WO2014203343A1 - Dispositif médical et procédé de fabrication du dispositif médical - Google Patents

Dispositif médical et procédé de fabrication du dispositif médical Download PDF

Info

Publication number
WO2014203343A1
WO2014203343A1 PCT/JP2013/066815 JP2013066815W WO2014203343A1 WO 2014203343 A1 WO2014203343 A1 WO 2014203343A1 JP 2013066815 W JP2013066815 W JP 2013066815W WO 2014203343 A1 WO2014203343 A1 WO 2014203343A1
Authority
WO
WIPO (PCT)
Prior art keywords
lumen
hollow tube
medical device
sub
operation line
Prior art date
Application number
PCT/JP2013/066815
Other languages
English (en)
Japanese (ja)
Inventor
兼政　賢一
Original Assignee
住友ベークライト株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 住友ベークライト株式会社 filed Critical 住友ベークライト株式会社
Priority to PCT/JP2013/066815 priority Critical patent/WO2014203343A1/fr
Publication of WO2014203343A1 publication Critical patent/WO2014203343A1/fr

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0136—Handles therefor

Definitions

  • the present invention relates to a medical device and a method for manufacturing the medical device.
  • catheters have been provided that can be manipulated in the direction of entry into a body cavity by bending the distal end.
  • two wire lumens (sublumens) having a smaller diameter are provided around the central lumen (main lumen) so as to face each other by 180 degrees, and a deflection wire is provided inside the sublumen.
  • a catheter through which is inserted is described. In this catheter, the tip of the catheter is bent by operating the deflection wire.
  • Patent Document 1 has the following room for improvement.
  • the deflection wire that is the operation line is operated with the catheter bent, it may be difficult to operate the operation line. Since the operation line can be easily operated with the catheter bent, the inner diameter of the circular wire lumen (sublumume) needs to be larger than the diameter of the operation line. As a result, the diameter of the catheter is increased.
  • the catheter was demonstrated and demonstrated here, the same subject is a subject which arises not only in a catheter but in the medical device which operates with an operation line.
  • a main body, a tubular body formed around the main lumen and a sub-lumen extending along a longitudinal direction of the main lumen, and the sub-lumen are arranged in the sub-lumen
  • a medical device is provided which is a twisted wire obtained by twisting a plurality of thin wires having a circular cross section orthogonal to each other, and the cross-sectional shape of the sub-lumen orthogonal to the longitudinal direction is a flat shape flat in the circumferential direction of the main lumen.
  • the operation line in the sub-lumen is a stranded wire formed of a plurality of thin wires having a circular cross section or a circular cross section.
  • the cross-sectional shape of the sub-lumen is flat in the circumferential direction of the main lumen. Therefore, in the cross section orthogonal to the longitudinal direction of the main lumen, a space is formed between the peripheral wall of the sub-lumen on the circumferential direction side of the main lumen and the operation line.
  • the manufacturing method of the medical device mentioned above can also be provided. That is, according to the present invention, a hollow tube in which a sub-lumen having a circular shape in a cross section perpendicular to the longitudinal direction is formed, and a core wire is loosely inserted (inserted in a state where there is a sufficient space) inside, a resin Arranging the main body portion and the hollow tube in a radial direction of the main body portion, and heating the main body portion and the hollow tube; It is also possible to provide a method for manufacturing a medical device including a step of pressurizing from the outer peripheral side to make the shape of the cross section of the sublumen flat.
  • a technique for providing a medical device with good operability is provided.
  • FIG. (A) (b) is a figure which shows the cross section orthogonal to the longitudinal direction of the main lumen of a catheter.
  • (A) (b) is sectional drawing of an operation line. It is a side view which shows the whole catheter, and a side view which shows the bending example of a front-end
  • FIG. 1, 2 is a cross-sectional view taken along the II-II direction of FIG.
  • the catheter 100 of the present embodiment is a tubular body in which a main lumen 20 and a sub-lumen 80 (80a, 80b) disposed around the main lumen 20 and extending along the longitudinal direction of the main lumen 20 are formed.
  • the operation line 70 (70a, 70b) has a circular cross section perpendicular to the longitudinal direction, or the operation line 70 (70a, 70b) is composed of a plurality of thin lines having a circular cross section orthogonal to the longitudinal direction. It is a twisted wire.
  • the cross-sectional shape of the sub-lumen 80 (80a, 80b) orthogonal to the longitudinal direction is a flat shape that is flat in the circumferential direction of the main lumen 20.
  • the catheter 100 includes a coat layer 50 and an operation unit 60 in addition to the tubular body 10 and the operation line 70 described above.
  • the tubular main body 10 includes a sheath including an inner layer 11 having a main lumen therein and an outer layer (main body portion) 12 covering the inner layer 11, a reinforcing layer 30, a hollow tube 82, and a marker 40.
  • a distal end DE the distal ends of the sheath 10 and the catheter 100 are referred to as a distal end DE, but the rear end of the sheath 10 is referred to as a proximal end PE, and the rear end of the catheter 100 is referred to as a proximal end CE.
  • the inner layer 11 is a hollow tubular layer, and a main lumen 20 extending along the longitudinal direction of the catheter 100 is formed therein.
  • a fluorine-based thermoplastic polymer material can be used for the inner layer 11. More specifically, polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), perfluoroalkoxy fluororesin (PFA), or the like can be used.
  • PTFE polytetrafluoroethylene
  • PVDF polyvinylidene fluoride
  • PFA perfluoroalkoxy fluororesin
  • the main lumen 20 has a circular cross section perpendicular to the longitudinal direction of the catheter 100.
  • the outer layer 12 is a resin tubular body that covers the inner layer 11.
  • the outer layer 12 is thicker than the inner layer 11 and constitutes the main thickness of the sheath.
  • a thermoplastic polymer is widely used for the outer layer 12. Examples include polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), nylon elastomer, polyurethane (PU), ethylene-vinyl acetate resin (EVA), poly Vinyl chloride (PVC) or polypropylene (PP) can be used.
  • the reinforcing layer 30 surrounds the inner layer 11 and is included in the outer layer 12.
  • This reinforcing layer 30 is a coil layer.
  • the wire material constituting the reinforcing layer 30 in addition to fine metal wires such as stainless steel (SUS) and nickel titanium alloy, fine fiber wires such as PI, PAI, and PET can be used.
  • the cross-sectional shape of the wire material 31 is not specifically limited, A round wire or a flat wire may be sufficient.
  • the sub-lumen 80 through which the operation lines 70 are inserted is formed inside the outer layer 12 and outside the reinforcing layer 30.
  • the hollow tubes 82 (82a, 82b) are embedded in the outer layer 12, and are arranged around the main lumen 20 so that the longitudinal direction thereof is along the longitudinal direction of the main lumen 20.
  • the hollow tube 82 defines the sub-lumen 80.
  • the hollow tube 82 that defines the sublumen 80 is provided along the longitudinal direction of the catheter 100, and although not shown, the proximal end PE side of the sheath 10 is open. The distal end side of the sheath 10 of the hollow tube 82 is closed by the marker 40.
  • the hollow tube 82 is disposed outside the reinforcing layer 30, and the inner side of the reinforcing layer 30, that is, the main lumen 20 protects the operation line 70 (70 a, 70 b) disposed inside the hollow tube 82.
  • a plurality of hollow tubes 82 are provided. Specifically, a plurality of hollow tubes 82 are arranged on the same circumference so as to surround the main lumen 20. In the present embodiment, four hollow tubes 82 are arranged at equal intervals.
  • the operation line 70 is arrange
  • the operation line 70 is not disposed inside the other pair of hollow tubes 82 facing each other across the center of the main lumen 20.
  • the number of the hollow tubes 82 and the sub-lumens 80 is not limited to four, and can be appropriately selected as necessary.
  • the sub-lumen 80 in each hollow tube 82 has a flat shape in which the cross-sectional shape orthogonal to the longitudinal direction of the catheter 100 is flat in the circumferential direction of the main lumen 20. More specifically, in the cross section orthogonal to the longitudinal direction of the catheter 100, the sub-lumen 80 has a length A in the circumferential direction of the main lumen 20 longer than a length B in the radial direction of the main lumen 20. Thereby, the torsional rigidity of the sheath 10 is increased. The torsion of the sheath 10 acts on the hollow tube 82 as a force in the bending direction, and the hollow tube 82 is longer in the bending direction than the hollow tube having a circular cross section.
  • the secondary moment increases and the torsional rigidity of the sheath 10 increases.
  • the length B in the radial direction of the main lumen 20 is preferably 1 to 3 times the predetermined diameter of the operation line 70, and more preferably 1 to 1.5 times. From the viewpoint of preventing the diameter of the catheter 100 from becoming large, 1 to 1.2 times is particularly preferable.
  • the ratio (A / B) between the circumferential length A and the radial length B of the main lumen 20 is preferably 1.2-4. From the viewpoint of operability when the catheter 100 is bent, 1.2 to 2.5 is more preferable. From the viewpoint of improving torsional rigidity, A / B is particularly preferably 1.8 to 2.5.
  • the sub-lumen 80 is curved along the outer shape of the main lumen 20 in a cross section orthogonal to the longitudinal direction of the catheter 100.
  • the inner peripheral edge positioned on the main lumen 20 side and the outer peripheral edge positioned on the outer peripheral side of the sheath 10 are curved in a convex arc shape toward the outer peripheral side of the sheath 10. is doing.
  • the cross section of the sub-lumen 80 has a so-called Magatama, Comma-shaped beads shape.
  • the operation line 70 is loosely inserted in such a subroutine 80.
  • the hollow tube 82 is made of a material different from that of the outer layer 12. By doing in this way, the hollow tube 82 can be comprised with the material whose bending rigidity and tensile elasticity modulus are higher than the outer layer 12.
  • FIG. Examples of the material constituting the hollow tube 82 include materials such as polytetrafluoroethylene (PTFE), perfluoroalkoxy fluororesin (PFA), and tetrafluoroethylene / hexafluoropropylene copolymer (FEP). . It is preferable that any one or more of these materials are the main component. These materials can improve the slidability (slidability) of the operation line and have high heat resistance.
  • PTFE polytetrafluoroethylene
  • PFA perfluoroalkoxy fluororesin
  • FEP tetrafluoroethylene / hexafluoropropylene copolymer
  • any one or more of these materials are the main component. These materials can improve the s
  • the cross-sectional shape of the sub-lumen 80 is not limited to the shape illustrated in FIG. 2, and may be a flat shape that is long and flat in the circumferential direction of the main lumen 20, that is, a shape that is crushed in the radial direction of the main lumen 20. .
  • an oval shape may be used as shown in FIG. 3A, and an elliptical shape may be used as shown in FIG.
  • the operation line 70 is loosely inserted in the sub-lumen 80 and extends along the longitudinal direction of the sub-lumen 80.
  • the operation line 70 may be constituted by a single line, or may be a stranded line constituted by twisting a plurality of thin wires 72 as shown in FIG.
  • the cross section perpendicular to the longitudinal direction has a circular shape.
  • the cross section orthogonal to the longitudinal direction of the thin wire 72 constituting the operation line 70 has a circular shape.
  • the circular shape of the cross section is not limited to a perfect circle.
  • the thin wire 72 is arranged so that each thin wire 72 constituting the outline of the operation wire 70 is inscribed in one circle R in a cross section orthogonal to the longitudinal direction.
  • the number of fine wires constituting one stranded wire is not particularly limited, but is preferably 3 or more.
  • a suitable example of the number of thin wires is three or seven.
  • the number of fine lines is 3, the three fine lines are arranged point-symmetrically in the cross section.
  • the seven fine lines are arranged point-symmetrically in a honeycomb shape in the cross section.
  • the distal end portion 71 (71 a, 71 b) of the operation line 70 (70 a, 70 b) is fixed to the marker 40 at the distal end DE of the sheath 10.
  • the tip portions 71 (71a, 71b) of 70a, 70b) are fixed to the distal end DE.
  • the operation line 70 is slidably inserted into the sub-lumen 80 (80a, 80b).
  • the distal end 15 of the catheter 100 is bent by pulling the proximal end of each operation line 70 (70a, 70b) (see FIG. 5).
  • the curvature and direction of the bent distal end portion 15 change in a plurality of ways depending on selection of the operation line 70 (70a, 70b) to be pulled.
  • polyether ether ketone PEEK
  • polyphenylene sulfide PPS
  • polybutylene terephthalate PBT
  • polymer fiber such as PI or PTFE
  • SUS Corrosion-resistant coated steel wires
  • metal wires such as titanium or titanium alloys
  • PVDF high density polyethylene (HDPE)
  • HDPE high density polyethylene
  • the catheter 100 includes an operation unit 60.
  • the operation unit 60 is provided at the proximal end portion 17 of the catheter 100.
  • a portion between the distal end portion 15 and the proximal end portion 17 is referred to as an intermediate portion 16.
  • the operation unit 60 includes a shaft portion 61 extending in the longitudinal direction of the catheter 100, a slider 64 (64a, 64b) that moves forward and backward in the longitudinal direction of the catheter 100 with respect to the shaft portion 61, and a handle portion that rotates the shaft portion 61 about its axis. 62 and a gripping portion 63 through which the sheath 10 is rotatably inserted. Further, the proximal end portion 17 of the sheath 10 is fixed to the shaft portion 61. Moreover, the handle
  • the operation unit 60 of the present embodiment rotates the distal end portion 15 of the tubular main body (sheath 10).
  • a handle portion 62 as a rotation operation portion for torque-rotating the sheath 10 and a slider 64 as a bending operation portion for bending the sheath 10 are integrally provided.
  • the present invention is not limited to this, and the handle portion 62 and the slider 64 may be provided separately.
  • the proximal end of the first operation line 70 a protrudes from the proximal end portion 17 of the sheath 10 to the proximal end side, and is connected to the slider 64 a of the operation portion 60.
  • the proximal end of the second operation line 70 b is also connected to the slider 64 b of the operation unit 60. Then, by sliding the slider 64a and the slider 64b individually to the proximal end side with respect to the shaft portion 61, the first operation line 70a or the second operation line 70b connected thereto is pulled and the distal end of the sheath 10 is pulled. A tensile force is applied to the end portion 15. As a result, the distal end portion 15 bends toward the pulled operation line 70.
  • a marker 40 is provided at the distal end DE of the sheath 10.
  • the marker 40 is a ring-shaped member made of a material that does not transmit radiation such as X-rays. Specifically, a metal material such as platinum can be used for the marker 40.
  • the marker 40 of this embodiment is provided around the main lumen 20 and inside the outer layer 12.
  • the coat layer 50 constitutes the outermost layer of the catheter 100 and is a hydrophilic layer.
  • a hydrophilic material such as polyvinyl alcohol (PVA) or polyvinyl pyrrolidone can be used.
  • the radius of the main lumen 20 can be about 200 to 300 ⁇ m
  • the thickness of the inner layer 11 can be about 10 to 30 ⁇ m
  • the thickness of the outer layer 12 can be about 100 to 150 ⁇ m
  • the thickness of the reinforcing layer 30 can be 20 to 30 ⁇ m.
  • the radius from the axial center of the catheter 100 to the center of the sublumen 80 can be about 300 to 350 ⁇ m
  • the inner diameter of the sublumen 80 can be about 40 to 100 ⁇ m
  • the thickness of the operation line 70 can be about 30 to 60 ⁇ m.
  • the outermost diameter of the catheter 100 can be about 350 to 450 ⁇ m.
  • the outer diameter of the catheter 100 of this embodiment is less than 1 mm in diameter, and can be inserted into blood vessels such as the celiac artery. Further, the catheter 100 according to the present embodiment is operated freely by pulling the operation line 70 (70a, 70b), so that the catheter 100 can be advanced in a desired direction even in a branching blood vessel, for example. Is possible.
  • the distal end portion 15 of the catheter 100 refers to a predetermined length region including the distal end DE of the catheter 100.
  • the proximal end portion 17 of the catheter 100 refers to a predetermined length region including the proximal end CE of the catheter 100.
  • the intermediate portion 16 refers to a predetermined length region between the distal end portion 15 and the proximal end portion 17. The bending of the catheter 100 means that a part or all of the catheter 100 is bent or bent.
  • the operation line 70 to be pulled is only the first operation line 70a, only the second operation line 70b, or whether the two operation lines 70a and 70b are pulled simultaneously.
  • the curvature of the bent distal end portion 15 changes in a plurality of ways. Thereby, the catheter 100 can be freely entered into a body cavity that branches at various angles.
  • the catheter 100 of the present embodiment can individually pull the proximal ends of the plurality of operation lines 70 (the first operation line 70a or the second operation line 70b).
  • the bending direction can be changed by the operating line 70 to be pulled. Specifically, when the first operation line 70a is pulled as shown in FIGS. 5B and 5C, the first operation line 70a is bent to the side where the first operation line 70a is provided, as shown in FIGS. 5D and 5E. When the second operation line 70b is pulled, the second operation line 70b is bent. Further, the curvature of curvature (the radius of curvature) can be changed by adjusting the pulling amount of each operation line 70 (70a, 70b). Specifically, as shown in FIGS.
  • the catheter 100 bends by operating the operation line 70 as described above.
  • the shape of the blood vessel into which the catheter 100 is inserted may be bent even when the operation line 70 is not operated.
  • the cross-sectional shape of the bent portion of the catheter 100 changes as shown in FIG. 6A shows a cross-sectional view of the catheter 100 that is not bent and is linear
  • FIG. 6B is a cross-sectional view in the bb direction of FIG. 6C.
  • FIG. 3 is a cross-sectional view of the catheter 100 in a bent state.
  • the expansion toward the direction opposite to the main lumen 20 is: This is more noticeable than the expansion toward the main lumen 20 (expansion in the direction of arrow Y2 in FIG. 6B). This is because the reinforcing layer 30 is provided around the main lumen 20, so that the main lumen 20 does not easily expand.
  • the hollow tube 82 inside the bent portion greatly expands in the radial direction of the main lumen 20 substantially perpendicular to the circumferential direction of the main lumen 20, so that the radial direction of the main lumen 20 increases.
  • the distance between the peripheral wall of the sub-lumen 80 and the operation line 70 increases.
  • the expansion of the sheath 10 occurs more significantly in the radial direction substantially orthogonal to the circumferential direction than in the circumferential direction of the main lumen 20 (arrows Y3 and 4 in FIG. 6B) (see FIG. 6).
  • the peripheral wall of the sub-lumen 80 on the circumferential side of the main lumen 20 may slightly approach the operation line 70.
  • the sub-lumen 80 has a flat shape that is flat in the circumferential direction of the main lumen 20, a space can be secured between the operation line 70 and the peripheral wall of the sub-lumen 80 on the circumferential side of the main lumen 20.
  • the cross-sectional shape of the hollow tube 82 becomes a substantially circular shape. Therefore, the operation line 70 in the hollow tube 82 is less likely to come into contact with the hollow tube 82, and the operability of the operation line 70 is improved.
  • the sub-lumen 80 has a flat shape that is flat in the circumferential direction of the main lumen 20. Therefore, when the catheter 100 is not bent (straight state), the diameter of the main lumen 20 of the sub-lumen 80 is The distance between the peripheral wall and the operation line 70 is shortened. Therefore, there is a possibility that the peripheral wall of the main lumen 20 in the radial direction of the sub lumen 80 is likely to come into contact with the operation line 70. However, in a state where the catheter 100 is not bent, a large tension is not applied to the operation line 70, so even if the operation line 70 and the peripheral wall of the sub-lumen 80 come into contact with each other, a large friction is unlikely to occur. Since the operability of the line 70 is not greatly affected, no problem occurs.
  • the sub-lumen 80 having a circular cross section perpendicular to the longitudinal direction is formed, and the hollow tube 82 in which the core wire 90 is loosely inserted is used as the main lumen 20 of the outer layer 12.
  • the outer layer 12 is extruded.
  • a material containing resin constituting the outer layer 12 is extruded around a mandrel (core material) (not shown).
  • the gas is so formed that a long hollow portion (hole) along the longitudinal direction is formed at each position where the sub-lumen 80 is formed by the hollow tube 82 being embedded later.
  • the hollow outer layer 12 can be formed by pulling out the mandrel.
  • the inner layer 11 is also prepared by extrusion molding.
  • a material containing a resin constituting the inner layer 11 may be extruded around a mandrel (core material) M shown in FIG. Thereafter, the coil 31 is placed around the inner layer 11 with the core material M. Therefore, at this stage, the mandrel M is still inserted in the inner layer 11.
  • the hollow tube 82 is also formed by extruding a material containing a resin constituting the hollow tube 82. Extrusion molding is performed while discharging a fluid such as gas to the material of the hollow tube 82 so that a long hollow portion along the longitudinal direction is formed.
  • the hollow tube 82 manufactured in this way has a ring shape with a circular cross section perpendicular to the longitudinal direction.
  • the core wire 90 is inserted into the hollow tube 82.
  • the core wire 90 has a circular cross section perpendicular to the longitudinal direction.
  • the diameter of the core wire 90 is larger than the diameter of the operation wire 70 (the diameter of the circle R in the case of a stranded wire).
  • the hollow tube 82 may be extruded around the core wire 90, the core wire 90 and the hollow tube 82 may be peeled off, and the core wire 90 may be loosely inserted into the hollow tube 82.
  • the core wire 90 By adopting a method of inserting the core wire 90 after forming the portion, the hollow portion of the hollow tube 82 can be surely formed into a desired shape.
  • FIG. 8 shows a cross-sectional view in the VIII-VIII direction of FIG. 8, the coil 31 is omitted.
  • the sub-lumen in the hollow tube 82 has a circular cross section perpendicular to the longitudinal direction. Note that a circular cross section is not limited to a perfect circle.
  • the heat shrinkable tube 91 is contracted by heating, and the outer layer 12, the coil 31, the inner layer 11, and the hollow tube 82 are pressurized from the outside in the radial direction of the inner layer 11. Further, the outer layer 12 is melted by the heating. The heating temperature is higher than the melting temperature of the outer layer 12 and lower than the melting temperature of the inner layer 11 and the hollow tube 82. By this heating, the outer layer 12 and the inner layer 11 are joined by welding. At this time, the material constituting the outer layer 12 encloses the coil 31 and the outer layer 12 is impregnated with the coil. Further, the outer layer 12 and the hollow tube 82 are joined by welding.
  • the outer peripheral surface of the outer layer 12 is substantially circular by tightening the outer peripheral surface of the outer layer 12 with the heat shrinkable tube 91.
  • the hollow tube 82 is crushed in the radial direction of the outer layer 12 by being pressurized in this step, and the cross section perpendicular to the longitudinal direction of the sub-lumen 80 inside the hollow tube 82 is the circumference of the outer layer 12. It becomes a flat shape flat in the direction. Even in a state where the cross section of the hollow tube 82 has a flat shape, it is preferable that the core wire 90 is loosely inserted into the hollow tube 82.
  • the heat shrinkable tube 91 is cut from the outer layer 12 by cutting the heat shrinkable tube 91 and tearing the heat shrinkable tube 91.
  • the operation line 70 is inserted into the hollow tube 82.
  • one end of the operation line 70 is connected to one end of the core wire 90.
  • the core wire 90 and the operation wire 70 are interchanged, and the operation wire 70 is disposed in the hollow tube 82.
  • a marker 40 that is an annular metal member is prepared.
  • fixing of the tip of the operation line 70 to the marker 40 and caulking and fixing of the marker 40 to the periphery of the tip of the outer layer 12 are performed.
  • a member (not shown) serving as an inlet for a chemical solution or the like is connected to the base end portion of the main lumen 20.
  • the mandrel M in the inner layer 11 is pulled out.
  • the mandrel M is pulled out in a state where the mandrel M is reduced in diameter by pulling both ends in the longitudinal direction of the mandrel M.
  • a hollow serving as the main lumen 20 is formed at the center of the inner layer 11.
  • the base end portion of the operation line 70 is connected to the separately created operation unit.
  • the coat layer 50 is formed. From the above, the catheter 100 can be obtained.
  • the effect of this embodiment is demonstrated.
  • the resin constituting the sheath 10 expands in the inner portion of the bent portion, and the cross-sectional shape of the sub-lumen 80 is deformed.
  • the sub-lumen 80 inside the bent portion expands in the radial direction of the main lumen 20 that is substantially orthogonal to the circumferential direction of the main lumen 20.
  • the cross-sectional shape orthogonal to the longitudinal direction of the sub-lumen 80 is a flat shape that is flat in the circumferential direction of the main lumen 20 in advance, and the peripheral wall of the sub-lumen 80 on the circumferential side of the main lumen 20 A large space is formed between the operation line 70 and the operation line 70. Therefore, even if the sub-lumen 80 expands in the radial direction of the main lumen 20 and the peripheral wall of the sub-lumen 80 in the circumferential direction of the main lumen 20 approaches the operation line 70, contact between the inner wall of the sub-lumen 80 and the operation line 70 is maintained. Can be suppressed.
  • the distance between the peripheral wall of the sub-lumen 80 in the radial direction of the main lumen 20 and the operation line 70 is increased.
  • the peripheral wall of the sub-lumen 80 on the circumferential direction side of the main lumen 20 slightly approaches the operation line 70.
  • the distance from the center of the sub-lumen 80 to the peripheral wall of the sub-lumen 80 becomes relatively uniform.
  • the cross-sectional shape of the sub-lumen 80 is a substantially circular shape. Therefore, the operation line 70 in the hollow tube 82 can be freely moved in the sub-lumen 80, and the operability of the operation line 70 is improved.
  • the bent catheter 100 may be bent further in various directions.
  • the operation line 70 in the hollow tube 82 can be freely moved in the sub-lumen 80, which is very useful.
  • FIG. 11 discloses a cross-sectional view orthogonal to the longitudinal direction of the catheter 900 disclosed in Patent Document 1.
  • the catheter 900 has a spaghetti tube 901 that partitions a wire lumen (sublumen), and a deflection wire 902 is inserted into the spaghetti tube 901.
  • a pressurized fluid is supplied into the spaghetti tube 901 at the time of manufacture to prevent the spaghetti tube 901 from collapsing. Therefore, the cross-sectional shape orthogonal to the longitudinal direction of the spaghetti tube 901 is a circle.
  • the cross-sectional shape of the bent portion is as shown in FIG.
  • the resin constituting the catheter 900 expands, the spaghetti tube 901 extends in the radial direction perpendicular to the circumferential direction of the main lumen, and the width in the circumferential direction of the main lumen becomes narrow. Therefore, the turning wire 902 can easily come into contact with the spaghetti tube 901. Therefore, friction is generated between the turning wire 902 and the spaghetti tube 901, and the operability of the turning wire is deteriorated when the catheter is bent. Even if the deflecting wire 902 does not contact the spaghetti tube 901 with the catheter 900 bent, the deflecting wire 902 is difficult to move in the width direction of the spaghetti tube 901. The operability of 902 is deteriorated.
  • the catheter 100 of the present embodiment has good operability of the operation line 70 while keeping the diameter of the catheter 100 small even when the catheter 100 is bent.
  • the hollow tube 82 constituting the sub-lumen 80 is made of a material having a higher tensile elastic modulus and bending rigidity than the outer layer 12.
  • the cross-sectional shape orthogonal to the longitudinal direction of the sub-lumen 80 is a flat shape that is flat in the circumferential direction of the main lumen 20.
  • the cross-sectional shape of the sub-lumen 80 is such that the length in the circumferential direction of the main lumen 20 is long, although the length in the radial direction of the main lumen 20 that is substantially orthogonal to the circumferential direction of the main lumen 20 is short.
  • the rigidity is increased with respect to the force along the circumferential direction of the main lumen 20, specifically, the force that twists the sheath 10, as compared with the case of forming a sub-lumen having a circular cross section as in the past. be able to.
  • the torsional rigidity of the sheath 10 is increased, and the sheath 10 can be prevented from being locally twisted.
  • the sub-lumen 80 is twisted by setting A / B to 1.2 to 4 when the circumferential length of the main lumen 20 is A and the radial length of the main lumen 20 is B. The above-mentioned effect that can be prevented can be exhibited remarkably.
  • an inner peripheral edge located on the main lumen 20 side and an outer peripheral edge located on the sheath outer peripheral side are in addition, the outer surface of the sheath 10 is curved in a convex arc shape.
  • the sub-lumen 80 is partitioned using the hollow tube 82.
  • the circular hollow tube 82 may be crushed in the radial direction of the main lumen 20, so that the flat sub-lumen 80 can be easily formed.
  • the hollow tube 82 is mainly made of a relatively soft material such as polytetrafluoroethylene (PTFE), perfluoroalkoxy fluororesin (PFA), or tetrafluoroethylene / hexafluoropropylene copolymer (FEP). Since the material included as a component is used, the hollow tube 82 can be easily crushed to form a flat-shaped sub-lumen 80.
  • PTFE polytetrafluoroethylene
  • PFA perfluoroalkoxy fluororesin
  • FEP tetrafluoroethylene / hexafluoropropylene copolymer
  • the core wire 90 is disposed in the circular hollow tube 82, and then the hollow tube 82 is crushed into a flat shape. Thereafter, the operation wire 70 having a diameter smaller than that of the core wire 90 is inserted into the hollow tube 82. Thereby, a gap can be reliably formed between the inner wall of the hollow tube 82 having a flat shape and the operation line 70, and the catheter 100 can be easily operated.
  • one of the two operation lines and the two sub-lumens 80 (80a, 80b) is selected as one operation line 70 (the first operation line 70a or the second operation line 70b).
  • the present invention is not limited to this. That is, as described above, three or more operation lines 70 may be inserted into the sheath 10 and then one or two or more of them may be pulled.
  • distal end portions 71 (71a, 71b) of the two operation lines 70 (70a, 70b) are separately fixed to the distal end DE of the sheath 10, but one continuous operation line is used. Then, both ends may be wound around a dial type operation unit, and the towing direction and the amount of towing may be adjusted by operating the dial.
  • the hollow tube 82 is inserted into the hollow portion formed in the outer layer 12 during the manufacturing method of the catheter 100.
  • the present invention is not limited to this.
  • the outer circumferential surface of the outer layer 12 may be cut out to form a groove, and the hollow tube 82 may be inserted into the groove.
  • the core wire 90 in the hollow tube 82 is replaced with the operation line 70 when the catheter 100 is manufactured.
  • the core wire 90 may be used as the operation line.
  • the core wire 90 was inserted,
  • the insertion method of the core wire 90 is not restricted to this.
  • the hollow tube 82 is extruded (coating extrusion) so as to cover the core wire 90, and then both ends of the core wire 90 are pulled to expand the core wire 90 and reduce the diameter. Remove completely.
  • the core wire 90 is loosely inserted into the hollow tube 82.
  • what is necessary is just to insert the hollow tube 82 in the hollow part (or groove
  • the hollow tube 82 is extruded (coating extrusion) so as to cover the core wire 90, and then the hollow portion (or the groove described above) formed in the outer layer 12 as in the above embodiment. Insert into. Next, the both ends of the core wire 90 are pulled, the core wire 90 is extended and reduced in diameter, and the core wire 90 is completely peeled off from the hollow tube. The core wire 90 may be loosely inserted into the hollow tube 82. By doing in this way, the process which inserts the core wire 90 in the hollow tube 82 can be skipped, and the productivity of a catheter can be improved.
  • the cross-sectional shape of the four sub-lumens 80 is a flat shape.
  • the cross-sectional shape of the sub-bloom 80 in which the operation line 70 is not inserted may not be a flat shape, and may be a circular shape. There may be.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Mechanical Engineering (AREA)
  • Physics & Mathematics (AREA)
  • Geometry (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'objectif de la présente invention est de fournir une technologie qui permet d'obtenir un dispositif médical présentant une grande facilité de fonctionnement. Un cathéter (100) comprend : un corps principal tubulaire (10) dans lequel sont formées une lumière principale (20) et une sous-lumière (80) qui est disposée autour de la lumière principale (20) et qui s'étend le long d'une direction longitudinale de la lumière principale (20) ; et une ligne de fonctionnement (70) qui est disposée dans la sous-lumière (80) et dont une extrémité distale est fixée à une extrémité distale du corps principal tubulaire (10). La ligne de fonctionnement (70) est circulaire selon une section transversale orthogonale à la direction longitudinale ou la ligne de fonctionnement (70) est un fil torsadé composé de multiples filaments qui sont circulaires selon une section transversale orthogonale à la direction longitudinale. La forme en coupe transversale de la sous-lumière (80 (80a, 80b)) orthogonale à la direction longitudinale est une forme plate qui est plate selon une direction circonférentielle de la lumière principale (20).
PCT/JP2013/066815 2013-06-19 2013-06-19 Dispositif médical et procédé de fabrication du dispositif médical WO2014203343A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/JP2013/066815 WO2014203343A1 (fr) 2013-06-19 2013-06-19 Dispositif médical et procédé de fabrication du dispositif médical

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2013/066815 WO2014203343A1 (fr) 2013-06-19 2013-06-19 Dispositif médical et procédé de fabrication du dispositif médical

Publications (1)

Publication Number Publication Date
WO2014203343A1 true WO2014203343A1 (fr) 2014-12-24

Family

ID=52104109

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2013/066815 WO2014203343A1 (fr) 2013-06-19 2013-06-19 Dispositif médical et procédé de fabrication du dispositif médical

Country Status (1)

Country Link
WO (1) WO2014203343A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017205662A1 (fr) * 2016-05-26 2017-11-30 Boston Scientific Scimed, Inc. Dispositifs d'articulation
US20180085555A1 (en) * 2016-09-26 2018-03-29 Boston Scientific Scimed, Inc. Injection catheter

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05184528A (ja) * 1992-01-14 1993-07-27 Olympus Optical Co Ltd 可撓管の湾曲機構
JPH08510152A (ja) * 1993-05-10 1996-10-29 インステント インコーポレーテッド ステントデリバリーシステム
JP2000512874A (ja) * 1996-06-17 2000-10-03 ハートポート インコーポレイテッド 多管腔カテーテルおよびその製造方法
JP2004147737A (ja) * 2002-10-29 2004-05-27 Nippon Zeon Co Ltd バルーンカテーテル及びその製造方法
JP2010227486A (ja) * 2009-03-30 2010-10-14 Kawasumi Lab Inc 管状治療具留置装置
JP2010284326A (ja) * 2009-06-11 2010-12-24 Sumitomo Bakelite Co Ltd カテーテルの製造方法
JP2012034801A (ja) * 2010-08-06 2012-02-23 Terumo Corp 吸引カテーテル及び該吸引カテーテルの製造方法
JP2013132432A (ja) * 2011-12-27 2013-07-08 Sumitomo Bakelite Co Ltd 医療機器および医療機器の製造方法

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05184528A (ja) * 1992-01-14 1993-07-27 Olympus Optical Co Ltd 可撓管の湾曲機構
JPH08510152A (ja) * 1993-05-10 1996-10-29 インステント インコーポレーテッド ステントデリバリーシステム
JP2000512874A (ja) * 1996-06-17 2000-10-03 ハートポート インコーポレイテッド 多管腔カテーテルおよびその製造方法
JP2004147737A (ja) * 2002-10-29 2004-05-27 Nippon Zeon Co Ltd バルーンカテーテル及びその製造方法
JP2010227486A (ja) * 2009-03-30 2010-10-14 Kawasumi Lab Inc 管状治療具留置装置
JP2010284326A (ja) * 2009-06-11 2010-12-24 Sumitomo Bakelite Co Ltd カテーテルの製造方法
JP2012034801A (ja) * 2010-08-06 2012-02-23 Terumo Corp 吸引カテーテル及び該吸引カテーテルの製造方法
JP2013132432A (ja) * 2011-12-27 2013-07-08 Sumitomo Bakelite Co Ltd 医療機器および医療機器の製造方法

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017205662A1 (fr) * 2016-05-26 2017-11-30 Boston Scientific Scimed, Inc. Dispositifs d'articulation
US10758709B2 (en) 2016-05-26 2020-09-01 Boston Scientific Scimed, Inc. Articulating devices and methods
US11759610B2 (en) 2016-05-26 2023-09-19 Boston Scientific Scimed, Inc. Articulating devices and methods
US20180085555A1 (en) * 2016-09-26 2018-03-29 Boston Scientific Scimed, Inc. Injection catheter

Similar Documents

Publication Publication Date Title
JP6149855B2 (ja) 医療機器
WO2013146673A1 (fr) Procédé de fabrication d'instrument médical et instrument médical
JP5604974B2 (ja) カテーテル
WO2018097258A1 (fr) Cathéter et procédé de fabrication d'un cathéter
TWI615161B (zh) 醫療用機器、導管及醫療用機器之製造方法
JP5636656B2 (ja) カテーテル
JP5990907B2 (ja) 医療機器および医療機器の製造方法
JP5747449B2 (ja) カテーテル
JP5927974B2 (ja) 医療機器
JP5577902B2 (ja) カテーテル
JP2012213627A (ja) カテーテル
WO2014203343A1 (fr) Dispositif médical et procédé de fabrication du dispositif médical
JP6137380B2 (ja) 医療機器の製造方法
JP2013192692A (ja) 医療用コイル、医療機器および医療用コイルの製造方法
JP6319390B2 (ja) 医療機器および医療機器の製造方法
JP2014018391A (ja) カテーテル
JP5994335B2 (ja) カテーテル
JP2012061070A (ja) カテーテル
JP6792587B2 (ja) 医療機器および医療機器の製造方法
TW201500071A (zh) 醫療機器及醫療機器之製造方法
JP2013192632A (ja) 医療機器の製造方法及び医療機器
JP2013208355A (ja) 医療機器及び医療機器の製造方法
JP2013158588A (ja) 医療用コイル、医療機器および医療用コイルの製造方法
JP2019024919A (ja) カテーテル

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 13887288

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 13887288

Country of ref document: EP

Kind code of ref document: A1