WO2022064789A1 - Medical tubular object conveyance device - Google Patents

Medical tubular object conveyance device Download PDF

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Publication number
WO2022064789A1
WO2022064789A1 PCT/JP2021/022557 JP2021022557W WO2022064789A1 WO 2022064789 A1 WO2022064789 A1 WO 2022064789A1 JP 2021022557 W JP2021022557 W JP 2021022557W WO 2022064789 A1 WO2022064789 A1 WO 2022064789A1
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WO
WIPO (PCT)
Prior art keywords
outer tube
rigidity
tubular body
transport device
medical
Prior art date
Application number
PCT/JP2021/022557
Other languages
French (fr)
Japanese (ja)
Inventor
想生 市村
健太郎 鈴木
一博 佐藤
貞雄 別所
Original Assignee
株式会社カネカ
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社カネカ filed Critical 株式会社カネカ
Priority to CN202180064574.3A priority Critical patent/CN116209411A/en
Priority to JP2022551145A priority patent/JPWO2022064789A1/ja
Publication of WO2022064789A1 publication Critical patent/WO2022064789A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Definitions

  • the present invention relates to a medical tubular body transport device.
  • a minimally invasive treatment technique in which a medical tubular body is transported and placed in a lesion in the body.
  • a medical tubular body for example, a stent, a stent graft, an occlusion tool, an infusion catheter, a prosthesis valve and the like are used.
  • stents are medical tubulars commonly used to treat a variety of diseases caused by the narrowing or obstruction of blood vessels or other in vivo lumens.
  • a transport device is used to transport and place a medical tubular body to a lesion through an internal lumen.
  • the transport device includes an outer tube, and the medical tubular body is transported to a lesion in the body through the internal lumen while the medical tubular body is held in the lumen of the outer tube. After transport, the medical tubular body is released from the lumen of the outer tube by pulling the traction member, which is connected to the outer tube and extends proximally, to the proximal side, and reaches the lesion in the body. Place a medical tubular body.
  • the hand side of the operator is the proximal end of the medical tubular body transport device, and the opposite side of the proximal end, that is, the side close to the lesion or the like is the distal end.
  • FIG. 1 shows an example of a conventional embodiment of a medical tubular body transport device.
  • FIG. 1 is a cross-sectional view of a medical tubular body transport device, showing the distal side of the medical tubular body transport device.
  • the medical tubular body transport device shown in FIG. 1 consists of an outer tube 12 in which the medical tubular body 11 is arranged in a lumen and a part of the outer tube 12 proximal to the medical tubular body 11. It has a tow tube 14 and an inner tube 13 located in the lumen of the outer tube 12. The distal end of the inner tube 13 reaches the lumen of the tip tip 16.
  • the proximal end of the inner tube 13 extends to the proximal end of the medical tubular body transfer device (operator's hand), and the operation of the operator's hand is carried out through the inner tube 13 for medical tubular body transfer. Can be transmitted to the distal side of the device.
  • a tow member 15 is connected to the tow tube 14 which is a part of the outer tube 12 and extends proximally along the inner tube 13.
  • Patent Document 1 describes a stretchable catheter, an elongated tubular sheath made of a relatively flexible material, and a tensile force transmitted to the sheath to pull the sheath in the vertical direction.
  • the tension element comprises an end disposed within the relatively flexible material, wherein at least the thickness of the end is substantially thinner than its length.
  • a telescopic catheter is described.
  • Patent Document 2 describes a stent device transfer system, which is a stent device and an outer sheath that covers the stent device in a radial compact transfer form of the stent device, and extends the stent device in the radial direction.
  • a retractable outer sheath and a pulling member that pulls and retracts the outer sheath proximally are provided, and the distal portion of the pulling member is A portion of the outer sheath is radially thermally shrunk on the heat shrinkable support member in order to be radially trapped between the outer sheath and the relatively heat shrinkable support member.
  • the stent device transfer system is described.
  • Patent Document 3 describes a stent device delivery system that covers the stent device and the stent device in a radially compact delivery form of the stent device and is retractable with respect to the stent device.
  • the outer sheath comprises a first layer and a reinforcing layer laminated with each other, the outer sheath comprising a first layer and a reinforcing layer laminated with each other, and a part of the pulling member has a radius of the part.
  • Described is a stenting device delivery system that is attached to the outer sheath by trapping between the first layer and the reinforcing layer of the outer sheath in orientation.
  • Such a medical tubular transport device is inserted into the internal lumen, but since the internal lumen is complicatedly bent, the medical tubular transport device is also bent following the bending of the internal lumen. Therefore, when the tow member 15 is pulled to the proximal side with the proximal end of the tow tube 14 bent as shown in FIG. 1, the tow member 15 is pulled in the direction shown by the dotted line 15a in FIG. Straighten towards. As a result, stress was concentrated on the most recent position 15b of the connecting portion between the towing member 15 and the towing tube 14, and the towing member 15 may come off from the towing tube 14.
  • the present invention has been made by paying attention to the above circumstances, and an object thereof is that even if the traction member is pulled to the proximal side in a state where the vicinity of the medical tubular body is bent, the traction member is an outer tube. It is an object of the present invention to provide a medical tubular body transport device capable of reliably releasing a medical tubular body without being disengaged from the medical tubular body.
  • the present invention includes the following inventions.
  • a device for transporting a medical tubular body into the body in which the medical tubular body is connected to an outer tube arranged in a lumen and the outer tube and extends proximally. Having a traction member, an inner tube located in the lumen of the outer tube, and a tubular low-rigidity member located at the proximal end of the outer tube and having a rigidity lower than that of the outer tube.
  • a medical tubular body transport device characterized by.
  • the ratio of the load b (b / a) to the load a is 20 to 85% [1].
  • the medical tubular body transport device described [3] The medical tubular body transport device according to [1] or [2], wherein the tubular low-rigidity member covers the proximal end of the outer tube. [4] The medical tubular body transport device according to [3], wherein the proximal end of the tubular low-rigidity member is proximal to the proximal end of the outer tube. [5] The medical tubular body transport device according to [1] or [2], wherein the distal end of the tubular low-rigidity member and the proximal end of the outer tube are in contact with each other.
  • the ratio of the load c (c / a) to the load a is 35 to 90% [7] to [9].
  • a tubular low-rigidity member having a rigidity lower than the rigidity of the outer tube is arranged at the proximal end of the outer tube, so that the medical tubular body is placed in the lumen.
  • the tubular low-rigidity member is preferentially deformed more than the outer tube.
  • the stress applied between the outer tube and the traction member is dispersed in the contact section between the traction member and the tubular low-rigidity member, the traction member is less likely to come off from the outer tube.
  • a tubular low-rigidity member having a rigidity lower than the rigidity of the outer tube is arranged at the proximal end of the outer tube, the followability of the outer tube to the bending inner tube can be improved, and the outer tube can be improved. It is possible to prevent an increase in the frictional resistance generated between the inner tube and the inner tube. As a result, the outer tube can be easily pulled proximally.
  • FIG. 1 is a cross-sectional view showing an example of a distal embodiment of a conventional medical tubular body transport device.
  • FIG. 2 is a cross-sectional view showing a first embodiment of the medical tubular body transport device according to the present invention.
  • FIG. 3 is an enlarged view of the vicinity of the connection position between the outer tube and the traction member shown in FIG.
  • FIG. 4 is a cross-sectional view showing a second embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the vicinity of the connection position between the outer tube and the traction member.
  • FIG. 1 is a cross-sectional view showing an example of a distal embodiment of a conventional medical tubular body transport device.
  • FIG. 2 is a cross-sectional view showing a first embodiment of the medical tubular body transport device according to the present invention.
  • FIG. 3 is an enlarged view of the vicinity of the connection position between the outer tube and the traction member shown in FIG.
  • FIG. 4 is a cross-section
  • FIG. 5 is a cross-sectional view showing a third embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the vicinity of the connection position between the outer tube and the traction member.
  • FIG. 6 is a cross-sectional view showing a fourth embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the vicinity of the connection position between the outer tube and the traction member.
  • FIG. 7 is a cross-sectional view showing a fifth embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the vicinity of the connection position between the outer tube and the traction member.
  • FIG. 6 is a cross-sectional view showing a fourth embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the vicinity of the connection position between the outer tube and the traction member.
  • FIG. 7 is a cross-sectional view showing a fifth embodiment of the medical tubular body transport device according to the present invention, and is an
  • FIG. 8 is a cross-sectional view showing a sixth embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the vicinity of the connection position between the outer tube and the traction member.
  • FIG. 9 is a schematic view showing a device for measuring a pushing load.
  • the medical tubular body transport device is a device for transporting a medical tubular body into the body, and is connected to an outer tube in which the medical tubular body is arranged in a lumen and the outer tube.
  • a traction member extending proximally, an inner tube located in the lumen of the outer tube, and a stiffness lower than that of the outer tube located at the proximal end of the outer tube. It is characterized by having a tubular low-rigidity member.
  • a tubular low-rigidity member having a rigidity lower than the rigidity of the outer tube is arranged at the proximal end of the outer tube, the vicinity of the proximal end of the outer tube is bent and connected to the outer tube.
  • the tubular low-rigidity member is preferentially deformed more than the outer tube, and the stress applied between the outer tube and the traction member is applied to the traction member and the tubular low-rigidity member. Since it is dispersed in the contact section of, the traction member is less likely to come off from the outer tube.
  • the inner tube is bent even if the inner tube arranged in the lumen of the outer tube is bent. It is possible to improve the followability of the outer tube with respect to. That is, since the tubular low-rigidity member is more easily deformed by stress than the outer tube, when stress is applied and the inner tube bends, the tubular low-rigidity member deforms earlier than the outer tube, and the inner tube is deformed earlier. It becomes easier to follow the bending of the tube.
  • the tensile stress applied to the connection portion between the traction member and the outer tube is dispersed due to the contact between the traction member and the tubular low-rigidity member, even if the traction member is pulled to the proximal side, it is proximal to the outer tube. The end and inner tube are less likely to come into contact. As a result, even if the traction member is pulled to the proximal side, the frictional resistance generated between the outer tube and the inner tube does not increase, so that the outer tube can be easily pulled to the proximal side. Therefore, the operability of the medical tubular body transport device is not deteriorated, and the medical tubular body can be reliably released from the medical tubular body transport device.
  • the ratio of the load b (b / a) to the load a satisfies 20 to 85%. It is preferable to do so. Since the ratio of the load b (b / a) to the load a is 20% or more, even if the towing member is pulled to the proximal side, the tubular low-rigidity member follows the direction in which the towing member is pulled without being damaged. It can be deformed and the traction member can be prevented from being cut off.
  • the ratio of b / a is more preferably 30% or more, still more preferably 40% or more.
  • the tubular low-rigidity member follows and deforms in the direction in which the traction member is pulled. It is possible to relieve the stress applied to the most recent position of the connection portion of the above, and prevent the traction member from disconnecting from the outer tube.
  • the ratio of b / a is more preferably 75% or less, still more preferably 50% or less. A specific method for measuring the ratio of the load b (b / a) to the load a will be described later.
  • the tubular low-rigidity member is located at the proximal end of the outer tube, for example, the distal end of the tubular low-rigidity member may cover the proximal end of the outer tube.
  • the distal end of the low stiffness member and the proximal end of the outer tube may be in contact (or abutted).
  • FIG. 2 is a cross-sectional view showing a first embodiment of the medical tubular body transport device according to the present invention. Note that FIG. 2 shows only the distal side of the medical tubular body transport device. Further, FIG. 3 is an enlarged cross-sectional view showing the vicinity of the connection position between the outer tube 24 and the traction member 25 shown in FIG. In FIG. 3, the left side with respect to the drawing is the distal side of the medical tubular body transport device, and the right side is the proximal side of the medical tubular body transport device.
  • the medical tubular body 21 is connected to the outer tube 24 in which the medical tubular body 21 is arranged in the lumen and the outer tube 24 and extends proximally.
  • a guide wire (not shown) is inserted into the lumen of the inner tube 23.
  • the distal end of the inner tube 23 reaches the lumen of the tip tip 26.
  • the proximal end of the inner tube 23 extends to the proximal side (the operator's hand side) of the medical tubular body transport device, and the operation of the operator's hand is performed for medical use via the inner tube 23. It can be transmitted to the distal side of the tubular body carrier.
  • the traction member 25 extends proximally along the inner tube 23, and by pulling the traction member 25 proximally, the outer tube 24 is pulled proximally and the medical tubular body 21 is the outer tube. It is extruded from the 24 lumens into the internal lumen and released.
  • the distal end of the tubular low-rigidity member 27 covers the proximal end of the outer tube 24 and the distal end of the traction member 25.
  • the proximal end 27a of the tubular low-rigidity member 27 is arranged proximal to the proximal end 24a of the outer tube 24.
  • the tubular low-rigidity member 27 When the member 25 is pulled to the proximal side, the tubular low-rigidity member 27 is deformed more preferentially than the outer tube 24, the tubular low-rigidity member 27 becomes a cushioning material, and the traction member 25 becomes difficult to straighten. As a result, stress is less likely to be concentrated at the most recent position of the connection portion between the traction member 25 and the outer tube 24, so that the traction member 25 can be prevented from being cut off from the outer tube 24.
  • the ratio (L2 / L1) of the distance L2 between the proximal end 24a of the outer tube 24 and the proximal end 27a of the tubular low-rigidity member 27 with respect to the axial length L1 of the tubular low-rigidity member 27 is. It is preferably 0.1 to 0.7. By setting the ratio (L2 / L1) to 0.1 or more, the stress relaxation effect of the tubular low-rigidity member 27 can be effectively exhibited.
  • the ratio (L2 / L1) is more preferably 0.3 or more, still more preferably 0.4 or more.
  • the tubular low-rigidity member 27 is less likely to come off from the outer tube 24.
  • the ratio (L2 / L1) is more preferably 0.6 or less, still more preferably 0.5 or less.
  • the axial length L2 of the above is, for example, preferably 3 to 30 mm, more preferably 25 mm or less, still more preferably 20 mm or less.
  • the pushing load b on the tubular low-rigidity member 27 may be measured at the position of the arrow b. That is, the pushing load a on the outer tube 24 is measured at a position not covered by the tubular low-rigidity member 27, and the pushing load b on the tubular low-rigidity member 27 is measured at a position not covering the outer tube 24. Just do it.
  • the distal portion of the traction member 25 is connected to the proximal portion of the outer tube 24, for example, as shown in FIG. 2, the distal portion of the traction member 25 and the proximal portion of the outer tube 24 are brought into contact with each other. It may be connected by an adhesive or the like, or the distal portion of the traction member 25 may be embedded and connected to the proximal portion of the outer tube 24.
  • the shape of the distal end portion of the traction member 25 can be any shape, and in order to increase the connection strength with the outer tube 24, for example, it may be cylindrical or flat. good.
  • the outer diameter may change from the distal end toward the proximal side, and for example, the cross-sectional shape may change from a perfect circle to an ellipse.
  • the thickness and width may change from the distal end to the proximal side.
  • the outer surface of the distal end portion of the traction member 25 may be surface-treated to increase the connection strength with the outer tube 24, and the surface treatment includes, for example, a satin-like roughening treatment.
  • the distal end portion of the traction member 25 may be wound around the proximal portion of the outer tube 24 and fixed, or may be deformed into a meandering shape and then fixed.
  • the distal end of the traction member 25 may be distal to the distal end of the tubular low stiffness member 27, but as shown in FIG. 3, the distal end of the traction member 25 has a tubular low rigidity. It is preferably proximal to the distal end of the member 27.
  • FIG. 4 is a cross-sectional view showing a second embodiment of the medical tubular body transport device according to the present invention, and shows an enlarged view of the vicinity of the connection position between the outer tube 24 and the traction member 25. Duplicate explanations are avoided by assigning the same reference numerals to the same parts as other drawings (hereinafter, the same).
  • the left side with respect to the drawing is the distal side of the medical tubular body transport device, and the right side is the proximal side of the medical tubular body transport device.
  • the traction member 25 is arranged inside the outer tube 24 with respect to the first embodiment shown in FIG. As a result, the traction member 25 is arranged close to the axial position of the medical tubular body transport device, so that the outer tube 24 can be easily pulled toward the proximal side. From the viewpoint of making it difficult for the traction member 25 to be separated from the outer tube 24, the traction member 25 may be arranged outside the outer tube 24 as shown in FIG. 3 rather than inside the outer tube 24. preferable.
  • FIG. 5 is a cross-sectional view showing a third embodiment of the medical tubular body transport device according to the present invention, and shows an enlarged view of the vicinity of the connection position between the outer tube 24 and the traction member 25.
  • the left side with respect to the drawing is the distal side of the medical tubular body transport device, and the right side is the proximal side of the medical tubular body transport device.
  • the traction member 25 is arranged outside the outer tube 24 and the tubular low-rigidity member 27 with respect to the first embodiment shown in FIG. This makes it possible to increase production efficiency.
  • the distal end portion of the traction member 25 is shown in FIG. 3 rather than being arranged outside the outer tube 24 and the tubular low-rigidity member 27.
  • FIG. 6 is a cross-sectional view showing a fourth embodiment of the medical tubular body transport device according to the present invention, and shows an enlarged view of the vicinity of the connection position between the outer tube 24 and the traction member 25.
  • the left side with respect to the drawing is the distal side of the medical tubular body transport device, and the right side is the proximal side of the medical tubular body transport device.
  • the proximal end of the outer tube 24 and the distal end of the tubular low-rigidity member 27 are in contact with each other.
  • the tubular low-rigidity member 27 follows the traction member 25 and takes precedence over the outer tube 24.
  • the traction member 25 is difficult to straighten because it is greatly deformed. As a result, stress is less likely to be concentrated at the connection position between the traction member 25 and the outer tube 24, so that the traction member 25 can be prevented from being cut off from the outer tube 24.
  • the length of the tubular low-rigidity member 27 in the longitudinal direction is preferably, for example, 3 to 25 mm. It is more preferably 4 mm or more, more preferably 20 mm or less, still more preferably 15 mm or less.
  • FIG. 7 is a cross-sectional view showing a fifth embodiment of the medical tubular body transport device according to the present invention, and shows an enlarged view of the vicinity of the connection position between the outer tube 24 and the traction member 25.
  • the left side with respect to the drawing is the distal side of the medical tubular body transport device, and the right side is the proximal side of the medical tubular body transport device.
  • the traction member 25 is arranged inside the outer tube 24 and the tubular low-rigidity member 27 with respect to the fourth embodiment shown in FIG.
  • the traction member 25 is arranged close to the axial position of the medical tubular body transport device, so that the outer tube 24 is moved to the proximal side. It becomes easy to pull.
  • the traction member 25 is the outer tube 24 as shown in FIG. 3 rather than being arranged inside the outer tube 24 and the tubular low-rigidity member 27. And it is preferable to arrange it on the outside of the tubular low-rigidity member 27.
  • the contact portion between the tubular low-rigidity member 27 and the outer tube 24 is not compatible with each other. .. This makes it possible to prevent stress from concentrating on the contact portion.
  • the position of the arrow a is relative to the outer tube 24.
  • the pushing load a may be measured, and the pushing load b on the tubular low-rigidity member 27 may be measured at the position of the arrow b.
  • FIG. 8 is a cross-sectional view showing a sixth embodiment of the medical tubular body transport device according to the present invention, and shows an enlarged view of the vicinity of the connection position between the outer tube 24 and the traction member 25.
  • the left side with respect to the drawing is the distal side of the medical tubular body transport device, and the right side is the proximal side of the medical tubular body transport device.
  • a tubular member 28 that covers at least a part of the proximal end portion of the outer tube 24 and the traction member 25 is arranged with respect to the fourth embodiment shown in FIG. .. This makes it difficult for the towing member 25 to separate from the outer tube 24.
  • the proximal end 27a of the tubular low-rigidity member 27 may be distal to the proximal end 28a of the tubular member 28, but as shown in FIG. 8, proximal to the tubular low-rigidity member 27.
  • the end 27a is preferably proximal to the proximal end 28a of the tubular member 28.
  • the traction member 25 Since it is sandwiched between the tubular low-rigidity members 27, the traction member 25 is pulled from the outer tube 24 regardless of whether the traction member 25 is pulled outward or inward with respect to the axis of the medical tubular body transport device. It becomes difficult to disconnect. Further, with such a configuration, when the traction member 25 is towed to move the outer tube 24 to the proximal side, the frictional resistance generated between the proximal end of the tubular low-rigidity member 27 and the inner tube 23. Can be reduced, and the operating load when deploying the medical tubular body can be suppressed.
  • the distal end of the traction member 25 may be distal to the distal end of the tubular member 28, but as shown in FIG. 8 from the viewpoint of making it difficult for the traction member 25 to be separated from the outer tube 24.
  • the distal end of the traction member 25 is preferably proximal to the distal end of the tubular member 28.
  • the rigidity of the tubular member 28 is preferably lower than the rigidity of the outer tube 24.
  • the rigidity of the tubular member 28 may be the same as the rigidity of the tubular low-rigidity member 27, but the rigidity of the tubular member 28 is preferably higher than the rigidity of the tubular low-rigidity member 27. That is, the rigidity of the tubular member 28 is preferably lower than the rigidity of the outer tube 24 and higher than the rigidity of the tubular low-rigidity member 27. With such a configuration, the rigidity from the proximal portion of the outer tube 24 to the proximal end 27a of the tubular low-rigidity member 27 can be continuously reduced, and the traction member 25 is moved outward in the radial direction of the outer tube 24. Even if the member is pulled up, the cylindrical member 28 or the tubular low-rigidity member 27 is preferentially bent, and it is possible to further suppress the occurrence of disconnection from the outer tube 24.
  • the tubular member 28 satisfies a ratio of the load c (c / a) to the load a of 35 to 90%, where a is the pushing load on the outer tube and c is the pushing load on the tubular member 28. Is preferable. Since the ratio of the load c (c / a) to the load a is 35% or more, the tubular member 28 is not damaged when the traction member 25 is pulled to the proximal side, and the pulling direction of the traction member 25 is not damaged. Since the deformation follows, the tensile stress is dispersed and the traction member 25 is less likely to be separated from the outer tube 24.
  • the ratio of c / a is more preferably 40% or more, still more preferably 70% or more.
  • the tubular member 28 follows the direction in which the towing member 25 is pulled and is easily deformed. It is possible to prevent stress from concentrating on the proximal end of the connection portion with the traction member 25, and it becomes difficult for the traction member 25 to be separated from the outer tube 24.
  • the ratio of c / a is more preferably 88% or less. A specific method for measuring the ratio of the load c (c / a) to the load a will be described later.
  • the pushing load a on the outer tube 24 is applied at the position of the arrow a. It may be measured and the pushing load c on the tubular member 28 may be measured at the position of the arrow c. That is, the pushing load a on the outer tube 24 may be measured at a position not covered by the tubular member 28, and the pushing load c on the tubular member 28 may be measured at a position covering the outer tube 24.
  • tubular member 28 and the tubular low-rigidity member 27 are adhered to each other. This makes it difficult for the traction member 25 arranged between the cylindrical member 28 and the tubular low-rigidity member 27 to be separated from the outer tube 24.
  • the tubular member 28 and the tubular low-rigidity member 27 may be bonded by, for example, an adhesive, may be bonded by thermocompression bonding, and are preferably bonded by thermocompression bonding.
  • the tubular member 28 and the outer tube 24 may be compatible with each other, but it is preferable that the tubular member 28 and the outer tube 24 are not compatible with each other. Since the tubular member 28 and the outer tube 24 can move independently due to the incompatibility, the tubular member 28 and the outer tube 24 are likely to be deformed according to the complicated movement of the medical tubular body transport device.
  • the distal end of the traction member 25 is preferably bonded to both the tubular member 28 and the outer tube 24, for example, whether it is bonded by an adhesive or by thermocompression bonding. Often, it is preferably bonded by thermocompression bonding. In the case of thermocompression bonding, the connection strength of the traction member 25 can be further increased by arranging an adhesive resin such as polyethylene on the inner surface of the tubular member 28.
  • the traction member 25 is connected to the tubular low-rigidity member 27 in addition to the outer tube 24. This makes it difficult for the towing member 25 to separate from the outer tube 24. Further, when the traction member 25 is pulled to the proximal side and the outer tube 24 is moved to the proximal side at the time of deploying the medical tubular body, the tension of the traction member 25 is applied to the outer tube 24 via the tubular low-rigidity member 27. Therefore, the traction tension can be transmitted to the outer tube 24 more efficiently in the bent shape, and as a result, the load of the stent deployment operation can be suppressed.
  • the traction member 25 and the tubular low-rigidity member 27 may be bonded to each other by, for example, an adhesive, or the tubular low-rigidity member 27 may be bonded by thermocompression bonding due to partial melting. It is preferable that they are adhered to each other.
  • the traction member 25 when the traction member 25 is connected to the tubular low-rigidity member 27, the traction member 25 is connected to the outer surface of the tubular low-rigidity member 27. Is preferable.
  • the traction member 25 is connected to the outer surface of the tubular low-rigidity member 27, which facilitates manufacturing.
  • At least the proximal end of the outer tube 24, the inner tube 23, and the traction member 25 have a protective tube arranged in the lumen.
  • a protective tube By covering with the protective tube, at least the proximal end of the outer tube 24, the inner tube 23, and the traction member 25 can be put together, which improves the operability of the medical tubular body transfer device.
  • Examples of the constituent materials of the outer tube 24 and the inner tube 23 include polyethylene, fluororesin [for example, polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), etc.], polyamide, and polyamide.
  • fluororesin for example, polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), etc.
  • PFA perfluoroalkyl vinyl ether copolymer
  • resin materials such as elastomer, polyimide, polyurethane, polyester, silicone, and polyetheretherketone (PEEK).
  • the outer tube 24 may have a single-layer structure or a multi-layer structure, and a multi-layer structure is preferable. By forming the multi-layer structure, the rigidity of the outer tube 24 can be easily increased more than the rigidity of the tubular low-rigidity member 27.
  • a two-layer structure in which the inner layer is polyimide and the outer layer is a polyamide elastomer can be exemplified.
  • the constituent material of the tubular low-rigidity member 27 is not particularly limited as long as the rigidity of the tubular low-rigidity member 27 is lower than the rigidity of the outer tube 24, and the above-mentioned resin material can be used. Of these, polyamide elastomers are preferred.
  • the tubular low-rigidity member 27 may have a single-layer structure or a multi-layer structure, and a multi-layer structure is preferable. By having a multi-layer structure, it is possible to improve the slipperiness inside the tubular low-rigidity member 27 and make it easier to slide.
  • the material constituting the outer layer of the tubular low-rigidity member 27 the above-mentioned resin material can be used, and as the material constituting the inner layer of the tubular low-rigidity member 27, for example, polyethylene or fluororesin [for example, poly] can be used.
  • Tetrafluoroethylene PTFE
  • PFA perfluoroalkyl vinyl ether copolymer
  • the multi-layer structure for example, a two-layer structure in which the inner layer is polyethylene and the outer layer is a polyamide elastomer can be exemplified.
  • the constituent material of the tubular member 28 is particularly limited as long as the rigidity of the tubular member 28 is the same as the rigidity of the tubular low-rigidity member 27 or is higher than the rigidity of the tubular low-rigidity member 27.
  • the above-mentioned resin material can be used. Of these, polyamide-based elastomers are preferable.
  • the constituent material of the traction member 25 may be the resin material described above, but is preferably a metal.
  • the metal include titanium, stainless steel, nickel-titanium alloy and the like.
  • a stent for example, a stent, a stent graft, an occlusion tool, an injection catheter, a prosthesis valve, or the like can be used. Above all, it is preferable to use a stent.
  • the stent include a coiled stent made of a single linear metal or polymer material, a stent obtained by cutting out a metal tube with a laser, and a metal sheet cut out with a laser and then wound into a cylindrical shape. Examples include laser-welded stents, laser-welded stents of linear members, and stents made by weaving multiple linear metals.
  • Stents are classified into balloon-expandable stents, which are expanded by a balloon on which the stent is mounted, and self-expandable stents, which are self-expanded by removing an external member that suppresses the expansion of the stent.
  • the rigidity of the medical tubular body transport device was evaluated by the following procedure.
  • FIG. 9 shows a schematic diagram of the device used for measuring the indentation load.
  • the left side of the drawing shows the distal end of the medical tubular transport device, and the right side shows the proximal end of the medical tubular transport device.
  • a part of the medical tubular body transport device 32 is attached to the pedestal 31 so that the distal end of the medical tubular body transport device 32 is on the distal side of the distal end B of the pedestal 31. Is sandwiched between the pedestals 31 and fixed. The distance from the position A where the medical tubular body transport device 32 is fixed to the distal end B of the pedestal 31 is 30 mm, and the indenter 33 is placed at the position C 13 mm away from the distal end B of the pedestal 31. Deploy. The indenter 33 is pushed vertically downward with respect to the medical tubular body transport device 32, and the load (pushing load) at this time is measured.
  • the indenter As the indenter, a wedge-shaped indenter was used, the pushing speed of the indenter was 1.0 mm / sec, the pushing distance of the indenter was 1.2 mm, and the load at the time of pushing to 1.0 mm was measured.
  • the medical tubular body transport device 32 shown in FIG. 8 was produced, and the rigidity of the medical tubular body transport device 32 was specifically evaluated.
  • the inner layer uses polyimide as the material constituting the outer tube 24, the outer layer uses a polyamide elastomer (Pebax 7233 manufactured by ARKEMA), and the inner layer is high-density polyethylene as the material constituting the tubular low-rigidity member 27.
  • Polyamide elastomer (Pebax7233 manufactured by ARKEMA) was used for the outer layer, polyamide elastomer (Pebax7233 manufactured by ARKEMA) was used as a material constituting the tubular member 28, and stainless steel (SUS304) was used as a material constituting the traction member 25. ..
  • the pushing load a at the position a shown in FIG. 8 (that is, the pushing load a for the outer tube) is 0.15N
  • the pushing load b at the position b that is, the pushing load b for the tubular low-rigidity member

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Abstract

Provided is a medial tubular object conveyance device in which even when a traction member is pulled to a proximal side while a proximal side of the medical tubular object is bent, the traction member is not deviated from an outer tube, has operability not easily degraded, and can reliably release the medical tubular object.　This medical tubular object conveyance device, which conveys the medical tubular object into a body, comprises: an outer tube in which the medical tubular object is disposed in an internal cavity; a traction member which is connected to the outer tube and extends to a proximal side; an inner tube disposed in the internal cavity of the outer tube; and a tubular low-stiffness member which is disposed on a proximal-side section of the outer tube and has stiffness lower than the stiffness of the outer tube.

Description

医療用管状体搬送装置Medical tubular body transport device
　本発明は、医療用管状体搬送装置に関する。 The present invention relates to a medical tubular body transport device.
　近年、体内の病変部に医療用管状体を搬送して配置する最小侵襲治療技術が開発されている。医療用管状体としては、例えば、ステント、ステントグラフト、閉塞具、注入カテーテル、プロテーゼ弁等が用いられる。これらのうちステントは、一般に、血管または他の生体内管腔が狭窄または閉塞することによって生じる様々な疾患を治療するために用いられる医療用管状体である。この技術では、体内管腔を通して病変部に医療用管状体を搬送して配置するために搬送装置が用いられている。搬送装置は外側チューブを備えており、この外側チューブの内腔に医療用管状体を保持させた状態で、体内管腔を通し、医療用管状体を体内の病変部に搬送する。搬送した後は、外側チューブに接続されており近位側に延伸している牽引部材を近位側に引くことによって、外側チューブの内腔から医療用管状体を解放し、体内の病変部に医療用管状体を配置する。なお、本明細書では、医療用管状体搬送装置のうち術者の手元側を近位端とし、近位端の反対側、すなわち病変部等に近い側を遠位端とする。 In recent years, a minimally invasive treatment technique has been developed in which a medical tubular body is transported and placed in a lesion in the body. As the medical tubular body, for example, a stent, a stent graft, an occlusion tool, an infusion catheter, a prosthesis valve and the like are used. Of these, stents are medical tubulars commonly used to treat a variety of diseases caused by the narrowing or obstruction of blood vessels or other in vivo lumens. In this technique, a transport device is used to transport and place a medical tubular body to a lesion through an internal lumen. The transport device includes an outer tube, and the medical tubular body is transported to a lesion in the body through the internal lumen while the medical tubular body is held in the lumen of the outer tube. After transport, the medical tubular body is released from the lumen of the outer tube by pulling the traction member, which is connected to the outer tube and extends proximally, to the proximal side, and reaches the lesion in the body. Place a medical tubular body. In the present specification, the hand side of the operator is the proximal end of the medical tubular body transport device, and the opposite side of the proximal end, that is, the side close to the lesion or the like is the distal end.
　従来における医療用管状体搬送装置の実施形態の一例を図１に示す。図１は、医療用管状体搬送装置の断面図であり、医療用管状体搬送装置の遠位側を示している。図１に示した医療用管状体搬送装置は、医療用管状体１１が内腔に配置されている外側チューブ１２と、該医療用管状体１１より近位側に、外側チューブ１２の一部である牽引チューブ１４と、外側チューブ１２の内腔に配置される内側チューブ１３とを有している。内側チューブ１３の遠位端は、先端チップ１６の内腔に達している。内側チューブ１３の近位端は、医療用管状体搬送装置の近位端（術者の手元）まで延伸しており、術者の手元の操作を、内側チューブ１３を介して医療用管状体搬送装置の遠位側へ伝えることができる。外側チューブ１２の一部である牽引チューブ１４には、牽引部材１５が接続されており、内側チューブ１３に沿って近位側に延伸している。牽引部材１５を近位側へ引くことにより牽引チューブ１４と外側チューブ１２が近位側に引かれ、医療用管状体１１が外側チューブ１２の内腔から体内管腔へ押し出され、解放され、体内の病変部に配置される。 FIG. 1 shows an example of a conventional embodiment of a medical tubular body transport device. FIG. 1 is a cross-sectional view of a medical tubular body transport device, showing the distal side of the medical tubular body transport device. The medical tubular body transport device shown in FIG. 1 consists of an outer tube 12 in which the medical tubular body 11 is arranged in a lumen and a part of the outer tube 12 proximal to the medical tubular body 11. It has a tow tube 14 and an inner tube 13 located in the lumen of the outer tube 12. The distal end of the inner tube 13 reaches the lumen of the tip tip 16. The proximal end of the inner tube 13 extends to the proximal end of the medical tubular body transfer device (operator's hand), and the operation of the operator's hand is carried out through the inner tube 13 for medical tubular body transfer. Can be transmitted to the distal side of the device. A tow member 15 is connected to the tow tube 14 which is a part of the outer tube 12 and extends proximally along the inner tube 13. By pulling the traction member 15 to the proximal side, the traction tube 14 and the outer tube 12 are pulled to the proximal side, and the medical tubular body 11 is pushed out from the lumen of the outer tube 12 into the internal lumen, released, and inside the body. It is placed in the lesion area of.
　こうした医療用管状体搬送装置は、例えば、特許文献１～３に開示されている。具体的には、特許文献１には、伸縮自在なカテーテルであって、相対的に柔軟な材料から作製される細長い管状シースと、前記シースに引張り力を伝達して、縦方向にシースを引き込むための引張り要素とを備え、前記引張り要素が、前記相対的に柔軟な材料内に配置された端部を備え、少なくとも前記端部の厚さが、実質的にその長さよりも薄いことを特徴とする伸縮自在なカテーテルが記載されている。 Such a medical tubular body transport device is disclosed in, for example, Patent Documents 1 to 3. Specifically, Patent Document 1 describes a stretchable catheter, an elongated tubular sheath made of a relatively flexible material, and a tensile force transmitted to the sheath to pull the sheath in the vertical direction. The tension element comprises an end disposed within the relatively flexible material, wherein at least the thickness of the end is substantially thinner than its length. A telescopic catheter is described.
　特許文献２には、ステント装置移送システムであって、ステント装置と、前記ステント装置の半径方向にコンパクトな移送形態で、前記ステント装置を覆う外側シースであって、前記ステント装置を半径方向に拡張して、展開形態に移行できるようにするために後退可能である、外側シースと、前記外側シースを近位側に引っ張って後退させる引っ張り部材とを備え、前記引っ張り部材の遠位部分を、前記外側シースと、相対的に耐熱収縮性を有する支持部材との間に半径方向に捕捉するために、前記外側シースの一部分が、前記耐熱収縮性を有する前記支持部材上で半径方向に熱収縮されているステント装置移送システムが記載されている。 Patent Document 2 describes a stent device transfer system, which is a stent device and an outer sheath that covers the stent device in a radial compact transfer form of the stent device, and extends the stent device in the radial direction. A retractable outer sheath and a pulling member that pulls and retracts the outer sheath proximally are provided, and the distal portion of the pulling member is A portion of the outer sheath is radially thermally shrunk on the heat shrinkable support member in order to be radially trapped between the outer sheath and the relatively heat shrinkable support member. The stent device transfer system is described.
　特許文献３には、ステント装置送達システムであって、ステント装置と、前記ステント装置の半径方向にコンパクトな送達形態における前記ステント装置を覆い、前記ステント装置に対して後退可能であり、前記ステント装置を半径方向に拡張して展開構成をとらせる外側シースとを備え、前記外側シースは、互いに積層された第１の層と補強層とを含み、引っ張り部材の一部が、前記一部を半径方向において前記外側シースの前記第１の層と前記補強層との間に捕捉することによって前記外側シースに取り付けられるステント装置送達システムが記載されている。 Patent Document 3 describes a stent device delivery system that covers the stent device and the stent device in a radially compact delivery form of the stent device and is retractable with respect to the stent device. The outer sheath comprises a first layer and a reinforcing layer laminated with each other, the outer sheath comprising a first layer and a reinforcing layer laminated with each other, and a part of the pulling member has a radius of the part. Described is a stenting device delivery system that is attached to the outer sheath by trapping between the first layer and the reinforcing layer of the outer sheath in orientation.
特表２０１２－５１０３２９号公報Japanese Patent Publication No. 2012-510329 特表２０１３－５１２７０５号公報Special Table 2013-512705 Gazette 特表２０１３－５１２７０６号公報Special Table 2013-512706 Gazette
　こうした医療用管状体搬送装置は体内管腔に挿入されるが、体内管腔は複雑に屈曲しているため、医療用管状体搬送装置も体内管腔の屈曲に追随して曲げられる。そのため図１に示したように牽引チューブ１４の近位端部を曲げた状態で牽引部材１５を近位側に引くと、牽引部材１５は、図１に点線１５ａで示すように引かれた方向に向かって直線化する。その結果、牽引部材１５と牽引チューブ１４の接続部分のうち最近位位置１５ｂに応力が集中し、牽引部材１５が牽引チューブ１４から外れることがあった。 Such a medical tubular transport device is inserted into the internal lumen, but since the internal lumen is complicatedly bent, the medical tubular transport device is also bent following the bending of the internal lumen. Therefore, when the tow member 15 is pulled to the proximal side with the proximal end of the tow tube 14 bent as shown in FIG. 1, the tow member 15 is pulled in the direction shown by the dotted line 15a in FIG. Straighten towards. As a result, stress was concentrated on the most recent position 15b of the connecting portion between the towing member 15 and the towing tube 14, and the towing member 15 may come off from the towing tube 14.
　本発明は上記の様な事情に着目してなされたものであって、その目的は、医療用管状体の近傍を曲げた状態で牽引部材を近位側に引いても、牽引部材が外側チューブから外れることなく、医療用管状体を確実に解放できる医療用管状体搬送装置を提供することにある。 The present invention has been made by paying attention to the above circumstances, and an object thereof is that even if the traction member is pulled to the proximal side in a state where the vicinity of the medical tubular body is bent, the traction member is an outer tube. It is an object of the present invention to provide a medical tubular body transport device capable of reliably releasing a medical tubular body without being disengaged from the medical tubular body.
　本発明は、以下の発明を含む。
　［１］　医療用管状体を体内に搬送する装置であって、前記医療用管状体が内腔に配置されている外側チューブと、前記外側チューブに接続されており近位側に延伸している牽引部材と、前記外側チューブの内腔に配置されている内側チューブと、前記外側チューブの近位端部に配置されており該外側チューブの剛性よりも低い剛性の筒状低剛性部材を有することを特徴とする医療用管状体搬送装置。
　［２］　前記外側チューブに対する押し込み荷重をａ、前記筒状低剛性部材に対する押し込み荷重をｂとしたとき、荷重ａに対する荷重ｂ（ｂ／ａ）の割合が２０～８５％である［１］に記載の医療用管状体搬送装置。
　［３］　前記筒状低剛性部材は、前記外側チューブの近位端部を覆っている［１］または［２］に記載の医療用管状体搬送装置。
　［４］　前記筒状低剛性部材の近位端は、前記外側チューブの近位端より近位側である［３］に記載の医療用管状体搬送装置。
　［５］　前記筒状低剛性部材の遠位端と前記外側チューブの近位端は当接している［１］または［２］に記載の医療用管状体搬送装置。
　［６］　前記筒状低剛性部材の遠位端と前記外側チューブの近位端の当接部は、相溶していない［５］に記載の医療用管状体搬送装置。
　［７］　前記外側チューブの近位端部と、前記牽引部材の少なくとも一部とを覆う筒状部材を有する［５］または［６］に記載の医療用管状体搬送装置。
　［８］　前記筒状部材の剛性は、前記外側チューブの剛性よりも低い［７］に記載の医療用管状体搬送装置。
　［９］　前記筒状部材の剛性は、前記筒状低剛性部材の剛性よりも高い［８］に記載の医療用管状体搬送装置。
　［１０］　前記外側チューブに対する押し込み荷重をａ、前記筒状部材に対する押し込み荷重をｃとしたとき、荷重ａに対する荷重ｃ（ｃ／ａ）の割合が３５～９０％である［７］～［９］のいずれかに記載の医療用管状体搬送装置。
　［１１］　前記筒状低剛性部材の近位端は、前記筒状部材の近位端より近位側である［７］～［１０］のいずれかに記載の医療用管状体搬送装置。
　［１２］　前記牽引部材は、前記外側チューブの外表面に接続されている［１］～［１１］のいずれかに記載の医療用管状体搬送装置。
　［１３］　前記牽引部材は、前記筒状低剛性部材にも接続されている［１］～［１２］のいずれかに記載の医療用管状体搬送装置。
　［１４］　前記牽引部材は、前記筒状低剛性部材の外表面に接続されている［１３］に記載の医療用管状体搬送装置。
　［１５］　前記内側チューブは、内腔にガイドワイヤが挿通されるものである［１］～［１４］のいずれかに記載の医療用管状体搬送装置。
　［１６］　前記外側チューブの少なくとも近位端部、前記内側チューブ、および前記牽引部材が、内腔に配置されている保護チューブを有する［１］～［１５］のいずれかに記載の医療用管状体搬送装置。
　［１７］　前記医療用管状体は、自己拡張型ステントである［１］～［１６］のいずれかに記載の医療用管状体搬送装置。 The present invention includes the following inventions.
[1] A device for transporting a medical tubular body into the body, in which the medical tubular body is connected to an outer tube arranged in a lumen and the outer tube and extends proximally. Having a traction member, an inner tube located in the lumen of the outer tube, and a tubular low-rigidity member located at the proximal end of the outer tube and having a rigidity lower than that of the outer tube. A medical tubular body transport device characterized by.
[2] When the pushing load on the outer tube is a and the pushing load on the tubular low-rigidity member is b, the ratio of the load b (b / a) to the load a is 20 to 85% [1]. The medical tubular body transport device described.
[3] The medical tubular body transport device according to [1] or [2], wherein the tubular low-rigidity member covers the proximal end of the outer tube.
[4] The medical tubular body transport device according to [3], wherein the proximal end of the tubular low-rigidity member is proximal to the proximal end of the outer tube.
[5] The medical tubular body transport device according to [1] or [2], wherein the distal end of the tubular low-rigidity member and the proximal end of the outer tube are in contact with each other.
[6] The medical tubular body transport device according to [5], wherein the contact portion between the distal end of the tubular low-rigidity member and the proximal end of the outer tube is incompatible.
[7] The medical tubular body transport device according to [5] or [6], which has a tubular member that covers a proximal end of the outer tube and at least a part of the traction member.
[8] The medical tubular body transport device according to [7], wherein the rigidity of the tubular member is lower than the rigidity of the outer tube.
[9] The medical tubular body transport device according to [8], wherein the rigidity of the tubular member is higher than the rigidity of the tubular low-rigidity member.
[10] When the pushing load on the outer tube is a and the pushing load on the tubular member is c, the ratio of the load c (c / a) to the load a is 35 to 90% [7] to [9]. ] The medical tubular body transport device according to any one of.
[11] The medical tubular body transport device according to any one of [7] to [10], wherein the proximal end of the tubular low-rigidity member is proximal to the proximal end of the tubular member.
[12] The medical tubular body transport device according to any one of [1] to [11], wherein the traction member is connected to the outer surface of the outer tube.
[13] The medical tubular body transport device according to any one of [1] to [12], wherein the traction member is also connected to the tubular low-rigidity member.
[14] The medical tubular body transport device according to [13], wherein the traction member is connected to the outer surface of the tubular low-rigidity member.
[15] The medical tubular body transport device according to any one of [1] to [14], wherein the inner tube is a device through which a guide wire is inserted into a lumen.
[16] The medical tubular according to any one of [1] to [15], wherein at least the proximal end of the outer tube, the inner tube, and the traction member have a protective tube disposed in the lumen. Body transport device.
[17] The medical tubular body transport device according to any one of [1] to [16], wherein the medical tubular body is a self-expandable stent.
　本発明の医療用管状体搬送装置は、外側チューブの近位端部に、該外側チューブの剛性よりも低い剛性の筒状低剛性部材を配置しているため、医療用管状体が内腔に配置されている外側チューブの近位端付近を曲げた状態で外側チューブに接続されている牽引部材を近位側に引くと、外側チューブよりも筒状低剛性部材の方が優先的に大きく変形し、外側チューブと牽引部材との間にかかる応力は牽引部材と筒状低剛性部材との接触区間で分散されるため、牽引部材が外側チューブから外れにくくなる。また、外側チューブの近位端に、該外側チューブの剛性よりも低い剛性の筒状低剛性部材を配置しているため、屈曲する内側チューブに対する外側チューブの追従性を高めることができ、外側チューブと内側チューブとの間に生じる摩擦抵抗が大きくなることを防止できる。その結果、外側チューブを近位側に容易に引くことができる。 In the medical tubular body transport device of the present invention, a tubular low-rigidity member having a rigidity lower than the rigidity of the outer tube is arranged at the proximal end of the outer tube, so that the medical tubular body is placed in the lumen. When the traction member connected to the outer tube is pulled to the proximal side with the vicinity of the proximal end of the arranged outer tube bent, the tubular low-rigidity member is preferentially deformed more than the outer tube. However, since the stress applied between the outer tube and the traction member is dispersed in the contact section between the traction member and the tubular low-rigidity member, the traction member is less likely to come off from the outer tube. Further, since a tubular low-rigidity member having a rigidity lower than the rigidity of the outer tube is arranged at the proximal end of the outer tube, the followability of the outer tube to the bending inner tube can be improved, and the outer tube can be improved. It is possible to prevent an increase in the frictional resistance generated between the inner tube and the inner tube. As a result, the outer tube can be easily pulled proximally.
図１は、従来の医療用管状体搬送装置における遠位側の実施形態の一例を示す断面図である。FIG. 1 is a cross-sectional view showing an example of a distal embodiment of a conventional medical tubular body transport device. 図２は、本発明に係る医療用管状体搬送装置の第１実施形態を示す断面図である。FIG. 2 is a cross-sectional view showing a first embodiment of the medical tubular body transport device according to the present invention. 図３は、図２に示した外側チューブと牽引部材との接続位置付近を拡大した図である。FIG. 3 is an enlarged view of the vicinity of the connection position between the outer tube and the traction member shown in FIG. 図４は、本発明に係る医療用管状体搬送装置の第２実施形態を示す断面図であり、外側チューブと牽引部材との接続位置付近を拡大して示した図である。FIG. 4 is a cross-sectional view showing a second embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the vicinity of the connection position between the outer tube and the traction member. 図５は、本発明に係る医療用管状体搬送装置の第３実施形態を示す断面図であり、外側チューブと牽引部材との接続位置付近を拡大して示した図である。FIG. 5 is a cross-sectional view showing a third embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the vicinity of the connection position between the outer tube and the traction member. 図６は、本発明に係る医療用管状体搬送装置の第４実施形態を示す断面図であり、外側チューブと牽引部材との接続位置付近を拡大して示した図である。FIG. 6 is a cross-sectional view showing a fourth embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the vicinity of the connection position between the outer tube and the traction member. 図７は、本発明に係る医療用管状体搬送装置の第５実施形態を示す断面図であり、外側チューブと牽引部材との接続位置付近を拡大して示した図である。FIG. 7 is a cross-sectional view showing a fifth embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the vicinity of the connection position between the outer tube and the traction member. 図８は、本発明に係る医療用管状体搬送装置の第６実施形態を示す断面図であり、外側チューブと牽引部材との接続位置付近を拡大して示した図である。FIG. 8 is a cross-sectional view showing a sixth embodiment of the medical tubular body transport device according to the present invention, and is an enlarged view showing the vicinity of the connection position between the outer tube and the traction member. 図９は、押し込み荷重を測定する装置を示した模式図である。FIG. 9 is a schematic view showing a device for measuring a pushing load.
　本発明に係る医療用管状体搬送装置は、医療用管状体を体内に搬送する装置であり、前記医療用管状体が内腔に配置されている外側チューブと、前記外側チューブに接続されており近位側に延伸している牽引部材と、前記外側チューブの内腔に配置されている内側チューブと、前記外側チューブの近位端部に配置されており該外側チューブの剛性よりも低い剛性の筒状低剛性部材を有する点に特徴がある。 The medical tubular body transport device according to the present invention is a device for transporting a medical tubular body into the body, and is connected to an outer tube in which the medical tubular body is arranged in a lumen and the outer tube. A traction member extending proximally, an inner tube located in the lumen of the outer tube, and a stiffness lower than that of the outer tube located at the proximal end of the outer tube. It is characterized by having a tubular low-rigidity member.
　外側チューブの近位端部に、該外側チューブの剛性よりも低い剛性の筒状低剛性部材を配置しているため、外側チューブの近位端付近を曲げた状態で外側チューブに接続されている牽引部材を近位側に引くと、外側チューブよりも筒状低剛性部材の方が優先的に大きく変形し、外側チューブと牽引部材との間にかかる応力は牽引部材と筒状低剛性部材との接触区間で分散されるため、牽引部材が外側チューブから外れにくくなる。また、外側チューブの近位端に、該外側チューブの剛性よりも低い剛性の筒状低剛性部材を配置することによって、外側チューブの内腔に配置されている内側チューブが屈曲しても内側チューブに対する外側チューブの追従性を高めることができる。即ち、応力に対して外側チューブよりも筒状低剛性部材の方が変形しやすいため、応力が加わって内側チューブが屈曲すると外側チューブよりも筒状低剛性部材の方が先に変形し、内側チューブの屈曲に追従しやすくなる。しかも牽引部材と筒状低剛性部材が接触していることにより牽引部材と外側チューブとの接続部分にかかる引張応力が分散されるため、牽引部材を近位側に引っ張っても外側チューブの近位端と内側チューブは接触しにくくなる。その結果、牽引部材を近位側に引っ張っても外側チューブと内側チューブとの間に生じる摩擦抵抗が大きくならないため、外側チューブを近位側に容易に引くことができる。よって医療用管状体搬送装置の操作性が低下せず、医療用管状体搬送装置から医療用管状体を確実に解放できる。 Since a tubular low-rigidity member having a rigidity lower than the rigidity of the outer tube is arranged at the proximal end of the outer tube, the vicinity of the proximal end of the outer tube is bent and connected to the outer tube. When the traction member is pulled to the proximal side, the tubular low-rigidity member is preferentially deformed more than the outer tube, and the stress applied between the outer tube and the traction member is applied to the traction member and the tubular low-rigidity member. Since it is dispersed in the contact section of, the traction member is less likely to come off from the outer tube. Further, by arranging a tubular low-rigidity member having a rigidity lower than the rigidity of the outer tube at the proximal end of the outer tube, the inner tube is bent even if the inner tube arranged in the lumen of the outer tube is bent. It is possible to improve the followability of the outer tube with respect to. That is, since the tubular low-rigidity member is more easily deformed by stress than the outer tube, when stress is applied and the inner tube bends, the tubular low-rigidity member deforms earlier than the outer tube, and the inner tube is deformed earlier. It becomes easier to follow the bending of the tube. Moreover, since the tensile stress applied to the connection portion between the traction member and the outer tube is dispersed due to the contact between the traction member and the tubular low-rigidity member, even if the traction member is pulled to the proximal side, it is proximal to the outer tube. The end and inner tube are less likely to come into contact. As a result, even if the traction member is pulled to the proximal side, the frictional resistance generated between the outer tube and the inner tube does not increase, so that the outer tube can be easily pulled to the proximal side. Therefore, the operability of the medical tubular body transport device is not deteriorated, and the medical tubular body can be reliably released from the medical tubular body transport device.
　筒状低剛性部材は、例えば、外側チューブに対する押し込み荷重をａ、筒状低剛性部材に対する押し込み荷重をｂとしたとき、荷重ａに対する荷重ｂ（ｂ／ａ）の割合が２０～８５％を満足するものであることが好ましい。荷重ａに対する荷重ｂ（ｂ／ａ）の割合が２０％以上であることにより、牽引部材が近位側に引っ張られても筒状低剛性部材は損傷することなく牽引部材が引っ張られる方向に追随して変形し、牽引部材の離断を防止できる。ｂ／ａの割合は、より好ましくは３０％以上であり、更に好ましくは４０％以上である。一方、荷重ａに対する荷重ｂ（ｂ／ａ）の割合が８５％以下であることにより、牽引部材が引っ張られた方向に筒状低剛性部材が追随して変形するため、外側チューブと牽引部材との接続部分のうち最近位位置にかかる応力を緩和でき、外側チューブから牽引部材が離断することを防止できる。ｂ／ａの割合は、より好ましくは７５％以下であり、更に好ましくは５０％以下である。荷重ａに対する荷重ｂ（ｂ／ａ）の割合の具体的な測定方法は、後述する。 For the tubular low-rigidity member, for example, when the pushing load on the outer tube is a and the pushing load on the tubular low-rigidity member is b, the ratio of the load b (b / a) to the load a satisfies 20 to 85%. It is preferable to do so. Since the ratio of the load b (b / a) to the load a is 20% or more, even if the towing member is pulled to the proximal side, the tubular low-rigidity member follows the direction in which the towing member is pulled without being damaged. It can be deformed and the traction member can be prevented from being cut off. The ratio of b / a is more preferably 30% or more, still more preferably 40% or more. On the other hand, when the ratio of the load b (b / a) to the load a is 85% or less, the tubular low-rigidity member follows and deforms in the direction in which the traction member is pulled. It is possible to relieve the stress applied to the most recent position of the connection portion of the above, and prevent the traction member from disconnecting from the outer tube. The ratio of b / a is more preferably 75% or less, still more preferably 50% or less. A specific method for measuring the ratio of the load b (b / a) to the load a will be described later.
　以下、本発明に係る医療用管状体搬送装置の実施形態の一例について、図面を参照しつつ具体的に説明する。本発明は図示例に限定される訳ではなく、前記および後記の趣旨に適合し得る範囲で変更を加えて実施することも可能であり、それらはいずれも本発明の技術的範囲に包含される。なお、各図面において、便宜上、部材符号等を省略する場合があるが、かかる場合、明細書や他の図面を参照するものとする。また、図面における種々の寸法は、本発明の特徴を理解に資することを優先しているため、実際の寸法とは異なる場合がある。 Hereinafter, an example of the embodiment of the medical tubular body transport device according to the present invention will be specifically described with reference to the drawings. The present invention is not limited to the illustrated examples, and it is possible to carry out modifications to the extent that it can be adapted to the above-mentioned and the purposes described below, and all of them are included in the technical scope of the present invention. .. In each drawing, the member code and the like may be omitted for convenience, but in such a case, the specification and other drawings shall be referred to. In addition, the various dimensions in the drawings may differ from the actual dimensions because priority is given to contributing to the understanding of the features of the present invention.
　筒状低剛性部材は、外側チューブの近位端部に配置されており、例えば、筒状低剛性部材の遠位端部が外側チューブの近位端部を覆っていてもよいし、筒状低剛性部材の遠位端と外側チューブの近位端が当接していてもよい（突き当てされている状態であってもよい）。 The tubular low-rigidity member is located at the proximal end of the outer tube, for example, the distal end of the tubular low-rigidity member may cover the proximal end of the outer tube. The distal end of the low stiffness member and the proximal end of the outer tube may be in contact (or abutted).
　まず、筒状低剛性部材の遠位端部が、外側チューブの近位端部を覆っている実施形態について説明する。 First, an embodiment in which the distal end of the tubular low-rigidity member covers the proximal end of the outer tube will be described.
　図２は、本発明に係る医療用管状体搬送装置における第１実施形態を示す断面図である。なお、図２には、医療用管状体搬送装置の遠位側のみを示した。また、図３は、図２に示した外側チューブ２４と牽引部材２５との接続位置付近を拡大して示した断面図である。図３では、図面に対して左側が医療用管状体搬送装置の遠位側であり、右側が医療用管状体搬送装置の近位側である。 FIG. 2 is a cross-sectional view showing a first embodiment of the medical tubular body transport device according to the present invention. Note that FIG. 2 shows only the distal side of the medical tubular body transport device. Further, FIG. 3 is an enlarged cross-sectional view showing the vicinity of the connection position between the outer tube 24 and the traction member 25 shown in FIG. In FIG. 3, the left side with respect to the drawing is the distal side of the medical tubular body transport device, and the right side is the proximal side of the medical tubular body transport device.
　本発明に係る医療用管状体搬送装置の第１実施形態では、医療用管状体２１が内腔に配置されている外側チューブ２４と、外側チューブ２４に接続されており近位側に延伸している牽引部材２５と、外側チューブ２４の内腔に配置される内側チューブ２３と、外側チューブ２４の近位端部に配置されており該外側チューブ２４の剛性よりも低い剛性の筒状低剛性部材２７を有している。 In the first embodiment of the medical tubular body transport device according to the present invention, the medical tubular body 21 is connected to the outer tube 24 in which the medical tubular body 21 is arranged in the lumen and the outer tube 24 and extends proximally. The traction member 25, the inner tube 23 arranged in the lumen of the outer tube 24, and the tubular low-rigidity member arranged at the proximal end of the outer tube 24 and having a rigidity lower than the rigidity of the outer tube 24. Has 27.
　内側チューブ２３の内腔には、ガイドワイヤ（図示せず）が挿通される。内側チューブ２３の遠位端は、先端チップ２６の内腔に達している。一方、内側チューブ２３の近位端は、医療用管状体搬送装置の近位側（術者の手元側）まで延伸しており、術者の手元の操作を、内側チューブ２３を介して医療用管状体搬送装置の遠位側へ伝えることができる。 A guide wire (not shown) is inserted into the lumen of the inner tube 23. The distal end of the inner tube 23 reaches the lumen of the tip tip 26. On the other hand, the proximal end of the inner tube 23 extends to the proximal side (the operator's hand side) of the medical tubular body transport device, and the operation of the operator's hand is performed for medical use via the inner tube 23. It can be transmitted to the distal side of the tubular body carrier.
　牽引部材２５は、内側チューブ２３に沿って近位側に延伸しており、牽引部材２５を近位側へ引くことにより外側チューブ２４が近位側に引かれ、医療用管状体２１が外側チューブ２４の内腔から体内管腔へ押し出され、解放される。 The traction member 25 extends proximally along the inner tube 23, and by pulling the traction member 25 proximally, the outer tube 24 is pulled proximally and the medical tubular body 21 is the outer tube. It is extruded from the 24 lumens into the internal lumen and released.
　図２、図３に示した医療用管状体搬送装置では、筒状低剛性部材２７の遠位端部が、外側チューブ２４の近位端部と牽引部材２５の遠位端部を覆っており、筒状低剛性部材２７の近位端２７ａは、外側チューブ２４の近位端２４ａより近位側に配置されている。外側チューブ２４の近位端２４ａより筒状低剛性部材２７の近位端２７ａを近位側とすることにより、図２に示すように、外側チューブ２４の近位端付近が曲がった状態で牽引部材２５を近位側に引くと、筒状低剛性部材２７が外側チューブ２４よりも優先的に大きく変形し、筒状低剛性部材２７が緩衝材となり、牽引部材２５は直線化しにくくなる。その結果、牽引部材２５と外側チューブ２４との接続部分のうち最近位位置に応力が集中しにくくなるため、外側チューブ２４から牽引部材２５が離断することを防止できる。 In the medical tubular body transport device shown in FIGS. 2 and 3, the distal end of the tubular low-rigidity member 27 covers the proximal end of the outer tube 24 and the distal end of the traction member 25. The proximal end 27a of the tubular low-rigidity member 27 is arranged proximal to the proximal end 24a of the outer tube 24. By setting the proximal end 27a of the tubular low-rigidity member 27 to the proximal side from the proximal end 24a of the outer tube 24, as shown in FIG. 2, the vicinity of the proximal end of the outer tube 24 is bent and pulled. When the member 25 is pulled to the proximal side, the tubular low-rigidity member 27 is deformed more preferentially than the outer tube 24, the tubular low-rigidity member 27 becomes a cushioning material, and the traction member 25 becomes difficult to straighten. As a result, stress is less likely to be concentrated at the most recent position of the connection portion between the traction member 25 and the outer tube 24, so that the traction member 25 can be prevented from being cut off from the outer tube 24.
　筒状低剛性部材２７の軸方向の長さＬ１に対して、外側チューブ２４の近位端２４ａと筒状低剛性部材２７の近位端２７ａとの距離Ｌ２の比（Ｌ２／Ｌ１）は、０．１～０．７であることが好ましい。比（Ｌ２／Ｌ１）を０．１以上とすることにより、筒状低剛性部材２７による応力緩和効果を有効に発揮させることができる。比（Ｌ２／Ｌ１）は、より好ましくは０．３以上、更に好ましくは０．４以上である。一方、比（Ｌ２／Ｌ１）を０．７以下とすることにより、筒状低剛性部材２７が外側チューブ２４から外れにくくなる。比（Ｌ２／Ｌ１）は、より好ましくは０．６以下、更に好ましくは０．５以下である。 The ratio (L2 / L1) of the distance L2 between the proximal end 24a of the outer tube 24 and the proximal end 27a of the tubular low-rigidity member 27 with respect to the axial length L1 of the tubular low-rigidity member 27 is. It is preferably 0.1 to 0.7. By setting the ratio (L2 / L1) to 0.1 or more, the stress relaxation effect of the tubular low-rigidity member 27 can be effectively exhibited. The ratio (L2 / L1) is more preferably 0.3 or more, still more preferably 0.4 or more. On the other hand, by setting the ratio (L2 / L1) to 0.7 or less, the tubular low-rigidity member 27 is less likely to come off from the outer tube 24. The ratio (L2 / L1) is more preferably 0.6 or less, still more preferably 0.5 or less.
　外側チューブ２４の近位端２４ａと筒状低剛性部材２７の近位端２７ａとの距離Ｌ２、即ち、外側チューブ２４の近位端２４ａよりも近位側に突出している筒状低剛性部材２７の軸方向の長さＬ２は、例えば、３～３０ｍｍであることが好ましく、より好ましくは２５ｍｍ以下、更に好ましくは２０ｍｍ以下である。 The distance L2 between the proximal end 24a of the outer tube 24 and the proximal end 27a of the tubular low-rigidity member 27, that is, the tubular low-rigidity member 27 projecting proximally from the proximal end 24a of the outer tube 24. The axial length L2 of the above is, for example, preferably 3 to 30 mm, more preferably 25 mm or less, still more preferably 20 mm or less.
　図２、図３に示した実施形態において、荷重ａに対する荷重ｂ（ｂ／ａ）の割合を算出する際には、図３に示すように、矢印ａの位置で外側チューブ２４に対する押し込み荷重ａを測定し、矢印ｂの位置で筒状低剛性部材２７に対する押し込み荷重ｂを測定すればよい。即ち、外側チューブ２４に対する押し込み荷重ａは、筒状低剛性部材２７で覆われていない位置で測定し、筒状低剛性部材２７に対する押し込み荷重ｂは、外側チューブ２４を覆っていない位置で測定すればよい。 In the embodiment shown in FIGS. 2 and 3, when calculating the ratio of the load b (b / a) to the load a, as shown in FIG. 3, the pushing load a on the outer tube 24 at the position of the arrow a. , And the pushing load b on the tubular low-rigidity member 27 may be measured at the position of the arrow b. That is, the pushing load a on the outer tube 24 is measured at a position not covered by the tubular low-rigidity member 27, and the pushing load b on the tubular low-rigidity member 27 is measured at a position not covering the outer tube 24. Just do it.
　牽引部材２５の遠位部分は、外側チューブ２４の近位部分に接続されており、例えば、図２に示すように、牽引部材２５の遠位部分と外側チューブ２４の近位部分とを接触させて接着剤等により接続されていてもよいし、牽引部材２５の遠位部分が外側チューブ２４の近位部分に埋め込まれて接続されていてもよい。 The distal portion of the traction member 25 is connected to the proximal portion of the outer tube 24, for example, as shown in FIG. 2, the distal portion of the traction member 25 and the proximal portion of the outer tube 24 are brought into contact with each other. It may be connected by an adhesive or the like, or the distal portion of the traction member 25 may be embedded and connected to the proximal portion of the outer tube 24.
　牽引部材２５の遠位端部の形状は、任意の形状をとることができ、外側チューブ２４との接続強度を高めるために、例えば、円筒状であってもよいし、平板状であってもよい。円筒状の場合は、遠位端から近位側に向かって外径が変化する形状でもよく、例えば、断面形状が真円から楕円に変化してもよい。平板状の場合は、遠位端から近位側に向かって厚み、幅が変化する形状でもよい。さらに、牽引部材２５の遠位端部の外表面に表面処理を施すことで外側チューブ２４との接続強度を高めてもよく、表面処理としては、例えば、梨地状に荒らす処理などが挙げられる。あるいは牽引部材２５の遠位端部を外側チューブ２４の近位部分に巻き付けて固定してもよいし、蛇行形状に変形させてから固定してもよい。 The shape of the distal end portion of the traction member 25 can be any shape, and in order to increase the connection strength with the outer tube 24, for example, it may be cylindrical or flat. good. In the case of a cylindrical shape, the outer diameter may change from the distal end toward the proximal side, and for example, the cross-sectional shape may change from a perfect circle to an ellipse. In the case of a flat plate, the thickness and width may change from the distal end to the proximal side. Further, the outer surface of the distal end portion of the traction member 25 may be surface-treated to increase the connection strength with the outer tube 24, and the surface treatment includes, for example, a satin-like roughening treatment. Alternatively, the distal end portion of the traction member 25 may be wound around the proximal portion of the outer tube 24 and fixed, or may be deformed into a meandering shape and then fixed.
　牽引部材２５の遠位端は、筒状低剛性部材２７の遠位端より遠位側であってもよいが、図３に示すように、牽引部材２５の遠位端は、筒状低剛性部材２７の遠位端より近位側であることが好ましい。 The distal end of the traction member 25 may be distal to the distal end of the tubular low stiffness member 27, but as shown in FIG. 3, the distal end of the traction member 25 has a tubular low rigidity. It is preferably proximal to the distal end of the member 27.
　次に、本発明に係る医療用管状体搬送装置における第２実施形態について説明する。図４は、本発明に係る医療用管状体搬送装置における第２実施形態を示す断面図であり、外側チューブ２４と牽引部材２５との接続位置付近を拡大して示している。他の図面と同一の箇所には同じ符号を付すことにより重複説明を避ける（以下、同じ）。図４では、図面に対して左側が医療用管状体搬送装置の遠位側であり、右側が医療用管状体搬送装置の近位側である。 Next, a second embodiment of the medical tubular body transport device according to the present invention will be described. FIG. 4 is a cross-sectional view showing a second embodiment of the medical tubular body transport device according to the present invention, and shows an enlarged view of the vicinity of the connection position between the outer tube 24 and the traction member 25. Duplicate explanations are avoided by assigning the same reference numerals to the same parts as other drawings (hereinafter, the same). In FIG. 4, the left side with respect to the drawing is the distal side of the medical tubular body transport device, and the right side is the proximal side of the medical tubular body transport device.
　図４に示した第２実施形態では、図３に示した第１実施形態に対し、牽引部材２５を外側チューブ２４の内側に配置している。これにより牽引部材２５が医療用管状体搬送装置の軸位置に近く配置されるため、外側チューブ２４を近位側へ引っ張りやすくなる。なお、牽引部材２５を外側チューブ２４から離断しにくくする観点では、牽引部材２５は、外側チューブ２４の内側に配置するよりも図３に示したように外側チューブ２４の外側に配置することが好ましい。 In the second embodiment shown in FIG. 4, the traction member 25 is arranged inside the outer tube 24 with respect to the first embodiment shown in FIG. As a result, the traction member 25 is arranged close to the axial position of the medical tubular body transport device, so that the outer tube 24 can be easily pulled toward the proximal side. From the viewpoint of making it difficult for the traction member 25 to be separated from the outer tube 24, the traction member 25 may be arranged outside the outer tube 24 as shown in FIG. 3 rather than inside the outer tube 24. preferable.
　次に、本発明に係る医療用管状体搬送装置における第３実施形態について説明する。図５は、本発明に係る医療用管状体搬送装置における第３実施形態を示す断面図であり、外側チューブ２４と牽引部材２５との接続位置付近を拡大して示している。図５では、図面に対して左側が医療用管状体搬送装置の遠位側であり、右側が医療用管状体搬送装置の近位側である。 Next, a third embodiment of the medical tubular body transport device according to the present invention will be described. FIG. 5 is a cross-sectional view showing a third embodiment of the medical tubular body transport device according to the present invention, and shows an enlarged view of the vicinity of the connection position between the outer tube 24 and the traction member 25. In FIG. 5, the left side with respect to the drawing is the distal side of the medical tubular body transport device, and the right side is the proximal side of the medical tubular body transport device.
　図５に示した第３実施形態では、図３に示した第１実施形態に対し、牽引部材２５を外側チューブ２４および筒状低剛性部材２７の外側に配置している。これにより生産効率を高めることができる。なお、牽引部材２５を外側チューブ２４から離断しにくくする観点では、牽引部材２５の遠位端部は、外側チューブ２４および筒状低剛性部材２７の外側に配置するよりも図３に示したように外側チューブ２４と筒状低剛性部材２７との間に配置することが好ましい。 In the third embodiment shown in FIG. 5, the traction member 25 is arranged outside the outer tube 24 and the tubular low-rigidity member 27 with respect to the first embodiment shown in FIG. This makes it possible to increase production efficiency. From the viewpoint of making it difficult for the traction member 25 to be separated from the outer tube 24, the distal end portion of the traction member 25 is shown in FIG. 3 rather than being arranged outside the outer tube 24 and the tubular low-rigidity member 27. As described above, it is preferable to arrange the outer tube 24 between the outer tube 24 and the tubular low-rigidity member 27.
　次に、筒状低剛性部材２７の遠位端と外側チューブ２４の近位端が当接している実施形態について説明する。図６は、本発明に係る医療用管状体搬送装置における第４実施形態を示す断面図であり、外側チューブ２４と牽引部材２５との接続位置付近を拡大して示している。図６では、図面に対して左側が医療用管状体搬送装置の遠位側であり、右側が医療用管状体搬送装置の近位側である。 Next, an embodiment in which the distal end of the tubular low-rigidity member 27 and the proximal end of the outer tube 24 are in contact with each other will be described. FIG. 6 is a cross-sectional view showing a fourth embodiment of the medical tubular body transport device according to the present invention, and shows an enlarged view of the vicinity of the connection position between the outer tube 24 and the traction member 25. In FIG. 6, the left side with respect to the drawing is the distal side of the medical tubular body transport device, and the right side is the proximal side of the medical tubular body transport device.
　図６に示した第４実施形態では、外側チューブ２４の近位端と筒状低剛性部材２７の遠位端が当接している。これにより、外側チューブ２４の近位端付近が曲がった状態で牽引部材２５を近位側に引いても、外側チューブ２４よりも筒状低剛性部材２７の方が牽引部材２５に追随して優先的に大きく変形するため、牽引部材２５は直線化しにくくなる。その結果、牽引部材２５と外側チューブ２４との接続位置に応力が集中しにくくなるため、外側チューブ２４から牽引部材２５が離断することを防止できる。 In the fourth embodiment shown in FIG. 6, the proximal end of the outer tube 24 and the distal end of the tubular low-rigidity member 27 are in contact with each other. As a result, even if the traction member 25 is pulled to the proximal side in a state where the vicinity of the proximal end of the outer tube 24 is bent, the tubular low-rigidity member 27 follows the traction member 25 and takes precedence over the outer tube 24. The traction member 25 is difficult to straighten because it is greatly deformed. As a result, stress is less likely to be concentrated at the connection position between the traction member 25 and the outer tube 24, so that the traction member 25 can be prevented from being cut off from the outer tube 24.
　筒状低剛性部材２７の遠位端と外側チューブ２４の近位端とを当接させる場合における筒状低剛性部材２７の長手方向の長さは、例えば、３～２５ｍｍであることが好ましく、より好ましくは４ｍｍ以上であり、より好ましくは２０ｍｍ以下、更に好ましくは１５ｍｍ以下である。 When the distal end of the tubular low-rigidity member 27 and the proximal end of the outer tube 24 are brought into contact with each other, the length of the tubular low-rigidity member 27 in the longitudinal direction is preferably, for example, 3 to 25 mm. It is more preferably 4 mm or more, more preferably 20 mm or less, still more preferably 15 mm or less.
　次に、本発明に係る医療用管状体搬送装置における第５実施形態について説明する。図７は、本発明に係る医療用管状体搬送装置における第５実施形態を示す断面図であり、外側チューブ２４と牽引部材２５との接続位置付近を拡大して示している。図７では、図面に対して左側が医療用管状体搬送装置の遠位側であり、右側が医療用管状体搬送装置の近位側である。 Next, a fifth embodiment of the medical tubular body transport device according to the present invention will be described. FIG. 7 is a cross-sectional view showing a fifth embodiment of the medical tubular body transport device according to the present invention, and shows an enlarged view of the vicinity of the connection position between the outer tube 24 and the traction member 25. In FIG. 7, the left side with respect to the drawing is the distal side of the medical tubular body transport device, and the right side is the proximal side of the medical tubular body transport device.
　図７に示した第５実施形態では、図６に示した第４実施形態に対し、牽引部材２５を外側チューブ２４および筒状低剛性部材２７の内側に配置している。牽引部材２５を外側チューブ２４および筒状低剛性部材２７の内側に配置することによって、牽引部材２５が医療用管状体搬送装置の軸位置に近く配置されるため、外側チューブ２４を近位側へ引っ張りやすくなる。なお、牽引部材２５を外側チューブ２４から離断しにくくする観点では、牽引部材２５は、外側チューブ２４および筒状低剛性部材２７の内側に配置するよりも図３に示したように外側チューブ２４および筒状低剛性部材２７の外側に配置することが好ましい。 In the fifth embodiment shown in FIG. 7, the traction member 25 is arranged inside the outer tube 24 and the tubular low-rigidity member 27 with respect to the fourth embodiment shown in FIG. By arranging the traction member 25 inside the outer tube 24 and the tubular low-rigidity member 27, the traction member 25 is arranged close to the axial position of the medical tubular body transport device, so that the outer tube 24 is moved to the proximal side. It becomes easy to pull. From the viewpoint of making it difficult for the traction member 25 to be separated from the outer tube 24, the traction member 25 is the outer tube 24 as shown in FIG. 3 rather than being arranged inside the outer tube 24 and the tubular low-rigidity member 27. And it is preferable to arrange it on the outside of the tubular low-rigidity member 27.
　筒状低剛性部材２７の遠位端と外側チューブ２４の近位端とを当接させる場合は、筒状低剛性部材２７と外側チューブ２４の当接部は、相溶していないことが好ましい。これにより当接部に応力が集中することを防止できる。 When the distal end of the tubular low-rigidity member 27 and the proximal end of the outer tube 24 are brought into contact with each other, it is preferable that the contact portion between the tubular low-rigidity member 27 and the outer tube 24 is not compatible with each other. .. This makes it possible to prevent stress from concentrating on the contact portion.
　図６、図７に示した実施形態において、荷重ａに対する荷重ｂ（ｂ／ａ）の割合を算出する際には、図６、図７に示すように、矢印ａの位置で外側チューブ２４に対する押し込み荷重ａを測定し、矢印ｂの位置で筒状低剛性部材２７に対する押し込み荷重ｂを測定すればよい。 In the embodiment shown in FIGS. 6 and 7, when calculating the ratio of the load b (b / a) to the load a, as shown in FIGS. 6 and 7, the position of the arrow a is relative to the outer tube 24. The pushing load a may be measured, and the pushing load b on the tubular low-rigidity member 27 may be measured at the position of the arrow b.
　次に、本発明に係る医療用管状体搬送装置における第６実施形態について説明する。図８は、本発明に係る医療用管状体搬送装置における第６実施形態を示す断面図であり、外側チューブ２４と牽引部材２５との接続位置付近を拡大して示している。図８では、図面に対して左側が医療用管状体搬送装置の遠位側であり、右側が医療用管状体搬送装置の近位側である。 Next, a sixth embodiment of the medical tubular body transport device according to the present invention will be described. FIG. 8 is a cross-sectional view showing a sixth embodiment of the medical tubular body transport device according to the present invention, and shows an enlarged view of the vicinity of the connection position between the outer tube 24 and the traction member 25. In FIG. 8, the left side with respect to the drawing is the distal side of the medical tubular body transport device, and the right side is the proximal side of the medical tubular body transport device.
　図８に示した第６実施形態では、図６に示した第４実施形態に対し、外側チューブ２４の近位端部と牽引部材２５の少なくとも一部を覆う筒状部材２８を配置している。これにより牽引部材２５が外側チューブ２４から離断しにくくなる。 In the sixth embodiment shown in FIG. 8, a tubular member 28 that covers at least a part of the proximal end portion of the outer tube 24 and the traction member 25 is arranged with respect to the fourth embodiment shown in FIG. .. This makes it difficult for the towing member 25 to separate from the outer tube 24.
　筒状低剛性部材２７の近位端２７ａは、筒状部材２８の近位端２８ａよりも遠位側であってもよいが、図８に示すように、筒状低剛性部材２７の近位端２７ａは、筒状部材２８の近位端２８ａよりも近位側であることが好ましい。筒状部材２８の近位端２８ａが、筒状低剛性部材２７の近位端２７ａよりも遠位側となるように筒状部材２８を配置することにより、牽引部材２５が筒状部材２８と筒状低剛性部材２７の間に挟まれるため、牽引部材２５が医療用管状体搬送装置の軸に対して外側方向に引っ張られても内側方向に引っ張られても牽引部材２５が外側チューブ２４から離断しにくくなる。また、このような構成により、牽引部材２５を牽引して外側チューブ２４を近位側に移動させる際に、筒状低剛性部材２７の近位端部と内側チューブ２３との間で生じる摩擦抵抗を低減でき、医療用管状体を展開するときの操作荷重を抑制できる。 The proximal end 27a of the tubular low-rigidity member 27 may be distal to the proximal end 28a of the tubular member 28, but as shown in FIG. 8, proximal to the tubular low-rigidity member 27. The end 27a is preferably proximal to the proximal end 28a of the tubular member 28. By arranging the tubular member 28 so that the proximal end 28a of the tubular member 28 is on the distal side of the proximal end 27a of the tubular low-rigidity member 27, the traction member 25 becomes the tubular member 28. Since it is sandwiched between the tubular low-rigidity members 27, the traction member 25 is pulled from the outer tube 24 regardless of whether the traction member 25 is pulled outward or inward with respect to the axis of the medical tubular body transport device. It becomes difficult to disconnect. Further, with such a configuration, when the traction member 25 is towed to move the outer tube 24 to the proximal side, the frictional resistance generated between the proximal end of the tubular low-rigidity member 27 and the inner tube 23. Can be reduced, and the operating load when deploying the medical tubular body can be suppressed.
　牽引部材２５の遠位端は、筒状部材２８の遠位端より遠位側であってもよいが、牽引部材２５を外側チューブ２４から離断しにくくする観点では、図８に示すように、牽引部材２５の遠位端は、筒状部材２８の遠位端より近位側であることが好ましい。 The distal end of the traction member 25 may be distal to the distal end of the tubular member 28, but as shown in FIG. 8 from the viewpoint of making it difficult for the traction member 25 to be separated from the outer tube 24. The distal end of the traction member 25 is preferably proximal to the distal end of the tubular member 28.
　筒状部材２８の剛性は、外側チューブ２４の剛性よりも低いことが好ましい。これにより外側チューブ２４の近位端付近が曲がった状態で牽引部材２５を近位側に引いたときに牽引部材２５に追随して外側チューブ２４よりも筒状部材２８の方が大きく変形するため、牽引部材２５は直線化しにくくなる。その結果、牽引部材２５と外側チューブ２４との接続部分における近位端に応力が集中しにくくなるため、外側チューブ２４から牽引部材２５が離断することを防止できる。また、このような構成により、牽引部材２５を牽引して外側チューブ２４を近位側に移動させる際に、筒状低剛性部材２７の近位端部と内側チューブ２３との間で生じる摩擦抵抗を低減することができ、医療用管状体を展開するときの操作荷重を抑制できる。 The rigidity of the tubular member 28 is preferably lower than the rigidity of the outer tube 24. As a result, when the traction member 25 is pulled to the proximal side in a state where the vicinity of the proximal end of the outer tube 24 is bent, the tubular member 28 follows the traction member 25 and deforms more than the outer tube 24. , The traction member 25 is difficult to straighten. As a result, stress is less likely to concentrate at the proximal end of the connection portion between the traction member 25 and the outer tube 24, so that the traction member 25 can be prevented from being cut off from the outer tube 24. Further, with such a configuration, when the traction member 25 is towed to move the outer tube 24 to the proximal side, the frictional resistance generated between the proximal end of the tubular low-rigidity member 27 and the inner tube 23. Can be reduced, and the operating load when deploying the medical tubular body can be suppressed.
　また、筒状部材２８の剛性は、筒状低剛性部材２７の剛性と同じでよいが、筒状部材２８の剛性は、筒状低剛性部材２７の剛性よりも高いことが好ましい。即ち、筒状部材２８の剛性は、外側チューブ２４の剛性より低く、筒状低剛性部材２７の剛性より高いことが好ましい。このような構成により、外側チューブ２４の近位部分から筒状低剛性部材２７の近位端２７ａまでの剛性を連続的に低減させることができ、牽引部材２５を外側チューブ２４の半径方向外側に引き上げても、筒状部材２８または筒状低剛性部材２７が優先的に屈曲して、外側チューブ２４からの離断の発生をより一層抑制することが可能となる。 Further, the rigidity of the tubular member 28 may be the same as the rigidity of the tubular low-rigidity member 27, but the rigidity of the tubular member 28 is preferably higher than the rigidity of the tubular low-rigidity member 27. That is, the rigidity of the tubular member 28 is preferably lower than the rigidity of the outer tube 24 and higher than the rigidity of the tubular low-rigidity member 27. With such a configuration, the rigidity from the proximal portion of the outer tube 24 to the proximal end 27a of the tubular low-rigidity member 27 can be continuously reduced, and the traction member 25 is moved outward in the radial direction of the outer tube 24. Even if the member is pulled up, the cylindrical member 28 or the tubular low-rigidity member 27 is preferentially bent, and it is possible to further suppress the occurrence of disconnection from the outer tube 24.
　筒状部材２８は、外側チューブに対する押し込み荷重をａ、筒状部材２８に対する押し込み荷重をｃとしたとき、荷重ａに対する荷重ｃ（ｃ／ａ）の割合が３５～９０％を満足するものであることが好ましい。荷重ａに対する荷重ｃ（ｃ／ａ）の割合が３５％以上であることにより、牽引部材２５が近位側に引っ張られたときに筒状部材２８が損傷することなく、牽引部材２５の引張方向に追随して変形するため、引張応力が分散し、牽引部材２５が外側チューブ２４から離断しにくくなる。ｃ／ａの割合は、より好ましくは４０％以上、更に好ましくは７０％以上である。一方、荷重ａに対する荷重ｃ（ｃ／ａ）の割合が９０％以下であることにより、牽引部材２５が引っ張られた方向に筒状部材２８が追随して変形しやすくなるため、外側チューブ２４と牽引部材２５との接続部分のうち近位端に応力が集中するのを防止でき、外側チューブ２４から牽引部材２５が離断しにくくなる。ｃ／ａの割合は、より好ましくは８８％以下である。荷重ａに対する荷重ｃ（ｃ／ａ）の割合の具体的な測定方法は、後述する。 The tubular member 28 satisfies a ratio of the load c (c / a) to the load a of 35 to 90%, where a is the pushing load on the outer tube and c is the pushing load on the tubular member 28. Is preferable. Since the ratio of the load c (c / a) to the load a is 35% or more, the tubular member 28 is not damaged when the traction member 25 is pulled to the proximal side, and the pulling direction of the traction member 25 is not damaged. Since the deformation follows, the tensile stress is dispersed and the traction member 25 is less likely to be separated from the outer tube 24. The ratio of c / a is more preferably 40% or more, still more preferably 70% or more. On the other hand, since the ratio of the load c (c / a) to the load a is 90% or less, the tubular member 28 follows the direction in which the towing member 25 is pulled and is easily deformed. It is possible to prevent stress from concentrating on the proximal end of the connection portion with the traction member 25, and it becomes difficult for the traction member 25 to be separated from the outer tube 24. The ratio of c / a is more preferably 88% or less. A specific method for measuring the ratio of the load c (c / a) to the load a will be described later.
　図８に示した第６実施形態において、荷重ａに対する荷重ｃ（ｃ／ａ）の割合を算出する際には、図８に示すように、矢印ａの位置で外側チューブ２４に対する押し込み荷重ａを測定し、矢印ｃの位置で筒状部材２８に対する押し込み荷重ｃを測定すればよい。即ち、外側チューブ２４に対する押し込み荷重ａは、筒状部材２８で覆われていない位置で測定し、筒状部材２８に対する押し込み荷重ｃは、外側チューブ２４を覆っている位置で測定すればよい。 In the sixth embodiment shown in FIG. 8, when calculating the ratio of the load c (c / a) to the load a, as shown in FIG. 8, the pushing load a on the outer tube 24 is applied at the position of the arrow a. It may be measured and the pushing load c on the tubular member 28 may be measured at the position of the arrow c. That is, the pushing load a on the outer tube 24 may be measured at a position not covered by the tubular member 28, and the pushing load c on the tubular member 28 may be measured at a position covering the outer tube 24.
　筒状部材２８と筒状低剛性部材２７は、接着されていることが好ましい。これにより筒状部材２８と筒状低剛性部材２７との間に配置されている牽引部材２５が外側チューブ２４から離断しにくくなる。 It is preferable that the tubular member 28 and the tubular low-rigidity member 27 are adhered to each other. This makes it difficult for the traction member 25 arranged between the cylindrical member 28 and the tubular low-rigidity member 27 to be separated from the outer tube 24.
　筒状部材２８と筒状低剛性部材２７は、例えば、接着剤によって接着されていてもよいし、熱圧着によって接着されていてもよく、熱圧着により接着されていることが好ましい。 The tubular member 28 and the tubular low-rigidity member 27 may be bonded by, for example, an adhesive, may be bonded by thermocompression bonding, and are preferably bonded by thermocompression bonding.
　筒状部材２８と外側チューブ２４は、相溶していてもよいが、相溶していないことが好ましい。相溶していないことにより、筒状部材２８と外側チューブ２４は独立して可動するため、医療用管状体搬送装置の複雑な動きに追随して変形しやすくなる。 The tubular member 28 and the outer tube 24 may be compatible with each other, but it is preferable that the tubular member 28 and the outer tube 24 are not compatible with each other. Since the tubular member 28 and the outer tube 24 can move independently due to the incompatibility, the tubular member 28 and the outer tube 24 are likely to be deformed according to the complicated movement of the medical tubular body transport device.
　牽引部材２５の遠位端部は、筒状部材２８と外側チューブ２４の両方に接着されていることが好ましく、例えば、接着剤によって接着されていてもよいし、熱圧着によって接着されていてもよく、熱圧着によって接着されていることが好ましい。熱圧着の場合、筒状部材２８の内側表面にポリエチレンなどの接着性樹脂を配置することで牽引部材２５の接続強度をより高めることができる。 The distal end of the traction member 25 is preferably bonded to both the tubular member 28 and the outer tube 24, for example, whether it is bonded by an adhesive or by thermocompression bonding. Often, it is preferably bonded by thermocompression bonding. In the case of thermocompression bonding, the connection strength of the traction member 25 can be further increased by arranging an adhesive resin such as polyethylene on the inner surface of the tubular member 28.
　本発明に係る医療用管状体搬送装置においては、牽引部材２５は、外側チューブ２４に加えて、筒状低剛性部材２７にも接続されていることが好ましい。これにより牽引部材２５が外側チューブ２４から離断しにくくなる。また、医療用管状体の展開時に牽引部材２５を近位側に牽引して外側チューブ２４を近位側に移動させる際、牽引部材２５の張力を筒状低剛性部材２７を介して外側チューブ２４に伝達できるため、屈曲形状においてより効率的に牽引張力を外側チューブ２４に伝達することが可能となり、その結果ステント展開操作の荷重を抑制できるようになる。 In the medical tubular body transport device according to the present invention, it is preferable that the traction member 25 is connected to the tubular low-rigidity member 27 in addition to the outer tube 24. This makes it difficult for the towing member 25 to separate from the outer tube 24. Further, when the traction member 25 is pulled to the proximal side and the outer tube 24 is moved to the proximal side at the time of deploying the medical tubular body, the tension of the traction member 25 is applied to the outer tube 24 via the tubular low-rigidity member 27. Therefore, the traction tension can be transmitted to the outer tube 24 more efficiently in the bent shape, and as a result, the load of the stent deployment operation can be suppressed.
　牽引部材２５と筒状低剛性部材２７は、例えば、接着剤によって接着されていてもよいし、筒状低剛性部材２７が一部溶融することによる熱圧着によって接着されていてもよく、熱圧着により接着されていることが好ましい。 The traction member 25 and the tubular low-rigidity member 27 may be bonded to each other by, for example, an adhesive, or the tubular low-rigidity member 27 may be bonded by thermocompression bonding due to partial melting. It is preferable that they are adhered to each other.
　本発明に係る医療用管状体搬送装置において、牽引部材２５が筒状低剛性部材２７に接続されている場合は、牽引部材２５は、筒状低剛性部材２７の外表面に接続されていることが好ましい。牽引部材２５が筒状低剛性部材２７の外表面に接続されていることによって製造しやすくなる。 In the medical tubular body transport device according to the present invention, when the traction member 25 is connected to the tubular low-rigidity member 27, the traction member 25 is connected to the outer surface of the tubular low-rigidity member 27. Is preferable. The traction member 25 is connected to the outer surface of the tubular low-rigidity member 27, which facilitates manufacturing.
　本発明に係る医療用管状体搬送装置においては、外側チューブ２４の少なくとも近位端部、内側チューブ２３、および牽引部材２５が、内腔に配置されている保護チューブを有することが好ましい。保護チューブで覆うことによって外側チューブ２４の少なくとも近位端部、内側チューブ２３、および牽引部材２５をまとめることができるため、医療用管状体搬送装置の操作性が向上する。 In the medical tubular body transport device according to the present invention, it is preferable that at least the proximal end of the outer tube 24, the inner tube 23, and the traction member 25 have a protective tube arranged in the lumen. By covering with the protective tube, at least the proximal end of the outer tube 24, the inner tube 23, and the traction member 25 can be put together, which improves the operability of the medical tubular body transfer device.
　外側チューブ２４および内側チューブ２３の構成材料としては、例えば、ポリエチレン、フッ素樹脂［例えば、ポリテトラフルオロエチレン（ＰＴＦＥ）、テトラフルオロエチレン・パーフルオロアルキルビニルエーテル共重合体（ＰＦＡ）等］、ポリアミド、ポリアミドエラストマー、ポリイミド、ポリウレタン、ポリエステル、シリコーン、ポリエーテルエーテルケトン（ＰＥＥＫ）等の樹脂材料が挙げられる。 Examples of the constituent materials of the outer tube 24 and the inner tube 23 include polyethylene, fluororesin [for example, polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), etc.], polyamide, and polyamide. Examples thereof include resin materials such as elastomer, polyimide, polyurethane, polyester, silicone, and polyetheretherketone (PEEK).
　外側チューブ２４は、単層構造であってもよいし、複層構造であってもよく、複層構造が好ましい。複層構造とすることにより、外側チューブ２４の剛性を筒状低剛性部材２７の剛性よりも容易に高めることができる。複層構造の例としては、例えば、内層がポリイミドであり、外層がポリアミドエラストマーである２層構造が例示できる。 The outer tube 24 may have a single-layer structure or a multi-layer structure, and a multi-layer structure is preferable. By forming the multi-layer structure, the rigidity of the outer tube 24 can be easily increased more than the rigidity of the tubular low-rigidity member 27. As an example of the multi-layer structure, for example, a two-layer structure in which the inner layer is polyimide and the outer layer is a polyamide elastomer can be exemplified.
　筒状低剛性部材２７の構成材料は、筒状低剛性部材２７の剛性が上記外側チューブ２４の剛性よりも低くなるものであれば特に限定されず、上述した樹脂材料を用いることができる。なかでも、ポリアミドエラストマーが好ましい。 The constituent material of the tubular low-rigidity member 27 is not particularly limited as long as the rigidity of the tubular low-rigidity member 27 is lower than the rigidity of the outer tube 24, and the above-mentioned resin material can be used. Of these, polyamide elastomers are preferred.
　筒状低剛性部材２７は、単層構造であってもよいし、複層構造であってもよく、複層構造が好ましい。複層構造とすることにより、筒状低剛性部材２７の内側の滑り性を高めて摺動しやすくすることができる。筒状低剛性部材２７の外層を構成する材料としては、上述した樹脂材料を用いることができ、筒状低剛性部材２７の内層を構成する材料としては、例えば、ポリエチレン、フッ素樹脂［例えば、ポリテトラフルオロエチレン（ＰＴＦＥ）、テトラフルオロエチレン・パーフルオロアルキルビニルエーテル共重合体（ＰＦＡ）等］、などが挙げられる。複層構造の例としては、例えば、内層がポリエチレンであり、外層がポリアミドエラストマーである２層構造が例示できる。 The tubular low-rigidity member 27 may have a single-layer structure or a multi-layer structure, and a multi-layer structure is preferable. By having a multi-layer structure, it is possible to improve the slipperiness inside the tubular low-rigidity member 27 and make it easier to slide. As the material constituting the outer layer of the tubular low-rigidity member 27, the above-mentioned resin material can be used, and as the material constituting the inner layer of the tubular low-rigidity member 27, for example, polyethylene or fluororesin [for example, poly] can be used. Tetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), etc.], and the like. As an example of the multi-layer structure, for example, a two-layer structure in which the inner layer is polyethylene and the outer layer is a polyamide elastomer can be exemplified.
　筒状部材２８の構成材料は、筒状部材２８の剛性が、上記筒状低剛性部材２７の剛性と同じであるか、筒状低剛性部材２７の剛性よりも高くなるものであれば特に限定されず、上述した樹脂材料を用いることができる。なかでもポリアミド系エラストマーが好ましい。 The constituent material of the tubular member 28 is particularly limited as long as the rigidity of the tubular member 28 is the same as the rigidity of the tubular low-rigidity member 27 or is higher than the rigidity of the tubular low-rigidity member 27. However, the above-mentioned resin material can be used. Of these, polyamide-based elastomers are preferable.
　牽引部材２５の構成材料としては、上述した樹脂材料であってもよいが、金属であることが好ましい。金属としては、例えば、チタン、ステンレス鋼、ニッケル・チタン合金などが挙げられる。 The constituent material of the traction member 25 may be the resin material described above, but is preferably a metal. Examples of the metal include titanium, stainless steel, nickel-titanium alloy and the like.
　医療用管状体２１としては、例えば、ステント、ステントグラフト、閉塞具、注入カテーテル、プロテーゼ弁等を用いることができる。中でもステントを用いることが好ましい。ステントとしては、例えば、１本の線状の金属または高分子材料で形成されたコイル状のステント、金属チューブをレーザーによって切り抜いて加工したステント、金属シートをレーザーで切り抜いた後に円筒形状に巻いてレーザー溶接したステント、線状の部材をレーザーによって溶接して組み立てたステント、または、複数の線状金属を織って作ったステントが挙げられる。ステントは、ステントをマウントしたバルーンによって拡張させるバルーン拡張型ステントと、ステントの拡張を抑制する外部部材を取り除くことによって自ら拡張させる自己拡張型ステントに分類される。本発明では、自己拡張型ステントを用いることが好ましい。 As the medical tubular body 21, for example, a stent, a stent graft, an occlusion tool, an injection catheter, a prosthesis valve, or the like can be used. Above all, it is preferable to use a stent. Examples of the stent include a coiled stent made of a single linear metal or polymer material, a stent obtained by cutting out a metal tube with a laser, and a metal sheet cut out with a laser and then wound into a cylindrical shape. Examples include laser-welded stents, laser-welded stents of linear members, and stents made by weaving multiple linear metals. Stents are classified into balloon-expandable stents, which are expanded by a balloon on which the stent is mounted, and self-expandable stents, which are self-expanded by removing an external member that suppresses the expansion of the stent. In the present invention, it is preferable to use a self-expandable stent.
　本願は、２０２０年９月２３日に出願された日本国特許出願第２０２０－１５８６１８号に基づく優先権の利益を主張するものである。上記日本国特許出願第２０２０－１５８６１８号の明細書の全内容が、本願に参考のため援用される。 This application claims the benefit of priority based on Japanese Patent Application No. 2020-158618 filed on September 23, 2020. The entire contents of the specification of Japanese Patent Application No. 2020-158618 are incorporated herein by reference.
　医療用管状体搬送装置の剛性を次の手順で評価した。 The rigidity of the medical tubular body transport device was evaluated by the following procedure.
　本発明では、医療用管状体搬送装置の剛性は、医療用管状体搬送装置に楔形圧子を押し込んだときの押し込み荷重に基づいて評価した。測定装置は、島津製作所製の小型卓上試験機「ＥＺ－ＳＸ」を用いた。図９に、押し込み荷重を測定するために用いた装置の模式図を示す。図９では、図面に対して左側が医療用管状体搬送装置の遠位端、右側が医療用管状体搬送装置の近位端を示している。 In the present invention, the rigidity of the medical tubular body transport device was evaluated based on the pushing load when the wedge-shaped indenter was pushed into the medical tubular body transport device. As the measuring device, a small desktop tester "EZ-SX" manufactured by Shimadzu Corporation was used. FIG. 9 shows a schematic diagram of the device used for measuring the indentation load. In FIG. 9, the left side of the drawing shows the distal end of the medical tubular transport device, and the right side shows the proximal end of the medical tubular transport device.
　図９に示すように、医療用管状体搬送装置３２の遠位端が台座３１の遠位端Ｂよりも遠位側となるように台座３１に取り付け、医療用管状体搬送装置３２の一部を台座３１に挟んで固定する。医療用管状体搬送装置３２を固定している位置Ａから台座３１の遠位端Ｂまでの距離を３０ｍｍとし、台座３１の遠位端Ｂから遠位側に１３ｍｍ離れた位置Ｃに圧子３３を配置する。医療用管状体搬送装置３２に対して圧子３３を垂直下方向に押し込み、このときの荷重（押し込み荷重）を測定する。圧子は、楔形圧子を用い、圧子の押し込み速度は１．０ｍｍ／秒、圧子の押し込み距離は１．２ｍｍとし、１．０ｍｍまで押し込んだ時点での荷重を測定した。 As shown in FIG. 9, a part of the medical tubular body transport device 32 is attached to the pedestal 31 so that the distal end of the medical tubular body transport device 32 is on the distal side of the distal end B of the pedestal 31. Is sandwiched between the pedestals 31 and fixed. The distance from the position A where the medical tubular body transport device 32 is fixed to the distal end B of the pedestal 31 is 30 mm, and the indenter 33 is placed at the position C 13 mm away from the distal end B of the pedestal 31. Deploy. The indenter 33 is pushed vertically downward with respect to the medical tubular body transport device 32, and the load (pushing load) at this time is measured. As the indenter, a wedge-shaped indenter was used, the pushing speed of the indenter was 1.0 mm / sec, the pushing distance of the indenter was 1.2 mm, and the load at the time of pushing to 1.0 mm was measured.
　図８に示した医療用管状体搬送装置３２を作製し、医療用管状体搬送装置３２の剛性を具体的に評価した。医療用管状体搬送装置３２は、外側チューブ２４を構成する材料として内層がポリイミド、外層がポリアミドエラストマー（ＡＲＫＥＭＡ製のＰｅｂａｘ７２３３）を用い、筒状低剛性部材２７を構成する材料として内層が高密度ポリエチレン、外層がポリアミドエラストマー（ＡＲＫＥＭＡ製のＰｅｂａｘ７２３３）を用い、筒状部材２８を構成する材料としてポリアミドエラストマー（ＡＲＫＥＭＡ製のＰｅｂａｘ７２３３）を用い、牽引部材２５を構成する材料としてステンレス鋼（ＳＵＳ３０４）を用いた。 The medical tubular body transport device 32 shown in FIG. 8 was produced, and the rigidity of the medical tubular body transport device 32 was specifically evaluated. In the medical tubular body transport device 32, the inner layer uses polyimide as the material constituting the outer tube 24, the outer layer uses a polyamide elastomer (Pebax 7233 manufactured by ARKEMA), and the inner layer is high-density polyethylene as the material constituting the tubular low-rigidity member 27. , Polyamide elastomer (Pebax7233 manufactured by ARKEMA) was used for the outer layer, polyamide elastomer (Pebax7233 manufactured by ARKEMA) was used as a material constituting the tubular member 28, and stainless steel (SUS304) was used as a material constituting the traction member 25. ..
　図８に示した位置ａにおける押し込み荷重ａ（即ち、外側チューブに対する押し込み荷重ａ）は０．１５Ｎ、位置ｂにおける押し込み荷重ｂ（即ち、筒状低剛性部材に対する押し込み荷重ｂ）は０．０６２Ｎ、位置ｃにおける押し込み荷重ｃ（即ち、筒状部材に対する押し込み荷重ｃ）は０．１３Ｎであった。従って、荷重ａに対する荷重ｂ（ｂ／ａ）の割合は、０．０６２／０．１５×１００＝４１．３％、荷重ａに対する荷重ｃ（ｃ／ａ）の割合は、０．１３／０．１５×１００＝８６．７％であった。 The pushing load a at the position a shown in FIG. 8 (that is, the pushing load a for the outer tube) is 0.15N, and the pushing load b at the position b (that is, the pushing load b for the tubular low-rigidity member) is 0.062N. The pushing load c at the position c (that is, the pushing load c for the tubular member) was 0.13N. Therefore, the ratio of the load b (b / a) to the load a is 0.062 / 0.15 × 100 = 41.3%, and the ratio of the load c (c / a) to the load a is 0.13 / 0. It was .15 × 100 = 86.7%.
　１１、２１　医療用管状体
　１２、２４　外側チューブ
　１３、２３　内側チューブ
　１４　　　　牽引チューブ
　１５、２５　牽引部材
　１６、２６　先端チップ
　２７　　　　筒状低剛性部材
　２８　　　　筒状部材
　３１　　　　台座
　３２　　　　医療用管状体搬送装置
　３３　　　　圧子 11, 21 Medical tubular body 12, 24 Outer tube 13, 23 Inner tube 14 Tow tube 15, 25 Tow member 16, 26 Tip tip 27 Cylindrical low-rigidity member 28 Cylindrical member 31 Pedestal 32 Medical tubular body transport device 33 Indenter

Claims (17)

  1. 　医療用管状体を体内に搬送する装置であって、
    　前記医療用管状体が内腔に配置されている外側チューブと、
    　前記外側チューブに接続されており近位側に延伸している牽引部材と、
    　前記外側チューブの内腔に配置されている内側チューブと、
    　前記外側チューブの近位端部に配置されており該外側チューブの剛性よりも低い剛性の筒状低剛性部材
    　を有することを特徴とする医療用管状体搬送装置。     A device that transports a medical tubular body into the body.
    The outer tube in which the medical tubular body is placed in the lumen, and
    A traction member connected to the outer tube and extending proximally,
    The inner tube located in the lumen of the outer tube and
    A medical tubular body transport device arranged at a proximal end of the outer tube and having a tubular low-rigidity member having a rigidity lower than that of the outer tube.
  2. 　前記外側チューブに対する押し込み荷重をａ、前記筒状低剛性部材に対する押し込み荷重をｂとしたとき、荷重ａに対する荷重ｂ（ｂ／ａ）の割合が２０～８５％である請求項１に記載の医療用管状体搬送装置。 The medical treatment according to claim 1, wherein when the pushing load on the outer tube is a and the pushing load on the tubular low-rigidity member is b, the ratio of the load b (b / a) to the load a is 20 to 85%. For tubular body transfer device.
  3. 　前記筒状低剛性部材は、前記外側チューブの近位端部を覆っている請求項１または２に記載の医療用管状体搬送装置。 The medical tubular body transport device according to claim 1 or 2, wherein the tubular low-rigidity member covers the proximal end of the outer tube.
  4. 　前記筒状低剛性部材の近位端は、前記外側チューブの近位端より近位側である請求項３に記載の医療用管状体搬送装置。 The medical tubular body transport device according to claim 3, wherein the proximal end of the tubular low-rigidity member is proximal to the proximal end of the outer tube.
  5. 　前記筒状低剛性部材の遠位端と前記外側チューブの近位端は当接している請求項１または２に記載の医療用管状体搬送装置。 The medical tubular body transport device according to claim 1 or 2, wherein the distal end of the tubular low-rigidity member and the proximal end of the outer tube are in contact with each other.
  6. 　前記筒状低剛性部材の遠位端と前記外側チューブの近位端の当接部は、相溶していない請求項５に記載の医療用管状体搬送装置。 The medical tubular body transport device according to claim 5, wherein the contact portion between the distal end of the tubular low-rigidity member and the proximal end of the outer tube is not incompatible.
  7. 　前記外側チューブの近位端部と、前記牽引部材の少なくとも一部とを覆う筒状部材を有する請求項５または６に記載の医療用管状体搬送装置。 The medical tubular body transport device according to claim 5 or 6, further comprising a tubular member that covers the proximal end of the outer tube and at least a portion of the traction member.
  8. 　前記筒状部材の剛性は、前記外側チューブの剛性よりも低い請求項７に記載の医療用管状体搬送装置。 The medical tubular body transport device according to claim 7, wherein the rigidity of the tubular member is lower than the rigidity of the outer tube.
  9. 　前記筒状部材の剛性は、前記筒状低剛性部材の剛性よりも高い請求項８に記載の医療用管状体搬送装置。 The medical tubular body transport device according to claim 8, wherein the rigidity of the tubular member is higher than the rigidity of the tubular low-rigidity member.
  10. 　前記外側チューブに対する押し込み荷重をａ、前記筒状部材に対する押し込み荷重をｃとしたとき、荷重ａに対する荷重ｃ（ｃ／ａ）の割合が３５～９０％である請求項７～９のいずれかに記載の医療用管状体搬送装置。 According to any one of claims 7 to 9, when the pushing load on the outer tube is a and the pushing load on the tubular member is c, the ratio of the load c (c / a) to the load a is 35 to 90%. The medical tubular body transport device described.
  11. 　前記筒状低剛性部材の近位端は、前記筒状部材の近位端より近位側である請求項７～１０のいずれかに記載の医療用管状体搬送装置。 The medical tubular body transport device according to any one of claims 7 to 10, wherein the proximal end of the tubular low-rigidity member is on the proximal side of the proximal end of the tubular member.
  12. 　前記牽引部材は、前記外側チューブの外表面に接続されている請求項１～１１のいずれかに記載の医療用管状体搬送装置。 The medical tubular body transport device according to any one of claims 1 to 11, wherein the traction member is connected to the outer surface of the outer tube.
  13. 　前記牽引部材は、前記筒状低剛性部材にも接続されている請求項１～１２のいずれかに記載の医療用管状体搬送装置。 The medical tubular body transport device according to any one of claims 1 to 12, wherein the traction member is also connected to the tubular low-rigidity member.
  14. 　前記牽引部材は、前記筒状低剛性部材の外表面に接続されている請求項１３に記載の医療用管状体搬送装置。 The medical tubular body transport device according to claim 13, wherein the traction member is connected to the outer surface of the tubular low-rigidity member.
  15. 　前記内側チューブは、内腔にガイドワイヤが挿通されるものである請求項１～１４のいずれかに記載の医療用管状体搬送装置。 The medical tubular body transport device according to any one of claims 1 to 14, wherein the inner tube is a device through which a guide wire is inserted into a lumen.
  16. 　前記外側チューブの少なくとも近位端部、前記内側チューブ、および前記牽引部材が、内腔に配置されている保護チューブを有する請求項１～１５のいずれかに記載の医療用管状体搬送装置。 The medical tubular body transport device according to any one of claims 1 to 15, wherein at least the proximal end of the outer tube, the inner tube, and the traction member have a protective tube arranged in a lumen.
  17. 　前記医療用管状体は、自己拡張型ステントである請求項１～１６のいずれかに記載の医療用管状体搬送装置。 The medical tubular body transport device according to any one of claims 1 to 16, wherein the medical tubular body is a self-expandable stent.
PCT/JP2021/022557 2020-09-23 2021-06-14 Medical tubular object conveyance device WO2022064789A1 (en)

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Citations (3)

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WO2011016386A1 (en) * 2009-08-03 2011-02-10 テルモ株式会社 Stent delivery system
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Publication number Priority date Publication date Assignee Title
US20120083869A1 (en) * 2009-04-07 2012-04-05 C. R. Bard, Inc. Delivery system for a prosthesis
WO2011016386A1 (en) * 2009-08-03 2011-02-10 テルモ株式会社 Stent delivery system
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