WO2019026220A1 - カテーテル - Google Patents
カテーテル Download PDFInfo
- Publication number
- WO2019026220A1 WO2019026220A1 PCT/JP2017/028140 JP2017028140W WO2019026220A1 WO 2019026220 A1 WO2019026220 A1 WO 2019026220A1 JP 2017028140 W JP2017028140 W JP 2017028140W WO 2019026220 A1 WO2019026220 A1 WO 2019026220A1
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- WO
- WIPO (PCT)
- Prior art keywords
- catheter
- tip
- coil body
- distal end
- tapered portion
- Prior art date
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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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/0069—Tip not integral with tube
-
- 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
- A61M25/001—Forming the tip of a catheter, e.g. bevelling process, join or taper
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
- A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/008—Strength or flexibility characteristics of the catheter tip
Definitions
- the present invention relates to a catheter comprising a catheter shaft and a tip made of resin.
- a coil body which is constituted by a helically wound strand or stranded wire and has a predetermined inner diameter, an inner layer which covers the inner peripheral surface of the coil body and has an axially extending hollow portion, and a coil
- a catheter provided with a catheter shaft having an outer layer covering the outer peripheral surface of the body (see Patent Document 1).
- the catheter is inserted into lumens such as blood vessels, digestive tracts and ureters, and internal tissues such as chest cavity and abdominal cavity, so the distal end (distal end) of the catheter is highly flexible. It is desirable to have. For this reason, a resin tip is joined to the distal end (distal end surface) of the catheter shaft to improve the flexibility of the distal end of the catheter.
- a catheter 601 is shown in FIG. 12 as an example of such a catheter.
- Arrow P indicates the proximal direction and arrow D indicates the distal direction.
- the catheter 601 includes a catheter shaft 620 having a coil body 622, an inner layer 624, and an outer layer 628, and a tip 630 joined to its distal end.
- the tip 630 is provided with a communication hole 632 communicating with the hollow portion 626 of the catheter shaft 620.
- the catheter 601 has a problem that the torque by the operation of the operator is difficult to be transmitted to the tip 630 (in other words, the torque transmission is low). That is, although torque is generally transmitted in the distal direction via the coil body, torque is not transmitted to the tip 630 because the coil body 622 is not disposed in the tip 630 in the catheter 601. Therefore, as shown in FIG. 13, a catheter 701 in which the coil body 722 and the inner layer 724 extend in the axial direction into the tip 730 has been proposed. According to the configuration of the catheter 701, since the torque is transmitted to the tip 730 through the coil body 722, a reduction in torque transmission can be suppressed.
- the tip in the catheter, it is desirable to downsize the tip (typically, to a shape that reduces in diameter in the distal direction) in order to improve the followability.
- the downsize of the chip is performed, for example, by machining the chip.
- the thickness (radial length) of the tip 730 in the portion where the coil body 722 and the inner layer 724 are disposed since the d3 is relatively small, the chip 730 may not be downsized sufficiently.
- the inner layer 724 disposed in the chip 730 is removed, and the diameter of the coil body 722 and the chip 730 in the chip 730 is reduced by a length corresponding to the thickness of the removed inner layer 724. It is conceivable that the chip 730 be downsized. According to this configuration, it is possible to downsize the tip 730 while suppressing a decrease in torque transferability.
- the bonding strength between the catheter shaft and the tip may be reduced. That is, in the catheter 701 shown in FIG. 13, the tip 730 is joined to the distal end 728 a of the outer layer 728 of the catheter shaft 720 and the distal end 724 a of the inner layer 724. On the other hand, in the configuration in which the inner layer 724 is removed to downsize the tip 730, the proximal end of the tip can be bonded only to the distal end of the outer layer of the catheter shaft. For this reason, when a tensile force in the distal direction acts on the tip, the tip may be broken (detached) from the catheter shaft at the junction between the tip and the catheter shaft.
- the present invention is made to address the problems described above. That is, one of the objects of the present invention is to provide a catheter capable of downsizing the tip while suppressing a reduction in torque transmission and further increasing the bonding strength between the tip and the catheter shaft. is there.
- the catheter of the present invention is A coil body comprising a helically wound wire or strand and having a first portion having a first inner diameter, and an axially extending hollow portion covering the inner peripheral surface of the first portion of the coil body
- a catheter shaft having an inner layer having an outer layer, and an outer layer covering an outer peripheral surface of the first portion of the coil body.
- the coil body further includes a tapered portion provided at the distal end of the first portion and reducing in diameter from the first inner diameter to a second inner diameter smaller than the first inner diameter.
- the tapered portion of the coil body is disposed inside the tip, In the tapered portion, a gap is provided between the adjacent strands of wire;
- the chip has an outer layer joint joined to the distal end of the outer layer, and an inner layer joint joined to the distal end of the inner layer, and the outer layer joint and the inner layer joint are It is integrated through the gap.
- the schematic diagram of the catheter which concerns on 1st Embodiment of this invention is shown.
- the sectional view when a part of catheter shaft of a catheter concerning a 1st embodiment of the present invention and a tip are cut by a plane including a central axis.
- Sectional drawing in the III-III line of FIG. 2 is shown.
- Sectional drawing in the IV-IV line of FIG. 2 is shown.
- the sectional view when a part of catheter shaft of a catheter concerning a 2nd embodiment of the present invention and a tip are cut by a plane including a central axis.
- the cross section at the time of cutting a part of catheter shaft of a catheter concerning a modification of a 2nd embodiment of the present invention, and a tip in the plane containing a central axis is shown.
- FIG. 7 The sectional view when a part of catheter shaft of a catheter concerning a 3rd embodiment of the present invention and a tip are cut by a plane including a central axis. Sectional drawing in the VIII-VIII line of FIG. 7 is shown. The cross section at the time of cutting a part of catheter shaft of a catheter concerning modification 1 of a 3rd embodiment of the present invention and a tip in the plane containing a central axis is shown. Sectional drawing in the XX line of FIG. 9 is shown. The cross section at the time of cutting a part of catheter shaft of a catheter concerning modification 2 of a 3rd embodiment of the present invention and a tip in the plane containing a central axis is shown. FIG.
- FIG. 2 shows a cross-sectional view of a portion of a catheter shaft of a conventional catheter and a tip taken along a plane including a central axis.
- FIG. 6 shows a cross-sectional view of a portion of the catheter shaft of another conventional catheter and a tip taken along a plane including the central axis.
- the catheter is a flexible medical device, and is inserted into lumens such as blood vessels, digestive tracts and ureteras, and body tissues such as chest cavity and abdominal cavity, and stents, embolic coils, etc. in the lesion of blood vessels. It is used for the purpose of transporting, injecting a drug solution or a contrast agent, or discharging the body fluid.
- FIG. 1 shows a schematic view of a catheter 1 of the present embodiment.
- the catheter 1 is a catheter for blood vessel insertion.
- the catheter 1 is an elongated member, and includes a connector 10, a catheter shaft 20 and a tip 30.
- the connector 10 is connected to the proximal end of the catheter shaft 20.
- the tip 30 is located at the distal end of the catheter 1.
- the catheter 1 for blood vessel insertion is illustrated in this embodiment, the use of a catheter is not restricted to this, What is necessary is just a catheter provided with the catheter shaft and tip corresponding to the catheter shaft 20 and the tip 30.
- the connector 10 is held and operated by the operator. When the operator operates the connector 10, the torque by the operator is transmitted to the tip 30 through the coil body 22 described later. Further, the connector 10 has a role of a connecting member for connecting various devices (for example, a three-way stopcock, a Y connector, etc.) to the catheter shaft 20.
- various devices for example, a three-way stopcock, a Y connector, etc.
- FIG. 2 shows a cross-sectional view of the distal end of the catheter shaft 20 and the tip 30 cut in a plane including the central axis of the catheter 1
- FIG. 3 shows the catheter in a plane orthogonal to the central axis of the catheter 1.
- FIG. 4 is a cross-sectional view when a portion of the tip 30 where a tapered portion 22 b (described later) is located is cut in a plane perpendicular to the central axis of the catheter 1.
- the catheter shaft 20 has a coil body 22, an inner layer 24 and an outer layer 28.
- the coil body 22 is configured by spirally winding eight metal strands, and the central axis thereof coincides with the central axis of the catheter 1.
- the strand diameter of each strand is constant from one end to the other end of the coil body 22 and equal to one another.
- stainless steel is used as the metal material that constitutes each strand, but the metal material that constitutes the strand is not limited to this, and for example, a Ni-Ti alloy may be used.
- each wire may be comprised with a mutually different metal material.
- the number of strands constituting the coil body 22 is not limited to eight, and may be appropriately determined according to the shape and size of the coil body 22.
- the coil body 22 may be configured using a stranded wire formed by twisting a plurality of strands instead of the strands.
- the coil body 22 has a substantially cylindrical first portion 22 a and a substantially frusto-conical tapered portion 22 b.
- the first portion 22a has a predetermined inner diameter d1.
- the individual strands are wound such that adjacent strands are in contact with each other in the axial direction (see FIG. 2) and the circumferential direction (see FIG. 3). That is, no gap is provided between adjacent strands.
- the tapered portion 22b is provided at the distal end of the first portion 22a, and decreases in diameter in the distal direction from the inner diameter d1 to a predetermined inner diameter d2 smaller than the inner diameter d1.
- the inner diameter d1 corresponds to an example of the "first inner diameter”
- the inner diameter d2 corresponds to an example of the "second inner diameter”.
- the tapered portion 22 b is disposed inside the chip 30 (described later).
- the respective strands are wound so that adjacent strands do not contact each other in the axial direction (see FIG. 2) and the circumferential direction (see FIG. 4). That is, a gap 50 is provided between adjacent strands.
- the tapered portion 22b can be manufactured, for example, as follows. That is, a substantially cylindrical coil body having an inner diameter d1 from the distal end of the first portion 22a and extending in the distal direction along the axial direction is crimped (caulked) radially outward from the outside of the coil body Ru.
- the coil body is formed into a substantially truncated cone shape which is reduced in diameter in the distal direction.
- a distal force is applied to the coil body to form a gap between adjacent strands. Thereafter, the excess coiled body at the distal end is cut off. Thereby, the tapered portion 22b is manufactured.
- the inner diameter of the coil body 22 means the diameter of a cross section (circle) obtained by cutting an imaginary cylindrical member inscribed in the coil body 22 in a plane perpendicular to the axial direction.
- the imaginary cylindrical member inscribed in the first portion 22a has a cylindrical shape
- the imaginary cylindrical member inscribed in the tapered portion 22b has a truncated cone shape.
- the “adjacent strands” are adjacent to each other in the axial direction and the circumferential direction among the plurality of strands. It means two strands of wire.
- "adjacent strands” means "axially adjacent windings" when the winding of one strand of the winding is defined. means.
- the inner layer 24 is made of resin and covers the inner peripheral surface 22 a 1 of the first portion 22 a of the coil body 22 with a predetermined thickness, and at the center in the radial direction, the axial direction And a cylindrical hollow portion 26 extending in the longitudinal direction.
- the inner layer 24 covers the entire inner peripheral surface 22a1 of the first portion 22a so that the first portion 22a of the coil body 22 is not exposed to the hollow portion 26.
- PTFE polytetrafluoroethylene
- the outer layer 28 is made of resin and covers the outer peripheral surface 22a2 of the first portion 22a of the coil body 22 with a predetermined thickness.
- the outer layer 28 covers the entire outer peripheral surface 22a2 of the first portion 22a so that the first portion 22a of the coil body 22 is not exposed to the outside of the outer layer 28.
- a polyamide elastomer is used as a resin material for forming the outer layer 28.
- the resin material for forming the outer layer 28 is not limited to this, and polyamide, polyester or the like is used.
- the chip 30 is made of resin and is provided at the distal end of the first portion 22 a of the coil body 22, the inner layer 24 and the outer layer 28.
- the outer diameter of the tip 30 is substantially constant at the proximal end (the end in the proximal direction P) and substantially equal to the outer diameter at the distal end of the outer layer 28 of the catheter shaft 20.
- tip 30 is diameter-reduced toward the distal direction D, and, thereby, the chip
- the tip 30 has a cylindrical communication hole 32 extending in the axial direction at the center in the radial direction.
- the communication hole 32 communicates with the hollow portion 26 of the inner layer 24 of the catheter shaft 20, and the diameter at the proximal end of the communication hole 32 is substantially equal to the diameter at the distal end of the hollow portion 26.
- the communication hole 32 and the hollow portion 26 are coaxially located, and their central axes coincide with the central axis of the catheter 1.
- the communication hole 32 and the hollow portion 26 constitute a lumen of the catheter 1.
- a resin material that is more flexible (i.e., has a lower Young's modulus) and has a lower melting point than the resin material that constitutes the inner layer 24 and the outer layer 28 is used.
- polyurethane is used as a resin material for forming the chip 30.
- the resin material for forming the chip 30 is not limited to this, and the melting point is higher than that of the resin material for forming the inner layer 24 and the outer layer 28. Can be selected as low resin material.
- the tapered portion 22b of the coil body 22 of the catheter shaft 20 is disposed inside the tip 30, and in the tapered portion 22b, the gap 50 is provided between adjacent strands (see FIG. 2 and 4).
- the portion 30 a of the tip 30 located on the outer peripheral side of the tapered portion 22 b is joined to the distal end 28 a of the outer layer 28 of the catheter shaft 20.
- a portion 30 b of the tip 30 located on the inner peripheral side of the tapered portion 22 b is joined to the distal end 24 a of the inner layer 24 of the catheter shaft 20. Therefore, in the following, the portion 30a is referred to as "the outer layer bonding portion 30a", and the portion 30b is referred to as the "inner layer bonding portion 30b".
- the outer layer bonding portion 30 a and the inner layer bonding portion 30 b are integrated via the gap 50.
- the resin (polyurethane) constituting the chip 30 is bonded to the distal end 28 a of the outer layer 28 and the distal end 24 a of the inner layer 24.
- the tapered portion 22b of the coil body 22 protrudes in the distal direction along the axial direction from the distal end 28a of the outer layer 28 and the distal end 24a of the inner layer 24 of the catheter shaft 20.
- a cored bar having substantially the same size as that of the hollow portion 26 and the communication hole 32 is inserted at the center of the coil body 22 in the radial direction.
- a cylindrical polyurethane tube having an inner diameter larger than the diameter of the cored bar is fitted on the outer periphery of the coil 22. Then, with one end of the polyurethane tube positioned near the distal end 28 a of the outer layer 28 and the distal end 24 a of the inner layer 24, the polyurethane tube is composed of the melting point of polyurethane or more and the inner layer 24 and the outer layer 28 Heating and pressing at a temperature below the melting point of the resin material (PTFE and polyamide elastomer), the molten polyurethane resin is bonded to the distal end 28 a of the outer layer 28 and the inner periphery of the tapered portion 22 b via the gap 50.
- the resin material PTFE and polyamide elastomer
- the portion bonded to the distal end 28a of the outer layer 28 is the outer layer bonding portion 30a
- the portion bonded to the distal end 24a of the inner layer 24 is the inner layer bonding portion 30b.
- the tip 30 is joined to the distal end 28 a of the outer layer 28 and the distal end 24 a of the inner layer 24.
- the tapered portion 22 b is embedded inside the tip 30.
- the torque by the operator is the tip through the coil body 22. It is transmitted up to 30. For this reason, it can suppress that a torque transferability falls by providing the chip
- the inner layer 24 is not disposed inside the chip 30, and only the tapered portion 22b of the coil body 22 is disposed, and the tapered portion 22b is distal by a length corresponding to the thickness of the inner layer 24.
- the diameter decreases in the direction. Therefore, it is possible to downsize the tip 30 by an amount corresponding to the diameter reduction of the tapered portion 22b, and the followability of the catheter 1 can be improved.
- the catheter 1 is a catheter for blood vessel insertion (that is, a catheter that travels in the blood vessel while following a guide wire)
- the tip 30 can be downsized to improve the followability of the tip 30 to the guide wire. It can be done.
- the tip 30 is not only the outer layer joint 30a joined to the distal end 28a of the outer layer 28 of the catheter shaft 20, but the inner layer joint joined to the distal end 24a of the inner layer 24 of the catheter shaft 20 It also has 30b. Therefore, even if the inner layer 24 is removed from the tip 30 to downsize the tip 30, the junction between the tip 30 and the catheter shaft 20 (that is, the junction between the outer layer junction 30a and the distal end 28a of the outer layer 28) Maintaining the joint strength at the joint and the joint between the inner layer joint 30b and the distal end 24a of the inner layer 24 at the same joint strength as that of the conventional catheter 601, 701 (see FIGS. 12 and 13) it can. However, the bonding strength between the tip 30 and the catheter shaft 20 can be made higher than the bonding strength in the conventional catheters 601 and 701 by the configuration of the catheter 1 described below.
- the coil body 22 that is, the tapered portion 22b embedded in the inside of the tip 30 has a substantially truncated conical shape whose diameter decreases in the distal direction, and each wire constituting the tapered portion 22b is , And are continuous with the respective strands constituting the first portion 22a.
- the tapered portion 22b functions as an anchor for suppressing the inner layer joint 30b from being pulled in the distal direction more than the tapered portion 22b.
- the inner layer bonding portion 30b is integrated with the outer layer bonding portion 30a via a gap 50 provided between adjacent strands in the tapered portion 22b. Therefore, it is suppressed that the tip 30 is broken (detached) from the joint with the catheter shaft 20 by suppressing the inner layer joint 30b from being pulled in the distal direction side more than the tapered portion 22b. Ru. As a result, the bonding strength between the tip 30 and the catheter shaft 20 can be made higher compared to the conventional catheters 601 and 701.
- the tip 30 is downsized while suppressing the reduction in torque transmission, and the bonding strength between the tip 30 and the catheter shaft 20 is further increased. Is possible.
- the inner layer joint 30b is caught on the tapered portion 22b by the tapered portion 22b functioning as an anchor. It is possible to suppress complete detachment of the tip 30 from the catheter shaft 20.
- a catheter 101 according to a second embodiment of the present invention will be described with reference to FIG.
- members having the same configuration as the catheter 1 according to the first embodiment are denoted by the same reference numerals, and the detailed description thereof is omitted. The same applies to the other embodiments and modifications.
- FIG. 5 shows a cross-sectional view when cutting the distal end of the catheter shaft 120 and the tip 30 in a plane including the central axis of the catheter 101.
- the diameter of the strands of each of the strands constituting the tapered portion 122b of the coil body 122 is smaller than the diameter of the strands of each of the strands constituting the first portion 22a.
- the tapered portion 122 b is a wire that immerses the tapered portion 22 b of the catheter 1 of the first embodiment in the electrolyte before joining the tip 30 to the outer layer 28 and the inner layer 24 of the catheter shaft 120 to form the tapered portion 22 b.
- the tapered portion 22b has the inner diameter of its proximal end slightly smaller than d1 in advance and the inner diameter of its distal end slightly smaller than d2 in advance. It is electropolished in the state which became small.
- the tapered portion 122b after the electropolishing has a shape having an inner diameter d1 at its proximal end and an inner diameter d2 at its distal end.
- the tapered portion 122b can also be manufactured by grinding the tapered portion 22b of the catheter 1 of the first embodiment with a rotary grindstone.
- the same function and effect as the catheter 1 according to the first embodiment can be obtained.
- the strand diameter of each strand constituting the coil body 122 (that is, the tapered portion 122b) disposed inside the chip 30 is smaller than the strand diameter of each strand constituting the first portion 22a. Therefore, as compared with the catheter 1 according to the first embodiment, the flexibility of the tip 30 can be improved while maintaining the torque transferability of the tip 30 in a favorable manner.
- FIG. 6 shows a cross-sectional view when cutting the distal end of the catheter shaft 220 and the tip 30 in a plane including the central axis of the catheter 201.
- the catheter 201 of this modification only the wire diameter of each wire constituting the distal end of the tapered portion 222 b of the coil body 222 is each wire constituting the first portion 22 a It differs from the catheter 101 of the second embodiment in that it is smaller than the wire diameter of the second embodiment.
- the tapered portion 222 b has a smaller diameter by electropolishing the strands constituting the distal end portion of the tapered portion 22 b of the catheter 1 of the first embodiment before joining the tip 30 to the outer layer 28 and the inner layer 24 of the catheter shaft 220.
- the tapered portion 222b can also be manufactured by grinding the distal end of the tapered portion 22b of the catheter 1 of the first embodiment with a rotary grindstone.
- the same function and effect as the catheter 1 according to the first embodiment can be obtained.
- the catheter 1 according to the first embodiment As compared with the configuration of (1), the flexibility of the tip 30 of the portion located near the distal end of the tapered portion 222b can be improved while maintaining the torque transmission of the tip 30 well.
- each wire constituting the distal end of the tapered portion 222b is reduced in diameter, even if the wire diameter of each wire constituting the other portion of the tapered portion 222b is reduced.
- the diameter of the strand of each strand constituting at least a part of the tapered portion 222b may be smaller than the diameter of the strand of each strand constituting the first portion 22a. According to this configuration, it is possible to improve the flexibility of the tip 30 of a portion of the tapered portion 222b which is located in the vicinity of the portion where each strand is reduced in diameter while maintaining the torque transferability of the tip 30 favorably. be able to.
- the coil body 222 is configured by a plurality of strands, it is not necessary that all of the plurality of strands forming at least a part of the tapered portion 222b be reduced in diameter. A configuration in which a part of the diameter is reduced in diameter may be adopted.
- FIGS. 7 and 8 show a cross-sectional view of the distal end of the catheter shaft 320 and the tip 30 cut in a plane including the central axis of the catheter 301
- FIG. 8 is a plane orthogonal to the central axis of the catheter 301, Sectional drawing when the part in which 2nd part 322c (after-mentioned) is located among the chip
- disconnected is shown.
- the catheter 301 of this embodiment differs from the catheter 1 of the first embodiment in that the coil body 322 has a second portion 322 c provided at the distal end of the tapered portion 22 b. ing.
- the second portion 322c has a generally cylindrical shape extending in the axial direction, and the inner diameter thereof is d2 (ie, an inner diameter having the same value as the inner diameter at the distal end of the tapered portion 22b).
- the respective strands are wound so that adjacent strands do not contact each other in the axial direction (see FIG. 7) and the circumferential direction (see FIG. 8). That is, a gap 352 is provided between adjacent strands.
- the second portion 322c after producing the tapered portion 22b by the method described above, crimps the coil body located on the distal end side of the tapered portion 22b with a constant force in the axial direction, and It can be manufactured by applying a lateral force to form a gap between adjacent strands and then cutting off the excess coiled body at the distal end.
- the same function and effect as the catheter 1 according to the first embodiment can be obtained.
- torque can be suitably transmitted to the distal end of the tip 30, thereby improving torque transmission. it can.
- the gap 352 between the adjacent strands in the second portion 322c when the force is applied to the chip 30, the adjacent strands in the second portion 322c are less likely to interfere with each other. For this reason, it can suppress that the softness
- FIG. 9 shows a cross-sectional view of the distal end of the catheter shaft 420 and the tip 30 cut in a plane including the central axis of the catheter 401
- FIG. 10 is a plane orthogonal to the central axis of the catheter 401
- a cross-sectional view of a portion of the chip 30 where a second portion 422c (described later) is located is cut.
- adjacent strands are in contact with each other in the axial direction (see FIG. 9) and the circumferential direction (see FIG. 10) in the second portion 422c of the coil body 422.
- the third embodiment is different from the catheter 301 of the third embodiment in that each wire is wound, that is, no gap is provided between adjacent wires.
- FIG. 11 shows a cross-sectional view of the distal end of the catheter shaft 520 and the tip 30 cut at a plane including the central axis of the catheter 501.
- the wire diameter of each of the strands constituting the tapered portion 522 b and the second portion 522 c of the coil body 522 corresponds to each of the first portion 22 a of the coil body 522. It differs from the catheter 301 of the third embodiment in that it is smaller than the wire diameter of the wire.
- the tapered portion 522 b and the second portion 522 c are wires that constitute the tapered portion 22 b and the second portion 322 c of the catheter 301 of the third embodiment before joining the tip 30 to the outer layer 28 and the inner layer 24 of the catheter shaft 520.
- the tapered portion 522b and the second portion 522c can also be manufactured by grinding the tapered portion 22b and the second portion 322c of the catheter 301 of the third embodiment with a rotary grindstone.
- the same function and effect as the catheter 301 according to the third embodiment can be obtained.
- the wire diameter of each wire constituting the tapered portion 522b and the second portion 522c of the catheter 501 of the present modification is the same as that of each of the tapered portion 22b and the second portion 322c of the catheter 301 of the third embodiment. It is smaller than the diameter of the wire of the wire. Therefore, the flexibility of the tip 30 can be further enhanced as compared with the catheter 301.
- each wire constituting the coil body 22 is constituted by a single continuous single wire, but the end faces of a plurality of single wires of different materials are joined to form a single wire.
- the end face of a single wire made of platinum and the end face of a single wire made of stainless steel may be joined to form a single wire.
- the portion made of platinum on the distal end side of the coil body 22, it is possible to project the tip (distal end) of the catheter 1 more clearly when radiographing.
- the junction portion is not located near the boundary between the first portion 22a and the tapered portion 22b. This is because, if the bonding site is located near the boundary, the tip 30 may be broken (detached) from the catheter shaft 20 by the coil body 22 breaking off at that position. However, when the bonding strength of the bonding site is higher than the tensile strength of the chip 30, the bonding site may be located in the vicinity of the boundary.
- the strand wire diameter of each strand may mutually differ.
- adjacent strands may be in partial contact in either the axial direction or the circumferential direction, and no gap may be provided in the portion.
- the catheter shaft 20 may further include a blade as a reinforcing body.
- the blade is a metal member having a substantially cylindrical shape, and is disposed in the inner layer 24 such that the central axis thereof coincides with the central axis of the catheter 1. By arranging the blade, it is possible to preferably ensure roundness in a plane orthogonal to the central axis of the catheter shaft 20.
- the blade may be disposed inside the tip 30.
- a gap may be provided between adjacent strands.
- the coil body 22 is not limited to metal but may be resin.
- tip 30 and the resin material which comprises the inner-layer junction part 30b may not necessarily be the same.
- a polyurethane may be used for the inner layer bonding portion 30b
- a material obtained by mixing tungsten powder with polyurethane may be used for the outer layer bonding portion 30a.
- the outer layer bonding portion 30 a and the inner layer bonding portion 30 b are integrated through the gap 50 without having an interface between them.
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- Pulmonology (AREA)
- Anesthesiology (AREA)
- Biophysics (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
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Abstract
Description
カテーテル601では、手技者の操作によるトルクがチップ630に伝達され難い(別言すれば、トルク伝達性が低い)という問題がある。即ち、通常、トルクはコイル体を介して遠位方向に伝達されるが、カテーテル601ではチップ630内にコイル体622が配設されていないため、トルクがチップ630まで伝達されない。そこで、図13に示すように、コイル体722及び内層724を軸方向に沿ってチップ730内にまで延在させたカテーテル701が提案されている。カテーテル701の構成によれば、トルクがコイル体722を介してチップ730まで伝達されるため、トルク伝達性の低下を抑制することができる。
本発明のカテーテルは、
螺旋状に巻回された素線又は撚線により構成され、第一内径を有する第一部分を有するコイル体と、前記コイル体の前記第一部分の内周面を被覆するとともに軸方向に延びる中空部を有する内層と、前記コイル体の前記第一部分の外周面を被覆する外層と、を有するカテーテルシャフトと、
前記コイル体の前記第一部分、前記内層及び前記外層の遠位端に設けられ、前記内層の前記中空部に連通する連通孔を有する樹脂製のチップと、
を備え、
前記コイル体は、更に、前記第一部分の遠位端に設けられ、前記第一内径から前記第一内径よりも小さい第二内径へと縮径するテーパー部分を有し、
前記コイル体の前記テーパー部分は、前記チップの内部に配設されており、
前記テーパー部分では、隣接する前記素線の間に隙間が設けられており、
前記チップは、前記外層の遠位端に接合されている外層接合部と、前記内層の遠位端に接合されている内層接合部と、を有し、前記外層接合部と前記内層接合部は前記隙間を介して一体化されている。
以下、本発明の第1実施形態に係るカテーテル1について図面を参照しながら説明する。カテーテルは、可撓性を有する医療器具であり、血管、消化管及び尿管等の管腔部、並びに、胸腔及び腹腔等の体内組織に挿入され、ステント及び塞栓コイル等を血管の病変部に運搬し、薬液や造影剤を注入し、或いは、体液を排出する目的で使用される。図1は、本実施形態のカテーテル1の模式図を示す。カテーテル1は、血管挿入用のカテーテルである。図1に示すように、カテーテル1は長尺部材であり、コネクタ10と、カテーテルシャフト20と、チップ30と、を備える。コネクタ10は、カテーテルシャフト20の近位端に接続されている。チップ30は、カテーテル1の遠位端部に位置している。なお、本実施形態では血管挿入用のカテーテル1を例示しているが、カテーテルの用途はこれに限られず、カテーテルシャフト20及びチップ30に相当するカテーテルシャフト及びチップを備えるカテーテルであればよい。
次に、図5を参照して本発明の第2実施形態に係るカテーテル101について説明する。以下では、第1実施形態に係るカテーテル1と同一の構成を有する部材には同一の符号を付し、その詳細な説明は省略する。その他の実施形態及び変形例についても同様である。
次に、図6を参照して本発明の第2実施形態の変形例に係るカテーテル201について説明する。図6は、カテーテル201の中心軸を含む平面でカテーテルシャフト220の遠位端部とチップ30とを切断したときの断面図を示す。図6に示すように、本変形例のカテーテル201は、コイル体222のテーパー部分222bのうち、遠位端部を構成する各素線の素線径のみが第一部分22aを構成する各素線の素線径よりも小さい点で、第2実施形態のカテーテル101と相違している。テーパー部分222bは、カテーテルシャフト220の外層28及び内層24にチップ30を接合する前に、第1実施形態のカテーテル1のテーパー部分22bの遠位端部を構成する各素線を電解研磨により小径化することにより製造され得る。或いは、テーパー部分222bは、第1実施形態のカテーテル1のテーパー部分22bの遠位端部を回転砥石により研磨することによっても製造され得る。
次に、図7及び図8を参照して本発明の第3実施形態に係るカテーテル301について説明する。図7は、カテーテル301の中心軸を含む平面でカテーテルシャフト320の遠位端部とチップ30とを切断したときの断面図を示し、図8は、カテーテル301の中心軸と直交する平面で、チップ30のうち第二部分322c(後述)が位置している部分を切断したときの断面図を示す。図7に示すように、本実施形態のカテーテル301は、コイル体322が、テーパー部分22bの遠位端に設けられた第二部分322cを有する点で、第1実施形態のカテーテル1と相違している。第二部分322cは、軸方向に延びる略円筒形状を有しており、その内径はd2(即ち、テーパー部分22bの遠位端における内径と同一の値を有する内径)である。第二部分322cでは、隣接する素線が軸方向(図7参照)及び周方向(図8参照)に互いに接触しないように各素線が巻回されている。即ち、隣接する素線の間には隙間352が設けられている。第二部分322cは、上述した方法でテーパー部分22bを製造した後に、テーパー部分22bの遠位端側に位置するコイル体を軸方向に亘って一定の力で加締めるとともに、当該コイル体に遠位方向の力を加えて隣接する素線の間に隙間を形成し、その後、遠位端部の余分なコイル体を切断することにより製造され得る。
次に、図9及び図10を参照して本発明の第3実施形態の変形例1に係るカテーテル401について説明する。図9は、カテーテル401の中心軸を含む平面でカテーテルシャフト420の遠位端部とチップ30とを切断したときの断面図を示し、図10は、カテーテル401の中心軸と直交する平面で、チップ30のうち第二部分422c(後述)が位置している部分を切断したときの断面図を示す。図9に示すように、本変形例のカテーテル401は、コイル体422の第二部分422cにおいて、隣接する素線が軸方向(図9参照)及び周方向(図10参照)に互いに接触するように各素線が巻回されている、即ち、隣接する素線の間には隙間が設けられていない点で第3実施形態のカテーテル301と相違している。
次に、図11を参照して本発明の第3実施形態の変形例2に係るカテーテル501について説明する。図11は、カテーテル501の中心軸を含む平面でカテーテルシャフト520の遠位端部とチップ30とを切断したときの断面図を示す。図11に示すように、本変形例のカテーテル501は、コイル体522のテーパー部分522b及び第二部分522cを構成する各素線の素線径が、コイル体522の第一部分22aを構成する各素線の素線径よりも小さい点で、第3実施形態のカテーテル301と相違している。テーパー部分522b及び第二部分522cは、カテーテルシャフト520の外層28及び内層24にチップ30を接合する前に、第3実施形態のカテーテル301のテーパー部分22b及び第二部分322cを構成する各素線を電解研磨により小径化することにより製造され得る。或いは、テーパー部分522b及び第二部分522cは、第3実施形態のカテーテル301のテーパー部分22b及び第二部分322cを回転砥石により研磨することによっても製造され得る。
Claims (4)
- 螺旋状に巻回された素線又は撚線により構成され、第一内径を有する第一部分を有するコイル体と、前記コイル体の前記第一部分の内周面を被覆するとともに軸方向に延びる中空部を有する内層と、前記コイル体の前記第一部分の外周面を被覆する外層と、を有するカテーテルシャフトと、
前記コイル体の前記第一部分、前記内層及び前記外層の遠位端に設けられ、前記内層の前記中空部に連通する連通孔を有する樹脂製のチップと、
を備え、
前記コイル体は、更に、前記第一部分の遠位端に設けられ、前記第一内径から前記第一内径よりも小さい第二内径へと縮径するテーパー部分を有し、
前記コイル体の前記テーパー部分は、前記チップの内部に配設されており、
前記テーパー部分では、隣接する前記素線の間に隙間が設けられており、
前記チップは、前記外層の遠位端に接合されている外層接合部と、前記内層の遠位端に接合されている内層接合部と、を有し、前記外層接合部と前記内層接合部は前記隙間を介して一体化されている、
カテーテル。 - 請求項1に記載のカテーテルにおいて、
前記コイル体の前記テーパー部分の少なくとも一部を構成する素線の素線径は、前記第一部分を構成する素線の素線径よりも小さい、
カテーテル。 - 請求項1に記載のカテーテルにおいて、
前記コイル体の前記テーパー部分を構成する素線の素線径は、前記第一部分を構成する素線の素線径よりも小さい、
カテーテル。 - 請求項1乃至請求項3の何れか一項に記載のカテーテルにおいて、
前記コイル体は、更に、前記テーパー部分の遠位端に設けられ、前記第二内径を有する第二部分を有し、
前記コイル体の前記第二部分では、隣接する前記素線の間に隙間が設けられている、
カテーテル。
Priority Applications (6)
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JP2019533809A JP7162957B2 (ja) | 2017-08-02 | 2017-08-02 | カテーテル |
CN201780093488.9A CN110997050A (zh) | 2017-08-02 | 2017-08-02 | 导管 |
PCT/JP2017/028140 WO2019026220A1 (ja) | 2017-08-02 | 2017-08-02 | カテーテル |
EP17920398.9A EP3662954A4 (en) | 2017-08-02 | 2017-08-02 | CATHETER |
KR1020207002498A KR20200022470A (ko) | 2017-08-02 | 2017-08-02 | 카테터 |
US16/752,732 US20200155805A1 (en) | 2017-08-02 | 2020-01-27 | Catheter |
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PCT/JP2017/028140 WO2019026220A1 (ja) | 2017-08-02 | 2017-08-02 | カテーテル |
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US16/752,732 Continuation US20200155805A1 (en) | 2017-08-02 | 2020-01-27 | Catheter |
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WO2019026220A1 true WO2019026220A1 (ja) | 2019-02-07 |
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EP (1) | EP3662954A4 (ja) |
JP (1) | JP7162957B2 (ja) |
KR (1) | KR20200022470A (ja) |
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Cited By (3)
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US20210001092A1 (en) * | 2018-03-29 | 2021-01-07 | Terumo Kabushiki Kaisha | Catheter assembly |
WO2021019924A1 (ja) * | 2019-07-31 | 2021-02-04 | 朝日インテック株式会社 | カテーテル |
US11369774B2 (en) * | 2018-01-26 | 2022-06-28 | Asahi Intecc Co., Ltd. | Catheter coil with tapered distal joint part |
Families Citing this family (2)
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DE102018121206A1 (de) * | 2018-08-30 | 2020-03-05 | Karl Storz Se & Co. Kg | Endoskopschaft mit einem schichtförmigen Aufbau und Verfahren zur Herstellung eines solchen |
CN111467650A (zh) * | 2020-05-27 | 2020-07-31 | 深圳北芯生命科技有限公司 | 微导管 |
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- 2017-08-02 KR KR1020207002498A patent/KR20200022470A/ko not_active Application Discontinuation
- 2017-08-02 JP JP2019533809A patent/JP7162957B2/ja active Active
- 2017-08-02 WO PCT/JP2017/028140 patent/WO2019026220A1/ja unknown
- 2017-08-02 CN CN201780093488.9A patent/CN110997050A/zh not_active Withdrawn
- 2017-08-02 EP EP17920398.9A patent/EP3662954A4/en not_active Withdrawn
-
2020
- 2020-01-27 US US16/752,732 patent/US20200155805A1/en not_active Abandoned
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US11369774B2 (en) * | 2018-01-26 | 2022-06-28 | Asahi Intecc Co., Ltd. | Catheter coil with tapered distal joint part |
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US11878130B2 (en) | 2018-01-26 | 2024-01-23 | Asahi Intecc Co., Ltd. | Catheter coil with tapered distal joint part |
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Also Published As
Publication number | Publication date |
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KR20200022470A (ko) | 2020-03-03 |
EP3662954A1 (en) | 2020-06-10 |
JPWO2019026220A1 (ja) | 2020-06-11 |
CN110997050A (zh) | 2020-04-10 |
US20200155805A1 (en) | 2020-05-21 |
JP7162957B2 (ja) | 2022-10-31 |
EP3662954A4 (en) | 2021-03-17 |
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