the second connecting portion 52. Thereby, the 1st connection part 24 and the 2nd connection part 52 can be fitted and connected still more firmly.
  • the catheter set 10A according to the present embodiment can also be used for the treatment of a relatively long stenosis part or the treatment of a stenosis part generated in a blood vessel of a lower limb.
  • the catheter 12 when treatment is performed to guide the catheter 12 inserted from the radial artery to a stenosis that has occurred in the blood vessel of the lower limb, the blood vessel has many curved portions, and the effective length of the catheter 12 may be insufficient. is there.
  • the catheter 12 since the effective length can be extended by connecting the extension shaft 14 to the catheter 12, the catheter 12 can be reliably attached to the stenosis without replacing the catheter 12 with another catheter having a long effective length. Treatment can be performed.
  • the catheter set 10A can also be used together with a therapeutic catheter such as a balloon catheter, a stent delivery catheter, or a drug injection catheter.
  • a therapeutic catheter such as a balloon catheter, a stent delivery catheter, or a drug injection catheter.
  • the catheter 12 can be inserted through the therapeutic catheter. It may be a penetrating catheter provided with a cylindrical body 20 having a cavity 40 at the distal end.
  • the catheter set 10B according to this embodiment is different from the catheter set 10A according to the first embodiment described above in the configuration of the shaft 62 and the extension shaft 64 of the catheter 60.
  • the shaft 62 is a tubular member having a lumen 66 that opens from the distal end to the proximal end thereof, and includes a shaft body 68 and a first connection portion 70 that is integrally provided at the proximal end portion of the shaft body 68.
  • the 1st connection part 70 is comprised as a female part.
  • the extension shaft 64 has a thin and solid extension shaft main body 72 and a second connection portion 74 provided at the tip of the extension shaft main body 72.
  • the outer diameter of the extension shaft main body 72 is set to be substantially the same as the outer diameter of the first connection portion 70.
  • the restoring force of the second connecting portion 74 acts on the inner surface of the first connecting portion 70.
  • the connecting portion 70 and the second connecting portion 74 are firmly fitted and coupled.
  • the same effects as those of the first embodiment described above can be obtained.
  • the extension shaft main body 72 is configured to be solid, the rigidity can be increased compared to the case where the extension shaft main body 72 is configured to be hollow. Thereby, the pushing force which acted on the base end side of the extension shaft main body 72 can be efficiently transmitted to the shaft 62.
  • the shaft 62 is a tubular member having a constant outer diameter by integrally providing the first connecting portion 70 at the base end portion of the shaft main body 68, the extension shaft 64 is connected to the first connecting portion 70.
  • the first connecting portion 70 can be prevented from interfering with the operator's fingers and other medical devices.
  • the catheter set 10B according to the present embodiment is not limited to the configuration described above.
  • the shaft body 68 may be configured to be solid.
  • the rigidity of the shaft main body 68 can be increased as compared with the case where the shaft main body 68 is hollow. Thereby, the pushing force which acted on the base end side of the shaft main body 68 can be efficiently transmitted to the cylindrical body 20.
  • first connection portion 70 may be made of a metal material that can be plastically deformed. If it does so, the 1st connection part 70 can be crimped with forceps etc., and, thereby, the 1st connection part 70 and the 2nd connection part 74 can be connected still more firmly.
  • the shaft main body 68 and the first connection portion 70 can be made of different materials.
  • the catheter set 10C according to the present embodiment is different from the catheter set 10A according to the first embodiment described above in the configuration of the extension shaft 80, and includes a connecting portion 82.
  • the extension shaft 80 has an extension shaft main body 84 and a second connection portion 86, and has the same configuration as the extension shaft 64 according to the second embodiment described above. Therefore, detailed description of the extension shaft 80 is omitted.
  • the connecting portion 82 is a tubular member having an inner cavity 88 that opens from the distal end to the proximal end, and can be made of the same material as the shaft body 22.
  • the connecting portion 82 is formed to be somewhat longer than the total length of the length along the axial direction of the shaft body 22 of the first connecting portion 24 and the length along the axial direction of the extension shaft main body 84 of the second connecting portion 86. Has been.
  • the restoring force of the first connecting part 24 acts on the inner surface of the connecting part 82, so the first connecting part 24 and the connecting part 82 is firmly fitted and coupled.
  • the 2nd connection part 86 is inserted in the other opening part of the connection part 82, since the restoring force of the 2nd connection part 86 will act on the inner surface of the connection part 82, the 2nd connection part 86 and the connection part 82 will be It is firmly fitted and connected. Thereby, the 1st connection part 24 and the 2nd connection part 86 will be firmly connected via the connection part 82.
  • FIG. According to the present embodiment, the same effects as those of the first embodiment described above can be obtained.
  • the catheter set 10D according to this embodiment differs from the catheter set 10A according to the first embodiment described above in the configuration of the shaft 92 of the catheter 90, and includes a connecting portion 94.
  • the shaft 92 has a shaft main body 96 and a first connection portion 98, and has the same configuration as the shaft 62 according to the second embodiment described above. Therefore, detailed description of the shaft 92 is omitted.
  • the connecting portion 94 has the same configuration as the first connecting portion 24 of the first embodiment described above, and a linear member made of a material having shape memory characteristics such as a Ti—Ni-based shape memory alloy is used. It is configured by bending in a wave shape.
  • the connecting portion 94 when one end side of the connecting portion 94 is inserted into the lumen 100 of the first connecting portion 98, the restoring force on the one end side of the connecting portion 94 acts on the inner surface of the first connecting portion 98.
  • the part 98 and the connecting part 94 are firmly fitted and coupled.
  • the restoring force on the other end side of the connecting portion 94 acts on the inner surface of the second connecting portion 52.
  • 52 and the connecting portion 94 are firmly fitted and coupled. Thereby, the 1st connection part 98 and the 2nd connection part 52 will be firmly connected via the connection part 94.
  • FIG. According to the present embodiment, the same effects as those of the first embodiment described above can be obtained.
  • the catheter and the catheter set according to the present invention are not limited to the above-described embodiments, and various configurations can be adopted without departing from the gist of the present invention.

Abstract

This catheter set (10A) is provided with a catheter (12) and an extension shaft (14) for extending the effective length of the catheter. The catheter (12) has a tubular body (20) and a flexible shaft (16) that is formed to be thinner and longer than the tubular body (20). The shaft (16) has a connecting part (24) which is provided on a proximal end of a shaft body (22) and to which the extension shaft (14) can be connected.

Description

カテーテル及びカテーテルセットCatheter and catheter set
 本発明は、有効長を延長可能なラピッドエクスチェンジ式のカテーテル及びカテーテルセットに関する。 The present invention relates to a rapid exchange type catheter and catheter set capable of extending the effective length.
 カテーテルには、ラピッドエクスチェンジ式のカテーテルとオーバーザワイヤ式のカテーテルがある。ラピッドエクスチェンジ式のカテーテルは、その先端部にのみガイドワイヤルーメンが設けられたものであって、オーバーザワイヤ式のカテーテルと比べてカテーテルの交換を容易に行うことが可能となっている。このようなラピッドエクスチェンジ式のカテーテルとして、血管等の生体管腔内に生じた狭窄部を貫通させるための貫通カテーテルが知られている(例えば、特開2004-275435号公報参照)。 There are rapid exchange type catheters and over-the-wire type catheters. The rapid exchange type catheter is provided with a guide wire lumen only at its distal end, and the catheter can be exchanged more easily than an over-the-wire type catheter. As such a rapid exchange type catheter, a penetrating catheter for penetrating a stenosis portion generated in a living body lumen such as a blood vessel is known (for example, see Japanese Patent Application Laid-Open No. 2004-275435).
 ところで、血管等の生体管腔内に生じた狭窄部又は閉塞部(以下、狭窄部と閉塞部を総称して単に「狭窄部」と称することがある。)にガイドワイヤを挿通させて当該狭窄部を治療することが広汎に行われている。そして、例えば、このように狭窄部にガイドワイヤを通過させる際、当該狭窄部を貫通させるための貫通カテーテルや、ガイドワイヤの先端部の撓みを抑制するために当該先端部を補助するサポートカテーテルが使用される。 By the way, a stenosis is formed by inserting a guide wire through a stenosis or occlusion (such as stenosis and occlusion), which may occur in a living body lumen such as a blood vessel. Treatment of the department is extensive. And, for example, when a guide wire is passed through the stenosis part in this way, there are a penetration catheter for penetrating the stenosis part and a support catheter for assisting the tip part to suppress bending of the tip part of the guide wire. used.
 しかしながら、ガイドワイヤに沿って貫通カテーテル又はサポートカテーテル(以下、単に「カテーテル」と称することがある。)を進行させる際、術者の想定以上に生体管腔内の狭窄部が長い場合又は生体管腔内に複数の狭窄部が連続して存在する場合、カテーテルの有効長が不足することがある。そうすると、生体管腔内に挿入しているカテーテルを抜去し、抜去したカテーテルよりも全長の長い異なるカテーテルを生体管腔内に挿入する必要があるため、コストが増大すると共に治療時間が長期化してしまう。 However, when a penetrating catheter or a support catheter (hereinafter sometimes simply referred to as “catheter”) is advanced along the guide wire, the stenosis in the living body lumen is longer than expected by the operator, or the living body tube When there are a plurality of constricted portions continuously in the cavity, the effective length of the catheter may be insufficient. Then, it is necessary to remove the catheter inserted into the living body lumen and insert a different catheter having a longer overall length than the removed catheter into the living body lumen, which increases the cost and the treatment time. End up.
 また、湾曲部が多い血管等の治療では、手術室に備えているカテーテルよりも有効長の長いカテーテルが必要になる可能性もある。このような場合、必要な全長を有するカテーテルの代替品が準備できないと、患者の治療を確実に行うことができないおそれがある。 Also, in the treatment of blood vessels with many curved portions, a catheter having a longer effective length than the catheter provided in the operating room may be required. In such a case, if a substitute for a catheter having the necessary overall length cannot be prepared, the patient may not be reliably treated.
 本発明は、このような課題を考慮してなされたものであり、治療時間の短縮化及びコストの低廉化を図ることができると共に生体管腔内の狭窄部を確実に治療することができるカテーテル及びカテーテルセットを提供することを目的とする。 The present invention has been made in consideration of such problems, and can reduce the treatment time and cost, and can reliably treat a stenosis in a living body lumen. And it aims at providing a catheter set.
 本発明に係るカテーテルは、ラピッドエクスチェンジ式のカテーテルであって、筒体と、前記筒体よりも細長く形成されて当該筒体の基端部に設けられた可撓性を有するシャフトと、を備え、前記シャフトは、シャフト本体と、前記シャフト本体の基端部に設けられて前記カテーテルの有効長を延長させるための延長シャフトが接続可能な接続部と、を有している、ことを特徴とする。 A catheter according to the present invention is a rapid exchange type catheter, and includes a cylindrical body, and a flexible shaft that is formed longer than the cylindrical body and provided at a proximal end portion of the cylindrical body. The shaft has a shaft body, and a connection portion provided at a proximal end portion of the shaft body to which an extension shaft for extending an effective length of the catheter can be connected. To do.
 本発明に係るカテーテルによれば、生体管腔内の狭窄部を治療する際にカテーテルの有効長が不足するような場合であっても、接続部に延長シャフトを接続してカテーテルの有効長を延長することができるので、当該カテーテルを交換することなく狭窄部に到達させることができる。これにより、治療時間の短縮化及びコストの低廉化を図ることができると共に狭窄部を確実に治療することができる。 According to the catheter of the present invention, even when the effective length of the catheter is insufficient when treating the stenosis in the living body lumen, the effective length of the catheter is increased by connecting the extension shaft to the connecting portion. Since it can be extended, the stenosis can be reached without exchanging the catheter. As a result, the treatment time can be shortened and the cost can be reduced, and the stenosis can be reliably treated.
 上記のカテーテルにおいて、前記接続部は、雄部又は雌部であってもよい。 In the above catheter, the connecting portion may be a male portion or a female portion.
 このような構成によれば、延長シャフトを接続部に対して嵌合結合により容易に接続することができる。 According to such a configuration, the extension shaft can be easily connected to the connection portion by fitting and coupling.
 上記のカテーテルにおいて、前記接続部は、形状記憶特性を有する材料で構成された雄部であってもよい。 In the above catheter, the connecting portion may be a male portion made of a material having shape memory characteristics.
 このような構成によれば、接続部の折損を抑制できる。 According to such a configuration, breakage of the connecting portion can be suppressed.
 上記のカテーテルにおいて、前記接続部は、波状に折曲して形成されていてもよい。 In the above catheter, the connecting portion may be formed in a wavy shape.
 このような構成によれば、接続部と延長シャフトとを嵌合させた状態で接続部の波山の高さが低くなるように当該接続部を弾性変形させることができるので、その復元力(弾発力)により接続部と延長シャフトとを強固に接続することができる。 According to such a configuration, since the connecting portion can be elastically deformed so that the height of the wavy portion of the connecting portion is lowered in a state where the connecting portion and the extension shaft are fitted, the restoring force (elasticity) The connecting portion and the extension shaft can be firmly connected by the force).
 上記のカテーテルにおいて、前記接続部は、塑性変形可能な金属材料で構成された雌部であってもよい。 In the above catheter, the connecting portion may be a female portion made of a plastically deformable metal material.
 このような構成によれば、接続部と延長シャフトとを嵌合させた状態で接続部を加締めることにより、接続部と延長シャフトとを強固に接続することができる。 According to such a configuration, the connection portion and the extension shaft can be firmly connected by crimping the connection portion in a state where the connection portion and the extension shaft are fitted.
 上記のカテーテルにおいて、前記シャフト本体及び前記延長シャフトに着脱可能に設けられる操作デバイスをさらに備えていてもよい。 The catheter may further include an operation device that is detachably provided on the shaft body and the extension shaft.
 このような構成によれば、シャフト本体に操作デバイスを装着することによりカテーテルの操作性を向上させることができる。また、延長シャフトを接続部に接続した状態において、操作デバイスをシャフトから延長シャフトに付け替えることができるので、カテーテルの有効長を延長させつつ操作性を向上させることができる。 According to such a configuration, the operability of the catheter can be improved by mounting the operation device on the shaft body. Further, since the operation device can be changed from the shaft to the extension shaft in a state where the extension shaft is connected to the connection portion, the operability can be improved while extending the effective length of the catheter.
 上記のカテーテルにおいて、前記操作デバイスには、前記筒体の内腔を挿通するガイドワイヤを保持するワイヤ保持部が設けられていてもよい。 In the above catheter, the operation device may be provided with a wire holding portion that holds a guide wire that is inserted through the lumen of the cylindrical body.
 このような構成によれば、操作デバイスのワイヤ保持部にガイドワイヤを保持することにより、操作デバイスを把持してカテーテルとガイドワイヤを同時に操作することができる。 According to such a configuration, by holding the guide wire in the wire holding portion of the operation device, the operation device can be grasped and the catheter and the guide wire can be operated simultaneously.
 本発明に係るカテーテルセットは、ラピッドエクスチェンジ式のカテーテルと、前記カテーテルの有効長を延長させるための延長シャフトと、を備えたカテーテルセットであって、前記カテーテルは、上述したカテーテルであることを特徴とする。 A catheter set according to the present invention is a catheter set comprising a rapid exchange type catheter and an extension shaft for extending the effective length of the catheter, wherein the catheter is the catheter described above. And
 本発明によれば、接続部に延長シャフトを接続することによりカテーテルの有効長を延長することができるので、治療時間の短縮化及びコストの低廉化を図ることができると共に生体管腔内の狭窄部を確実に治療することができる。 According to the present invention, since the effective length of the catheter can be extended by connecting the extension shaft to the connecting portion, the treatment time can be shortened and the cost can be reduced, and the stenosis in the living body lumen can be achieved. The part can be treated reliably.
本発明の第1実施形態に係るカテーテルセットの概略縦断面図である。It is a schematic longitudinal cross-sectional view of the catheter set which concerns on 1st Embodiment of this invention. 図1のII-II線に沿った横断面図である。FIG. 2 is a transverse sectional view taken along line II-II in FIG. 図3Aは前記カテーテルセットを構成するカテーテルの第1接続部と延長シャフトの第2接続部の一部断面拡大図であり、図3Bは前記第1接続部と前記第2接続部とが接続した状態を示す一部断面拡大図である。FIG. 3A is an enlarged partial cross-sectional view of a first connection portion of a catheter and a second connection portion of an extension shaft constituting the catheter set, and FIG. 3B is a connection of the first connection portion and the second connection portion. It is a partial cross section enlarged view which shows a state. 図4Aは第1狭窄部にガイドワイヤを通過させた状態を示す説明図であり、図4Bは第2狭窄部にガイドワイヤを導いた状態を示す説明図である。FIG. 4A is an explanatory view showing a state in which a guide wire is passed through the first constriction, and FIG. 4B is an explanatory view showing a state in which the guide wire is guided to the second constriction. 延長シャフトに操作デバイスを装着した状態を示す説明図である。It is explanatory drawing which shows the state which attached the operating device to the extension shaft. 第2狭窄部にガイドワイヤを通過させた状態を示す説明図である。It is explanatory drawing which shows the state which passed the guide wire through the 2nd constriction part. 図7Aは第2実施形態に係るカテーテルセットの一部省略説明図であり、図7Bは第3実施形態に係るカテーテルセットの一部省略説明図であり、図7Cは第4実施形態に係るカテーテルセットの一部省略説明図である。7A is a partially omitted explanatory view of the catheter set according to the second embodiment, FIG. 7B is a partially omitted explanatory view of the catheter set according to the third embodiment, and FIG. 7C is a catheter according to the fourth embodiment. It is a partially omitted illustration of the set.
 以下、本発明に係るカテーテルを備えたカテーテルセットについて好適な実施形態を挙げ、添付の図面を参照しながら説明する。 Hereinafter, preferred embodiments of a catheter set including a catheter according to the present invention will be described with reference to the accompanying drawings.
(第1実施形態)
 図1に示すように、カテーテルセット10Aは、カテーテル12と、延長シャフト14とを備えている。本実施形態に係るカテーテル12は、例えば、血管、胆管、気管、食道、尿道等の生体管腔内の狭窄部に通過させるガイドワイヤGWの先端部の撓みを抑制するために当該先端部を補助するラピッドエクスチェンジ式のサポートカテーテルである。ただし、カテーテル12は、狭窄部を貫通するラピッドエクスチェンジ式の貫通カテーテルであってもよい。
(First embodiment)
As shown in FIG. 1, the catheter set 10 </ b> A includes a catheter 12 and an extension shaft 14. The catheter 12 according to the present embodiment assists the distal end in order to suppress bending of the distal end of the guide wire GW that passes through a narrowed portion in a biological lumen such as a blood vessel, bile duct, trachea, esophagus, or urethra. This is a rapid exchange type support catheter. However, the catheter 12 may be a rapid exchange type penetrating catheter that penetrates the narrowed portion.
 カテーテル12は、細径で長尺なシャフト16と、シャフト16の基端側に着脱可能に設けられる操作デバイス18と、シャフト16の先端部に設けられる筒体20とを備えている。 The catheter 12 includes a thin and long shaft 16, an operation device 18 that is detachably provided on the proximal end side of the shaft 16, and a cylindrical body 20 that is provided on the distal end portion of the shaft 16.
 シャフト16は、シャフト本体22と、シャフト本体22の基端部に設けられた第1接続部24とを有している。シャフト本体22は、筒体20よりも細長く(細径で長尺に)形成された中実の線状部材であって、可撓性を有している。シャフト本体22は、任意の材料で構成可能であるが、例えば、ステンレス鋼、Ni-Ti合金、又はコバルト系合金等の金属材料で構成することができる。特に、カテーテル12を貫通カテーテルとして構成する場合には、シャフト本体22を中実の金属線で構成すると、シャフト本体22に適度な剛性が得られ、シャフト本体22の基端側に作用した押し込み力を筒体20に効率的に伝達させることができるので好適である。 The shaft 16 has a shaft main body 22 and a first connection portion 24 provided at a base end portion of the shaft main body 22. The shaft body 22 is a solid linear member that is formed to be longer (thinner and longer) than the cylindrical body 20, and has flexibility. The shaft body 22 can be made of any material, but can be made of a metal material such as stainless steel, Ni—Ti alloy, or cobalt alloy. In particular, when the catheter 12 is configured as a penetrating catheter, if the shaft main body 22 is formed of a solid metal wire, an appropriate rigidity is obtained in the shaft main body 22 and a pushing force acting on the proximal end side of the shaft main body 22 is obtained. Can be efficiently transmitted to the cylindrical body 20.
 第1接続部24は、カテーテル12の有効長を延長させるための延長シャフト14が接続可能に構成される。この第1接続部24の構成については追って説明する。 The first connecting portion 24 is configured such that the extension shaft 14 for extending the effective length of the catheter 12 can be connected. The configuration of the first connection unit 24 will be described later.
 操作デバイス18は、人手によって操作し易い大きさに形成されており、シャフト16が挿通する内腔26を有する円筒状のハンドル28と、ハンドル28の先端開口部に配設されたチャック30と、ハンドル28の先端側にねじ嵌合するキャップ32とを含む。 The operation device 18 is formed in a size that can be easily operated by a human hand, and includes a cylindrical handle 28 having a lumen 26 through which the shaft 16 is inserted, a chuck 30 disposed at a distal end opening of the handle 28, A cap 32 that is screw-fitted to the distal end side of the handle 28.
 チャック30は、その中心部にシャフト16が挿通する貫通孔が形成されており、基端側の小径部がハンドル28の先端開口部に配設された状態で先端側の大径部がハンドル28の内腔から露出する。大径部の外面は、小径部に向かって徐々に縮径するテーパ状に形成されている。また、チャック30には、軸線方向に延在して貫通孔に連通する図示しないスリット38が周方向に複数形成されている。各スリット38は、大径部の先端から小径部の途中まで延在している。 The chuck 30 has a through-hole through which the shaft 16 is inserted at the center thereof, and the large-diameter portion on the distal end side is the handle 28 with the small-diameter portion on the proximal end side disposed in the distal-end opening of the handle 28. Exposed from the lumen. The outer surface of the large diameter portion is formed in a tapered shape that gradually decreases in diameter toward the small diameter portion. The chuck 30 is formed with a plurality of slits 38 (not shown) extending in the axial direction and communicating with the through holes in the circumferential direction. Each slit 38 extends from the tip of the large diameter portion to the middle of the small diameter portion.
 このような構成の操作デバイス18では、チャック30の貫通孔を介してハンドル28の内腔26にシャフト本体22を通した状態でキャップ32のハンドル28に対するねじ嵌合力を強めると、チャック30の大径部がハンドル28に向かって押圧されてチャック30の貫通孔が縮径する。そうすると、貫通孔を構成する壁面がシャフト本体22の外面に押し付けられるため、操作デバイス18がシャフト本体22に対して固定される。一方、キャップ32のハンドル28に対するねじ嵌合力を弱めると、チャック30の貫通孔が拡径するため、操作デバイス18の固定が解除されて操作デバイス18とシャフト本体22とが相対的に移動可能となる。 In the operation device 18 having such a configuration, when the screw fitting force of the cap 32 with respect to the handle 28 is increased with the shaft body 22 being passed through the lumen 26 of the handle 28 through the through hole of the chuck 30, the size of the chuck 30 is increased. The diameter portion is pressed toward the handle 28 and the through hole of the chuck 30 is reduced in diameter. If it does so, since the wall surface which comprises a through-hole is pressed on the outer surface of the shaft main body 22, the operation device 18 will be fixed with respect to the shaft main body 22. FIG. On the other hand, when the screw fitting force of the cap 32 with respect to the handle 28 is weakened, the diameter of the through hole of the chuck 30 is increased, so that the fixing of the operating device 18 is released and the operating device 18 and the shaft body 22 can move relatively. Become.
 本実施形態に係る操作デバイス18は、ハンドル28の基端側に固着されてガイドワイヤGWを保持するためのワイヤ保持部34をさらに備えている。ワイヤ保持部34は、例えば、ゴム材料で構成することができる。 The operation device 18 according to the present embodiment further includes a wire holding portion 34 that is fixed to the proximal end side of the handle 28 and holds the guide wire GW. The wire holding part 34 can be comprised with a rubber material, for example.
 図2に示すように、ワイヤ保持部34には、円形状の孔部36と、孔部36に連通してハンドル28とは反対側の面に開口するスリット38とが形成されている。孔部36とスリット38のそれぞれは、ハンドル28の軸線方向に沿ってワイヤ保持部34を貫通している(図1参照)。孔部36の孔径は、ガイドワイヤGWの外径よりも小さく形成されている。スリット38は、孔部36に向かって徐々に幅狭に形成されている。 As shown in FIG. 2, the wire holding part 34 is formed with a circular hole 36 and a slit 38 that communicates with the hole 36 and opens on the surface opposite to the handle 28. Each of the hole 36 and the slit 38 passes through the wire holding portion 34 along the axial direction of the handle 28 (see FIG. 1). The hole 36 has a hole diameter that is smaller than the outer diameter of the guide wire GW. The slit 38 is formed so as to gradually narrow toward the hole 36.
 このように構成されたワイヤ保持部34では、スリット38を介して孔部36にガイドワイヤGWを挿入することにより、孔部36を構成する壁面がガイドワイヤGWによって半径方向外方に押し広げられるので、ワイヤ保持部34の復元力によってガイドワイヤGWが孔部36を構成する壁面に保持される。 In the wire holding portion 34 configured as described above, the wall of the hole 36 is pushed outward in the radial direction by the guide wire GW by inserting the guide wire GW into the hole 36 through the slit 38. Therefore, the guide wire GW is held on the wall surface forming the hole 36 by the restoring force of the wire holding portion 34.
 筒体20は、円筒状に構成されており、その基端部にシャフト16の先端部が固着されている。筒体20は、ガイドワイヤGWが挿通可能な内腔(ガイドワイヤルーメン)40を有する内層42と、内層42の外周側に設けられた外層44と、内層42と外層44との間に配設された補強体(ブレード)46とを含む。また、筒体20の先端部は、狭窄部への進入性、及び、生体管腔内に損傷を防止する観点から、ガイドワイヤGWの外周面と筒体20の先端の外周面との境界に形成される段差面が小さくなるように、先端に向かってテーパ状になっていることが好ましい。なお、サポートカテーテルの場合、ガイドワイヤの先端部を補助し易いように、筒体20のテーパ状の先端部の径方向の肉厚は、筒体20の基端部の径方向の肉厚よりも厚くなっている方が好ましい。 The cylindrical body 20 is configured in a cylindrical shape, and a distal end portion of the shaft 16 is fixed to a proximal end portion thereof. The cylindrical body 20 is disposed between an inner layer 42 having a lumen (guide wire lumen) 40 through which the guide wire GW can be inserted, an outer layer 44 provided on the outer peripheral side of the inner layer 42, and the inner layer 42 and the outer layer 44. Reinforcing body (blade) 46. In addition, the distal end portion of the cylindrical body 20 is located at the boundary between the outer peripheral surface of the guide wire GW and the outer peripheral surface of the distal end of the cylindrical body 20 from the viewpoint of entering into the constricted portion and preventing damage to the living body lumen. It is preferable that the tapered surface is tapered toward the tip so that the formed step surface is small. In the case of the support catheter, the radial thickness of the tapered distal end portion of the cylindrical body 20 is larger than the radial thickness of the proximal end portion of the cylindrical body 20 so that the distal end portion of the guide wire can be easily assisted. It is preferable that the thickness is too thick.
 内層42は、任意の材料で構成可能であるが、例えば、PTFE(ポリテトラフルオロエチレン)等のフッ素系樹脂で構成することができる。この場合、内腔40を構成する面の摩擦係数を比較的小さくすることができるので、ガイドワイヤGWを円滑に内腔40に挿通することができる。 The inner layer 42 can be made of any material, but can be made of, for example, a fluorine resin such as PTFE (polytetrafluoroethylene). In this case, since the friction coefficient of the surface constituting the lumen 40 can be made relatively small, the guide wire GW can be smoothly inserted into the lumen 40.
 外層44は、任意の材料で構成可能であるが、例えば、ポリウレタンエラストマー、ポリエステルエラストマー、ポリアミドエラストマー等の各種熱可塑性エラストマーや、これらの混合物等で構成することができる。また、外層44の先端部は、先細りのテーパ部が形成されている。このように先端部を先細りにすることによって、カテーテル12は狭窄部を通過し易くなる。 The outer layer 44 can be composed of any material, but can be composed of, for example, various thermoplastic elastomers such as polyurethane elastomer, polyester elastomer, polyamide elastomer, and mixtures thereof. Further, a tapered portion is formed at the tip of the outer layer 44. By tapering the distal end in this manner, the catheter 12 can easily pass through the stenosis.
 補強体46は、網状に形成された状態で外層44に埋設されている。補強体46は、任意の材料で構成可能であるが、例えば、タングステン、ステンレス鋼等を用いることができる。なお、補強体46は、螺旋コイル状、棒状に形成しても構わない。 The reinforcing body 46 is embedded in the outer layer 44 in a net-like state. The reinforcing body 46 can be made of any material, but for example, tungsten, stainless steel, or the like can be used. The reinforcing body 46 may be formed in a spiral coil shape or a rod shape.
 なお、筒体20には、カテーテル12の生体管腔内での位置を確認できるように、X線不透過マーカー等を設けておくことが好ましい。例えば、筒体20には、生体管腔内での筒体20の位置を把握するために、筒体20を構成する材料に硫酸バリウム、酸化ビスマス、タングステン等のX線不透過材を添加しておいてもよい。また、筒体20は、生体管腔内の狭窄部等の測長のため、白金等のX線不透過マーカーを筒体20の先端部と基端部に設けておいてもよい。 In addition, it is preferable to provide an X-ray opaque marker or the like on the cylinder 20 so that the position of the catheter 12 in the living body lumen can be confirmed. For example, an X-ray opaque material such as barium sulfate, bismuth oxide, tungsten or the like is added to the material constituting the cylinder 20 in order to grasp the position of the cylinder 20 in the living body lumen. You may keep it. Further, the cylindrical body 20 may be provided with an X-ray opaque marker such as platinum on the distal end portion and the proximal end portion of the cylindrical body 20 in order to measure the stenosis portion in the living body lumen.
 図3Aに示すように、第1接続部24は、Ti-Ni系形状記憶合金等の形状記憶特性を有する材料で構成された線状部材をシャフト本体22の基端面の略中心から波状に折曲するように延出して形成されている。すなわち、第1接続部24は、雄部として構成されている。 As shown in FIG. 3A, the first connecting portion 24 folds a linear member made of a material having shape memory characteristics, such as a Ti—Ni shape memory alloy, into a wave shape from the approximate center of the base end surface of the shaft body 22. It is formed so as to bend. That is, the 1st connection part 24 is comprised as a male part.
 第1接続部24の幅寸法(波の山と谷の間隔)Wは、シャフト本体22の外径D1と略同一の寸法に形成されている。これにより、カテーテル12を操作する際に第1接続部24が術者の手指や他の医療機器等と干渉することを抑えることができる。 The width dimension (interval between wave peaks and valleys) W of the first connection portion 24 is formed to be approximately the same as the outer diameter D1 of the shaft body 22. Thereby, when operating the catheter 12, it can suppress that the 1st connection part 24 interferes with an operator's finger | toe, another medical device, etc. FIG.
 延長シャフト14は、その先端から基端まで開口した内腔48を有する管状部材であって、延長シャフト本体50と、延長シャフト本体50の先端部に一体的に設けられてカテーテル12の第1接続部24に接続可能な第2接続部52とを有する。延長シャフト14は、シャフト本体22と同じ材料で構成可能であって、任意の長さに設定可能である。 The extension shaft 14 is a tubular member having a lumen 48 opened from the distal end to the proximal end thereof, and is provided integrally with the extension shaft main body 50 and the distal end portion of the extension shaft main body 50 so that the first connection of the catheter 12 is achieved. And a second connecting portion 52 connectable to the portion 24. The extension shaft 14 can be made of the same material as that of the shaft body 22 and can be set to an arbitrary length.
 第2接続部52は、雄部である第1接続部24に嵌合結合する雌部として構成されている。第2接続部52の孔径D2は、第1接続部24の幅寸法Wよりも小さい。そのため、第2接続部52の内腔48に第1接続部24を挿入する際に、第1接続部24は、その幅寸法が狭くなるように(第1接続部24の波山の高さが低くなるように)弾性変形するため、第2接続部52の内面には第1接続部24の復元力を作用させることができる。これにより、第1接続部24と第2接続部52とを強固に嵌合結合することができる(図3B参照)。 The second connection portion 52 is configured as a female portion that is fitted and coupled to the first connection portion 24 that is a male portion. The hole diameter D <b> 2 of the second connection portion 52 is smaller than the width dimension W of the first connection portion 24. Therefore, when the first connection portion 24 is inserted into the lumen 48 of the second connection portion 52, the first connection portion 24 has a narrow width (the height of the crest of the first connection portion 24 is reduced). Since it is elastically deformed (to be lowered), the restoring force of the first connecting portion 24 can be applied to the inner surface of the second connecting portion 52. Thereby, the 1st connection part 24 and the 2nd connection part 52 can be firmly fittingly joined (refer FIG. 3B).
 また、第2接続部52の外径D3は、シャフト本体22の外径D1と略同一に形成されている。これにより、第1接続部24と第2接続部52とを接続した状態で、シャフト本体22の外面と第2接続部52の外面とが面一となるため、シャフト本体22と第2接続部52との境界部が他の医療機器(ガイディングカテーテル等)と干渉することを回避することができる。 Further, the outer diameter D3 of the second connection portion 52 is formed substantially the same as the outer diameter D1 of the shaft body 22. Thereby, in the state which connected the 1st connection part 24 and the 2nd connection part 52, since the outer surface of the shaft main body 22 and the outer surface of the 2nd connection part 52 become flush, the shaft main body 22 and the 2nd connection part It can be avoided that the boundary with 52 interferes with other medical devices (such as a guiding catheter).
 さらに、図示していないが、カテーテル12の基端部(シャフト本体22の基端部又は第1接続部24)には、白金等のX線不透過マーカーを設けておくことが好ましい。このように構成することで、カテーテル12と延長シャフト14を接続した際、X線造影下において接続位置を把握することができる。また、図示していないが、延長シャフト14の先端部又は第2接続部52にもX線造影マーカーを設けておいてもよい。このように構成することで、X線造影下において、生体管腔内等での第1接続部24及び第2接続部52の接続度合を確認することができる。 Further, although not shown, it is preferable to provide an X-ray opaque marker such as platinum at the proximal end portion of the catheter 12 (the proximal end portion of the shaft body 22 or the first connection portion 24). By comprising in this way, when connecting the catheter 12 and the extension shaft 14, a connection position can be grasped under X-ray contrast. Although not shown, an X-ray contrast marker may also be provided at the distal end portion of the extension shaft 14 or the second connection portion 52. By configuring in this way, it is possible to confirm the degree of connection of the first connection part 24 and the second connection part 52 in the body lumen or the like under X-ray contrast.
 本実施形態に係るカテーテルセット10Aは、基本的には以上のように構成されるものであって、以下、作用効果について説明する。 The catheter set 10A according to the present embodiment is basically configured as described above, and the effects will be described below.
 本実施形態に係るカテーテルセット10Aは、例えば、血管200内に生じた狭窄度の高い病変又は慢性完全閉塞病変(CTO:Chronic Total Occlusion)である第1狭窄部202及び第2狭窄部204を続けて治療する方法に適用することができる。このような第1狭窄部202及び第2狭窄部204を治療する場合、先ず、例えば、セルジンガー法により図示しないシースイントロデューサを血管(例えば、橈骨動脈や大腿動脈等)に穿刺し、ガイドワイヤGWを先行して導入すると共にガイディングカテーテル206を所定の血管200内の所定の位置に留置する。このとき、ガイドワイヤGWは、単独で第1狭窄部202を通過することができないため、第1狭窄部202の手前側(中枢側であって図4Aの右側)に位置している。 The catheter set 10 </ b> A according to the present embodiment continues, for example, a first stenosis part 202 and a second stenosis part 204 that are lesions with a high degree of stenosis or chronic total occlusion lesions (CTO: Chronic Total Occlusion) occurring in the blood vessel 200. Can be applied to the treatment method. When treating the first stenosis 202 and the second stenosis 204, first, for example, a sheath introducer (not shown) is punctured into a blood vessel (for example, radial artery or femoral artery) by the Seldinger method, and a guide wire is inserted. The GW is introduced in advance and the guiding catheter 206 is placed at a predetermined position in the predetermined blood vessel 200. At this time, since the guide wire GW cannot pass through the first constricted portion 202 alone, the guide wire GW is positioned on the near side (the central side and the right side in FIG. 4A) of the first constricted portion 202.
 次に、サポートカテーテルとしてのカテーテル12の筒体20の内腔40にガイドワイヤGWを通し、ガイドワイヤGWに沿ってガイディングカテーテル206の内腔を介してカテーテル12を前進させ、その先端をガイドワイヤGWの先端の近傍に位置させる。なお、カテーテル12は、初期状態において、延長シャフト14が取り付けられておらず、シャフト本体22の基端部に操作デバイス18が装着されている。 Next, the guide wire GW is passed through the lumen 40 of the cylindrical body 20 of the catheter 12 as a support catheter, the catheter 12 is advanced through the lumen of the guiding catheter 206 along the guide wire GW, and the distal end thereof is guided. It is located near the tip of the wire GW. In the initial state, the extension shaft 14 is not attached to the catheter 12, and the operation device 18 is attached to the proximal end portion of the shaft body 22.
 続いて、術者は、ガイドワイヤGWの先端部をカテーテル12によって補助しながら当該ガイドワイヤGWを第1狭窄部202に通過させる(図4A参照)。このとき、術者は、ガイドワイヤGW及びカテーテル12を交互に所定長ずつ第1狭窄部202に押し進めるように操作してもよいし、ガイドワイヤGW及びカテーテル12を一緒に第1狭窄部202に押し進めるように操作してもよい。 Subsequently, the surgeon passes the guide wire GW through the first constricted portion 202 while assisting the distal end portion of the guide wire GW with the catheter 12 (see FIG. 4A). At this time, the operator may operate to push the guide wire GW and the catheter 12 alternately to the first stenosis part 202 by a predetermined length alternately, or the guide wire GW and the catheter 12 together to the first stenosis part 202. You may operate so that it may push forward.
 ガイドワイヤGW及びカテーテル12を一緒に操作する場合には、ガイドワイヤGWの基端側をワイヤ保持部34のスリット38を介して孔部36に挿入することにより操作デバイス18に固定する。これにより、術者は、操作デバイス18を把持してガイドワイヤGW及びカテーテル12の両方を同時に容易に操作することができる。ガイドワイヤGWを第1狭窄部202に通過させることにより、当該第1狭窄部202の治療が完了する。 When the guide wire GW and the catheter 12 are operated together, the proximal end side of the guide wire GW is fixed to the operation device 18 by inserting it into the hole 36 through the slit 38 of the wire holding portion 34. Thus, the operator can easily operate both the guide wire GW and the catheter 12 simultaneously by grasping the operation device 18. By passing the guide wire GW through the first stenosis 202, the treatment of the first stenosis 202 is completed.
 この段階で、治療された第1狭窄部202よりも末梢側に第2狭窄部204が存在しているため、第1狭窄部202の末梢側に十分な血液の灌流が得られないことがある。この場合、第2狭窄部204の治療が続けて行われる。 At this stage, since the second stenosis part 204 is present on the distal side of the treated first stenosis part 202, sufficient blood perfusion may not be obtained on the distal side of the first stenosis part 202. . In this case, the treatment of the second stenosis 204 is continued.
 すなわち、術者は、ガイドワイヤGWを操作してその先端を第2狭窄部204に押し付ける(図4B参照)。なお、第1狭窄部202の治療において、ガイドワイヤGWを操作デバイス18に固定していた場合には、ガイドワイヤGWを操作デバイス18のワイヤ保持部34から取り外した上で当該ガイドワイヤGWを操作する。 That is, the surgeon operates the guide wire GW and presses the distal end thereof against the second constricted portion 204 (see FIG. 4B). In the treatment of the first constricted portion 202, when the guide wire GW is fixed to the operation device 18, the guide wire GW is operated after the guide wire GW is removed from the wire holding portion 34 of the operation device 18. To do.
 そして、ガイドワイヤGWを第2狭窄部204に通過させるのが容易ではない場合には、カテーテル12の先端をガイドワイヤGWの先端の近傍に位置させる。このとき、第1狭窄部202と第2狭窄部204との間隔が比較的長い場合には、カテーテル12が第2狭窄部204まで届かないことがある。 If it is not easy to pass the guide wire GW through the second constricted portion 204, the distal end of the catheter 12 is positioned in the vicinity of the distal end of the guide wire GW. At this time, when the distance between the first stenosis part 202 and the second stenosis part 204 is relatively long, the catheter 12 may not reach the second stenosis part 204.
 そこで、本実施形態では、第2狭窄部204の治療を行うに際して、カテーテル12の第1接続部24に延長シャフト14を接続することにより、カテーテル12の有効長を延長する。すなわち、波状に折曲するように形成された第1接続部24を第2接続部52の内腔48に挿入する。そうすると、第1接続部24が波山の高さが低くなるように弾性変形すると共にその復元力が第2接続部52の内面に作用するため、第1接続部24と第2接続部52とが強固に嵌合結合される。なお、このとき、術者は、第1狭窄部202から第2狭窄部204までの距離に対応する長さの延長シャフト14を選択してカテーテル12に接続することは言うまでもない。 Therefore, in the present embodiment, when the second stenosis portion 204 is treated, the effective length of the catheter 12 is extended by connecting the extension shaft 14 to the first connection portion 24 of the catheter 12. That is, the first connection portion 24 formed to be bent in a wave shape is inserted into the lumen 48 of the second connection portion 52. Then, the first connecting portion 24 is elastically deformed so that the height of the wavy mountain is lowered and the restoring force acts on the inner surface of the second connecting portion 52, so that the first connecting portion 24 and the second connecting portion 52 are It is firmly fitted and connected. At this time, it goes without saying that the operator selects the extension shaft 14 having a length corresponding to the distance from the first stenosis part 202 to the second stenosis part 204 and connects it to the catheter 12.
 また、術者は、操作デバイス18のキャップ32を操作してハンドル28に対するねじ嵌合力を弱めることにより、操作デバイス18のシャフト16に対する固定を解除する。その後、操作デバイス18を延長シャフト本体50の基端側の任意の位置に移動させた状態でキャップ32を操作してハンドル28に対するねじ嵌合力を強めることにより、操作デバイス18を延長シャフト14に対して固定する(図5参照)。 Further, the operator releases the fixation of the operation device 18 to the shaft 16 by operating the cap 32 of the operation device 18 to weaken the screw fitting force to the handle 28. Thereafter, the operating device 18 is moved with respect to the extension shaft 14 by operating the cap 32 in a state where the operating device 18 is moved to an arbitrary position on the proximal end side of the extension shaft main body 50 to increase the screw fitting force with respect to the handle 28. (See FIG. 5).
 続いて、ガイドワイヤGWの先端部をカテーテル12によって補助しながら当該ガイドワイヤGWを第2狭窄部204に通過させる(図6参照)。この第2狭窄部204の治療は、上述した第1狭窄部202の治療と同様であるため、その詳細な説明は省略する。第2狭窄部204の治療後、カテーテル12及びガイドワイヤGWを血管200から抜去する。 Subsequently, the guide wire GW is passed through the second constricted portion 204 while assisting the distal end portion of the guide wire GW with the catheter 12 (see FIG. 6). Since the treatment of the second stenosis part 204 is the same as the treatment of the first stenosis part 202 described above, detailed description thereof is omitted. After the treatment of the second stenosis 204, the catheter 12 and the guide wire GW are removed from the blood vessel 200.
 本実施形態によれば、カテーテル12の第1接続部24に延長シャフト14の第2接続部52を接続することにより、カテーテル12の有効長を延長することができる。そのため、手前側(中枢側)の第1狭窄部202の治療を行った後で、第1狭窄部202よりも末梢側に存在する第2狭窄部204を治療する際に、カテーテル12の有効長が不足していた場合であっても、当該カテーテル12に延長シャフト14を接続することによりカテーテル12を第2狭窄部204に到達させることができる。これにより、第1狭窄部202を治療した後に、当該カテーテル12を有効長の長い異なるカテーテルに交換する必要がないため、治療時間の短縮及びコストの低廉を図ることができると共に第1狭窄部202及び第2狭窄部204を確実に治療することができる。 According to the present embodiment, the effective length of the catheter 12 can be extended by connecting the second connection portion 52 of the extension shaft 14 to the first connection portion 24 of the catheter 12. Therefore, after treating the first stenosis 202 on the near side (central side), the effective length of the catheter 12 is used when treating the second stenosis 204 present on the distal side of the first stenosis 202. Even if this is insufficient, the catheter 12 can reach the second constricted portion 204 by connecting the extension shaft 14 to the catheter 12. This eliminates the need to replace the catheter 12 with a different catheter having a long effective length after treating the first stenosis 202, thereby reducing the treatment time and reducing the cost and the first stenosis 202. And the 2nd constriction part 204 can be treated reliably.
 本実施形態では、カテーテル12の第1接続部24が雄部であり延長シャフト14の第2接続部52が雌部であるため、第1接続部24と第2接続部52を嵌合結合することにより、カテーテル12に延長シャフト14を容易に接続することができる。また、形状記憶特性を有する材料で第1接続部24を構成しているので、第1接続部24の折損を抑制できる。 In the present embodiment, since the first connecting portion 24 of the catheter 12 is a male portion and the second connecting portion 52 of the extension shaft 14 is a female portion, the first connecting portion 24 and the second connecting portion 52 are fitted and joined. Thus, the extension shaft 14 can be easily connected to the catheter 12. Moreover, since the 1st connection part 24 is comprised with the material which has a shape memory characteristic, breakage of the 1st connection part 24 can be suppressed.
 さらに、第1接続部24を波状に折曲して形成しているので、第1接続部24を第2接続部52の内腔48に挿入した際に、第1接続部24の波山の高さが低くなるように第1接続部24を弾性変形させることができる。これにより、第1接続部24の復元力を第2接続部52の内面に作用させることができるので、第1接続部24と第2接続部52とを強固に接続することができる。 Further, since the first connecting portion 24 is formed in a wave shape, when the first connecting portion 24 is inserted into the inner cavity 48 of the second connecting portion 52, the height of the wave mountain of the first connecting portion 24 is increased. The first connecting portion 24 can be elastically deformed so that the height is low. Thereby, since the restoring force of the 1st connection part 24 can be made to act on the inner surface of the 2nd connection part 52, the 1st connection part 24 and the 2nd connection part 52 can be connected firmly.
 本実施形態によれば、シャフト16に操作デバイス18を装着することができるので、カテーテル12の操作性を向上させることができる。また、延長シャフト14を第1接続部24に接続した状態において、操作デバイス18をシャフト16から延長シャフト14に付け替えることができるので、カテーテル12の有効長を延長させつつ操作性を向上させることができる。 According to this embodiment, since the operation device 18 can be attached to the shaft 16, the operability of the catheter 12 can be improved. Further, since the operation device 18 can be changed from the shaft 16 to the extension shaft 14 in a state where the extension shaft 14 is connected to the first connection portion 24, the operability can be improved while extending the effective length of the catheter 12. it can.
 さらに、操作デバイス18のワイヤ保持部34にガイドワイヤGWを保持することができるので、操作デバイス18を把持してカテーテル12とガイドワイヤGWを同時に操作することが可能となる。 Furthermore, since the guide wire GW can be held by the wire holding portion 34 of the operation device 18, the operation device 18 can be held and the catheter 12 and the guide wire GW can be operated simultaneously.
 本実施形態に係るカテーテルセット10Aは、上述した構成に限定されない。延長シャフト14は、例えば、細径で中実の延長シャフト本体50の先端部に管状の第2接続部52を設けることにより構成してもよい。この場合、延長シャフト本体50の剛性が高くなるので、延長シャフト本体50に付与された押し込み力をシャフト16に効率的に伝達させることができる。 The catheter set 10A according to the present embodiment is not limited to the configuration described above. The extension shaft 14 may be configured, for example, by providing a tubular second connection portion 52 at the distal end portion of a thin and solid extension shaft main body 50. In this case, since the rigidity of the extension shaft main body 50 is increased, the pushing force applied to the extension shaft main body 50 can be efficiently transmitted to the shaft 16.
 また、第2接続部52は、塑性変形可能な金属材料で構成してもよい。この場合、第1接続部24を第2接続部52の内腔48に挿入した状態で、第2接続部52を鉗子等で挟み加締めることが可能となる。これにより、第1接続部24と第2接続部52とをより一層強固に嵌合結合することができる。 Further, the second connection portion 52 may be made of a plastically deformable metal material. In this case, it is possible to clamp the second connecting portion 52 with forceps or the like while the first connecting portion 24 is inserted into the lumen 48 of the second connecting portion 52. Thereby, the 1st connection part 24 and the 2nd connection part 52 can be fitted and connected still more firmly.
 本実施形態に係るカテーテルセット10Aは、比較的長い狭窄部の治療や下肢の血管内に生じた狭窄部の治療に対しても用いることができる。後者の場合、例えば、橈骨動脈から挿入したカテーテル12を下肢の血管内に生じた狭窄部に導くような治療を行う際、当該血管に湾曲部が多く、カテーテル12の有効長が不足することがある。しかしながら、本実施形態によれば、カテーテル12に延長シャフト14を接続することにより有効長を延長することができるので、カテーテル12を有効長の長い別のカテーテルに交換することなく前記狭窄部に確実に到達させて治療を行うことができる。 The catheter set 10A according to the present embodiment can also be used for the treatment of a relatively long stenosis part or the treatment of a stenosis part generated in a blood vessel of a lower limb. In the latter case, for example, when treatment is performed to guide the catheter 12 inserted from the radial artery to a stenosis that has occurred in the blood vessel of the lower limb, the blood vessel has many curved portions, and the effective length of the catheter 12 may be insufficient. is there. However, according to the present embodiment, since the effective length can be extended by connecting the extension shaft 14 to the catheter 12, the catheter 12 can be reliably attached to the stenosis without replacing the catheter 12 with another catheter having a long effective length. Treatment can be performed.
 また、カテーテルセット10Aは、バルーンカテーテル、ステントデリバリーカテーテル、又は薬剤注入用カテーテル等の治療用カテーテルと一緒に使用することも可能であり、この場合、カテーテル12は、治療用カテーテルを挿通可能な内腔40を有する筒体20を先端部に備えた貫通カテーテルであってもよい。 The catheter set 10A can also be used together with a therapeutic catheter such as a balloon catheter, a stent delivery catheter, or a drug injection catheter. In this case, the catheter 12 can be inserted through the therapeutic catheter. It may be a penetrating catheter provided with a cylindrical body 20 having a cavity 40 at the distal end.
(第2実施形態)
 次に、本発明の第2実施形態に係るカテーテルセット10Bについて説明する。なお、第2実施形態に係るカテーテルセット10Bについて、上述した第1実施形態に係るカテーテルセット10Aと同一の構成には同一の参照符号を付し、詳細な説明は省略する。後述する第3実施形態に係るカテーテルセット10C及び第4実施形態に係るカテーテルセット10Dについても同様である。
(Second Embodiment)
Next, a catheter set 10B according to the second embodiment of the present invention will be described. In addition, about the catheter set 10B which concerns on 2nd Embodiment, the same referential mark is attached | subjected to the structure same as catheter set 10A which concerns on 1st Embodiment mentioned above, and detailed description is abbreviate | omitted. The same applies to a catheter set 10C according to a third embodiment described later and a catheter set 10D according to the fourth embodiment.
 図7Aに示すように、本実施形態に係るカテーテルセット10Bは、カテーテル60のシャフト62と延長シャフト64の構成が上述した第1実施形態に係るカテーテルセット10Aと異なる。 As shown in FIG. 7A, the catheter set 10B according to this embodiment is different from the catheter set 10A according to the first embodiment described above in the configuration of the shaft 62 and the extension shaft 64 of the catheter 60.
 すなわち、シャフト62は、その先端から基端まで開口する内腔66を有する管状部材であって、シャフト本体68と、シャフト本体68の基端部に一体的に設けられた第1接続部70とを有する。すなわち、第1接続部70は、雌部として構成されている。 That is, the shaft 62 is a tubular member having a lumen 66 that opens from the distal end to the proximal end thereof, and includes a shaft body 68 and a first connection portion 70 that is integrally provided at the proximal end portion of the shaft body 68. Have That is, the 1st connection part 70 is comprised as a female part.
 延長シャフト64は、細径で中実の延長シャフト本体72と、延長シャフト本体72の先端部に設けられた第2接続部74とを有する。延長シャフト本体72の外径は、第1接続部70の外径と略同一に設定されている。これにより、第1接続部70と第2接続部74とを接続した状態で、第1接続部70の外面と延長シャフト本体72の外面とが面一となるため、第1接続部70と延長シャフト本体72との境界部が他の医療機器(ガイディングカテーテル等)と干渉することを回避することができる。なお、第2接続部74は、上述した第1実施形態の第1接続部24と同様の構成を有しているため、その詳細な説明は省略する。 The extension shaft 64 has a thin and solid extension shaft main body 72 and a second connection portion 74 provided at the tip of the extension shaft main body 72. The outer diameter of the extension shaft main body 72 is set to be substantially the same as the outer diameter of the first connection portion 70. Thereby, in the state which connected the 1st connection part 70 and the 2nd connection part 74, since the outer surface of the 1st connection part 70 and the outer surface of the extension shaft main body 72 become flush | planar, extension with the 1st connection part 70 is carried out. It is possible to avoid the boundary portion with the shaft main body 72 from interfering with other medical devices (such as a guiding catheter). Since the second connection portion 74 has the same configuration as the first connection portion 24 of the first embodiment described above, detailed description thereof is omitted.
 本実施形態では、カテーテル60の第1接続部70の内腔66に第2接続部74を挿入すると、第2接続部74の復元力が第1接続部70の内面に作用するので、第1接続部70と第2接続部74とが強固に嵌合結合される。 In the present embodiment, when the second connecting portion 74 is inserted into the lumen 66 of the first connecting portion 70 of the catheter 60, the restoring force of the second connecting portion 74 acts on the inner surface of the first connecting portion 70. The connecting portion 70 and the second connecting portion 74 are firmly fitted and coupled.
 本実施形態によれば、上述した第1実施形態と同様の効果を奏する。また、延長シャフト本体72を中実に構成しているので、延長シャフト本体72を中空に構成した場合と比較してその剛性を高めることができる。これにより、延長シャフト本体72の基端側に作用した押し込み力をシャフト62に効率的に伝達させることができる。 According to the present embodiment, the same effects as those of the first embodiment described above can be obtained. In addition, since the extension shaft main body 72 is configured to be solid, the rigidity can be increased compared to the case where the extension shaft main body 72 is configured to be hollow. Thereby, the pushing force which acted on the base end side of the extension shaft main body 72 can be efficiently transmitted to the shaft 62.
 さらに、シャフト本体68の基端部に第1接続部70を一体的に設けることによりシャフト62が一定外径の管状部材となっているので、延長シャフト64を第1接続部70に接続していない状態で、カテーテル60を操作する際に、第1接続部70が術者の手指や他の医療機器等に干渉することを回避することができる。 Further, since the shaft 62 is a tubular member having a constant outer diameter by integrally providing the first connecting portion 70 at the base end portion of the shaft main body 68, the extension shaft 64 is connected to the first connecting portion 70. When the catheter 60 is operated in the absence, the first connecting portion 70 can be prevented from interfering with the operator's fingers and other medical devices.
 本実施形態に係るカテーテルセット10Bは、上述した構成に限定されない。例えば、シャフト本体68は、中実に構成してもよい。この場合、シャフト本体68を中空に構成した場合と比較してその剛性を高めることができる。これにより、シャフト本体68の基端側に作用した押し込み力を筒体20に効率的に伝達させることができる。 The catheter set 10B according to the present embodiment is not limited to the configuration described above. For example, the shaft body 68 may be configured to be solid. In this case, the rigidity of the shaft main body 68 can be increased as compared with the case where the shaft main body 68 is hollow. Thereby, the pushing force which acted on the base end side of the shaft main body 68 can be efficiently transmitted to the cylindrical body 20.
 また、第1接続部70は、塑性変形可能な金属材料で構成してもよい。そうすると、第1接続部70を鉗子等で加締めることができ、これによって、第1接続部70と第2接続部74とをより一層強固に接続することができる。この場合、シャフト本体68と第1接続部70とを異なる材料で構成することも可能である。 Further, the first connection portion 70 may be made of a metal material that can be plastically deformed. If it does so, the 1st connection part 70 can be crimped with forceps etc., and, thereby, the 1st connection part 70 and the 2nd connection part 74 can be connected still more firmly. In this case, the shaft main body 68 and the first connection portion 70 can be made of different materials.
(第3実施形態)
 次に、本発明の第3実施形態に係るカテーテルセット10Cについて説明する。図7Bに示すように、本実施形態に係るカテーテルセット10Cは、延長シャフト80の構成が上述した第1実施形態に係るカテーテルセット10Aと異なり、連結部82を備える。
(Third embodiment)
Next, a catheter set 10C according to a third embodiment of the present invention will be described. As shown in FIG. 7B, the catheter set 10C according to the present embodiment is different from the catheter set 10A according to the first embodiment described above in the configuration of the extension shaft 80, and includes a connecting portion 82.
 延長シャフト80は、延長シャフト本体84と第2接続部86とを有し、上述した第2実施形態に係る延長シャフト64と同様の構成を備えている。そのため、この延長シャフト80の詳細な説明は省略する。 The extension shaft 80 has an extension shaft main body 84 and a second connection portion 86, and has the same configuration as the extension shaft 64 according to the second embodiment described above. Therefore, detailed description of the extension shaft 80 is omitted.
 連結部82は、その先端から基端まで開口する内腔88を有する管状部材であって、シャフト本体22と同様の材料で構成することができる。連結部82は、第1接続部24のシャフト本体22の軸線方向に沿った長さと第2接続部86の延長シャフト本体84の軸線方向に沿った長さとの合計の長さよりも幾らか長く形成されている。 The connecting portion 82 is a tubular member having an inner cavity 88 that opens from the distal end to the proximal end, and can be made of the same material as the shaft body 22. The connecting portion 82 is formed to be somewhat longer than the total length of the length along the axial direction of the shaft body 22 of the first connecting portion 24 and the length along the axial direction of the extension shaft main body 84 of the second connecting portion 86. Has been.
 本実施形態では、第1接続部24を連結部82の一方の開口部に挿入すると、第1接続部24の復元力が連結部82の内面に作用するので、第1接続部24と連結部82とが強固に嵌合結合される。そして、第2接続部86を連結部82の他方の開口部に挿入すると、第2接続部86の復元力が連結部82の内面に作用するので、第2接続部86と連結部82とが強固に嵌合結合される。これにより、第1接続部24と第2接続部86とが連結部82を介して強固に接続されることとなる。本実施形態によれば、上述した第1実施形態と同様の効果を奏する。 In the present embodiment, when the first connecting part 24 is inserted into one opening of the connecting part 82, the restoring force of the first connecting part 24 acts on the inner surface of the connecting part 82, so the first connecting part 24 and the connecting part 82 is firmly fitted and coupled. And if the 2nd connection part 86 is inserted in the other opening part of the connection part 82, since the restoring force of the 2nd connection part 86 will act on the inner surface of the connection part 82, the 2nd connection part 86 and the connection part 82 will be It is firmly fitted and connected. Thereby, the 1st connection part 24 and the 2nd connection part 86 will be firmly connected via the connection part 82. FIG. According to the present embodiment, the same effects as those of the first embodiment described above can be obtained.
(第4実施形態)
 次に、本発明の第4実施形態に係るカテーテルセット10Dについて説明する。図7Cに示すように、本実施形態に係るカテーテルセット10Dは、カテーテル90のシャフト92の構成が上述した第1実施形態に係るカテーテルセット10Aと異なり、連結部94を備える。
(Fourth embodiment)
Next, a catheter set 10D according to a fourth embodiment of the present invention will be described. As shown in FIG. 7C, the catheter set 10D according to this embodiment differs from the catheter set 10A according to the first embodiment described above in the configuration of the shaft 92 of the catheter 90, and includes a connecting portion 94.
 シャフト92は、シャフト本体96と第1接続部98とを有し、上述した第2実施形態に係るシャフト62と同様の構成を備えている。そのため、このシャフト92の詳細な説明は省略する。連結部94は、上述した第1実施形態の第1接続部24と同様の構成を有しており、Ti-Ni系形状記憶合金等の形状記憶特性を有する材料で構成された線状部材を波状に折曲させることにより構成されている。 The shaft 92 has a shaft main body 96 and a first connection portion 98, and has the same configuration as the shaft 62 according to the second embodiment described above. Therefore, detailed description of the shaft 92 is omitted. The connecting portion 94 has the same configuration as the first connecting portion 24 of the first embodiment described above, and a linear member made of a material having shape memory characteristics such as a Ti—Ni-based shape memory alloy is used. It is configured by bending in a wave shape.
 本実施形態では、第1接続部98の内腔100に連結部94の一端側を挿入すると、連結部94の一端側の復元力が第1接続部98の内面に作用するので、第1接続部98と連結部94とが強固に嵌合結合される。そして、第2接続部52の内腔48に連結部94の他端側を挿入すると、連結部94の他端側の復元力が第2接続部52の内面に作用するので、第2接続部52と連結部94とが強固に嵌合結合される。これにより、第1接続部98と第2接続部52とが連結部94を介して強固に接続されることとなる。本実施形態によれば、上述した第1実施形態と同様の効果を奏する。 In the present embodiment, when one end side of the connecting portion 94 is inserted into the lumen 100 of the first connecting portion 98, the restoring force on the one end side of the connecting portion 94 acts on the inner surface of the first connecting portion 98. The part 98 and the connecting part 94 are firmly fitted and coupled. When the other end side of the connecting portion 94 is inserted into the lumen 48 of the second connecting portion 52, the restoring force on the other end side of the connecting portion 94 acts on the inner surface of the second connecting portion 52. 52 and the connecting portion 94 are firmly fitted and coupled. Thereby, the 1st connection part 98 and the 2nd connection part 52 will be firmly connected via the connection part 94. FIG. According to the present embodiment, the same effects as those of the first embodiment described above can be obtained.
 本発明に係るカテーテル及びカテーテルセットは、上述の実施形態に限らず、本発明の要旨を逸脱することなく、種々の構成を採り得ることはもちろんである。 The catheter and the catheter set according to the present invention are not limited to the above-described embodiments, and various configurations can be adopted without departing from the gist of the present invention.

Claims (8)

  1.  ラピッドエクスチェンジ式のカテーテル(12、60、90)であって、
     筒体(20)と、
     前記筒体(20)よりも細長く形成されて当該筒体(20)の基端部に設けられた可撓性を有するシャフト(16、62、92)と、
     を備え、前記シャフト(16、62、92)は、シャフト本体(22、68、96)と、前記シャフト本体(22、68、96)の基端部に設けられて前記カテーテル(12、60、90)の有効長を延長させるための延長シャフト(50、72、84)が接続可能な接続部(24、70、98)と、を有している、
     ことを特徴とするカテーテル(12、60、90)。
    A rapid exchange catheter (12, 60, 90),
    A cylinder (20);
    A flexible shaft (16, 62, 92) that is formed longer than the cylindrical body (20) and provided at the proximal end of the cylindrical body (20);
    The shaft (16, 62, 92) includes a shaft body (22, 68, 96) and a proximal end portion of the shaft body (22, 68, 96) and the catheter (12, 60, 96). 90) and a connecting portion (24, 70, 98) to which an extension shaft (50, 72, 84) for extending the effective length can be connected.
    Catheter (12, 60, 90) characterized in that.
  2.  請求項1記載のカテーテル(12、60、90)において、
     前記接続部(24、70、98)は、雄部又は雌部であることを特徴とするカテーテル(12、60、90)。
    The catheter (12, 60, 90) according to claim 1,
    The catheter (12, 60, 90), wherein the connecting part (24, 70, 98) is a male part or a female part.
  3.  請求項2記載のカテーテル(12)において、
     前記接続部(24)は、形状記憶特性を有する材料で構成された雄部であることを特徴とするカテーテル(12)。
    Catheter (12) according to claim 2,
    The catheter (12), wherein the connecting portion (24) is a male portion made of a material having shape memory characteristics.
  4.  請求項3記載のカテーテル(12)において、
     前記接続部(24)は、波状に折曲して形成されていることを特徴とするカテーテル(12)。
    Catheter (12) according to claim 3,
    The catheter (12), wherein the connecting portion (24) is formed in a wave shape.
  5.  請求項2記載のカテーテル(60、90)において、
     前記接続部(70、98)は、塑性変形可能な金属材料で構成された雌部であることを特徴とするカテーテル(60、90)。
    The catheter (60, 90) according to claim 2,
    The catheter (60, 90), wherein the connecting portion (70, 98) is a female portion made of a plastically deformable metal material.
  6.  請求項1記載のカテーテル(12、60、90)において、
     前記シャフト本体(22、68、96)及び前記延長シャフト(50、72、84)に着脱可能に設けられる操作デバイス(18)をさらに備えることを特徴とするカテーテル(12、60、90)。
    The catheter (12, 60, 90) according to claim 1,
    The catheter (12, 60, 90) further comprising an operation device (18) detachably provided on the shaft body (22, 68, 96) and the extension shaft (50, 72, 84).
  7.  請求項6記載のカテーテル(12、60、90)において、
     前記操作デバイス(18)には、前記筒体(20)の内腔(40)を挿通するガイドワイヤ(GW)を保持するワイヤ保持部(34)が設けられていることを特徴とするカテーテル(12、60、90)。
    The catheter (12, 60, 90) according to claim 6,
    The operation device (18) is provided with a wire holding portion (34) for holding a guide wire (GW) inserted through the lumen (40) of the cylindrical body (20) ( 12, 60, 90).
  8.  ラピッドエクスチェンジ式のカテーテル(12、60、90)と、
     前記カテーテル(12、60、90)の有効長を延長させるための延長シャフト(50、72、84)と、
     を備えたカテーテルセット(10A~10D)であって、
     前記カテーテル(12、60、90)は、筒体(20)と、
     前記筒体(20)よりも細長く形成されて当該筒体(20)の基端部に設けられた可撓性を有するシャフト(16、62、92)と、
     を備え、前記シャフト(16、62、92)は、シャフト本体(22、68、96)と、前記シャフト本体(22、68、96)の基端部に設けられて前記カテーテル(12、60、90)の有効長を延長させるための前記延長シャフト(50、72、84)が接続可能な接続部(24、70、98)と、を有している、
     ことを特徴とするカテーテルセット(10A~10D)。
    Rapid exchange catheters (12, 60, 90);
    An extension shaft (50, 72, 84) for extending the effective length of the catheter (12, 60, 90);
    A catheter set (10A-10D) comprising:
    The catheter (12, 60, 90) includes a cylinder (20),
    A flexible shaft (16, 62, 92) that is formed longer than the cylindrical body (20) and provided at the proximal end of the cylindrical body (20);
    The shaft (16, 62, 92) includes a shaft body (22, 68, 96) and a proximal end portion of the shaft body (22, 68, 96) and the catheter (12, 60, 96). 90) the connecting shaft (24, 70, 98) to which the extension shaft (50, 72, 84) for extending the effective length can be connected.
    A catheter set (10A to 10D) characterized by the above.
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109310849A (en) * 2016-08-10 2019-02-05 尼普洛株式会社 Support conduit
WO2020059576A1 (en) * 2018-09-21 2020-03-26 テルモ株式会社 Catheter and treatment method using catheter

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JP2009508548A (en) * 2005-09-19 2009-03-05 マンヴァシス Apparatus and method for protective angioplasty and stenting at the carotid bifurcation

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JP2000279534A (en) * 1999-01-27 2000-10-10 Kaneka Medeikkusu:Kk Baloon catheter device and baloon catheter system
JP2009508548A (en) * 2005-09-19 2009-03-05 マンヴァシス Apparatus and method for protective angioplasty and stenting at the carotid bifurcation

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109310849A (en) * 2016-08-10 2019-02-05 尼普洛株式会社 Support conduit
WO2020059576A1 (en) * 2018-09-21 2020-03-26 テルモ株式会社 Catheter and treatment method using catheter
JPWO2020059576A1 (en) * 2018-09-21 2021-08-30 テルモ株式会社 Catheter and treatment method using catheter
JP7383625B2 (en) 2018-09-21 2023-11-20 テルモ株式会社 catheter

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